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REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Application No. 60/724,917 entitled “Utilizing Sucralose to Reduce Saltiness” filed Oct. 7, 2005. BACKGROUND [0002] Colonoscopy screening coupled with polyp removal (polypectomy) significantly reduces the incidence of colorectal carcinoma. Unfortunately, of the 147,500 new cases of colorectal carcinoma diagnosed in 2003, the American Cancer Society estimates that only 37% of these cases were diagnosed early enough for treatment to offer the best possible prognosis. [0003] Colonoscopy screening should be repeated more frequently for subjects who have previously undergone a polypectomy due to their increased risk of recurrent polyp formation. However, in a follow-up phase of the National Polyp Study, at least 20% of subjects who had previously undergone polypectomies failed to return for their follow-up screening. In a more recent study, where 8,865 subjects who had previously undergone a polypectomy underwent a second colonoscopy screening, 2,704 (30.5%) were diagnosed with recurrent polyps. A statistical analysis based on the data from this report projected that 50% of subjects will have recurrent polyps within 7.6 years. Despite this level of risk, many subjects do not undergo additional screening. [0004] Prior to colonoscopy, the bowel must be cleansed so the surgeon may see any polyps that exist on the interior wall of the colon. The bowel is the portion of the large intestine extending from the termination of the small intestine at the duodenum and extending to the rectum. Bowel cleansing generally entails the drinking of one or more laxative solutions. In addition to colonoscopy, bowel cleansers also may be used to cleanse the bowel before surgical and other endoscopic procedures. [0005] Suitable laxative solutions for use as bowel cleansers include phosphate salt bowel cleansers or polyethylene glycol (PEG) combined with various salts. For example, phosphate salt bowel cleansers (monobasic and dibasic sodium phosphate), such as FLEET® PHOSPHO-SODA®, are very effective oral laxatives and are extensively used prior to colonoscopy, radiographic procedures, and surgery. For pre-colonoscopy use of PHOSPHO-SODA®, a split regimen is often preferred that includes one 45 mL dose given the evening before colonoscopy and a second 45 mL dose given at least three hours prior to the procedure on the following morning. [0006] One of the main reasons subjects cite for avoiding colonoscopy re-screening is the unpleasant salty taste of bowel cleansing solutions. In fact, for phosphate salt bowel cleansers, the extremely salty taste of the solution is believed to be a cause of the nausea and vomiting that has been reported by from 15 to 51% of the subjects, depending on the study. Frequently, subjects cannot tolerate the ingestion of the complete initial dose of the preparation, which often prevents them from consuming more than a small portion of the second dose. [0007] Thus, there is an ongoing need for bowel cleansers that taste less salty to the user and are thus more palatable. A better tasting pre-colonoscopy bowel cleanser could increase subject compliance with re-screening appointments and reduce the need for repeat procedures resulting from inadequate colon cleansing attributable to insufficient consumption of the cleanser solution. The materials and methods of the present invention provide bowel cleansers that are significantly less salty tasting and thus more palatable than conventional bowel cleansing solutions. SUMMARY [0008] Colonoscopy screening coupled with polyp removal significantly reduces the incidence of colon cancer. Prior to colonoscopy, the colon must be cleansed so the surgeon may see any polyps that exist on the interior wall of the colon. Phosphate salt bowel cleansers, such as FLEET® PHOSPHO-SODA®, are very effective oral laxatives and are extensively used prior to colonoscopy. One of the main reasons subjects cite for avoiding colonoscopy re-screening is the unpleasant taste of the bowel cleansing solution. [0009] The present invention makes use of the discovery that adding a sweetener, such as a chlorinated sucrose isomer, to a bowel cleansing solution, such as a phosphate salt bowel cleanser, significantly increases the palatability of the cleanser. The sweetener also may include Ace-K. The resultant sweetener/cleanser formulations may increase the subject's willingness to consume the cleansing solution, thus decreasing the repeat rate for initial colonoscopy procedures attributed to incomplete colon cleansing and increasing the subject's willingness to undergo follow-up procedures. [0010] In a first aspect, the invention is a composition for bowel cleansing having a perceived saltiness equivalent to from 0.2 to 2.6% sodium chloride in water that includes from 0.01 to 0.1% of a sweetener selected from a chlorinated sucrose isomer, acesulfame potassium, saccharin, and mixtures thereof. In a related aspect, the perceived saltiness of the bowel cleanser and the sweetener amount may correspond to the relationship of FIG. 1 or Table 7. [0011] In another aspect, the invention is a method of reducing the saltiness of an orally consumed substance having a perceived saltiness equivalent to from 0.2 to 2.6% sodium chloride in water where the substance is combined with from 0.01 to 0.1% of a sweetener selected from the group consisting of a chlorinated sucrose isomer, acesulfame potassium, saccharin, and mixtures thereof. In one aspect, the orally consumed substance may be bowel cleanser. [0012] In another aspect, the invention is a method for improving the palatability of a bowel cleanser having a perceived saltiness equivalent to from 0.2 to 2.6% sodium chloride in water by combining the laxative with from 0.01 to 0.07% of a sweetener including Sucralose. BRIEF DESCRIPTION OF THE DRAWINGS [0013] FIG. 1 shows the preferred Sucralose concentrations to reduce the saltiness of NaCI/water solutions of varying saltiness. [0014] FIG. 2 plots the Likert preferability scores for multiple sweetener concentrations in a phosphate salt bowel cleanser. DETAILED DESCRIPTION [0015] The present invention makes use of the discovery that adding a sweetener, such as one including a chlorinated sucrose isomer such as Sucralose, to a salty liquid, such as a bowel cleanser, significantly increases the palatability of the liquid by a reduction in perceived saltiness. In addition to a chlorinated sucrose, the sweetener also may include acesulfame potassium (Ace-K). Furthermore, depending on the saltiness of the liquid, a preferable sweetener concentration may be selected. Stable flavorings also may be added to the bowel cleanser to increase palatability. The resulting sweetener/salty liquid formulations may improve subject compliance for both primary screening of asymptomatic colorectal carcinoma, and for return surveillance in those subjects who may benefit from more frequent colonoscopy. [0016] Phosphate salt bowel cleansers, such as commercially available FLEET® PHOSPHO-SODA® (C.B. Fleet Company, Inc., Lynchburg, Va.) taste extremely salty. Phosphate salt bowel cleansers include monobasic sodium phosphate (sodium dihydrogen phosphate, monohydrate) (NaH 2 PO 4 H 2 O) and dibasic sodium phosphate (disodium hydrogen phosphate, heptahydrate) (Na 2 HPO 4 7 H 2 O) as active ingredients in water. Phosphate salt bowel cleansers have a pH from about 4.4 to about 5.2 and may be produced in multiple ways, such as by combining phosphoric acid with dibasic sodium phosphate or with caustic soda. Bowel cleansers of this type are very stable, thus having a long shelf-life, and are considered to work in a mild and very effective manner. [0017] In one aspect, the phosphate salt bowel cleanser includes from 0.05 to 1.5 gram/mL of monobasic sodium phosphate and from 0.02 to 0.6 gram/mL of dibasic sodium phosphate. In another aspect, the phosphate salt bowel cleanser includes from 0.25 to 1 or from 0.4 to 1 gram/mL of monobasic sodium phosphate and from 0.1 to 0.4 or from 0.13 to 0.25 gram/mL of dibasic sodium phosphate. At present, an especially preferred phosphate salt bowel cleanser includes about 0.48 g/mL of monobasic sodium phosphate and about 0.18 g/mL of dibasic sodium phosphate. Phosphate salt bowel cleansers that include one phosphate salt, such as dibasic sodium phosphate, also may be used. [0018] PEG based bowel cleansers, such as commercially available NuLYTELY® and GoLYTELY® from Braintree Laboratories, Inc., Braintree, Mass., also taste salty. While the active ingredient, PEG, lacks taste, the substantial amounts of salt, impart a salty taste to the bowel cleanser. Percent (%) compositions are expressed on a weight/weight (w/w) basis in the specification and appended claims, unless stated otherwise. [0019] Although many sweeteners and flavorings exist, at least three significant factors must be considered when selecting sweeteners and/or flavorings to increase the palatability, thus reducing the perceived saltiness, of bowel cleansers. These factors are the ability of the sweetener to reduce saltiness, a lack of digestible sugars, and stability in the bowel cleanser solution. [0020] Sweeteners and/or flavorings for use in bowel cleansers preferably exclude natural sugars that may be digested in the colon to form hydrogen gas, which may ignite during polypectomy. Furthermore, phosphate salts, for example, decompose most commonly available sweeteners and flavorings. As this decomposition of the sweeteners and/or flavorings proceeds, any palatability benefit gained from the sweetener and/or flavoring may vanish. [0021] While it is possible to add the sweetener and/or flavoring a short time before consumption of a phosphate salt bowel cleanser and retain at least a portion of the palatability benefits, one goal of the present bowel cleansing compositions is to provide stable liquids having increased palatability. Thus, numerous sweeteners and flavorings were tested for stability in phosphate salt bowel cleanser. Of the sweeteners tested, chlorinated sucrose isomers, such as Sucralose, Ace-K, and Saccharin were found to have acceptable stability in solution. [0022] Chlorinated sucrose is a no-calorie sweetener made by replacing three of the hydroxy groups (OH) of the sugar molecule with chlorine (Cl). The chlorine atoms are tightly bound to the sugar molecule, thus making it exceptionally stable. This stability is believed to prevent the body from digesting the molecule, allowing the chlorinated sugar molecules to pass through the body unchanged. The chlorination process may create multiple isomers of the sugar, depending on the reaction conditions and other variables. Sucralose is the common name for one of the isomers resulting from the chlorination process. [0023] At present, Sucralose is a preferred chlorinated sucrose isomer for use in bowel cleansers. Sucralose is considered to be about 600 times sweeter than sucrose and to have a medium intensity of sweetness coupled with a relatively long-lasting sweetness in the mouth. While not wishing to be bound by any particular theory, it is believed that the stability provided by substituting the hydroxyl groups with chlorine atoms prevents the phosphate salts present in phosphate salt bowel cleansers from degrading chlorinated sucrose isomers. [0024] Ace-K is a no-calorie sweetener made from the potassium salt of acetoacetic acid. Ace-K is very stable and not metabolized or stored in the body, thus passing through the body unchanged. Ace-K is considered to be about 200 times sweeter than sucrose and to have a high intensity and shorter lasting sweetness in the mouth. It also is considered to have a more “sugar-like” taste than other no-calorie sweeteners. The lack of hydroxyl groups may contribute to its stability in the phosphate salt bowel cleansers. [0025] Saccharin is the oldest no-calorie sweetener and has been used to sweeten foods and beverages for almost 100 years. It is highly stable and is not digested, thus passing through the body without providing any calories. Saccharin is considered to be about 200 times sweeter than sugar and to have a slightly bitter aftertaste. [0026] For liquids having a saltiness equivalent to NaCI/water solutions ranging from 0% NaCI to 2.4% NaCI, from 0.01 to 0.06% of a chlorinated sucrose isomer, such as Sucralose, is more preferred to decrease the saltiness of the liquid. Similar amounts of Ace-K and 5:1 Ace-K/Sucralose combination also are preferred. A 0.01 to 0.1% concentration of Saccharin also may be used. Thus, once baseline saltiness is determined for a specific liquid in relation to a NaCI/water solution, the preferred concentration of chlorinated sucrose isomer to reduce saltiness may be selected from FIG. 1 . [0027] For phosphate salt bowel cleansers, such as diluted FLEET® PHOSPHO-SODA®, from 0.01 to 0.2%, from 0.03 to 0.1%, or from 0.04 to 0.08% sweetener are preferred. For PEG based bowel cleansers, such as NuLytely® or GoLytely®, from 0.01 to 0.2%, from 0.01 to 0.08, or from 0.02 to 0.04% sweetener is preferred, with about 0.025% of the sweetener especially preferred at present for the NuLytely® cleanser. In one aspect, the sweetener includes one or more chlorinated sucrose isomers, with the Sucralose isomer being more preferred. The sweetener also may include Ace-K in combination with the chlorinated sucrose isomers. In one aspect, a ratio of about five parts Ace-K to one part Sucralose is preferred. [0028] In addition to one or more sweeteners, many natural and/or artificial flavorings also were tested for palatability and stability in the phosphate salt bowel cleanser. Of the flavorings tested, ginger ale, such as Ginger Ale FAET253, mangosteen, such as Mangosteen FAES387, and cola, such as Cola FAES389, were found to have acceptable stability. [0029] In one aspect the bowel cleanser includes from 0.3 to 2.3% flavoring. In a second aspect, bowel cleanser includes from 0.8 to 1.8% flavoring. In a third aspect, the bowel cleanser includes from 1 to 1.6% flavoring. At present, a phosphate salt bowel cleansers including about 1.3% of Cola WONF FAES389, Ginger Ale FAET253, or Mangosteen FAES387 is especially preferred. In PEG based bowel cleansers, these and other flavorings may be used. [0030] By orally administering the sweetened or sweetened and flavored bowel cleansers of the present invention to a subject, the bowel may be cleansed. Generally, phosphate salt based cleansers are administered so that from 0.4 to 0.85 grams of monobasic sodium phosphate and from 0.1 to 0.5 grams of dibasic sodium phosphate per kilogram of body weight are consumed. A first aliquot of the cleanser may be administered to the subject about 14 hours prior to the colonoscopy. This initial dose may be followed by a second aliquot of the cleanser administered about 3 hours prior to the colonoscopy. The first dose may include an amount of phosphate salt bowel cleanser equivalent to 45 ml of FLEET® PHOSPHO-SODA® and the second dose may include an amount of phosphate salt bowel cleanser equivalent to 45 ml or 30 ml of FLEET® PHOSPHO-SODA®. The subject should consume large amounts of liquids, 3 to 4 Liters for example, in addition to the cleanser to maintain adequate hydration. These additional liquids may include aqueous solutions that include electrolytes, such as GATORADE® and other oral re-hydration beverages. [0031] Generally, PEG based bowel cleansers are prepared by combining a dry PEG/salt combination with about 4 Liters of water. This solution is then consumed in 8 ounce portions every 10 minutes for nearly 3 hours. Due to the unpleasant taste of the solution and the large water volume, patients often do not consume the complete amount in the 4 hour maximum time period. The large volume of water may result in over-hydration and bloating. Furthermore, the colon begins to empty within about 30 minutes of consumption of the first 8 ounce portion. [0032] In the examples below, it was unexpectedly discovered that subjects indicate a higher palatability for salty liquids that include a sweetener, in comparison to unsweetened salty liquids. Because palatability may be considered the inverse of saltiness, the addition of the sweetener was found to reduce the perceived saltiness of the bowel cleanser. The preferred concentration of a sweetener useful to provide the desired reduction in saltiness was also determined for solutions of varying saltiness. In this manner, a correlation was determined for the preferred concentration of a sweetener to combine with bowel cleansers of varying perceived saltiness. [0033] It also was unexpectedly discovered that subjects significantly preferred phosphate salt bowel cleansers combined with a sweetener that included Sucralose in comparison to sweeteners that included Ace-K or Saccharin alone. Furthermore, it was determined that an approximate five to one mixture of Ace-K and Sucralose may be used as an acceptable substitute for Sucralose. The data below demonstrated that Sucralose and Sucralose containing sweeteners were effective at reducing saltiness and improving the palatability of bowel cleansers. EXAMPLES Example 1 [0034] Sucrose, Saccharin, Sucralose, Aspartame, Ace-K, Thaumatin (Talin), Neohesperidine Dihydrochalcone (NHDC), and Trehalose were tested for stability in FLEET® PHOSPHO-SODA®. Of these sweeteners, Sucralose, Ace-K, and Saccharin were found to have acceptable stability in the laxative. While the other sweeteners retained their effectiveness when mixed, their effectiveness diminished over time. Example 2 [0035] Phosphate salt bowel cleansers were prepared for preference comparisons. An exemplary composition was prepared as shown in the table below. The percentages are on a weight/weight (w/w) basis. TABLE 1 Ingredient Amount (%) Purified Water 55.7 Flavor - Cola WONF FAES389 1.3 Sweetener various Phosphoric Acid (75%) 16.6 Dibasic Sodium Phosphate 25.4 Glycerin 0.8 Sodium Benzoate 0.03 Example 3 [0036] To determine whether test subjects preferred the taste of salty liquids with or without a sweetener, a hedonistic type preference test with 40 test subjects was conducted. Each subject was asked to rate two salty liquids on a scale of 1 to 9 with 1 being highly preferred and 9 being least preferred. Two percent NaCl/water solutions were prepared that included 1.29% ginger ale flavor. [0037] The first NaCl/water solution (T in Table 2 below) included no sweetener, while the second NaCl/water solution (G in Table 2 below) included 0.13% Sucralose. Similarly, unsweetened (J in Table 2 below) and sweetened (K in Table 2 below) phosphate salt bowel cleansers were prepared. In comparison to the phosphate salt bowel cleanser of Example 2, these cleansers included 1.3% of ginger ale flavor instead of Cola. TABLE 2 Salty Liquid Test Subject T G J K 1 5 7 2 7 2 3 7 5 4 9 3 5 7.5 4.5 6 1 8 7 8.5 4 8 7 5 9 8.5 4 10 7 3 11 9 6 12 8 6 13 9 3 14 7 7 15 2.5 8.5 16 8.5 1.5 17 3.5 2.5 18 3 2 19 8.5 8.5 20 8 7 21 9 1 22 3.5 8.5 23 5.5 5.5 24 7.5 6.5 25 8.5 1 26 8.5 6.5 27 8 5 28 7 3 29 6 3 30 7.5 7.5 31 8 5.5 32 9 7 33 6.5 9 34 5 3 35 5.5 2.5 36 4.5 3.5 37 8.5 1.5 38 7 6.5 39 8.5 5 40 7 4 Average 6.6 4.7 7.1 4.9 Standard Deviation 1.8 2.3 2.2 2.3 [0038] As can be seen from the data in Table 2, the test subjects preferred sweetened salty liquids G and K over their unsweetened counterparts by approximately 47% for the two percent salt solution and by approximately 45% for the phosphate salt bowel cleanser. Thus, the unpleasant saltiness of an orally consumed liquid was reduced with Sucralose. Example 4 [0039] Before a preferred sweetener for use in salty liquids could be determined, the amount of each sweetener required to provide an equivalent sweetness was determined. Multiple taste tests were performed comparing various concentrations of Sucralose, Ace-K, the 5:1 Ace-K/Sucralose blend, Saccharin, and sucrose in a salty liquid to determine an equivalent saltiness. These tests established that 0.05% Sucralose, 0.05% Ace-K, 0.05% Ace-K/Sucralose, 0.083% Saccharin, and 15% sucrose provide an equivalent sweetness. While the remaining Examples rely on 0.05% sweetener concentrations, these may be converted to Saccharin concentrations using the 0.05/0.083 ratio. Example 5 [0040] To determine which sweetener was preferred to increase the palatability and thus decrease the saltiness of bowel cleansers, forty test subjects were asked to rate which of five cleansing solutions were most preferred on a scale of 1 to 4. Each solution was prepared by diluting 60 mL of the phosphate salt bowel cleanser from Example 2 in 355 mL of water and using either 0.05% Ace-K, 0.05% Sucralose, 0.08% saccharin, 0.05% of a 5:1 Ace-K/Sucralose blend, or 15% sucrose as the sweetener. [0041] When the preference data was averaged, the average values obtained were 3.3 for sucrose, 3.2 for Sucralose, 2.8 for Ace-K/Sucralose, 2.5 for saccharin, and 2.45 for Ace-K. Thus, sucrose was most preferred followed by Sucralose, Ace-K/Sucralose, saccharin, and Ace-K. Surprisingly, Sucralose performed almost as well as sucrose. The Ace-K/Sucralose blend was superior to saccharin or Ace-K alone, but was not as preferred as Sucralose. Thus, while Sucralose alone was more preferred, the Sucralose/Ace-K sweetening system provides an alternative. Example 6 [0042] A comparison between Saccharin/Ace-K and Sucralose/Ace-K was performed to determine which of these two sweetener systems most improved the palatability of a salty bowel cleanser. Table 3, below, provides the mean acceptability ratings for 19 test subjects who tasted 5:1 Saccharin/Ace-K and 5:1 Sucralose/Ace-K sweetener systems in 60 mL of the phosphate salt bowel cleanser from Example 2 in 355 mL of water. TABLE 3 Concentration Standard Sweetening System % (w/w) Mean* Deviation Sucralose/Ace-K 0.13 3.11 1.05 Sucralose/Ace-K 0.26 3.32 1.00 Sucralose/Ace-K 0.39 3.47 1.02 Saccharin/Ace-K 0.38 2.24 1.16 *Rankings were on a Likert scale from 1 to 5, with the following descriptors: 1 = unbearable; 2 = less preferred; 3 = ok; 4 = more preferred; 5 = great. Thus, the higher the value, the more preferred was the sweetening system. [0043] The data confirm a substantial preference for Sucralose over Saccharin (up to about 55% at the same 0.38% concentration), with a slight increase in preference for higher Sucralose concentrations. While the linear trend of increasing palatability with increasing Sucralose concentration may not be significant (p=0.2593), the sweetening system that included Saccharin was judged significantly less palatable than any of the Sucralose systems (p =0.001 6). [0044] While there were deviations in the mean acceptability ratings provided by the 19 testers, when averaged across the four sweetening systems, the deviations were not significantly different from the “noise” or error within ratings across the testers and sweetening systems (p=0.1175). Mean acceptability ratings for the testers were as low as 2.00 and as high as 4.25, illustrating the difference among people in the palatability of the phosphate salt bowel cleanser, regardless of the sweetening system. Example 7 [0045] To determine a baseline saltiness “taste” for bowel cleansers, such as 60 mL of the phosphate salt bowel cleanser from Example 2 in 355 mL of water, and the PEG cleansers, multiple test subjects rated the saltiness of 1, 1.5, and 2% solutions of sodium chloride (NaCI) in water. Of these NaCI solutions, it was discovered that a 2% solution of NaCI in water most closely approximated the saltiness of the phosphate salt bowel cleanser. Similarly, it was determined that a 0.4% solution of NaCI in water most closely approximated the saltiness of a PEG bowel cleanser including from about 420 to 240 g (10 to 6%) of PEG and from about 18 to 38 g (0.4 to 1%) of salt in water. Example 8 [0046] To establish the reliability of the NaCI to bowel cleanser comparison, test subjects were asked to taste sweetened and unsweetened NaCI solutions and sweetened and unsweetened phosphate salt bowel cleansers. In this comparison of the sweetened and unsweetened NaCI solutions, out of 19 test subjects, 17 preferred the 2% NaCI solution that included 0.13% Sucralose. Furthermore, in the preference comparison of the sweetened and unsweetened phosphate salt bowel cleanser, 18 out of 20 test subjects preferred the phosphate salt bowel cleanser including 0.13% Sucralose. Therefore, the palatability increase provided by the Sucralose was similarly observed for the 2% NaCI/water solution and the phosphate salt bowel cleanser. Example 9 [0047] To determine the preferred concentration of Sucralose to reduce the saltiness of bowel cleansers having different perceived saltiness, varying concentrations of Sucralose were tasted in water, a 0.4% NaCI water solution, and a 2% NaCI water solution. For each solution, approximately 40 testers were asked to rate four different concentrations of Sucralose. Tables 4, 5, and 6, below, present the average test data for the water, 0.4% NaCI water solution, and 2% NaCI water solution, respectively. TABLE 4 (1-Dislike, (1 -Least Favorite, 5-Like Very Much) 4-Most Favorite) Water Rating/St. Dev Ranking/St. Dev   0% Sucralose 2.59/1.22 1.90/1.14 0.005% Sucralose  3.04/1.13 2.71/0.82 0.01% Sucralose 2.78/1.15 2.74/0.96 0.02% Sucralose 2.59/1.15 2.65/1.33 [0048] TABLE 5 (1-Dislike, (1-Least Favorite, 5-Like Very Much) 4-Most Favorite) 0.4% NaCl Rating/St. Dev Ranking/St. Dev   0% Sucralose 2.35/0.92 2.00/1.15 0.01% Sucralose 2.86/0.95 2.70/1.05 0.02% Sucralose 3.05/1.10 2.89/0.88 0.04% Sucralose 2.78/1.20 2.41/1.21 [0049] TABLE 6 (1-Dislike, (1-Least Favorite, 5-Like Very Much) 4-Most Favorite) 2% NaCl Rating/St. Dev Ranking/St. Dev   0% Sucralose 1.71/0.90 2.06/1.18 0.025% Sucralose  2.06/0.96 2.74/0.86 0.05% Sucralose 2.26/1.18 2.77/1.02 0.10% Sucralose 2.23/1.26 2.42/1.29 [0050] Table 4 establishes that a relatively low level of Sucralose, 0.005%, is preferred in water alone. However, as increasing amounts of salt are added in Tables 5 and 6, the amount of Sucralose preferred increases, with 0.02% being preferred in the 0.4% NaCI solution and with 0.05% being preferred in the 2% NaCI solution. Thus, salty liquids having an equivalent saltiness to 0.02% NaCI in water, such as PEG based bowel cleansers, become most palatable with 0.02% Sucralose. Similarly, salty liquids having an equivalent saltiness to 2% NaCI in water, such as 60 mL of the phosphate salt bowel cleanser from Example 2 in 355 mL of water, become most palatable with 0.05% Sucralose. [0051] FIG. 1 plots the increasing salinity of the solutions from Tables 4, 5, and 6 against the preferred concentration of Sucralose required to reduce the saltiness and increase the palatability of each solution. The graph establishes that as saltiness increases, the amount of sweetener that should be added to improve palatability linearly increases (R 2 =0.997). The X-axis NaCI and the Y-axis Sucralose concentrations represented by the correlation line from FIG. 1 are presented below in Table 7. TABLE 7 NaCl Concentration Preferred Sucralose (wt %) Concentration (wt %) 0.0 0.011 0.2 0.015 0.4 0.019 0.6 0.023 0.8 0.027 1.0 0.031 1.2 0.035 1.4 0.038 1.6 0.042 1.8 0.046 2.0 0.050 2.2 0.054 2.4 0.058 2.6 0.062 2.8 0.066 3.0 0.070 [0052] By determining the saltiness of any bowel cleanser in relation to NaCI/water solutions, the preferred concentration of Sucralose required to reduce the saltiness and increase the palatability of the solution may be determined from FIG. 1 and/or Table 7. Similarly, by extrapolating a Sucralose concentration value from FIG. 1 and/or Table 7 using an equivalent sweetness value from Example 4, the preferred amount of Ace-K, Saccharin, or a 5:1 Ace-K/Sucralose blend to add to the salty solution may be similarly determined. Example 10 [0053] To confirm the correlation of FIG. 1 in a bowel cleanser with multiple sweeteners, approximately 35 testers were asked to select the most palatable solution from five possibilities. Each of the five solutions included 60 mL of the phosphate salt bowel cleanser from Example 2 in 355 mL of water. This solution has an equivalent saltiness to the 2% NaCI/water solution of Example 9. The first of the five solutions lacked any sweetener, while an increasing concentration of sweetener was added to the remaining four. Tests were performed using Sucralose, the 5:1 Ace-K/Sucralose blend, Ace-K, or Saccharin as the sweetener. [0054] Each of about thirty-five test subjects were asked to rate each of the five solutions on a scale of 1 to 4 with 4 being highly preferred and 1 being least preferred. Tables 8, 9, 10, and 11, below, present the average test data for each sweetener, respectively. TABLE 8 Sucralose % (w/w) None 0.0125 0.025 0.05 0.1 Average 2.13 2.56 2.72 3.22 2.88 Standard Deviation 1.13 1.05 1.05 1.21 1.24 [0055] TABLE 9 5:1 Ace-K/Sucralose Blend % (w/w) None 0.0125 0.025 0.05 0.1 Average 1.86 2.46 2.97 3.03 2.77 Standard Deviation 1.00 1.01 0.95 1.01 1.19 [0056] TABLE 10 Ace-K % (w/w) None 0.025 0.05 0.1 0.2 Average 1.78 1.88 2.63 2.16 2.16 Standard Deviation 0.97 0.71 1.13 0.88 0.95 [0057] TABLE 11 Saccharin % (w/w) None 0.0208 0.0416 0.0832 0.1664 Average 1.74 2.29 2.47 2.47 1.97 Standard Deviation 0.86 0.91 1.05 1.05 1.06 [0058] The data from the tables establish that in the phosphate salt bowel cleanser, 0.05% of the Sucralose, Ace-K/Sucralose blend, or Ace-K is preferred to decrease saltiness, while for Saccharin about 0.0832% may be preferred. Thus, FIG. 1 and/or Table 7 allow one to select a preferable concentration of sweetener to add to the bowel cleansing solution. [0059] FIG. 2 plots the Likert preferability scores for each sweetener concentration on a scale of 1 to 5 with 5 being the most preferred. The sweetener concentration for each data point corresponds to those in Tables 8 through 11, above, with higher values on the X-axis corresponding to higher sweetener concentrations. FIG. 2 also shows the preference towards sucrose at concentrations of 5, 10, 15, and 20%. [0060] The graph establishes that Sucralose is most preferred, even over sucrose in the bowel cleanser. Unlike in Example 5, where sucrose was slightly more preferred than Sucralose, in this study Sucralose was more preferred. Surprisingly, in bowel cleansers where sucrose rapidly degrades, the artificial sweetener Sucralose demonstrates an equivalent or even superior preference. The Ace-K/Sucralose blend was significantly superior to saccharin or Ace-K alone, but was not as preferred as Sucralose. Thus, while Sucralose alone was more preferred, the Sucralose/Ace-K sweetening system provides an alternative. [0061] The inferior performance of Saccharin in this aspect is believed attributable to a bitter taste detected at higher concentrations. The equivalent preference values for the 0.0416 and 0.0832% saccharin solutions may be attributed to the fact that some tasters have a stronger negative reaction to this bitter taste, thus preferring the lower 0.0416% concentration. Thus, in addition to the test subjects preferring the sweetened phosphate salt bowel cleanser over the unsweetened liquid, a preferred level of sweetness when using a chlorinated sucrose isomer, such as Sucralose, was established. Example 11 [0062] To determine the preferred concentration of Sucralose to reduce the saltiness of a PEG based bowel cleanser, test subjects were asked to taste unsweetened and three sweetened solutions of NuLytely®. NuLytely® is an aqueous liquid including approximately 420 g of 3350 PEG, 5.72 g of sodium bicarbonate, 11.2 g of NaCI, and 1.48 g of KCI. It has a similar perceived saltiness to the similar GoLytely®, which is an aqueous liquid including approximately 236 g of 3350 PEG, 22.74 g of sodium sulfate, 6.74 g of sodium bicarbonate, 5.86 g of NaCI, and 2.97 g of KCI. Either solution has a saltiness that approximates the 0.4% NaCl/water solution of Example 9. [0063] Each of thirty test subjects was asked to rate the four solutions on a scale of 1 to 5 with 5 being highly preferred and 1 being least preferred. The first solution included no sweetener. The second, third, and fourth solutions included 0.01%, 0.025%, or 0.05% (w/w) of Sucralose, respectively. PEG Based Bowel Cleanser % Sucralose Test Subject None 0.01 0.025 0.05 1 1 3 5 3 2 2 3 2 2 3 2 2 4 4 4 3 4 2 1 5 2 2 3 2 6 2 4 3 2 7 2 4 4 1 8 3 4 4 2 9 1 2 2 1 10 2 3 2 1 11 1 4 3 2 12 2 2 1 1 13 1 2 4 5 14 1 3 2 2 15 3 4 1 1 16 1 2 3 4 17 3 3 5 2 18 2 3 2 1 19 2 2 2 1 20 3 2 4 4 21 2 2 3 4 22 1 2 2 3 23 2 2 2 2 24 4 3 2 2 25 2 3 4 4 26 1 3 4 4 27 3 3 2 2 28 2 4 4 5 29 2 2 2 2 30 1 2 4 4 Average 1.97 2.80 2.90 2.47 Standard Deviation 0.81 0.81 1.12 1.31 [0064] The data establishes that test subjects preferred the sweetened PEG based bowel cleanser by approximately 37% when compared with the unsweetened PEG cleanser. Thus, the subjects found sweetened PEG based bowel cleanser solutions significantly more palatable. Furthermore, the subjects preferred the PEG based bowel cleanser including 0.025% Sucralose in relation to the lower 0.01% Sucralose solution and substantially preferred the 0.025% solution over the much sweeter 0.05% Sucralose solution. Thus, in addition to the test subjects preferring the sweetened PEG based bowel cleanser over the unsweetened liquid, a preferred level of sweetness when using a chlorinated sucrose isomer, such as Sucralose, was established. Additionally, FIG. 1 and/or Table 7 in combination with Example 4 allow one to select a preferable concentration of sweetener to add to the PEG based bowel cleanser. Example 12 [0065] A further study was undertaken to determine which flavorings were preferred by test subjects to improve the palatability of FLEET® PHOSPHO-SODA® and to determine which flavorings were stable in FLEET® PHOSPHO-SODA®. The flavorings tested included sour apple, apple, banana, kiwi melon banana, mixed berry, berry, cantaloupe, caramel, celery, creamy cherry, cherry, wild cherry, chocolate chip cookie, chocolate wafer cookie, chocolate, German fudge brownie, mocha, chocolate fudge, citrus, citrus berry, coffee, cranberry, creme soda, cucumber, fruit punch, mixed fruit, herbal ginger, ginger, ginger ale, white grape, grape, tang grapefruit, lulo grapefruit, cran grapefruit, grapefruit, guanabana, guava, key lime, lime, margarita, lime, tequila lime, citrus blend margarita, mango melon, mangosteen, orange cream, orange, orange carrot, lemon orange carambola, passion fruit, peach, tropical peach, peach mango, pear, peppermint, pineapple - white sapote, pineapple, pitahaya, plum mulberry, raspberry, blue raspberry, raspberry, root beer, starfruit, strawberry, strawberry melon, sweet, tomato, tropical, tropical passion fruit, French vanilla cappuccino, vanilla, French vanilla, vanilla cookie, creamy vanilla, vanilla, raspberry vanilla, watermelon honeydew, wacky watermelon, watermelon, and yuzu. [0066] Of these flavorings, apple, banana, kiwi melon banana, mixed berry, cherry, double fudge brownie, citrus, cantaloupe, fruit punch, mixed fruit, ginger ale, grape, grapefruit, citrus blend margarita, mango melon, mangosteen, plum mulberry, raspberry, root beer, strawberry melon, sweet, tomato, tropical, tropical passionfruit, and watermelon honeydew were selected on the basis of their ability to improve the palatability of the FLEET® PHOSPHO-SODA® when used in combination with the sweetener. These flavorings were then tested for stability in FLEET® PHOSPHO-SODA® over a three month period. Of these flavorings, Ginger Ale FAET253, Mangosteen FAES387, and Cola FAES389 were found to have acceptable stability in the phosphate salt bowel cleanser. Thus, Ginger Ale FAET253, Mangosteen FAES387, and Cola FAES389 are the preferably flavorings to improve the palatability of FLEET® PHOSPHO-SODA® when used in combination with the sweetener. [0067] All percentages, ratios, parts, and other amounts described herein, unless otherwise noted, are weight/weight percentages, ratios, parts and amounts. All flavorings were obtained from WILD Flavors, Inc., of Erlanger, Ky. While various embodiments of the invention have been described, it will be apparent to those of ordinary skill in the art that other embodiments and implementations are possible within the scope of the invention. Accordingly, the invention is not to be restricted except in light of the attached claims and their equivalents.

The present invention provides compositions for bowel cleansing that have improved palatability through the inclusion of a sweetener, such as a chlorinated sucrose isomer. The invention also provides methods of reducing the saltiness of an orally consumed substance, including phosphate salt and PEG/salt bowel cleansers, through the use of a sweetener. Utilizing a sweetener including Sucralose to reduce the saltiness of a substance unexpectedly contradicts the conventional belief that sweeteners amplify saltiness.

FIELD OF THE INVENTION This invention concerns a poultry wing segment separator and deboning system for separating segments of the wings of poultry carcasses, and for deboning an end portion of the segments, leaving the end portions of the bones of the segments exposed. BACKGROUND OF THE INVENTION The use of poultry wings is somewhat limited because the amount of meat in the wing segments is relatively small when compared to other parts of the poultry carcass, and because the wing segments contain bones that are difficult to remove. This causes the use of poultry wings to be less economical than the use of other available poultry parts and parts of other carcasses. Because of these problems, poultry wings and wing segments have been eaten by holding the cooked wings or wing segments in the hands and eating the meat away from the bones. While this use of poultry wings and wing segments is economical because the products do not have to be deboned before consumption, the wings are somewhat difficult to eat, particularly because the person eating the wings must grasp the wing with his or her hands, leaving a residue of grease or other undesirable matter on the hands. In recent years, it has become desirable to produce cooked poultry wing segments with an end portion of the bones of the segments exposed. During the cooking process, the grease and other undesirable matter that is present on the exposed ends of the bones is evaporated or otherwise dissipated, leaving a relatively dry bone end for grasping by the hand of the person to eat the meat from the bone. Also, during the cooking process, the meat usually shrinks and moves away from the exposed bone end, increasing the amount of exposed bone. At first, the separation of the wing segments from one another and pulling the meat away from a bone end was performed by hand. However, the hand operations were expensive and, therefore, the process was not economical. More recently, efforts have been made to automatically separate wing segments of poultry products from one another and to retract the meat from about an end portion of the bone of the wing segments. When the wing segments are cooked, this achieves the desired end result of producing a cooked wing segment having a bone end exposed and substantially dry for handling by the person consuming the meat from the wing. However, the small size of the poultry wings and wing segments causes the process of producing the product to become cumbersome, unreliable, and uneconomical. This invention is directed to the solution of the problems associated with this process. SUMMARY OF THE INVENTION Briefly described, the present invention concerns a method and apparatus for separating the segments of poultry wings from one another and deboning an end of the bones of the segments, leaving the end portions of the bones exposed. The products are later cooked so as to evaporate or otherwise diminish the residue of grease, etc. on the exposed bone ends, making them more suitable for grasping by the person that consumes the meat from the bone. The poultry wings are received independently from the carcass, having been previously separated from the carcasses. The wing comprises the primary segment that was separated from the carcass, the mid-wing segment that is connected by an elbow joint to the primary segment, and a tip segment that is connected to the mid-wing segment by a tip joint. The primary segment is elongated and has a bone extending longitudinally there through. The mid-wing segment is also elongated and has two bones extending there through. The tip segment contains less edible meat than the other segments, and is substantially flat. Therefore, the method and apparatus described herein concentrates on the mid-wing segments and primary segments of the wings. A plurality of poultry wings are moved sequentially through a processing path, by suspending each wing from its tip segment and moving them along the processing path. Each wing segment is oriented so that its elbow joint is either leading or following in the processing path so that the outside of all of the poultry wings face one side of the processing path. As the wings are advanced, the mid-wing segments are maintained upright and the primary segments of the wings, which are lowermost, are bent at the elbow joint laterally and upwardly about an elbow guide that is positioned on the outside of the mid-wing joints of the poultry wings. The bending of the primary segments is in a direction extending outside of and about the elbow guide and continues until the end of the mid-wing bone at the elbow joint is opened away from the mid-wing segment, about the elbow guide. As the elbow joint is opened, the bone end at the elbow joint of the primary segment moves away from the bone end of the mid-wing segment and becomes positioned beside the bone end of the mid-wing segment having been urged laterally about the elbow guide. The tissue extending from the mid-wing segment to the primary segment at the elbow joint becomes stretched away from the bone end of the primary segment, with less tissue remaining at the bone end of the primary segment than at the bone end of the mid-wing segment. The stretched tissue is separated, as by cutting, and the meat at the ends of the bones of the primary segments tend to retract about the ends of the bones of the primary segments. This leaves the ends of the bones of the primary segments exposed. The meat at the ends of the bones of the mid-wing segments tends to remain at the ends of the mid-wing segments. A similar process is performed between the mid-wing segment and the tip segment, leaving the bone end of the mid-wing segment adjacent the tip segment exposed. In a preferred embodiment, the step of suspending the poultry wings from their tip segments comprise wedging the tip segments into the slots of shackles, and advancing the shackles along the processing line. There are lateral protrusions in the tip segments that help retain the tip segments in the slots of the shackles. The mid-wing segments and the primary segments become suspended below the tip segments until the bending and joint separation functions begin. Another feature of a preferred embodiment of the invention is to advance the wings along a substantially rectilinear path to a rotary guide, and then place the mid-wing segment of the wing in contact with the rotary guide so as to stabilize the wing during the later-performed functions of the system. Another feature of a preferred embodiment of the invention is to advance the wings about the rotary guide at a faster speed than the speed at which the wings are advanced toward the rotary guide, so pushing blocks carried by the rotary guide positively register with the poultry wings, so as to stabilize the wings with the pushing blocks through the subsequent steps of the process. These and other features of the invention will become apparent upon reviewing the following specification when taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a top view of the poultry wing separator and partial deboner. FIG. 2 is a perspective illustration of the rotary guide used for separating the primary segment from the mid-wing segment. FIG. 3 is a perspective illustration of the rotary guide used for separating the mid-wing segment from the tip segment. FIG. 4 is a perspective illustration of the shackle used to suspend the wing of a poultry carcass, showing the shackle oriented so that the wing tips of the wings can be easily inserted into the shackles by a person loading the wings into the shackles. FIG. 5 is a perspective illustration of the shackle as it carries the poultry wing to the rotary guide, showing the shackle turned to its operative position. FIG. 6 illustrates the poultry wing as the mid-wing segment is urged against the rotary guide and one of its pusher blocks by the mid-wing guide. FIG. 7 illustrates the poultry wing as the elbow guide and bending guide begin the outward bending movement of the primary segment about the elbow joint. FIG. 8 illustrates the poultry wing as the bending guide further bends the primary segment at the elbow joint about the elbow guide, separating the elbow joint. FIG. 9 illustrates the configuration of the wing as a rotary disk cutter begins its cutting function at the elbow joint. FIG. 10 shows the separated primary segment adjacent the mid-wing immediately after the elbow joint has been opened and the tissue cut through by the cutter, showing the exposed bone end of the primary segment. FIG. 11 shows the mid-wing segment as it passes about the second rotary guide. FIG. 12 shows the mid-wing segment as it is bent at its tip segment joint, showing the bone end as it pops out of the tip segment. FIG. 13 shows the primary segment that has been separated from the mid-wing segment. FIG. 14 shows the mid-wing segment that has been separated at opposite ends from the primary segment and the tip segment. DETAILED DESCRIPTION Referring now in more detail to the drawings, in which like numerals indicate like parts throughout the several views, FIG. 1 illustrates the top of the poultry wing separator and partial deboner 10 , showing the drive system for moving the shackles in series along the processing path. Primary segment rotary guide 12 is operatively connected to the mid-wing segment rotary guide 14 by drive gear 15 , driven gear 16 , the teeth 17 of the gears, and continuous drive chain 18 . The teeth 17 of the drive gear and driven gear mesh with the chain, and a motor or other source of power (not shown) is connected to drive gear to impart rotary movement to the drive gear, drive chain and driven gear as indicated by direction arrows 19 , 20 and 21 about upright axes 22 A and 22 B. The drive chain 18 is driven adjacent a cam track 23 that extends about the drive and driven gears 15 and 16 , and shackle supports 25 are carried at spaced intervals by the drive chain and project on the opposite side of the cam track 23 from the drive chain 18 . Shackles, such as shackles 26 A and 26 B of FIG. 2 , are rotatably supported by the shackle supports and are oriented in a vertical attitude. The upper ends of the shackles 26 are each connected to a turning gear. 28 that functions to rotate its shackle. The rectilinear segments 29 and 30 of the continuous drive chain form a front or loading side 31 and a rear side 32 . Workers hand-load the shackles with poultry wings at the loading side 31 as the shackles move in the direction of arrows 19 – 21 from driven gear 16 to drive gear 15 . Rotary guides 12 and 14 are of larger diameter than the breadth of the continuous drive chain 18 . This means that the shackle supports 25 and their shackles travel at a slower speed than the speed of the periphery of the rotary guides 12 and 14 . It will be noted that the shackles 26 extend laterally from the continuous drive chain 18 so that when the shackle supports 25 and the shackles 26 carried thereby reach the rotary guides 12 and 14 and begin to move around the arcs illustrated by direction arrows 19 and 20 , the speed of movement of the shackles increases. The rotary guides 12 and 14 each include a plurality of guide blocks 33 , 34 for guiding the wings as they travel around the rotary guides 12 and 14 . The primary segment rotary guide 12 includes guide blocks 33 at equally spaced intervals about the perimeter of the rotary guide, and the mid-wing segment rotary guide 14 includes its guide blocks 34 , also at equally spaced intervals about the perimeter of the rotary guide 14 . The guide blocks 33 and 34 , which can be of various configurations, form a surface against which the poultry wings engage as the poultry wings are moved by the shackles about the rotary guides 12 and 14 . An effect of the guide blocks 33 and 34 on the larger perimeter rotary guides 12 and 14 is that they tend to “catch up” to a poultry wing suspended by a shackle since they move at a faster speed than the poultry shackle as the shackles move along the rectilinear segments 29 and 30 with the continuous drive chain 18 . However, since the continuous drive chain is of a narrower breadth than the breadth of the shackles moving along the rectilinear segments 29 and 30 , the shackles begin to move at the same surface speed of the periphery of the rotary guides as they move around the arcuate portions of the rotary guides 12 and 14 , and the guide blocks 33 and 34 progressively move into contact with the poultry wings, assuring that the poultry wings become properly registered at the guide blocks. It will be noted in FIG. 1 that the turning gears 28 at the top of the shackles rotate in one direction when leaving the mid-wing segment rotary guide 14 , and rotate in the opposite direction when approaching the primary segment rotary guide 12 . This pattern of rotation reorients the shackles so that the open ends of the shackles face a worker at the loading side 31 of the continuous drive chain 18 . But after having been loaded with a wing, the shackles are reoriented so that the closed loop end of the shackles lead as the shackles begin their movements about the primary segment rotary guide 12 . As illustrated in FIG. 2 , each shackle 26 , such as shackle 26 A, includes a support stem 36 oriented in an upright attitude and connected at its upper end to a turning gear 28 and carried by a shackle support 25 ( FIG. 3 ). The lower end portion of each shackle includes a U-shaped, horizontally extending carrier 37 that defines an elongated horizontally oriented shackle slot 38 that is open at one end. The person loading the poultry wings 39 on the shackles inserts the tip segments 40 of the wings through the open ends of the carriers 37 of the shackles 26 . There are small protrusions from the tip segments 40 that help maintain the wing segments in the slots 38 of the carriers 37 of the shackles. The tip segments become wedged by friction in the slots and the mid-wing segments 41 are suspended below the tip segments 40 and the primary segments 42 are suspended below the mid-wing segments 41 . The worker is careful to orient each wing 39 50 that when the shackle is turned to its operative position ( FIG. 5 ), the outside surface of the wing is oriented to the outside of the processing path. This is true for both left and right wings of the carcass, so that in one situation the right wing will have its elbow joint leading in the direction of movement of the wing through the system, and when the left wing is loaded, it will have its elbow joint trailing the wing through the process. This is desired so that the direction of bending of the primary segment of the wing is always toward the outside of the wing, which is the direction in which the opening of the elbow joint can more effectively take place, with less force and with more reliable wing opening without fracture of the bones. This is due to the anatomical structure of the right and left elbow joints of a chicken and of other poultry species. As illustrated in FIG. 6 , the poultry wings 39 engage a mid-wing guide 44 intermediate the ends of the mid-wing segments. The mid-wing guide is in the form of a stationary curved rod that extends in the processing path adjacent the perimeter of the rotary guide 14 . The mid-wing guide urges the mid-wings against the perimeter surface of the primary segment rotary guide 12 . In the meantime, the guide blocks 33 move in behind the wings 39 at a faster speed than the movement of the wings until the wings begin to move in an arcuate path about the rotary guide. This assures that the guide blocks 33 will always be properly positioned immediately behind the wings 39 and urge the wings through the arcuate path as the wings are being frictionally engaged by the mid-wing guide 44 and the other guides hereinafter described. This properly orients the wings for the subsequent processes. As the wings 39 continue in sequence about the rotary guide 12 , they are engaged by elbow guide 46 that is spaced below the mid-wing guide 44 .and which engages at first slightly above the elbow joints 47 of the wings that connect the primary segments 42 to the mid-wing segments 41 . This begins the opening of the elbow joints of the wings. The elbow guide 46 also is in the form of a curved rod. In the meantime, a bending guide 48 also extends in the curved processing path, but at a level lower than the rotary guide 12 . The bending guide, in the form of a curved rod, is sloped from inside the wings 39 , outwardly and upwardly, and engages against the primary segments 42 of the wings so as to bend the primary segments 42 laterally and then upwardly about the elbow guide 46 . This pivots the bone ends of the primary segments 42 laterally away from the bone ends of the mid-wing segments 41 and opens the elbow joints of the wings. This movement of the bone ends of the primary segments about the elbow guide 46 stretches the tissue extending between the bone ends and tends to separate the tissue from about the bone ends of the primary segments at the elbow joints while the tissue remains connected to the bone ends of the mid-wing segments. As illustrated in FIG. 8 , further movement of the wings about the rotary guide 12 causes further upward bending of the wings at their elbow joints. At this position, the bone ends of the primary segments usually pop out laterally away from the mid-wing segments. FIG. 9 illustrates the last phase of the bending operation of the primary segments 42 with respect to the mid-wing segments 41 , as the wings approach the disk cutter 50 . The disk cutter is oriented so that it is in the path traveled by the opened elbow joints and cuts through the tissue that is stretched between the primary segments 42 and the mid-wing segments 41 about the elbow joints. This completely separates the primary segments 42 from the mid-wing segments 41 . Since the bones of the elbow joints are separated and are now positioned on opposite sides of the elbow guide, the cutter will not engage the bones as the cutter cuts through the stretched tissue. FIG. 10 shows a wing immediately after the primary segment 42 has been separated from the mid-wing segment 41 , showing the exposed bone end 50 of the separated primary segment 42 . The primary segment is now allowed to drop from the apparatus to a receptacle where it is further processed. FIG. 11 shows a mid-wing segment 41 of a wing as it moves about the mid-wing segment rotary guide 14 . A tip segment guide 52 extends adjacent the perimeter of the mid-wing segment rotary guide 14 and engages the mid-wing segments 41 and the tip segments 40 , at the joint between the segments. The tip segment guide forces the tip segments against the rotary guide 34 , compressing and weakening the tip joints. A guide block 34 engages behind the tip and mid-wing segments to assure that they move in unison with the perimeter of the mid-wing segment rotary guide 14 . As illustrated in FIG. 12 , the tip segment guide 52 urges the tip about the lower perimeter edge of the rotary guide 14 , urging the bones of the mid-wing segment 41 laterally inwardly beneath the rotary guide 14 . The compression of the tip segments together with the lateral force applied to the mid-wing segments urges the bone ends 55 , 56 of the mid-wing segment adjacent the tip segment to break away from the tip segment. This tends to “pop” the ends 55 and 56 of the bones of the mid-wing segment 41 out of the skin and other tissue extending between the tip segment 40 and the mid-wing segment 41 . The tissue left extending between the mid-wing segment 41 and the tip segment 40 is cut by a disk cutter, similar to disk cutter 50 of FIG. 9 , thereby completely separating the mid-wing segment 41 from the tip segment 40 , allowing the mid-wing segment to fall away from the processing path to a receptacle. FIG. 13 shows the separated primary segment 42 of a wing with its bone end 50 exposed and protruding out of the meat, with the meat and other tissue clinging to the other portion of the bone. FIG. 14 shows the separated mid-wing segment 41 of a wing with its bone ends 55 and 56 exposed and protruding out from the meat, skin and other tissue clinging to the other portions of the bones. Once the mid-wing and primary wing segments have been separated and configured as shown in FIGS. 13 and 14 , they are accumulated and later cooked for edible consumption. The bone ends 50 , 55 and 56 are dried during the cooking process so as to evaporate or otherwise remove or diminish the grease and other matter that would have accumulated on the bone ends, leaving the bone ends dry and suitable for grasping by the human hand as the meat is consumed by a person. Although preferred embodiments of the invention have been disclosed in detail herein, it will be obvious to those skilled in the art that variations and modifications of the disclosed embodiments can be made without departing from the spirit and scope of the invention as set forth in the following claims.

Poultry wings are suspended by their tip segments and oriented so that their outside surfaces face one side of the processing path, with right wings oriented with their elbows leading, and left wings oriented with their elbows trailing. The lower, primary segments are bent at the elbow joints by a bending guide, laterally and upwardly about an elbow guide, opening the elbow joints. The open joints are cut so as to release the primary segments. The mid-wing segments are compressed and the bone ends are moved laterally from the wing tip segments, causing the bone ends of the mid-wing segments to pop out of the tip segments. In both instances, the bones of the segments are exposed in the final products, so when the products are cooked, the exposed bone ends are free of grease, etc. and are suitable for grasping by the fingers of the hand for eating as finger food.

BACKGROUND OF THE INVENTION A very successful fish stringer widely present on the market consists of a length of chain with a plurality of safety-pin-like fish clips secured to the chain at spaced intervals. The sharp end of the clip wire is normally lodged in a shielded pocket. To string a fish, the end is sprung out of the socket and threaded through the lower and upper lips of the fish and closed again. The bight of the clip permits enough jaw movement of the fish so that it can breathe freely while it is on the stringer. This type of stringer does a notably good job of keeping the fish alive until the day's fishing is done. The spaced intervals of the clips prevent crowding of the fish on the stringer and eventual jaw destruction and suffocation. In pier and bridge fishing common in Florida and elsewhere, the fishing platform may be 12' to 20' or more above the water. Carrying such a length of line or chain with clips attached would present difficulties in tangling. Also, tailoring the length of the line to a variety of fishing locations presents obvious difficulties. The lip hooking of the fish also raises problems in regard to a conventional stringer. The lips, while fairly strong and tough, can tear through. Such tearing is a likely eventuality when the fishing is good and the stringer must frequently be raised 12' in the air, for instance, to add another fish to it, the fish already on the stringer jerking and flopping. Even if the already caught fish should not shake themselves free, damage to the jaws and breathing mechanism is likely such that the fish may die prematurely. SUMMARY OF THE INVENTION This invention is directed to a fish stringer and to the link forming a part thereof which avoids the above difficulties. The link itself consists of a closed loop of stiff wire to which a fish clip is secured, the link being adapted for a secure, sliding attachment to a line, cable or chain intermediate its length such that the fish holders can be carried separately from the line and the length of the line be determined according to the particular requirements of the fishing location. The separate and detached transport of the line and the holders greatly reduces tangling. The closed-loop nature of the link minimizes tangling as among the holders themselves. The length of the links on the line is substantial so as to afford good spacing for the fish on the stringer. The ready attachability of the holders to the line between its ends permits the attachment of each fish individually to the line at the fishing platform and permitting the fish and holder to drop down into the water without the necessity of hauling up the stringer with the fish already caught on it and without the necessity of untying the line from its anchoring point on the bridge or pier. Attention is directed to the following patents, the first two particularly. ______________________________________Patent No. To Issued______________________________________2,125,770 S. Dabroski Aug. 2, 19383,055,332 V. J. Linsdeau Sept. 25, 19622,111,958 D. M. Bardon Mar. 22, 19382,217,972 W. E. Smith Oct. 15, 19403,120,715 A. E. Long Feb. 11, 1964______________________________________ BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective of a portion of a stringer line with a pair of the fish holders mounted thereto; FIG. 2 is a front elevation of the fish holder of FIG. 1; FIG. 3 is an end elevation of the link of FIG. 2; FIG. 4 is a perspective view of a link of the invention and a section of stringer cord illustrating the beginning of the attachment of the link to the cord; FIG. 5 is a view similar to FIG. 4 illustrating a final step in the attachment of the link to the cord; FIG. 6 is a fragmentary front elevation similar to FIG. 2 illustrating a modified form of the link; and FIG. 7 is an end elevation of the link of FIG. 6. DESCRIPTION OF THE PREFERRED EMBODIMENT In FIG. 1 is shown a length of fish stringer line or cord 10 with two fish holders 12 mounted thereto. The fish holders consist of a clip 14 and a link 16. The cord 10 may be rope, chain, or cable, but it must be flexible. The cord should have a stop on one end thereof, here shown to be a relatively large washer 18 to which the cord is knotted. The link consists of a length of stiff wire, for instance 14 gauge iron wire, which may be plated for corrosion resistance. The wire is formed to have a pair of oppositely wound coils 20 and 22 formed therefrom having a common center line or axis. A bridging portion or tongue 24 which may be pointed, round or straight (FIG. 6) bridges the adjacent ends of the coils and extends beyond the periphery of the coils. In the drawings, the left hand coil 20 has a right hand twist to it and the right hand coil 22 has a left hand twist to it. As illustrated in FIGS. 1-5, the coils are wound through about 540° and the turns 25, 26 of each coil are imperatively spaced apart by at least the diameter of the cord, chain or cable which is to constitute the string for the stringer. The wire at the remote ends of the coils 20, 22 occupy a common plane tangent to the two coils 20, 22 and extend away from the coils convergently toward each other to a point of meeting 28 well spaced from the common axis of the two coils 20 and 22. The tongue extends from the coils a short distance parallel to the plane of the wires and tangent to the other side of the coils. The link may perhaps be visualized better from one method of fabrication. If the wire were to be bent into a V shape (FIGS. 1-5) or with a U shape with divergent legs (FIG. 6) the apex at the center of the wire, the two arms of the wire laid against the same side of a cylindrical mandrel a short distance away from the apex, the apex positionally anchored to the mandrel, and the arms bent around the mandrel an equal number of turns in an outwardly spiraling fashion, the twin coil structure will be achieved. Thereafter, the unspiralled arm ends will be bent toward each other, first a slightly convergent angle to define legs 30 and then a sharply convergent angle to meet and define a crossbar 32 generally parallel to and well spaced from the axis of the coils. The juncture of the legs at the point of meeting may be effected in various ways. In the embodiment illustrated in FIGS. 1 through 5, the two ends of the wire are formed into overlapping eyes 34, and one loop 36 of a swivel 38 passes through both eyes to hold them together. The other end 40 of the swivel mounts the fish clip 42. In the modification shown in FIGS. 6 and 7, the two ends of the wire are welded together as at 44. Where welding is the means for connecting the two ends of the wire, the weld may be located at any point in the length of the wire, the center of the tongue 24 linking the two coils, for instance. Other means of connecting the ends of the wire might be twisting them together, enclosing them in the ends of a sleeve, etc. In the modification shown in FIGS. 6 and 7, it will be noted that the swivel 38 is mounted directly on the closed loop of the link 16 and thus is not positionally fixed on the link as is the modification shown in FIGS. 1 through 5. It is possible to mount the fish clip 42 directly to the link without the interposition of the swivel 38. The method of attaching the link to the stringer cord is particularly illustrated in FIG. 4 and 5. The link is oriented with the legs to the back and the tongue to the front. The cord is laid against the front of the legs 30 and in contact with the underside of the coils 20 and 22. A shallow loop of the cord between the legs is drawn backward and upward to lodge the cord in the upper part of the outermost turn of the coils as shown in FIG. 4. The loop is then drawn forwardly and down over the end of the tongue 24 and released (FIG. 5). This lodges the cord in the innermost turn of the coils and the link is thereby entrained on the cord with the cord extending along the common axis of the two loops. The link, thus, is attached in an encircling, sliding relationship to the cord between its ends without the necessity of threading an end of the cord through the coils. Detachment is similarly easy. The tongue extending well away from the periphery of the coils requires substantial slack in the cord for the cord's passage thereover, so contributing to the security of the attachment. The angularity or rotation of the coils 20 and 22 is subject to some variation. Obviously, there is no point in carrying their rotation farther than is necessary to obtain a positive, loss-proof attachment to the cord. The illustrated 540° angularity of the coils of FIGS. 1 through 5 serves this purpose well. There is no point in carrying the rotation farther than this degree in that it consumes additional wire and requires somewhat more effort to attach the link to the cord. The modification illustrated in FIGS. 6 and 7 illustrates coils wound through 540°. The extension of the tongue in both instances contributes to the security. The limiting case, of course, is a bend of greater than 180° such that the plane of the tongue and of the legs intersect. Thus, a coil of 270° would provide fair security for the attachment of the link to the cord if the tongue projected well through and beyond the plane established by the legs. Such a link, however, in addition to lacking the security of a greater angularity of bend, would have the disadvantage of a substantial projection in two planes at right angles to each other which would add to the space required in transporting a number of such links. A characteristic length of the link would be about two inches between the outer ends of the coils. This provides adequate spacing of the fish on the stringer cord. The links, of course, will stack on the cord. The links may be longer if larger fish are anticipated. The convergence of the legs 30 permits independent swiveling of the links with a minimum of interference.

A fish stringer comprising a cord and a plurality of fish holders including links which are attachable to the cord between its ends in sliding relation thereon.

[0001] This application claims the benefit of U.S. Provisional Patent Application 61/847,093, filed on 17 Jul. 2013, and U.S. Provisional Patent Application 61/865,625, filed on 14 Aug. 2013, the specifications of which are hereby incorporated herein by reference. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] Embodiments of the invention generally relate to implantable biventricular heart therapy devices that detect ventricular tachycardia and fibrillation. [0004] 2. Description of the Related Art [0005] Typically, tachycardia identification units allow biventricular detection of tachyarrhythmias, such as ventricular tachycardias (VT) or fibrillations (VF). Generally, therapy device control may initiate suitable therapies based on the detection. [0006] A system known as an S-ICD system typically operates with a far-field channel for VT/VF identification. [0007] For example, a specific type of tachyarrhythmias is “dissimilar” ventricular tachycardias, in which different (beat or contraction) rates prevail in the right ventricle (RV) and in the left ventricle (LV). [0008] Generally, ICD systems available on the market operate exclusively with a right-ventricular VT/VF identification channel. The left-ventricular sensing signals are typically used only for the inhibition of unnecessary LV stimulation and for the recording of an intracardial electrocardiogram (IEGM), but not for VT/VF identification. Based on the observation that there are ventricular tachycardias that have a considerable frequency difference between the right and left ventricle over a considerable period of time, typically, in the event of just right-ventricular detection, there is a potential risk that patients having these dysrhythmias are not being cared for sufficiently. [0009] For example, with a much quicker VT/VF in the left ventricle with a moderate VT in the right ventricle, generally, there is a risk of a lethal appearance of the dysrhythmia, since the time it takes for effective defibrillation is considerably too long as a result of the underestimation only using right-ventricular sensing. [0010] Typically, purely biventricular sensing poses a risk that, for example in the event of a left-ventricular electrode (coronary sinus electrode) dislocated in the region of the atrium, an atrial fibrillation is incorrectly classified as left-ventricular fibrillation (left-VF) and thus leads to an inadequate therapy delivery. A dislocated right-ventricular electrode, generally, may cause a comparable effect. [0011] As such, typically, isolated left-ventricular tachyarrhythmias may be cited as particularly relevant, since they are not generally correctly detected and treated using existing right-ventricular systems. Analyses of biventricular IEGM recordings, generally, reveal a considerable proportion of dysrhythmias of this type. [0012] Known biventricular heart therapy devices are generally inadequate with respect to dissimilar ventricular tachycardias. In view of the above, there is a need for a biventricular heart therapy device, which is able to adequately respond to dissimilar ventricular tachycardias. BRIEF SUMMARY OF THE INVENTION [0013] One or more embodiments of the invention are related to an implantable biventricular heart therapy device having a therapy device control unit, which includes a tachycardia identification unit connected, at least indirectly, to a right-ventricular sensing electrode and a left-ventricular sensing electrode. In at least one embodiment of the invention, the right-ventricular sensing electrode and the left-ventricular sensing electrode feed at least one signal from the heart's right ventricle and at least one signal from the heart's left ventricle, respectively to the tachycardia identification unit. In one or more embodiments, the signals represent a course over time of electrical potentials in the heart. During operation, in one or more embodiments, the signals representing a course over time of electric potentials in the heart or signals derived therefrom are fed to the tachycardia identification unit. By way of at least one embodiment, the tachycardia identification unit may evaluate the signals fed thereto or the course over time thereof, and generate a tachyarrhythmia signal if the fed signal meets predefined criteria, for example frequency criteria with regard to specific signal features, such as detected R waves. Due to the output of a tachyarrhythmia signal, in one or more embodiments, the tachycardia identification unit may signal a (pathological) tachycardia or fibrillation. In at least one embodiment, the heart therapy device may include an implantable cardioverter-defibrillator (ICD). Embodiments of the invention are generally configured to respond adequately to dissimilar ventricular tachycardias. [0014] In one or more embodiments, the tachycardia identification unit may simultaneously evaluate the heart rate at the right-ventricular and at the left-ventricular sensing electrode to identify ventricular tachycardia. [0015] In at least one embodiment, the therapy device control may include a dislocation identification unit connected, at least indirectly, to the right-ventricular sensing electrode and the left-ventricular sensing electrode. As such, in one or more embodiments, during operation, the signals representing a course over time of electric potentials in the heart or signals derived therefrom are fed to the dislocation identification unit. In at least one embodiment, the dislocation identification unit may simultaneously evaluate the heart rate at the right-ventricular and the left-ventricular sensing electrodes, signal a right-ventricular or left-ventricular dislocation, and generate a corresponding dislocation signal whenever the dislocation identification unit senses a sudden rise in heart rate at the right-ventricular or left-ventricular electrode, without detecting a significant rhythm change at the left-ventricular or the right-ventricular electrode within a predefined and/or adjustable time window. In one or more embodiments the therapy device control unit, in the event of a signaled dislocation of the right-ventricular or the left-ventricular electrode, may ignore the rhythm information of the dislocated right-ventricular or left-ventricular sensing electrode, or electrode in question, during tachycardia detection. [0016] The left-ventricular and/or right-ventricular signals fed into the tachycardia identification unit and to the dislocation identification unit, in at least one embodiment of the invention, may be signals derived from the signals sensed by the respective electrodes, for example marker signals generated by corresponding right-ventricular/left-ventricular sensing units, when one or more of the right-ventricular sensing unit, the left-ventricular sensing unit, the right-ventricular sensing electrode and the left-ventricular sensing electrode detect right-ventricular or a left-ventricular chamber contraction, for example on the basis of a corresponding R-spike in the electrocardiogram. [0017] The heart therapy device, according to one or more embodiments the invention, ensures an adequate antitachycardia therapy for ICD patients, in which dissimilar ventricular VT/VF episodes occur, for example tachycardia dysrhythmias, that may progress at different speeds in the right ventricle and in the left ventricle. The heart therapy device, according to at least one embodiment the invention, may prevent an atrial fibrillation from accidentally being incorporated into the VT/VF detection via a dislocated ventricle electrode. [0018] One or more embodiments of the invention allow an adequate therapy in good time in patients having ventricular tachycardias of different speeds in both ventricles, without an inadequate therapy being delivered in the event of an electrode dislocation. In at least one embodiment, the heart therapy device enables the avoidance of incorrect detections in the event of a dislocated probe, or electrode, and simultaneous atrial fibrillation. [0019] During operation, the heart therapy device according to at least one embodiment of the invention, may include an implantable defibrillator having at least one right-ventricular electrode and at least one left-ventricular (preferably coronary sinus) electrode, wherein each electrode may be connected to a tachycardia identification unit. In one or more embodiments, the tachycardia identification unit may, to identify ventricular tachycardias, simultaneously evaluate the heart rate at the right-ventricular and at the left-ventricular electrode. In at least one embodiment, the right-ventricular and left-ventricular electrode, in each case, correspond to a sensing electrode pole for bipolar or unipolar sensing of electric potential courses in the myocardium of the respective ventricle. In one or more embodiments, the electrode poles, for example, may be part of a corresponding electrode line and may be connected via the electrode line to the heart therapy device. According to at least one embodiment, the dislocation identification unit allows the detection of a possible dislocation of one of the ventricular electrodes and may simultaneously evaluate the heart rate at the right-ventricular and the left-ventricular electrode. In one or more embodiments, the dislocation identification unit may signal a right-ventricular or left-ventricular dislocation whenever a sudden rise in heart rate is sensed at the right-ventricular or left-ventricular electrode, without detecting a considerable change in rhythm at the left-ventricular or right-ventricular electrode around the same time, such that, in the event of a signaled dislocation of one of the ventricular electrodes, the rhythm information of the dislocated electrode, or electrode in question, may be ignored for, or during, tachycardia detection. [0020] In one or more embodiments, the tachycardia identification unit, following a dislocation signal of the dislocation identification unit, may ignore a signal originating from a respective dislocated electrode, or electrode in question, for, or during, the tachycardia detection. In at least one embodiment, the signal originating from an electrode identified as being dislocated, may not be fed to the tachycardia identification unit. [0021] One or more embodiments of the invention include at least one atrial electrode, wherein the heart therapy device may only carry out the electrode dislocation check using the dislocation identification unit when an atrial fibrillation (AF) is sensed at the at least one atrial electrode. For example, in at least one embodiment, an AF identification unit that detects atrial fibrillations may be provided. In one or more embodiments, in the event of a detected atrial fibrillation, the AF identification unit may output an AF signal that may cause a deactivation of the dislocation identification unit. [0022] By way of at least one embodiment, the dislocation identification unit may use at least one criteria of the following criteria or a combination thereof, to identify, or signal, the left-ventricular dislocation identification: a maximum permissible anteriority of a left-ventricular contraction before a right-ventricular contraction, stability of A-RV conductor time (conductor time from the atrium to the right ventricle), a rate comparison between the atrium and heart's left ventricle, a left-ventricular stimulation stimulus threshold, and morphology of left-ventricular R-waves before a preliminarily detected tachycardia with confirmed amplitudes impedances and stimulus thresholds. [0023] According to at least one embodiment, the heart therapy device may include a three-chamber device and a right-atrial electrode wherein the three-chamber device is connected to the right-atrial electrode, the right-ventricular electrode and the left-ventricular electrode. The tachycardia identification unit, in at least one embodiment, may perform a three-chamber discrimination algorithm, which is extended by comparison, in which, to classify the origin of a tachycardia, interval information of the left ventricle is and A-LV conductor times from the atrium to the left ventricle are recorded. [0024] By way of one or more embodiments, to discriminate between a physiological rise in heart rate (which leads to a sinus tachycardia) and a ventricular tachycardia of sudden onset, the tachycardia identification unit may extend an onset criterion (such as a sudden onset or a sudden rise in the heart rate within one heart cycle or just a rather low number of heart cycles) by the left-ventricular rhythm evaluation, and may signal a sinus tachycardia (by outputting a corresponding tachyarrhythmia signal) whenever there is no sudden rise in heart rate in the right ventricle and no sudden rise in heart rate in the left ventricle, and/or the interventricular conductor times (the A-LV conductor times and the A-RV conductor times) remain unchanged under consideration of a tolerance. [0025] In at least one embodiment, the tachycardia identification unit may apply a ventricular stability criterion to distinguish between a stable monomorphic ventricular tachycardia and a conducted atrial fibrillation in extended form, wherein a ventricular tachycardia (VT) is then only detected when the rhythm in both ventricles is classified as stable. [0026] The heart therapy device, in at least one embodiment, includes a therapy control, such that the heart therapy device may automatically switch the timer control over to the left-ventricular side (such that the times are controlled based on detected left-ventricular events) using the therapy device control unit. In one or more embodiment, using the timer control, the heart therapy device may control blank-out times necessary for the tachycardia detection, the left-ventricular signals are classified as suitable for the tachycardia detection, for example when no dislocation is identified. United Stated Patent Publication 2011/0082512 and European Patent 2 308 558, both of which are incorporated herein by reference, relating to a cardiac stimulator that may detect a stability parameter, include a timer control and a programmable automatic switch applicable to the present invention. Blank-out time, that is to say periods in which a respective sensing unit either cannot sense cardiac events or periods in which sensed cardiac events, in at least one embodiment, are ignored for the tachycardia identification. [0027] According to at least one embodiment, the tachycardia identification unit for the biventricular detection may include two separate detection counters for the right-ventricular and the left-ventricular signal, such as a right ventricle detection counter and a left ventricle detection counter. In at least one embodiment, when a predefined counter state is reached, one of the two counters, the right ventricle detection counter and the left ventricle detection counter triggers a corresponding detection and therefore a corresponding tachyarrhythmia signal. [0028] In one or more embodiments, the tachycardia identification unit for biventricular detection may include at least one single common detection counter for both the at least one right-ventricular signal and the at least one left-ventricular signal, wherein, in the event of, or during, a deviating interval time between the at least one right-ventricular signal and at least one the left-ventricular signal, tachycardia detection is always determined by the quicker ventricle, via the at least one single common detection counter. [0029] Regarding a termination criterion, used for the therapy device control unit to terminate an antitachycardia therapy (ATP, antitachycardia pacing), by way of at least one embodiment, the therapy device control unit may implement a termination criterion, which is then only considered to be met when measured interval times in both the right ventricle and in the left ventricle are greater than a predefined interval limit for the termination. [0030] In one or more embodiments, the therapy device control unit may consider the termination criterion to be met when the measured interval time, only in the right ventricle, is greater than a predefined interval limit for the termination. [0031] According to at least one embodiment, the heart therapy device may include a right-ventricular and left-ventricular undersense identification, for example, using a plausibility check of numbers of one or more of right-ventricular and left-ventricular intervals and atrial intervals. In one or more embodiments, the heart therapy device may switch over to a right-ventricular or left-ventricular detection whenever one of the ventricular electrodes has considerable undersensing, for example when one of the ventricular electrodes detects much fewer cardiac cycles than the other electrode(s), due in part to undetected cardiac events. [0032] In at least one embodiment, the tachycardia identification unit may be switched between a purely, or exclusively, right-ventricular tachycardia identification, in which only signals originating from a right-ventricular electrode and possibly additionally from an atrial electrode are evaluated for the tachycardia identification, and a biventricular tachycardia identification, in which signals also originating from a left-ventricular electrode are evaluated for the tachycardia identification. After implantation of the heart therapy device or a connected electrode line, in at least one embodiment, a purely, or exclusively, right-ventricular detection may thus always initially occur, until a stable electrode position in the left ventricle has been automatically determined by the heart therapy device, and the biventricular detection is then automatically activated. In at least one embodiment, the heart therapy device enables and may carry out automatic switchover between different tachycardia identification techniques. [0033] In at least one embodiment, one or more of the heart therapy device may include a shock electrode that delivers at least one defibrillation shock, wherein the heart therapy device and/or the therapy control unit may carry out an additional dislocation check of the left-ventricular sensing electrode as discussed above, or after each delivery of the at least one defibrillation shock. [0034] According to at least one embodiment, the dislocation identification unit may only detect a dislocation of a left-ventricular electrode, wherein the dislocation identification carried out by the dislocation identification unit relates only to a respective left-ventricular (coronary sinus) electrode, wherein the likelihood of a dislocation is greater. BRIEF DESCRIPTION OF THE DRAWINGS [0035] The above and other aspects, features and advantages of at least one embodiment of the invention will be more apparent from the following more particular description thereof, presented in conjunction with the following drawings wherein: [0036] FIG. 1 : shows an example of a dissimilar ventricular tachyarrhythmia; [0037] FIG. 2 : shows a biventricular cardiac pacemaker, with a right-ventricular defibrillation shock coil, as an implantable cardiac stimulator; [0038] FIG. 3 : shows components of the implantable cardiac stimulator of FIG. 2 in the form of a simplified block diagram; [0039] FIG. 4 : shows a biventricular three-chamber cardiac pacemaker and implantable cardioverter-defibrillator (ICD) as an implantable cardiac stimulator; [0040] FIG. 5 : shows a flow diagram illustrating the dislocation identification; [0041] FIG. 6 : shows an example of biventricular detection; and [0042] FIG. 7 : shows a three-chamber discrimination algorithm. DETAILED DESCRIPTION OF THE INVENTION [0043] The following description is of the best mode presently contemplated for carrying out at least one embodiment of the invention. This description is not to be taken in a limiting sense, but is made merely for the purpose of describing the general principles of the invention. The scope of the invention should be determined with reference to the claims. [0044] FIG. 1 shows an example of a dissimilar ventricular tachyarrhythmia. As shown in FIG. 1 , the rhythm changes in the right ventricle (RV) from a stable VT over a short phase of VF to a slower VT 110 , and at the same time the rhythm in the LV channel changes at a later moment in time from a stable VT to a lasting VF, which is not sensed with a purely right-ventricular detection and may lead to an incorrect choice of therapy. [0045] FIG. 2 shows a biventricular cardiac pacemaker-defibrillator (ICD or CRT-D), having a right-ventricular defibrillation shock coil, as an implantable cardiac stimulation such as an implantable heart therapy device (heart stimulator) 10 , according to at least one embodiment of the invention. In at least one embodiment, the implantable heart therapy device 10 is connected via electrode lines 16 and 30 to stimulation electrodes 18 and 20 , and to sensing electrodes 32 and 34 , in the right and left ventricle of a heart respectively. In one or more embodiments, the heart therapy device may deliver stimulation pulses to the heart and record electric potentials from the heart. [0046] The electrode lines 16 and 30 , in at least one embodiment, are electrically connected via plug connections to contact sockets in a header (terminal housing) 11 of the heart stimulator 10 . In one or more embodiments, the electrode lines 16 and 30 may be connected to electronic components inside a hermetically tight metal housing 42 of the heart stimulator 10 . The electronic components, according to at least one embodiment, schematically illustrated hereinafter in FIG. 3 , may determine the operating principles of the heart stimulator 10 . [0047] In one or more embodiments, the electrode line 16 is a right-ventricular electrode line and has at its distal end a right-ventricular tip electrode pole RV Tip 18 , and in a direct or indirect vicinity thereof a right-ventricular ring electrode pole RV Ring 20 . In at least one embodiment, both electrode poles may be arranged in the apex of the right ventricle of the heart 12 . [0048] According to at least one embodiment, the electrode line 30 is a left-ventricular electrode line and includes at the distal end a bipolar stimulation and sensing electrode having a distal tip electrode pole LV Tip 34 , and in the direct or indirect vicinity thereof a left-ventricular ring electrode pole LV Ring 32 . In one or more embodiments, the left-ventricular electrode line 30 may be guided from the right atrium 26 of the heart 12 (illustrated in FIG. 4 ) via the coronary sinus into a lateral vein branching therefrom, also referred to as the coronary sinus electrode line or CS electrode line. [0049] In at least one embodiment, the right-ventricular electrode line 16 may include a right-ventricular shock coil RV Shock 38 , such as a large-area electrode pole that delivers defibrillation shocks. [0050] FIG. 3 shows components, such as key functional units, of the heart stimulator 10 . Also in FIG. 3 , additional components are illustrated via dashed lines, as may be provided in at least one embodiment of the invention. [0051] By way of one or more embodiments, as shown on the left hand side, electrical terminals for the various electrode poles 18 , 20 , 32 , 34 and 38 are illustrated. The shock electrode (shock coil) 38 , in at least one embodiment, is connected to a shock pulse generator 50 . In one or more embodiments, the shock pulse generator 50 may be connected to a control unit 54 , which controls the shock pulse generator 50 , as required, to generate and deliver a cardioversion or defibrillation shock. In at least one embodiment, the control unit 54 acts as a therapy device control unit 54 ′. The therapy device control unit 54 ′, in at least one embodiment of the invention, may be connected, for example, to the shock pulse generator 50 , to a right-ventricular stimulation unit 56 , and to a left-ventricular stimulation unit 64 . [0052] The control unit 54 , in at least one embodiment, may include a tachycardia identification unit 90 and a dislocation identification unit 92 . [0053] By way of one or more embodiments, the terminal for the right-ventricular tip electrode pole RV Tip, and the terminal for the right-ventricular ring electrode pole RV Ring, are each connected to both the right-ventricular stimulation unit 56 and to a right-ventricular sensing unit 58 . Both the right-ventricular stimulation unit 56 and the right-ventricular sensing unit 58 , in one or more embodiments, are each connected to the control unit 54 . [0054] According to at least one embodiment, the right-ventricular stimulation unit 56 , following a control signal of the control unit 54 , may generate a right-ventricular stimulation pulse and may deliver the right-ventricular stimulation pulse via the terminals for the right-ventricular ring electrode pole and the right-ventricular tip electrode pole. In one or more embodiments, the housing 42 of the heart stimulator 10 may form a neutral electrode, and the right-ventricular stimulation unit 56 may be connected to the terminal for the right-ventricular tip electrode pole RV Tip and to the housing 42 as another electrode to deliver a stimulation pulse. In at least one embodiment, a right-ventricular stimulation pulse differs from a defibrillation shock in that the stimulation pulse has a much lower pulse intensity, such that, by contrast to a defibrillation shock, it does not excite the entire heart tissue (myocardium) of an atrium in one attempt, but only the heart muscle cells in the direct vicinity of the right-ventricular tip electrode pole 18 . In one or more embodiments, the excitation then propagates further as a result of natural conduction over the entire ventricle and thus ensures a stimulated contraction of the ventricle. [0055] In at least one embodiment, the right-ventricular sensing unit 58 may first amplify, using an input amplifier, and then filter electric potentials applied across the terminal for the right-ventricular ring electrode pole RV Ring and the right-ventricular tip electrode pole RV Tip. By way of one or more embodiments, the right-ventricular sensing unit 58 may evaluate the course of the electric signals applied across its inputs in such a way that the right-ventricular sensing unit 58 automatically detects a natural (intrinsic) beat, such as an automatic contraction of the right ventricle. In at least one embodiment, the evaluation may be achieved, for example, by comparing the course of the signal applied across the inputs of the right-ventricular sensing unit 58 to a threshold value. In one or more embodiments, the largest amplitude of the signal is in the form of an R-spike, which is characteristic for a natural contraction of the right ventricle and which may be detected by comparison with a threshold value. In at least one embodiment, the right-ventricular sensing unit 58 , therefrom, may output a corresponding output signal (for example a marker signal), indicating a natural contraction of the right ventricle, to the control unit 54 , the tachycardia identification unit 90 and the dislocation identification unit 92 thereof. [0056] In one or more embodiments, the terminal for the left-ventricular tip electrode pole LV Tip and the terminal for the left-ventricular ring electrode pole LV Ring are also connected to the left-ventricular stimulation unit 64 and a left-ventricular sensing unit 66 . In at least one embodiment, the left-ventricular stimulation unit 64 and the left-ventricular sensing unit 66 may be connected to the control unit 54 . In one or more embodiments, the left-ventricular stimulation unit 64 and the left-ventricular sensing unit 66 may function similarly to the stimulation units 56 and 60 and sensing units 58 and 62 as described above. [0057] In at least one embodiment, the heart stimulator 10 may include an activity sensor 72 connected to the control unit 54 . The activity sensor 72 , in one or more embodiments, may detect a signal, for example a motion signal, dependent on the physical activity of a patient and may output a corresponding signal to the control unit 54 indicating the physical activity of the patient. As such, in at least one embodiment, the control unit 54 may adapt the timing of the stimulation pulse to the demand of the patient (haemodynamic demand). [0058] According to at least one embodiment, the heart stimulator 10 may include a memory unit 80 , connected to the control unit 54 , that stores signals generated or evaluated by the control unit 54 . In one or more embodiments, the memory unit 80 may store control programs for the control unit 54 in modifiable form. In at least one embodiment, the control unit 54 may be connected to a timer 82 . [0059] By way of one or more embodiments, the heart stimulator 10 may include at least one bidirectional telemetry interface 84 to transfer stored data from the implant 10 to an external device 100 and, vice versa, to also receive program settings and therapy commands from the external device 100 . [0060] FIG. 4 shows a biventricular three-chamber cardiac pacemaker and implantable cardioverter-defibrillator (ICD) as an implantable cardiac stimulator. As shown in FIG. 4 , the implantable cardiac stimulator 10 ′, in at least one embodiment, is connected via its terminal block 11 (header) to one or more of a right-ventricular electrode line 16 , a left-ventricular electrode line 30 and a right-atrial electrode line 14 . [0061] In one or more embodiments, the electrode lines may be implanted permanently in the heart 12 . In at least one embodiment, the right-ventricular electrode line 16 has at the distal end a bipolar stimulation and sensing electrode with a tip electrode pole RV Tip 18 and ring electrode pole RV Ring 20 . According to at least one embodiment, the electrode line may include a distal shock coil RV Coil 38 and additionally a proximal shock coil SVC Coil 40 . The distal shock coil RV Coil 38 , in at least one embodiment, may be arranged such that it is located in the right ventricle 28 . The proximal shock coil SVC Coil 40 , in at least one embodiment, may be located in the upper part of the right atrium 26 or in the superior vena cava (precava). [0062] By way of one or more embodiments, the electrode line 14 is an atrial electrode line and may include at the distal end a bipolar stimulation and sensing electrode, formed by a tip electrode pole RA Tip 22 and a ring electrode pole RA Ring 24 , implanted in the right atrium 26 . [0063] As shown in FIG. 4 , according to one or more embodiments, the left-ventricular electrode line 30 may include a left-ventricular shock coil 36 to deliver defibrillation shocks to the left ventricle. In at least one embodiment, the shock coil 36 may reach out from the left ventricle 44 as far as the left atrium 46 . In at least one embodiment, the implantable cardiac stimulator 10 ′ may include a second electrode, to deliver a shock, as the electrically active housing 42 of the implant 10 ′. [0064] As shown from FIG. 3 , in at least one embodiment of the invention, according to the components illustrated in a dotted manner, the terminal for the right-atrial tip electrode pole and the terminal for the right-atrial ring electrode pole may be connected to both a right-atrial stimulation unit 60 and to a right-atrial sensing unit 62 , which are each in turn connected to the control unit 54 . In one or more embodiments, the right-atrial stimulation unit 60 may generate stimulation pulses, of which the intensity is sufficient to excite the right-atrial myocardium. In at least one embodiment, the right-atrial stimulation pulses may have a pulse intensity different from the right-ventricular stimulation pulses. The right-atrial sensing unit 62 , in at least one embodiment, may detect a P-wave from the course of the differential signal applied across the inputs thereof, wherein the P-wave represents a natural (intrinsic) contraction of the right atrium. If the right-atrial sensing unit 62 detects a corresponding P-wave, in at least one embodiment of the invention, it generates an output signal and forwards the output signal to the control unit 54 , wherein the output signal represents a natural contraction of the right atrium. [0065] As shown in FIG. 3 , according to the components shown in a dotted manner, the left-ventricular shock coil 36 , as illustrated in FIG. 4 , may be connected to the shock generator 50 via a terminal LV-COIL and an electrode selection unit 52 . Using the electrode selection unit 52 , in one or more embodiments, the control unit 54 may select two or more electrodes (including the conductive housing 42 ), via which a shock is delivered. [0066] According to the heart therapy devices illustrated in FIGS. 2 to 4 , according to at least one embodiment of the invention, the tachycardic ventricular dysrhythmias may be classified simultaneously by the right-ventricular and the left-ventricular electrode line, primarily via the sensed heartbeats, wherein the quicker dysrhythmia primarily determines the therapy selection. At the same time, in at least one embodiment, a check is also performed for a possible dislocation of one of the ventricular electrodes in order to prevent inadequate therapy delivery. If such a dislocation is determined, in one or more embodiments, the relevant, dislocated or possibly dislocated, electrode is no longer used for the tachycardia detection. [0067] FIG. 5 shows a flow diagram illustrating the dislocation identification. In at least one embodiment, the dislocation identification is provided for the biventricular detection and may be carried out by the dislocation identification unit 92 . FIG. 5 shows an example of an LV dislocation identification, that is to say an identification of a dislocation of the left-ventricular electrode, according to at least one embodiment of the invention. [0068] Since the left-ventricular electrode line 30 (and therefore the left-ventricular electrode that surrounds the left-ventricular tip electrode pole LV Tip 34 and the left-ventricular ring electrode pole LV Ring 32 ), in one or more embodiments, may shift within the coronary vein in such a way that the electrode poles 32 and 34 are therefore located in the region of the atrium, it is not ruled out that an atrial tachycardia is incorrectly sensed as a left-ventricular tachycardia, and an inadequate therapy is initiated with biventricular detection (as described further below with reference to FIG. 6 ). [0069] In at least one embodiment, the dislocation identification unit 92 checks a possible dislocation of the left-ventricular electrode as follows: [0070] If the left-ventricular rate lies in a range of a VT/VF zone 310 , and if the right-ventricular rate lies in no zone or in a slower zone 320 , in one or more embodiments, the right-ventricular rate is checked as to whether it has changed significantly at the start of a respective left-ventricular tachycardia 330 . In at least one embodiment, if the right-ventricular rate remains largely unchanged, the heat therapy device thus detects a dislocation of the left-ventricular electrode 350 , and otherwise an actual ventricular arrhythmia 340 . [0071] According to at least one embodiment, to further improve the specificity of the dislocation identification, further electrodes and ECG discharge lines, such as a right-atrial electrode or a far-field ECG, may be used. In one or more embodiments, the criteria for LV dislocation identification may additionally include one or more of the following information for example: maximum anteriority of an LV sense before RV sense; stability check of the A-RV conductor time; comparison of the atrial frequency with the LV frequency or interval time; LV simulation stimulus threshold; LV-R wave morphology analysis; and, QRS far-field analysis (if the FF-QRS morphology remains the same, a dislocation is to be assumed when L-VF is indicated—specifically in the case of atrial fibrillation). [0078] FIG. 6 shows an example of biventricular detection. As shown in FIG. 6 , in at least one embodiment, biventricular detection includes counter logic and is represented as a marker chain. [0079] In one or more embodiments, the detection using the tachycardia identification unit may be performed via just one detection counter, which is incremented whenever an interval falls below the programmed tachycardia zone limit. In at least one embodiment, intervals sensed at the right ventricle and at the left ventricle are used to evaluate which ventricle is quicker using a count interval, wherein a right-ventricular interval is only permitted for the counting whenever it is shorter than or equal to the preceding left-ventricular interval, and a left-ventricular interval is only permitted for the counting whenever it is shorter than the preceding right-ventricular interval. [0080] According to at least one embodiment, the detection counter, implemented in the following example by the function cnt(RV), may increment a counter value by 1 whenever it is addressed: [0000] IF RV ( n )≦ LV ( n− 1) THEN cnt ( RV ); and, [0000] IF LV ( n )< RV ( n− 1) THEN cnt ( RV ); [0081] In one or more embodiments, only the “quicker” ventricle side is therefore always used for the tachycardia evaluation. As shown in FIG. 6 , in at least one embodiment, the interval markers permissible for the tachycardia evaluation are characterized by the following symbol: ↓. [0082] FIG. 7 shows a three-chamber discrimination algorithm with biventricular detection. According to at least one embodiment, the algorithm as shown in FIG. 7 demonstrates one of the possible implementation variants, since the biventricular discrimination may be integrated into any discrimination algorithms. In one more embodiments, the sensitivity and specificity of VT/SVT discrimination (the distinction between original ventricular tachycardias (VT) and supraventricular tachycardias (SVT)) may be improved. [0083] According to at least one embodiment, FIG. 7 illustrates the following symbols: RV: interval time, measured at the right-ventricular electrode; LV: interval time, measured at the left-ventricular electrode; A: interval time, measured at the atrial electrode; AV: atrio-ventricular conductor time (wherein, the algorithm may be extended by a distinction between the right-ventricular and left-ventricular conductor) VT: evaluation of the current ventricle excitation as the ventricular origin of tachycardia; and, SVT: evaluation of the current ventricle excitation as the supraventricular origin of tachycardia. [0090] It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teaching. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention.

A heart therapy device having a right-ventricular electrode and a left-ventricular electrode connected to a tachycardia identification unit. The tachycardia identification unit identifies ventricular tachycardia and simultaneously evaluates the heart rate at the right-ventricular and left-ventricular electrodes. The ventricular electrodes each include an electrode line having a corresponding sensing electrode pole that senses electric potential courses in the myocardium of the respective ventricle. The heart therapy device includes a dislocation identification unit that detects a possible dislocation of one of the ventricular electrodes, simultaneously evaluates the heart rate at both ventricular electrodes, and signals a right-ventricular or left-ventricular dislocation when a sudden rise in heart rate is sensed at the right-ventricular or left-ventricular electrode, without detecting a considerable change in rhythm at the respective electrode. In the event of the dislocation of one of the ventricular electrodes, the rhythm information of the electrode in question is ignored for tachycardia detection.

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to a garden tool having a ground engaging member (for example a tine assembly or a cutter assembly) driven by a motor. The invention is particularly concerned with scarifying or raking tools and with grass cutters. 2. Brief Description of the Prior Art In an existing form of scarifier, the body of the tool is made of a number of metal parts assembled together. In this way, a strong body can be obtained and a compartment for a motor, wheel or roller mountings and other facilities provided on the body without undue difficulty. Such a construction is, however, expensive and also liable to corrode. SUMMARY OF THE INVENTION According to the invention, there is provided a garden tool including a body moulded in one piece from plastics material, the body defining a chamber for receiving a driving motor, and a forward chamber for receiving a scarifying, raking or cutter assembly. By making the body in one piece from plastics material, considerable cost savings are achieved and corrosion problems are eliminated. Preferably, the chamber for receiving the motor and defined by the tool body is upwardly open. A cover may be provided to fit over the top of the motor chamber thereby closing the chamber. This protects the motor from dirt and also protects an operator against accidental contact with the motor. The cover is preferably also moulded in one piece from plastics material. A pair of wheels or a roller may be mounted at the front and/or the back of the body. In one embodiment of the invention, a rear roller is provided below the top of the body in a rearward chamber defined in the body. The wheels or roller may be mounted in openings in the sides of the body. A speed reducing gear box may be drivingly connected between the motor and the scarifying, raking or cutter assembly. The motor and the speed reducing gear box may together define a sub-assembly. The gear box of the sub-assembly may be located outside a side of the body and the motor may project through the side of the body into the chamber. The gear box may be located in an enclosed space defined between the side of the body and a side portion of the cover. The side portion of the cover may include one or more openings providing an air passageway from the enclosed space to the exterior of the tool. A further air passageway may be provided from the exterior of the tool into the chamber. A handle may be mounted on the body. The handle may be mounted at the rear of the tool. Other objects, features and advantages of the present invention will become more fully apparent from the following detailed description of the preferred embodiment, the appended claims and the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS By way of example, a lawn mower scarifier embodying the invention will now be described with reference to the accompanying drawings, of which: FIG. 1 is a perspective view of the lawn scarifier, FIG. 2 is a side view of one side of the main body of the scarifier, FIG. 3 is a side view of the other side of the main body, FIG. 4 is a top plan view of the main body, FIG. 5 is an underneath plan view of the main body, FIG. 6 is a sectional view along the lines VI--VI of FIG. 4, FIG. 7 is a sectional view along the lines VII--VII of FIG. 4, FIG. 8 is an underneath plan view, partly in section of a motor and gear box assembly which is received in the main body, FIG. 9 is a partly cut away end view of the motor and gear box assembly, in the direction of the arrow IX in FIG. 8, FIG. 10 is a plan view of a cover for the main body, FIG. 11 is a side view of the cover, taken in the direction of the arrow XI in FIG. 10, and FIG. 12 is a view, similar to FIG. 1 of the main body of the scarifier, partly brokenaway and with the cover removed. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring first to FIG. 1, a lawn scarifier has a body 1, a handle 2, with a control switch (not shown) but operable by a pivoted lever 3, and a tine assembly 4 rotated in use by a motor and gear box assembly (not visible in FIG. 1 but shown in FIG. 12). The scarifier is supported on a pair of front wheels 5 rotatably mounted on the body 1 and a rear roller 6A (not visible in FIG. 1 but shown in FIG. 12), the height of which may be adjusted by rotating a pair of knobs 6. An electric cable 13 leads from the switch 3 down the handle to the body 1 of the tool. The tine assembly may be as described in British patent application No. 82.36612 (publication No. 2 112 613A) or European patent application No. 80104985.9 (publication No. 0 024 696). The body 1 comprises a main body 7 and a cover of inverted ␣-shape and which has a grooved top portion 9 and 10 depending from the top portion and extending down to the bottom of the body 1. Each of the sides 10 includes an enlarged box part 11 having air vents 12 providing an air passage between the interior of the body 1 and the outside atmosphere. The main body 7 and the cover 8 are each moulded in one piece from plastics material. The shape of the main body 7 will now be described in further detail with reference to FIGS. 1 to 7 and that of the cover 8 with reference to FIGS. 10 and 11. The main body 7 has a front 60, a back 30, similar but not identical sides 14, 15 (the side 14 being shown in FIG. 2 and the side 15 in FIG. 3), and a top which can be divided into three parts: a rear part 16, an upwardly-open central part 17 and a front part 18. The front and central parts are shallowly inclined towards the front of the scarifier while the rear part is more steeply inclined towards the rear of the scarifier. The bottom of the body 7 is open (this being the route by which the main core of the mould is inserted and withdrawn), while the other sides of the body are in general solid, apart from the front part 18 of the top which has an opening in which the tine assembly 4 is mounted and the back 30 which is cut away along much of its length to accommodate the roller. Each of the sides 14, 15 has a substantially circular opening 23 towards the rear in which a respective one of the height adjustment knobs 6 for the rear roller is mounted. As can be seen from FIG. 5, a respective interior side wall 24 is provided parallel to each of the sides 14, 15 at the rear of the main body and each interior wall has an opening 23A (FIG. 6) aligned with the openings 23 and providing a second mounting of the knob 6. The details of the height adjustable rear roller mounting are not relevant to the present invention and will not be described further. The mounting is described in pending British Patent Application No. 84.24499 (publication No. 2147185A). Towards the front of each side 14, 15 a respective circular opening 24 surrounded by an outstanding boss 25 is provided to receive a respective stub axle for a respective one of the wheels 5. On each of the sides 14, 15 there are two further generally circular openings which are coaxial with one another. On the side 14, there is an opening 26 which is located below the central part 17 of the top of the main body and there is an opening 27 coaxial with the tine assembly 4. An air filter 26A (in FIG. 12) is mounted in the opening 26 and a bearing (not shown) for the tine assembly is releasably mounted in the opening 27. The details of the bearing mounting are not relevant to the present invention and will not be described further. On the side 15, there is a circular opening 28 coaxial with the opening 26 in which a part of the motor and gear box assembly shown in FIG. 9 is received as will be described in more detail later, and there is a circular opening 29 coaxial with the opening 27 through which the output drive shaft of the motor and gear box assembly passes from the exterior to the interior of the main body 7, as will be described below. In the centre of the inclined rear part 16 a generally rectangular projecting housing 20 is provided with a central tubular portion 21 in which the handle 2 is mounted. The details of this handle mounting arrangement are not relevant to the present invention and will not be described further. Immediately below the housing 20 is a slightly recessed panel 22 on which the manufacturer's label or nameplate may be fixed. Adjacent to the housing 20 at the top of the rear part 16, a groove 32 is formed in the body providing a passageway into a motor chamber 34 defined by the upwardly open part 17 of the main body and below the cover 8. The cable 13 from the switch 3 passes through this passageway and a cable clamp 33 is provided in the motor chamber 34 where the cable enters the chamber. The motor chamber 34 extends across substantially the entire width of the tool and has a rear wall 35 with an upper sloping portion and a lower upright portion, a bottom wall 36 and a curved front wall 37. Towards the side 15 a transverse wall 38 with an arcuate top (see FIGS. 6 and 7) is provided between walls 35 and 37 and at each end of the wall 38 there are bosses 39 with threaded bores 40. The curved front wall 37 of the motor chamber 34 also defines the rearward boundary of the opening at the front of the tool for the tine assembly 4. The forward boundary of this opening is defined by a vertical wall 41 depending from the front part 18 of the top of the main body. On each side of the front part 18, sockets 42 are provided to receive mounting parts of a collector box (not shown). Referring now also to FIGS. 8 and 9, the motor and gear box assembly generally comprises an electric motor 50, a gear box housing 51, gears 52 and 53 and an output drive shaft 54. The motor 50 is fixed to the gear box housing 51, which is made in two mating parts, and includes a lamination stack 54A, a centrifugal fan 55 and end caps 56. The armature shaft of the motor carries a pinion 57 at one end projecting into the gear box housing 51 and the pinion 57 meshes with teeth 58 formed on a large diameter of the gear 52 which is mounted on a long shaft in the housing. The gear 52 also has a set of teeth 59 meshing with teeth on the gear 53 which is fixed to the output drive shaft 54 passing out through the gear box housing 51 parallel to the motor armature shaft. As shown in FIG. 12, the motor and gear box assembly is mounted on the main body 7 of the tool with the motor inserted into the motor chamber 34 through the opening 28 and the output drive shaft 54 passing through the opening 29 in the side 15 and drivingly connected to the tine assembly 4. The gear box housing 51 is located outside the side 15 immediately adjacent thereto and the side 15 is stepped inwardly below a curved boundry wall 61 (FIG. 3) to accommodate the housing 51. The side 15 is strengthened in the region of the openings 28 and 29 by circular ribs 62 around the openings and interconnecting tangential ribs 63. Holes are provided in lugs 90 on the gear box housing 51 and in corresponding locations in the side 15 to enable the motor and gear box assembly to be secured in position. The motor 50 rests on the arcuate top of the transverse wall 38 in the motor chamber and the electric cable 13 is connected to the motor. When the motor 50 is in position, the cover 8 shown in FIGS. 10 and 11 is secured over the hollow central part 17 of the main body. The cover 8 locates in grooves 64 provided in the tops of the sides 14,15 and is secured in position by screws secured in holes 65 in the sides 14,15 and holes 70 in the cover 8. When a user closes the switch 3, the motor 50 is actuated rotating the tine assembly 4 via the gears 52,53. The fan 55 draws air in through the vents 12 of the cover 8 over the side 14, through the air filter 26A in the side 14 and into the motor chamber 34. Air is discharged by the fan into the space between the cover 8 and the side 15 of the body and passes out of the tool through the vents 12 on that side of the cover. The main body 7 of the scarifier described above, being moulded in one piece from plastics material, is comparatively simple and inexpensive to produce, and the use of plastics material results in a main body 7 which is comparatively lightweight and will not corrode, so that the scarifier is easy to handle and is also easy to maintain. The structure of the main body 7 (in particular, the provision of the various walls defining the motor chamber and the tine assembly chamber) ensures that the body is sufficiently robust despite its lightweight. Moreover, assembly of the scarifier is faciliated since the structure provides, in a simple manner, a location for the various components of the scarifier including, in particular, a compartment 34 in which the motor can be completely enclosed by the provision of the cover 8 and thereby protected.

A motor driven lawn scarifier or cutter has a body which houses the motor and the scarifying/cutter assembly and also wheel or roller mountings. With a view to simplifying manufacture and assembly of the tool and eliminating corrosion problems, the body is moulded in one piece from plastics material and is shaped to provide a chamber (34) for the motor (50) and a forward chamber for the scarifying/cutter assembly (4). A roller (6A), located in a rearward chamber in the body, is mounted in openings (23) in the sides of the body and wheels (5) are mounted in openings (24) at the front of the body. A cover (8) which is also moulded in one piece from plastics material closes the motor chamber (34).

RELATED APPLICATIONS [0001] This application is a divisional of co-pending U.S. patent application Ser. No. 10/653,448, filed Sep. 2, 2003, which claims the benefit of U.S. patent application Ser. No. 09/556,169, filed Apr. 21, 2000, (now U.S. Pat. No. 6,645,201) entitled “Systems and Methods for Treating Dysfunctions in the Intestines and Rectum,” which are incorporated herein by reference. FIELD OF THE INVENTION [0002] The invention relates generally to systems and methods for treating interior tissue regions of the body. In particular, this invention relates to the treatment of hemorrhoids. BACKGROUND OF THE INVENTION [0003] Hemorrhoids are cushions of tissue and varicose veins located in and around the rectal area. Hemorrhoids are very common, especially during pregnancy and after childbirth. It has been estimated that about half the population has hemorrhoids by age 50. They are caused by increased pressure in the veins of the anus. The most common cause is straining during bowel movements. Constipation, prolonged sitting during bowel movements, and anal infection may also contribute to the development of hemorrhoids. In some cases, hemorrhoids may be a manifestation of other diseases, such as liver cirrhosis. [0004] Symptoms of hemorrhoids include rectal bleeding, particularly after bowel movements, pain during bowel movements, anal itching, mucus discharge, epithelial cell changes, thrombosis, incarcerations, skin tags, and disordered defecation. Symptoms may range from mild to severe. [0005] In many cases, hemorrhoids are diagnosed by rectal examination. However, stool guaiac testing for the presence of occult blood, as well as sigmoidoscopy, anoscopy, and proctoscopy procedures may also be useful in establishing a diagnosis. [0006] Treatment is generally based on the severity of symptoms. Mild cases may be controlled by conservative, non-invasive techniques such as drinking fluids, adhering to a high-fiber diet, use of stool softeners, and/or use of stool-bulking agents such as fiber supplements. In addition, treatments for symptomatic relief may include corticosteroid cream and/or warm baths to reduce pain and swelling. [0007] For more severe cases involving severe pain and itching in patients who have not responded to conservative therapy, surgical intervention may be required to prevent more serious complications. For example, frequent or prolonged bleeding may result in iron deficiency anemia. [0008] Conventional surgical techniques may be generally classified in three categories as being directed to either the anal sphincter, the hemorrhoidal tissue, or to the hemorrhoid feeding vessels. Surgical procedures directed to stretching or cutting of the internal anal sphincter include Lord's procedure, incisional sphincterotomy, and closed lateral anal sphincterotomy. However, these procedures may result in incontinence and thus are rarely indicated. [0009] Surgical procedures directed to hemorrhoidal tissue include excisional hemorrhoidectomy and laser-assisted hemorrhoidectomy. Such procedures are relatively invasive and thus have a longer recovery period. [0010] Surgical procedures directed to the feeder vessels include elastic or rubber band ligation, sclerosis, and photocoagulation. These procedures are associated with a variety of complications, including infection, hemorrhage, ulceration, oleogranuloma, allergic reaction, and prostate infection. [0011] The need remains for minimally-invasive systems and methods for treating hemorrhoids. SUMMARY OF THE INVENTION [0012] The invention provides systems and methods that treat hemorrhoids. The systems and methods introduce a treatment device into the anal canal to extend above a hemorrhoidal plexus and adjacent a tissue region containing blood vessels that feed the hemorrhoidal plexus. The systems and methods operate the treatment device to affect tissue morphology in the tissue region to occlude or otherwise reduce blood flow through the vessels. BRIEF DESCRIPTION OF THE DRAWINGS [0013] FIG. 1 is an anatomical view of the rectum and anal canal. [0014] FIG. 2 is a section view taken along line 2 - 2 in FIG. 1 . [0015] FIG. 3 is an anatomical view of an external hemorrhoid. [0016] FIG. 4 is an anatomical view of an internal hemorrhoid. [0017] FIG. 5 is an anatomical view of a mixed internal and external hemorrhoid. [0018] FIG. 6 is a schematic view of a system for treating hemorrhoids that includes a treatment device with a tissue-piercing member. [0019] FIG. 7 illustrates a treatment device deployed in the anal canal with the tissue-piercing member in a retracted position. [0020] FIG. 8 is a view similar to FIG. 7 and illustrating the tissue-piercing member piercing tissue containing blood vessels that feed the internal and external hemorrhoidal plexes. [0021] FIG. 9 illustrates a treatment device with multiple tissue-piercing members deployed in the anal canal and having multiple tissue-piercing members in a retracted position. [0022] FIG. 10 is a view similar to FIG. 9 and illustrating the tissue-piercing members piercing tissue containing blood vessels that feed the internal and external hemorrhoidal plexes. [0023] FIG. 11 illustrates the shrinkage of tissue in a feeder vessel region that occludes or otherwise reduces flow through the feeder vessels. DESCRIPTION OF THE PREFERRED EMBODIMENT [0024] Although the disclosure hereof is detailed and exact to enable those skilled in the art to practice the invention, the physical embodiments herein disclosed merely exemplify the invention which may be embodied in other specific structure. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims. [0000] I. Anatomy of the Rectum and Anal Canal [0025] As FIG. 1 shows, the rectum 10 is the terminal part of the large intestine 12 . The rectum 10 extends from the sigmoid flexure 14 (which is the narrowest part of the colon) to the anal orifice 16 . The rectum 10 is about 15 to 17 cm in overall length. [0026] The lower or inferior portion of the rectum 10 is called the anal canal 18 . It typically extends about 4 to 5 cm above the anal orifice 16 . A visible line of demarcation between tissue, called the pectinate (dentate) line 20 , exists about 2.5 to 3 cm above the anal orifice 16 . [0027] As best seen in FIG. 2 , feeder vessels 22 descend to the anal canal 18 in three locations, the right posterior (RP), right anterior (RA), and left posterior (LP). Each of the three locations (RP, RA, and LP) then splits to form an internal hemorrhoidal plexus (or cushion) 24 (see FIG. 3 ) located above the dentate line 20 and an external hemorrhoidal plexus (or cushion) 26 located below the dentate line 20 . That is, there are three internal hemorrhoidal plexes 24 (RP, RA, and LP) located above the dentate line 20 and three external hemorrhoidal plexes 26 (RP, RA, and LP) located below the dentate line 20 . [0028] Increased pressure in the veins of the anus causes the enlargement and swelling of one or more hemorrhoidal plexes 24 or 26 . This inflamed state is commonly referred to as a hemorrhoid (or pile). When the inflammation occurs in a hemorrhoidal plexus 26 below the dentate line 20 at the anal opening 16 , it is referred to as an external hemorrhoid, shown in FIG. 3 . When the inflammation occurs in a hemorrhoidal plexus 24 above the dentate line 20 near the beginning of the anal canal 18 , it is referred to as an internal hemorrhoid, shown in FIG. 4 . In some cases, a mix of internal and external hemorrhoids may be present, as illustrated in FIG. 5 . A hemorrhoid may even protrude outside the anus. [0029] It should be noted that the views of the rectum 10 and anal canal 18 shown in FIG. 1 , and elsewhere in the drawings, are not intended to be strictly accurate in an anatomic sense. The drawings show the rectum 10 and anal canal 18 in somewhat diagrammatic form to demonstrate the features of the invention. [0000] II. System Overview [0030] A tissue treatment system 28 that embodies features of the invention is shown in FIG. 6 . The tissue treatment system 28 includes a tissue treatment device 30 . The treatment device 30 is sized and configured to affect tissue morphology above the dentate line 20 , to occlude or otherwise reduce blood flow through one or more feeder vessels for one or both hemorrhoidal plexus 24 or 26 . [0031] The treatment device 30 can affect tissue morphology by different physiologic mechanisms. For example, the treatment device 30 can serve to inject an agent used to seal vascular access sites, e.g., collagen or PEG hydrogel material—or to place a material that cause blood to clot, e.g., platinum coils deployed at the site of an aneurysm. In the illustrated embodiment, heat is applied to shrink tissue. In this arrangement, the treatment device 30 is coupled to a source of energy 32 by cable 33 . If desired, the system 28 can also include certain auxiliary processing equipment. In the illustrated embodiment, the auxiliary processing equipment comprises an external fluid delivery or irrigation source 34 coupled to the treatment device 30 by tubing 35 . [0032] A. The Tissue Treatment Device [0033] The tissue treatment device 30 serves to deliver energy to tissue regions at or near feeder vessels 22 above the internal or external hemorrhoidal plexes 24 and 26 to occlude or otherwise reduce the blood supply to the hemorrhoidal plexes 24 and 26 . In the illustrated embodiment, the energy source 32 supplies radiofrequency energy. It is contemplated that other forms of energy can be applied, e.g., coherent or incoherent light, heated or cooled fluid, resistive heating, microwave, ultrasound, a tissue ablation fluid, or a cryogenic fluid. Energy is delivered submucosally to heat targeted feeder vessel regions to create scar tissue and shrink tissue, thereby occluding or otherwise reducing blood flow through a vessel or vessels 22 . By occluding or otherwise reducing blood supply from above the hemorrhoidal plexes 24 or 26 , blood is essentially prevented from pooling in the vessels 22 and the hemorrhoidal plexes 24 or 26 . Since blood is prevented from pooling, hemorrhoids are shrunk or prevented. [0034] As FIG. 6 shows, the tissue treatment device 30 includes a handle or hand grip 36 that carries an operative element 38 . In the illustrated embodiment, the operative element 38 takes the form of a hollow tubular barrel 40 , although it should be appreciated that a semi-circular device, e.g., shaped like curved tongue depressor, could be used as well. In the illustrated embodiment, the barrel 40 may be made from a transparent, molded plastic material or other suitable material to enable visualization through the barrel 40 . The barrel 40 terminates with a blunt, rounded distal working end 42 to aid passage of the barrel 40 through the anal canal 18 without need for a separate introducer. The hand grip 36 desirably includes a viewing port 44 for looking into the transparent, hollow interior of the barrel 40 to visualize surrounding tissue. [0035] The hand grip 36 and operative element 38 can form an integrated construction intended for single use and subsequent disposal as a unit. Alternatively, the hand grip 36 can comprise a nondisposable component intended for multiple uses. In this arrangement, the operative element 38 comprises a disposable assembly, which the physician releasably connects to the hand grip 36 at the time of use and disconnects and discards after use. The proximal end of the barrel 40 can, for example, include a male plug connector that couples to a female plug receptacle on the hand grip 36 . [0036] With reference to FIGS. 7 and 8 , a tissue-piercing member 46 is movably contained within the barrel 40 . In the illustrated embodiment, the tissue-piercing member 46 takes the form of a needle electrode. The electrode 46 is selectively movable between a retracted position ( FIG. 7 ) and an extended position ( FIG. 8 ). Means are provided for moving the electrode 46 between the retracted and extended positions. For example, the needle electrode 46 can be mechanically linked to a finger-operated pull lever 48 on the hand grip 36 . By operation of the pull lever 48 , the distal ends of the needle electrodes 46 are moved between the retracted position and the extended position. An electrical insulating material 50 is desirably coated about the needle electrodes 46 , except for a prescribed region of the distal ends, where radio frequency energy is applied to tissue. [0037] In an alternate embodiment, the operative element 38 carries an array of needle electrodes 46 . The array of electrodes 46 is configured to deliver energy in a prescribed pattern to a targeted treatment site. It is contemplated that the number and placement of electrodes 46 can vary as needed for the desired procedure and to accommodate individual anatomy. FIGS. 9 and 10 illustrate an embodiment in which a pair of needle electrodes 46 is movably contained in a side-by-side relationship on the barrel 40 . [0038] The barrel 40 also preferably carries temperature sensor 52 , one of which is associated with each needle electrode 46 . The sensors 52 sense tissue temperature conditions in the region adjacent to each needle electrode 46 . Preferably, the distal end of each needle electrode 46 also carries a temperature sensor 54 . [0039] In an optional embodiment, the treatment agent delivery apparatus 30 may convey processing fluid from a fluid source 34 for discharge at or near the treatment site. The processing fluid can comprise, e.g., saline or sterile water, to cool surface tissue while energy is being applied by the electrode 46 to thereby protect the surface tissue from thermal injury. For example, as seen in FIG. 6 , barrel 40 may be coupled via tubing 35 to the fluid source 34 to convey fluid, e.g., through holes (not shown) in the barrel 40 , to contact tissue at a localized position surrounding the electrodes 46 . Alternatively, one or more electrodes 46 deployed by the operative element 38 can also be used to inject the fluid into the treatment site. In this arrangement, the electrode 46 includes an interior lumen (not shown) and the fluid source 34 is coupled to the lumen. [0000] III. System Use [0040] In use, the physician grasps the hand grip 36 and guides the barrel 40 into the anal canal 18 (see FIGS. 7 and 9 ). The pull lever 48 is in the neutral position and not depressed, so the needle electrodes 46 occupy their normal retracted position. Looking through the viewing port 44 , the physician visualizes the pectinate (dentate) line 20 through the barrel 40 . Looking through the barrel 40 , the physician positions the distal ends of the needle electrodes 46 at a desired location above the pectinate (dentate) line 20 , e.g., 2-4 cm above the dentate line 20 . A fiberoptic can also be inserted into the barrel 40 to provide local illumination, or the physician can wear a headlamp for this purpose. In an embodiment where the barrel is not completely circumferential, but more U-shaped (thereby not occupying the entire anal canal 18 ), an endoscope or mirrors may be used to acquire visualization of the dentate line 20 . [0041] It may be desirable to bias the end of the treatment device 30 with a bend, to thereby facilitate contact with tissue in this region of the anal canal, as tissue in this region tends to be loose or flaccid. An expandable member may be desired to dilate tissue in this region in concert with use of the treatment device 30 . [0042] Once the distal end of the barrel 40 is located at the targeted site, the physician depresses the pull lever 48 . The needle electrodes 46 advance to their extended positions (see FIGS. 8 and 10 ). The distal ends of the electrodes 46 pierce and pass through the mucosal tissue adjacent the targeted feeder vessel region without penetration of a hemorrhoidal plexus 24 or 26 . The physician applies radio frequency energy through the needle electrodes 46 . The energy can be applied simultaneously by all electrodes 46 , or in any desired sequence, to apply energy in a selective fashion to a targeted feeder vessel region below mucusal tissue. The applied energy creates one or more lesions, or a prescribed pattern of lesions, below the mucosal surface. The electrodes 46 are then retracted, and the device 30 withdrawn. [0043] If desired, the process may be repeated to form a desired lesion pattern at a single location or at multiple locations. With the electrodes 46 in the retracted position, the operative element 38 may be rotated and/or axially advanced or retracted. The electrodes 46 are then advanced to their extended position and energy is again applied to form a lesion or series of lesions. The lesion pattern may be along a particular feeder vessel region for treatment of a single hemorrhoidal plexus 24 or 26 . Alternatively, the lesions may be created in multiple feeder vessel regions for treatment of multiple hemorrhoidal plexes 24 or 26 . For example, FIG. 11 illustrates the formation of a pair of lesions 58 A in a first internal hemorrhoidal plexus 24 A, and a second pair of lesions 58 B in a second internal hemorrhoidal plexus 24 B. As FIG. 11 also illustrates, the lesions 58 A and 58 B occlude or otherwise reduce, at least in part, blood flow through the feeder vessels 22 and thereby occlude or otherwise reduce the blood supply from above the hemorrhoidal plexes 24 A and 24 B. As a result, blood is essentially prevented from pooling in the vessels 22 and the hemorrhoidal plexes 24 A and 24 B. Since blood is prevented from pooling, hemorrhoids are shrunk or prevented. By targeting selected feeder vessel regions, the procedure can be adapted for the treatment of a single or multiple internal hemorrhoids, a single or multiple external hemorrhoids, or a combination of internal and external hemorrhoids. [0044] The foregoing is considered as illustrative only of the principles of the invention. Furthermore, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.

Systems and methods treat hemorrhoids by introducing a treatment device into the anal canal to extend above a hemorrhoidal plexus and adjacent a tissue region containing blood vessels that feed the hemorrhoidal plexus. The systems and methods operate the treatment device to affect tissue morphology in the tissue region to occlude or otherwise reduce blood flow through the vessels.

BACKGROUND AND OBJECTS 1. Field of the Invention The present invention relates to an enclosed sanitary facility for animals, and more particularly to an enclosed indoor commode for use by cats. 2. Description of the Prior Art It is well known to provide indoor toilet facilities for household pets, particularly cats. Such facilities are normally used to contain a loose, absorbent material, such as granulated clay, for receiving animal excretions. The material is commonly referred to as litter. It has previously been known to provide litter containers which are completely enclosed but which include an opening for providing access for the animal to the enclosed space. Examples of completely enclosed litter containers are found in U.S. Pat. No. 3,246,630 to Dearing et al, U.S. Pat. No. 3,885,523 to Coleman, and U.S. Pat. No. 394,258, filed Sept. 5, 1973, and now abandoned. These devices include upper and lower enclosure portions which are removably joined together. The lower enclosure portion contains the litter, and the upper enclosure portion may be separated therefrom to allow for cleaning of the container and changing of the litter. A drawback of some known devices having separable upper and lower enclosure portions is that certain pets have a tendency to spray urine against the inside walls of the container. This urine may leak from the joint between the enclosure portions to the exterior of the container and it may also collect in the region of the joint and cause odor problems. Preventing urine from collecting in the joint or leaking therefrom conflicts with providing low cost construction, ease of separability of the enclosure portions and use of a resilient, unbreakable, thin walled material in the construction of the container. While the aforementioned U.S. Patent to Coleman shows a construction which may minimize the problem of urine leakage or collection of urine in the joints between the enclosure portions, the construction does not provide the advantages of simplicity, low cost, ease of manufacturing, ease of separation of the enclosure portions, and use of a resilient material in construction. In this regard, it is advantageous to provide a device wherein each enclosure portion has a one-piece construction and is molded from low density polyethylene or other resilient plastic material. In such a device it is desirable to provide a widened flange or widened rim portion on each enclosure portion. The rim and flange strengthen and add rigidity to the enclosure portions and provide a relatively rigid bearing region for joining the two enclosure portions together. Also, the widened rim portion on the upper enclosure portion, particularly when it fits over the outside of the widened flange portion of the lower enclosure portion, as here, provides a desirable handle or gripping surface for removing the upper enclosure portion from the lower enclosure portion to clean the litter container. It is also desirable, in a construction of the foregoing type, to provide a relatively free fit between the upper and lower enclosure portions. This provides ease of manufacturing and lower cost. It also ensures easy separability of the upper enclosure portion from the lower enclosure portion. This type of free fitting construction, however, while having important advantages, may lead to the urine collection and urine leakage problem discussed above. OBJECTS OF THE INVENTION It is therefore an object of the present invention to overcome the foregoing drawbacks and provide a litter container having upper and lower enclosure portions which may fit together relatively freely or loosely so as to be easily separated from each other but wherein urine is prevented from escaping or collecting in the joint between the enclosure portions. It is a further object of the invention to provide an animal litter container which is of a simple and inexpensive construction with easily separable upper and lower enclosure portions and wherein urine is prevented from escaping from or collecting in the joint between the enclosure portions. It is a further object of the invention to provide an animal litter container wherein urine entering the region of the joint between the upper and lower enclosure portions is directed away from the joint and toward the bottom of the lower enclosure portion which contains the litter. It is another object of the invention to provide an animal litter container with widened rims or flanges which both provide a bearing region for joining the upper and lower enclosure portions together, provide a handle or gripping area for easy separability of the enclosure portions, and which also direct urine toward the bottom of the lower enclosure portion and away from the bearing area in the joint between the two enclosure portions. It is a further object of the invention to provide an animal litter container having easily separable enclosure portions which may be constructed entirely of a resilient, plastic material and wherein urine is prevented from escaping from or collecting in the joint between the enclosure portions. These, and other objects, advantages, and features of the present invention will be apparent from the specification which follows and from the drawing. SUMMARY To overcome the drawbacks of the prior art and to achieve the foregoing objects, the litter container of the present invention includes upper and lower enclosure portions which define an enclosed space when coupled together. One of the enclosure portions includes a means for providing access for an animal to the enclosed space. Also included is means between the upper and lower enclosure portions for coupling the enclosure portions together, the upper enclosure portion including a portion projecting into the enclosed space. This projecting portion extends substantially entirely around the upper enclosure portion and has a free extremity which is spaced from the coupling means. The upper enclosure portion includes a main body portion and a widened rim portion disposed outwardly of the main body portion. The widened rim portion extends about the entire periphery of the upper enclosure portion, one part of the widened rim portion providing the projecting portion. The projecting portion may take the form of a downwardly convex convolution in the widened rim portion, the crest or vertex of the convolution providing the aforementioned free extremity. The widened rim portion also includes a bearing portion which engages with an upper edge of the lower enclosure portion to provide the coupling between the enclosure portions. The bearing portion of the upper enclosure portion is disposed outwardly of the projecting portion in the widened rim portion and at a level above the projection portion. The bearing portion is provided by a downwardly concave convolution in the widened rim portion, and the vertex of this convolution provides the bearing portion against which the upper edge of the lower enclosure portion engages. When urine is directed into the region between the upper and lower enclosure portions, it will flow by gravity to the free extremity or vertex of the projecting portion and drip therefrom. Since the bearing portion is spaced outwardly of the free extremity of the projecting portion, urine cannot flow to the bearing portion. The lower enclosure portion includes a main container portion and a widened flange portion, the widened flange portion extending about the entire periphery of the lower enclosure portion. The widened flange portion includes an outwardly extending shoulder, and a generally vertical flange wall with an upper edge. The upper edge bears against the bearing portion of the upper enclosure portion to couple respective portions together. The outwardly extending shoulder has an undulating configuration which includes an inner, upwardly bowed portion adjacent the main container portion and an outer, downwardly bowed portion adjacent the outer, vertical flange wall. A plurality of downwardly and inwardly sloping channels extend from the downwardly bowed portion of the shoulder, through the upwardly bowed portion thereof, and to the main container portion. Urine dripping from the free extremity of the projecting portion on the upper enclosure portion will enter into the downwardly bowed portion of the widened flange on the lower enclosure portion and will drain through the channels into the litter containing cavity of the lower enclosure portion. Each of the enclosure portions is of a one-piece construction. The enclosure portions are molded from a resilient plastic material, preferably low density polyethylene. BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is a front elevation of the animal litter container of the present invention; FIG. 2 is a plan view of the animal litter container of FIG. 1; FIG. 3 is a plan view of the lower enclosure portion of the animal litter container of FIG. 1 with the upper enclosure portion removed; FIG. 4 is a horizontal sectional view taken on the line 4--4 of FIG. 2. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT In the following description and in the drawing, like reference characters refer to like features or elements among the various figures of the drawing. Referring to the drawing, the overall animal litter container is generally referred to by reference character 10. The container includes an upper enclosure portion 12 and a lower enclosure portion 14. Enclosure portions 12, 14 may be coupled together as shown in FIGS. 1 and 4 to define a space which is completely enclosed except for an opening 16, which opening provides access for an animal to the enclosed space. Upper enclosure portion 12 includes a top wall 18, a front wall 20, oppositely disposed side walls 22, and a rear wall 24. Opening 16 is in the front wall 20. Together walls 18, 20, 22 and 24 define a cavity 26 (see FIG. 4) which forms part of the enclosed space defined by the overall container 10. Walls 18, 20, 22 and 24 form the main body portion 28 of upper enclosure portion 12. Extending outwardly from main body portion 28 is a widened rim portion 30. Widened rim portion 30 extends entirely around the periphery of upper enclosure portion 12. Widened rim portion 30 includes a downwardly projecting portion 32 (see FIG. 4) extending entirely around the upper enclosure portion. Projecting portion 32 includes a free extremity 34 disposed in the enclosed space formed by the upper and lower enclosure portions 12, 14. Free extremity 34 is spaced inwardly from the joint or coupling between the enclosure portions. As will be apparent from FIG. 4, projecting portion 32 is defined by a downwardly convex convolution in widened rim portion 30 of upper enclosure portion 12. As will also be apparent from FIG. 4, the free extremity 34 of projecting portion 32 is provided by the vertex or crest of the downwardly convex convolution which forms projecting portion 32. The litter container 10 includes a coupling or joint 36 between the upper and lower enclosure portions. Coupling 36 is provided, in part, by a downwardly concave convolution 38 in the widened rim portion. As will be apparent from FIG. 4 downwardly concave convolution 38 is disposed outwardly of projecting portion 32. Convolution 38 extends entirely around the periphery of upper enclosure portion 12, entirely outside projecting portion 32. The vertex of downwardly concave convolution 38 provides a bearing portion 40 in the upper enclosure portion 12. An upper edge 42 of lower enclosure portion 14 abuttingly engages bearing portion 40 to provide the coupling 36 between enclosure portions 12, 14. Bearing portion 40 extends around upper enclosure portion 12 interiorly of and at a level above the level of free extremity 34 of projecting portion 32. That is, the free extremity or vertex 34 is spaced inwardly from bearing portion 40 and disposed therebelow. Widened rim portion 30 of upper enclosure portion 12 includes an outer vertical rim wall 44, the bottom edge of which has an inwardly extending lip 46 which extends around the entire upper enclosure portion 12. Lower enclosure portion 14 includes a front wall 48, oppositely disposed side walls 50, a rear wall 52 and a bottom wall 54. Together these walls form a cavity 56 (FIG. 4). Cavity 56 forms part of the enclosed space defined by the overall litter container 10. The litter or other absorbent and/or loose material for receiving animal excretions will be contained in cavity 56. A set of surface engaging feet 58 extend downwardly from bottom wall 54. Walls 48, 50, 52 and 54 form a main container portion 59 of lower enclosure portion 14. Extending outwardly from main container portion 59 is a widened flange portion 60. Widened flange portion 60 extends about the entire periphery of lower enclosure portion 14 at the upper end thereof, i.e. the end which engages with the lower end of upper enclosure portion 12. Widened flange portion 60 includes an outwardly extending shoulder 62 and an upstanding vertical flange wall 64. The top of vertical flange 64 forms the aforementioned upper edge 42 which engages with the bearing portion 40 of upper enclosure portion 12 to couple the enclosure portions together. As will be apparent from FIG. 4, the shoulder 62 of widened flange portion 60 has an undulating configuration including an inner, upwardly bowed portion 66 adjacent main container portion 59, and an outer, downwardly bowed portion 68 adjacent vertical flange wall 64. A plurality of downwardly and inwardly sloping channels 70 extend from downwardly bowed portion 68 of widened flange portion 60, through upwardly bowed portion 66 thereof, and to the main container portion 59. Urine, entering into the downwardly bowed portion 68 extending around the lower enclosure portion, will drain through channel 70 into cavity 56 which contains the litter. Each enclosure portion is of a one-piece molded construction. That is, walls 18, 20, 22 and 24 and widened rim portion 30 of upper enclosure portion 12 are all of one piece. Likewise, walls 48, 50, 52, and 54, feet 58, and widened flange portion 60 of lower enclosure 14 are all of one piece. Also, each enclosure portion consists, overall, of a one-piece wall of substantially uniform thickness. Each enclosure portion is constructed entirely of a resilient plastic material, preferably low density polyethylene. The structure described above is particularly suitable for litter containers constructed of such materials, i.e. resilient plastic materials. Such materials have the advantages of ease of molding and unbreakability. Use of resilient plastic materials, however, calls for a construction which will render the respective enclosure portions somewhat rigid in the region where they are coupled together and a construction which is free from close tolerance requirements. Widened rim portion 30 of upper enclosure portion 12 and widened flange portion 60 of lower enclosure 14 achieve the desired rigidity. At the same time, the construction and configuration of the upper and lower enclosure portions in the regions of rim and flange portions 30, 60 is such as to provide relatively freely fitting parts for ease of separation, while at the same time preventing leakage of urine from or collection of urine in the joint between the sections. In this latter regard, any urine sprayed by an animal against the walls of upper enclosure portion 12 and adhering thereto by surface attraction, or any urine sprayed into the region of the joint between the enclosure portions 12, 14, will flow to the free extremity 34 of projecting portion 32 and drip therefrom into the trough formed by the downwardly bowed portion 68 of lower enclosure portion 14. From there the urine will flow through the sloping channel 70 into the cavity 56 containing the litter. Because the portion of widened rim 30 disposed immediately outwardly of projecting portion 32 is at a level above free extremity 34 urine cannot flow upwardly and thence into the region of the joint between the sections. That is, the projecting portion 32, and in particular the free extremity 34 thereof, is spaced from the coupling means between the upper and lower enclosure portions, and this spacing prevents urine from flowing into the coupling means. In this instance, the coupling means includes the bearing portion 40 of the upper enclosure portion 12 and the upper edge 42 of the lower enclosure portion 14. In the preferred embodiment, these are located at a level above the free extremity 34 of the projecting portion 32. In the preferred embodiment, the inwardly extending lip 46 of the outer vertical rim wall 44 of upper enclosure portion 12 engages the vertical flange wall 64 of the lower enclosure portion 14. The lip 46 maintains a spacing or at least a looseness between the major surfaces of rim wall 44 and flange wall 64, as will be apparent from FIG. 4. At the same time, however, lip 46 resiliently and grippingly engages vertical flange wall 64 to hold the enclosure portions together by the force of friction. That is, the lip both maintains a certain degree of freedom between rim 44 and flange 64 to permit relatively easy disengagement of the upper and lower enclosure portions when desired, yet at the same time the lip 46 provides a sufficient grip to normally hold the upper and lower enclosure portions together. The term "enclosed space," when used herein to refer to the space defined by the upper and lower enclosure portions when joined together, includes not only the upper and lower cavities 26, 56 but also the interior space 72 (FIG. 4) extending around the litter container and defined by widened rim portion 30 and widened flange portion 60. It will be understood that the foregoing specification describes only a preferred embodiment which exemplifies the invention, and many modifications, variations, and other embodiments are possible. The invention, of course, is limited only by the scope of the appended claims.

An enclosed litter container for animals, the container having upper and lower enclosure portions coupled together to provide an enclosed space. The upper enclosure portion has an opening therein to provide access for an animal to the enclosed space. The lower enclosure portion defines a cavity for containing litter. The upper enclosure portion includes a widened rim portion, and the lower enclosure portion includes a mating widened flange portion. Part of the widened rim portion of the upper enclosure portion includes a downwardly convex convolution having a vertex or free extremity extending into the enclosed space. The construction prevents urine from collecting in and/or escaping from the joint between the enclosure portions. A series of downwardly sloped channels in the widened flange portion of the lower enclosure portion help direct the urine toward the litter.

RELATED APPLICATIONS This application is a national phase application of PCT Application PCT/US2007/004193, filed Feb. 15, 2007, and published in English on Aug. 30, 2007, as International Publication No. WO 2007/098053, and which claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application Ser. No. 60/774,442, filed Feb. 17, 2006, U.S. Provisional Patent Application Ser. No. 60/774,587, filed Feb. 17, 2006, and U.S. Provisional Patent Application Ser. No. 60/774,920, filed Feb. 17, 2006, the disclosures of each of which is incorporated herein by reference in its entirety. This application is related to: Mark E. Van Dyke, U.S. patent application Ser. No. 11/205,800, titled: Ambient Stored Blood Plasma Expanders, filed Aug. 17, 2005, and published on Mar. 9, 2006, as 2006/0051732; Mark E. Van Dyke, U.S. patent application Ser. No. 11/673,212, titled: Nerve Regeneration Employing Keratin Biomaterials, filed Feb. 9, 2007, and published on Dec. 27, 2007, as 2007/0298070; and Mark E. Van Dyke, U.S. patent application Ser. No. 11/676,072, and PCT Application (published Aug. 30, 2007 as W02007/098114), titled: Clotting and Healing Compositions Containing Keratin Biomaterials, filed Feb. 16, 2007. GOVERNMENT SUPPORT This invention was made with Government support under contract number W81XWH-04-1-0105 from the United States Army. The U.S. Government has certain rights to this invention. FIELD OF THE INVENTION The present invention is generally related to keratin biomaterials and the use thereof in biomedical applications. BACKGROUND OF THE INVENTION The earliest documented use of keratin in medicine comes from a Chinese herbalist named Li Shi-Zhen (Ben Cao Gang Mu. Materia Medica, a dictionary of Chinese herbs, written by Li Shi Zhen (1518-1593)). Over a 38-year period, he wrote a collection of 800 books known as the Ben Cao Gang Mu . These books were published in 1596, three years after his death. Among the more than 11,000 prescriptions described in these volumes, is a substance known as Xue Yu Tan, also known as Crinis Carbonisatus, that is made up of ground ash from pyrolized human hair. The stated indications for Xue Yu Tan were accelerated wound healing and blood clotting. In the early 1800s, when proteins were still being called albuminoids (albumin was a well known protein at that time), many different kinds of proteins were being discovered. Around 1849, the word “keratin” appears in the literature to describe the material that made up hard tissues such as animal horns and hooves (keratin comes from the Greek “kera” meaning horn). This new protein intrigued scientists because it did not behave like other proteins. For example, the normal methods used for dissolving proteins were ineffective with keratin. Although methods such as burning and grinding had been known for some time, many scientists and inventors were more interested in dissolving hair and horns in order to make better products. The resolution to this insolubility problem came from a trade more than 700 years old—the tanning industry. In the years preceding World War I, lime was applied to the manufacture of keratin gels. In a United States patent issued in 1905, John Hoffmeier described a process for extracting keratins from animal horns using lime (German Pat No. 184,915, Dec. 18, 1905). He then used the extracted keratins to make gels that could be strengthened by adding formaldehyde (formaldehyde “crosslinking” is a popular method of strengthening such gels and is still used today to “fix” tissues containing structural proteins like keratin and collagen). During the years from 1905 to 1935, many methods were developed to extract keratins using oxidative and reductive chemistries (Breinl F and Baudisch O, Z physiol Chem 1907; 52:158-69; Neuberg C, U.S. Pat. No. 926,999, Jul. 6, 1909; Lissizin T, Biochem Bull 1915; 4:18-23; Zdenko S, Z physiol Chem 1924; 136:160-72; Lissizin T, Z physiol Chem 1928; 173:309-11). By the late 1920s many techniques had been developed for breaking down the structures of hair, horns, and hooves, but scientists were confused by the behavior of some of these purified proteins. Scientists soon concluded that many different forms of keratin were present in these extracts, and that the hair fiber must be a complex structure, not simply a strand of protein. In 1934, a key research paper was published that described different types of keratins, distinguished primarily by having different molecular weights (Goddard DR and Michaelis L, J Biol Chem 1934; 106:605-14). This seminal paper demonstrated that there were many different keratin homologs, and that each played a different role in the structure and function of the hair follicle. It was during the years of World War II and immediately after that one of the most comprehensive research projects on the structure and chemistry of hair fibers was undertaken. Driven by the commercialization of synthetic fibers such as Nylon and polyester, Australian scientists were charged with protecting the country's huge wool industry. Synthetic fibers were seen as a threat to Australia's dominance in wool production, and the Council for Scientific and Industrial Research (later the Commonwealth Scientific and Industrial Research Organisation or CSIRO) established the Division of Protein Chemistry in 1940. The goal of this fundamental research was to better understand the structure and chemistry of fibers so that the potential applications of wool and keratins could be expanded. CSIRO scientists developed many methods for the extraction, separation, and identification of keratins. In 1965, CSIRO scientist W. Gordon Crewther and his colleagues published the definitive text on the chemistry of keratins (Crewther W G et al., The Chemistry of Keratins. Anfinsen C B Jr et al., editors. Advances in Protein Chemistry 1965. Academic Press. New York: 191-346). This chapter in Advances in Protein Chemistry contained references to more than 640 published studies on keratins. Once scientists knew how to extract keratins from hair fibers, purify and characterize them, the number of derivative materials that could be produced with keratins grew exponentially. In the decade beginning in 1970, methods to form extracted keratins into powders, films, gels, coatings, fibers, and foams were being developed and published by several research groups throughout the world (Anker C A, U.S. Pat. No. 3,642,498, Feb. 15, 1972; Kawano Y and Okamoto S, Kagaku To Seibutsu 1975; 13(5):291-223; Okamoto S, Nippon Shokuhin Kogyo Gakkaishi 1977; 24(1):40-50). All of these methods made use of the oxidative and reductive chemistries developed decades earlier. In 1982, Japanese scientists published the first study describing the use of a keratin coating on vascular grafts as a way to eliminate blood clotting (Noishiki Y et al., Kobunshi Ronbunshu 1982; 39(4):221-7), as well as experiments on the biocompatibility of keratins (Ito H et al., Kobunshi Ronbunshu 1982; 39(4):249-56). Soon thereafter in 1985, two researchers from the UK published a review article speculating on the prospect of using keratin as the building block for new biomaterials development (Jarman T and Light J, World Biotech Rep 1985; 1:505-12). In 1992, the development and testing of a host of keratin-based biomaterials was the subject of a doctoral thesis for French graduate student Isabelle Valherie (Valherie I and Gagnieu C. Chemical modifications of keratins: Preparation of biomaterials and study of their physical, physiochemical and biological properties. Doctoral thesis. Inst Natl Sci Appl Lyon, France 1992). Soon thereafter, Japanese scientists published a commentary in 1993 on the prominent position keratins could take at the forefront of biomaterials development (Various Authors, Kogyo Zairyo 1993; 41 (15) Special issue 2:106-9). Taken together, the aforementioned body of published work is illustrative of the unique chemical, physical, and biological properties of keratins. However, there remains a need to create optimal fractionations of keratins that have superior biomedical activity. SUMMARY OF THE INVENTION The invention provides methods of making charged (i.e. acidic and basic) keratins by separating one from the other, e.g., by chromatography, and optionally further processing or purifying the retained fraction or fractions. In some embodiments, the keratins fractionated based on acidity consist essentially of alpha keratoses, gamma keratoses, or mixtures thereof. In other embodiments, the keratins fractionated consist essentially of alpha kerateines, gamma kerateines, or mixtures thereof. Another aspect of the present invention is an implantable biomedical device, comprising: a substrate and a keratin derivative on the substrate, wherein the keratin derivative is present in an amount effective to reduce cell and tissue adhesion to the substrate. In some embodiments the keratin derivative comprises, consists of or consists essentially of basic alpha keratose, basic gamma keratose, basic alpha kerateine, basic gamma kerateine, or combinations thereof. A further aspect of the present invention is an implantable anti-adhesive tissue barrier, comprising: a solid, physiologically acceptable substrate; and a keratin derivative on the substrate. In some embodiments the keratin derivative comprises, consists of or consists essentially of basic alpha keratose, basic gamma keratose, basic alpha kerateine, basic gamma kerateine, or combinations thereof. Yet another aspect of the present invention is a method of treating blood coagulation in a subject in need thereof, comprising administering a keratin derivative to said subject in an amount effective to inhibit blood coagulation in said subject, wherein said keratin derivative consists essentially of basic keratose, basic kerateine, or combinations thereof. Another aspect of the present invention is the use of a keratin derivative as described herein for the preparation of a composition or medicament for carrying out a method of treatment as described herein, or for making an article of manufacture as described herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The unique properties of subfamilies of keratins can be revealed and utilized through more sophisticated means of purification. “Subjects” (or “patients”) to be treated with the methods and compositions described herein include both human subjects and animal subjects (particularly other mammalian subjects such as dogs, cats, horses, monkeys, etc.) for veterinary purposes. Human subjects are particularly preferred. The subjects may be male or female and may be any age, including neonate, infant, juvenile, adolescent, adult, and geriatric subjects. The disclosures of all United States patent references cited herein are to be incorporated herein by reference. The ability of extracted keratin solutions to spontaneously self-assemble at the micron scale was published in two papers in 1986 and 1987 (Thomas H et al., Int J Biol Macromol 1986; 8:258-64; van de Löcht M, Melliand Textilberichte 1987; 10:780-6). This phenomenon is not surprising given the highly controlled superstructure whence hair keratins are obtained. When processed correctly, this ability to self-assemble can be preserved and used to create regular architectures on a size scale conducive to cellular infiltration. When keratins are hydrolyzed (e.g., with acids or bases), their molecular weight is reduced and they lose the ability to self-assemble. Therefore, processing conditions that minimize hydrolysis are preferred. This ability to self-assemble is a particularly useful characteristic for tissue engineering scaffolds for two reasons. First, self-assembly results in a highly regular structure with reproducible architectures, dimensionality, and porosity. Second, the fact that these architectures form of their own accord under benign conditions allows for the incorporation of cells as the matrix is formed. These two features are critically important to any system that attempts to mimic the native extracellular matrix (ECM). Cellular recognition is also an important characteristic of biomaterials that seek to mimic the ECM. Such recognition is facilitated by the binding of cell surface integrins to specific amino acid motifs presented by the constituent ECM proteins. Predominant proteins include collagen and fibronectin, both of which have been extensively studied with regard to cell binding. Both proteins contain several regions that support attachment by a wide variety of cell types. It has been shown that in addition to the widely know Arginine-Glycine-Aspartic Acid (RGD) motif, the “X”-Aspartic Acid-“Y” motif on fibronectin is also recognized by the integrin α4β1, where X equals Glycine, Leucine, or Glutamic Acid, and Y equals Serine or Valine. Keratin-biomaterials derived from human hair contain these same binding motifs. A search of the NCBI protein database revealed sequences for 71 discrete, unique human hair keratin proteins. Of these, 55 are from the high molecular weight, low sulfur, alpha-helical family. This group of proteins is often referred to as the alpha-keratins and is responsible for imparting toughness to human hair fibers. These alpha-keratins have molecular weights greater than 40 kDa and an average cysteine (the main amino acid responsible for inter- and intramolecular protein bonding) content of 4.8 mole percent. Moreover, analysis of the amino acid sequences of these alpha keratin proteins showed that 78% contain at least one fibronectin-like integrin receptor binding motif, and 25% contain at least two or more. Two recent papers have highlighted the fact that these binding sites are likely present on the surface of keratin biomaterials by demonstrating excellent cell adhesion onto processed keratin foams (Tachibana A et al., J Biotech 2002; 93:165-70; Tachibana A et al., Biomaterials 2005; 26(3):297-302). Other examples of natural polymers that may be utilized in a similar fashion to the disclosed keratin preparations include, but are not limited to, collagen, gelatin, fibronectin, vitronectin, laminin, fibrin, mucin, elastin, nidogen (entactin), proteoglycans, etc. (See, e.g., U.S. Pat. No. 5,691,203 to Katsuen et al.). There are two theories for the biological activity of human hair extracts. The first is that the human hair keratins (“HHKs”) themselves are biologically active. Over 70 human hair keratins are known and their cDNA-derived sequences published. However, the full compliment of HHKs is unknown and estimates of over 100 have been proposed (Gillespie J M, The structural proteins of hair: isolation characterization, and regulation of biosynthesis. Goldsmith L A (editor), Biochemistry and physiology of the skin (1983), Oxford University Press. New York; 475-510). Within the complete range of HHKs are a small number that have been shown to participate in wound contracture and cell migration (Martin, P, Science 1997; 276:75-81). In particular, keratins K-6 and K-16 are expressed in the epidermis during wound healing and are also found in the outer root sheath of the hair follicle (Bowden P E, Molecular Aspects of Dermatology (1993), John Wiley & Sons, Inc., Chichester: 19-54). The presence of these HHKs in extracts of human hair, and their subsequent dosing directly into a wound bed, may be responsible for “shortcutting” the otherwise lengthy process of differentiation, migration, and proliferation, or for alleviating some biochemical deficiency, thereby accelerating the tissue repair and regeneration process. It has been known for more than a decade that growth factors such as bone morphogenetic protein-4 (BMP-4) and other members of the transforming growth factors (TGF-β) superfamily are present in developing hair follicles (Jones C M et al., Development 1991; 111:531-42; Lyons K M et al., Development 1990; 109:833-44; Blessings M et al., Genes and Develop 1993; 7:204-15). In fact, more than 30 growth factors and cytokines are involved in the growth of a cycling hair follicle (Hardy M H, Trends Genet 1992; 8(2):55-61; Stenn K S et al., J Dermato Sci 1994; 7S:S109-24; Rogers G E, Int J Dev Biol 2004; 48(2-3):163-70). Many of these molecules have a pivotal role in the regeneration of a variety of tissues. It is highly probable that a number of growth factors become entrained within human hair when cytokines bind to stem cells residing in the bulge region of the hair follicle (Panteleyev A A et al., J Cell Sci 2001; 114:3419-31). These growth factors would most certainly be extracted along with the keratins from end-cut human hair. This observation is not without precedent, as it has previously been shown that many different types of growth factors are present in the extracts of various tissues, and that their activity is maintained even after chemical extraction. Observations such as these show mounting evidence that a number of growth factors may be present in end-cut human hair, and that the keratins may be acting as a highly effective delivery matrix of, inter alia, these growth factors. Keratins are a family of proteins found in the hair, skin, and other tissues of vertebrates. Hair is a unique source of human keratins because it is one of the few human tissues that is readily available and inexpensive. Although other sources of keratins are acceptable feedstocks for the present invention, (e.g. wool, fur, horns, hooves, beaks, feathers, scales, and the like), human hair is preferred for use with human subjects because of its biocompatibility. Keratins can be extracted from human hair fibers by oxidation or reduction using methods that have been published in the art (See, e.g., Crewther W G et al. The chemistry of keratins, in Advances in protein chemistry 1965; 20:191-346). These methods typically employ a two-step process whereby the crosslinked structure of keratins is broken down by either oxidation or reduction. In these reactions, the disulfide bonds in cysteine amino acid residues are cleaved, rendering the keratins soluble (Scheme 1). The cuticle is essentially unaffected by this treatment, so the majority of the keratins remain trapped within the cuticle's protective structure. In order to extract these keratins, a second step using a denaturing solution must be employed. Alternatively, in the case of reduction reactions, these steps can be combined. Denaturing solutions known in the art include urea, transition metal hydroxides, surfactant solutions, and combinations thereof. Preferred methods use aqueous solutions of tris in concentrations between 0.1 and 1.0 M, and urea solutions between 0.1 and 10M, for oxidation and reduction reactions, respectively. If one employs an oxidative treatment, the resulting keratins are referred to as “keratoses.”. If a reductive treatment is used, the resulting keratins are referred to as “kerateines” (See Scheme 1) Crude extracts of keratins, regardless of redox state, can be further refined into “gamma” and “alpha” fractions, e.g., by isoelectric precipitation. High molecular weight keratins, or “alpha keratins,” (alpha helical), are thought to derive from the microfibrillar regions of the hair follicle, and typically range in molecular weight from about 40-85 kiloDaltons. Low molecular weight keratins, or “gamma keratins,” (globular), are thought to derive from the extracellular matrix regions of the hair follicle, and typically range in molecular weight from about 10-15 kiloDaltons. (See Crewther W G et al. The chemistry of keratins, in Advances in Protein Chemistry 1965; 20:191-346) Even though alpha and gamma keratins possess unique properties, the properties of subfamilies of both alpha and gamma keratins can only be revealed through more sophisticated means of purification. For example, keratins may be fractionated into “acidic” and “basic” protein fractions. A preferred method of fractionation is ion exchange chromatography. These fractions possess unique properties, such as their differential effects on blood cell aggregation (See Table 1 below; See also: U.S. Patent Application Publication No. 2006/0051732). “Keratin derivative” as used herein refers to any keratin fractionation, derivative, subfamily, etc., or mixtures thereof, alone or in combination with other keratin derivatives or other ingredients, including but not limited to alpha keratose, gamma keratose, alpha kerateine, gamma kerateine, meta keratin, keratin intermediate filaments, and combinations thereof, including the acidic and basic constituents thereof unless specified otherwise, along with variations thereof that will be apparent to persons skilled in the art in view of the present disclosure. In some embodiments, the keratin derivative comprises, consists or consists essentially of a particular fraction or subfraction of keratin. The derivative may comprise, consist or consist essentially of at least 80, 90, 95 or 99 percent by weight of said fraction or subfraction (or more). In some embodiments, the keratin derivative comprises, consists of, or consists essentially of acidic alpha keratose. In some embodiments, the keratin derivative comprises, consists of or consists essentially of alpha keratose, where the alpha keratose comprises, consists of or consists essentially of at least 80, 90, 95 or 99 percent by weight of acidic alpha keratose (or more), and where the alpha keratose comprises, consists of, or consists essentially of not more than 20, 10, 5 or 1 percent by weight of basic alpha keratose (or less). In some embodiments, the keratin derivative comprises, consists of, or consists essentially of basic alpha keratose. In some embodiments, the keratin derivative comprises, consists of or consists essentially of alpha keratose, where the alpha keratose comprises, consists of or consists essentially of at least 80, 90, 95 or 99 percent by weight of basic alpha keratose (or more), and where the alpha keratose comprises, consists of or consists essentially of not more than 20, 10, 5 or 1 percent by weight of acidic alpha keratose (or less). In some embodiments, the keratin derivative comprises, consists of, or consists essentially of acidic alpha kerateine. In some embodiments, the keratin derivative comprises, consists of or consists essentially of alpha kerateine, where the alpha kerateine comprises, consists of or consists essentially of at least 80, 90, 95 or 99 percent by weight of acidic alpha kerateine (or more), and where the alpha kerateine comprises, consists of or consists essentially of not more than 20, 10, 5 or 1 percent by weight of basic alpha kerateine (or less). In some embodiments, the keratin derivative comprises, consists of, or consists essentially of basic alpha kerateine. In some embodiments, the keratin derivative comprises, consists of or consists essentially of alpha kerateine, where the alpha kerateine comprises, consists of or consists essentially of at least 80, 90, 95 or 99 percent by weight of basic alpha kerateine (or more), and where the alpha kerateine comprises, consists of or consists essentially of not more than 20, 10, 5 or 1 percent by weight of acidic alpha kerateine (or less). In some embodiments, the keratin derivative comprises, consists of or consists essentially of unfractionated alpha+gamma-kerateines. In some embodiments, the keratin derivative comprises, consists of or consists essentially of acidic alpha+gamma-kerateines. In some embodiments, the keratin derivative comprises, consists of or consists essentially of basic alpha+gamma-kerateines. In some embodiments, the keratin derivative comprises, consists of or consists essentially of unfractionated alpha+gamma-keratose. In some embodiments, the keratin derivative comprises, consists of or consists essentially of acidic alpha+gamma-keratose. In some embodiments, the keratin derivative comprises, consists of or consists essentially of basic alpha+gamma-keratose. In some embodiments, the keratin derivative comprises, consists of or consists essentially of unfractionated beta-keratose (e.g., derived from cuticle). In some embodiments, the keratin derivative comprises, consists of or consists essentially of basic beta-keratose. In some embodiments, the keratin derivative comprises, consists of or consists essentially of acidic beta-keratose. The basic alpha keratose is preferably produced by separating basic alpha keratose from a mixture comprising acidic and basic alpha keratose, e.g., by ion exchange chromatography, and optionally the basic alpha keratose has an average molecular weight of from 10 to 100 or 200 kiloDaltons. More preferably, the average molecular weight is from 30 or 40 to 90 or 100 kiloDaltons. Optionally but preferably the process further comprises the steps of re-disolving said basic alpha-keratose in a denaturing and/or buffering solution, optionally in the presence of a chelating agent to complex trace metals, and then re-precipitating the basic alpha keratose from the denaturing solution. It will be appreciated that the composition preferably contains not more than 5, 2, 1, or 0.1 percent by weight of acidic alpha keratose, or less. The acidic alpha keratose is preferably produced by a reciprocal of the foregoing technique; that is, by separating and retaining acidic alpha keratose from a mixture of acidic and basic alpha keratose, e.g., by ion exchange chromatography, and optionally the acidic alpha keratose has an average molecular weight of from 10 to 100 or 200 kiloDaltons. More preferably, the average molecular weight is from 30 or 40 to 90 or 100 kiloDaltons. Optionally but preferably the process further comprises the steps of re-dissolving said acidic alpha-keratose in a denaturing solution and/or buffering solution, optionally in the presence of a chelating agent to complex trace metals, and then re-precipitating the basic alpha keratose from the denaturing solution. It will be appreciated that the composition preferably contains not more than 5, 2, 1, or 0.1 percent by weight of basic alpha keratose, or less. Basic and acidic fractions of other keratoses can be prepared in like manner as described above for basic and acidic alpha keratose. The basic alpha kerateine is preferably produced by separating basic alpha kerateine from a mixture of acidic and basic alpha kerateine, e.g., by ion exchange chromatography, and optionally the basic alpha kerateine has an average molecular weight of from 10 to 100 or 200 kiloDaltons. More preferably, the average molecular weight is from 30 or 40 to 90 or 100 kiloDaltons. Optionally but preferably the process further comprises the steps of re-dissolving said basic alpha-kerateine in a denaturing and/or buffering solution, optionally in the presence of a chelating agent to complex trace metals, and then re-precipitating the basic alpha kerateine from the denaturing solution. It will be appreciated that the composition preferably contains not more than 5, 2, 1, or 0.1 percent by weight of acidic alpha kerateine, or less. The acidic alpha kerateine is preferably produced by a reciprocal of the foregoing technique: that is, by separating and retaining acidic alpha kerateine from a mixture of acidic and basic alpha kerateine, e.g., by ion exchange chromatography, and optionally the acidic alpha kerateine has an average molecular weight of from 10 to 100 or 200 kiloDaltons. Optionally but preferably the process further comprises the steps of re-dissolving said acidic alpha-kerateine in a denaturing and/or buffering solution), optionally in the presence of a chelating agent to complex trace metals, and then re-precipitating the basic alpha kerateine from the denaturing solution. It will be appreciated that the composition preferably contains not more than 5, 2, 1, or 0.1 percent by weight of basic alpha kerateine, or less. Basic and acidic fractions of other kerateines can be prepared in like manner as described above for basic and acidic alpha kerateine. Keratin materials are derived from any suitable source, including, but not limited to, wool and human hair. In one embodiment keratin is derived from end-cut human hair, obtained from barbershops and salons. The material is washed in hot water and mild detergent, dried, and extracted with a nonpolar organic solvent (typically hexane or ether) to remove residual oil prior to use. Keratoses. Keratose fractions are obtained by any suitable technique. In one embodiment they are obtained using the method of Alexander and coworkers (P. Alexander et al., Biochem. J. 46, 27-32 (1950)). Basically, the hair is reacted with an aqueous solution of peracetic acid at concentrations of less than ten percent at room temperature for 24 hours. The solution is filtered and the alpha-keratose fraction precipitated by addition of mineral acid to a pH of approximately 4. The alpha-keratose is separated by filtration, washed with additional acid, followed by dehydration with alcohol, and then freeze dried. Increased purity can be achieved by re-dissolving the keratose in a denaturing solution such as 7M urea, aqueous ammonium hydroxide solution, or 20 mM tris base buffer solution (e.g., Trizma® base), re-precipitating, re-dissolving, dialyzing against deionized water, and re-precipitating at pH 4. A preferred method for the production of keratoses is by oxidation with hydrogen peroxide, peracetic acid, or performic acid. A most preferred oxidant is peracetic acid. Preferred concentrations range from 1 to 10 weight/volume percent (w/v %), the most preferred being approximately 2 w/v %. Those skilled in the art will recognize that slight modifications to the concentration can be made to effect varying degrees of oxidation, with concomitant alterations in reaction time, temperature, and liquid to solid ratio. It has also been discussed by Crewther et al. that performic acid offers the advantage of minimal peptide bond cleavage compared to peracetic acid. However, peractic acid offers the advantages of cost and availability. A preferred oxidation temperature is between 0 and 100 degrees Celsius (° C.). A most preferred oxidation temperature is 37° C. A preferred oxidation time is between 0.5 and 24 hours. A most preferred oxidation time is 12 hours. A preferred liquid to solid ratio is from 5 to 100:1. A most preferred ratio is 20:1. After oxidation, the hair is rinsed free of residual oxidant using a copious amount of distilled water. The keratoses can be extracted from the oxidized hair using an aqueous solution of a denaturing agent. Protein denaturants are well known in the art, but preferred solutions include urea, transition metal hydroxides (e.g. sodium and potassium hydroxide), ammonium hydroxide, and tris(hydroxymethyl)aminomethane (tris base). A preferred solution is Trizma® base (a brand of tris base) in the concentration range from 0.01 to 1M. A most preferred concentration is 0.1M. Those skilled in the art will recognize that slight modifications to the concentration can be made to effect varying degrees of extraction, with concomitant alterations in reaction time, temperature, and liquid to solid ratio. A preferred extraction temperature is between 0 and 100 degrees Celsius. A most preferred extraction-temperature is 37° C. A preferred extraction time is between 0.5 and 24 hours. A most preferred extraction time is 3 hours. A preferred liquid to solid ratio is from 5 to 100:1. A most preferred ratio is 40:1. Additional yield can be achieved with subsequent extractions with dilute solutions of tris base or deionized (DI) water. After extraction, the residual solids are removed from solution by centrifugation and/or filtration. The crude extract can be isolated by first neutralizing the solution to a pH between 7.0 and 7.4. A most preferred pH is 7.4. Residual denaturing agent is removed by dialysis against DI water. Concentration of the dialysis retentate is followed by lyophilization or spray drying, resulting in a dry powder mixture of both gamma- and alpha-keratose. Alternately, alpha-keratose is isolated from the extract solution by dropwise addition of acid until the pH of the solution reaches approximately 4.2. Preferred acids include sulfuric, hydrochloric, and acetic. A most preferred acid is concentrated hydrochloric acid. Precipitation of the alpha fraction begins at around pH 6.0 and continues until approximately 4.2. Fractional precipitation can be utilized to isolate different ranges of protein with different isoelectric properties. Solid alpha-keratose can be recovered by centrifugation or filtration. The alpha keratose can be further purified by re-dissolving the solids in a denaturing solution. The same denaturing solutions as those utilized for extraction can be used, however a preferred denaturing solution is tris base. Ethylene diamine tetraacetic acid (EDTA) can be added to complex and remove trace metals found in the hair. A preferred denaturing solution is 20 mM tris base with 20 mM EDTA or DI water with 20 mM EDTA. If the presence of trace metals is not detrimental to the intended application, the EDTA can be omitted. The alpha-keratose is re-precipitated from this solution by dropwise addition of hydrochloric acid to a final pH of approximately 4.2. Isolation of the solid is by centrifugation or filtration. This process can be repeated several times to further purify the alpha-keratose. The gamma keratose fraction remains in solution at pH 4 and is isolated by addition to a water-miscible organic solvent such as alcohol, followed by filtration, dehydrated with additional alcohol, and freeze dried. Increased purity can be achieved by re-dissolving the keratose in a denaturing solution such as 7M urea, aqueous ammonium hydroxide solution, or 20 mM tris buffer solution, reducing the pH to 4 by addition of a mineral acid, removing any solids that form, neutralizing the supernatant, re-precipitating the protein with alcohol, re-dissolving, dialyzing against deionized water, and re-precipitating by addition to alcohol. The amount of alcohol consumed in these steps can be minimized by first concentrating the keratose solution by distillation. After removal of the alpha keratose, the concentration of gamma keratose from a typical extraction solution is approximately 1-2%. The gamma keratose fraction can be isolated by addition to a water-miscible non-solvent. To effect precipitation, the gamma-keratose solution can be concentrated by evaporation of excess water. This solution can be concentrated to approximately 10-20% by removal of 90% of the water. This can be done using vacuum distillation or by falling film evaporation. After concentration, the gamma-keratose solution is added dropwise to an excess of cold non-solvent. Suitable non-solvents include ethanol, methanol, acetone, and the like. A most preferred non-solvent is ethanol. A most preferred method is to concentrate the gamma keratose solution to approximately 10 w/v % protein and add it dropwise to an 8-fold excess of cold ethanol. The precipitated gamma keratose can be isolated by centrifugation or filtration and dried. Suitable methods for drying include freeze drying (lyophilization), air drying, vacuum drying, or spray drying. A most preferred method is freeze drying. Kerateines. Kerateine fractions can be obtained using a combination of the methods of Bradbury and Chapman (J. Bradbury et al., Aust. J. Biol. Sci. 17, 960-72 (1964)) and Goddard and Michaelis (D. Goddard et al., J. Biol. Chem. 106, 605-14 (1934)). Essentially, the cuticle of the hair fibers is removed ultrasonically in order to avoid excessive hydrolysis and allow efficient reduction of cortical disulfide bonds in a second step. The hair is placed in a solution of dichloroacetic acid and subjected to treatment with an ultrasonic probe. Further refinements of this method indicate that conditions using 80% dichloroacetic acid, solid to liquid of 1:16, and an ultrasonic power of 180 Watts are optimal (H. Ando et al., Sen'i Gakkaishi 31(3), T81-85 (1975)). Solid fragments are removed from solution by filtration, rinsed and air dried, followed by sieving to isolate the hair fibers from removed cuticle cells. In some embodiments, following ultrasonic removal of the cuticle, alpha- and gamma-kerateines are obtained by reaction of the denuded fibers with mercaptoethanol. Specifically, a low hydrolysis method is used at acidic pH (E. Thompson et al., Aust. J. Biol. Sci. 15, 757-68 (1962)). In a typical reaction, hair is extracted for 24 hours with 4M mercaptoethanol that has been adjusted to pH 5 by addition of a small amount of potassium hydroxide in deoxygenated water containing 0.02M acetate buffer and 0.001M surfactant. The solution is filtered and the alpha-kerateine fraction precipitated by addition of mineral acid to a pH of approximately 4. The alpha-kerateine is separated by filtration, washed with additional acid, followed by dehydration with alcohol, and then dried under vacuum. Increased purity is achieved by re-dissolving the kerateine in a denaturing solution such as 7M urea, aqueous ammonium hydroxide solution, or 20 mM tris buffer solution, re-precipitating, re-dissolving, dialyzing against deionized water, and re-precipitating at pH 4. The gamma kerateine fraction remains in solution at pH 4 and is isolated by addition to a water-miscible organic solvent such as alcohol, followed by filtration, dehydrated with additional alcohol, and dried under vacuum. Increased purity can be achieved by re-dissolving the kerateine in a denaturing solution such as 7M urea, aqueous ammonium hydroxide solution, or 20 mM tris buffer solution, reducing the pH to 4 by addition of a mineral acid, removing any solids that form, neutralizing the supernatant, re-precipitating the protein with alcohol, re-dissolving, dialyzing against deionized water, and reprecipitating by addition to alcohol. The amount of alcohol consumed in these steps can be minimized by first concentrating the keratin solution by distillation. In an alternate method, the kerateine fractions are obtained by reacting the hair with an aqueous solution of sodium thioglycolate. A preferred method for the production of kerateines is by reduction of the hair with thioglycolic acid or beta-mercaptoethanol. A most preferred reductant is thioglycolic acid (TGA). Preferred concentrations range from 1 to 10M, the most preferred being approximately 1.0M. Those skilled in the art will recognize that slight modifications to the concentration can be made to effect varying degrees of reduction, with concomitant alterations in pH, reaction time, temperature, and liquid to solid ratio. A preferred pH is between 9 and 11. A most preferred pH is 10.2. The pH of the reduction solution is altered by addition of base. Preferred bases include transition metal hydroxides, sodium hydroxide, and ammonium hydroxide. A most preferred base is sodium hydroxide. The pH adjustment is effected by dropwise addition of a saturated solution of sodium hydroxide in water to the reductant solution. A preferred reduction temperature is between 0 and 100° C. A most preferred reduction temperature is 37° C. A preferred reduction time is between 0.5 and 24 hours. A most preferred reduction time is 12 hours. A preferred liquid to solid ratio is from 5 to 100:1. A most preferred ratio is 20:1. Unlike the previously described oxidation reaction, reduction is carried out at basic pH. That being the case, keratins are highly soluble in the reduction media and are expected to be extracted. The reduction solution is therefore combined with the subsequent extraction solutions and processed accordingly. Reduced keratins are not as hydrophilic as their oxidized counterparts. As such, reduced hair fibers will not swell and split open as will oxidized hair, resulting in relatively lower yields. Another factor affecting the kinetics of the reduction/extraction process is the relative solubility of kerateines. The relative solubility rankings in water is gamma-keratose>alpha-keratose>gamma-kerateine>alpha-kerateine from most to least soluble. Consequently, extraction yields from reduced hair fibers are not as high. This being the case, subsequent extractions are conducted with additional reductant plus denaturing agent solutions. Preferred solutions for subsequent extractions include TGA plus urea, TGA plus tris base, or TGA plus sodium hydroxide. After extraction, crude fractions of alpha- and gamma-kerateine can be isolated using the procedures described for keratoses. However, precipitates of gamma- and alpha-kerateine re-form their cystine crosslinks upon exposure to oxygen. Precipitates must therefore be re-dissolved quickly to avoid insolubility during the purification stages, or precipitated in the absence of oxygen. Residual reductant and denaturing agents can be removed from solution by dialysis. Typical dialysis conditions are 1 to 2% solution of kerateines dialyzed against DI water for 24 to 72 hours. Those skilled in the art will recognize that other methods exist for the removal of low molecular weight contaminants in addition to dialysis (e.g. microfiltration, chromatography, and the like). The use of tris base is only required for initial solubilization of the kerateines. Once dissolved, the kerateines are stable in solution without the denaturing agent. Therefore, the denaturing agent can be removed without the resultant precipitation of kerateines, so long as the pH remains at or above neutrality. The final concentration of kerateines in these purified solutions can be adjusted by the addition/removal of water. Regardless of the form of the keratin (i.e. keratoses or kerateines), several different approaches to further purification can be employed to keratin solutions. Care must be taken, however, to choose techniques that lend themselves to keratin's unique solubility characteristics. One of the most simple separation technologies is isoelectric precipitation. In this method, proteins of differing isoelectric point can be isolated by adjusting the pH of the solution and removing the precipitated material. In the case of keratins, both gamma- and alpha-forms are soluble at pH >6.0. As the pH falls below 6, however, alpha-keratins begin to precipitate. Keratin fractions can be isolated by stopping the precipitation at a given pH and separating the precipitate by centrifugation and/or filtration. At a pH of approximately 4.2, essentially all of the alpha-keratin will have been precipitated. These separate fractions can be re-dissolved in water at neutral pH, dialyzed, concentrated, and reduced to powders by lyophilization or spray drying. However, kerateine fractions must be stored in the absence of oxygen or in dilute solution to avoid crosslinking. Another general method for separating keratins is by chromatography. Several types of chromatography can be employed to fractionate keratin solutions including size exclusion or gel filtration chromatography, affinity chromatography, isoelectric focusing, gel electrophoresis, ion exchange chromatography, and immunoaffinity chromatography. These techniques are well known in the art and are capable of separating compounds, including proteins, by the characteristics of molecular weight, chemical functionality, isoelectric point, charge, or interactions with specific antibodies, and can be used alone or in any combination to effect high degrees of separation and resulting purity. A preferred purification method is ion exchange (IEx) chromatography. IEx chromatography is particularly suited to protein separation owning to the amphiphilic nature of proteins in general and keratins in particular. Depending on the starting pH of the solution, and the desired fraction slated for retention, either cationic or anionic IEx (CIEx or AIEx, respectively) techniques can be used. For example, at a pH of 6 and above, both gamma- and alpha-keratins are soluble and above their isoelectric points. As such, they are anionic and can be bound to an anionic exchange resin. However, it has been discovered that a sub-fraction of keratins does not bind to a weakly anionic exchange resin and instead passes through a column packed with such resin. A preferred solution for AIEx chromatography is purified or fractionated keratin, isolated as described previously, in purified water at a concentration between 0 and 5 weight/volume %. A preferred concentration is between 0 and 4 w/v %. A most preferred concentration is approximately 2 w/v %. It is preferred to keep the ionic strength of said solution initially quite low to facilitate binding to the AIEx column. This is achieved by using a minimal amount of acid to titrate a purified water solution of the keratin to between pH 6 and 7. A most preferred pH is 6. This solution can be loaded onto an AIEx column such as DEAE-Sepharose® resin or Q-Sepharose® resin columns. A preferred column resin is DEAE-Sepharose® resin. The solution that passes through the column can be collected and further processed as described previously to isolate a fraction of acidic keratin powder. In some embodiments the activity of the keratin matrix is enhanced by using an AIEx column to produce the keratin that may be useful for, inter alia, promoting cell adhesion. Without wishing to be bound to any particular theory, it is envisioned that the fraction that passes through an anionic column, i.e. acidic keratin, promotes cell adhesion. Another fraction binds readily, and can be washed off the column using salting techniques known in the art. A preferred elution medium is sodium chloride solution. A preferred concentration of sodium chloride is between 0.1 and 2M. A most preferred concentration is 2M. The pH of the solution is preferred to be between 6 and 12. A most preferred pH is 12. In order to maintain stable pH during the elution process, a buffer salt can be added. A preferred buffer salt is Trizma® base. Those skilled in the art will recognize that slight modifications to the salt concentration and pH can be made to effect the elution of keratin fractions with differing properties. It is also possible to use different salt concentrations and pH's in sequence, or employ the use of salt and/or pH gradients to produce different fractions. Regardless of the approach taken, however, the column eluent can be collected and further processed as described previously to isolate fractions of basic keratin powders. A complimentary procedure is also feasible using CIEx techniques. Namely, the keratin solution can be added to a cation exchange resin such as SP Sepharose® resin (strongly cationic) or CM Sepharose® resin (weakly cationic), and the basic fraction collected with the pass through. The retained acid keratin fraction can be isolated by salting as previously described. Meta keratins. Meta keratins are synthesized from both the alpha and gamma fractions of kerateine using substantially the same procedures. Basically, the kerateine is dissolved in a denaturing solution such as 7M urea, aqueous ammonium hydroxide solution, or 20 mM tris buffer solution. Pure oxygen is bubbled through the solution to initiate oxidative coupling reactions of cysteine groups. The progress of the reaction is monitored by an increase in molecular weight as measured using SDS-PAGE. Oxygen is continually bubbled through the reaction solution until a doubling or tripling of molecular weight is achieved. The pH of the denaturing solution can be adjusted to neutrality to avoid hydrolysis of the proteins by addition of mineral acid. Keratin intermediate filaments. IFs of human hair fibers are obtained using the method of Thomas and coworkers (H. Thomas et al., Int. J. Biol. Macromol. 8, 258-64 (1986)). This is essentially a chemical etching method that reacts away the keratin matrix that serves to “glue” the IFs in place, thereby leaving the IFs behind. In a typical extraction process, swelling of the cuticle and sulfitolysis of matrix proteins is achieved using 0.2M Na 2 SO 3 , 0.1M Na 2 O 6 S 4 in 8M urea and 0.1M Tris-HCl buffer at pH 9. The extraction proceeds at room temperature for 24 hours. After concentrating, the dissolved matrix keratins and IFs are precipitated by addition of zinc acetate solution to a pH of approximately 6. The IFs are then separated from the matrix keratins by dialysis against 0.05M tetraborate solution. Increased purity is obtained by precipitating the dialyzed solution with zinc acetate, redissolving the IFs in sodium citrate, dialyzing against distilled water, and then freeze drying the sample. Further discussion of keratin preparations are found in U.S. Patent Application Publication 2006/0051732 (Van Dyke), which is incorporated by reference herein. Formulations. Dry powders may be formed of keratin derivatives as described above in accordance with known techniques such as freeze drying (lyophilization). In some embodiments, compositions of the invention may be produced by mixing such a dry powder composition form with an aqueous solution to produce a composition comprising an electrolyte solution having said keratin derivative solubilized therein. The mixing step can be carried out at any suitable temperature, typically room temperature, and can be carried out by any suitable technique such as stirring, shaking, agitation, etc. The salts and other constituent ingredients of the electrolyte solution (e.g., all ingredients except the keratin derivative and the water) may be contained entirely in the dry powder, entirely within the aqueous composition, or may be distributed between the dry powder and the aqueous composition. For example, in some embodiments, at least a portion of the constituents of the electrolyte solution is contained in the dry powder. The formation of a matrix comprising keratin materials such as described above can be carried out in accordance with techniques long established in the field or variations thereof that will be apparent to those skilled in the art. In some embodiments, the keratin preparation is dried and rehydrated prior to use. See, e.g., U.S. Pat. No. 2,413,983 to Lustig et al., U.S. Pat. Nos. 2,236,921 to Schollkipf et al., and 3,464,825 to Anker. In preferred embodiments, the matrix, or hydrogel, is formed by re-hydration of the lyophilized material with a suitable solvent, such as water or phosphate buffered saline (PBS). The gel can be sterilized, e.g., by γ-irradiation (806 krad) using a Co60 source. Other suitable methods of forming keratin matrices include, but are not limited to, those found in U.S. Pat. No. 6,270,793 (Van Dyke et al.), U.S. Pat. No. 6,274,155 (Van Dyke et al.), U.S. Pat. No. 6,316,598 (Van Dyke et al.), 6,461,628 (Blanchard et al.), U.S. Pat. No. 6,544,548 (Siller-Jackson et al.), and U.S. Pat. No. 7,01,987 (Van Dyke). In some composition embodiments, the keratin derivatives (particularly alpha and/or gamma kerateine and alpha and/or gamma keratose) have an average molecular weight of from about 10 to 70 or 85 or 100 kiloDaltons. Other keratin derivatives, particularly meta-keratins, may have higher average molecular weights, e.g., up to 200 or 300 kiloDaltons. In general, the keratin derivative (this term including combinations of derivatives) may be included in the composition in an amount of from about 0.1, 0.5 or 1 percent by weight up to 3, 4, 5, or 10 percent by weight. The composition when mixed preferably has a viscosity of about 1 or 1.5 to 4, 8, 10 or 20 centipoise. Viscosity at any concentration can be modulated by changing the ratio of alpha to gamma keratose. The keratin derivative composition or formulation may optionally contain one or more active ingredients such as one or more growth factors (e.g., in an amount ranging from 0.0000001 to 1 or 5 percent by weight of the composition that comprises the keratin derivative(s)) to facilitate growth or healing, facilitate or inhibit coagulation, facilitate or inhibit cell or tissue adhesion, etc. Examples of suitable active ingredients include but are not limited to nerve growth factor, vascular endothelial growth factor, fibronectin, fibrin, laminin, acidic and basic fibroblast growth factors, testosterone, ganglioside GM-1, catalase, insulin-like growth factor-I (IGF-I), platelet-derived growth factor (PDGF), neuronal growth factor galectin-1, and combinations thereof. See, e.g., U.S. Pat. No. 6,506,727 to Hansson et al. and U.S. Pat. No. 6,890,531 to Horie et al. As used herein, “growth factors” include molecules that promote the regeneration, growth and survival of tissue. Growth factors that are used in some embodiments of the present invention may be those naturally found in keratin extracts, or may be in the form of an additive, added to the keratin extracts or formed keratin matrices. Examples of growth factors include, but are not limited to, nerve growth factor (NGF) and other neurotrophins, platelet-derived growth factor (PDGF), erythropoietin (EPO), thrombopoietin (TPO), myostatin (GDF-8), growth differentiation factor-9 (GDF9), basic fibroblast growth factor (bFGF or FGF2), epidermal growth factor (EGF), hepatocyte growth factor CHGF), granulocyte-colony stimulating factor (G-CSF), and granulocyte-macrophage colony stimulating factor (GM-CSF). There are many structurally and evolutionarily related proteins that make up large families of growth factors, and there are numerous growth factor families, e.g., the neurotrophins (NGF, BDNF, and NT3). The neurotrophins are a family of molecules that promote the growth and survival of, inter alia, nervous tissue. Examples of neurotrophins include, but are not limited to, nerve growth factor (NGF), brain-derived neurotrophic factor (BDNF), neurotrophin 3 (NT-3), and neurotrophin 4 (NT-4). See U.S. Pat. No. 5,843,914 to Johnson, Jr. et al.; U.S. Pat. No. 5,488,099 to Persson et al.; U.S. Pat. No. 5,438,121 to Barde et al.; U.S. Pat. No. 5,235,043 to Collins et al.; and U.S. Pat. No. 6,005,081 to Burton et al. For example, nerve growth factor (NGF) can be added to the keratin matrix composition in an amount effective to promote the regeneration, growth and survival of various tissues. The NGF is provided in concentrations ranging from 0.1 ng/mL to 1000 ng/mL. More preferably, NGF is provided in concentrations ranging from 1 ng/mL to 100 ng/mL, and most preferably 10 ng/mL to 100 ng/mL. See U.S. Pat. No. 6,063,757 to Urso. Other examples of natural polymers that may be prepared and utilized in a similar fashion to the disclosed keratin preparations include, but are not limited to, collagen, gelatin, fibronectin, vitronectin and laminin (See, e.g., U.S. Pat. No. 5,691,203 to Katsuen et al.), with the necessary modifications apparent to those skilled in the art. The composition is preferably sterile and non-pyrogenic. The composition may be provided preformed and aseptically packaged in a suitable container, such as a flexible polymeric bag or bottle, or a foil container, or may be provided as a kit of sterile dry powder in one container and sterile aqueous solution in a separate container for mixing just prior to use. When provided pre-formed and packaged in a sterile container the composition preferably has a shelf life of at least 4 or 6 months (up to 2 or 3 years or more) at room temperature, prior to substantial loss of viscosity (e.g., more than 10 or 20 percent) and/or substantial precipitation of the keratin derivative (e.g., settling detectable upon visual inspection). Coatings and biomedical implants. As noted above, the present invention provides an implantable biomedical device, comprising: a substrate and a keratin derivative on the substrate, wherein the keratin derivative is present in an amount effective to reduce cell and/or tissue adhesion to the substrate. In some embodiments the keratin derivative comprises, consists of or consists essentially of basic alpha keratose, basic alpha kerateine, or combinations thereof. The chemistry of keratins can be utilized to optimize the properties of keratin-based coatings. Alpha and gamma keratoses have inert sulfur residues. The oxidation reaction is a terminal step and results in the conversion of cystine residues into two non-reactive sulfonic acid residues. Kerateines, on the other hand, have labile sulfur residues. During the creation of the kerateines, cystine is converted to cysteine, which can be a source of further chemical modifications (See Scheme 1). One such useful reaction is oxidative sulfur-sulfur coupling. This reaction simply converts the cysteine back to cystine and reforms the crosslinks between proteins. This is a useful reaction for increasing the molecular weight of the gamma or alpha fraction of interest, which in turn will modify the bulk properties of the material. Increasing molecular weight influences material properties such as viscosity, dry film strength, gel strength, etc. Such reformed kerateines are referred to as meta keratins. Meta keratins can be derived from the gamma or alpha fractions, or a combination of both. Oxidative re-crosslinking of the kerateines is affected by addition of an oxidizing agent such as peracetic acid or hydrogen peroxide. A preferred oxidizing agent is oxygen. This reaction can be accomplished simply by bubbling oxygen through the kerateine solution or by otherwise exposing the sample to air. Optimizing the molecular weight through the use of meta-keratins allows formulations to be optimized for a variety of properties including viscosity, film strength and elasticity, fiber strength, and hydrolytic susceptibility. Crosslinking in air works to improve biocompatibility by providing biomaterial with a minimum of foreign ingredients. Any suitable substrate (typically a device intended for implanting into or inserting into a human or animal subject) may be coated or treated with keratin materials or keratin derivatives as described herein, including but not limited to grafts such as vascular grafts, vascular stents, catheters, leads, pacemakers, cardioverters, valves, fasteners or ports such as heart valves, etc. The substrate may be formed from any suitable material, including but not limited to organic polymers (including stable polymers and biodegradable or bioerodable polymers), natural materials (e.g., collagen), metals (e.g., platinum, gold, stainless steel, etc.) inorganic materials such as silicon, glass, etc., and composites thereof. Coating of the substrate may be carried out by any suitable means, such as spray coating, dip coating, or the like. In some embodiments, steps may be taken to couple or covalently couple the keratin to the substratem such as with a silane coupling agent, if so desired. The keratin derivative may be subsequently coated with another material, and/or other materials may be co-deposited with the keratin derivative, such as one or more additional active agents, stabilizers, coatings, etc. Another aspect of the present invention is an implantable anti-adhesive tissue barrier, comprising: a solid, physiologically acceptable substrate (typically a sheet material, including but not limited to films, and woven and non-woven sheet materials formed from organic polymers or natural materials); and a keratin derivative on the substrate. In some embodiments the keratin derivative comprises, consists of or consists essentially of basic alpha keratose, basic alpha kerateine, or combinations thereof. The present invention is explained in greater detail in the following non-limiting Examples. EXAMPLE 1 Crude Keratose Samples Keratose fractions were obtained using a method based on that of Alexander and coworkers. However, the method was substantially modified to minimize hydrolysis of peptide bonds. Briefly, 50 grams of clean, dry hair that was collected from a local barber shop was reacted with 1000 mL of an aqueous solution of 2 w/v % peracetic acid (PAA) at room temperature for 12 hr. The oxidized hair was recovered using a 500 micron sieve, rinsed with copious amounts of DI water, and the excess water removed. Keratoses were extracted from the oxidized hair fibers with 1000 mL of 100 mM Trizma® base. After 3 hours, the hair was separated by sieve and the liquid neutralized by dropwise addition of hydrochloric acid (HCl). Additional keratoses were extracted from the remaining hair with two subsequent extractions using 1000 mL of 0.1M Trizma® base and 1000 mL of DI water, respectively. Each time the hair was separated by sieve and the liquid neutralized with HCl. All three extracts were combined, centrifuged, and any residual solid material removed by filtration. The combined extract was purified by tangential flow dialysis against DI water with a 1 KDa nominal low molecular weight cutoff membrane. The solution was concentrated and lyophilized to produce a crude keratose powder. EXAMPLE 2 Crude Kerateine Samples Kerateine fractions were obtained using a modification of the method described by Goddard and Michaelis. Briefly; the hair was reacted with an aqueous solution of 1M TGA at 37° C. for 24 hours. The pH of the TGA solution had been adjusted to pH 10.2 by dropwise addition of saturated NaOH solution. The extract solution was filtered to remove the reduced hair fibers and retained. Additional keratin was extracted from the fibers by sequential extractions with 1000 mL of 100 mM TGA at pH 10.2 for 24 hours, 1000 mL of 10 mM TGA at pH 10.2 for 24 hours, and DI water at pH 10.2 for 24 hours. After each extraction, the solution was centrifuged, filtered, and added to the dialysis system. Eventually, all the extracts were combined and dialyzed against DI water with a 1 KDa nominal low molecular weight cutoff membrane. The solution was concentrated, titrated to pH 7, and stored at approximately 5% total protein concentration at 4° C. Alternately, the concentrated solution could be lyophilized and stored frozen and under nitrogen. EXAMPLE 3 Ion Exchange Chromatography Just prior to fractionation, keratose samples were re-dissolved in ultrapure water and titrated to pH 6 by addition of dilute HCl solution. Kerateine samples were titrated to pH 6 by careful addition of dilute HCl solution as well. The samples were loaded onto a 200 mL flash chromatography column containing either DEAE-Sepharose (weakly anionic) or Q-Sepharose (strongly anionic) exchange resin (50-100 mesh; Sigma-Aldrich, Milwaukee, Wis.) with gentle pressure and the flow through collected (acidic keratin). A small volume of 10 mM Trizma® base (approximately 200 mL) at pH 6 was used to completely wash through the sample. Basic keratin was eluted from the column with 100 mM tris base plus 2M NaCl at pH 12. Each sample was separately neutralized and dialyzed against DI water using tangential flow dialysis with a LMWCO of 1 KDa, concentrated by rotary evaporation, and freeze dried. EXAMPLE 4 Evaluation of Viscosity and Red Blood Cell Aggregation As previously described, a sample of alpha-keratose was produced, separated on a DEAE-Sepharose IEx column into acidic and basic fractions, dissolved in PBS, and the pH adjusted to 7.4. These solutions were prepared at 5 weight percent concentration and their RBC aggregation characteristics grossly evaluated with fresh whole human blood by mixing at a 1:1 ratio. Samples were taken after 20 minutes and evaluated by light microscopy. The ion exchange chromatography was highly effective at separating the aggregation phenomenon (data not shown). Basic alpha-keratose was essentially free from interactions with blood cells while the acidic alpha-keratose caused excessive aggregation. Samples of acidic and basic alpha keratose, unfractionated alpha+gamma-kerateines, unfractionated alpha+gamma-keratose, and beta-keratose (derived from cuticle) were prepared at approximately 4 w/v % and pH 7.4 in phosphate buffered saline (PBS). Samples were tested for viscosity and red blood cell (RBC) aggregation. These results are shown in TABLE 1 Results of viscosity and RBC aggregation tests on keratin solutions. Fluid formulations were prepared at approximately 4 w/v % in PBS at pH 7.4 and tested with human whole blood at a ratio of 1:1. Viscosity RBC Sample Description (centipoise) Aggregation* acidic alpha-keratose (1X AlEx) 5.65 3 acidic alpha-keratose (2X AlEx) 19.7 5 basic alpha-keratose 1.57 2 alpha + gamma-keratose (hydrolyzed) 1.12 1 alpha + gamma-kerateine (unfractionated) 1.59 2 *Degree of aggregation: 1 = none, 5 = high The foregoing is illustrative of the present invention, and is not to be construed as limiting thereof. The invention is defined by the following claims, with equivalents of the claims to be included therein.

Methods are provided to produce optimal fractionations of charged keratins that have superior biomedical activity. Also provided are medical implants coated with these keratin preparations. Further provided are methods of treating blood coagulation in a patient in need thereof.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims benefit to U.S. Provisional Application Ser. No. 61/127,883, filed May 16, 2008, and U.S. Provisional Application Ser. No. 61/212,072, filed Apr. 7, 2009, the contents of which are incorporated herein by reference in their entirety. BACKGROUND [0002] According to the World Health Organization, there are five million people dying from cancer every year. Drug treatment is one of the three major therapies for cancer. At present, the anticancer directions are as follows: Interfere with or inhibit cell division, Regulate cell generation cycle, Promote tumor cell to apoptosis, Inhibit angiogenesis, Inhibit oncogene, Promote tumor suppressing gene, Tumor antigen, Inhibitor of telomerase and Interfere with information transfer of tumor cells. [0003] In view of the high mortality rates associated with abnormal proliferative diseases including cancer, there exists a need in the art for an effective treatment for benign proliferative diseases as well as cancer. SUMMARY [0004] This invention is based on the discovery that a combination of certain known drugs is effective in treating hyperproliferative diseases including cancer. [0005] In one aspect, the invention features a composition that includes (A) a first agent that possesses anti-inflammatory activity or acetaminophen, phenacetin, tramadol and the like, a second agent (B) that can be an oxidative phosphorylation inhibitor, an ionophore, or an adenosine 5′-monophosphate-activated Protein kinase (AMPK) activator, and a third agent (C) that possesses or maintains serotonin activity. [0006] The first agent can be any suitable anti-inflammatory compound (e.g., non-steroidal anti-inflammatory compounds) or acetaminophen, phenacetin, tramadol and the like. Examples include aspirin, diclofenac (e.g., diclofenac potassium or diclofenac sodium), ibuprofen (e.g., dexibuprofen or dexibuprofen lysine), indomethacin, nimesulide, and a COX-2 inhibitor (e.g., a nitric oxide-based COX-2 inhibitor or Celebrex® (4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide)). Other examples of the first agent include Aspirin-arginine, Alxiling, L-arginine acetylsalicylic; Aspirin-DL-lysine; Bismuth Salicylate Basic; Bismuth salicylate; Magnesium Salicylate; Diethylamine Salicylate; Salicylic acid, sodium salt; imidazole salicylate; Sodium Aminosalicylate; Isoniazid Aminosalicylate; Physostigmine Salicylate; Pregnenolone Acetylsalicylate; Choline Magnesium Trisalycylate (Trilisate); Salicylic Acid Zinc Oxide; Sodium Salicylate and Sodium Iodide; Salicylic Acid and Acetic Acid Glacial Solution; and Methyl Salicylate. [0007] The second agent is an oxidative phosphorylation inhibitor, ionophore or AMPK activator). The term “oxidative phosphorylation inhibitor” refers to any suitable agents that inhibit oxidative phosphorylation, such as oxidative phosphorylation uncouplers. An ionophore is a lipid-soluble molecule capable of transporting an ion across the lipid bilayer of cell membranes; and an AMPK activator is an agent that activates AMPK to phosphorylate its substrates, e.g., acetyl-CoA carboxylase and malonyl-CoA decarboxylase. Examples of the second agent include metformin (e.g., metformin chloride), phenformin and buformin. [0008] The third agent can be a compound possessing or maintaining at least one of the serotonin's activities and, when used in combination with the first and second agents, effectively treats one or more of the target diseases of this invention. Examples include serotonin (e.g., serotonin sulfate, serotonin creatinine sulfate complex, or serotonin hydrochloride) and a serotonin re-uptake inhibitor. [0009] A preferred composition of the present invention contains aspirin, metformin hydrochloride, and serotonin creatinine sulfate complex. [0010] In another aspect, the invention features a composition consisting essentially of a first agent that possesses anti-inflammatory activity or acetaminophen, phenacetin, tramadol and the like, a second agent that can be an oxidative phosphorylation inhibitor, an ionophore, or an AMPK activator, and a third agent that possesses serotonin activity. The term “consisting essentially of” used herein limits a composition to the three specified agents and those that do not materially affect its basic and novel characteristics, i.e., the efficacy in treating a target disease described herein. An example of such a composition contains the above-mentioned three agents and a pharmaceutically acceptable carrier. The compositions described above can contain 5-5,000 mg (e.g., 5-3,000 mg, 5-1,500 mg or 5-1,000 mg) of the first agent, 1-5,000 mg (e.g., 1-3000 mg, 1-1,000 mg, 1-500 mg, or 1-100 mg) of the second agent, and 0.1-1,000 mg (e.g., 0.1-100 mg, 0.1-50 mg, or 0.1-30 mg) of the third agent, or in quantities of the same ratio as that calculated based on the above amounts. [0011] In still another aspect, the invention features a method for treating hyperproliferative diseases. The method includes administering to a subject in need thereof an effective amount of one or more of the compositions described above. The diseases mentioned above also include their associated disorders. [0012] The term “treating” or “treatment” used herein refers to administering one or more above-described compositions to a subject, who has a disease described above, a symptom of such a disease, or a predisposition toward such a disease, with the purpose to confer a therapeutic effect, e.g., to cure, relieve, alter, affect, ameliorate, or prevent the disease, the symptom of it, or the predisposition toward it. [0013] The composition described above can be in form suitable for any route of administration. For example, when the composition is orally administered, the present invention in certain embodiments may be administered by any pharmaceutically acceptable oral dosage form including, solids (e.g., tablets, capsules), liquids (e.g., syrups, solutions and suspensions), orally dissolving dosage forms (e.g., orally disintegrating dosage forms, lozenges and troches), powders or granules. [0014] The compositions may also be prepared for parenteral administration as a solution, or suspension. The compositions may also be in dry form ready for reconstitution (e.g., with the additional of sterile water for injection), prior to parenteral administration. Parenteral administration includes administration into any body space or tissue, for example intravenous, intra-arterial, intramuscular and subcutaneous. Where the intended cite of action is a solid tumor, in certain embodiments the composition may be injected directly into the tumor. [0015] In certain other embodiments of the invention, one or more active compounds of the present invention are associated with a carrier substance such as a compound or molecule (e.g., an antibody), to facilitate the transport of the one or more active compounds to the intended cite of action. In certain preferred embodiments, active compound B (useful for treating a hyperproliferating tissue), is covalently bonded to an antibody that corresponds to a marker located on the hyperproliferative tissue. According to this aspect of the invention, it is contemplated that toxicity and adverse effects can be reduced because lower levels of the active agent are capable of providing the desired therapeutic effect relative to administration of the active agent that is not associated with a carrier substance. [0016] The first, second, and third agents described above include active compounds, as well as any pharmaceutically acceptable derivatives such as their salts, pro-drugs, and solvates, if applicable. A salt, for example, can be formed between an anion and a positively charged group (e.g., amino) on an agent. Examples of suitable anions include chloride, bromide, iodide, sulfate, nitrate, phosphate, citrate, methanesulfonate, trifluoroacetate, acetate, chlorophenyoxyacetate, malate, tosylate, tartrate, fumarate, glutamate, glucuronate, lactate, glutarate, benzoate, embonate, glycolate, pamoate, aspartate, parachlorophenoxyisobutyrate, formate, succinate, cyclohexanecarboxylate, hexanoate, octonoate, decanoate, hexadecanoate, octodecanoate, benzenesulphonate, trimethoxybenzoate, paratoluenesulphonate, adamantanecarboxylate, glycoxylate, pyrrolidonecarboxylate, naphthalenesulphonate, 1-glucosephosphate, sulphite, dithionate, and maleate. Likewise, a salt can also be formed between a cation and a negatively charged group (e.g., carboxylate) on an agent. Examples of suitable cations include sodium ion, potassium ion, magnesium ion, calcium ion, and an ammonium cation such as tetramethylammonium ion. In certain embodiments, the agents also include salts containing quaternary nitrogen atoms. Examples of pro-drugs include esters and other pharmaceutically acceptable derivatives, which, upon administration to a subject, are capable of providing active compounds. A solvate refers to a complex formed between an active compound and a pharmaceutically acceptable solvent. Examples of pharmaceutically acceptable solvents include water, ethanol, isopropanol, ethyl acetate, acetic acid, and ethanolamine. [0017] Other examples of the salts include arginine, L-arginine; DL-lysine; Bismuth Salicylate Basic; Bismuth salicylate; Magnesium; Diethylamine; sodium salt; imidazole; Sodium Aminosalicylate; Isoniazid Aminosalicylate; Physostigmine; Pregnenolone Acetylsalicylate; Choline Magnesium Trisalycylate (Trilisate); Zinc Oxide; Iodide; Acetic Acid Glacial Solution and Methyl. [0018] Also within the scope of this invention is one or more compositions described above for use in treating a disease described herein, and the use of such a composition for the manufacture of a medicament for the treatment of a disease described herein. [0019] The details of one or more embodiments of the invention are set forth in the description below. Other features, objects, and advantages of the invention will be apparent from the description and from the claims. DETAILED DESCRIPTION [0020] In certain embodiments, a composition of this invention can include three agents. [0021] Examples of the first agent can include steroidal anti-inflammatory drugs and non-steroidal anti-inflammatory drugs. Examples of steroidal anti-inflammatory drugs include glucocorticoids, hydrocortisone, cortisone, beclomethasone, dipropionate, betamethasone, dexamethasone, prednisone, methylprednisolone, triamcinolone, fluocinolone acetonide, fludrocortisone, and beclometasone propionate. [0022] Examples of non-steroidal anti-inflammatory drugs (NSAIDs) include A183827, ABT963, aceclofenac, acemetacin, acetyl salicylic acid, AHR10037, alclofenac, alminoprofen, ampiroxicam, amtolmetin guacil, apazone, atliprofen methyl ester, AU8001, benoxaprofen, benzydamine flufenamate, bermoprofen, bezpiperylon, BF388, BF389, BIRL790, BMS347070, bromfenac, bucloxic acid, butibufen, BW755C, C53, C73, C85, carprofen, CBS1108, celecoxib, CHF2003, chlorobiphenyl, choline magnesium trisalicylate, CHX108, cimicoxib, cinnoxicam, clidanac, CLX1205, COX-2 inhibitors, CP331, CS502, CS706, D1367, darbufelone, deracoxib, dexketoprofen, DFP, DFU, diclofenac potassium, diclofenac sodium, diclofenac sodium misoprostol, diflunisal, DP155, DRF4367, E5110, E6087, eltenac, ER34122, esflurbiprofen, etoricoxib, etodolac, F025, felbinac ethyl, fenbufen, fenclofenac, fenclozic acid, fenclozine, fenoprofen, fentiazac, feprazone, filenadol, flobufen, florifenine, flosulide, flubichin methanesulfonate, flufenamic acid, fluprofen, flurbiprofen, FPL62064, FR122047, FR123826, FR140423, FR188582, FS205397, furofenac, GR253035, GW406381, HAI105, HAI106, HCT2035, HCT6015, HGP12, HN3392, HP977, HX0835. HYAL AT2101, ibufenac, ibuproxam-beta-cyclodextrin, icodulinum, IDEA070, iguratimod, imrecoxib, indoprofen, IP751, isoxepac, isoxicam, KC764, ketoprofen, L652343, L745337, L748731, L752860, L761066, L768277, L776967, L783003, L784520, L791456, L804600, L818571, LAS33815, LAS34475, licofelone, LM 4108, lobuprofen, lomoxicam, lumiracoxib, mabuprofen, meclofenamic acid, meclofenamate sodium, mefenamic acid, meloxicam, mercaptoethylguanidine, mesoporphyrin, metoxibutropate, miroprofen, mofebutazone, mofezolac, MX1094, nabumetone, naproxen sodium, naproxen-sodium/metoclopramide, NCX1101, NCX284, NCX285, NCX4016, NCX4215, NCX530, niflumic acid, nimesulide, nitric oxide-based NSAIDs (NitroMed, Lexington, Mass.), nitrofenac, nitroflurbiprofen, nitronaproxen, NS398, ocimum sanctum oil, ONO3144, orpanoxin, oxaprozin, oxindanac, oxpinac, oxycodone/ibuprofen, oxyphenbutazone, P10294, P54, P8892, pamicogrel, parcetasal, parecoxib, PD138387, PD145246, PD164387, pelubiprofen, pemedolac, phenylbutazone, pirazolac, piroxicam, piroxicam beta-cyclodextrin, piroxicam pivalate, pirprofen, pranoprofen, resveratrol, R-ketoprofen, R-ketorolac, rofecoxib, RP66364, RU43526, RU54808, RWJ63556, S19812, S2474, S33516, salicylsalicylic acid, salsalate, satigrel, SC236, SC57666, SC58125, SC58451, SFPP, SKF105809, SKF86002, sodium salicylate, sudoxicam, sulfasalazine, sulindac, suprofen, SVT2016, T3788, TA60, talmetacin, talniflumate, tazofelone, tebufelone, tenidap, tenoxican, tepoxalin, tiaprofenic acid, tilmacoxib, tilnoprofen arbamel, tinoridine, tiopinac, tioxaprofen, tolfenamic acid, tolmetin, triflusal, tropesin, TY10222, TY10246, TY10474, UR8962, ursolic acid, valdecoxib, WAY120739, WY28342, WY41770, ximoprofen, YS134, zaltoprofen, zidometacin, and zomepirac. Other examples of the first agent include acetaminophen, phenacetin, tramadol and the like. [0023] Still other examples of the first agent include Aspirin-arginine, Alxiling, L-arginine acetylsalicylic; Aspirin-DL-lysine; Bismuth Salicylate Basic; Bismuth salicylate; Magnesium Salicylate; Diethylamine Salicylate; Salicylic acid, sodium salt; imidazole salicylate; Sodium Aminosalicylate; Isoniazid Aminosalicylate; Physostigmine Salicylate; Pregnenolone Acetylsalicylate; Choline Magnesium Trisalycylate (Trilisate); Salicylic Acid Zinc Oxide; Sodium Salicylate and Sodium Iodide; Salicylic Acid and Acetic Acid Glacial Solution; and Methyl Salicylate. [0024] Examples of the second agent can include, in addition to those described above, 4,6-dinitro-ocresol, uncoupling proteins (e.g., UCP1, UCP2, or UCP3), carbonyl cyanide p(trifluoromethoxy)phenyl-hydrazone, carbonyl cyanide m-chlorophenyl-hydrazone, C5 gene products, dinitrophenol (e.g., 2,4-dinitrophenol), efrapeptin (A23871), guanethidine, chlorpromazine, amytal, secobarbital, rotenone, progesterone, antimycin A, naphthoquinone, 8-hydroxyquinoline, carbon monoxide, cyanides, azides (e.g., NaN3), dicoumarin, bilirubin, bile pigment, ephedrine, hydrogen sulfide, tetraiodothyronine, quercetin, 2,4-bis(p-chloroanilino)pyrimidine, glyceraldehyde-3 phosphate dehydrogenase, oligomycin, tributyltin chloride, aurovertin, rutamycin, venturicidin, mercurials, dicyclohexylcarbdiimide, Dio-9, m-chlorophenyl-hydrazone mesoxalonitrile, ionomycin, calcium ionophores (e.g., A23187, NMDA, CA 1001, or enniatin B), compounds that increase the Ca+2 concentration in mitochondria (e.g., atractyloside, bongkrekic acid, thapsigargin, amino acid neurotransmitters, glutamate, N-methyl-D-aspartic acid, carbachol, ionophores, inducers of potassium depolarization), apoptogens (i.e., compounds that induce apoptosis), valinomycin, gramicidin, nonactin, nigericin, lasalocid, and monensin. The second agent can be an AMPK activator (e.g., metformin or phenformin, buformin, AICAR, thienopyridones, resveratrol, nootkatone, thiazole, adiponectin, thiazolidinediones, rosiglitazone, pioglitazone or dithiolethiones). [0025] The third agent includes serotonin and its functional equivalents. Examples of the functional equivalents of serotonin include: [0026] Serotonin 1A agonists such as: (e.g., arylpiperazine compounds, azaheterocyclylmethyl derivatives of heterocycle-fused benzodioxans, or buspirone, 3-amino-dihydro-[1]-benzopyrans and benzothiopyrans, (S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone—311C90) and 8-OH-DPAT), 5-Carboxamidotyptamine hemiethanolate maleate salt, N,N-Dipropyl-5-carboxamidotryptamine maleate salt, R(+)-UH-301 HCl, S15535, gepirone, psilocybin, xaliproden HCl and tandospirone; [0027] Serotonin 1B agonists such as: CGS-12066a, N-Methylquipazine dimaleate salt, rizatriptan and naratriptan; [0028] Serotonin 1C agonists such as: dexnorfenfluramine; [0029] Serotonin 1A, 1B, 1D and 1F agonists such as Sumatriptan and 5-Carboxamidotryptamine hemiethanolate maleate salt; [0030] Serotonin 1B and 1D agonists such as: dihydroergotamine and GR46611; [0031] Serotonin 1A and 1D agonists such as: LY-165,163; [0032] Serotonin 1A and 1E agonists such as: ergonovine and BRL 54443 maleate salt; [0033] 5-HT 2A/2C agonists such as: DOI (2,5-dimethoxy-4-iodoamphetamine), mCPP (m-chlorophenyl-piperazine), TFMPP (3-Trifluoromethylphenylpiperazine), mescaline, DMT, psilocin, 2C-B, lorcaserin, methylserotonin laleaste salt and 1-(3-Chlorophenyl)piperazine HCl; [0034] Serotonin 2B agonist such as: BW 723C86; [0035] Serotonin receptor 2C modulators such as: (e.g., BVT933, DPCA37215, IK264, PNU22394, WAY161503, R-1065, YM348, VER-3323 hemifumarate and those disclosed in U.S. Pat. No. 3,914,250, WO 01/66548, WO 02/10169, WO 02/36596, WO 02/40456, and WO02/40457, WO 02/44152, WO 02/48124, WO 02/51844, and WO 03/033479), the disclosures of which are incorporated by reference in their entireties; [0036] 5-HT 3 agonists such as Phenylbiguanide, O-Methylserotonin HCl, SR 57227A and 1-(3-Chlorophenyl)biguanide HCl; [0037] 5-HT 4 agonist such as cisapride, mosapride citrate duhydrate and ML 10302; [0038] 5HT7 receptor agonist such as: 4-(2-pyridyl) piperazines, LP 12 hydrochloride hydrate, LP44 and quinoline derivatives; [0039] Serotonin transporter inhibitors such as: imipramine; [0040] Serotonin reuptake inhibitors such as (e.g., arylpyrrolidine compounds, phenylpiperazine compounds, benzylpiperidine compounds, piperidine compounds, tricyclic gamma-carbolines duloxetine compounds, pyrazinoquinoxaline compounds, pyridoindole compounds, piperidyindole compounds, milnacipran, citalopram, sertraline metabolite, demethylsertraline, norfluoxetine, desmethylcitalopram, escitalopram, 1-fenfluramine, femoxetine, ifoxetine, cyanodothiepin, litoxetine, dapoxetine, nefazodone, cericlamine, trazodone, mirtazapine, fluvoxamine, indalpine, indeloxazine, milnacipran, paroxetine, sibutramine, zimeldine, trazodone hydrochloride, dexfenfluramine, bicifadine, vilazodone, desvenlafaxine, duloxetine, amitriptyline, butriptyline, desipramine, dosulepin, doxepin, lofepramine, nortriptyline, protriptyline, trimipramine, amoxapnie, maprotiline, adhyperforin, bromopheniramine, chlorpheniramine, dextromethorphan, diphenhydramine, hyperforin, ketamine, nefazodone, pethidine, phencyclidine, pheniramine, propoxyphene and those in U.S. Pat. No. 6,365,633, WO 01/27060, and WO 01/162341), the disclosures of which are hereby incorporated by reference in their entireties, EPTI, 8-OH-DPAT, Prozac® (fluoxetine hydrochloride) and Zoloft® (Sertraline hydrochloride); [0041] Serotonin and noradrenaline reuptake inhibitors such as: (e.g., venlafaxine, venlafaxine metabolite O-desmethylvenlafaxine, clomipramine, and clomipramine metabolite desmethylclomipramine); [0042] Monoamine re-uptake inhibitors such as: (e.g., amides); [0043] Pyridazinone aldose reductase inhibitors such as: (e.g., pyridazinone compounds); [0044] Serotonergic agents, which are also stimulants of serotonin receptors, such as: (e.g., ergoloid mesylate or pergolide mesylate); [0045] Stimulants of serotonin synthesis such as: (e.g., vitamin B1, vitamin B3, vitamin B6, biotin, Sadenosylmethionine, folic acid, ascorbic acid, magnesium, coenzyme Q10, or piracetam); [0046] Serotonin receptor agonists such as: Rauwolscine, Yohimbine, .alpha.-Methyl-5-hydroxytryptamine, 1-(1-Naphthyl)piperazine, metoclopramide, HTF-919, R-093877, Zolmitriptan, 5-Methoxy-N,N-dimethyltryptamine, 5-MEO-DIPT hydrochloride hydrate and lysergic acid diethylamide; [0047] Serotonin precursors such as tryptophan; [0048] Agents that promote serotonin release from nerve terminals such as: fenfluramine, and norfenfluramine; [0049] All of the compounds mentioned above are known drugs and are readily available to the public. Some of the drugs can be purchased from chemical companies, such as Sigma-Aldrich, St. Louis, Mo. Where the drugs are not readily available, in certain embodiments, one of ordinary skill in art will appreciate that the compounds can be organically manufactured and identified according to accepted standards such as those found in the Merck Index, Remington's Pharmaceutical Sciences, USP/NF, and foreign publications. In certain embodiments, regimens for administering these drug compounds are well known and, if necessary, can be easily re-established by an ordinary skilled clinician. Effective doses will vary, as recognized by those skilled in the art, depending on the type or degree of the disease to be treated; the subject's size, weight, age, and sex; the route of administration; the excipient usage; rate of metabolism, rate of excretion, and the possible co-usage with other therapeutic treatment. In certain embodiments, coadministration of other drugs can lead to increased or decreased metabolism and or excretion requiring an adjustment in dose. In certain other embodiments, where one or more of the active agents are bound to plasma proteins, coadministration of other drugs that effect the extent of binding may also require an adjustment of dose. The daily dose of the compositions described above can be 5-10,000 mg (e.g., 10-5000 or 10-3,000 mg) of the first agent, 1-5,000 mg (e.g., 2-1,000 or 2-3,000 mg) of the second agent, and 0.1-1,000 mg (e.g., 1-50 mg) of the third agent. [0050] In certain preferred embodiments the human dose of the composition of the present invention is about 5-5,000 mg of metformin, about 1-5,000 mg aspirin and about 0.1-1,000 mg serotonin creatinine complex. In certain more preferred embodiments, the human dose of the composition is about 1000 mg of metformin, about 400 mg aspirin and about 4 mg serotonin creatinine complex administered as multiple daily doses. In certain further preferred embodiments, this dose is administered three times a day. [0051] One aspect of this invention features a method of administering an effective amount of one or more of the above-mentioned compositions to a subject for treating a disease described herein. Such a subject can be identified by a health care professional such as a clinician based on results from any suitable diagnostic method. “An effective amount” refers to the amount of one or more compositions described herein that is required to confer a therapeutic effect on a treated subject. [0052] To practice the method of the present invention, in certain embodiments, one or more of the above-described compositions can be administered parenterally, orally, nasally, rectally, topically, or buccally. The term “parenteral” as used herein refers to subcutaneous, intracutaneous, intravenous, intramuscular, intraarticular, intraarterial, intrasynovial, intrasternal, intrathecal, intralesional, or intracranial injection, as well as any suitable infusion or injection technique. [0053] A sterile injectable composition can be a solution or suspension in a non-toxic parenterally acceptable diluent or solvent, such as a solution in 1,3-butanediol. Examples of the acceptable vehicles and solvents that can be employed are mannitol, water, Ringer's solution, and isotonic sodium chloride solution. In addition, fixed oils are conventionally employed as a solvent or suspending medium (e.g., synthetic mono- or diglycerides). Fatty acid, such as oleic acid and its glyceride derivatives are useful in the preparation of injectables, as are natural pharmaceutically acceptable oils, such as olive oil or castor oil, especially in their polyoxyethylated versions. [0054] These oil solutions or suspensions can also contain a long chain alcohol diluent or dispersant, carboxymethyl cellulose, or similar dispersing agents. Other commonly used surfactants such as Tweens or Spans or other similar emulsifying agents or bioavailability enhancers which are commonly used in the manufacture of pharmaceutically acceptable solid, liquid, or other dosage forms can also be used for the purpose of formulation. [0055] A composition for oral administration can be any orally acceptable dosage form including capsules, tablets, emulsions and aqueous suspensions, dispersions, and solutions. In the case of tablets, commonly used carriers include lactose and corn starch. Lubricating agents, such as magnesium stearate, are also typically added. For oral administration in a capsule form, useful diluents include lactose and dried corn starch. When aqueous suspensions or emulsions are administered orally, the active ingredient can be suspended or dissolved in an oily phase combined with emulsifying or suspending agents. If desired, certain sweetening, flavoring, or coloring agents can be added. [0056] A nasal aerosol or inhalation composition can be prepared according to techniques well known in the art of pharmaceutical formulation. For example, such a composition can be prepared as a solution in saline, employing benzyl alcohol or other suitable preservatives, absorption promoters to enhance bioavailability, fluorocarbons, and/or other solubilizing or dispersing agents known in the art. [0057] A composition for topical administration can be prepared in form of an ointment, a gel, a plaster, an emulsion, a lotion, a foam, a cream of a mixed phase or amphiphilic emulsion system (oil/water-water/oil mixed phase), a liposome, a transfersome, a paste, or a powder. [0058] Any of the compositions described above can also be administered in the form of suppositories for rectal administration. It also can be designed such that the composition is released in the intestine. For example, the composition is confined in a solid sub-unit or a capsule compartment that has respectively a matrix or a wall or a closure comprising an enteric polymer which dissolves or disperses at the pH of the small or large intestine to release the drug substance in the intestine. Suitable such polymers have been described above, for example with reference to U.S. Pat. No. 5,705,189. [0059] In certain embodiments, the carrier in the pharmaceutical composition must be “acceptable” in the sense that it is compatible with the active ingredient of the composition (and preferably, capable of stabilizing the active ingredient) and not deleterious to the subject to be treated. One or more solubilizing agents can be utilized as pharmaceutical excipients for delivery of an active compound. Examples of other carriers include colloidal silicon oxide, magnesium stearate, cellulose, sodium lauryl sulfate, and D&C Yellow # 10. Benign Tumors [0060] The compounds and methods of the present invention are also suitable for treatment of variety of benign tumors. Exemplary benign tumors include: Adrenal tumors such as adenoma, Adrenal Pheochromocytoma and Adrenal Ganglioneuroma; Brain tumors such as Meningioma and Adenoma; Peripherial Nerve tumors such as Neurofibroma and Schwannoma; Liver tumors such as Adenoma; Thyroid tumors such as Follicular Adenoma; Parathyroid tumors such as Adenoma; Thymus tumors such as Thymoma; Salivary Gland tumors such as Pleomorphic Adenoma; Small Intestine tumor such as Villous Adenoma; Colon tumors such as Tubulovillous Adenoma, Adenomatous Polyp of Colon and Polyposis Coli; Pancreas tumors such as Serous Cystadenoma; Islet tumors such as Pancreatic Islet Cell Tumor; Nasopharyngyl tumors such as Nasal Angiofibroma; Ovary tumors such as: Atypical Proliferating Mucinous Neoplasm, Brenner Tumor of Ovary, Mucinous Cystadenoma, Papillary cystadenoma, Dermoid Cyst of Ovary, Ovarian Teratoma, Ovarian Fibroma, Luteoma and Struma ovarii; Uterus tumors such as Uterine Cellular Leiomyoma and Leiomyoma; Placenta tumors such as Chorioangioma, Partial hydatidiform mole, Complete Hydatidiform and Mole; Bone tumors such as Cavernous Hemangioma and Giant Cell Tumor; Soft Tissue tumors such as Cavernous hemangioma, Desmoid Tumor, lipoma, Myelolipoma and osteochondroma; Joint tumors such as Synovial Chondromatosis; Lung tumors such as Carcinoid Tumor, Granular Cell Tumor and Hemangioma; Myocardium tumors such as Atrial Myxoma; Breast tumors such as Fibroadenoma, Intraductal Papilloma and Schwannoma; Kidney tumors such as Congenital Mesoblastic Nephroma; and Skin tumors such as Giant Congenital Intradermal Nevus; Kidney tumors such as Congenital Mesoblastic Nephroma. [0061] The present composition can be administered for the treatment of hyperproliferative disorders. The term “hyperproliferative disorders” refers to excess cell proliferation that is not governed by the usual limitation of normal growth. The term denotes malignant as well as nonmalignant cell populations. The excess cell proliferation can be determined by reference to the general population and/or by reference to a particular patient, e.g. at an earlier point in the patient's life. Hyperproliferative cell disorders can occur in different types of animals and in humans, and produce different physical manifestations depending upon the affected cells. [0062] Hyperproliferative cell disorders include tumors as well as nontumors. A “tumor” here refers to an abnormal mass of tissue that results from excessive cell division that is uncontrolled and progressive, also called a neoplasm. [0063] Examples of tumors include a variety of solid tumor such as laryngeal tumors, brain tumors, other tumors of the head and neck; colon, rectal and prostate tumors; breast and thoracic solid tumors; ovarian and uterine tumors; tumors of the esophagus, stomach, pancreas and liver; bladder and gall bladder tumors; skin tumors such as melanomas; and the like, and a fluid tumor such as leukemia. [0064] A “solid tumor”, as used herein, refers to an abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumors may be benign (not cancerous), or malignant (cancerous). Solid tumors have a distinct structure that mimics that of normal tissues and comprises two distinct but interdependent compartments: the parenchyma (neoplastic cells) and the stroma that the neoplastic cells induce and in which they are dispersed. Different types of solid tumors are named for the type of cells that form them. Examples of solid tumors are sarcomas, carcinomas, and lymphomas. [0065] “Solid tumor” means a locus of tumor cells where the majority of the cells are tumor cells or tumor-associated cells. [0066] More particularly, tumor here refers to either benign (not cancerous) or malignant tumors. Malignant Tumors [0067] Examples of malignant tumors include but not limited to: Breast cancer: [0000] 1. Ductal carcinoma: A1. Ductal Carcinoma In Situ (DCIS): Comedocarcinoma, Cribriform, Papillary, Micropapillary; A2. Infiltrating Ductal Carcinoma (IDC): Tubular Carcinoma, Mucinous (Colloid) Carcinoma, Medullary Carcinoma, Papillary Carcinoma, Metaplastic Carcinoma, Inflammatory Carcinoma 2. Lobular Carcinoma: B1. Lobular Carcinoma In Situ (LCIS); B2. Invasive lobular carcinoma 3. Paget's Disease of the Nipple [0068] Female Reproductive System [0069] CERVIX UTERI: Cervical intraepithelial neoplasia, grade I, Cervical intraepithelial neoplasia, grade II, Cervical intraepithelial neoplasia, grade III (Squamous cell carcinoma in situ), Keratinizing Squamous Cell Carcinoma, Nonkeratinizing Squamous Cell Carcinoma, Verrucous Carcinoma, Adenocarcinoma in situ, Adenocarcinoma in situ, endocervical type, Endometrioid adenocarcinoma, Clear cell adenocarcinoma, Adenosquamous carcinoma, Adenoid cystic carcinoma, Small cell carcinoma, Undifferentiated carcinoma [0070] CORPUS UTERI: Endometrioid carcinoma, Adenocarcinoma, Adenocanthoma (adenocarcinoma with squamous metaplasia), Adenosquamous carcinoma (mixed adenocarcinoma and squamous cell carcinoma, Mucinous adenocarcinoma, Serous adenocarcinoma, Clear cell adenocarcinoma, Squamous cell adenocarcino, Undifferentiated adenocarcinoma [0071] OVARY: Serous cystadenoma, Serous cystadenocarcinoma, Mucinous cystadenoma, Mucinous cystadenocarcinoma, Endometrioid tumor, Endometrioid adenocarcinoma, Clear cell tumor, Clear cell cystadenocarcinoma, Unclassified tumor [0072] VAGINA: Squamous cell carcinoma, Adenocarcinoma [0073] VULVA: Vulvar intraepithelial neoplasia, grade I, Vulvar intraipithelial neoplasia, grade II, Vulvar intraepithelial neoplasia, grade III (squamous cell carcinoma in situ), Squamous Cell Carcinoma, Verrucous carcinoma, Padget's disease of the vulva, Adenocarcinoma, NOS, Basal cell carcinoma, NOS, Bartholin's gland carcinoma [0074] Male Reproductive System [0075] PENIS: Squamous Cell Carcinoma [0076] PROSTATE: Adenocarcinoma, Sarcoma, Transitional cell carcinoma of the prostate [0077] TESTIS: Seminomatous tumor, Nonseminomatous tumor, Teratoma, Embryonal carcinoma, Yolk sac tumor, Choriocarcinoma [0078] CARDIAC: sarcoma (angiosarcoma, fibrosarcoma, rhabdomyosarcoma, liposarcoma), myxoma, rhabdomyoma, fibroma, lipoma and teratoma [0079] Respiratory System [0080] LARYNX: Squamous cell carcinoma [0081] PLEURAL MESOTHELIOMA: Primary pleural mesothelioma [0082] PHARYNX: Squamous cell carcinoma [0083] Lung [0084] 1. Squamous cell carcinoma (epidermoid carcinoma), Variant: Spindle cell; [0085] 2. Small cell carcinoma, Other cell carcinoma, Intermediate cell type, Combined oat cell carcinoma; [0086] 3. Adenocarcinoma: Acinar adenocarcinoma, Papillary adenocarcimoma, Bronchiolo-alveolar carcinoma, Solid carcinoma with mucus formation; [0087] 4. Large cell carcinoma: Giant cell carcinoma, Clear cell carcinoma, Sarcoma; [0088] Gastrointestinal Tract [0089] AMPULLA OF VATER: Primary adenocarcinoma, Carcinoid tumor, Lymphoma [0090] ANAL CANAL: Adenocarcinoma, Squamous cell carcinoma, Melanoma [0091] EXTRAHEPATIC BILE DUCTS: Carcinoma in situ, Adenocarcinoma, Papillary adenocarcinoma, Adenocarcinoma, intestinal type, Mucinous adenocarcinoma, Clear cell adenocarcinom, Segnet-ring cell carcinoma, Adenosquamous carcinoma, Squamous cell carcinoma, Small cell (oat) carcinoma, Undifferentiated carcinoma, Carcinoma, NOS, Sarcoma, Carcinoid tumor [0092] COLON AND RECTUM: Adenocarcinoma in situ, Adenocarcinoma, Mucinous adenocarcinoma (colloid type; greater than 50% mucinous carcinoma), Signet ring cell carcinoma (greater than 50% signet ring cell), Squamous cell (epidermoid) carcinoma, Adenosquamous carcinoma, Small cell (oat cell) carcinoma, Undifferentiated carcinoma, Carcinoma, NOS, Sarcoma, Lymphoma, Carcinoid tumor [0093] ESOPHAGUS: squamous cell carcinoma, adenocarcinoma, leiomyosarcoma lymphoma [0094] GALLBLADDER: Adenocarcinoma, Adenocarcinoma, intestinal type, Adenosquamous carcinoma, Carcinoma in situ, Carcinoma, NOS, Clear cell adenocarcinoma, Mucinous adenocarcinoma, Papillary adenocarcinoma, Signet-ring cell carcinoma, Small cell (oat cell) carcinoma, Squamous cell carcinoma, Undifferentiated carcinoma [0095] LIP AND ORAL CAVITY: Squamous cell carcinoma [0096] LIVER: hepatoma (hepatocellular carcinoma), cholangiocarcinoma, hepatoblastoma, angiosarcoma, hepatocellular adenoma, hemangioma [0097] EXOCRINE PANCREAS: Duct cell carcinoma, Pleomorphic giant cell carcinoma, Giant cell carcinoma, osteoclastoid type, Adenocarcinoma, Adenosquamous carcinoma, Mucinous (colloid) carcinoma, Cystadenocarcinoma, Acinar cell carcinoma, Papillary carcinoma, Small cell (oat cell) carcinoma, Mixed cell typed, Carcinoma, NOS, Undifferentiated carcinoma, Endocrine cell tumors arising in the islets of Langerhans, Carcinoid [0098] SALIVARY GLANDS: Acinic (acinar) cell carcinoma, Adenoid cystic carcinoma (cylindroma), Adenocarcinoma, Squamous cell carcinoma, Carcinoma in pleomorphic adenoma (malignant mixed tumor), Mucoepidermoid carcinoma, Well differentiated (low grade), Poorly differentiated (high grade) [0099] STOMACH: Adenocarcinoma, Papillary adenocarcinoma, Tubular adenocarcinoma, Mucinous adenocarcinoma, Signet ring cell carcinoma, Adenosquamous carcinoma, Squamous cell carcinoma, Small cell carcinoma, Undifferentiated carcinoma, Lymphoma, Sarcoma, Carcinoid tumor [0100] SMALL INTESTINE: adenocarcinoma, lymphoma, carcinoid tumors, Karposi's sarcoma, leiomyoma, hemangioma, lipoma, neurofibroma, fibroma [0101] Urinary System [0102] KIDNEY: Renal cell carcinoma, Carcinoma of Bellini's collecting ducts, Adenocarcinoma, Papillary, Tubular carcinoma, Granular cell carcinoma, Clear cell carcinoma (hypemephroma), Sarcoma of the kidney, Nephroblastoma, Nephroblastoma [0103] RENAL PELVIS AND URETER: Transitional cell carcinoma, Papillary transitional cell carcinoma carcinoma, Squamous cell carcinoma, Adenomcarcinoma [0104] URETHRA: Transitional cell carcinoma, Squamous cell carcinoma, Adenocarcinoma [0105] URINARY BLADDER: Carcinoma in situ, Transitional urothelial cell carcinoma, Papillary transitional cell carcinoma, Squamous cell carcinoma, Adenocarcinoma, Undifferentiated [0106] Muscle, Bone, and Soft Tissue [0000] BONE: A. Bone-forming: Osteosarcoma; B. Cartilage-forming: Chondrosarcoma, Mesenchymal chondrosarcoma, C. Giant cell tumor, malignant, D. Ewing's sarcoma, E. Vascular tumors: Hemangioendothelioma, Hemangiopericytoma, Angiosarcoma; F. Connective tissue tumors: Fibrosarcoma, Liposarcoma, Malignant mesenchymoma, Undifferentiated sarcoma; G. Other tumors: Chordoma, Adamantinoma of long bones [0107] SOFT TISSUES: Alveolar soft-part sarcoma, Angiosarcoma, Epithelioid sarcoma, Extraskeletal chondrosarcoma, Fibrosarcoma, Leiomyosarcoma, Liposarcoma, Malignant fibrous histiocytoma, Malignant hemangiopericytoma, Malignant mesenchymoma, Malignant schwannoma, Rhabdomyosarcoma, Synovial sarcoma, Sarcoma, NOS [0108] NERVOUS SYSTEM: skull (osteoma, hemangioma, granuloma, xanthoma, osteitis deformans), meninges (meningioma, meningiosarcoma, gliomatosis), brain (astrocytoma, medulloblastoma, glioma, ependymoma, germinoma (pilealoma), glioblastoma multiform, oligodendroglioma, schwannoma, retinoblastoma, congenital tumors), spinal cord neurofibroma, meningioma, glioma, sarcoma) [0109] HEMATOLOGY: blood (myeloid leukemia (acute and chronic), acute lymphloblastic leukemia, chronic lymphocytic leukemia, myeloproliferative diseases, multiple myeloma, myelodysplastic syndrome), Hodgkin's disease, non-Hodgkin's lymphoma (malignant lymphonoma); [0110] Endocrine System [0000] THYROID GLAND: Papillary carcinoma (including those with follicular foci), Follicular carcinoma, Medullary carcinoma, Undifferentiated (anaplastic) carcinoma NEUROBLASTOMA: Sympathicoblastoma, Sympathicogonioma, Malignant ganglioneuroma, Gangliosympathicoblastma, Ganglioneuroma [0111] Skin [0000] Squamous cell carcinoma, Spindle cell variant of squamous cell carcinoma, Basal cell carcinoma, Adenocarcinoma developing from sweat or sebaceous gland, Malignant Melanoma [0112] Eye [0113] THE CONJUNCTIVA: Carcinoma of the conjunctiva; [0114] THE EYELID: Basal cell carcinoma, Squamous cell carcinoma, Sebaceous cell carcinoma; [0115] THE LACRIMAL GLAND: Adenocarcinoma, Adenoid cystic carcinoma, Carcinoma in pleomorphic adenoma, Mucoepidermoid carcinoma, Squamous cell carcinoma; [0116] THE EYELID: Melanoma of the eyelid [0117] THE UVEA: Spindle cell melanoma, Mixed cell melanoma, Epithelioid cell melanoma [0118] SARCOMA OF THE ORBIT: Soft tissue tumor, Sarcoma of bone [0119] RETINOBLASTOMA: Retinoblastoma [0120] Examples of nontumor hyperproliferative disorders include but not limited to myelodysplastic disorders; cervical carcinoma-in-situ; familial intestinal polyposes such as Gardner syndrome; oral leukoplakias; histiocytoses; keloids; hemangiomas; inflammatory arthritis; hyperkeratoses and papulosquamous eruptions including arthritis. Also included are viral induced hyperproliferative diseases such as warts and EBV induced disease (i.e., infectious mononucleosis), scar formation, blood vessel proliferative disorders such as restenosis, atherosclerosis, in-stent stenosis, vascular graft restenosis, etc.; fibrotic disorders; psoriasis; glomerular nephritis; macular degenerative disorders; benign growth disorders such as prostate enlargement and lipomas; autoimmune disorders and the like. [0121] The present composition can also be administered for the treatment of Cardiac dysrhythmias, including but not limited to the Wolff-Parkinson-White syndrome and atrioventricular nodal reentrant tachycardia ventricular tachycardia (VT), atrial tachycardias, atrial flutter and atrial fibrillationsupraventricular tachycardias. [0122] The present composition can also be administered for the treatment of Endometriosis, uterine fibroid (Uterine leiomyomata) menorrhagia, cervical erosion, cervical polyp, and the like. [0123] The present composition can also be administered for the treatment of the defects or disorders of intervertebral discs include but not limited to annular fissures, fragmentation of the nucleus pulposus, and contained herniation a herniated intervertebral disc, degenerative intervertebral discs. [0124] The compositions described above can be preliminarily screened for their efficacy in treating above-described diseases by an in vitro assay and then confirmed by animal experiments (See Examples 1-9 below) and clinic trials. Having the information set forth in the present invention, other methods will also be apparent to those of ordinary skill in the art. [0125] The specific examples below are to be construed as merely illustrative, and not limitative of the remainder of the disclosure in any way whatsoever. Without further elaboration, it is believed that one skilled in the art can, based on the description herein, utilize the present invention to its fullest extent. All of the publications cited herein are incorporated by reference in their entirety. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0126] Cells can exist in different periods of a cell cycle such as: G1 phase cells, S phase cells, (indicating synthesis and doubling of DNA), and G2 phase cells. Comparing cancer cells to normal cells, one finds a decrease in the proportion of G1 phase cells in cancer, an increase in the proportion of cells in synthesis in cancer and an increase in the proportion of cells in G2 phase and S phase. Example 1 [0127] In Example 1, B20L (Metformin 1 mM+aspirin 0.4 mM+serotonin creatinine sulfate complex 0.002 mM) and B20H (Metformin 10 mM+aspirin 4 mM+serotonin creatinine sulfate complex 0.02 mM) were tested to determine the effect on the cell cycle of pancreatic cancer cells after 24 hours. Each of the cell samples were then tested in a flow cytometer. The testing methodology and equipment used are set forth as follows. Cells were harvested and washed twice with phosphate buffered saline, (PBS) and fixed in 70% cold ethanol at 4° C. overnight. Before analysis, cells were washed twice with PBS, containing 1% bovine serum albumin (BSA), then resuspended with 400 μl PBS and treated with 100 μg/ml RNase A (Roche Diagnostics) and 50 μg/ml propidium iodide (PI) (Sigma). After incubation for 30 min at 37° C., the cells were subjected to DNA content analysis. propidium iodide, (PI) fluorescence was analyzed with a FACS calibur flowcytometer, (Becton Dickinson). Data from at least 10,000 cells were analyzed with software. The results of a control group as well as the two active treatment groups are set forth in Table 1 below. [0000] TABLE 1 Effect of B20L Metformin + aspirin + serotonin creatinine sulfate complex and B20H Metformin + aspirin + serotonin creatinine sulfate complex on Pancreatic Cancer Cells after 24 Hours Group G1 S G2 Control   63% 35.5%  1.5% B20L Metformin 87.30% 9.40% 3.30% 1 mM + aspirin 0.4 mM + serotonin creatinine sulfate complex 0.002 mM Metformin 10 mM + 88.70% 7.80% 3.40% aspirin 4 mM + serotonin creatinine sulfate complex 0.02 mM [0128] The results indicate that Metformin+aspirin+serotonin creatinine sulfate complex can block pancreatic cancer cells in G1 phase from progressing into S phase and G2 phase after 24 hours as the two treatment groups have a higher proportion of cancer cells in the G1 phase. Example 2 [0129] In Example 2, the testing procedure according to Example 1 above was carried out for 48 and 72 hours comparing the control group to a B20L treatment group. The results are provided in Table 2 below. [0000] TABLE 2 Effect of B20L Metformin + aspirin + serotonin creatinine sulfate complex on Pancreatic Cancer Cells after 48 and 72 Hours Group G1 S G2 The effect of B20L on cell cycle in 48 hours Control   47% 46.20% 6.60% Metformin 1 mM + 71.70% 25.40% 2.90% aspirin 0.4 mM + serotonin creatinine sulfate complex 0.002 mM The effect of B20L on cell cycle in 72 hours Control   57% 37.40% 5.80% Metformin 1 mM + 63.80% 31.50% 4.60% aspirin 0.4 mM + serotonin creatinine sulfate complex 0.002 mM [0130] The results indicate that Metformin+aspirin+serotonin creatinine sulfate complex can block pancreatic cancer cells in G1 phase from progressing into S phase and G2 phase after 24, 48 and 72 hours as the two treatment groups have a higher proportion of cancer cells in the G1 phase. Example 3 [0131] In Example 3, different dosages of Metformin+aspirin+serotonin creatinine sulfate complex were tested to determine the effect on the cell cycle of breast cancer cells after 24 hours. Each of the cell samples were then tested in a flow cytometer according to the procedures set forth in Example 1 above. The results of a control group as well as the two active treatment groups are set forth in Table 3 below. [0000] TABLE 3 Effect of different dosages of Metformin + aspirin + serotonin creatinine sulfate complex on Breast Cancer Cells after 24 Hours Group G1 S G2 Control   43% 46.10% 10.6% (Metformin 1 mM + 59.60% 36.30% 4.10% aspirin 0.4 mM + serotonin creatinine sulfate complex 0.002 mM) Metformin 10 mM + 73.80% 20.00% 6.20% aspirin 4 mM + serotonin creatinine sulfate complex 0.02 mM [0132] The results indicate that B20 different dosages of Metformin+aspirin+serotonin creatinine sulfate complex can block breast cancer cells in G1 phase from progressing into S phase cells after 24 hours as the two treatment groups have a lower proportion of cancer S phase cells. Example 4 [0133] In Example 4, different dosages of Metformin+aspirin+serotonin creatinine sulfate complex were tested to determine the effect on proliferation speed of pancreatic cancer cells after 24, 48 and 72 hours. The testing methodology and equipment used are set forth as follows. Pancreatic cancer cells were subcultured into 96-well plates at approximately 4×10 4 cells per ml and allowed to adhere for 24 h at 37° C. before being treated with the drug. Cell viability was assessed using the Dojindo Cell Counting Kit-8. The cell viability was in direct proportion to the absorbance at 450 nm. Accordingly, the cell viability was expressed as the absorbance at 450 nm. All experiments were performed in triplicate on three separate occasions. The results of a control group as well as the two active treatment groups are set forth in Table 4 below. [0000] TABLE 4 Effect of different dosages of Metformin + aspirin + serotonin creatinine sulfate complex on Proliferation Speed of Pancreatic Cancer Cells after 24, 48 and 72 Hours Group 24 H 48 H 72 H Control 0.40 ± 0.023 0.89 ± 0.053  1.805 ± 0.033  Metformin 1 0.335 ± 0.021* 0.725 ± 0.047** 0.787 ± 0.066** mM + aspirin 0.4 mM + serotonin creatinine sulfate complex 0.002 mM Metformin 10  0.296 ± 0.017** 0.491 ± 0.034** 0.565 ± 0.060** mM + aspirin 4 mM + serotonin creatinine sulfate complex 0.02 mM *p < 0.05, **p < 0.01 [0134] The results indicate that different dosage of Metformin+aspirin+serotonin creatinine sulfate complex can inhibit pancreatic cancer cell proliferation and the effects are time and dose dependent. Example 5 [0135] In Example 5, Metformin 5 mM; Metformin 5 mM+aspirin 2 mM; and Metformin 5 mM+aspirin 2 mM+serotonin creatinine sulfate complex 0.001 mM were tested to determine the effect on cell cycle on B16 (mice melanoma cells) during the G1, S and G2 cell phases. The procedure for testing using the flow cytometer was carried out as set forth in Example 1 above. The results are set forth in Table 5 below. [0000] TABLE 5 Effect of Metformin 5 mM, Metformin 5 mM + aspirin 2 mM, and Metformin 5 mM + aspirin 2 mM + serotonin creatinine sulfate complex 0.01 mM on B16 mice melanoma cells during G1, S and G2 cell phases. Group G1 S G2 Control 64 12.8 23.1 Metformin 5 mM 71.8 4.6 23.6 Metformin 5 mM + 82.4 6.0 11.6 aspirin 2 mM Metformin 5 mM + 85.1 6.9 8.0 aspirin 2 mM + serotonin creatinine sulfate complex 0.01 mM [0136] The results indicate that metformin was effective. Metformin+aspirin had better effect metformin alone, while metformin+aspirin+serotonin creatinine sulfate complex is better than metformin+aspirin. Example 6 [0137] In Example 6, Metformin 50 mM; Metformin 100 mM, Metformin 150 mM; and metformin 200 mM were tested to determine the kill effect on breast cancer cells after 3, 12 and 24 hours. The testing methodology and equipment used are set forth as follows. Breast cancer cells were subcultured into 96-well plates at approximately 4×10 4 cells per ml and allowed to adhere for 24 h at 37° C. before being treated with the drug. Cell viability was assessed using the Dojindo Cell Counting Kit-8. The cell viability was in direct proportion to the absorbance at 450 nm. Accordingly, the cell viability was expressed as the absorbance at 450 nm. All experiments were performed in triplicate on three separate occasions. The results are set forth in Table 6 below showing the kill ratio (compared to control group) of different concentrations and different action times of metformin on MCF-7 cells (breast cancer cells). [0000] TABLE 6 Effect of metformin on MCF-7 kill ratio of Breast Cancer Cells after 3, 12 and 24 Hours Time Concentration 3 h (%) 12 h (%) 24 h (%) Metformin 0.139 ± 0.041** 0.397 ± 0.042** 0.404 ± 0.061** 50 mM Metformin 0.123 ± 0.057** 0.353 ± 0.083** 0.542 ± 0.095** 100 mM Metformin 0.318 ± 0.032** 0.488 ± 0.036** 0.887 ± 0.068** 150 mM Metformin 0.321 ± 0.07**  0.769 ± 0.088** 0.983 ± 0.018** 200 mM *p < 0.05, **p < 0.01 [0138] The results indicate that Metformin was effective, can kill breast cancer cell and the effects are time and dose dependent. Example 7 [0139] In Example 7, Metformin+serotonin creatinine sulfate complex+different compounds with anti-inflammatory activity or acetaminophen or tramadol (different first agent), were tested to determine the kill effect on liver cancer cells after 24 and 48 hours. The testing methodology and equipment was carried out as set forth in Example 6 above. The results are set forth in Table 7 below showing the kill ratio (compared to the control group), of different compositions and different action times on HepG-2 cells (liver cancer cells). [0000] TABLE 7 The kill ratio of different compositions and different action times on HepG-2 cells 24 hr (%) 48 hr (%) Metformin 0.975 ± 0.004** 0.995 ± 0.004** 100 mM + aspirin 40 mM + serotonin creatinine sulfate complex 0.2 mM Metformin 100 mM + 0.953 ± 0.010** 0.985 ± 0.008** indomethacin 30 mM + serotonin creatinine sulfate complex 0.2 mM Metformin 100 mM + 0.935 ± 0.022** 0.974 ± 0.007** nimesulide 30 mM + serotonin creatinine sulfate complex 0.2 mM Metformin 100 mM + 0.925 ± 0.027** 0.971 ± 0.005** celebrex 30 mM + serotonin creatinine sulfate complex 0.2 mM Metformin 100 mM + 0.957 ± 0.015** 0.975 ± 0.009** Piroxicam33 mM + serotonin creatinine sulfate complex 0.2 mM Metformin 100 mM + 0.964 ± 0.016** 0.981 ± 0.007** diclofenac25 mM + serotonin creatinine sulfate complex 0.2 mM Metformin 100 mM + 0.757 ± 0.115** 0.969 ± 0.014** acetaminophen 17 mM + serotonin creatinine sulfate complex 0.2 mM Metformin 100 mM + 0.884 ± 0.015** 0.978 ± 0.008** Tramadol hydrochloride 17 mM + serotonin creatinine sulfate complex 0.2 mM (*p < 0.05, **p < 0.01) [0140] The results indicate that Metformin+serotonin creatinine sulfate complex+different compounds with anti-inflammatory activity, acetaminophen, and tramadol (different first agent), can kill the live cancer cells well, and the effect is better than metformin only. Example 8 [0141] In Example 8, phenformin (different second agent)+serotonin creatinine sulfate complex+different compounds with anti-inflammatory activity or acetaminophen, or tramadol, were tested to determine the kill effect on liver cancer cells after 24 and 48 hours. The testing methodology and equipment was carried out as set forth in Example 6 above. The results are set forth in Table 8 below showing the kill ratio (compared to control group) of different compositions and different action times on HepG-2 cells. [0000] TABLE 8 The kill ratio of different compositions and different actions time on HepG-2 cells 24 hours (%) 48 hours (%) Phenformin 0.936 ± 0.016** 0.991 ± 0.006** 2 mM + aspirin 40 mM + serotonin creatinine sulfate complex 0.2 mM Phenformin 2 mM + 0.762 ± 0.032** 0.920 ± 0.02**  indomethacin 30 mM + serotonin creatinine sulfate complex 0.2 mM Phenformin 2 mM + 0.789 ± 0.039** 0.956 ± 0.012** nimesulide 30 mM + serotonin creatinine sulfate complex 0.2 mM Phenformin 2 mM + 0.817 ± 0.028** 0.957 ± 0.002** celebrex 30 mM + serotonin creatinine sulfate complex 0.2 mM Phenformin 2 mM + 0.973 ± 0.004** 0.994 ± 0.007** Piroxicam33 mM + serotonin creatinine sulfate complex 0.2 mM Phenformin 2 mM + 0.965 ± 0.006** 0.992 ± 0.005** diclofenac25 mM + serotonin creatinine sulfate complex 0.2 mM Phenformin 2 mM + 0.940 ± 0.022** 0.991 ± 0.005** acetaminophen 17 mM + serotonin creatinine sulfate complex 0.2 mM Phenformin 2 mM + 0.721 ± 0.027** 0.940 ± 0.004** tramadol hydrochloride 17 mM + serotonin creatinine sulfate complex 0.2 mM (*p < 0.05, **p < 0.01) [0142] The results indicate that phenformin (different second agent)+serotonin creatinine sulfate complex+compounds with different anti-inflammatory activity or acetaminophen, tramadol, can kill the live cancer cell well and the effect is better than metformin only. Example 9 [0143] In Example 9, the effect of B10 (Metformin 50 mg/kg+aspirin 40 mg/kg+serotonin creatinine sulfate complex 0.4 mg/kg) was tested to determine the effect on volume of hepatoma in Strain Kunming Mice (KM) relative to a 10% glucose saline (GS) group. The drugs were administered by intratumor injection, twice a day for 3 days. Volume was measured before and after treatment for each group. The results including the change in volume are set forth in Table 6 below. [0000] TABLE 9 The effect of B10 Metformin 50 mg/kg + aspirin 40 mg/kg + serotonin creatinine sulfate complex 0.4 mg/kg on the volume of hepatoma in KM mice Group Before Drug After Drug 10% G.S. (glucose saline) 321 ± 54 388 ± 275 Metformin 50 mg/kg + aspirin 40 mg/kg + 219 ± 68  13 ± 6** serotonin creatinine sulfate complex 0.4 mg/kg (n = 4, *p < 0.05, **p < 0.01) [0144] The results indicate that B10 Metformin 50 mg/kg+aspirin 40 mg/kg+serotonin creatinine sulfate complex 0.4 mg/kg can eliminate hepatoma volume in KM mice at the rate of 94.1%. Example 10 [0145] In Example 10, the effect of B10 Metformin 50 mg/kg+aspirin 40 mg/kg+serotonin creatinine sulfate complex 0.4 mg/kg was tested to determine the effect on the weight and volume of transplanted human hepatoma in hairless mice relative to a 10% GS group and a dehydration alcohol group. The procedures for performing this test were as follows. Hep G2 cells were prepared at 25*10 6 cells/ml and 0.2 ml of the cell suspension (5*10 6 cells) was injected in an exposed mouse mammary fat pad. When tumors achieved the required size (0.5 cm 3 ), animals would be treated with 50 μl of B10, dehydrated alcohol or 10% glucose solution once daily for 6 days. During 12 days after the last injection, tumor volume will be assessed by measuring tumor dimensions (long (L) and short (S)) and estimated it as V=0.52*L*S 2 . 12 days after the last injection, mice would be sacrificed and tumors would be dissected, weighed and stored in a formaline solution for further evaluation.). Volume was measured before and after treatment for each group. The results including the change in volume are set forth in Table 7 below. [0000] TABLE 10 The effect of B10 on the weight and volume of hepatoma in KM mice Volume Before After Group Treatment Treatment Changes 10% G.S.  172 ± 65.5 444 ± 199    ↑158% Dehydration ethanol 188 ± 119  89 ± 120**  ↓52.7% Metformin 50 mg/kg + 180 ± 128 1.05 ± 2.09** ↓199.4% aspirin 40 mg/kg + serotonin creatinine sulfate complex 0.4 mg/kg (n = 4, *p < 0.05, **p < 0.01) [0146] The results indicate that B10 can eliminate hepatoma volume in hairless mice at the rate 99.4%, compared to the dehydration ethanol group rate of 52.7%. Example 11 [0147] In Example 11, the effect of B3 (Metformin 50 mg/kg+celebrex 10 mg/kg+serotonin creatinine sulfate complex 0.4 mg/kg) was tested to determine the effect on metastasis of hepatoma carcinoma H22 cells. Fifty thousand (50,000) mice hepatoma carcinoma H22 cells were injected into the abdominal cavity of KM mice, and then administered 10% G.S. in the control group, or Metformin 50 mg/kg+celebrex 10 mg/kg+serotonin creatinine sulfate complex 0.4 mg/kg two times a day for only the first 30 days in the active treatment group. After treatment was stopped, survival time was observed. The results of the active treatment group and the 10% G.S. group are set forth in Table 8 below. [0000] TABLE 11 Survival Data of KM Mice Treated with Metformin 50 mg/kg + celebrex 10 mg/kg + serotonin creatinine sulfate complex 0.4 mg/kg three times a day for 30 days Number Surviving Group 120 Days Survival Time 10% G.S. 2/12 64.8 ± 27.8 Metformin 50 mg/kg + celebrex 9/12   95 ± 37.9* 10 mg/kg + serotonin creatinine sulfate complex 0.4 mg/kg (n = 12, *p < 0.05, **p < 0.01) [0148] The results indicate that the metformin 50 mg/kg+celebrex 10 mg/kg+serotonin creatinine sulfate complex 0.4 mg/kg group, 9 mice survived 120 days, and in the control group only 2 mice survived. The active drug group survival time was also better than control group indicating that this drug therapy can extend mice survival time and reduce cancer cell transplantation rate. Example 12 [0149] In Example 12, the effect of B3 and B10 was tested to determine the effect on oncogenesis rate of hepatoma carcinoma H22 cells in KM mice. Fifty thousand (50,000) mice hepatoma carcinoma H22 cells were injected subcutaneously into KM mice. Treatment groups consisted of B3 and B10, administered three times a day for 30 days. After the drug was stopped, the mice were observed for the presence of tumor tissue to determine whether oncogenesis has occurred. The results of the B10 and B3 treatment groups and the G.S. group are set forth in Table 9 below. [0000] TABLE 12 Oncogenesis Rate for Weeks 1, 2, 3, 4, 6 and 8 After Inoculation and Treatment with B10 (Metformin 50 mg/kg + aspirin 40 mg/kg + serotonin creatinine sulfate complex 0.4 mg/kg) and B3 (Metformin 50 mg/kg + celebrex 10 mg/kg + serotonin creatinine sulfate complex 0.4 mg/kg) Time after administration of drug and Oncogenesis Rate Group 1 w 2 w 3 w 4 w 6 w 8 w GS 60 70 70 80 90 90 Metformin 50 mg/kg + 10 20 20 20 20 20 aspirin40 mg/kg + serotonin creatinine sulfate complex 0.4 mg/kg Metformin 50 mg/kg + 30 50 50 50 50 50 celebrex 10 mg/kg + serotonin creatinine sulfate complex 0.4 mg/kg [0150] The results indicate that 8 weeks after the drugs were administered, the Metformin 50 mg/kg+aspirin 40 mg/kg+serotonin creatinine sulfate complex 0.4 mg/kg group only had a 20% oncogenesis rate. The Metformin 50 mg/kg+celebrex 10 mg/kg+serotonin creatinine sulfate complex 0.4 mg/kg only had a 50% oncogenesis rate. Both active drug groups had a lower oncogenesis rate than the control group (90%). Therefore, these drugs can decrease the rate of transplantation of tumor cells. Other Embodiments [0151] All of the features disclosed in this specification may be combined in any combination. Each feature disclosed in this specification may be replaced by an alternative feature serving the same, equivalent, or similar purpose. Thus, unless expressly stated otherwise, each feature disclosed is only an example of a generic series of equivalent or similar features. From the above description, one skilled in the art can easily ascertain the essential characteristics of the present invention, and without departing from the spirit and scope thereof, can make various changes and modifications of the invention to adapt it to various usages and conditions. Thus, other embodiments are also within the scope of the following claims.

The invention relates to a composition that includes a first agent selected including an agent that possesses anti-inflammatory activity or acetaminophen, phenacetin, tramadol and the like; a second agent selected from the group consisting of an oxidative phosphorylation inhibitor, an ionophore, and an adenosine 5-monophosphate-activated Protein kinase (AMPK) activator; a third agent that possesses or maintains serotonin activity.

BACKGROUND OF THE INVENTION My invention relates to a method for processing the entrails of slaughtered poultry and to a device for treating the intestines of poultry. In a known way of processing slaughtered poultry the entrails are either mechanically or not, removed from the body whereupon from the package consisting of gizzards, liver, heart, intestines crop and gullet, the liver and the gizzards are severed and the stomach is introduced by hand into a device provided with a chain conveyor for cutting open and washing the same. This process is performed at a plurality of treatment stations through which the intestines pass. Since it is increasingly difficult to attract personnel willing to perform this time consuming treatment, there is an urgent need for a method and a device by means of which these treatments can be mechanically performed. It is an object of the invention to provide such a method. SUMMARY OF THE INVENTION The method according to my invention provides in that in a continuous process utilizing worm conveyors merging into each other the following treatments are performed: FEEDING THE COMPLETE PACKAGE OF ENTRAILS AT THE INLET ENDS; POSITIONING THE GIZZARD WITH RESPECT TO A CUTTING MEMBER; SEVERING THE GIZZARD FROM THE REST OF THE PACKAGE; POSITIONING THE GIZZARD WITH RESPECT TO A SECOND CUTTING MEMBER; CUTTING OPEN THE GIZZARD POSITIONING THE GIZZARD WITH RESPECT TO A MECHANICAL CLEANING MEMBER; FURTHER CONVEYING AND POSITIONING THE GIZZARD TO A PEELING MEMBER FOR REMOVING THE GIZZARD LINING. Due to my method it is for the first time possible to perform consecutively the various required operations by means of a single device which can be incorporated into the processing line for the poultry. The otherwise required transport between the various treatment stations, with the necessity of intermediate storage, is omitted. The synchronization of the treatments prevents the occurence of a congestion. A device for processing the intestines of slaughtered poultry according to my invention comprises two mutually parallel worm conveyors which are synchronously driver in opposite directions and engage one the other, each consisting of a core and a helical ribbon disposed around it, and an inlet for the gizzards and the organs including the stomach and intestines connected therewith, which is situated above the inlet end of the pair of worms, while the helical ribbon of the first worm extends from the inlet end over a distance shorter than that of the second worm and the cores of both worms are set with carrier members, distributed in the circumferential direction thereon, protruding radially and extending in axial direction and/or arranged in axial rows, the arrangement being such that on the first worm the members are only disposed on the part thereof which is not provided with a helical ribbon. The carrier members are further preferably arranged in such a way that in the space between the worms the members on the one worm are situated between those on the other worm, while the spacing between the cores of the worms is such that the intestines are moved by the carrier members through the space between the cores, while the gizzards, bearing on the cores, are moved on by the helical ribbon of the cores of the second worms and at the end of the two worms a knife is disposed with a cutting edge perpendicular to the axes of the worms. The carrier members may consist of oblong projections protruding from the surface of the core while the height of the projections may be substantially equal to the height over which the helical ribbons rise above the core. On the second worm, and preferably at the location of the end of the helical ribbon a radially protruding cam is provided, while in a preferred embodiment follows, as seen in the direction of conveyance on the first worm a third and follows on the second worm a fourth worm, both with a core diameter which is smaller than that of the preceding core and both carrying a helical ribbon on their entire length, and situated thereunder and thereinbetween two mutually spaced, parallel, guide rods a cutting member thereinbetween and thereabove a guide member extending downwardly as seen in the direction of conveyance. Preferably a fifth worm is arranged, following on the fourth worm as seen in the direction of conveyance, with a greater core diameter, under which and besides which extends the guide rod cooperating with the fourth worm and under which is arranged at least one scraper, rotating in a plane perpendicular to the direction of conveyance, with radial projections, while on this scraper follow, as seen in the direction of conveyance, a plurality of scraper rollers, situated beside each other in one plane and under the fifth worm, which are driven in pairs so as to rotate in opposite directions and which have helically extending sharp-edged scraper edges on their surface. When scraper rollers are used then the previously required cleaning of the gizzards, by which operation a very large quantity of polluted water is produced, can almost entirely be omitted. It is now only necessary to wash the gizzards with a rather small quantity of water. Preferably the first rod, the third rod and a rod situated in alignment therewith on the one hand, as the second, the fourth and the fifth worm on the other hand are coaxially coupled with each other and are commonly driven from one end of the device. The helical ribbon of the fifth worm may only extend on a portion of the part situated above the scraper rollers, while the end of the core of the fifth worm on a short part of the length thereof, carries a helical ejection ribbon. THE DRAWINGS FIG. 1 is a plan view of an embodiment according to my invention; FIG. 2 is a side elevation of this embodiment; FIG. 3 is a perspective view of the part of the device where the gizzard is severed from the intestines hanging thereon. DESCRIPTION OF PREFERRED EMBODIMENTS The device according to my invention comprises two parallel rotatably supported, cylindrical members 1, 2 which are driven so as to rotate in opposite directions, via a suitable gearing 3, by the motor 4. The members 1 and 2 are provided on a part of their lengths with helical ribbons with a different pitch; the members have mutually different diameters, and parts thereof don't carry a helical ribbon at all. The members 1 and 2 are supported at their right hand end in a gear box 3 and at their left hand end in bearings in the support 5. Above the left hand end of the members 1 and 2 is disposed a hopper 6 and under the first part of the members 1 and 2, denoted by 1a for the member 1 and 2a for the member 2, these parts adjoining the hopper, is arranged a chute 7. The part 2a has a diameter greater than that of the adjoining part 2b; it is set with a helical ribbon, while the part 1a which likewise has a greater diameter than the adjoining part 1b only carries the helical ribbon 9 on the first part of its length. Moreover the two parts 1a, 2a are set with carrier members 10, 11, respectively extending in the longitudinal direction, which are equidistantly spaced on the circumference of and around the parts, while the members 1 and 2 are coupled with each other in such a way that always one carrier on the one part is situated between two carriers on the other part. Below the members 1 and 2 and at the location of the end of the parts 1a, 2a is disposed, in a plane perpendicular to the longitudinal axis thereof, a cutting disc 14 which is driven in rotation via a suitable gearing 15 driven by a motor 16. The function of the aformentioned parts is: the severing of the gizzard from internal parts hanging thereon (crop and gullet). This is effected as follows: The worms which are driven so as to rotate in opposite directions convey the intestines, which via the hopper 6 are introduced into the space between the cylindrical cores of the parts 1a, 2a in the direction of the arrow 17. The distance between the centerlines of the cylindrical members 1, 2 and the diameters of the parts 1a, 2a is selected in such a way that the gizzards do not fall from between the parts 1a, 2a , but the intestines hanging thereon are pressed away downwardly, consequently in the direction of the arrow 18, by the carrier members 11. After some revolutions the situation shown in FIG. 3 as gizzards 23 with intestines 23' connected therewith arises. The package of intestines 23' is hanging under the parts 1a, 2a and the gizzard 23 is bearing on the outer surfaces of these parts. Owing to the fact that the intestines are hanging under these parts the gizzard remains in contact with the worm ribbon 9 on the part 2a and in spite of the fact that on the second portion of the part 1a no helical ribbon is provided it is nevertheless further conveyed in the direction of the arrow 17. Due to the absence of the second helical ribbon the gizzard can, however, freely assume a particular position. At the end of the part 2a there is provided a radially protruding cam 20 situated slightly before the rotating cutting disc 14. At that location the parts 1a, 2a merge into the parts 1b, 2b with a smaller diameter and set with helical ribbons 21, 22 respectively. When the gizzard with the package of intestines hanging thereon is past the bridge part between the parts 1a, 2a and as a consequence further conveyed towards the right by the helical ribbons 21, 22 then, as soon as the gizzard lies almost completely in the space between two consecutive helical ribbons, the cam 20, turning to the left as seen in the direction of the arrow 17, will press downwardly the back part of the gizzard, with which the gullet is still connected, into the cutting disc 14. The intestines 23' are severed, fall into the chute 7 and are discharged at 24. The severed gizzard in order to be cleaned, must now be cut open and unfolded. This operation is performed by the members following on the parts 1b, 2b, to wit: below and between the parts 1a, 1b two oblong, mutually parallel, guide rods 27, 28, interconnected via a curved part 26 at the right hand end of the part 1a, 1b, the guide rod 27 of which is shorter than the rod 28 which merges into an obliquely outwardly extending part 29 which is continued by an end part 30 extending again in a direction parallel to the axes of the parts 1, 2. Above that part is a push rod 31 sloping in the direction of the arrow 17, while a cutting disc 32 is arranged between the parts 1b, 2b, the disc is driven by the motor 16 via the transmission 33. A gizzard which by the helical ribbons 21, 22 is conveyed in the direction of the arrow 17 comes, when situated between the helical ribbons, to lie on the guide rods 27 and 28 and is conveyed by the helical ribbons across the cutting edge 32. The gizzard is then longitudinally cut through and, after having passed by the cutting knife 32, it is then further conveyed by the helical ribbons 21, 22. This further conveyance is initially effected by the helical ribbon parts 1b, 2b, in common; the part 1b continues, however into a part 1c, without helical ribbons, whereas the part 2b merges into a part 2c, with a greater diameter on which is provided the helical ribbon 35. Under the beginning of the helical ribbon 35 are two scrapers 36, 37 both constructed with a shaft 38 with blades 39 radially protruding therefrom. The gizzard which is hanging on the guide rod 30, is further conveyed by the helical ribbon 35 and is internally scraped clean by the scraper blades. It should be noted that after this scraping clean the conventional washing of the gizzard is almost superfluous, which not only results into a considerable saving on water but also into a considerable decrease of the quantity of polluted water produced during the processing of the poultry, The lining covering the inner wall of the gizzards, which are now cleaned for the greater part, should then be removed. This is done by means of four peeling rollers 40, 41, 42, 43 below the parts 1c, 2c, arranged parallel to the axes thereof and driven in pairs in opposite directions from the gear box 3. The gizzards are advanced by the helical ribbons 35 until they land on the peeler rollers and are then further conveyed by the peeler rollers themselves; they are now lying under the parts 1c, 2c. At the extreme right hand end the part 2c carries a helical ribbon part 44 which removes the gizzards from the peeling ribbons. Under the unit consisting of the scrapers and the peeling rollers a suction chute 45 is mounted where the offal is discharged at 46.

A device for processing the intestines of slaughtered poultry, in particular of the gizzards comprising two synchronously driven worm conveyors, engaging each other, the first worm being shorter than the second one, the worms being set with cooperating radially extending carrier members such that the intestines are moved by the carrier members through the space between the cores, while the gizzards, bearing on the cores, are moved on by the second worm to a knife, placed at the end of the worms with the cutting edge directed perpendicular to the axes of the worms.

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to a cushioning insert into the heel area of a shoe, especially an athletic shoe, such as a soccer shoe, which has a honeycomb body, and to a shoe with such a cushioning insert. 2. Description of Related Art A cushioning insert of this type and a shoe with one such cushioning insert are known from the German utility model 89 01 236. There, a gastight honeycomb body of elastic compressible material is inserted into a depression in the heel area of a shoe, into a cavity of an outsole which is made spring-elastic or in a soft elastic through-sole of the sole of the shoe. The honeycomb cells which are closed in the border area of the finished molded body clearly increase the restoration force in this area of the honeycomb body so that the inner area of the cushioning honeycomb body or the honeycomb body which produces the restoration forces is even softer than this border area. Published German Patent Application DE 36 29 264 A1 discloses reducing the deep immersion of the heel into the heel cap by the tread surface which is surrounded by the heel cap having a pressure distribution membrane. Furthermore, German Patent DE 39 24 360 C2 discloses providing in the heel area of an outsole a depression into which a coupling element can be inserted into which, in turn, a grip element which projects down can be interchangeably screwed from the outside. Above the coupling element there is an elastic cushioning element in the form of a honeycomb body. This elastic cushioning element is fixed in its position to the top by a relatively stiff cover plate. The grip element when treading along with the coupling element can dip into the depression through the inserted cushioning insert. In this way, when treading, cushioning is achieved without the heel being moved relative to the heel cap. But the thickness of the sole is relatively large since the cushioning insert and the coupling element are located on top of one another. SUMMARY OF THE INVENTION The object of this invention is to improve a cushioning insert of the initially mentioned type such that it ensures good cushioning properties even with relatively thin outsoles or shoe soles of hard elastic material, as can be encountered for example in soccer shoes, and good support of the heel is ensured. This object is achieved by the cushioning insert being made of a structural unit composed of a heel shell and a gas-tight honeycomb body which is provided on the top or on the underside of the bottom of the heel shell or of a honeycomb cell body which is connected in a gas-tight manner to the heel shell, and by the bottom of the cushioning insert being matched to the contour of the top of the shoe sole and attached on it. This invention ensures that no relative motion or only an insignificant amount of relative motion occurs between the heel and heel cap since the upper cover plate or the bottom of the heel shell can spring down. The upper cover plate therefore executes essentially the same motion as the heel cap, by which the heel is securely held in the shoe. Other advantageous details of the invention will become apparent from the following detailed description of the preferred embodiments and the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a side view of a shoe section with a cushioning insert in accordance with the invention taken along line I—I of FIG. 2, FIG. 2 is a cross-sectional view of the shoe section shown in FIG. 1 taken along line II—II therein, FIG. 3 shows a bottom view of the tongue area of the cushioning insert, FIGS. 4 and 5 shows two versions of the execution of the tongue, FIGS. 6 and 7 each show one possible embodiment of honeycomb cell webs of one component and the associated ribs of this component, FIG. 8 schematically shows a combination of the heel shell with a honeycomb cell body in a side view, FIG. 9 shows an exploded view of the heel shell of FIG. 8, FIG. 10 shows the honeycomb cell body of FIG. 8, and FIG. 11 shows an overhead view of the cell structure of a honeycomb cell body. DETAILED DESCRIPTION OF THE INVENTION The cushioning insert 1 shown in FIGS. 1 and 2 is made as a structural unit composed of a honeycomb cell body 2 which is open on one side or of a gas-tight honeycomb body and a heel shell 3 . Honeycomb webs 5 which project up and a peripheral border 6 which runs in or roughly in the direction of the honeycomb webs 5 are molded onto the bottom 4 of the honeycomb cell body 2 . The honeycomb cell body 2 is formed of a molded part made of an elastic resilient material with a hardness of roughly 60 to 92 Shore A, especially of roughly 70 to 80 Shore A. Especially thermoplastic polyurethane is suited as the material. The honeycomb cell body 2 is attached from underneath to the bottom 7 of the heel shell 3 , the edges 8 of the honeycomb webs 5 and the edge 9 of the peripheral border 6 adjoining the underside 10 of the shell bottom 7 . The web edges 8 and the edge 9 of the border 6 are joined in a gas-tight manner to the shell bottom 7 by suitable means, for example, by an adhesive connection and/or by an ultrasonic connection and/or by a weld. In this way, gas-tight honeycomb cells 11 are formed. The heel shell 3 can be made of a material which has the same properties as those of the honeycomb cell body 2 . But preferably, the material of the heel shell 3 has a hardness which is greater than that of the honeycomb cell body 2 and varies roughly between 60, preferably between 65, and 90 Shore A. For the heel shell 3 , preferably thermoplastic polyurethane or polyamide is used as the material. The superficial extent of the honeycomb cell body 2 corresponds to that or almost that of the shell bottom 7 . Both parts extend preferably into the area of the arch of the foot, the heel shell 3 and/or the honeycomb cell body 2 there passing into a tongue 12 and 13 which is thin in cross section. One or both tongues 12 , 13 are advantageously made wedge-shaped or roughly wedge-shaped and run angularly to their end 12 . 1 and 13 . 1 . Here, the respective top 12 . 2 and 13 . 2 runs in the same plane as the top 7 . 1 of the shell bottom 7 or as the virtual top 2 . 1 of the honeycomb cell body 2 . Preferably, at the start of the tongue 13 , there is a step 14 with a height 14 . 1 which corresponds to the thickness 15 . 1 of the insole 15 of a corresponding shoe. Without diverging from the inventive idea, instead of the honeycomb cell body 2 , there can be a gas-tight honeycomb body. This gas-tight honeycomb body can be attached to the underside 10 or the top 7 . 1 of the shell bottom 7 . Furthermore, the honeycomb body can be formed of the honeycomb cell body 2 with a cover plate applied to its virtual top 2 . 1 in a gas-tight manner, or if the honeycomb webs 5 and the border 6 point down, then accordingly to its bottom. The honeycomb body or the honeycomb cell body 2 can be attached on the top 7 . 1 of the shell bottom 7 . The honeycomb cell body 2 which is not provided with a cover plate is then attached gas-tight on the top 7 . 1 of the shell bottom 7 with the honeycomb webs 5 and the border 6 pointed down. For a honeycomb cell body 2 which is closed by the cover plate, the latter can be made of the same material as of the honeycomb cell body 2 . But, it can also be made of a harder and more inelastic material. Especially when, the honeycomb cell body 2 is joined to the bottom 7 of the heel shell 3 , the shell bottom 7 is made membrane-like and preferably elastically extensible. According to one advantageous development of the invention, the heel shell 3 and/or the honeycomb body and/or the honeycomb cell body 2 , and an optionally pertinent cover plate, are made of transparent or translucent material. In this case, the shoe sole 16 also is preferably made, at least in the area or roughly in the area of the shell bottom 7 , at least in part, partially or in sections of transparent or translucent material. The underside 7 . 1 of the shell bottom 7 is advantageously surrounded by a peripheral border 7 . 2 so that the shell bottom 7 is located somewhat recessed. When the honeycomb cell body or the honeycomb cell body 2 is inserted, its peripheral border 6 interacts with the border 7 . 2 so that the honeycomb body or honeycomb cell body 2 is fixed in position. The honeycomb body or the honeycomb cell body 2 and the heel shell 3 are joined securely to one another by means of cement or ultrasound along the borders 6 and 7 . 2 . The position can also be fixed via a depression which is provided in one component and via a border web which is provided on the other component, for example, the edge 9 of the border 6 of the honeycomb cell body 2 , and cementing and/or ultrasonic welding. The depression and the border web can each be made in the manner of a tongue-in-groove joint. This applies to all connections between the components heel shell 3 , the honeycomb body or the honeycomb cell body 2 and optionally the cover plate. For example, this connection takes place between the honeycomb body and the heel shell 3 or the bottom 4 of the honeycomb cell body 2 and the heel shell 3 or the cover plate of the honeycomb cell body 2 and the honeycomb cell body 2 or the cover plate of the honeycomb cell body 2 and the heel shell 3 . Advantageously, the tread surface of the honeycomb body or the honeycomb cell body 2 or its cover plate is matched to the profile of the heel in the manner of a trough. The underside 17 of the cushioning insert 1 , for example, the bottom 4 of the honeycomb body or the honeycomb cell body 2 or its cover plate or of the bottom 7 of the heel shell 3 is matched to the planar shape of the surface of a shoe sole 16 on which the cushioning insert 1 is placed and is connected to it. In the area of the tread by the heel, the bottom 17 of the cushioning insert 1 can be pulled flat and in the border area upward in an arc-shape. As already mentioned, there can be tongues 12 , 13 on the cushioning insert. In general, at least two of the components, heel shell 3 , the top or bottom cover plate of a honeycomb cell body 2 and/or the honeycomb body, can have tongues which lie on top of one another and which are joined securely to one another, for example, by cementing or ultrasound. Furthermore, it can be useful to make the lower tongue narrower than the overlying upper tongue. In this way, for example, the lateral surface 18 of the upper tongue or of the shell bottom 7 , which lateral surface remains free by virtue of the narrower tongue, can be used for attaching the corresponding upper material of the shoe. For example, in the cutout shown in FIG. 3 from underneath, the tongue can be composed of the upper tongue 12 of the heel shell 3 and the lower tongue 13 of the upper cover plate of the honeycomb cell body 2 or of the honeycomb cell body 2 itself. These parts lie on top of one another and are securely joined to one another, especially cemented or welded. Preferably, the lower tongue 13 is narrower than the upper tongue 12 . In this way, on both sides, a free surface 18 is formed; it is shown by the broken crosshatching and is used for cementing or otherwise attaching a correspondingly sized part of the upper material of the shoe. One version of the execution of the tongue is shown in FIG. 4 . Here, the tongues 12 and 13 are attached underneath by a step 14 which is provided at the top of the shell bottom 7 and the insole 15 rests on the upper tongue 13 and is, for example, cemented to it. In the version shown in FIG. 5, the tongue 13 of the shell bottom 7 is made obliquely descending towards the end 12 . 1 as far as the lower tongue 13 . The insole 15 which rests on this lower tongue 13 is made to run diametrically opposed, obliquely upward, so that a continuous transition results. In order to obtain a good gas-tight connection between the honeycomb webs 3 and the cover plate or the shell bottom 7 , according to FIGS. 6 and 7, the cover plate or the shell bottom 7 can have a system of ribs 19 which corresponds to the system of arrangement of the honeycomb webs 5 , for example, of a honeycomb cell body 2 . An especially good connection is obtained when the web edge 8 is made straight or roof-like and the edge 19 . 1 of the ribs 19 is made recessed in a V-shape, see FIG. 6 in this respect. In addition, a good connection can be obtained when the ribs 19 are wider than the honeycomb webs 5 . Then, the edge 19 . 1 which runs perpendicular to the direction of the honeycomb webs 5 can also run flat and also the edges 8 of the honeycomb webs 5 can be made flat, compare FIG. 7 in this respect. FIG. 8 schematically shows a heel shell 3 with a tongue 12 and a honeycomb cell body 2 attached underneath, from the side. FIG. 9 also shows that, at the start of the tongue 12 , there is a rib 19 via which the section 20 of the honeycomb cell body 2 shown in FIG. 10 can be effectively and securely joined, as was explained above using FIGS. 6 and 7 for the honeycomb webs 5 . FIG. 11 shows an overhead view of a honeycomb cell body 2 or a gas-tight honeycomb body with the cover plate removed. It should be mentioned that the edge of an inner lining 21 is placed in or on the border 3 . 2 . Furthermore, using especially FIGS. 1, 8 and 10 , the peripheral support edge 22 can be recognized. It is placed against the edge of the upper material of the shoe. The cushioning insert 1 according to the invention with its bottom 17 which is matched to the contour of the top of the outsole 16 , therefore the bottom of the cover plate or of the shell bottom 7 , is inserted into the heel area of a shoe and is securely connected to it, for example, cemented in and/or sewn in. The existing insole 15 extends as far as the step 14 and lies under the tongue 13 (FIG. 1) or it lies on the tongue 12 (FIG. 4) or it is continuously matched (FIG. 5 ). The insole 15 is permanently joined to the tongue 12 and 13 , especially cemented.

A cushioning insert ( 1 ) to be inserted in the heel zone of a shoe is provided with a honey-comb structure ( 2 ) which is improved in such a manner that it provides good cushioning properties and sufficiently supports the heel even if the outsoles or soles ( 16 ) of the shoe are relatively thin. To this end, the cushioning insert ( 1 ) is made of a structural unit that includes heel shell ( 3 ) and a gas-tight honey-comb structure that is provided on the upper side ( 7.1 ) or the lower side ( 10 ) of the shell bottom ( 7 ) of the heel shell ( 3 ).

CROSS-REFERENCE TO RELATED APPLICATIONS The present invention finds particular utility for use in combination with that certain Venturi System for Agricultural Spreaders of Solid Particles disclosed in co-pending application Ser. No. 07/315,277, filed Feb. 24, 1989, and assigned to the same assignee as the present invention. BACKGROUND OF THE INVENTION The present invention relates generally to an improved pneumatic spreader system for distribution of agricultural crop treating chemicals in granular, particulate or pulverulent solid form upon the soil, and more particularly to a system for achieving such distribution through the use of a plurality of elongated delivery tubes or booms with discharge orifices arranged adjacent the outer tips thereof, and wherein shut-off means are provided for individual booms so as to interrupt flow of particulate or granular material from certain specific selected booms, while the other booms are permitted to remain active and in normal operation. The apparatus of the present invention is effective against granular material build-up or clogging, and is adapted to produce a more uniform distribution of solids at a constant application rate through those booms remaining active. Pressurized pneumatic systems utilizing a single distribution head delivering or metering a supply of granular or particulate material for controlled discharge of such material from a plurality of elongated booms have been employed in the past, however the systems currently in use normally deliver granular products through all of the booms at all of the time. Reliable and non-clogging means capable of providing uniform distribution and application rates have not been available for those systems providing for periodic and controlled interruption of delivery of granular products or materials from certain selected booms. The present invention provides a reliable and non-clogging system for such controlled distribution, while at the same time maintaining the distribution and application rate at a substantially uniform and constant level through the active booms. Agricultural techniques require the utilization of soil treating agents to either encourage, discourage, destroy, or inhibit plant growth. Such agents may generally be characterized as crop treating chemicals, and include materials designated as nutrients such as fertilizers, and pesticides such as insecticides and herbicides including pre-emergent and/or post-emergent plant growth inhibitors. Accordingly, the term "crop treating chemical" is used in a comprehensive sense to incorporate those various ingredients utilized in agriculture to treat either the soil, the growing crop or plants, or certain insects which may damage the crop. Active materials used for treatment are commonly found in one of three forms, either water soluble, water wettable, particulate solid or in surface-impregnated solid form. In connection with the present invention, granular materials and/or surface-impregnated (wetted) granular materials are of particular interest, with the system of the present invention being particularly adapted for use in connection with the selective and uniform distribution of such materials through the system and onto the soil or other surfaces being treated. In the treatment of agricultural fields and crops through spreading of one or more active treating ingredients, the efficiency of the treatment operation may be enhanced if the distribution of the ingredients is maintained at a uniform and/or controllable rate. Uniform application rates have become an important factor, particularly with the use of certain pesticides and/or herbicides which require a predetermined application rate in order to be effective, and yet not harmful to the crop being treated. Additionally, the efficiency of the operation may be enhanced if the actual load required to be carried by the spreading equipment is reduced. Therefore, the utilization of dry particulate solids will substantially reduce the load requirement, inasmuch as water or other treatment medium or treatment vehicle is not required. The need for multiple passes may be reduced if surface-impregnated granular material may be uniformly spread, such as through the use of a granular fertilizer having a surface impregnated with a particular pesticide. The utilization of pressurized pneumatic systems will normally eliminate or substantially reduce the vehicle load by eliminating the need for large quantities of water, since pneumatic systems normally utilize a compressor to generate a supply of compressed air in lieu of a liquid plus liquid pressure source as a means to create a medium for accomplishing delivery of the treating ingredient onto the soil. Pneumatic spreader systems typically are mounted upon self-propelled vehicles, thereby providing a means for achieving the distribution. In order to render these systems efficient, elongated booms are employed, and it is not uncommon for such booms to extend outwardly a distance of 18 feet or more from the center axis of the vehicle. Frequently, when the operator is close to the edge of a field, the entire width-spreading capability of the system is not needed, and in fact any double-coverage may be both wasteful and possibly damaging to the crop being treated. Accordingly, and in order to achieve both a wide expanse spreading capability, as well as the capability of selectively reducing the width, the system of the present invention permits periodic interruption of flow or delivery of particulate material from certain selected booms. In order to render the system more highly advantageous, this interruption of flow is achieved while maintaining uniform application rates and without increasing the tendency of the system to become clogged. An added advantage of the system permits intermittent shut-down of certain booms when the fertility index varies across the field being treated. In such instances, it may become desirable to eliminate application of certain materials in certain pre-defined areas across a given field, thus providing greater versatility for the apparatus of the present invention. In order to maintain normal flow of particulate solids through a pressurized pneumatic system, uniform, consistent and uninterrupted flow patterns are desirable. However, such application rate consistency becomes difficult, if not impossible to achieve, when attempts are made to periodically block-off the flow of particulate solids to selected booms. Such attempts frequently create a non-uniformity in application rates and normally lead to a tendency of the particulate solids or granular materials, particularly surface treated granular materials, to clog portions of the distribution system, and thereby establish a need for temporary shut-down of the equipment until the boom may be cleared and thus relieve the clogging. As indicated, uniformity of distribution of particulate materials depends to a certain extent upon predetermined patterns of air movement through the entire system, including the distribution head, the material transferring conduits, as well as the individual booms. Attempts to simply block-off the flow of air through one or more booms may interfere with normal and anticipated patterns through the system. Furthermore, attempts to modify the position of individual material transferring conduits throughout the system contributes to interference with normal patterns of flow through the system, and thus leads to lack of uniformity of distribution of particulate materials. As indicated, pressurized pneumatic systems normally employ a plurality of elongated hollow delivery booms, with these booms extending outwardly of the vehicle to certain predetermined and differing lengths. In order to preserve operational integrity and predictability, therefore, uniformity of patterns of air movement, including uniformity of flow volumes through individual booms comprising the entire system is a desirable objective and goal. The features of the present invention permit selective shut-off of flow of granular material through certain preselected booms, it having been found that the system accomplishes this goal without increasing the tendency to clog, and thus preserving uniformity of continued distribution of particulate solids from the remaining operative booms in the system. The features of the present invention have been found desirable for improving the performance of systems utilizing elongated hollow discharge or delivery booms through selective shut-off of certain predetermined booms, whenever it is desired that the system operate with certain selected booms being non-functional. SUMMARY OF THE INVENTION Briefly, and in accordance with the present invention, an improved solid granular chemical applicator system is provided which improves the performance of pressurized pneumatic spreader systems utilizing elongated booms by providing a means for selectively interrupting flow of material to certain booms while maintaining uniform flow of materials through the remaining booms, and at the same time, providing for substantially uniform distribution of particulate solids upon the surface of the soil being treated. A particular advantageous feature of the present invention is its ability to effectively handle and utilize impregnated or surface treated granular materials such as pesticide/herbicide impregnated fertilizers while maintaining desired and uniform application patterns without creating unusual material build-up or clogging of individual booms. The improved system is normally and preferably mounted upon a vehicle chassis such as the chassis of a self-propelled vehicle including either a tractor or a trailer. The system includes a reservoir with a source of supply of agricultural crop treating chemicals in granular or particulate solid form to be distributed, such as, for example, a nutrient such as a fertilizer and/or a pesticide such as an insecticide or herbicide, along with a spreader and distribution mechanism. As indicated, the granular materials may have their surfaces impregnated with a coating of a pesticide/herbicide. The applicator systems of the present invention are typically provided with a number of conventional components, including the following: (a) a reservoir or hopper for retaining a supply of particulate solids; (b) a means of conveying the granular particulate solids to a distribution head where the supply is metered by being divided into a number of aliquot portions, with this conveying means being driven with a variable speed motor so as to control the quantity of granular particulate material delivered to the distribution head; (c) a means for delivering the metered aliquot portions to the elongated booms; and (d) a means, such as a blower or compressor for delivering a supply of compressed air, to move the material along with a flow of air outwardly through the booms and ultimately to a point of discharge. These systems may optionally be provided with the following: (e) a means for impregnating the individual granular particles with an additional crop or soil-treating ingredient, such as an aqueous coating of a pesticide material. Turning to these components briefly, and individually, a distribution head controllably vented to atmosphere is provided, as indicated, for receiving a supply of particulate solids, and for metering and apportioning these solids into a plurality of generally aliquot portions. As will be shown in greater detail hereinafter, controlled venting of the distribution head is desired, so as to accommodate an in-flow of air when all booms are operating normally, while reducing and/or eliminating the introduction of such air when some of the individual booms are in shut-off mode. While conventional distribution heads of this general type are known in the art, modifications and added features of the type shown hereinafter permit individual boom shut-off while preserving uniformity of distribution from those booms remaining active. In the present system, a plurality of elongated hollow discharge or delivery booms are employed, with the proximal end of each boom being coupled to and receiving a source of pressurized or compressed air such as at a plenum chamber, with means being provided to shut off one or more of the individual booms, as are indicated by the immediate requirements of the system. OPERATION WITH ALL BOOMS FUNCTIONING NORMALLY A discharge or delivery port is formed in the boom at or adjacent the distal end thereof, with the granular crop treating material or chemical being discharged from that point. A tubular conduit or feed supply tube is coupled to the normal output of the distribution head, and is adapted to normally convey one aliquot portion of granular material from the distribution head to a junction point with a discharge or delivery boom. The junction point is located adjacent the inner or proximal end of the boom at a point closely spaced from and immediately downstream of the proximal end thereof. In normal operation, the flow of air through the booms serves a dual purpose, one purpose being to carry or support the flow of granular material to the discharge point of the boom, the other being to create a partial vacuum in the tubular conduit or feed supply tube for introduction of granular solids into the air stream. Therefore, each conduit or tubular feed member delivers one aliquot portion from the distribution head into the boom, with the compressed air normally carrying or moving the particulate solids outwardly to the delivery point located at the boom tip. This normal operation is modified significantly when individual booms are arranged in shut-off mode, as will be pointed out in detail hereinafter. Continuing with the normal operation of the system, in order to provide for the introduction and transfer of particulate solid or granular material into the boom, particularly at the point of introduction, a zone of reduced pressure is created, such as through the Venturi means in accordance with the system disclosed in co-pending application Ser. No. 07/315,277, filed Feb. 24, 1989, and referred to hereinabove. The arrangement of the present invention has been found to function well in combination with the system disclosed in co-pending application Ser. No. 07/315,277, however the system of the present invention is compatible with and may be utilized with other systems as well. OPERATION WITH ONE OR MORE BOOMS IN SHUT-OFF MODE The boom selection means of the present invention includes a flow restriction device which may be introduced into each of the booms selected for operation in the non-discharge or shut-off mode, with this flow interrupter device preferably being in the form of a damper, valve, or gate which may be introduced across at least a substantial portion of the inner cross-sectional area of the boom. In one operational embodiment, the damper means includes a plate or the like which is actuated by means of an electrically or hydraulically actuated cylinder, with articulating push rods or the like being coupled between the cylinder ram and the damper means. The damper preferably blocks a zone representing between about 70 percent and 100 percent of the overall cross-sectional area of the boom, it being noted that broader percentage ranges may be found useful as well. Generally speaking, and for most applications however, flow of particulate material will be substantially completely interrupted when approximately 75 percent of the inner cross-sectional area of the boom is blocked. When some residual flow of air is permitted to continue through the system, the air passing through the balance of approximately 25 percent of the boom cross-sectional area allows adequate residual flow to avoid excessive build-up of pressure in the system, as well as to assist in freedom from clogging, by reducing the tendency of trapped granular material to accumulate within the boom. With the flow of air along one or more of the elongated booms being either shut-off or substantially reduced (with the exception of the residual flow), the pressurized air entering the system from the plenum is discharged through the tubular conduit or feed supply tube coupled to the output of the distribution head, and thus is free to move through those individual booms remaining open and/or operational. In other words, during normal operation, the tubular conduit or feed supply tube functions as a means for conveying granular material from the distribution head to the boom, while during periods of boom shut-off, this conduit or tube functions as a means to recirculate air from the shut-off boom back to the distribution head. In order to accommodate this flow of additional air entering the distribution head from the feed supply tubes, means are provided for closing the vent which normally couples the distribution head to ambient, with this closure providing for passage of this pressurized air into the distribution head, and thence outwardly of the system through those certain booms remaining open. Closing of the vent also eliminates the possibility of granular material being blown outwardly of the vent during periods of partial boom shut-off. In other words, that portion of the pressurized air entering the distribution head through the feed supply tube is utilized to maintain the flow of granular or particulate material from the distribution head to those discharge booms which remain operative during times of partial shut-off without risking inadvertent blow-off of granular material from the vent whenever an over-pressure condition would arise in the head. Whenever one or more booms are placed in shut-off mode, the flow of granular material from the supply hopper to the distribution head is reduced in proportion to the number of booms shut-off so as to preserve a uniform rate of application through the remaining booms. Specifically, a means is provided which interconnects the boom shut-off control and the variable speed motor driving the conveyor feeding the auger. This arrangement will be discussed in greater detail hereinafter. As indicated hereinabove, the system of the present invention has been found to function well in combination with that certain system disclosed in application Ser. No. 07/315,277, filed Feb. 24, 1989, and referred to hereinabove, with the apparatus of the present invention being disclosed while mounted within, and functioning with such a system. As indicated, that system includes a Venturi means which comprises a flow wedge with an inlet ramp portion, an outlet ramp portion, and a throat portion intermediate the inlet and outlet ramp. In addition, a flow control blade means is provided in generally opposed relationship to the throat portion of the Venturi, with the blade means having an outer tip which, itself, extends generally along a chordal line across the boom and in generally parallel relationship to the chordal line defined by the Venturi throat. The blade means further extends radially inwardly of the boom and at an angle which converges toward the distal end of the boom. The opening which is defined between the inner tip of the flow control blade and the surface of the Venturi ramp is substantially rectangular. This rectangular configuration for the open area or zone provides a means for equalizing the flow of air across the entire opening within the boom, with this feature having been found to considerably reduce any tendency of the granular material, particularly wetted granular material, to build up in the area of the Venturi and thus contribute to clogging. This reduction in tendency toward clogging has been found to be useful in connection with the selective boom shut-off system of the present invention, and further contributes to a continuous recirculation of air from the individual booms back to and through the distribution head for ultimate passage through booms functioning normally. In order to maintain desired and predetermined and uniform application rates, means are preferably provided to reduce the flow of incoming material to the distribution head in an amount proportional to the reduction in output quantity. In other words, since the overall output volume of the system is at least temporarily reduced, the rate of delivery of incoming material to the distribution head is correspondingly reduced so as to compensate for the reduced output of the system. Such an operational feature is conveniently accomplished by means of correlating the shut-off of one or more booms with a proportional reduction in drive rate of the conveyor transferring material from the hopper to the feed auger. It has been found that the shut-off means of the present invention provides for even and positive flow for granular and/or particulate materials present in the system, including the flow or movement of these solids through those certain booms which remain operative. By maintaining the rate of input of granular material to the system proportional to the system output, uniform application rates are achieved. Furthermore, this uniform flow of granular or particulate material is maintained without creating additional tendencies toward unusual distribution patterns within the system, or toward clogging of granular materials within the elongated boom structures. Therefore, it is a primary object of the present invention to provide an improved system for delivery of granular material or particulate solids from a pressurized pneumatic system, wherein an improved boom shut-off means is provided in order to achieve temporary interruption of delivery of particulate solids to preselected booms, while maintaining uniform delivery of granular or particulate solids into the flow of pressurized air moving through each of the elongated delivery booms which remain active. It is a further object of the present invention to provide an improved selective delivery system for use in combination with pressurized pneumatic systems for distribution of granular or particulate solids therefrom, including surface-wetted granular solids, and wherein the system includes means mounted within preselected elongated delivery booms designed to controllably interrupt the flow of air and accordingly check introduction of particulate solids to the preselected booms. It is yet a further object of the present invention to provide an improved pressurized pneumatic system for the distribution of particulate solids upon an agricultural field, and wherein the system is provided with an improved means for interrupting the flow of granular or particulate solids through certain preselected tubes, while maintaining an even and uniform flow of granular solids through the tubes remaining active, and wherein means are further provided to avoid clogging of the granular solids in and along those hollow delivery booms which are in shut-off mode. Other and further objects of the present invention will become apparent to those skilled in the art upon a study of the following specification, appended claims, and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1A is a perspective view of the side and rear portions of a typical vehicle chassis supporting a vehicular-mounted system incorporating a distribution head, a compressor, and a plurality of elongated hollow delivery booms, and wherein the booms are provided with the improved shut-off control means of the present invention; FIG. 1B is a fragmentary perspective view of the central or manifolding portion of the system illustrated in FIG. 1A; FIG. 1C is a detail side elevational view, partially broken away and on a slightly enlarged scale, of the upper portion of the plenum or manifold utilized to distribute and deliver pressurized air from a source into the individual booms, and with the lower portion of the plenum being broken away; FIG. 2 is a detail perspective view of the external portions of the hollow delivery booms of the present invention, and illustrating the point at which the solid supply tube joins the delivery boom, and also the point at which the improved shutoff means of the present invention is positioned; FIG. 3 is a view taken through the diameter of that portion of the device illustrated in FIG. 2 and illustrating the damper of the shut-off means while in its closed disposition for boom shut-off; FIG. 4 is a view similar to FIG. 3, but illustrating the flow damper in its open disposition; FIGS. 2A, 3A, and 4A are views similar to FIGS. 2, 3 and 4 respectively, and illustrating a modified form of valve for achieving boom shut-off; FIG. 5 is a vertical sectional view of a typical distribution head, in combination with a plurality of booms, and with all of the booms being in open or normal operational mode, and with the vent to the head being open; FIG. 6 is a view similar to FIG. 5, but illustrating the system with one of the booms being in shut-off mode, and with the air vent to the head being closed; FIG. 7 is a vertical sectional view of a segment of the boom located downstream from the point where the distribution head feed lines intersect the booms, and illustrating a modified form of shut-off valve in the form of a shuttle valve and showing the shuttle valves in closed disposition; FIG. 8 is a view similar to FIG. 7, and illustrating the shuttle valve arrangement in open disposition; and FIG. 9 is a view taken axially of that portion of the booms shown in FIGS. 7 and 8, and illustrating the shuttle valves in open disposition. DESCRIPTION OF THE PREFERRED EMBODIMENT In accordance with the preferred modification of the present invention, and with particular attention being directed to FIGS. 1A and 1B of the drawings, the pressurized pneumatic distribution system generally designated 10 is mounted upon vehicle chassis 11, and includes a reservoir 12 for retaining a source of supply of granular or particulate solids to be distributed through the system. A distribution head 13 is provided for apportioning or dividing the particulate solids received or delivered from reservoir or hopper 12 into a plurality of generally aliquot portions, with this distribution head having a controllable vent to atmosphere in the upper plate thereof (more fully described hereinafter), for controlling the amount of air introduced into the system. The opening and/or closing of the vent to atmosphere is coordinated with the closure of one or more of the booms to shut-off mode, and is provided with means for controllably opening and/or closing the communication with atmosphere in order to accommodate the recirculation flow of air introduced into the distribution head during periods of partial boom shut-off. Also, impregnation valve means may be provided to controllably impregnate the surface of fertilizer with a pesticide/herbicide, this typically occurring as the granular material moves into the vertical auger of the distribution system. Suitable impregnation devices for accomplishing the wetting operation are commercially available. Also, fertilizers which are pre-impregnated with specific types of pesticides and/or herbicides are commercially available. A plurality of elongated hollow delivery booms 15--15 are provided to receive, transfer or move laterally outwardly, and ultimately spread the solids on the ground, with the booms being of predetermined and differing lengths, and extending laterally outwardly of the vehicle from proximal ends 16--16 to distal discharge ends 17--17. A source of compressed air such as fan blower 14 for the pressurized pneumatic system is utilized to create a flow of pressurized air into a plenum or manifold 14A and from the plenum into the proximal ends 16--16 of each boom, and ultimately through each of the hollow elongated booms 15 to outlet or discharge. Such blowers or other sources of compressed air, and their arrangement in this type of system are, of course, well known to those in the art, and need not be described in detail here. As is apparent in FIG. 1A, a cooler device may be employed in combination with one of the blowers in order to cool hydraulic fluid being used to drive components within the system. Such a device is illustrated in FIG. 1A, with this cooler being removed in the view of FIG. 1B. A plurality of tubular feed members 18--18 are also provided, with each of such tubular feed members extending between and coupling a selected output of the distribution head 13 to a selected one of said delivery booms 15--15. Also, as is conventional, the tubular feed members 18--18 provide for delivery of each of the aliquot portions into the elongated boom 15 at a point adjacent the proximal end 16, and for ultimate delivery to the distal discharge end 17 of the boom. Also, as indicated, such spreader structures are known in the art and need not be discussed and described in detail here. One such spreader structure is illustrated in U.S. Pat. No. 3,568,937 to Grataloup, with another such system being disclosed in U.S. Pat. No. 2,206,876 to Chater. As will become apparent hereinafter, each of the tubular feed members 18--18 is coupled to a selected one of the hollow delivery booms 15--15 at a juncture point adjacent the proximal end of one of the booms, and thus achieves its purpose of continuously and uniformly introducing one aliquot portion of the particulate solids to the flow of pressurized air moving through each of the delivery booms, while functioning as a return conduit for the flow of compressed air during that time when the shut-off means has been activated. During normal operation, and while the boom is delivering particulate solids through its delivery port, introduction of those particulate solids into the delivery booms is undertaken on a basis such that the actual introduction of the solids into the flow of pressurized air is enhanced, thereby reducing if not totally eliminating tendencies of the solid particles to build up in selected locations, and thereby leading to clogging of the boom. When the boom is in shut-off mode, the tubular members 18--18 function to carry or recirculate the flow of compressed air from the plenum back to the distribution head. This added flow of air is thereafter passed through the distribution head to flow through those tubular feed members 18--18 which remain open and active and which are carrying a flow of particulate solids outwardly through their associated delivery booms. Attention is now directed to FIGS. 2-4 of the drawings wherein details of one embodiment of the boom shut-off arrangement provided within each of the hollow delivery booms is disclosed. Specifically, and with attention being directed to FIGS. 2-4 of the drawings, the boom shut-off containing portion generally designated 20 of the system 10, comprises a relatively short axial segment 21 of one of the delivery booms 15--15, with the end 22 being an end adjacent to or constituting the inner or proximal end of tube 21. A segment 22A of a tubular feed member 18 is also shown, with this segment having been previously referred to as a portion of one of the plurality of tubular feed members 18--18 which are in communication with the distribution head 13. Tube segment 22A is coupled with boom segment 21 at juncture point 24. Venturi means are provided within the system as shown generally at 26. Venturi 26 includes a body portion 27 with an inlet ramp 28, an outlet ramp 29, and a generally rectangular throat portion 30 therebetween. Throat portion 30 extends radially inwardly from the inner surface of the boom and defines generally a chordal line across the hollow delivery boom, such as is seen in the views of FIGS. 3 and 4. The Venturi means 26 further functions in cooperation with blade means 32, with blade means 32 being mounted in generally opposed relationship to the throat portion of the Venturi means 26. The zone between the radially inwardly disposed tip of blade 32 and the throat portion 30 defines a gap therebetween, and thus controlling the cross-sectional area available for the flow of air through the throat zone 30 of the Venturi 26. The tip of the blade 32 extends generally along a chordal line of delivery boom segment 21, with the tip being shown at 35 (FIG. 4). Blade 32 is mounted at an angle which converges toward the distal end of the boom. Furthermore, the inner tip of blade 32, as at 35, intersects at least a portion of a projection of an inwardly directed projection of tubular feed member 22A into delivery boom segment 21. This disposition of blade 32 assists in controlling the constant width opening across the flow of air through the system and in creating the vacuum in tube 22A during periods of normal operation. As indicated in the drawings, blade 32 is normally set in place, but can be made to be adjustably positioned in order to create the maximum vacuum in the tube 22A during times of normal operation. When the system is functioning with an individual boom in shut-off condition, then and in that event, the related tubular feed members 18--18 function as a flow conduit for recirculation of compressed air through tubular feed member 18 and into the distribution head for ultimate discharge through one or more of the booms which remain operational in the normal mode. Blade 32 further aids in effecting positive flow directions for the solids at all times, and the configuration of the opening eliminates or substantially reduces any build up or clogging of particulate solids within the delivery tubes, regardless of the immediate mode of operation. With continued attention being directed to FIGS. 2, 3 and 4 of the drawings, it will be observed that arrow 23 represents the direction of flow of air through the proximal end of the boom, with arrow 23A illustrating the normal and continuing flow of air during period of normal operation. Air from the distribution head, along with the aliquot portion of solids flows through each of the tubes 18--18 in the direction of arrow 23B. During times of boom shut-off with damper 41 closed, air passing from the plenum and into the boom along the direction of arrow 23 is diverted, and flows back to the distribution head along one of the tubular feed members 18--18 and in the direction of the arrow 23C. Any particulate material which may have been confined within the boom at a point in time when shut-off was initiated will accordingly be entrained or suspended within the flow of air in the direction of arrow 23C and either become suspended in the air column or ultimately returned to the distribution head without contributing to an accumulation or clogging of material within the relevant boom member. Attention is now directed to FIG. 1C of the drawings wherein the arrangement of the individual outlets is shown. This arrangement provides a system wherein the individual tubular feed members 18--18 can be disposed in an arrangement where individual coupling elements are less likely to interfere, one with the other. Additionally, it is believed that a more uniform flow of air through the system results from the arrangement as illustrated in FIG. 1C. Specifically, the coupling between the proximal ends 16--16 of the booms and the face of the plenum are arranged in staggered positions at the juncture points with the plenum body. Thus, and as illustrated in somewhat exaggerated form in FIG. 1C, the individual tubular feed members 18--18 may be arranged in neater and less concentrated positions. In certain instances, it may be desirable to utilize a baffle and/or scoop in the plenum area so as to tend to equalize the flow of air through the individual booms. When utilized, such scoops and/or baffles are usually positioned and utilized on those booms which are disposed most closely adjacent the inlet of the pressurized air from the blower or other source. Turning now to the shut-off feature of the present invention, and with particular attention being directed to FIGS. 2-4 inclusive of the drawings, boom shut-off system generally designated 40 comprises a flow-blocking damper 41 disposed in each boom for which shut-off may be desired, with the position of damper 41 being controlled by actuating or articulating linkage 42. Linkage 42 includes, as indicated, actuating rod 43 together with pivotal linkage means 44. The position of the individual dampers 41 is determined by associated hydraulic cylinder 45 and its ram 46. Alternatively, solenoids may be utilized to actuate the damper linkage members. The immediate position of ram 46, such as either extended position or retracted position, will, of course, determine the open or closed position of the associated damper plate 41. As indicated hereinabove, the percentage or portion of the cross-sectional area of the boom which is closed or blocked by blocking damper 41 is preferably greater than about 75 percent and up to 100 percent of the total cross-sectional area. It has been found that essentially total interruption of flow will be achieved when at least about 75 percent of the area is closed, and it has been further found that the boom structures remain free of accumulation of the granular or particulate material being distributed when at least about 25 percent of the cross-sectional area is permitted to remain open. The system of the present invention is particularly adapted for use with spreader systems wherein it is desired that one or more of the delivery booms be deactivated or shut-off during times when the remaining booms are in normal operation. Such periods of deactivation would typically occur when the spreader is making its final pass across a field, and while the end portion of a field is being treated with the area remaining to be treated having a width less than the full width of the spreader. Because excessive or double-application of materials can be extremely detrimental, particularly when utilizing a combination of fertilizers and/or herbicides, it becomes necessary to provide a means for avoiding such double-application, while maintaining the application at its preselected rate. Thus, the system of the present invention is useful with those systems having a plurality of hollow delivery booms of differing lengths and wherein it becomes desirable for deactivating or shutting-off preselected booms so as to preserve uniform rates of application. In certain instances and for purposes of uniformity, it has been found desirable to increase the diameter of the longer booms utilized in multiple boom systems in order to reduce the amount of back pressure created in these longer booms. Also, the outward portions of the longer booms may be coupled with an expanded zone so as to have at least a portion of the delivery boom provided with a somewhat increased diameter relative to the shorter booms. Such a design also provides a means of reducing back pressure within longer booms, along with maximum vacuum being maintained in tube 22A coupled to the distributor head. As indicated hereinabove, whenever the system is operating in a partial shut-off mode, the quantity of granular or particulate material being introduced into the system must be reduced in order to compensate for the reduction in overall delivery. With attention being directed to FIG. 1B of the drawings, it will be noted that the auger shown generally at 50 includes an outer sleeve 51, together with an internally arranged screw 52. Screw 52 is driven by a constant speed motor 53 with the conveyor bringing material from hopper 12 to the auger screw 52 being driven by variable speed motor 53A, the speed of which is controlled by motor speed control 54 (see FIGS. 5 and 6). Thus, whenever one or more booms are shut off, steps are taken to proportionally reduce the speed of conveyor system including motor 53A supplying auger screw 52 in order to maintain a constant material application rate. A speed proportioning means is adequate to provide for control of the conveyor speed of horizontal conveyor drive motor 53A. Variable speed motors are utilized in connection with conveyor motor 53A, with a conventional speed control being also appropriate for utilization in speed control 54. Such drive motors and speed controls are, of course, commercially available. Attention is now directed to FIGS. 5 and 6 of the drawings wherein the interior of the distribution head is illustrated. Specifically, and in FIG. 5, distribution head 13 includes a cover member 60 overlying flanged outer scalloped member 61, with cover 60 joining member 61 at and along mating surfaces 62 and 63 respectively. An internally arranged spinner 64 is provided which rotates with auger screw 52 disposed within auger housing or sleeve 51. Shaft 66 extends upwardly from auger screw 52, and is maintained within a bearing housing such as at 67. In the arrangement illustrated, bearing housing 67 is shown mounted upon the top surface of plate member 68, although in certain applications, it may be desirable for bearing 67 to be disposed on the underside of plate 68. Spinner 64 is preferably provided with arcuately formed arms, which are mounted at their inner ends on shaft 66. Spinner 64 moves solid material, such as granular material, outwardly along the path of arrows 69 and 70. As indicated, the granular material, such as fertilizer or the like, moves along a path from the lifting auger 51-52, outwardly through spinner elements 64, and thence into tubular feed members 18--18. As is indicated in FIG. 5, both dampers 41 and 41A are in open or normal position, thus permitting flow to occur through the associated booms. Attention is now directed to FIG. 6 of the drawings wherein damper 41 is closed, while damper 41A remains open. In this arrangement, the flow of air and granular material is modified from the arrangement of FIG. 5. Specifically, the granular material continues to move along path 69, but assumes a modified path of travel as along the path of arrow 72. Air from the manifold moves along path of arrow 73, and upwardly through tubular feed member 18 along the path of arrow 74. This added flow of air requires attention be given to the air inlet or communication with atmosphere. With continued attention being directed to both FIGS. 5 and 6, it will be noted that vent valve 75 of lenticular configuration is provided within top 60. Vent valve 75 is arranged to control the open and/or closed disposition of cap opening 76 which establishes communication between the interior of the distributor head and atmosphere. Actuating means, such as solenoid or hydraulically actuated means, are provided as shown at 77 for controlling the opening and/or closure of valve 75. Vent valve 75 seats appropriately upon the perimeter of opening 76 so as to controllably close the opening. Appropriate screen or grid members are provided as at 77A in order to prevent influx of undesired extraneous trash and/or other materials. It has been found that air motion within the confines of the distributor head contributes to the flow of granular material into and through the active or open booms. Accordingly, the utilization of a vent valve having a configuration in which a portion of the valve body enters the distribution head may assist in equalizing air motion within the head. Also, the positioning of bearing housing 67 can be utilized to equalize and/or otherwise control the flow of air, motion of air, and/or air currents within the distribution head so as to equalize distribution of material into and through the open booms. With attention now being directed to FIG. 6, it will be noted that vent valve 75 is in closed disposition on its seat formed about cap opening 76, thereby closing any communication between interior of the distributor head and atmosphere. Because of the additional flow of air from the fan source through the plenum or manifold, an adequate flow of air is provided for the entire system, and particularly for the system serving the open, operational, and functional booms. DESCRIPTION OF ALTERNATE PREFERRED EMBODIMENT Attention is now directed to FIGS. 2A, 3A and 4A of the drawings wherein a modified form of flow control valve is illustrated, particularly the shut-off valve for use in individual booms. The valve generally designated 80 may be characterized as a pinch valve, with the valve including a body portion 81 with a bladder 82 formed therewithin. Bladder 82 forms a continuum with the individual boom, and is arranged to respond to pressure applied externally thereof to interrupt or shut-off flow therealong. Outer chamber 83 is pressurized with an appropriate pressurized fluid, and thereby driving or pinching the surfaces of bladder 82 into contact, one with the other, thereby achieving shut-off. Valves of the type illustrated in FIGS. 2A, 3A and 4A are commercially available, with one such valve being marketed by Red Valve Company of Carnegie, Pa. under the trade designation "TYPE A". DESCRIPTION OF SECOND ALTERNATE PREFERRED EMBODIMENT Attention is now directed to FIGS. 7, 8 and 9 wherein a still further shut-off valve embodiment is illustrated. In this arrangement, a system of shuttle or sliding plates with openings formed therealong is provided, with the shuttle valve arrangement of FIG. 7 being mounted along the booms, preferably within or adjacent the hinge point 91 of the booms 15--15 of FIG. 1A. Specifically, booms 15--15 are intercepted with vertically sliding shuttle plate members 92 and 93, with each of the shuttle plate members 92 and 93 having a plurality of bores 94, 95, and 96 formed therein. By appropriate positioning of shuttle plates 92 and 93, the openings between continuous segments of booms 15--15 may be interrupted, thus causing a recirculation of pressurized air in the manner discussed in the embodiment of FIGS. 2-4 hereinabove. Shuttle plates 92 and 93 are moved upwardly and/or downwardly in response to reciprocal sliding motion of linkage arms moving in the direction of arrows 97 and 98, so as to properly position the respective openings therewithin. As indicated above, when in open position, bores 94, 95 and 96 of shuttle plates 92 and 93 provide open communication along boom 15, however when shifted in their vertical position so as to each partially block such flow, the associated booms are shut off. In the event the staggered relationship of booms 15--15 is such that the inter-boom spacing is less than one boom diameter, then the utilization of a pair of plates such as shuttle plates 92 and 93 will permit substantially complete opening and/or closure of individual booms therealong. The arrangement illustrated in FIG. 7 is particularly adapted for operation with one lateral set of booms being shut off, and with the other lateral set of booms remaining in open and operational disposition. DESCRIPTION OF THIRD ALTERNATE PREFERRED EMBODIMENT As an additional modification, the system of sliding plates may be replaced with a blocking plate which may be introduced into the boom system at the hinge plate or boom folding point. In this arrangement, a blocking plate may be introduced either manually or automatically, with the blocking plate being interposed between separate hinged sections of an otherwise continuous boom. This blocking plate functions to close off the individual booms, as desired. It will be further appreciated that the details of the design illustrated here are for purposes of illustration only, and are not to be construed as a limitation upon the scope of the present invention.

An improved system for pneumatic spreader systems for selective distribution of particulate material onto agricultural fields from selected ones of a plurality of elongated delivery tubes or booms. The improved feature of the present invention comprises a means to interrupt flow of particulate material from certain preselected booms without clogging the system. The system includes a means for substantially completely blocking the flow cross-sectional area from a preselected one or plurality of delivery tubes, along with a line which normally functions as a feed line when the system is in normal operation, but as a recycling line when the delivery tube is in blocked or shut-off disposition. The arrangement provides a means for converting a twin-boom arrangement to a single-boom arrangement for accommodating unusual operation such as less-than-a-full boom width when undertaking the final run of a field application.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority under 35 U.S.C. §119 to U.S. Application No. 60/745,829, filed Apr. 27, 2006, the disclosure of which is incorporated by reference as if fully set forth herein. INCORPORATION BY REFERENCE [0002] All publications and patent applications mentioned in this specification 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 BACKGROUND OF THE INVENTION Neuropathy and Spinal Cord Stimulation (“SCS”) [0003] Neuropathic pain is prevalent in the US in approximately 1.5% of the population, 1% in the UK, and at a comparable level in Canada (“Spinal Cord Stimulation for Neuropathic Pain, Health Technology Literature Review,” Ministry of Health and Long Term Care, Toronto, Ontario, Canada, 2005). In 2002, it was reported that between 6 and 10 million Americans were afflicted with Neuropathic pain (P. S. Staats, “Intrathecal Therapy for Neuropathic Pain,” Proceedings of the 18 th Annual Meeting of the American Academy of pain Medicine ( AAPM ), San Francisco, 2002). Neuropathic pain is generally caused by a dysfunction in the nervous system and is a known complication of diabetes mellitus, which represents 6% of the US population. About 15 percent of patients with diabetes have both symptoms and signs of neuropathy, but nearly 50 percent have evidence of peripheral nerve damage as judged by nerve conduction abnormalities (A. H. Ropper, R. H. Brown, ADAMS AND VICTOR'S PRINCIPLES OF NEUROLOGY, Eighth Edition, The McGraw-Hill Companies, Inc, 2005, ch.46). People suffering from neuropathic pain are generally considered to have chronic pain, which can lead to loss of productivity, depression and reduction in Quality of Life. Neuropathy presents as Failed Back Surgery Syndrome (FBSS), Complex Regional Pain Syndrome (CRPS), and postherpetic neuralgia. For each of these conditions, Spinal Cord Stimulation (SCS) is considered as a viable therapy only after failure of treatments with pharmacological, nonpharmacological and surgical treatments. [0004] SCS systems are comprised of an implantable pulse generator and a lead with electrodes at the distal end surgically positioned in the epidural space, posterior to the spinal cord. SCS treatment is considered weakly to moderately effective in the treatment of chronic pain due to neuropathy when all else fails. SCS works by passing impulses through a nerve fiber that is either inhibiting the pain signal, or disrupting a nerve fiber that is conducting the pain signal. SCS Limitations [0005] For patients studied between 2000 and 2005, about 1.2% had complication due to infection and another 1.2% due to dural puncture and 11% technical failures due to electrode migration or malpositioning. Additionally, SCS electrodes used to be implanted in a less conductive medium than that of the Cerebral Spinal Fluid (CSF), percutaneously, but complications with fibrosis altered device behavior (K. M. Alo, “Recent Advances in Neurostimulation Analgesia,” Techniques in Regional Anesthesia and Pain Management, Vol. 5, No. 4, 2001, pp: 142-151). Since the CSF is highly conductive, it acts as a shunt, requiring electrode guarding techniques and increase in number of stimulation sites to four in order to obtain adequate current focusing. This approach is highly sensitive to electrode placement due to the need to focus the electric current across the stimulated axon, and over time, the electrodes migrate in the epidural space, decreasing the effectiveness of the treatment. Nociceptive Pain [0006] More generally, chronic pain (CP) that is nociceptive has been poorly defined and documented until recently and is considered widely undertreated. According to the International Association for the Study of Pain (IASP), CP prevalence ranges from 10.5% to 55.2%. The American College of Rheumatology (ACR) estimated CP prevalence at 10.1% to 13%. Studies show that there is little variation of prevalence in populations, ranging from 8% in children to approximately 11% in Adults. CP is generally defined as pain that persists beyond the normal time of healing and may be associated with a disease where healing may never occur (M. Ospina and C. Harstall, “Prevalence of Chronic Pain: An Overview,” Alberta Heritage Foundation for Medical Research, Health Technology Assessment, Edmonton, Alberta, Canada, (2002)). Different associations have generally defined CP to present as chronic if it persists beyond the range of one to six months, with many agreeing on three. [0007] Treatment of nociceptive pain that is acute, post-surgical or chronic is generally done with analgesics. In particular, chronic pain has given rise to patient-controlled-analgesic infusion pumps (PCA's) (see U.S. Pat. No. 5,630,710), which are capped to limit amount of opiates and reduce dependency. In addition, transcutaneous electrical neural stimulators (TENS) devices (see, e.g., U.S. Pat. No. 4,121,594) demonstrated moderate impact on the suppression of pain, but were never used alone to suppress severe pain. Many TENS devices are commonly used for massage, where they pass electrical current through large muscle fiber, contracting it and in essence stimulating ascending large fiber neurons which were thought to suppress pain. SCS devices are deployed when all pharmacological solutions are exhausted in patients with intractable pain. Studies have also shown that intermittent stimulation of the spinal cord in sessions provides relief for both nociceptive and neuropathic pain, allowing of the scheduling of stimulation sessions using non-implantable subcutaneous needle electrodes. Mechanisms of Pain [0008] Pain, whether introduced nociceptively by tissue damage, or neuropathically by nerve damage, is conducted through the peripheral nervous system and transmitted to the spinal cord via Aδ and C-fibers. C fibers are small, non-myelenated and slow conducting in the range of 0.5-1.2 m/s. C-fiber diameter is in the order of 1 mm and has a membrane time constant of 0.25-3 ms. Some Aδ fibers are faster conducting 12-36 m/s and have membrane time constants that range to 0.1 ms (L. R. Squire, F. E. Bloom, S. K. McConnell, J. L. Roberts, N. C. Spitzer, M. J. Zigmond, Fundamental Neuroscience, Second Edition, Academic Press, Elsevier Science, San Diego Calif., 2003, ch. 25). [0009] Aδ fibers, the faster conductors of pain, are carriers of the “first pain” sensation that is very highly localized. First pain is much more tolerable than the sustained second pain, and is the trigger to a reflexive withdrawal to cutaneous pricking, for instance. Aδ fibers are also mechanoceptors that respond to application of heat with very high threshold. Repeated application of heat stimuli on Aδ mechanoceptors receptor sites decreases the threshold, increases the response, thus leading to sensitization. [0010] C fibers are polymodal, responding to tissue deformation, noxious stimuli and heat. They are responsible for the second pain which is poorly localized and poorly tolerated. In general, they transmit burning sensations. Aβ fibers are larger mechanoceptors, synapsing more anteriorally within the spinal cord to Aδ and C fibers. These larger fibers are considered by some researchers to be responsible for the “Gate Control Theory,” where their stimulation is responsible for neuromodulation, or suppression, of pain sensation in the smaller fiber group. Many have refuted this finding, yet it is known that muscle contraction of pain-sites using TENS devices decreases pain response and provides prolonged relief. Neuromagnetic Stimulation [0011] Devices and methods for performing neurostimulation using a combination of a magnetic field and ultrasound have been described. See., e.g., U.S. Pat. No. 5,476,438. Such systems purport to stimulate nerves by applying a magnetic field generally to the nerve and simultaneously focusing an ultrasound beam on the nerve. SUMMARY OF THE INVENTION [0012] The present invention relates to a device and method for non-invasive stimulation of nerves for, e.g., treating pain, controlling nerve function or performing mapping studies. In some aspects, the present invention relates to devices and methods that stimulate nerves non-invasively within the human body, and more particularly, Aδ-fibers and C-fibers for pain control, with improvements on Transcutaneous Electrical Nerve Stimulation (TENS); spinal cord stimulation (SCS) for inducing anesthesia and controlling pain; any deep-brain stimulation (DBS) including any part of the cortex, hippocampus, basal ganglia, the subthalamic nucleus, the caudate and the dentate; pudendal nerve for controlling urinary incontinence; and the vagal nerve for inducing parasympathetic modulation. Some aspects of the method relate to improved non-invasive stimulation of any target site, nerve or muscle that is deeply or superficially located utilizing localized Hall Effect phenomenon. The device induces Hall Effect stimulation by combining ultrasound delivered by an external transducer, with a magnetic fields delivered by external electromagnets, boosted by a subthreshold electric field delivered transcutaneously utilizing surface electrodes. [0013] The device and method of this invention may be used for the following indications: post-surgical acute pain, nociceptive acute and chronic pain, neuropathic chronic pain, localized anesthesia, and substitute for epidural during surgery and caesarian delivery. The device could be used in conjunction with analgesics to reduce dosage of barbiturates and long-term dependency on opiates. [0014] In another aspect of this invention, the device and method may be used by neurosurgeons for brain mapping prior to permanent implantation of deep-brain stimulator (DBS) devices. DBS is indicated for the control of: epilepsy, Parkinson's disease, Essential Tremor, severe migraines, phantom limbs and chronic pain, depression, dementia due to Alzheimer's and other intractable conditions requiring technological and surgical interventions. In current procedures, following MRI, stereotactic intraoperative mapping is employed to localize DBS targets while the skull is open and the patient is awake, providing psychophysical and instrumented feedback. The results of such procedures are often suspect since drugs are used to block patient pain throughout the procedure, present a transient response, compounded by the presence of a single-unit mapping electrode. Permanent electrode target localization is a lengthy process that requires multiple insertions of single-unit electrodes through a cannula. Repeated insertions of mapping electrodes are known to produce nerve damage in the insertion path. Using this invention, mapping is conducted prior to operating, without the insertion of the mapping electrode, thereby allowing the neurosurgeon to reduce or eliminate intraoperative brain mapping prior to permanent electrode placement and test stimulation parameters of DBS devices to determine in advance the efficacy of such technological interventions. [0015] In another aspect, the device and method of this invention are intended for stimulation-induced lipolysis for regulation of long-term energy balance cycle in obese patients. The preferred target is the lateral cutaneous femoral nerve. Such use may supplement future implanted obesity devices that focus on short-term satiety measures, but do not address endocrine modulators such as leptin, that may relate to suppression of natural lipolysis in morbidly obese patients. [0016] In yet another aspect of this invention, the device and method serve as research tools for new implantable stimulators intended for nerve or muscular targets, for, e.g., the control of urinary incontinence by targeting the pudendal nerve, obesity by targeting the vagus nerve or nerves controlling intestinal peristalsis, and other systemic endocrine processes regulated by the autonomic nervous system that may benefit from such non-invasive stimulation. The research devices would allow clinicians and regulating agencies to determine prior to implantation whether permanent implants would result in favorable outcomes. Mechanism of Stimulation [0017] The mechanism of stimulation utilizes the superposition of electric currents introduced by the following electric field sources: [0018] (1) Hall Effect due to the interaction of Ultrasound and Magnetic Fields (see, S. J. Norton, “Can Ultrasound be Used to Stimulate Nerve Tissue?” Biomedical Engineering Online, (2003); Angelo Campanella, “Investigations of Sound Waves Generated by the Hall Effect in Electrolytes”, J. Acoust. Soc. Am., Vol 111, No.5, 2002, pp. 2087-2096; H. Wen, E. Bennett, J. Shah, R. S. Balaban, “An Imaging Method Using the Interaction between Ultrasound and Magnetic Field,” IEEE Ultrasonics Symposium, 1997, pp. 1407-1410); [0019] (2) Magnetic induction of electric current due to oscillating magnetic fields, as is the case with coil electrodes or Transcranial Magnetic Stimulation (TMS) (see, W. J. Fry, “Electrical Stimulation of Brain Localized without Probes—Theoretical Analysis of a Proposed Method,” J. Acoust. Soc. Am., Vol 44, No.4, 1968, pp. 919-931; Ruohonen, P. Ravazzani, J. Nilsson, M. Panizza, F. Grandori, G. Tognola, “A volume-conduction analysis of magnetic stimulation of peripheral nerves,” IEEE Trans. Biomed. Eng., vol. 43, pp. 669-677 (1996); K. Davey, C. M. Epstein, “Magnetic Stimulation Coil and Circuit Design,” IEEE Trans. Biomed. Eng., Vol. 47, No. 11, 2000, pp. 1493-1499; F. Grandori, P. Ravazzani, “Magnetic stimulation of the motor cortex-Theoretical considerations,” IEEE Trans. Biomed. Eng, Vol. 38, No.2 1991 pp. 180-191; B. J. Roth et al., “A theoretical calculation of the electric field induced in the cortex during magnetic stimulation,” Electroencephalography and Clinical Neurophysiology, Vol. 81, 1991, pp. 47-56); and [0020] (3) Transcutaneous Electrical Neural Stimulation (TENS) devices. [0021] This invention entails localization of electric fields via spatial focusing of power over a small biological target. The spatial focusing is limited only by the wavelength of the ultrasonic wave and, in the presence of a magnetic field, creates a Lorentz Force in an electrolytic medium. The induced current due to the Lorentz Force (see, B. S. Guru, H. R. Hiziroglu, Electromagnetic Field Theory Fundamentals, Second Edition, Cambridge University Cambridge, UK, 2004, ch. 6-7) is: [0000] {right arrow over (J)}=σ{right arrow over (v)}×{right arrow over (B)}   (1) [0022] where, J is the current density vector in A/m 2 , σ is the conductivity of tissue in S/m, v is the velocity of particle motion due to the ultrasonic wave pressure in m/s, and B is the magnetic flux density in T. [0027] Current traveling through a coil activates the magnetic field. The coil may be wound on a ferromagnetic core (or a similar magnetic material, such as an iron-cobalt alloy) to enhance the magnetic field, or could be a simple set of wire loops without any core. The magnetic field oscillates at a frequency that is equal or less than that of the ultrasound, and could theoretically be a constant DC field. Oscillating magnetic field amplitudes within the range of 0-3 T may be generated, and for practical reasons, dampened sinusoids or pulses are selected. This disclosure, however, covers any frequency or amplitude sufficient to introduce an incremental Hall Effect electric field sufficient to stimulate tissue. [0028] A secondary effect of oscillating magnetic fields is an induced current density in the conductive tissue, which is derived from Faraday's induction law and Lenz's law, is described below: [0000] J → = σ   E → = σ  ( K    φ  t ) = σ   K   μ   N  (  I  t )  ∫ A   s → ( 2 ) [0029] where, [0030] J is the current density vector in A/m 2 , [0031] E is the electric field in V/m, [0032] σ is the conductivity of tissue in S/m, [0033] K is the effective mutual inductance between the coil and the biological medium, [0034] Φ is the magnetic flux through the coil [0035] N is the number of turns on the coil, [0036] I is the current in the coil windings, [0037] ds is an element of the cross-sectional area of the electromagnet producing the coupled magnetic field, [0038] and μ is the core permeability. [0039] This current is much less localized than that of the one induced by the Hall Effect phenomenon, yet it provides a subthreshold component to which the Hall Effect current is added. This generalized current could play an important role in lowering the total required energy delivered by ultrasonic stimulation and is an added benefit of using switched oscillating current to achieve the desired magnetic field strengths required for the Localized Hall Effect of this invention to operate. Many published simulations using the Hodgkins-Huxley model have shown that nerve stimulation would occur in induced electric fields ranging from 6 V/m−100 V/m (see, e.g., F. Grandori, P. Ravazzani, “Magnetic stimulation of the motor cortex—Theoretical considerations,” IEEE Trans. Biomed. Eng., Vol. 38, No.2 1991 pp. 180-191; J. P. Reilly, “Peripheral nerve stimulation by induced electric currents: exposure to time-varying magnetic field,” Medical and Biological Engineering and Computing, Vol. 27, 1989, 101-110; P. Tofts, “The distribution of induced currents in magnetic stimulation of the nervous system”, Phys. Med. Biol. Vol. 35, 1990, 1119-1128; P. J. Maccabee, S. S. Nagarajan, V. E. Amassian, D. M. Durand, A. Z. Szabo, A. B. Ahad, R. Q. Cracco, K. S. Lai, L. P. Eberle, “Influence of pulse sequence, polarity and amplitude on magnetic stimulation of human and porcine peripheral nerve,” J. Physiology, vol. 513.2, 1998, pp. 571-585; B. J. Roth, P. J Basser, “Model of the Stimulation of a Nerve Fiber by Electromagnetic Induction,” IEEE Trans. Biomed. Eng, vol. 37, 1990, 588-597). Based on experience, adequate recruitment in the cortex with invasive electrodes requires around 100 V/m at frequencies exceeding that of the membrane time constant requirements and is estimated to be significantly less in large myelinated nerves. [0040] The third component in this approach entails the widely utilized concept of Transcutaneous Electric Neural Stimulation (TENS), introduced by surface electrodes. The surface electrodes are needed only in some cases and provide a baseline electric current component, which is non-localized, at a subthreshold level. The addition of all three currents provides deep neural stimulation of any targeted axon with electric field gradients that are dictated by the wavelength of the ultrasonic carrier frequency. [0041] Hall Effect generation of Lorentz forces was successfully demonstrated by Wen for use as a novel imaging modality, called Hall Effect Imaging (HEI). For imaging, the reverse approach is applied where large pulses of electric field are generated across an electrolytic medium, resulting in pressure waves. The strength of the resultant ultrasonic source is proportional to the electrical conductivity of the medium. The ultrasonic wave is then detected by a hydrophone. In this way, an image of tissue conductivity can be built up. Ultrasound Demodulation and Wave Interaction [0042] High spatial resolution requires high-frequency ultrasound, resulting in small wavelengths. In DBS applications, spatial separation between electrodes is in the order of 1-5 mm. The Hall Effect phenomenon generates electric fields that are at the same frequency of ultrasound within a DC, or a much slower oscillating magnetic field. To obtain high spatial resolution, an ultrasound frequency on the order of several hundred kHz to MHz or above is required, depending on the clinical application. [0043] Non-destructive amplitudes for nerve stimulation tend to be at periods close to the natural membrane time constant and shown repeatedly in the literature on strength duration curves (see L. A. Geddes, L. E. Baker, Principles of Applied Biomedical Instrumentation, Third Edition, John Wiley & Sons, New York, 1989). Such periods equate to frequencies of 1-10 kHz for SCS and DBS applications. [0044] Fatemi and Greenleaf published a breakthrough discovery in 1998 documenting that MHz-frequency ultrasound could be utilized to measure elasticity and other mechanical characteristics of biological targets, that have natural frequencies that are orders of magnitude lower than those of the carrier signals. (See M. Fatemi, J. F. Greenleaf, “Ultrasound-Stimulated Vibro-Acoustic Spectrography,” Science, VOL. 280, 1998, pp. 82-85.) The concept involves two incident waves, at slightly different frequencies, introduced by con-focal ultrasonic transducers, and later by sector arrays (see G. T. Silva, S. Chen, A. C. Frery, J. F. Greenleaf, M. Fatemi, “Stress Field Forming of Sector Array Transducers for Vibro-Acoustography,” IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control, 2005, vol. 52, no. 11, pp. 1943-1951). The two co-incident waves interact in a non-linear manner and produce a detectable sonic wave at the difference frequency. Their imaging method is called vibro-acoustography and was demonstrated as useful in the detection of breast cancer, since tumors have different mechanical characteristics than the surrounding tissue. [0045] The device disclosed herein uses difference frequency approaches to demodulate MHz-range ultrasound in some embodiments for stimulation purposes. The difference frequency method will allow the generation of 1-10 kHz electric field potential, transmitted deep into the body and modulated by two co-incident ultrasonic sources operating in the MHz range. Neural Stimulation using Hall Effect [0046] As indicated earlier, the device and method of this invention has three components to its current, added with superposition: [0047] (1) Current due to the Hall Effect localized at a small target region within an ultrasonic wavelength and perpendicular to the magnetic field. The current may be induced at the fundamental frequency of the ultrasound with long wavelengths, or at difference frequencies from two separate sources. We define the current density due to Hall Effect as {right arrow over (J)} HE . [0048] (2) Current inducted by Lenz's and Faraday's laws due to the use of oscillating magnetic fields, since large magnetic fields created by DC current in the windings may be impractical. We refer to current density due to magnetic oscillation as {right arrow over (J)} mg . [0049] (3) Current conducted by the application of electrodes around the stimulation site utilizing TENS. We refer to current density due to surface electrodes as {right arrow over (J)} SE . [0050] The total current density is therefore, [0000] {right arrow over (J)} TOT ={right arrow over (J)} HE +{right arrow over (J)} mg +{right arrow over (J)} SE .   (3) [0051] {right arrow over (J)} HE is defined in equation (1) and {right arrow over (J)} mg is defined in equation (2) above. The current density between two electrodes, positioned on the z-axis, with separation distance, d, and current, I, obeys Laplace's equation and is represented as: [0000] J → SE  ( 0 , 0 , z ) = I 4  π [ 1 ( z + d 2 ) 2 + 1 ( z - d 2 ) 2 ]  z ^ . ( 4 ) [0052] The final component is the Hall Effect current density, derived from equation (1) above, and assuming a magnetic field that is perpendicular to the propagation of ultrasound, it can be expressed in scalar form as: [0000] J=σvB.   (5) [0053] Let the particle velocity function be a sinusoid with frequency, ω a , wave constant, k, and peak velocity ν 0 , then time-averaged J along the x-axis is expressed as: [0000] J  ( x ) = σ T  ∫ 0 T  V 0  sin  ( ω a  t - kx )  B  ( t )   t ( 6 ) [0054] One embodiment of the device of this invention operates in a manner such that {right arrow over (J)} HE is direct current (DC). We can obtain DC current density by setting B(t)=sin(ω a t), in which case (6) becomes: [0000] J dc  ( x ) = 1 2  σ   v 0  B 0  cos  ( ikx ) ( 7 ) [0055] The DC current may be turned on and off to achieve optimal modulation or pulse train stimulation. [0056] In another embodiment, a current density oscillating at a low frequency (rather than DC) can be achieved by varying the magnetic field at a slighting different frequency than the ultrasonic frequency. In this case, one sets B(t)=sin((ω a +Δω)t). Using this in Eq. (6) gives a current density similar to Eq. (7), but with a temporal modulation at the frequency Δω. This frequency could be selected for optimal stimulation (e.g., approximately 10 kHz). [0057] One aspect of the invention provides a method of stimulating a nerve in tissue of a patient. The method includes the following steps: applying a focused ultrasound beam to the tissue; applying a first magnetic field to the tissue; and applying a second magnetic field to the tissue, the second magnetic field differing from the first magnetic field, the ultrasound beam and the first and second magnetic fields combining to stimulate the nerve. In some embodiments, the nerve is in a dorsal spinal root or dorsal column, and in such embodiments the method could includes the step of stimulating the nerve to treat pain. In some embodiments the nerve is a peripheral nerve, and in such embodiments the method could include the step of controlling the function of the peripheral nerve. In some embodiments the nerve is in the deep brain, and in such embodiments the method could include the step of stimulating the nerve to perform a mapping study. [0058] In some embodiments, the first magnetic field is a DC field. In other embodiments, the step of applying a first magnetic field includes the step of pulsing or oscillating the first magnetic field at a frequency from, e.g., about 0.5 Hz to about 300 Hz. [0059] In some embodiments, the step of applying a first magnetic field includes the step of applying the first magnetic field at a first polarity and the step of applying a second magnetic field includes the step of applying the second magnetic field at a second polarity opposite to the first polarity. In other embodiments, the first and second magnetic fields are applied at the same polarity. The first and second magnetic fields may generate a substantially toroidal magnetic field in the tissue. In some embodiments, the spacing between first and second magnetic fields sources may be changed. [0060] In some embodiments, the method includes the step of applying an electric voltage, or controlled current, to a surface of the tissue (such as, e.g., the patient's skin) using electrodes that are spaced apart from the nerve yet create electric fields that encompass the nerve. In such embodiments, an electrode may be adhered to the tissue surface. The electric field may be applied with a TENS device and may be applied to the nerve may be less than a stimulation threshold for the nerve. [0061] In some embodiments, the step of applying a focused ultrasound beam includes the step of applying a continuous wave ultrasound beam. In other embodiments, the step of applying a focused ultrasound beam includes the step of applying a pulsed ultrasound beam. In some embodiments a second focused ultrasound beam is applied to the tissue, and the first and second ultrasound beams may be at different frequencies. [0062] Yet another aspect of the invention provides a method of stimulating a nerve in tissue of a patient, the method including the steps of applying a focused ultrasound beam to the tissue; applying a first magnetic field to the tissue; applying a second magnetic field to the tissue; and applying an electric field to a tissue surface spaced apart from the nerve (such as a skin surface), the ultrasound beam, the first and second magnetic fields and the electric field combining to stimulate the nerve. In some embodiments, the electric field is applied with a TENS device. [0063] Another aspect of the invention provides a nerve stimulation device having two magnetic coils of opposite polarity each adapted to generate a magnetic field in a patient's tissue, the coils being positioned to generate a substantially toroidal magnetic field within the patient's tissue; and an ultrasound source adapted to transmit a focused ultrasound beam into the patient's tissue. In some embodiments, the device also includes a first electrode adapted to be applied to a surface of the patient's tissue and a power source adapted to provide a voltage between the first electrode and a second electrode. The device may also include a controller adapted to control the voltage and/or current between the electrodes. [0064] In some embodiments, the device has a second ultrasound source adapted to transmit a focused ultrasound beam into the patient's tissue. In some embodiments, the device includes a controller adapted to control operation of the magnetic coils and the ultrasound source. The controller may include a user control adapted to adjust an operation parameter of at least one of the magnetic coils and the ultrasound source. [0065] Further details of the device and method of the invention will be described with reference to the drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0066] The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which: [0067] FIG. 1 is a schematic drawing of a patient/device interface according to one embodiment of the invention. [0068] FIG. 2 shows the architecture of a stimulator system according to one embodiment of the invention. [0069] FIG. 3 is a schematic drawing of a magnetic coil drive circuit for use with this invention. [0070] FIG. 4 is a computer-generated representation of an ultrasound array factor suitable for use with this invention. [0071] FIG. 5 is a block diagram showing beam forming architecture for use with this invention. [0072] FIG. 6 is the block diagram of a TENS drive circuit for use with this invention. [0073] FIG. 7 shows strength duration curves for nerve stimulation. DETAILED DESCRIPTION OF THE INVENTION [0074] FIG. 1 shows schematically an interface between a stimulation device and a patient. The interface 10 has two magnetic coils 12 and 14 with opposite polarity which together generate a magnetic field in the shape of a torus. In this embodiment, the distance between the two magnetic coils may be varied as desired. In other embodiments, the distance between the magnetic coils may be fixed. Coils 12 and 14 connect to a controller (not shown) via conductors 16 and a conduit 18 . In use, coils 12 and 14 may be adhered to the skin or other tissue surface of the patient. [0075] One or more ultrasound sources are disposed in the center of interface 10 . In some embodiments, the ultrasound sources will be focused on the axon of interest to create a Hall Effect current. The ultrasound source may be a single transducer, a con-focal transducer, two separate transducers, or two separate arrays operating at slightly different frequencies, with a resultant wave at the difference frequency representing the stimulation profile. The embodiment shown in FIG. 1 employs two ultrasound sources, 20 and 22 , connected to the controller via conduit 18 . Holes (not shown) may be provided beneath the ultrasound sources to provide room for gel application. In use, the ultrasound sources may be adhered to the patient's skin or other tissue surface. [0076] This embodiment also uses surface electrodes 24 and 26 to add a baseline electric field in order to decrease the stimulation amplitudes required by the localized Hall Effect phenomenon. Electrodes 24 and 26 communicate with the controller via conductors 28 and 30 , respectively. In use, these surface electrodes are adhered to the patient's skin or other tissue surface and may use conductive gel to create electric current uniformity at the electrode/tissue interface. [0077] FIG. 2 shows the architecture of a stimulator system 200 according to one embodiment of the invention. The device architecture is that of a host-controller model. The host 202 provides a user interface allowing the clinician to alter stimulation parameters for the magnetic coils 206 , the ultrasound sources 208 , and the transcutaneous electrodes 210 comprising the patient interface 212 . The host is comprised of software running on a personal computer. The controller 204 is an embedded processor, interfaced with the host via a communication port 214 , with a processor that controls each of the three modalities. Once the stimulation parameters are downloaded, the host 202 and controller 204 could be disconnected. A simple user interface 216 is provided via buttons and LEDs on the controller front panel. [0078] Other elements of the system of this embodiment include a power supply 218 , a DC step up 220 , an ultrasound beamformer circuit 222 , a TENS generator 224 , a magnetic coil drive circuit 226 and flash ROM 228 . [0079] In one embodiment, shown in FIG. 3 , the magnetic coil drive circuit 300 is a simple DC charge capacitor circuit powered by a step-up transformer 302 via a full-wave rectifier 304 . The two coils 306 and 308 are powered via a silicone controlled rectifier (SCR) which discharges the capacitor into the windings of the coils. The coils may possibly be wound around a ferromagnetic core to enhance the field strength, or could simply be a wire loop with multiple turns. The ferromagnetic core may have any shape such that the flux at its end or side is optimized for the clinical application. The microprocessor allows the circuit to oscillate once at its natural frequency using the SCR and another transistor switch 310 . The voltage source, not shown in this figure, is an amplified voltage controlled oscillator driven by a digital potentiometer that the microprocessor programs through a serial connection. [0080] Up to two ultrasonic beamformers could be used in this device, and as few as one transducer depending on the clinical application. In one embodiment, each beam former is operating at a slightly different frequency than the other. As documented earlier by Fatemi and Greenfield, the interaction of the two co-incident waves results in a third wave generated non-linearly at the difference frequency. There is a fourth wave that is not of interest to this application oscillating at the sum of the two frequencies. A typical array factor pointing at 180 degrees is shown in FIG. 4 . The image was generated in MATLAB from 20 different elements, simulating a phased-array antenna. Other embodiments of this invention may produce an array factor that is different than the one shown in FIG. 4 . [0081] Beam forming architecture is shown in the block diagram shown in FIG. 5 . In this embodiment, the beam forming architecture includes a microprocessor 502 providing phase control to a series of phase shifters 504 , the output of which are amplified with amplifiers 506 , which are connected to a DC step up circuit 508 to power the ultrasound transducers 510 . A digital potentiometer 512 operating with a VCO 514 provide the raw signals driving each of the transducers and processed by the phase shifter block. [0082] The ultrasound sources are intended to operate in continuous wave mode, thus justifying the use of programmable phase shifters. In another embodiment, pulsed ultrasound may also be used to generate a dampened sinusoidal response. With pulsed ultrasound, the microprocessor drives the transducers through an array of FET push-pull transistor-pairs, with each pulse delayed as a function of the transducer phase angle. [0083] The third modality of the device of this invention is that of the transcutaneous neural stimulator. As mentioned earlier, this modality is only used to provide subthreshold stimulation, aiding the Hall Effect to trigger action potentials in the targeted axons. In DBS applications, for example, the use of surface electrodes may generate undesirable outcomes, while in spinal cord and peripheral applications, it may be programmed in a complex manner to exhibit a variety of neuromodulation mechanisms. [0084] The surface electrodes could produce a variety of waveforms commonly used in neural stimulation, such as trapezoidal, asymmetric, and half-wave. The waveforms are generated by the host and downloaded into memory. The microcontroller reads the digitized waveforms, converts them to analog and sends them to the electrode pair, via current-controlled amplifiers. [0085] FIG. 6 shows the block diagram of a TENS drive circuit. In this embodiment, a microprocessor 602 obtains waveforms from flash memory 604 . A microcontroller 606 (possibly communicating with RAM 608 ) provides the current waveform to the electrodes 614 through an amplifier 610 and DC step up circuit 612 . A separate patient ground 616 may also be provided. In another embodiment, isolation transformers or push-pull mechanisms are used to activate the surface electrodes. [0086] In operation, the system is first set up by connecting the three major modules together: the device to the PC-host and the device to the patient-interface module. Both device and host are powered up, and the Graphical User Interface (GUI) software is run on the PC-host. The GUI contains a mathematical model that estimates magnetic induced current density due to magnetic coil operating parameters. The following parameters are then set for the magnetic drive circuit shown in FIG. 3 : [0087] (1) Amplitude of input voltage (Amc); [0088] (2) Frequency of input voltage (Fmc); [0089] (3) Discharge output voltage (Vo); and [0090] (4) Discharge repetition rate (DRR). [0091] Both Amc and Fmc influence the operation of the charging circuit and are limited by a model of that circuit for optimal and safe operation. Vo and DRR determine the physiologic response to the magnetic coils. Larger Vo results in larger coil currents, thus introducing larger fluctuation in magnetic flux. The induced current in the target membrane is proportional to dB/dt. DRR determines the steady-state response of the axon, and may result in the following physiologic effects: (1) subthreshold stimulation; (2) hyperpolarization; and/or (3) sensitization. The preferred operation of the system is the first response so that subthreshold non-localized stimulation of many nerves in the magnetic field is aided by an incremental addition of the Hall Effect voltage introduced by the ultrasound sources at the target. [0092] Next, the ultrasound sources are programmed for continuous operation. In one embodiment, a single ultrasound source operates at a stimulation frequency much greater than the fluctuation frequency of the magnetic flux density, but is considered effective for the targeted axon according to the nerve stimulation strength-duration curve shown in FIG. 7 . [0093] In another embodiment, two ultrasound sources, whether single element or phased arrays, are programmed to operate at a wavelength that achieves desired localization. Ultrasound propagating in an axis transverse to that of the magnetic field, as shown in equation (1), will introduce a Hall Effect electric current. This localized phenomenon acts similar to a physical electrode, referred to herein as a “virtual electrode.” The two sources operate at slightly different frequencies, and the difference of the two is the stimulation frequency determined by the strength-duration curve shown in FIG. 7 . [0094] Depending on the clinical application, stimulation sites may be too responsive to the induced current by the magnetic coils, thus requiring a decrease in flux density to a point where the Hall Effect voltage strength becomes less dominant. This situation may require the assistance of another subthreshold stimulation source, generated by the surface electrodes shown in FIG. 1 . The next step in setting up the device would be to program the stimulation current in these electrodes according to a predetermined mathematical model, such that the total current due to the surface electrodes and those of the magnetic coils result in the desired non-localized physiologic effect. The added current by the Hall Effect phenomenon resulting from ionic disturbance in the magnetic field by the ultrasound pressure waves induces the incremental effect of stimulation, only at the target site within the mentioned “virtual electrode” target region.

One aspect of the invention provides a method of stimulating a nerve in tissue of a patient. The method includes the following steps: applying a focused ultrasound beam to the tissue; applying a first magnetic field to the tissue; and applying a second magnetic field to the tissue, the ultrasound beam and the first and second magnetic fields combining to stimulate the nerve. Another aspect of the invention provides a nerve stimulation device having two magnetic coils of opposite polarity each adapted to generate a magnetic field in a patient's tissue, the coils being positioned to generate a substantially toroidal magnetic field within the patient's tissue; and an ultrasound source adapted to transmit a focused ultrasound beam into the patient's tissue.

BACKGROUND OF THE INVENTION This invention relates to chub packaging machinery, utilized to produce chub products by stuffing of casing with comminuted material, and more particularly, to a stuffing horn telescoping and pivoting mechanism. U.S. Pat. No. 4,675,945 and allowed application Ser. No. 07/285,325 filed Dec. 13, 1988 are incorporated by reference. In apparatus as disclosed in U.S. Pat. No. 4,675,945, chub products are rapidly formed of casing, comminuted material and metal clips. The comminuted material often constitutes sausage meats, and the casing constitutes sausage casing. Metal clips sold by Tipper Tie, Inc. are the standard of the industry. Comminuted material is placed in a hopper of a pumping apparatus, and pumped. The material is pumped through a horn among the several hours of a horn turret assembly. The horn extends to a casing brake, and the horn has a casing segment shirred on its exterior. Tension of the casing is adjusted at the casing horn to provide proper advancement of both the comminuted material and casing. Stuffed casing is intermittently voided and clipped to provide ends of resulting chub products. Casing as used in the apparatus of U.S. Pat. No. 4,675,945 must be used in segments. Loading of such segments presents a major hurdle in increasing speed of chub forming machines. As the horn turret assembly is shown in FIGS. 1 and 2 of U.S. Pat. No. 4,675,945, which are FIGS. 1 and 2 of this specification, multiple horns are provided on a turret such that while one horn is in operative position, another horn is in service position for placement of casing thereon. Depletion of casing on the horn in operative position results in interruption of the chub forming, retraction of the horn, and pivoting of the turret to bring the serviced horn into operative position. While the stuffing horn mechanism of U.S. Pat. No. 4,675,945 and allowed application Ser. No. 07/285,325 is highly desirable for a variety of reasons, research and development has continued toward a simpler, equally rapidly acting stuffing horn mechanism. SUMMARY OF THE INVENTION Thus, a principal object of the present invention was a simple stuffing horn mounting and actuating mechanism. Another principal object was ruggedness in the embodiment of the invention, for survival over the mechanical abuse to which equipment is often subjected in a meat packing environment. Another principal object was that the mechanism prevent the introduction of significant air pockets into chub products. Casing materials such as plastics do not permit air to escape after products are sealed. Another principal object was that the comminuted material or other stuffing material flow through the mechanism without change of direction, for applications where product characteristics do not lend themselves to changes of direction. Another principal object was that the sequence of operations of the mechanism by an operator be simple and easily reproduced. Another principal object was that the mechanism be self-compensating to prevent purging of the mechanism during loading of casing. Another principal object was that the mechanism be self-aligning. Another principal object was that the mechanism be readily and rapidly cleaned. Another principal object was that the mechanism provide for rapid change of filling horn sizes. Other principal objects were that the mechanism be all-mechanical, manually operated and powered, and adaptable to a variety of chub forming machines. In a principal aspect, this invention constitutes a stuffing horn mechanim for chub packaging machinery, utilized in association with such machinery to produce chub products by stuffing of casing with comminuted material, which is an advancement of the mechanism of U.S. Pat. No. 4,675,945. The stuffing horn mechanism comprises a telescoping stuffing horn, a comminuted material reservoir, and reservoir volume varying means. The telescoping horn is variable in volume during telescoping, and the reservoir is in communication with the stuffing horn. The reservoir volume varying means is operatively connected to the stuffing horn, for varying the volume of the reservoir in inverse relation to the volume of the stuffing horn during telescoping. As preferred, and in another principal aspect, the mechanism comprises a frame, slide guideways on the frame, a slide plate on the slide guideways, a telescoping stuffing horn, a turret mounted to the slide plate, a turret lever, a pump cylinder and piston, and a cable drive mechanism. The slide plate is mounted on the slide guideways for axial reciprocating motion. The stuffing horn defines an axial comminuted material passage, and includes an axially extending telescopic extension tube, an axially extending turret extension tube, an axially extending filling horn adapter, and an axially extending filling horn. The turret extension tube axially telescopes over the telescopic extension tube. The filling horn adapter and filling horn are connected and extend from the turret. The turret includes a rotatable turret inner member to which the filling horn adapter is connected for rotation with the rotatable turret inner member. The telescopic extension tube is fixedly attached to the turret. The turret lever is pivotally attached to both the frame and the turret, and on manual movement, causes reciprocal sliding of the turret, filling horn, filling horn adapter, telescopic extension tube and slide plate, relative to the slide guideways and frame. The pump cylinder extends transversely from the turret and is in communication through the turret inner member with the comminuted material passage. The pump cylinder is axially slidable with the turret. The pump piston reciprocates transversely in the pump cylinder, under action of the cable mechanism. Piston rods are mounted to the pump piston and extend transversely from the pump piston away from the turret. A near sheave is adjacent the pump cylinder mounted for axial sliding movement with the pump cylinder, and a remote sheave is remote from the pump cylinder, mounted for axial sliding movement with the pump cylinder and near sheave. A cable extends about the sheaves. From the sheaves, the cable extends axially to fixed attachments to the frame. A cable clamp clamps the cable to the piston rods, such that sliding movement of the turret, filling horn, filling horn adapter, telescopic extension tube and slide plate causes, through the cable, transverse motion of the piston rods and pump piston. Thus, axial extension of the stuffing horn causes advancement of the pump piston to the turret, and axial retraction of the stuffing horn causes retraction of the pump piston. Also, pivoting of the turret lever causes telescoping of the stuffing horn, and pivoting of the filling tube about the turret causes pivoting of the filling tube, filling tube adapter and turret inner member. The stuffing horn mechanism permits retraction and pivoting of the filling tube, for placement of casing segments on the filling tube, and simultaneous accommodation of the comminuted material, displaced from the stuffing horn during retraction, in the reservoir. Return of the filling tube to axial alignment and advancement simultaneously causes return of the comminuted material from the reservoir into the stuffing horn. Replacement of casing on the filling tube is accomplished without significant air inclusions in the comminuted material, rapidly and automatically. These and other aspects, objects and advantages of the invention will be more clearly understood by a reading of a detailed description of the preferred embodiment of the invention, which follows a brief description of the drawing. BRIEF DESCRIPTION OF THE DRAWING In the accompanying drawing, the figures of the drawing are briefly described as follows: FIG. 1 is an elevation view of a chub forming apparatus, taken from U.S. Pat. No. 4,675,945; FIG. 2 is a plan view of the chub forming apparatus of FIG. 1; FIG. 3 is a partial plan view of the stuffing horn mechanism of the present invention, used in replacement of the stuffing horn mechanism of U.S. Pat. No. 4,675,945; FIG. 4 is a cross-section view of the stuffing horn mechanism of FIG. 3, taken along line 4--4 in FIG. 3; FIG. 5 is a detail, elevation view of the pin mounting of the frame of the preferred embodiment to the frame 56 of the clipper apparatus 25 of U.S. Pat. No. 4,675,945; FIG. 6 is a partial perspective view, generally from the opposite side of FIG. 4, of the mannual lever of the preferred embodiment and pivotal mounting thereof in relation to the frame; FIG. 7 is a detail elevation view of the attachment of a cable end to the frame of the apparatus; and FIG. 8 is a detail plan view of a cable tensioning mechanism. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to FIGS. 1 and 2, an apparatus or machine 25 includes a control panel 26 with controls 28 and internal electronic and pneumatic circuitry alongside a clipper 30, a looper 31, a casing brake 32, and a voider assembly 34. The casing brake 32 defines the stuffing and casing intake to the machine 25. Casing 36 enters from a horn 38, which is one of several horns on a horn support structure 40. Stuffing 42 enters from the hopper 44 of a pumping apparatus 46, through the horn 38. While the horn 38 is in operative alignment with the casing brake 32, the horn 41 is in service position for placement of additional casing 39 on the horn 41. With reference to an axial direction across FIGS. 1 and 2, horns 38, 41 are transversely rotatable about an axially extending turret 45, for sequential movement to and from the operative and service positions. The horns are also axially advanceable and retractable, without telescoping, to and from an advanced, operative position. Clips are stored for use in clip trays 47. A power conveyor 48 moves chub products away, to a diverter 50, to be diverted to a sloped product discharge tray 52 for manual removal. A movable product recognition paddle 54 trips upon product contact, to initiate product cut-off and clipping. All the foregoing components are supported on a frame 56. The horn support structure 40 is pivotally mounted to the frame 56 at pivot 58, to be swung away from the apparatus 25, for servicing of the casing brake 32, clipper 30 and looper 31, and away from the apparatus 46 for servicing thereof. The turret 45 is releasably connected to the pumping apparatus 46. Referring now to FIGS. 3 and 4, the preferred embodiment of the present invention is one possible embodiment of the invention. The preferred embodiment constitutes a stuffing horn mechanism 60 including a tubular welded frame 62 attachable for horizontal pivoting about the pivot 58 to a machine such as machine 25, in replacement of horns 38, 41, turret 45, structure 40 and associated elements. The pivot 58 is uniquely provided in the mechanism 60 by a threaded pin 59, shown in FIG. 5. The pin 59 is threaded in a bracket 61 on the frame 60, and a non-threaded portion 63 extends into a bushing 65 of a frame member of the frame 56 of the stuffing machine 25. A fixed pin ring 67 of the pin rests on a bronze bearing 69 on the frame 56. The pint 59 provides vertical alignment of the mechanism 60 with the machine 25 by adjustment of the height of the bracket 61 and frame 62 above the frame member of the frame 56. Atop the frame 62, a slide plate 64 is mounted on slide guideways 66, 68. A turret assembly 70 is atop the slide plate 64, and a telescoping stuffing horn assembly 72 is mounted to the turret assembly 70. A pump assembly 74 extends below the turret assembly 70, and a pump drive assembly 76 extends below the pump assembly 74. The horn assembly 72 includes several aligned components. The components extend longitudinally in a direction left to right in FIG. 3, defined as the axial direction. The slide plate 64 is mounted between the slide guideways 66, 68 for axial reciprocating motion. The turret assembly 70 extends about a vertical transverse axis of rotation, and the pump assembly 74 extends along the same vertical, transverse axis of rotation. The pump drive assembly 76 includes downwardly, transversely extending pump piston rods or pins 78, 80 and a cable 82 which extends both axially as at 84, 86 and transversely as at 88. The telescoping stuffing horn assembly 72 defines an axially extending comminuted material passage as marked at 90 throughout its length. From right to left in FIG. 3, the assembly 72 first includes an axially extending telescopic extension tube 92. Remote from the turret assembly 70, the telescopic extension tube 92 has a retaining collar (not shown) which secures a coupling nut (not shown) for coupling of the tube 92 to the output tube of the pumping apparatus 46. An elastomeric gland (not shown) over the retaining collar compensates for slight misalignment of the tube 92 and pump output tube. The gland provides stress relief at the coupling and an airtight seal. Opposite its secured outer end, the tube 92 is encircled by a U-cap seal 94, and extends within a turret extension tube 96. The seal 94 is located in a groove of the turret extension tube 96, and provides airtight connection of the tube 92 and tube 96. The turret extension tube 96 extends from an end remote the turret which is slidably sealed over the telescopic extension tube 92 toward the turret to attachment to the outer barrel 98 of the turret assembly 70. The turret barrel 98 is tubular, with porting to the turret extension tube and opposite thereto, porting to a filling horn adapter 100. Within the turret barrel 98, a cylindrical turret inner body 112 rotates, with a comminuted material passage extending through the turret inner body. Upper and lower wear rings 114, 115, 116 support the turret 112 during rotation of the turret 112. The turret extension tube 96 is fixedly mounted to the turret barrel 98 as by welding; as shown in FIG. 4, the filling horn adapter 100 is releasably mounted to the barrel 98 by an adapter locking assembly 102, for adaption to filling horns of differing sizes by interchange of the adapter 100 with other adapters. A filling horn 106 to which adapter 100 is sized is shown in FIG. 3 only, extending axially from the adapter 100. As shown, the horn members 92, 96, 100, 106 extend coaxially. The comminuted material passage 90 extends completely through the horn members 92, 96, 100, 106 and turret inner member 112. The turret barrel 98 is bolted to the slide plate 64 via bolts such as bolt 104. Sliding of the slide plate 64 causes sliding of the turret barrel 98 and turret assembly 70, and thereby, sliding movement of the filling horn adapter 100, filling horn 106, and turret extension tube 96. The turret extension tube 96 slides within the telescopic extension tube 92. Referring to FIG. 3 (FIG. 3 only), a turret lever 108 provides for manual driving of the sliding motion of the slide plate 64. The turret lever 108 is pinned for pivoting motion atop the turret inner member 112, and more specifically pinned via a lever pivot assembly 110 (FIGS 4 and 5). The turret lever 108 is also restricted in its motion relative to the frame at heel 111 by two spaced, standing pins 125, 126. The pins 125, 126 are fixed in a wear block 127 on the frame 62. The lever heel 111 of the lever 108 extends between the pins but is not attached to the pins 125, 126, wear block 127 or frame 62. The pins restrict the lever heel 111 to a motion which combines pivoting and transverse translation. The frame is immobile when fixed in place to the stuffing apparatus 25 and pump apparatus 46; thus, mannual force applied to the turret lever 108 causes pivoting of the turret lever 108 about the lever heel 111 in the direction of arrow 113. Under action of the lever 108, the turret assembly 70 and associated slidable horn elements slide along the slide guideways 66, 68 in the direction of arrow 119. As the transverse distance between the lever pivot assembly 110 and pins 125, 126 decreases, the heel 111 is free to extend transversely as necessary. Through application of moderate manual force to the turret lever 108, the filling horn 106 is advanced toward the stuffing apparatus 25, into operative position with the casing brake 32, and retracted away from the stuffing apparatus 25. While retracted, the filling horn 106 may be pivoted in the direction of arrow 117 from axial alignment as shown, by light manual force applied to the filling horn 106. Application of such force pivots the filling horn 106, filling horn adapter 100 and turret inner member 112. The porting of the turret barrel 98 through which the filling horn adapter 100 extends is enlarged horizontally to allow horizontal pivoting of the adapter 100. An O-ring seal is provided between the adapter 100 and turret inner member 112. An O-ring seal is also provided in a dovetail groove in the turret inner member 112 about the opening along the comminuted material passage adjacent the turret extension tube 96. The groove is dovetailed to prevent extrusion of the O-ring seal from the groove as the turret inner body 112 rotates. The turret lever 108 itself is telescopic, for purpose of alternately maximizing leverage during pivoting, and minimizing the obstruction of the lever during servicing of the mechanism 60. An outer lever member 121 telescopes within an inner lever member 123. A detent mechanism including a detent pin 118 on member 121 and a dual detent slot on member 123 releasably locks the outer member 121 at the extremes of its inward and outward extension. In the base of the turret inner member 112, as shown in FIG. 4, a socket 120 extends into open communication with the comminuted material passage of the horn and turret assemblies 72, 70. The socket 120 is centered on the axis of rotation of the turret inner member 112. A pump cylinder 122 is fitted to the socket 120, and extends below the turret assembly 70. Near its proximal end, the cylinder 122 has mounted thereon a pump mounting ring 124. The mounting ring 124 is bolted to the slide plate 64, and the cylinder 122 is welded to the mounting ring 124. Thus, the cylinder 122 travels with the slide plate 64. At its distal end, the cylinder 122 has mounted thereon, as by welding, a cylinder flange 126. A drive mounting flange 128 supports a drive assembly flange 130, and is itself supported below the cylinder flange 126. The drive mounting flange 128 is supported below and against the cylinder flange 126 by screw threaded fasteners 132, 134 which include hand-operated knobs. Because the drive mounting flange 128 is fastened to the cylinder flange 126 and thereby to the cylinder 122, the flanges and drive assembly frame 130 travel with the slide plate 64. A pair of pulley elements such as sheaves 136, 138 are mounted on the drive assembly frame 130. The sheaves are mounted for rotation about transverse, horizontal axes of rotation. The sheaves include a near or proximal sheave 136, and a remote or distal sheave 138. Except to the extent they travel as the slide plate 64 travels, the sheaves 136, 138 are fixed: they do not travel transversely toward or away from the turret and horn assemblies 70, 72. The cable 82 extends about the sheaves 136, 138, therebetween, and extends in both axial directions away from the sheaves 136, 138 to attachment to the frame 62 of the stuffing horn mechanism 60. Attachment adjacent the distal sheave 138 is releasable. Attachment at the opposite end of the cable 82 is to a cable tensioning mechanism 142, and also releasable. Referring to FIG. 7, a fitting 137 swedged on the cable end slides into a slot 139 of a cable retaining block, for quick disconnection. Referring to FIG. 8, the cable tensioning mechanism 142 includes a draw rod 154 passed through a clearance opening 155 in a fixed frame member 156. The draw rod 154 is externally threaded and an internally threaded knob 158 is mounted by cooperation of screw threads thereon. A tension block 160 has a cable retaining block 162 bolted to the block 160, and is slidably mounted on pins 164, 166 welded to the frame member 156. A helical spring 168 interposes the frame member 156 and the tension block 160. A friction washer 170 interposes the knob 158 and frame member 156. Turning of the knob 158 tensions the cable 82, which is held to the cable retaining block 162 by a swedged fitting 172. As the sheaves 136, 138 travel axially, under action of the slide plate 64, the portion of the cable which extends transversely varies. As the proximal sheave 136 travels toward the pumping apparatus 46, to the right in FIG. 4, the portion of the cable which is axially adjacent the sheave 136 moves about the sheave 136, and then extends transversely. As the distal sheave 138 simultaneously moves, the portion of the cable transversely adjacent the distal sheave 138 moves about the sheave 138 and then extends axially. Reverse motion causes reverse action. Transversely adjacent and below the proximal sheave 136, a cable clamp block 144 clamps the cable and a pair of piston rods or actuator pins 78, 80 to each other. The actuator pins 78, 80 extend through bushings on the cylinder and drive mounting flanges 126, 128 and through bushings on a base plate 150 on the drive assembly frame 130. The actuator pins 78, 80 extend into the pump cylinder 122, to attachment to a pump piston 152. Transverse motion of the cable between the sheaves 136, 138 causes transverse motion of the actuator pins 78, 80, and transverse motion of the pump piston 152. Thus, sliding of the slide plate 64 toward the pumping apparatus 46, to the right in FIGS. 3 and 4, causes retraction of the pump piston 152 transversely, and downward, toward the base of the pump cylinder 122. Sliding of the slide plate toward the stuffing apparatus 25, to the left in FIGS. 3 and 4, causes advancement of the pump piston 152 transversely, and upward, toward the top of the pump cylinder 122. While the horn mechanism 60 is in operation with comminuted material inside the horn assembly 72, retraction of the filling horn 106 may be desired, to place casing on the filling horn 106. At such times, with the mechanism 60, the pumping apparatus 46 is interrupted, and manual retraction of the filling horn through use of the turrent lever 108 may begin immediately. If desired, a limit switch and associated clamp on casing on the horn 106 may cause automatic recognition of the end of loaded casing and interrupt operation of both apparatus 25 and apparatus 46. Also, unintended sliding of the slide plate 64 may be prevented by a rod releasably fastened between the slide plate 64 and frame 62 which prohibits motion. Sliding of the slide plate 64 under action of the lever 108 causes manual retraction of the filling horn 106, and also through cable movement of cable 82, causes retraction of the pump piston 152. Retraction of the pump piston 152 creates a low pressure area above the pump piston 152 in the comminuted material passage 90. Atmospheric pressure from outside the filling horn 106 forces comminuted material in the filling horn 106 into the pump cylinder 122 above the piston 152. As the piston 152 retracts, the pump cylinder 122 fills with comminuted material. Air below the piston 152 within the pump cylinder 122 is vented. Comminuted material is not lost, but retained in the cylinder, which is a reservoir for such material. Afte loading of casing, as the filling horn 106 is then advanced, the piston 152 advances, forcing the comminuted material from the pump cylinder 122 into the filling horn 106, filling the horn 106, for speedy return to operation with the stuffing apparatus 25. The preferred embodiment of the invention, and the invention itself, are now described in such full, clear, concise and exact detail as to enable a person of ordinary skill in the art to make and use the invention. A variety of variations beginning from the preferred embodiment are possible without departing from the scope of the invention. As a result, the following claims conclude this specification, to particularly point out and distinctly claim the subject matter regarded as invention.

A stuffing horn mechanism for chub packaging machinery, utilized in association with such machinery to produce chub products by stuffing of casing with comminuted material. The stuffing horn mechanism comprises a telescoping stuffing horn, a comminuted material reservoir, and reservoir volume varying apparatus. The telescoping horn is variable in volume during telescoping, and the reservoir is in communication with the stuffing horn. The reservoir volume varying apparatus is operatively connected to the stuffing horn, for varying the volume of the reservoir in inverse relation to the volume of the stuffing horn during telescoping.

FIELD OF THE INVENTION [0001] The present invention relates to sweetener compositions comprising glycoside blends. The sweetener compositions of the present invention can further comprise other ingredients. In some particular embodiments, the sweetener compositions can further comprise one or more bulking agents. The present invention also relates to incorporation of the sweetener compositions into foods and/or beverages. BACKGROUND OF THE INVENTION [0002] The species Stevia rebaudiana (“ Stevia ”) has been the subject of considerable research and development efforts directed at the purification of certain naturally occurring sweet glycosides of Stevia that have potential as non-caloric sweeteners. Sweet glycosides that may be extracted from Stevia include the six rebaudiosides (i.e., rebaudioside A to F), stevioside, and dulcoside A. In particular, significant commercial interest has been focused on obtaining and purifying rebaudioside A from Stevia. SUMMARY OF THE INVENTION [0003] The present invention relates to sweetener compositions having particular glycoside blends. The sweetener compositions of the present invention can also include other ingredients such as bulking agents, flavorings, other high intensity sweeteners, or the like. The present invention also pertains to the use of the sweetener compositions in foods and beverages. [0004] Applicants have surprisingly discovered that certain blends of rebaudioside A, rebaudioside B, and rebaudioside D, in binary and ternary forms, result in blends which have higher effective sweetening ability than the pure component steviol glycosides of which the blends are made. That is, the same level of sweetness can be achieved with a lower concentration of the blend of glycosides than the amount that would be needed with the pure component rebaudioside A, rebaudioside B, or rebaudioside D component. The reduction in concentration of glycoside needed to achieve a certain level of sweetness can result in ample savings by allowing the utilization of lower amounts of the glycoside in sweetener compositions yet achieving the same level of sweetness. Additionally, lower levels of glycoside could allow for easier incorporation into certain foods and beverages. In some embodiments, the added benefit of reduced bitterness (while attaining the same sweetness) is also achieved. [0005] In certain preferred embodiments, the blends are high purity glycoside blends. In other preferred embodiments, the glycoside blends provide relatively high sucrose equivalent value (“SEV”) in the sweetener compositions. In these embodiments, when a higher level of sweetness is needed in sweetener compositions for certain food or beverage applications, the substantial benefit that the glycoside blends provide could better be realized. [0006] One aspect of the invention features a sweetener composition comprising a glycoside blend. The glycoside blend comprises from 15% to 85% rebaudioside B and from 15% to 85% rebaudioside D (of the total rebaudioside B and rebaudioside D in the glycoside blend), and the glycoside blend provides an SEV of greater than 3.6 in the sweetener composition, and rebaudioside B and rebaudioside D comprise at least 40% of the glycoside blend. [0007] Another aspect of the invention features a sweetener composition comprising a glycoside blend. The glycoside blend comprises from 30% to 60% rebaudioside A and from 40% to 70% rebaudioside D (of the total rebaudioside A and rebaudioside D in the glycoside blend), and rebaudioside A and rebaudioside D comprise at least 60% of the glycoside blend. [0008] Yet another aspect of the invention features a sweetener composition comprising a glycoside blend. The glycoside blend comprises from 11% to 95% rebaudioside A and from 5% to 89% rebaudioside D (of the total rebaudioside A and rebaudioside D in the glycoside blend), and the glycoside blend provides an SEV of greater than 3.4 in the sweetener composition, and rebaudioside A and rebaudioside D comprise at least 60% of the glycoside blend. [0009] Yet another aspect of the invention features a sweetener composition comprising a glycoside blend. The glycoside blend comprises from 40% to 85% rebaudioside A and from 15% to 60% rebaudioside B (of the total rebaudioside A and rebaudioside B in the glycoside blend), and the glycoside blend provides an SEV of greater than 3.6 in the sweetener composition, and rebaudioside A and rebaudioside B comprise at least 60% of the glycoside blend. [0010] Yet another aspect of the invention features a sweetener composition comprising a glycoside blend. The glycoside blend comprises from 10% to 55% rebaudioside A, from 30% to 75% rebaudioside B, and 10% to 30% rebaudioside D (of the total rebaudioside A, rebaudioside B, and rebaudioside D in the glycoside blend), and the glycoside blend provides an SEV of greater than 3.9 in the sweetener composition, and rebaudioside A, rebaudioside B, and rebaudioside D comprise at least 70% of the glycoside blend. [0011] Other objects, features, and advantages of the invention will be apparent from the following detailed description and claims. BRIEF DESCRIPTION OF THE DRAWINGS [0012] FIG. 1 is a table showing the sweet and bitter response of rebaudioside B and rebaudioside D blends (REB-BD glycoside blends). [0013] FIG. 2 is a table showing sweet and bitter response of rebaudioside A and rebaudioside D blends (REB-AD glycoside blends). [0014] FIG. 3 is a table showing sweet and bitter response of rebaudioside A and rebaudioside B blends (REB-AB glycoside blends). [0015] FIG. 4 is a table showing sweet and bitter response of rebaudioside A, rebaudioside B, and rebaudioside D blends (REB-ABD glycoside blends). DETAILED DESCRIPTION OF THE INVENTION Introduction [0016] The term “glycoside blend” as used herein means a blend of the various glycosides obtained from the Stevia plant. These glycosides include, but are not limited to, rebaudiosides A-F, stevioside, dulcoside, steviobioside, and rubusoside. In particular, the glycoside blends of the present invention include blends consisting predominantly of rebaudioside A, rebaudioside B, and/or rebaudioside D. [0017] The term “REB-AD glycoside blend”, as used herein, refers to a glycoside blend in which the primary components of the glycoside blend are rebaudioside A and rebaudioside D. In a REB-AD glycoside blend, the combination of rebaudioside A and rebaudioside D will make up at least 60% of the total glycosides in the glycoside blend. [0018] The term “REB-AB glycoside blend”, as used herein, refers to a glycoside blend in which the primary components of the glycoside blend are rebaudioside A and rebaudioside B. In a REB-AB glycoside blend, the combination of rebaudioside A and rebaudioside B will make up at least 60% of the total glycosides in the glycoside blend. [0019] The term “REB-BD glycoside blend”, as used herein, refers to a glycoside blend in which rebaudioside B and rebaudioside D make up a significant portion of the glycoside blend. In a REB-BD glycoside blend, the combination of rebaudioside B and rebaudioside D will make up at least 30% of the total glycosides in the glycoside blend. [0020] The term “REB-ABD glycoside blend”, as used herein, refers to a glycoside blend in which the primary components of the glycoside blend are rebaudioside A, rebaudioside B, and rebaudioside D. In a REB-ABD glycoside blend, the combination of rebaudioside A, rebaudioside B, and rebaudioside D will make up at least 70% of the total glycosides in the glycoside blend. [0021] Rebaudioside A is a compound having the following chemical structure: [0000] [0022] Rebaudioside B is a compound having the following chemical structure: [0000] [0023] Rebaudioside D is a compound having the following chemical structure: [0000] [0000] Sweetener Compositions with Glycoside Blends [0024] REB-BD Glycoside Blends [0025] Applicants have surprisingly discovered that at certain SEV levels, certain blends of rebaudioside B and rebaudioside D surprisingly have higher sweetening ability than either pure rebaudioside B or pure rebaudioside D. Thus, the utilization of these blends rather than pure rebaudioside B or rebaudioside D could result in significant cost savings. [0026] In some embodiments, the sweetener compositions include a REB-BD glycoside blend wherein the REB-BD glycoside blend comprises from 15% to 85% rebaudioside B and from 15% to 85% rebaudioside D (of the total rebaudioside B and rebaudioside D in the glycoside blend), and wherein the REB-BD glycoside blend provides an SEV of greater than 3.6 in the sweetener composition. In other embodiments, the sweetener compositions include a REB-BD glycoside blend wherein the REB-BD glycoside blend comprises from 19% to 80% rebaudioside B and from 20% to 81% rebaudioside D (of the total rebaudioside B and rebaudioside D in the glycoside blend), and wherein the REB-BD glycoside blend provides an SEV of greater than 3.6 in the sweetener composition. Increased benefit can be seen in embodiments where the REB-BD glycoside blends provides an SEV of greater levels to the sweetener compositions. In some of these embodiments, the REB-BD glycoside blend provides an SEV of greater than 4.5, 5.5, 6.9, 7.2, 7.4, or 7.7 to the sweetener composition. In other embodiments, the REB-BD glycoside blend provides an SEV that ranges from 7.0 to 9.0 to the sweetener composition. In yet other embodiments, the REB-BD glycoside blend provides an SEV that ranges from 7.0 to 8.5 to the sweetener composition. In yet other embodiments, the REB-BD glycoside blend provides an SEV that ranges from 7.0 to 8.0 to the sweetener composition. In yet other embodiments, the REB-BD glycoside blend provides an SEV that ranges from 7.5 to 8.0 to the sweetener composition. [0027] In other embodiments, the sweetener compositions include a REB-BD glycoside blend wherein the REB-BD glycoside blend comprises from 60% to 85% rebaudioside B and from 15% to 40% rebaudioside D (of the total rebaudioside B and rebaudioside D in the glycoside blend), and wherein the REB-BD glycoside blend provides an SEV of greater than 3.6 in the sweetener composition. In yet other embodiments, the sweetener compositions include a REB-BD glycoside blend wherein the REB-BD glycoside blend comprises from 63% to 80% rebaudioside B and from 20% to 37% rebaudioside D (of the total rebaudioside B and rebaudioside D in the glycoside blend), and wherein the REB-BD glycoside blend provides an SEV of greater than 3.6 in the sweetener composition. In some of these embodiments, the REB-BD glycoside blend provides an SEV of greater than 4.5, 5.0, 6.5, 6.9, 7.2, 7.4, or 7.7 in the sweetener composition. In other embodiments, the REB-BD glycoside blend provides an SEV that ranges from 4.0 to 9.0 to the sweetener composition. In yet other embodiments, the REB-BD glycoside blend provides an SEV that ranges from 6.0 to 8.5 to the sweetener composition. In yet other embodiments, the REB-BD glycoside blend provides an SEV that ranges from 7.0 to 8.0 to the sweetener composition. In yet other embodiments, the REB-BD glycoside blend provides an SEV that ranges from 7.5 to 8.0 to the sweetener composition. [0028] The combination of rebaudioside B and rebaudioside D in REB-BD glycoside blends will make up relatively substantial percentage of the total of all glycosides in the blends. The remaining portion of these REB-BD glycoside blends can be made up of various concentrations of the remaining glycosides which may be obtained from the Stevia plant (rebaudiosides A, C, E, and F, stevioside, dulcoside, etc). [0029] In some embodiments, the combination of rebaudioside B and rebaudioside D makes up at least 30% of the REB-BD glycoside blend. In other embodiments, the combination of rebaudioside B and rebaudioside D makes up at least 40% of the REB-BD glycoside blend. In yet other embodiments, the combination of rebaudioside B and rebaudioside D makes up at least 50% of the REB-BD glycoside blend. In yet other embodiments, the combination of rebaudioside B and rebaudioside D makes up at least 60% of the REB-BD glycoside blend. In yet other embodiments, the combination of rebaudioside B and rebaudioside D makes up at least 70% of the REB-BD glycoside blend. In yet other embodiments, the combination of rebaudioside B and rebaudioside D makes up at least 80% of the REB-BD glycoside blend. In yet other embodiments, the combination of rebaudioside B and rebaudioside D makes up at least 90% of the REB-BD glycoside blend. [0030] In some particular embodiments, it may be desired that rebaudioside B and rebaudioside D make up even more of the total REB-BD glycoside blend. In some of these embodiments, the combination of rebaudioside B and rebaudioside D makes up at least 93% of the REB-BD glycoside blend. In other embodiments, the combination of rebaudioside B and rebaudioside D makes up at least 95% of the REB-BD glycoside blend. In yet other embodiments, the combination of rebaudioside B and rebaudioside D makes up at least 97% of the REB-BD glycoside blend. In yet other embodiments, the combination of rebaudioside B and rebaudioside D makes up at least 98% of the REB-BD glycoside blend. [0031] All of the sweetener compositions with REB-BD glycoside blends at the rebaudioside B and rebaudioside D ratios and SEV disclosed herein are also contemplated at the purity levels described herein. [0032] Without being bound by theory, applicants believe that, at particular SEV levels and ratios, a higher level of purity in the REB-BD blend could allow for improved sweetness synergism between rebaudioside B and rebaudioside D without substantial hindrance from the other glycosides. In some particularly preferred embodiments, the sweetener compositions include a REB-BD glycoside blend wherein the REB-BD glycoside blend comprises from 60% to 85% rebaudioside B and from 15% to 40% rebaudioside D (of the total rebaudioside B and rebaudioside D in the glycoside blend), wherein the REB-BD glycoside blend provides an SEV of greater than 3.6 in the sweetener composition, and wherein the combination of rebaudioside B and rebaudioside D makes up at least 70% of the REB-BD glycoside blend. In other particularly preferred embodiments, the sweetener compositions include a REB-BD glycoside blend wherein the REB-BD glycoside blend comprises from 63% to 80% rebaudioside B and from 20% to 37% rebaudioside D (of the total rebaudioside B and rebaudioside D in the glycoside blend), wherein the REB-BD glycoside blend provides an SEV of greater than 7.2 in the sweetener composition, and wherein the combination of rebaudioside B and rebaudioside D makes up at least 85% of the REB-BD glycoside blend. In other of these particularly preferred embodiments, the REB-BD glycoside blend provides an SEV of greater than 7.7 in the sweetener composition. [0033] REB-AD Glycoside Blends [0034] Applicants have discovered that certain blends of rebaudioside A and rebaudioside D surprisingly have higher sweetening ability than either pure rebaudioside A or pure rebaudioside D. In some embodiments, the sweetener compositions include a REB-AD glycoside blend wherein the REB-AD glycoside blend comprises from 30% to 60% rebaudioside A and from 40% to 70% rebaudioside D (of the total rebaudioside A and rebaudioside D in the glycoside blend). In other embodiments, the sweetener compositions include a REB-AD glycoside blend wherein the REB-AD glycoside blend comprises from 33% to 55% rebaudioside A and from 45% to 67% rebaudioside D (of the total rebaudioside A and rebaudioside D in the glycoside blend). [0035] In these embodiments, an even greater benefit is realized when the REB-AD glycoside blend provides particular levels of SEV in the sweetener composition. Thus, in some of these embodiments, the REB-AD glycoside blend provides an SEV of greater than 3.4, 5.0, 7.1, 7.4, or 7.8 in the sweetener composition. In other embodiments, the REB-AD glycoside blend provides an SEV that ranges from 3.5 to 9.0 to the sweetener composition. In yet other embodiments, the REB-AD glycoside blend provides an SEV that ranges from 6.0 to 8.5 to the sweetener composition. In yet other embodiments, the REB-AD glycoside blend provides an SEV that ranges from 7.0 to 8.5 to the sweetener composition. In yet other embodiments, the REB-AD glycoside blend provides an SEV that ranges from 7.5 to 8.1 to the sweetener composition. [0036] At these ratios of rebaudioside A and rebaudioside D, and when the REB-AD glycoside blend provides these levels of SEV in the sweetener composition, the REB-AD blend provides considerable benefits compared to pure rebaudioside A or pure rebaudioside D. Substantially less of the blend is needed to obtain the same sweetness level. In these embodiments, up to 25% less of the glycoside (or 100 ppm less) of the blend was needed to obtain the same sweetness as either pure rebaudioside A or rebaudioside D. Even more surprising was that not only was sweetening ability improved, but the blend was less bitter at the same sweetness level of the pure component. [0037] Thus, in some of the more preferred embodiments, the sweetener compositions include a REB-AD glycoside blend wherein the REB-AD glycoside blend comprises from 30% to 60% rebaudioside A and from 40% to 70% rebaudioside D (of the total rebaudioside A and rebaudioside D in the glycoside blend), and wherein the REB-AD glycoside blend provides an SEV of greater than 7.0 in the sweetener composition. In other of the more preferred embodiments, the sweetener compositions include a REB-AD glycoside blend wherein the REB-AD glycoside blend comprises from 30% to 60% rebaudioside A and from 40% to 70% rebaudioside D (of the total rebaudioside A and rebaudioside D in the glycoside blend), and wherein the REB-AD glycoside blend provides an SEV of greater than 7.8 in the sweetener composition. [0038] In other embodiments, the sweetener compositions include a REB-AD glycoside blend wherein the REB-AD glycoside blend comprises from 11% to 95% rebaudioside A and from 5% to 89% rebaudioside D (of the total rebaudioside A and rebaudioside D in the glycoside blend), and wherein the REB-AD glycoside blend provides an SEV of greater than 3.4 in the sweetener composition. In other embodiments, the REB-AD glycoside blend provides an SEV of greater than 4.0, 5.0, 6.0, or 7.0 in the sweetener composition. In yet other embodiments, the REB-AD glycoside blend provides an SEV that ranges from 3.5 to 9.0 to the sweetener composition. In yet other embodiments, the REB-AD glycoside blend provides an SEV that ranges from 5.0 to 8.5 to the sweetener composition. In yet other embodiments, the REB-AD glycoside blend provides an SEV that ranges from 6.0 to 8.5 to the sweetener composition. [0039] The combination of rebaudioside A and rebaudioside D in REB-AD glycoside blends will make up a considerable percentage of the total of all glycosides in the blends. The remaining portion of these REB-AD glycoside blends can be made up of various concentrations of the remaining glycosides which may be obtained from the Stevia plant (rebaudiosides B, C, E, and F, stevioside, dulcoside, rubusoside, etc). [0040] In some embodiments, the combination of rebaudioside A and rebaudioside D makes up at least 60% of the REB-AD glycoside blend. In other embodiments, the combination of rebaudioside A and rebaudioside D makes up at least 70% of the REB-AD glycoside blend. In yet other embodiments, the combination of rebaudioside A and rebaudioside D makes up at least 80% of the REB-AD glycoside blend. In yet other embodiments, the combination of rebaudioside A and rebaudioside D makes up at least 90% of the REB-AD glycoside blend. [0041] In some particular embodiments, it may be desired that rebaudioside A and rebaudioside D make up even more of the total REB-AD glycoside blend. In some of these embodiments, the combination of rebaudioside A and rebaudioside D makes up at least 93% of the REB-AD glycoside blend. In other embodiments, the combination of rebaudioside A and rebaudioside D makes up at least 95% of the REB-AD glycoside blend. In yet other embodiments, the combination of rebaudioside A and rebaudioside D makes up at least 97% of the REB-AD glycoside blend. In yet other embodiments, the combination of rebaudioside A and rebaudioside D makes up at least 98% of the REB-AD glycoside blend. [0042] All of the sweetener compositions with REB-AD glycoside blends at the rebaudioside A and rebaudioside D ratios and SEV disclosed herein are also contemplated at the purity levels described herein. [0043] Without being bound by theory, applicants believe that, at particular SEV levels and ratios, a higher level of purity in the REB-AD blend could allow for improved sweetness synergism between rebaudioside A and rebaudioside D without substantial hindrance from the other glycosides. Additionally, higher purity at certain ratios may allow for reduction in bitterness in addition to increased sweetening ability. [0044] In some particular embodiments, the sweetener compositions include a REB-AD glycoside blend wherein the REB-AD glycoside blend comprises from 30% to 60% rebaudioside A and from 40% to 70% rebaudioside D (of the total rebaudioside A and rebaudioside D in the glycoside blend), wherein the REB-AD glycoside blend provides an SEV of greater than 3.4 in the sweetener composition, and wherein the combination of rebaudioside A and rebaudioside D makes up at least 80% of the REB-AD glycoside blend. In other particular embodiments, the sweetener compositions include a REB-AD glycoside blend wherein the REB-AD glycoside blend comprises from 30% to 60% rebaudioside A and from 40% to 70% rebaudioside D (of the total rebaudioside A and rebaudioside D in the glycoside blend), wherein the REB-AD glycoside blend provides an SEV of greater than 7.0 in the sweetener composition, and wherein the combination of rebaudioside A and rebaudioside D makes up at least 85% of the REB-AD glycoside blend. In yet other particular embodiments, the sweetener compositions include a REB-AD glycoside blend wherein the REB-AD glycoside blend comprises from 33% to 55% rebaudioside A and from 45% to 67% rebaudioside D (of the total rebaudioside A and rebaudioside D in the glycoside blend), wherein the REB-AD glycoside blend provides an SEV of greater than 7.8 in the sweetener composition, and wherein the combination of rebaudioside A and rebaudioside D makes up at least 90% of the REB-AD glycoside blend. [0045] REB-AB Glycoside Blends [0046] Applicants have surprisingly discovered that at certain SEV levels, certain blends of rebaudioside A and rebaudioside B surprisingly have higher sweetening ability than either pure rebaudioside A or pure rebaudioside B. [0047] In some embodiments, the sweetener compositions include a REB-AB glycoside blend wherein the REB-AB glycoside blend comprises from 40% to 85% rebaudioside A and from 15% to 60% rebaudioside B (of the total rebaudioside A and rebaudioside B in the glycoside blend), and wherein the REB-AB glycoside blend provides an SEV of greater than 3.6 in the sweetener composition. In other embodiments, the sweetener compositions include a REB-AB glycoside blend wherein the REB-AB glycoside blend comprises from 42% to 82% rebaudioside A and from 18% to 58% rebaudioside B (of the total rebaudioside A and rebaudioside B in the glycoside blend), and wherein the REB-AB glycoside blend provides an SEV of greater than 3.6 in the sweetener composition. [0048] In other embodiments, the REB-AB glycoside blend provides an SEV of greater than 4.0, 5.0, 6.5, or 7.2 in the sweetener composition. In yet other embodiments, the REB-AB glycoside blend provides an SEV that ranges from 3.7 to 9.0 to the sweetener composition. In yet other embodiments, the REB-AB glycoside blend provides an SEV that ranges from 6.0 to 8.5 to the sweetener composition. In yet other embodiments, the REB-AB glycoside blend provides an SEV that ranges from 7.3 to 8.0 to the sweetener composition. [0049] The combination of rebaudioside A and rebaudioside 13 in REB-AB glycoside blends will make up considerable percentage of the total of all glycosides in the blends. The remaining portion of these REB-AB glycoside blends can be made up of various concentrations of the remaining glycosides which may be obtained from the Stevia plant (rebaudiosides C, D, E, and F, stevioside, dulcoside, rubusoside, etc). [0050] In some embodiments, the combination of rebaudioside A and rebaudioside B makes up at least 60% of the REB-AB glycoside blend. In other embodiments, the combination of rebaudioside A and rebaudioside B makes up at least 70% of the REB-AB glycoside blend. In yet other embodiments, the combination of rebaudioside A and rebaudioside B makes up at least 80% of the REB-AB glycoside blend. In yet other embodiments, the combination of rebaudioside A and rebaudioside B makes up at least 90% of the REB-AB glycoside blend. [0051] In some particular embodiments, it may be desired that rebaudioside A and rebaudioside B make up even more of the total REB-AB glycoside blend. In some of these embodiments, the combination of rebaudioside A and rebaudioside B makes up at least 93% of the REB-AB glycoside blend. In other embodiments, the combination of rebaudioside A and rebaudioside B makes up at least 95% of the REB-AB glycoside blend. In yet other embodiments, the combination of rebaudioside A and rebaudioside B makes up at least 97% of the REB-AB glycoside blend. In yet other embodiments, the combination of rebaudioside A and rebaudioside B makes up at least 98% of the REB-AB glycoside blend. [0052] All of the sweetener compositions with REB-AB glycoside blends at the rebaudioside A and rebaudioside B ratios and SEV values disclosed herein are also contemplated at the purity levels described herein. [0053] Without being bound by theory, applicants believe that, at particular SEV levels and ratios, a higher level of purity in the REB-AB blend could allow for improved sweetness synergism between rebaudioside A and rebaudioside B without substantial hindrance from the other glycosides. [0054] In some particularly preferred embodiments, the sweetener compositions include a REB-AB glycoside blend wherein the REB-AB glycoside blend comprises from 40% to 85% rebaudioside A and from 15% to 60% rebaudioside B (of the total rebaudioside A and rebaudioside B in the glycoside blend), wherein the REB-AB glycoside blend provides an SEV of greater than 7.0 in the sweetener composition, and wherein the combination of rebaudioside A and rebaudioside B makes up at least 80% of the REB-AB glycoside blend. In other particularly preferred embodiments, the sweetener compositions include a REB-AB glycoside blend wherein the REB-AB glycoside blend comprises from 42% to 82% rebaudioside A and from 18% to 58% rebaudioside B (of the total rebaudioside B and rebaudioside D in the glycoside blend), wherein the REB-AB glycoside blend provides an SEV of greater than 7.2 in the sweetener composition, and wherein the combination of rebaudioside A and rebaudioside B makes up at least 90% of the REB-AB glycoside blend. [0055] REB-ABD Glycoside Blends [0056] Certain ternary blends of rebaudioside A, rebaudioside B, and rebaudioside D, at certain SEV levels, were surprisingly found to have improved sweetening ability compared to pure rebaudioside A, rebaudioside B, or rebaudioside D. [0057] In some embodiments, the sweetener compositions include a REB-ABD glycoside blend wherein the REB-ABD glycoside blend comprises from 10% to 55% rebaudioside A, from 30% to 75% rebaudioside B, and from 10% to 30% rebaudioside D (of the total rebaudioside A, rebaudioside B, and rebaudioside D in the glycoside blend), and wherein the REB-ABD glycoside blend provides an SEV of greater than 3.9 in the sweetener composition. In other embodiments, the sweetener compositions include a REB-ABD glycoside blend wherein the REB-ABD glycoside blend comprises from 15% to 52% rebaudioside A, from 32% to 71% rebaudioside B, and from 14% to 25% rebaudioside D (of the total rebaudioside A, rebaudioside B, and rebaudioside D in the glycoside blend), and wherein the REB-ABD glycoside blend provides an SEV of greater than 3.9 in the sweetener composition. [0058] In other embodiments, the REB-ABD glycoside blend provides an SEV of greater than 5.0, 6.0, 7.0, or 7.2 in the sweetener composition. In yet other embodiments, the REB-ABD glycoside blend provides an SEV that ranges from 6.0 to 9.0 to the sweetener composition. In yet other embodiments, the REB-ABD glycoside blend provides an SEV that ranges from 7.0 to 8.5 to the sweetener composition. In yet other embodiments, the REB-ABD glycoside blend provides an SEV that ranges from 7.6 to 8.0 to the sweetener composition. [0059] The combination of rebaudioside A, rebaudioside B, and rebaudioside D in REB-ABD glycoside blends will make up considerable percentage of the total of all glycosides in the blends. The remaining portion of these REB-ABD glycoside blends can be made up of various concentrations of the remaining glycosides which may be obtained from the Stevia plant (rebaudiosides C, E, and F, stevioside, dulcoside, etc). [0060] In some embodiments, the combination of rebaudioside A, rebaudioside B, and rebaudioside D makes up at least 70% of the REB-ABD glycoside blend. In other embodiments, the combination of rebaudioside A, rebaudioside B, and rebaudioside D makes up at least 80% of the REB-ABD glycoside blend. In yet other embodiments, the combination of rebaudioside A, rebaudioside B, and rebaudioside D makes up at least 90% of the REB-ABD glycoside blend. [0061] In some particular embodiments, it may be desired that rebaudioside A, rebaudioside B, and rebaudioside D make up even more of the total REB-ABD glycoside blend. In some of these embodiments, the combination of rebaudioside A, rebaudioside B, and rebaudioside D makes up at least 93% of the REB-ABD glycoside blend. In other embodiments, the combination of rebaudioside A, rebaudioside B, and rebaudioside D makes up at least 95% of the REB-ABD glycoside blend. In yet other embodiments, the combination of rebaudioside A, rebaudioside B, and rebaudioside D makes up at least 97% of the REB-ABD glycoside blend. In yet other embodiments, the combination of rebaudioside A, rebaudioside B, and rebaudioside D makes up at least 98% of the REB-ABD glycoside blend. [0062] In some particularly preferred embodiments, the sweetener compositions include a REB-ABD glycoside blend wherein the REB-ABD glycoside blend comprises from 10% to 55% rebaudioside A, from 30% to 75% rebaudioside B, and from 10% to 30% rebaudioside D (of the total rebaudioside A, rebaudioside B, and rebaudioside D in the glycoside blend), and wherein the REB-ABD glycoside blend provides an SEV of greater than 6.0 in the sweetener composition, and wherein the combination of rebaudioside A, rebaudioside B, and rebaudioside D makes up at least 85% of the REB-ABD glycoside blend. In other particularly preferred embodiments, the sweetener compositions include a REB-ABD glycoside blend wherein the REB-ABD glycoside blend comprises from 15% to 52% rebaudioside A, from 32% to 71% rebaudioside B, and from 14% to 25% rebaudioside D (of the total rebaudioside A, rebaudioside B, and rebaudioside D in the glycoside blend), and wherein the REB-ABD glycoside blend provides an SEV of greater than 7.2 in the sweetener composition, and wherein the combination of rebaudioside A, rebaudioside B, and rebaudioside D makes up at least 90% of the REB-AB glycoside blend. Other Ingredients of the Sweetener Compositions [0063] The sweetener compositions of the present inventions including a particular glycoside blend can also include other ingredients. In some embodiments, the sweetener composition can further comprise one or more of a bulking agent, a high-intensity sweetener, a flavoring, an antioxidant, caffeine, other nutritive sweetener, salts, protein, or a sweetness enhancer. [0064] A bulking agent can include any compositions known in the art used to add bulk to high intensity sweeteners. A bulking agent may be chosen from a bulk sweetener, a lower glycemic carbohydrate, a fiber, a hydrocolloid, and combinations thereof. A bulk sweetener may be chosen from corn sweeteners, sucrose, dextrose, invert sugar, maltose, dextrin, maltodextrin, fructose, levulose, high fructose corn syrup, corn syrup solids, galactose, trehalose, isomaltulose, fructo-oligosaccharides, and combinations thereof. A lower glycemic carbohydrate may be chosen from fructo-oligosaccharide, galactooligosaccharide, isomaltooligosaccharide, oligodextran, D-tagatose, sorbitol, mannitol, xylitol, lactitol, erythritol, maltitol, other polyols, hydrogenated starch hydrolysates, isomalt, D-psicose, 1,5 anhydro D-fructose, and combinations thereof. [0065] A fiber may be chosen from polydextrose, resistant maltodextrin, resistant starch, inulin, soluble corn fiber, beta-glucan, psyllium, cellulose, hemicellulose, and combinations thereof. A hydrocolloid may be chosen from pectin (apple, beet, citrus), gum Arabic, guar gum, carboxymethylcellulose, nOSA (n-octenyl succinic anhydride), locust bean gum, cassia gum, xanthan gum, carrageenan, alginate, and combinations thereof. [0066] A high intensity sweetener may be chosen from sucralose, aspartame, saccharin, acesulfame K, alitame, thaumatin, dihydrochalcones, neotame, cyclamates, mogroside, glycyrrhizin, phyllodulcin, monellin, mabinlin, brazzein, circulin, pentadin, and combinations thereof. A flavoring may be chosen from a cola flavor, a citrus flavor, a root beer flavor, and combinations thereof. A sweetness enhancer may be chosen from curculin, miraculin, cynarin, chlorogenic acid, caffeic acid, strogins, arabinogalactan, maltol, dihyroxybenzoic acids, and combinations thereof. [0067] Other ingredients such as food starch, flours, protein isolates, protein concentrates, food fats and oils (such as cocoa butter), food extracts (such as malt extract), and juice concentrates may also be included in the sweetener compositions. [0068] In some particular embodiments, the sweetener composition comprising a glycoside blend can also include a lower glycemic carbohydrate. In certain preferred embodiments, the lower glycemic carbohydrate is erythritol or another polyol. In especially preferred embodiments, the sweetener composition includes a particular glycoside blend and erythritol. [0069] In other particular embodiments, the sweetener composition comprising a glycoside blend can also include a fiber. In certain preferred embodiments the fiber is polydextrose, resistant maltodextrin, or inulin. Food and Beverage Compositions [0070] The sweetener compositions of the present inventions can also be incorporated into food and beverage compositions. Thus, the present invention also contemplates food compositions and beverage compositions which include the sweetener compositions of the present invention. Methods of Producing Sweetener Compositions [0071] The present invention also contemplates methods for producing the sweetener compositions. Typical conventional Stevia based sweeteners include a glycoside blend which consists primarily of rebaudioside A (for example greater than 95% rebaudioside A, or greater than 97% rebaudioside A). [0072] The present invention contemplates adding rebaudioside B and or rebaudioside D to such conventional sweeteners. In some embodiments, rebaudioside B could be added to such sweeteners to achieve the desired rebaudioside A to rebaudioside B glycoside blend ratio. In other embodiments, rebaudioside D could be added to such sweeteners to achieve the desired rebaudioside A to rebaudioside D glycoside blend ratio. In yet other embodiments, rebaudioside B and rebaudioside D could be added to such sweeteners to achieve the desired rebaudioside A to rebaudioside B to rebaudioside D glycoside blend ratio. [0073] The present invention also contemplates controlled conversion between one glycoside and another glycoside to achieve the glycoside blends of the present invention. Thus, in one embodiment, a substantially pure rebaudioside A composition can be converted to particular REB-AB blend, REB-BD blend, or REB-ABD blend at the claimed ratios. EXAMPLE Example 1 Sensory Testing of Various Glycoside Blends [0074] A 20 person sensory panel was trained to scale sweetness and bitterness. Reference tasting standards were prepared by dissolving respective standard material (sucrose for sweetness and caffeine for bitterness) into reverse osmosis water according to the scale values shown in Table 1 below. [0000] TABLE 1 Reference Tasting Standards Concentration (g/kg) Sucrose Caffeine Scale (Sweetness) (Bitterness) 1 10 0.107 2 20 0.153 3 30 0.200 4 40 0.246 5 50 0.293 6 60 0.340 7 70 0.386 8 80 0.433 9 90 0.479 10 100 0.526 11 110 0.572 12 120 0.619 13 130 0.666 14 140 0.712 15 150 0.759 [0075] Pure rebaudioside A, rebaudioside B, and rebaudioside D were obtained. Rebaudioside A (99% purity) was obtained from ChromaDex®. Rebaudioside B (97.3% purity) was obtained from Cargill, Incorporated. Rebaudioside D (92.5% purity) was obtained from a commercial source. [0076] The trained sensory panel evaluated pure and blended solutions of rebaudioside A, rebaudioside B, and rebaudioside D at ratios and concentrations shown in the tables and in FIGS. 1-4 . Solutions were made in Evian® water. All solutions were heated to 47° C. for 10 minutes to ensure that all the glycoside material was completely dissolved. The solutions were allowed to cool to room temperature before serving to the panelists. Each solution was given a random 3-digit code and was served to the panelists in random order. Panelists dispensed 1 mL of each solution into their mouths from a pipette. The panelists were then asked to rate the “sweetness intensity” and “bitterness intensity” of the solutions and mark their responses on an un-anchored, 15 cm line ballot. The length of the line directly corresponded to the scale values (1-15) on which the participants were trained. [0077] In order to prepare the panelists' palates, a control solution of commercial rebiana (300 ppm) was the first sample each panelist tasted during a sitting. In between testing samples, the panelists cleansed their palates with water and apple slices. The panelists also waited 5 minutes between each sample. The panelists' responses were measured, compiled, and averaged for each sample. [0000] TABLE 2 Sweet and Bitter Response of the Pure Glycosides Reb A Reb B Reb D (ppm) (ppm) (ppm) Sweetness Bitterness 0 0 126 3.5 4.3 0 0 251 6.9 5.3 0 0 377 8.1 6.3 0 0 503 8.6 6.1 0 0 629 9.2 6.7 0 0 880 9.6 6.5 0 57 0 1.8 3.9 0 114 0 2.7 4.2 0 171 0 3.6 4.3 0 286 0 5.8 5.0 0 343 0 6.5 5.1 0 400 0 7.6 5.8 114 0 0 3.1 4.2 229 0 0 5.7 5.3 343 0 0 7.4 6.6 457 0 0 8.4 7.0 571 0 0 9.2 8.4 800 0 0 10.1 9.0 [0078] Table 2 describes the sweet and bitter responses of rebaudioside A, rebaudioside B, and rebaudioside D in pure form. The sweet and bitter responses of binary blends are shown in FIGS. 1-3 (REB-BD blends, REB-AD blends, and REB-AB blends respectively). FIG. 4 shows the results for ternary blends (REB-ABD blends). As described above, the samples were tasted by the panelists in random order. The results are being presented in table 2 and FIGS. 1-4 as a matter of convenience to more easily display and describe the results. [0079] The figures show the concentration of the blend tested (ppm) as well as the ratio of one glycoside to another in the blend as a percentage. Each blend's sweetness and bitterness was measured by the trained panel. The blend's sweetness is measured as SEV. [0080] Each blend was then compared to an isosweet concentration of the pure glycosides. This value represents the concentration of the pure glycoside needed to achieve the SEV value measured for the blend. Thus, if the value is greater than that of the blend, then a larger concentration of the pure glycoside would be needed to achieve the same sweetness as achieved by the blend (at the lower dosage). The tables also include an isosweet bitterness value for each pure glycoside. This value represents the intensity of bitterness measured for that concentration of pure glycoside. The concentration of the isosweet solution of rebaudioside A, rebaudioside B, or rebaudioside D and the bitterness of the isosweet solutions were calculated by a fit of the pure component sensory response (table 2) to standard psycho-sensory models. [0081] FIG. 1 represents data obtained for REB-BD blends. The 3 highest SEV values show a surprising sweetness synergy between rebaudoside B and rebaudioside D at these higher SEV levels. The same sweetness intensity was achieved in these 3 samples with a lower concentration of glycosides in the blend than with either pure rebaudioside B or pure rebaudioside D. [0082] FIG. 2 represents data obtained for REB-AD blends. Surprisingly, Certain intermediate ratios of rebaudioside A and rebaudioside D showed sweetness synergy across all SEV levels. Specifically, 33%/67%, 35%/65%, 55%/45%, and 56%/44% rebaudioside A/rebaudioside D blends all showed higher effective sweetening ability than either pure component rebaudioside A or rebaudioside D. Interestingly, at the lower SEV any adjustment outside of these narrow ranges did not yield these benefits. [0083] Blends with the five highest SEV values all showed higher effective sweetening ability than either pure rebaudioside A or rebaudioside D. More surprising was the magnitude of improvement for the two highest, and especially the two highest SEV values. At these highest SEV values, the concentration of pure component rebaudioside A or rebaudioside D needed to reach the blend sweetness was significantly greater. Utilization of these blends could significantly reduce the amount of glycoside needed to achieve a particular sweetness. [0084] Also very unexpected was the improvement in bitterness for the two highest SEV values. At 55%/45% and 33%/67% rebaudioside A/rebaudioside D at SEV of 8.0 and 8.1 respectively, a bitterness reduction was discovered. Thus, not only could significantly less glycoside be used, the glycoside blends would also be less bitter than their pure component counterparts. [0085] FIG. 3 represents the data obtained for REB-AB blends. Particular ratios of rebaudioside A to rebaudioside B at higher SEV levels show higher effective sweetening ability than either pure rebaudioside A or rebaudioside B. Specifically, 82%/18%, 61%/39%, and 42%/58% rebaudioside A/rebaudioside B all showed higher effective sweetening ability than either pure component rebaudioside A or rebaudioside B. Surprisingly, at similar high SEV levels, blends with less rebaudioside A and more rebaudioside B did not show the same beneficial effect. [0086] FIG. 4 shows data obtained for REB-ABD blends. Particular ratios of the three glycosides at higher SEV levels show higher effective sweetening ability than either pure rebaudioside A, rebaudioside B, or rebaudioside D. Specifically, 52%/32%/15%, 28%/46%/25%, and 15%/71%/14% rebaudioside A/rebaudioside B/rebaudioside D blends all showed higher effective sweetening ability than pure component rebaudioside A, rebaudioside B, and rebaudioside D. Surprisingly, blends at similar SEV with low levels of rebaudioside A or D (less than 10%) or lower levels of rebaudioside B (less than 25%) did not show such benefits.

Sweetener compositions comprising particular glycoside blends are described in this paper. The glycioside blends comprise rebaudioside A, rebaudioside B, and/or rebaudioside D in various proportions. The sweetener composition can also include one or more bulking agents or other ingredients. The sweetener compositions can be used in foods and beverages.

RELATED APPLICATION This patent application claims the benefit of co-pending U.S. Provisional Patent Application No. 61/484,239, filed on May 10, 2011, which is hereby incorporated by reference in its entirety. TECHNICAL FIELD The present inventive disclosure relates to an implantable medical lead for transmitting electrical pulses to excitable bodily tissue and/or signals detected at bodily tissue to a detection and evaluation unit, comprising a distal electrode or a distal sensor or actuator, a proximal electrode connector or sensor/actuator connector, and a lead pole which connects the electrode or the sensor/actuator to the electrode connector or sensor/actuator connector and extends in the lead body. These are electrode leads in particular, although they can also be connecting lines of sensor systems or measuring systems for intracorporeal use, for example. BACKGROUND Medical implants such as, for example, pacemakers and defibrillators often include an electrical connection to the inside of the patient's body. A connection of this type is generally used to measure electrical signals and/or stimulate cells of the body. This connection is usually an electrode lead of the type described above. Currently, electrical signals are transmitted between the implant and the electrode contacts (e.g., tip, rings, HV shock helixes, sensors, etc.) using materials having good electrical conductivity. If a system comprised of an implant and an electrode is exposed to strong interference fields (e.g., EMI, MRI), unwanted consequences can occur, especially a heating-up of parts of the system or electrical malfunctions (i.e., resets). The heating can result in damage to bodily tissue or organs if the heated parts have direct contact with such tissue. This is the case with the electrode tip, in particular. The unwanted malfunction is generally caused by the interaction of the field with the elongate lead structure of the electrode: The electrode functions as an antenna and receives energy from the surrounding fields. The antenna can dissipate this energy on the leads, which are used for therapeutic purposes, distally into the tissue via the electrode contacts (e.g., tip, ring, etc.), or proximally into the implant. Similar problems occur with other elongate conductive structures, the proximal end of which is not necessarily connected to an implant (i.e., catheters, temporary electrodes, etc.). Shielded electrodes are known. The shielding of the electrode mainly counteracts electrical fields that are coupled in from the outside. In addition, these shieldings provide only a particular shielding strength and are stable over the long term. A compromise must therefore be found between increasing the diameter of the electrode—which would have a corresponding effect on the costs and handling of the electrode—and a diminished shielding effect. Due to the high requirements on biocompatibility and biostability, materials that have proven useful in terms of the shielding effect thereof, e.g., soft magnetic nickel-iron alloys, cannot be used. To prevent interferences by magnetic alternating fields and, in particular, in magnetic resonance apparatuses (MRI), especially to limit the heating of the electrode tip in fields of this type, it was proposed in U.S. Publication No. 2008/0243218 to provide a protective conductor in an electrode lead that turns back on itself in the longitudinal direction. This “billabong” principle utilizes mutual inductances to diminish induced currents. In this case, however, the three-layered helical winding is likewise expected to increase the diameter of the electrode. The present inventive disclosure is directed toward overcoming one or more of the above-identified problems. SUMMARY A problem addressed by the present inventive disclosure is that of providing an improved implantable lead of the type described initially that has improved properties in strong external alternating magnetic fields and has a simple design, thereby enabling it to be produced at low cost. This problem is solved by an implantable lead having the features of the independent claim(s). Further advantageous developments of the present inventive disclosure are the subject matter of the dependent claims. The present invention is based on the idea of utilizing a plurality of separate, individually insulated conductors (especially those having a lead structure which is present per se) to implement the aforementioned billabong principle, instead of “folding” one continuous conductor. It is also based on the idea of electrically interconnecting the separate conductors at a point which then functions as a reversal point in the lead. It is understood that, to prevent irregular signal transmissions, at least one of the separate conductors is interrupted and/or must not be connected on at least one of the ends thereof. The arteries that remain when the billabong circuit is implemented have a damping effect, even without resistive contact, or they are still contacted in nodes, and extend in parallel with an open end and function as an energy sink (i.e., Lecher lead) due to mismatch. Without utilizing the billabong principle, the following variants also result: 1. Other conductors are connected in parallel, incrementally, with axial separation, to the continuous therapeutic conductor, and are open on the end thereof and axially reduce the wave impedance of the lead. 2. Other conductors are connected in parallel with the therapeutic conductor, which are shut off toward the electrode head. The wave impedance in the direction of the head is thereby increased. The energy that is coupled in is reflected. In expedient embodiments that are characterized largely by the technological details of the manufacture of diverse medical leads, the separate conductors are securely interconnected by a soldered connection, a welded connection, or a bonded connection using conductive adhesive. However, other connection methods are also contemplated. In another embodiment, which is also novel from a technological perspective, the separate conductors are securely interconnected by, for example, crimping, in particular, using a crimp clamp. In a suitable embodiment, the latter connection method is particularly technologically simple and therefore low-cost. The location of the connection point can be selected in a particularly flexible manner using a crimp connection, in particular, although a constant crimping process can be used. Supply leads can be produced, for instance, that can be adapted individually to the prevailing conditions and are thereby optimized in terms of the heating thereof, for example. The connection points designed in said manner are then protected using an insulating material in a suitable form. They can be bonded, cast, extruded, or enclosed. To link an additional functionality to the embodiments of the present invention, other embodiments are designed such that one or more electrical components, in particular, a resistor, a capacitor, an inductor, a filter component, an integrated circuit, a sensor component, or an actuator, are provided in the interchange point, or reversal point. One example of an actuator is an implantable drug pump which is controlled using the supply lead according to the present invention. Another example relates to mechanical devices on the electrode end for affixation of the electrode, which are operated via the cable. The fundamental electrical properties of the lead can therefore be optimized with respect to certain conditions of use, or the lead can improve the scope of functionality or the functioning of an electronic medical device attached thereto. In structural variants of the present invention, the lead pole comprises n≧2 separate and individually insulated conductors, of which two or more are electrically interconnected at each interchange point, or reversal point, such that the lead pole comprises one to (n−1) reversal points. This can be designed, in particular, such that the, or an, electrode pole comprises separate and individually insulated conductors which extend along the axis of the lead in parallel, or about the axis in the manner of a helix, wherein one or two reversal points are formed. The present invention can be used, for example, directly in the widespread multipolar electrode leads such that it comprises a plurality of lead poles, each of which has at least two separate and individually insulated conductors and at least one interchange point, or reversal point. In an embodiment that is adapted to common types of electrode leads, the separate conductors of the lead pole are elongated conductors that extend parallel to one another and are woven in the manner of a rope, in particular. An embodiment that is adapted to another common type of electrode lead is characterized in that the separate conductors of the, or a, lead pole are designed as conductor helixes which, in particular, are interwoven or are disposed coaxially to a longitudinal axis of the lead. In another embodiment, one of the separate conductors of the, or an, electrode pole is at a potential that is independent of electrode potentials and has a shielding effect, in particular. In addition to device-related aspects, the present invention also has manufacturing-related aspects which are expressed in a method having the features of the independent method claim(s). The present invention is characterized in that separate and individually insulated conductors, which are provided initially, are stripped locally and specifically, and are electrically interconnected at the stripped points to form interchange points, or reversal points, and the resulting lead poles are then embedded in the lead body. In a method-related embodiment, laser processing or resistance welding is used to destroy the insulation and electrically connect the separate conductors to form the interchange point, or reversal point. In an alternative embodiment that is technologically particularly simple and low-cost, crimping is used to destroy the insulation and electrically connect the conductors to form the reversal point, in particular, using a crimp clamp. Another embodiment is advantageous with respect to the aspect of technological simplicity and the use of established methods of plastics processing and, therefore, with respect to low costs, according to which the lead body is formed by coating the electrode pole, in particular, the integrated coating of a plurality of electrode poles, or extruding a plastic body around the electrode pole or electrode poles. Other aspects of embodiments of the present invention are the following, which are in no way meant to be limiting: 1. The reversal points are designed as electrical short-circuit points. 2. Depending on the electrode pole, at least four mutually electrically insulated conductors are disposed along the symmetry axis of the lead body, and which are arranged, for example, in the shape of an “x” or a star in the cross-sectional area thereof, each comprising at least one interchange point, or reversal point, along the lead body. 3. At least four individually insulated conductors, which extend helically about a core along the symmetry axis of the lead body, are provided for each electrode pole, and are arranged, for example, in the shape of an “x” or a star in the cross-sectional area thereof, each comprising at least 1 reversal point along the lead body, and two or more conductors are electrically connected in parallel. 4. At least four individually insulated conductors, which extend helically about a core along the symmetry axis of the lead body, are provided for each electrode pole, and are arranged, for example, in the shape of an “x” or a star in the cross-sectional area thereof, each comprising at least one interchange point, or reversal point, along the lead body and, in each case, one of the electrically insulated conductors lies on a potential that is independent of the electrode potential. 5. The two to nine conductors are combined in one conductor complex, and are insulated from each other. 6. The conductors in one conductor complex are twisted. 7. There is at least one interchange point or reversal point between at least two conductors in one conductor complex. 8. There is at least one change in position between at least two conductors in one conductor complex. 9. One electrical resistor is located at the reversal point, or the change in position point. 10. One electrical capacitor is located at the reversal point, or the change in position point. 11. One electrical inductor is located at the reversal point, or the change in position point. 12. One or more electromechanical elements (filters) are located at the reversal point, or the change in position point. 13. One or more electrical circuits are located at the reversal point, or the change in position point. 14. A combination of the aforementioned electrical elements is located at the reversal point, or the change in position point. 15. One or more sensors are located at the reversal point, or the change in position point. 16. At least two of the conductors in one conductor complex are partially exposed by a laser. 17. At least one of the conductors in one conductor complex is severed by a laser. 18. At least two of the conductors in one conductor complex are welded together by a laser. 19. At least two of the conductors in one conductor complex are welded together by a resistance welding device. 20. At least two of the conductors in one conductor complex are soldered together. 21. At least two of the conductors in one conductor complex are interconnected by a crimp clamp. 22. Reversal points and redirection points represent a lead principle. 23. The conductors in one conductor complex are twisted. 24. The conductor complex is guided parallel to the axis in the lead body. 25. The conductor complex is guided helically about the axis in the lead body. 26. The conductor complex extends in the lead body in a helical shape with varying slope (including the parallel course). 27. The conductor complex extends in the lead body in a helical shape with a reversal of the slope of the helix. 28. Another insulated conductor can extend in the core. In one form, said conductor can be equipped with a lumen. In another form, it can also be designed to be rotatable or displaceable in order to transfer forces or moments. In a further form, it can be designed as an optical fiber. Various other objects, aspects and advantages of the present inventive disclosure can be obtained from a study of the specification, the drawings, and the appended claims. DESCRIPTION OF DRAWINGS Advantages and useful features of the present inventive disclosure also result from the descriptive of embodiments and examples that follow, with reference to the Figures. They show: FIG. 1 shows a schematic representation of a conventional implantable electrode lead. FIG. 2 shows, in a perspective sectional view, an example of a highly developed electrode lead comprising a plurality of supply leads accommodated in one lead body. FIG. 3 shows, in a perspective sectional view, another highly developed electrode lead comprising a plurality of supply leads in a coaxial arrangement. FIGS. 4A-4C show schematic depictions of embodiments of the present invention, in partial perspective sectional views. FIG. 5 shows a perspective view of another embodiment of the present invention. FIG. 6 shows a perspective view of a variant of the embodiment shown in FIG. 4A . FIG. 7 shows a perspective view to illustrate the placement of the conductor complex—which is depicted in FIG. 6 —in a lead body. FIG. 8 shows a schematic depiction of a four-pole electrode lead in a first embodiment according to the present invention. FIG. 9 shows a schematic depiction of a four-pole electrode lead in a second embodiment according to the present invention. FIG. 10 shows a schematic depiction of a four-pole electrode lead in a third embodiment according to the present invention. FIGS. 11A-11B show schematic depictions of variant connections which can be implemented according to the present invention in a two-pole supply lead. FIGS. 12A-12B show schematic depictions of variant connections which can be implemented according to the present invention in a three-pole supply lead. FIG. 13 shows a schematic depiction of a variant connection which can be implemented according to the present invention in a four-pole supply lead. DETAILED DESCRIPTION In the description of the Figures that follow, similar reference numerals are used for identical or identically-acting parts or sections, and previous descriptions are not repeated for subsequent Figures provided they refer to such parts and no special circumstances exist. FIG. 1 is a schematic depiction of a bipolar electrode lead 1 , on the distal end of which a tip electrode 3 a and a ring electrode 3 b are disposed. Two corresponding electrode contacts 5 a and 5 b are provided on the proximal end thereof, being connected to the respective associated electrode by a first and a second supply lead 7 a and 7 b . The electrodes, electrode contacts, and supply leads are accommodated on or in a lead body 9 , which typically comprises multiple layers. FIG. 2 shows, in a perspective sectional view having various cutting planes, a modern electrode lead 201 , in the case of which three lumina 208 a having a smaller diameter and an additional lumen 208 b having a larger diameter are provided in an inner tube 209 a which is the core of a supply lead body 209 . Each of the smaller lumina 208 a contains an electrode supply lead 207 a having a rope structure which is provided with an insulating jacket comprised of, e.g., PTFE, ETFE or PI, and which is not labeled separately. A supply lead coil 207 b , which can accommodate a guide wire during implantation to reinforce the electrode lead, extends in the larger lumen 208 b . To improve the sliding and wear properties of lead body 209 , it is provided with an outer shell 209 b which positively influences these properties. FIG. 3 shows a further embodiment of an implantable electrode lead, in the case of which an inner coil 307 a , which comprises a plurality of wound individual wires, is disposed, as the first electrode supply lead (or the first group of electrode supply leads), coaxially to an outer coil 307 b , which likewise comprises a plurality of wound individual wires (and which can likewise form a group of electrode supply leads). A silicone tube 309 a is provided between the inner coil and the outer coil, and the outer coil is enclosed by a further insulating tube 309 b which can likewise be comprised of silicone or a polyurethane or a copolymer, for example. A combination of a plurality of tubes can also be used here. FIG. 4A shows a supply lead 407 which can be embedded in a lead body (not shown), and can then be a component of an electrode lead. Supply lead 407 has a four-pole design and therefore comprises four separate strands or conductors 411 which are embedded in a plastic supply lead body 410 and are woven in the manner of a rope. As shown in FIG. 4A , two of the strands or conductors 411 have been severed along the course of the lead, and two ends which have been exposed as a result are interconnected in a conductive manner at a connection point 412 by, for example, welding, soldering, or conductive bonding. If an electrical signal is applied from one end of supply lead 407 into one of the two interconnected conductors 411 , and a corresponding signal is tapped at the other of the two interconnected conductors, then connection point 412 functions as a reversal point of a continuous lead course created by the electrical connection of the two conductors. Said reversal point makes it possible to achieve an effect which corresponds to the billabong principle and is based on the mutual inductance of conductor sections through which current flows in opposite directions, and which can be used to reduce the influence of external magnetic fields on the electrode lead structure. FIG. 4B shows another supply lead 407 ′ which is a modified embodiment of the supply lead which is shown in FIG. 4A and is described above. In this case as well, at least two of the strands or conductors 411 extending in supply lead body 410 have been severed along the course of the particular lead, and have been electrically interconnected at a connection point (reversal point) 412 ′. In this case, however, an electrical or electronic component 413 is incorporated in said electrical connection, and can be an ohmic resistor, an inductor, a capacitor, or a filter element, for instance. It is also possible to provide a sensor component at the reversal point, which may be advantageous in terms of special functions of devices that are connected via the electrode lead. FIG. 4C shows, as another variant, a supply lead 407 ″, in which two strands or conductors 411 have been severed along the course of the particular lead, and have been electrically interconnected at a connection point 412 ″. In this case, however, the connection point is not a reversal point, but rather results in a change of position in the course of the lead (the beginning of the lead compared to the end of the lead). The change of position changes the distance between the conductors and therefore adjusts the wave impedances that result in mismatches that convert the energy in the line instead of carrying it to the tip. According to the concept of the present invention, this distance can be adjusted very easily using design measures and can even be varied since conductors having different distances can be selected in one conductor bundle. It therefore determines the extent of the coupling of conductors extending in parallel, and therefore the effect of the damping. It is therefore possible to adjust the electrode to various requirements, such as, for example, 1.5-tesla or 3-tesla devices. FIG. 5 shows, using the example of a supply lead 507 of the type depicted in FIGS. 4A and 4B , a sketch of a possible embodiment of the simultaneous interruption of the course of the lead of two strands, or conductors, 511 and the mutual connection thereof at a reversal point. A crimp clamp 510 is used for this purpose, which is pressed over a portion of the circumference of supply lead 507 such that the lead interruption and mutual electrical connection of adjacent conductors 511 is brought about by the mechanical effect of clamp 514 which has a suitable geometric configuration around the inner circumference thereof. FIG. 6 shows, as another modification of the embodiment of the present invention depicted in FIG. 4A , a three-pole supply lead 607 having three strands, or conductors, 611 , two of which are electrically interconnected at a connection and reversal point 612 . An insulating encapsulation of reversal point 612 and the “blind” ends of severed adjacent conductor 611 opposite thereto is accomplished using an extruded insulating shell 615 which is shown only partially in the left part of FIG. 6 , but which extends along the entire length of finished supply lead. FIG. 7 shows how supply lead 711 , which is protected by extruded tube 615 and is finished, is placed in one of the smaller lumina 708 of an electrode lead body 709 of an electrode lead 701 . Different variants of electrode contacts 5 . 1 to 5 . 4 of a four-pole electrode lead 1 with electrodes 3 . 1 to 3 . 4 thereof disposed in the distal region are depicted schematically in FIGS. 8-10 . In the variant shown in FIG. 8 , each of the lead poles (which are not labeled separately) comprises two reversal points which are created according to the present invention by creating an electrical connection between adjacent strands or conductors extending in the lead body. In the embodiment shown in FIG. 9 , three of the electrode poles each comprises a reversal point in the course of the lead thereof, while the fourth (between electrode connector 5 . 4 and electrode 3 . 1 ) does not have a reversal point. The connection between electrode connectors and electrodes in the variant shown in FIG. 10 has a similar design; in that case the conductor sections between the reversal point and the particular electrode in the distal section of the electrode lead have the same length in the three lead poles provided with a reversal point. FIGS. 11A and 11B show schematic illustrations of variant connections having a two-pole line, in fact, with each being designed as a Lecher lead they are easily created using the design according to the present invention, and the effect of which in the MRT is damping due to mismatching. FIGS. 12A and 12B show two variants of the lead extension with a three-pole lead complex (of a supply lead) 1207 . All three separate conductors 1211 of supply lead 1207 or 1207 ′ are incorporated in a signal-carrying lead extension. The signal is applied in one end of the supply lead in the strand or conductor located at the top in the figures, and is tapped at the other end at the middle strand or conductor. Lead 1207 ′ shown in FIG. 12A comprises two reversal points 1212 along the lead extension thereof, which are located close to the ends of the strands or conductor, while in the embodiment depicted in FIG. 12B , a plurality of connection and reversal points 1212 ′ are created along the longitudinal extension of the conductor in each case, and the direction of current flow is reversed multiple times. Overall, the supply lead can perform the function of a conventional conductor rope. In variants of both embodiments, the lead lengths between the reversal points can be varied and, possibly, the reversal points can be placed at varying distances (in order to obtain conductor sections of unequal length and different directions of current flow). FIG. 13 is a schematic depiction of a current flow, which can be achieved in a four-pole supply lead (which is not depicted), in the case of which the four leads are used to obtain two electrical connections, and a plurality of reversal points are provided in each case. The four leads, which are used in pairs, can be used separately, e.g., for a supply lead and a terminal lead, or they can be connected in parallel. A special embodiment can comprise a twisting of the supply lead complex, and the supply lead can be installed in the electrode lead in a helical form. The embodiments of the present invention are not limited to the above-described examples and emphasized aspects but, rather, are possible in a large number of modifications that lie within the scope of handling by a person skilled in the art. It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teachings of the disclosure. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention, which is to be given the full breadth thereof. Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range.

An implantable medical lead for transmitting electrical pulses to excitable bodily tissue and/or signals detected at bodily tissue to a detection and evaluation unit, including a distal electrode or a distal sensor, or actuator; a proximal electrode connector or sensor/actuator connector; and a lead pole which connects the electrode or the sensor or actuator to the electrode connector or sensor/actuator connector and extends in the lead body, wherein the lead pole comprises at least two separate and individually insulated conductors which are electrically interconnected at least at one point which functions as an interchange point, or reversal point, in the lead extension from the proximal electrode or sensor connector to the distal electrode or the distal sensor, and wherein at least one of the separate conductors, in particular close to the reversal point, is interrupted at least once and/or is not connected at one end.

BACKGROUND OF THE INVENTION Field of the Invention [0001] The present invention relates to a control program, a control method, and a game device. Background Art [0002] A domination game in which a plurality of players respectively occupies a plurality of territories included in a game field and deprives a territory of other players is known. In such a domination game, a game in which a player correlates the owned point (which may be virtual currency and the like) or the owned character, with a territory, and the player competes with another player for the territory, in accordance with the amount of points or the strength of the character correlated with the territory may be performed. [0003] For example, JP-A-2014-73164 discloses a game program for realizing a domination game in which a competition may be executed between players who respectively own territories, and the territory owned by the player losing in the competition may be ceded to the player winning in the competition. SUMMARY OF THE INVENTION [0004] However, in the domination game of the related art, it may be determined whether or not the territory of a player can be acquired, based on the amount of owned points, the strength of the owned character of the player, and the like. Thus, it may not be possible for a player to progress the game by using a strategy. In addition, a player can easily predict a game result based on the amount of points owned by the player, the strength of the owned character of the player, and the like, which may reduce the will of the player to continuously play the game. [0005] To solve the above problem, according to an exemplary embodiment, a control program, a control method, and a game device which can realize a game which requires a strategy of a player, which can thereby improve the player's interest in the game may be provided. [0006] According to an exemplary embodiment, there may be provided a control program of a game device which includes a storage unit and progresses a game by using a game field including a plurality of game regions. The control program may cause the game device to execute: storing, in the storage unit, points which are respectively associated with a plurality of players; correlating at least a portion of the points associated with a first player with a game region designated by the first player among the plurality of game regions in accordance with a request of the first player, and designating these correlated points as region points of the first player; setting the game region correlated with the region points of the first player to be a corresponding region of the first player in a case where the region points of the first player are greater than the region points of a player different from the first player in the game region correlated with the region points of the first player; in a case where game regions (between the corresponding region of the first player, which is set, and another corresponding region of the first player, which has been previously set) are disposed in predetermined arrangement, and all of the game regions disposed in the predetermined arrangement are corresponding regions of a player different from the first player, extracting region points of the first player correlated with the game regions disposed in the predetermined arrangement, and region points of the player who has the game regions as the corresponding regions; and correlating the extracted region points of the player, as the region points of the first player, with the game regions disposed in the predetermined arrangement, and setting the game regions disposed in the predetermined arrangement, to be corresponding regions of the first player in a case where the region points of the first player are larger than the region points of the player, which have been correlated with the game regions, in the game regions disposed in the predetermined arrangement. [0007] In the control program according to an exemplary embodiment, the game device may cause the extracted region points of the first player to be correlated, as the region points of the player who has the game regions as the corresponding regions, with the game regions disposed in the predetermined arrangement. [0008] In the control program according to an exemplary embodiment, in a case where the first player designates a first specific region from the plurality of game regions when the region points are correlated in accordance with a request of the first player, a predetermined point value and the points correlated as the region points may be consumed from the points stored in the storage unit. [0009] In the control program according to an exemplary embodiment, the game field may include a restricted region of which designation by a player may not be possible, and the restricted region may be changed to a game region depending on the number of times region points are correlated according to the request of the first player. [0010] In the control program according to an exemplary embodiment, i the game device may be caused to execute a process which may include specifying color information associated with the first player in the corresponding region of the first player, changing brightness, chroma, or hue of the specified color information, based on both or any one of the region point of the first player and the region point of another player, which may be correlated with the corresponding region of the first player, and displaying the corresponding region of the first player with the changed color information. [0011] According to another exemplary embodiment, there may be provided a control program of a game device which may include a storage unit and may progress a game by using a game field including a plurality of game regions. The control program may cause the game device to execute: storing points which may be respectively associated with a plurality of players, in the storage unit; correlating at least a portion of the points associated with a first player, as region points of the first player, with a game region designated by the first player among the plurality of game regions in accordance with a request of the first player; setting the game region correlated with the region points of the first player to be a corresponding region of a first group, in a case where a summation value of region points of players included in the first group to which the first player belongs is larger than a summation value of region points of players included in a group different from the first group, in the game region correlated with the region point of the first player; in a case where game regions between the corresponding region of the first group which may be set, and another corresponding region of the first group, which has been previously set are disposed in a predetermined arrangement, and all of the game regions disposed in the predetermined arrangement may be corresponding regions of a second group different from the first group, extracting region points of the first group correlated with the game regions disposed in the predetermined arrangement, and region points of the second group who has the game regions as the corresponding regions; and correlating the extracted region points of the group, as the region points of the first group, with the game regions disposed in the predetermined arrangement, and setting the game regions disposed in the predetermined arrangement, to be corresponding regions of the first group in a case where the region points of the first group are larger than the region points of the second group, in the game regions disposed in the predetermined arrangement. [0012] In the control program according to another exemplary embodiment, the game device may be caused to execute a process which may include calculating a summation value of region points correlated by each player, for each of the players included in the first group, and storing a player reward depending on the calculated summation value, in the storage unit in association with each player; and storing a group reward depending on a summation value of region points of the first group, which may be correlated with corresponding regions of the first group, in the storage unit in association with each of the players included in the first group. [0013] According to still another exemplary embodiment, there may be provided a control method of a game device which may include a storage unit and may progress a game by using a game field including a plurality of game regions. The control method may include storing points which may be respectively associated with a plurality of players, in the storage unit; correlating at least a portion of the points associated with a first player, as region points of the first player, with a game region designated by the first player among the plurality of game regions in accordance with a request of the first player; setting the game region correlated with the region points of the first player to be a corresponding region of the first player in a case where the region points of the first player are larger than the region points of a player different from the first player in the game region correlated with the region points of the first player; in a case where game regions between the corresponding region of the first player which may be set, and another corresponding region of the first player, which has been previously set are disposed in predetermined arrangement, and all of the game regions disposed in the predetermined arrangement may be corresponding regions of a player different from the first player, extracting region points of the first player correlated with the game regions disposed in the predetermined arrangement, and region points of the player who has the game regions as the corresponding regions; and correlating the extracted region points of the player, as the region points of the first player, with the game regions disposed in the predetermined arrangement, and setting the game regions disposed in the predetermined arrangement, to be corresponding regions of the first player in a case where the region points of the first player may be larger than the region points of the player, which have been correlated with the game regions, in the game regions disposed in the predetermined arrangement. [0014] According to still another exemplary embodiment, there may be provided a game device which may progress a game by using a game field including a plurality of game regions. The game device may include a storage unit that stores points which may be respectively associated with a plurality of players; a correlation unit that correlates (i.e. links/associates/stores) at least a portion of the points associated with a first player, as region points of the first player, with a game region designated by the first player among the plurality of game regions in accordance with a request of the first player; and a setting unit that sets the game region correlated with the region points of the first player, to be a corresponding region of the first player in a case where the region point of the first player is larger than a region point of a player different from the first player in the game region correlated with the region point of the first player. In a case where game regions between the corresponding region of the first player which may be set, and another corresponding region of the first player, which has been previously set may be disposed in predetermined arrangement, and all of the game region disposed in the predetermined arrangement may be corresponding regions of a player different from the first player, the correlation unit may extract region points of the first player correlated with the game regions disposed in the predetermined arrangement, and region points of the player who has the game regions as the corresponding regions, and may correlate the extracted region points of the player, as the region points of the first player, with the game regions disposed in the predetermined arrangement. The setting unit may set the game regions disposed in the predetermined arrangement, to be corresponding regions of the first player in a case where the region points of the first player may be larger than the region points of the player, which have been correlated with the game regions, in the game regions disposed in the predetermined arrangement. [0015] According to the control program, the control method, and the game device of the invention, it may be possible to realize a game requiring the player to exercise a strategy, which may thus improve the player's interest in the game. BRIEF DESCRIPTION OF THE DRAWINGS [0016] FIGS. 1A and 1B are diagrams illustrating an example of a game provided by a game device. [0017] FIG. 2 is a diagram illustrating another example of the game provided by the game device. [0018] FIG. 3 is a diagram illustrating an example of a schematic configuration of a game system. [0019] FIG. 4 is a diagram illustrating an example of a schematic configuration of a portable terminal. [0020] FIGS. 5A and 5B are diagrams illustrating an example of a game screen displayed by the portable terminal. [0021] FIGS. 6A and 6B are diagrams illustrating another example of the game screen displayed by the portable terminal. [0022] FIGS. 7A and 7B are diagrams illustrating an example of a game screen displayed by the portable terminal. [0023] FIGS. 8A and 8B are diagrams illustrating an example of a game screen displayed by the portable terminal. [0024] FIGS. 9A and 9B are diagrams illustrating still another example of the game screen displayed by the portable terminal. [0025] FIG. 10 is a schematic diagram illustrating an example of setting a corresponding region. [0026] FIG. 11 is a schematic diagram illustrating the example of setting the corresponding region. [0027] FIG. 12 is a schematic diagram illustrating the example of setting the corresponding region. [0028] FIG. 13 is a schematic diagram illustrating an example of region-point changing processing. [0029] FIG. 14 is a schematic diagram illustrating the example of the region-point changing processing. [0030] FIG. 15 is a schematic diagram illustrating the example of the region-point changing processing. [0031] FIG. 16 is a schematic diagram illustrating the example of the region-point changing processing. [0032] FIG. 17 is a diagram illustrating an example of a schematic configuration of a server. [0033] FIGS. 18A and 18B are diagrams illustrating an example of data structures of various tables. [0034] FIGS. 19A and 19B are diagrams illustrating an example of data structures of various tables. [0035] FIG. 20 is a diagram illustrating an example of an operation sequence of the game system. [0036] FIG. 21 is a diagram illustrating an example of an operation flow of game progress processing. [0037] FIGS. 22A and 22B are schematic diagrams illustrating an example of a game field. [0038] FIG. 23 is a diagram illustrating another example of the operation sequence of the game system. DETAILED DESCRIPTION OF THE INVENTION [0039] Hereinafter, various exemplary embodiments will be described with reference to the drawings. It may not beed that the technical range of the present invention may not be limited to the exemplary embodiments described herein, and the exemplary embodiments described in claims and equivalents thereof may be included. [0040] Outline of Game [0041] FIGS. 1A to 2 may be diagrams illustrating an example of a game that may be provided by a game device. An example of a game provided by a game device according to an embodiment will be described below with reference to FIGS. 1A to 2 . [0042] In an exemplary embodiment, a player may progress a game in which a game region may be correlated with a player, by operating the game device that displays a game field including a plurality of game regions on a display screen, so as to designate the game region. The game region may be a predetermined closed region which may be displayed on the display screen and may be designated by an input of a player. A game object, such as a panel, a card, or a character, may be used instead of the game region. The game field may be a game space which may be displayed on the display screen and may be used for disposing a plurality of game regions. As an example, a domination game in which a plurality of players (player A, player B, and player C) participate, which may be a game progressed by the game device, will be described below. [0043] As illustrated in FIGS. 1A to 2 , a game field F including a plurality of game regions R may be displayed on the display screen of the game device, and the game device may cause the domination game using the displayed game field F to progress. Each of the plurality of players participating in the domination game may have a number of owned points. The owned points correspond to numerical information of virtual currency, game execution points, and the like. In a case where a predetermined condition may be satisfied in the game, the owned points may be stored by the game device, associated with the player. For example, in a case where it is determined that the game may be started, in a case where it is determined that a predetermined period elapses from the start of the game, or in a case where a progress state of the game coincides with a specific situation, the owned points may be stored in association with the player. The case where a progress state of the game coincides with a specific situation refers to a case where a specific game region R may be set as a corresponding region of a player, which will be described later, a case where the number of corresponding regions of a player reaches a predetermined value, a case where the number of times of a game region R being designated by a player reaches a predetermined value, or the like. In this case, region points of a player and/or points of a value corresponding to the region points of another player in the corresponding region may be given to the player as owned points. [0044] Each of the plurality of players participating in the domination game may designate a game region R included in the displayed game field F, in a predetermined order. The predetermined order may be referred to as an input operation order below. A player who performs an input operation in the input operation order may be an example of a first player. The game device may receive a request of a player, which may include information indicating a game region R which has been designated by the player. The game device may correlate a portion of the owned points associated with the player, with the game region R designated by the player, in accordance with the received request of the player. The owned points of one or each of the plurality of players who respectively designate game regions R may be associated with the corresponding game region R. The owned points correlated with the game region R may be referred to as region points below. [0045] In a case where the region points may be correlated with the game region R by the request of the player, the game device may determine whether or not the region points of the player, which may be correlated with the game region R may be larger than the region points of another player, which may be correlated with the game region R. In a case where the game device determines that the region points of the player, which may be correlated with the game region Rare larger than the region points of another player, which may be correlated with the game region R, the game device may set the game region R to be a corresponding region of the player. In this manner, the game device sets each of the plurality of game regions R to be a corresponding region of the player which may be correlated with the largest value of region points among region points correlated with the game region R. [0046] In the example of the game field F illustrated in FIG. 1A , 30 points, 20 points, and 10 points may be correlated with a game region Ra 1 , as the region points of a first player, player A, a second player, player B, and a third player, player C, respectively. 20 points, 30 points, and 10 points may be correlated with a game region Rb 1 , as the region points of player A, player B, and player C, respectively. 20 points, 10 points, and 30 points may be correlated with a game region Rc 1 , as the region points of player A, player B, and player C, respectively. [0047] Players correlated with the region point having the largest value among the region points which may be respectively correlated with the game region Ra 1 , the game region Rb 1 , and the game region Rc 1 may be player A, player B, and player C. Thus, the game region Ra 1 may be set as the corresponding region of player A, the game region Rb 1 may be set as the corresponding region of player B, and the game region Rc 1 may be set as the corresponding region of player C. [0048] FIG. 1B illustrates a case where 100 points of the owned points of player A may be correlated with a game region Ra 2 , as region points. The game region Ra 2 has not been designated by player A, player B, and player C before. Thus, before player A correlates the region points of 100 points with the game region Ra 2 , 0 points have been correlated with the game region Ra 2 , as the region points of player A, player B, and player C, respectively. However, at this time, the region point of 100 points may be correlated with game region Ra 2 by player A. Thus, the game region Ra 2 may be set as the corresponding region of player A, who correlates the region point having the largest value with the game region Ra 2 . [0049] An example of region points changing processing executed by the game device in a case where the game region Ra 2 may be set as the corresponding region of player A will be described below. [0050] Firstly, the game device may specify the corresponding region Ra 1 of player A, which has been previously set and may be different from the corresponding region Ra 2 of player A, which may be set this time. Then, the game device may determine whether or not one or a plurality of game regions R (in FIG. 1B , Rb 1 and Rc 1 ) between the corresponding region Ra 2 of player A which may be set, and the specified corresponding region Ra 1 of player A may be disposed in a predetermined arrangement. The predetermined arrangement may be an arrangement of game regions R on a predetermined line which has end points in the corresponding region Ra 2 of player A, which may be set this time, and in the corresponding region Ra 1 of player A, which has been previously set. The predetermined line may have a shape of a straight line, a polygonal line, a curved line, or the like. [0051] In a case where the game device determines that the game regions Rb 1 and Rc 1 are disposed in the predetermined arrangement, the game device may determine whether or not all of the determined game regions Rb 1 and Rc 1 maybe corresponding regions of another player who may be different from player A. Then, in a case where the game device determines that all of the game regions Rb 1 and Rc 1 are the corresponding regions of the other player, the game device may extract region points of player A correlated with the game regions Rb 1 and Rc 1 , and region points of the other player who has the game regions Rb 1 and Rc 1 as the corresponding regions. [0052] In the example of the game field F illustrated in FIG. 2 , the region points (20 points) of player A, which may be correlated with the game region Rb 1 , and the region points (30 points) of player B who has the game region Rb 1 as the corresponding region may be extracted. The region points (20 points) of player A, which may be correlated with the game region Rc 1 , and the region points (30 points) of player C who has the game region Rc 1 as the corresponding region may be extracted. [0053] Regarding the game region Rb 1 , the game device may replaces the extracted region points of player A with the extracted region points of player B, and correlates the replaced region points with the game region Rb 1 . That is, regarding the game region Rb 1 , the game device correlates the extracted region points (30 points) of player B, with the game region Rb 1 , as the region points of player A. In addition, regarding the game region Rb 1 , the game device correlates the extracted region points (20 points) of player A with the game region Rb 1 , as the region points of player B. [0054] Similarly, regarding the game region Rc 1 , the game device replaces the extracted region points of player A with the extracted region points of player C, and correlates the replaced region points with the game region Rc 1 . That is, regarding the game region Rc 1 , the game device correlates the extracted region points (30 points) of player C, with the game region Rc 1 , as the region points of player A. In addition, regarding the game region Rc 1 , the game device correlates the extracted region points (20 points) of player A with the game region Rc 1 , as the region points of player C. [0055] According to an exemplary embodiment, the region points of player A may thus become larger than the region points of another player, in the game region R having the changed region point values, and as such the game device may set the game region R as the corresponding region of player A. In the example of the game field F illustrated in FIG. 2 , the region points (30 points) of player A, which may be correlated with the game region Rb 1 may be larger than the region points of player B and player C, which may be correlated with the game region Rb 1 . Thus, the game device sets the game region Rb 1 as the corresponding region of player A. The region points (30 points) of player A, which may be correlated with the game region Rc 1 may be larger than the region points of player B and player C, which may be correlated with the game region Rc 1 . Thus, the game device may set the game region Rc 1 as the corresponding region of player A. A game region R (in the example illustrated in FIG. 2 , game regions Rb 1 and Rc 1 ) as a target of the region-point changing processing may be referred to as a point-change target region below. [0056] Hitherto, the descriptions may be made with reference to FIGS. 1A to 2 . In the above-described game device and a control method of the game device, the region-point changing processing may be performed in the domination game. Thus, a player can receive the region points of another player, which may be correlated with a game region R, as the region points of the player, without an operation of designating the game region R. In this manner, it may be possible to realize a domination game requiring a strategy of a player, which may therefore improve the interest in the game by the game device performing the region-point changing processing, and by the control method of the game device. A player who has the largest total amount of the region points when the game may be ended, or has the largest number of corresponding regions may be determined to be the winning player. [0057] The above descriptions of FIGS. 1A to 2 may be just descriptions for better understanding the details of the present invention. The present invention may be implemented in embodiments which will be described below, and may be implemented in various modification examples in a range without departing from the gist of the present invention. All of such modification examples may be included in the disclosure scope of the present invention and this specification. [0058] Configuration of Game System 1 [0059] FIG. 3 may be a diagram illustrating an example of a schematic configuration of the game system 1 . [0060] The game system 1 may include a server 3 and a plurality of portable terminals 2 which may be respectively operated by a plurality of players. The portable terminal 2 and the server 3 may be connected to each other through, for example, a communication network such as a base station 4 , mobile communication network 5 , a gateway 6 , and the Internet 7 . A program (for example, a display processing program) executed in the portable terminal 2 and a program (for example, a region-point changing processing program) executed in the server 3 may communicate with each other by using a communication protocol such as the Hypertext Transfer Protocol (HTTP). The server 3 may be an example of the game device. The game device may not be limited to the server 3 . A portable terminal 2 which has some or all of functions of the server 3 , which will be described later may be used as the game device. The game system 1 including the portable terminal 2 and the server 3 may be used as the game device. [0061] A multi-function portable phone (so-called a “smart phone”) may be used as the portable terminal 2 , but the present invention may not be limited thereto. As the portable terminal 2 , any device may be provided as long as the present invention can be applied. For example, an information processing device such as a portable phone (a so-called “feature phone”), a portable information terminal (personal digital assistant, PDA), a portable game machine, a portable audio player, a tablet terminal, a tablet PC, and a notebook PC may be provided. [0062] Configuration of Portable Terminal 2 [0063] FIG. 4 may be a diagram illustrating an example of a schematic configuration of the portable terminal 2 . [0064] The portable terminal 2 may execute a game such as the domination game, and may be connected to the server 3 through the base station 4 , the mobile communication network 5 , the gateway 6 , and the Internet 7 , so as to communicate with the server 3 . The portable terminal 2 may control the progress of a game in accordance with an operation of an input unit (touch panel and the like) 23 by a player. The portable terminal 2 may receive various types of data from the server 3 , and may control the progress of the game. For this, the portable terminal 2 may include a communication unit 21 , a storage unit 22 , the input unit 23 , a display unit 24 , and a processing unit 25 . [0065] The communication unit 21 may include a communication interface circuit which may include an antenna having a predetermined frequency band as a reception band. The communication unit 21 may connect the portable terminal 2 to a wireless communication network. The communication unit 21 may establish a wireless signal line by the code division multiple access (CDMA) scheme and the like, between the portable terminal 2 and the base station 4 through a channel allocated by the base station 4 . Thus, the communication unit 21 may communicate with the base station 4 . The communication unit 21 may transmit data supplied from the processing unit 25 to the server 3 and the like. The communication unit 21 may supply data received from the server 3 and the like to the processing unit 25 . [0066] The storage unit 22 may include a semiconductor memory device, for example. The storage unit 22 may store an operating system program, a driver program, an application program including a game control program, data, and the like which may be used when the processing unit 25 performs processing. For example, the storage unit 22 may store an input device driver program for controlling the input unit 23 , an output device driver program for controlling the display unit 24 , and the like, as the driver program. The storage unit 22 may store a display processing program and the like for progressing the game based on instruction data, data retrieved from the server 3 , and the like, and displaying display data relating to the progress of the game, as the application program. The instruction data may be input by a player operating the input unit 23 . The storage unit 22 may store data retrieved from the server 3 , display data relating to the progress of the game, video data, image data, and the like, as the data. Further, the storage unit 22 may temporarily store temporary data relating to predetermined processing. [0067] The input unit 23 may be any device as long as the device enables an operation for the portable terminal 2 . For example, a pointing device such as a touch panel may be provided. A player can input a character, a number, a symbol, and the like by using the input unit 23 . If the input unit 23 is operated by a player, the input unit 23 may generate a signal corresponding to the operation. The generated signal may be supplied to the processing unit 25 in accordance with an instruction of the player. [0068] The display unit 24 may be also any device as long as the device enables display of a video, an image, and the like. For example, a liquid crystal display or an organic electro-luminescence (EL) device may be provided. The display unit 24 may display a video corresponding to video data supplied from the processing unit 25 or may display an image and the like corresponding to image data supplied from the processing unit 25 . [0069] The processing unit 25 may include one or a plurality of processors and a peripheral circuit. The processing unit 25 may collectively control the overall operation of the portable terminal 2 , and may be a central processing unit (CPU), for example. The processing unit 25 may control operations of the communication unit 21 , the display unit 24 , and the like, so as to perform various types of processing of the portable terminal 2 in appropriate procedures, based on the program stored in the storage unit 22 , an operation of the input unit 23 , and the like. The processing unit 25 may perform processing based on the program (operating system program, driver program, application program, and the like) stored in the storage unit 22 . The processing unit 25 can perform a plurality of programs (application programs and the like) in parallel. [0070] The processing unit 25 may include at least a display processing unit 251 and an input processing unit 252 . The units may be functional modules realized by a program which maybe executed by a processor included in the processing unit 25 . In addition, the units may be mounted as a firmware in the portable terminal 2 . [0071] An example of a game screen will be described below with reference to FIGS. 5A to 9B . The game screen may be displayed in display units 24 of a portable terminal 2 a, a portable terminal 2 b, and a portable terminal 2 c which may be respectively held by player A, player B, and player C who participate in the game. [0072] FIG. 5A may be a diagram illustrating an example of game screens 500 a, 500 b, and 500 c which may be respectively displayed in display units 24 of the portable terminal 2 a, the portable terminal 2 b, and the portable terminal 2 c. [0073] If the game is started, firstly, the portable terminal 2 a displays a game screen 500 a for causing player A to designate a game region R included in the game field F, in the display unit 24 . The portable terminal 2 b and the portable terminal 2 c may respectively display a game screen 500 b and a game screen 500 c for browsing the game field F, in the display units 24 during a period when the game screen 500 a may be displayed in the display unit 24 of the portable terminal 2 a. A period when the game screen for designating a game region R may be displayed in the display unit 24 of the portable terminal 2 may be referred to as an operable period below. [0074] FIG. 5B may be a diagram illustrating an example of the game screen 500 a displayed in the display unit 24 of the portable terminal 2 a. [0075] The game field F and a region-point designation button 501 a which may be operation targets of player A may be displayed on the game screen 500 a. The region-point designation button 501 a may be a button for designating a unit point of the owned points correlated with a game region R, from the owned points associated with player A. For example, in the example of the game screen 500 a illustrated in FIG. 5B , a region-point designation button for one point, a region-point designation button for 10 points, and a region-point designation button for 100 points may be displayed as the region-point designation button 501 a. An example of an operation method of a player for correlating at least a portion of the owned points associated with player A, with a game region R as region points of the game region R will be described below with reference to FIGS. 6A and 6B . [0076] As illustrated in FIG. 6A , in a case where 30 points of the owned point associated with player A may be correlated with a desired game region Ra, for example, player A may designate the region-point designation button 501 a for 10 points, and may designate the desired game region Ra three times. For example, in a case where player A may cause a region point of five points to be correlated with the desired game region Ra, player A may designate the region-point designation button 501 a for one point, and may designate the desired game region Ra five times. For example, in a case where player A may cause a region point of 200 points to be correlated with the desired game region Ra, player A may designate the region-point designation button 501 a for 100 points, and may designate the desired game region Ra two times. Player A may designate a plurality of game regions Ra for the operable period. [0077] In the example of the game screen 500 a illustrated in FIG. 6B , the region points may be respectively correlated with four game regions Ra by player A. Because the region points having the largest value may be correlated with the four game regions Ra by player A, the four game regions Ra may be set as the corresponding regions of player A. The corresponding region Ra of player A may be displayed based on predetermined color information associated with player A, so as to enable the region Ra to be distinguished from other game regions R. [0078] The game field F displayed on the game screen 500 a illustrated in FIGS. 5B, 6A, and 6B may be displayed on the game screens 500 b and 500 c which may be respectively displayed in the display units 24 of the portable terminals 2 b and 2 c, so as to be browsable. The region-point designation button 501 a may not be displayed on the game screens 500 b and 500 c which may be respectively displayed in the display units 24 of the portable terminals 2 b and 2 c, and the game screens 500 b and 500 c may be controlled to cause the game region Ra not to be designated by the players B and C. [0079] FIG. 7A may be a diagram illustrating an example of game screens 700 a, 700 b, and 700 c which may be respectively displayed in the display units 24 of the portable terminals 2 a, 2 b, and 2 c when a predetermined operable period from when the game screen 500 a may be displayed in the display unit 24 of the portable terminal 2 a may be ended. [0080] When the predetermined operable period from when the game screen 500 a may be displayed in the display unit 24 of the portable terminal 2 a may be ended, the portable terminal 2 b may display the game screen 700 b in the display unit 24 . The game screen 700 b may be used for causing player B to designate a game region R included in the game field F. The portable terminals 2 a and 2 c may respectively display the game screens 700 a and 700 c for browsing the game field F, in the display units 24 during an operable period when the game screen 700 b may be displayed in the display unit 24 of the portable terminal 2 b. [0081] FIG. 7B may be a diagram illustrating an example of the game screen 700 b displayed in the display unit 24 of the portable terminal 2 b. [0082] The game field F and a region-point designation button 701 b which may be operation targets of player B may be displayed on the game screen 700 b. The corresponding region Ra of player A which has been set before the game screen 700 b may be displayed (when the previous operable period may be ended) may be displayed in the game field F. Player B may designate the region-point designation button 701 b, so as to designate a desired game region R. Thus, player B correlates at least a portion of the owned points associated with player B, with the desired game region R, as the region points. Player B may correlate the region points with the corresponding region Ra of player A. [0083] The game field F displayed on the game screen 700 b illustrated in FIG. 7B may be displayed on the game screens 700 a and 700 c which may be respectively displayed in the display units 24 of the portable terminals 2 a and 2 c, so as to be browsable. The region-point designation button 701 b may not be displayed on the game screens 700 a and 700 c which may be respectively displayed in the display units 24 of the portable terminals 2 a and 2 c, and the game screens 700 a and 700 c may be controlled to cause the game region Ra not to be designated by the players A and C. [0084] FIG. 8A may be a diagram illustrating an example of game screens 800 a, 800 b, and 800 c which may be respectively displayed in the display units 24 of the portable terminals 2 a, 2 b, and 2 c when a predetermined operable period from when the game screen 700 b may be displayed in the display unit 24 of the portable terminal 2 b may be ended. [0085] When the predetermined operable period from when the game screen 700 b may be displayed in the display unit 24 of the portable terminal 2 b is ended, the portable terminal 2 c may display the game screen 800 c in the display unit 24 . The game screen 800 c may be used for causing player C to designate a game region R included in the game field F. The portable terminals 2 a and 2 b may respectively display the game screens 800 a and 800 b for browsing the game field F, in the display units 24 during an operable period when the game screen 800 c may be displayed in the display unit 24 of the portable terminal 2 c. [0086] FIG. 8B may be a diagram illustrating an example of the game screen 800 c displayed in the display unit 24 of the portable terminal 2 c. [0087] The game field F and a region-point designation button 801 c which may be operation targets of player C may be displayed on the game screen 800 c. The corresponding region Ra of player A and the corresponding region Rb of player B which have been set before the game screen 800 c may be displayed (when the previous operable period may be ended) may be displayed in the game field F. The corresponding region Rb of player B may be displayed based on predetermined color information associated with player B, so as to enable the region Rb to be distinguished from other game regions R and the corresponding region Ra of player A. Player C may designate the region-point designation button 801 c, so as to designate a desired game region R. Thus, player C may correlate at least a portion of the owned points associated with player C, with the desired game region R, as region points. Player C may correlate the region point with the corresponding region Ra of player A and the corresponding region Rb of player B. [0088] The game field F displayed on the game screen 800 c illustrated in FIG. 8B may be displayed on the game screens 800 a and 800 b which may be respectively displayed in the display units 24 of the portable terminals 2 a and 2 b, so as to be browsable. The region-point designation button 801 c may not be displayed on the game screens 800 a and 800 b which may be respectively displayed in the display units 24 of the portable terminals 2 a and 2 b, and the game screens 700 a and 700 c may be controlled to cause the game region Ra not to be designated by the players A and B. [0089] FIG. 9A may be a diagram illustrating an example of the game screens 500 a, 500 b, and 500 c which may be respectively displayed in the display units 24 of the portable terminals 2 a, 2 b, and 2 c when a predetermined operable period, from when the game screen 800 c may be displayed in the display unit 24 of the portable terminal 2 c, may be ended. [0090] When the predetermined operable period from when the game screen 800 c may be displayed in the display unit 24 of the portable terminal 2 c may be ended, the portable terminal 2 a displays the game screen 500 a for causing player A to designate a game region R included in the game field F again, in the display unit 24 . The portable terminals 2 b and 2 c may respectively display the game screens 500 b and 500 c for browsing the game field F, in the display units 24 during an operable period when the game screen 500 a may be displayed in the display unit 24 of the portable terminal 2 a. [0091] FIG. 9B may be a diagram illustrating an example of the game screen 500 a which may be displayed again in the display unit 24 of the portable terminal 2 a. [0092] The game field F and a region-point designation button 501 a which may be operation targets of player A may be displayed on the game screen 500 a. The corresponding region Ra of player A, the corresponding region Rb of player B, and the corresponding region Rc of player C which have been set before the game screen 500 a may be displayed again (when the previous operable period may be ended) may be displayed in the game field F. The corresponding region Rc of player C may be displayed based on predetermined color information associated with player C, so as to enable the region Rc to be distinguished from from other game regions R, the corresponding region Ra of player A, and the corresponding region Rb of player B. Player A may designate the region-point designation button 501 a, so as to designate a desired game region R. Thus, player A correlates at least a portion of the owned points associated with player A, with the desired game region R, as the region points. [0093] Player A may correlate the region points with the corresponding region Ra of player A, the corresponding region Rb of player B, and the corresponding region Rc of player C which have been displayed in the game screen 500 a. In a case where player A sets one or more region points in the corresponding region Ra of player A before the game screen 500 a may be displayed again, the region points which may be designated this time may be added to the region points of player A for the corresponding region Ra, which have been already correlated. Then, the region points of player A, which may be obtained by the addition may be correlated with the corresponding region Ra. [0094] As described above, a set of the game screens 500 a, 500 b, and 500 c, a set of the game screens 700 a, 700 b, and 700 c, and a set of the game screens 800 a, 800 b, and 800 c may be sequentially displayed in the display units 24 of the portable terminals 2 a, 2 b, and 2 c for each predetermined operable period. Then, the set of the game screens 500 a, 500 b, and 500 c, a set of the game screens 700 a, 700 b, and 700 c, and a set of the game screens 800 a, 800 b, and 800 c may be displayed again in the display units 24 of the portable terminals 2 a, 2 b, and 2 c for each predetermined operable period. In an exemplary embodiment, if a series of processes in which all players who participate in the game perform an input operation in the input operation order for each predetermined operable period is performed the predetermined number of times, the game may be ended. [0095] FIGS. 10 to 12 may be schematic diagrams illustrating an example of setting the corresponding region Ra of player A, the corresponding region Rb of player B, and the corresponding region Rc of player C. [0096] In the example of the game field F illustrated in FIG. 10 , 10 points, 20 points, and 30 points may be respectively correlated with the game region Rc 1 , as the region points of player A, player B, and player C. Thus, the game region Rc 1 may be set as the corresponding region of player C. [0097] 30 points, 20 points, and 10 points may be respectively correlated with the game region Ra 1 , as the region points of player A, player B, and player C. Thus, the game region Ra 1 maybe set as the corresponding region of player A. 20 points, 0 point, and 0 point may be respectively correlated with the game region Ra 2 , as the region points of player A, player B, and player C. Thus, the game region Ra 2 may be set as the corresponding region of player A. [0098] FIG. 11 illustrates a case where player A further correlates 60 points as the region point, with the corresponding region Rc 1 of player C in the game field F illustrated in FIG. 10 . In this case, a region point of 60 points, which may be correlated this time may be added to the region point of 10 points of player A, which has been already correlated with the corresponding region Rc 1 . Thus, the region point of 70 points of player A after addition may be correlated with the corresponding region Rc 1 . [0099] FIG. 12 illustrates a display form in a case where a new region point of player A may be correlated with the corresponding region Rc 1 of player C in the game field F illustrated in FIG. 11 . The region point of player A, which may be correlated with the corresponding region Rc 1 may be 70 points which may be larger than the region points of player B and player C. Thus, the corresponding region Rc 1 may be set as a corresponding region Ra 3 of player A. The corresponding region Ra 3 may be displayed based on the predetermined color information associated with player A. [0100] FIGS. 13 to 16 may be schematic diagrams illustrating an example of the region-point changing processing. [0101] In the example of the game field F illustrated in FIG. 13 , 30 points, 20 points, and 10 points may be respectively correlated with the game region Ra 1 , as the region points of player A, player B, and player C. Thus, the game region Ra 1 may be set as the corresponding region of player A. [0102] 30 points, 50 points, and 0 points may be respectively correlated with the game region Rb 1 , as the region points of player A, player B, and player C. Thus, the game region Rb 1 may be set as the corresponding region of player B. 0 points, 0 points, and 70 points may be respectively correlated with the game region Rc 1 , as the region points of player A, player B, and player C. Thus, the game region Rc 1 may be set as the corresponding region of player C. [0103] 0 points, 0 points, and 0 points may be respectively correlated with the game region Ra 2 , as the region points of player A, player B, and player C. Thus, the game region Ra 2 may not be set as the corresponding region of the players. [0104] FIG. 14 illustrates a display form in a case where player A correlates 100 points as a new region point, with the game region Ra 2 in the game field F illustrated in FIG. 13 . In this case, the region point of player A may not be correlated with the game region Ra 2 . Thus, the region point of 100 points, which may be correlated this time may be correlated with the game region Ra 2 . Since the region point of player A, which may be correlated with the game region Ra 2 may be 100 points which may be larger than the region points of player B and player C, the game region Ra 2 may be set as the corresponding region of player A. [0105] FIG. 15 illustrates a case where the game regions Rb 1 and Rc 1 may be arranged between the corresponding region Ra 2 of player A, which may be set this time, and the other corresponding region Ra 1 of player A, which has been previously set. [0106] In the example illustrated in FIG. 15 , the region points of player A, which may be correlated with the game region Rb 1 , and the region points of player B who has the game region Rb 1 as the corresponding region may be extracted. The extracted region points of 50 points of player B may become region points of player A, with the game region Rb 1 . The extracted region point of 30 points of player A may become the region points of player B, in the game region Rb 1 . [0107] In addition, the region points of player A, which may be correlated with the game region Rc 1 , and the region points of player C who has the game region Rc 1 as the corresponding region may be extracted. The extracted region points of 70 points of player C may become the region points of player A, with the game region Rc 1 . The extracted region point of 0 point of player A may become the region points of player C, in the game region Rc 1 . [0108] FIG. 16 illustrates a display form after the region-point changing processing may be performed on the corresponding regions Rb 1 and Rc 1 in the game field F illustrated in FIG. 15 . The region points of 50 points of player A, which may be correlated with the game region Rb 1 may be larger than the region points of 30 points of player B, and the region points of 10 points of player C, which may be correlated with the game region Rb 1 . Thus, the game region Rb 1 may be set as a corresponding region Ra 1 of player A. The region points of 70 points of player A, which may be correlated with the game region Rc 1 may be larger than the region points of 20 points of player B, and the region points of 0 point of player C, which may be correlated with the game region Rc 1 . Thus, the game region Rc 1 may be set as a corresponding region Ra 4 of player A. [0109] Hitherto, the descriptions may be made with reference to FIGS. 13 to 16 . In the game in which a game region may be correlated with a player, it may be possible to obtain a game region as a corresponding region of a player without the player designating a corresponding region of another player, by the region-point changing processing. That is, a player can acquire the region points of another player, which corresponds to the corresponding region of this player, without directly consuming the owned point for the corresponding region of this player. Thus, it may be possible to provide a game requiring players to exercise a strategy. [0110] Configuration of Server 3 [0111] FIG. 17 may be a diagram illustrating an example of a schematic configuration of the server 3 . FIGS. 18A to 19B may be diagrams illustrating an example of data structures of various tables stored in a server storage unit 32 . [0112] The server 3 may include a server communication unit 31 , the server storage unit 32 , and a server processing unit 33 . The server 3 may cause various games such as a domination game to proceed, in accordance with a request from the portable terminal 2 . The server 3 may create display data and the like regarding the progress of the game, and may transmit the created display data to the portable terminal 2 . [0113] The server communication unit 31 may include a communication interface circuit for connecting the server 3 to the Internet 7 , and may thus perform communication with the Internet 7 . The server communication unit 31 may supply data which has been received from the portable terminal 2 and the like, to the server processing unit 33 . The server communication unit 31 may transmit data supplied from the server processing unit 33 , to the portable terminal 2 and the like. [0114] The server storage unit 32 may include at least one of a magnetic tape device, a magnetic disk device, and an optical disk device, for example. The server storage unit 32 may store an operating system program, a driver program, an application program, data, and the like which may be used in processing in the server processing unit 33 . For example, the server storage unit 32 may store a game program and the like of causing the game to proceed and creating display data regarding a result, as the application program. For example, the computer program maybe installed on the storage unit 22 from a computer-readable portable type recording medium such as a CD-ROM and a DVD-ROM, by using a well-known set-up program and the like. [0115] The server storage unit 32 may store a player table illustrated in FIG. 18A , a game field table illustrated in FIG. 18B , and the like, as the data. The server storage unit 32 may store a game table illustrated in FIG. 19A , and may store a region point table illustrated in FIG. 19B . The server storage unit 32 may store various types of image data and the like regarding the progress of the game. Further, the server storage unit 32 may temporarily store temporary data regarding predetermined processing. That is, the server storage unit 32 may include a volatile memory (random access memory, RAM), and may store dynamic data which changes depending on the progress of the game. [0116] FIG. 18A illustrates the player table for managing a player. A player ID, the name, the owned point, and the like of a player may be stored in the player table for each player, in a state of being associated with each other. The player ID may be an example of identification information for recognizing players at once. [0117] FIG. 18B illustrates the game field table for managing the game field F. A field ID, game region information, and the like of the game field may be stored in the game field table for each game field, in a state of being associated with each other. The field ID may be an example of identification information for recognizing game fields at once. [0118] A region ID, a position, and the like of each of a plurality of game regions R included in each game field may be stored in the game region information, in a state of being associated with each other. The region ID may be an example of identification information for recognizing game regions R which may be included in each game field at once. The position may be a position at which each of the game regions R may be disposed in each game field. For example, the position may be two-dimensional coordinates of the center point of each of the game regions R. [0119] FIG. 19A illustrates the game table for managing a game. A game ID, a field ID, participation player information, and the like of a game may be stored in the game table for each executed game, in a state of being associated with each other. The game ID may be an example of identification information for recognizing games at once. The field ID may be a field ID of a game field used in a game, and may be a field ID stored in the game field table. [0120] Player IDs of participation players who participate in a game may be stored in the participation player information, in a state of being arranged in an input operation order. In a game, the first player in the input operation order may be referred to as the first player below. The second player, the third player, and the like in the input operation order may be referred to as the second player, the third player, and the like below. [0121] FIG. 19B illustrates the region point table for managing a region point correlated with a game region R. The region point table may be created for each executed game. The region point table may be stored in association with the game ID of the game. A region ID, region point information, and the like of a game region R may be stored in the region point table for each game region R of a game field F used in the game, in a state of being associated with each other. [0122] Region points of each game region, which may be respectively correlated by a plurality of players who participate in the game may be stored in the region point information, in a state of being associated with each other. That is, region points of each game region, which may be respectively correlated by the first player, the second player, and the like may be stored in association with each other. [0123] Returning to FIG. 17 , the server processing unit 33 may include at least a progress control unit 331 , a point retrieval unit 332 , a correlation unit 333 , and a setting unit 334 . The units may be functional modules realized by a program which maybe executed by a processor included in the server processing unit 33 . In addition, the units may be mounted as a firmware in the server 3 . [0124] An example of the display processing unit 251 and the input processing unit 252 included in the processing unit 25 of the portable terminal 2 , and an example of the progress control unit 331 , the point retrieval unit 332 , the correlation unit 333 , and the setting unit 334 included in the server processing unit 33 of the server 3 will be described below. [0125] Function of Display Processing Unit 251 [0126] The display processing unit 251 in the portable terminal 2 may display a game screen in the display unit 24 , based on display data which has been received from the server 3 through the communication unit 21 . In a case where the received display data may be display data for displaying a game screen which may be used for causing a player to designate a game region R included in a game field F, the display processing unit 251 may display a region-point designation button along with the game field F. In a case where the received display data may be display data for displaying a game screen which may be used for browsing the game field F, the display processing unit 251 may display the game field F. [0127] In a case where the owned point of a player who will perform an input operation in the next operable period may be received from the server 3 through the communication unit 21 , the display processing unit 251 may store the received owned point of the player in the storage unit 22 . [0128] Function of Input Processing Unit 252 [0129] In a case where an instruction to transmit a request of participating in a game provided by the server 3 may be performed by a player operating the input unit 23 , the input processing unit 252 in the portable terminal 2 may transmit a participation request for participating in the game, to the server 3 through the communication unit 21 . The participation request may include the player ID of a player who transmits the participation request, the game ID of a game to be participated, and the like. [0130] If the game screen for causing a player to designate a game region R included in the game field F may be displayed by the display processing unit 251 , the input processing unit 252 accepts game region designation in an operable period. In accepting processing of the game region designation, firstly, the input processing unit 252 may store region points correlated with a game region R, based on a region-point designation button and the game region R which have been designated by a player operating the input unit 23 . The region points may be stored in the storage unit 22 , in association with the region ID of the game region R. The input processing unit 252 subtracts the correlated region points from the owned point of the player, which may be stored in the storage unit 22 . The input processing unit 252 may store the subtracted owned point in the storage unit 22 . Whenever the owned point maybe subtracted, the display processing unit 251 may display the subtracted owned point on the game screen. [0131] The input processing unit 252 instructs the display processing unit 251 to end display of the game screen when the operable period may be ended. The input processing unit 252 transmits input data to the server 3 through the communication unit 21 . The transmitted input data may include the player ID of a player who holds the portable terminal 2 , and a region point associated with the region ID stored in the storage unit 22 . [0132] Function of Progress Control Unit 331 [0133] If a participation request is received from the portable terminal 2 through the server communication unit 31 , the progress control unit 331 in the server 3 may perform game start processing. In the game start processing, firstly, the progress control unit 331 may specify a player ID and a game ID included in the participation request received from the portable terminal 2 . Then, the progress control unit 331 may store the specified player ID in the participation player information of the game table. The specified player ID may be stored as the player ID of a participation player who participates in a game indicated by the specified game ID, in association with the specified game ID. The specified player ID may be stored as the player ID of a participation player, in the participation player information, in an order of receiving the participation request. Then, in a case where there is a game in which the number of persons participating reaches an upper limit which enables participation in the game, with reference to the participation player information of the game table, the progress control unit 331 may start the game. The input operation order for each player, which may be stored in the participation player information may not be limited to the order of receiving the participation request. For example, in a case where the number of persons participating reaches an upper limit which enables participation in the game, with reference to the participation player information of the game table, the progress control unit 331 may randomly line up player IDs included in the participation player information, and may store the list of the player IDs in the participation player information. [0134] If the game is started, the progress control unit 331 may transmit display data for displaying a game screen of the started game, to portable terminals 2 of players ID included in the participation player information associated with the started game, with reference to the game table. A game field F including a game region R based on game region information which may be extracted from the game field table and relates to a field ID associated with the game ID of the started game may be included in the game screen of the started game. The region-point designation button may be included along with the game field F, in the game screen transmitted to the portable terminal 2 of the first player ID included in the participation player information. [0135] If the region points for each region ID after the region-point changing processing are stored by the setting unit 334 , the progress control unit 331 may create display data for displaying a game screen. The created display data may be display data for displaying a game screen including the game field F which may include a corresponding region colored based on the region point after the region-point changing processing. The progress control unit 331 may specify the player ID corresponding to the next input operation order among player IDs included in input data, with reference to the game table. The progress control unit 331 may create display data which maybe transmitted to the portable terminal 2 for the specified player ID. In the created display data, the region-point designation button may be included in the game screen. [0136] The progress control unit 331 may transmit display data to the portable terminal 2 for the player ID corresponding to the next input operation order, and may simultaneously extract the owned point associated with the player ID, from the player table. The progress control unit 331 may transmit the extracted owned point to the portable terminal 2 for the player ID. [0137] Function of Point Retrieval Unit 332 [0138] The point retrieval unit 332 in the server 3 may retrieve input data which has been received from the portable terminal through the server communication unit 31 . The point retrieval unit 332 may retrieve the player ID of a player, and a region point associated with the region ID. The player ID and the region point may be included in the retrieved input data. [0139] The point retrieval unit 332 may retrieve region point information associated with the region ID stored in the region point table. [0140] The point retrieval unit 332 may calculate the summation value of region points which may be respectively associated with region IDs included in the input data received when an operable period may be ended. The point retrieval unit 332 may subtract the calculated summation value from the owned point of the player, which has been stored in the player table. The point retrieval unit 332 may store the subtracted owned point of the player, in the player table. [0141] Function of Correlation Unit 333 [0142] The correlation unit 333 in the server 3 may add a region point associated with each region ID, to the region point corresponding to the player ID included in input data. The region ID may be included in the input data retrieved by the point retrieval unit 332 . The region point may be stored in the region point information associated with each region ID stored in the region point table. The correlation unit 333 may output a region point after addition. The correlation unit 333 may specify the region ID of a game region R in which the region point value corresponding to the player ID included in the input data may be larger than all region points of other players in the region point after addition, and, in the region point information, the region point value corresponding to the player ID included in the input data may be smaller than region points of all other players, as the current corresponding region ID. [0143] Function of Setting Unit 334 [0144] If the current corresponding region ID is specified by the correlation unit 333 , the setting unit 334 in the server 3 performs specifying processing of a point-change target region. According to an exemplary embodiment, when specifying processing of a point-change target region, firstly, the setting unit 334 may extract region point information stored in the region point table. Then, the setting unit 334 may specify a region ID of a game region in which a region point corresponding to the player ID stored in the input data may be larger than region points of all other players, as the previous corresponding region ID in the region point information. Then, the setting unit 334 may specify region IDs of game regions disposed in predetermined arrangement, between the current corresponding region ID and the previous corresponding region ID with reference to the game field table. In a case where all of the specified game regions disposed in the predetermined arrangement may be corresponding regions of other players which may be different from the player of the player ID included in the input data, the setting unit 334 may specify the specified game regions disposed in the predetermined arrangement, as point-change target regions. With the above descriptions, the specifying processing of a point-change target region may be ended. [0145] In a case where the point-change target region is specified by the specifying processing of a point-change target region, the setting unit 334 may perform point change processing. In the point change processing, firstly, the setting unit 334 may extract region point information associated with a region ID of a region-point changing target region, from the region point table. Then, the setting unit 334 may extract the largest region point and a region point corresponding to the player ID included in the input data, in the extracted region point information, for the region ID of the region-point changing target region. Then, the setting unit 334 may generate region point information obtained by replacing the extracted largest region point with the region point corresponding to the player ID included in the input data, for the region ID of the region-point changing target region. The setting unit 334 may store the generated region point information in the region point table. [0146] Operation Sequence of Game System 1 [0147] FIG. 20 may be a diagram illustrating an example of an operation sequence of the game system 1 . The operation sequence may be executed based on a program which has been stored in advance in the storage unit 22 and the server storage unit 32 . The operation sequence may be mainly executed by the processing unit 25 and the server processing unit 33 , in cooperation with the components of the portable terminal 2 and the server 3 . As an example, an operation sequence of the game system 1 in which the server 3 provides a game in which player A, player B, and player C participate, for the portable terminal 2 a of player A, the portable terminal 2 b of player B, and the portable terminal 2 c of player C will be described below. [0148] Firstly, the input processing unit 252 in the portable terminal 2 a of player A may transmit a participation request for participating in a game, to the server 3 through the communication unit 21 in accordance with an operation of the input unit 23 by player A (Step S 101 ). [0149] The input processing unit 252 in the portable terminal 2 b of player B may transmit a participation request for participating in a game, to the server 3 through the communication unit 21 in accordance with an operation of the input unit 23 by player B (Step S 102 ). [0150] The input processing unit 252 in the portable terminal 2 c of player C may transmit a participation request for participating in a game, to the server 3 through the communication unit 21 in accordance with an operation of the input unit 23 by player C (Step S 103 ). [0151] In Steps S 101 to S 103 in the operation sequence illustrated in FIG. 20 , the participation requests may be transmitted to the server 3 in an order of the portable terminal 2 a, the portable terminal 2 b, and the portable terminal 2 c. However, the order of transmission may not be limited thereto. That is, processes of Steps S 101 to S 103 may be executed in an order of the participation request being transmitted by the portable terminal 2 . [0152] Then, if the participation request is received from each of the portable terminal 2 through the server communication unit 31 , the progress control unit 331 in the server 3 may perform the game start processing (Step S 104 ). Descriptions will be made below on the assumption that player A, player B, and player C respectively correspond to the first player, the second player, and the third player. [0153] Then, the progress control unit 331 may transmit display data for displaying the game screen 500 a which may be used for causing player A to designate a game region R included in the game field F, to the portable terminal 2 a of player A through the server communication unit 31 (Step S 105 ). The progress control unit 331 may transmit the owned point of player A to the portable terminal 2 a of player A through the server communication unit 31 . [0154] The progress control unit 331 may transmit display data for displaying the game screen 500 b which may be used for browsing the game field F, to the portable terminal 2 b of player B through the server communication unit 31 (Step S 106 ). [0155] The progress control unit 331 may transmit display data for displaying the game screen 500 c which may be used for browsing the game field F, to the portable terminal 2 c of player C through the server communication unit 31 (Step S 107 ). [0156] Then, the display processing unit 251 of the portable terminal 2 a may display the game screen 500 a based on the display data which has been received from the server 3 through the communication unit 21 . The input processing unit 252 of the portable terminal 2 a may accept game region designation in an operable period (Step S 108 ). The display processing unit 251 may store the received owned point of player A, in the storage unit 22 before execution of Step S 108 . [0157] Then, the input processing unit 252 of the portable terminal 2 a may transmit input data which may include a region point correlated with the game region R, to the server 3 through the communication unit 21 (Step S 109 ). [0158] Then, if the input data may be received from the portable terminal 2 a of player A, the progress control unit 331 , the point retrieval unit 332 , the correlation unit 333 , and the setting unit 334 in the server 3 execute the game progress processing (Step S 110 ). Details of the game progress processing will be described later. [0159] Then, the progress control unit 331 may transmit display data for displaying the game screen 700 a which may be used for browsing the game field F, to the portable terminal 2 a of player A through the server communication unit 31 (Step S 111 ). [0160] The progress control unit 331 transmits display data for displaying the game screen 700 b which may be used for causing player B to designate a game region R included in the game field F, to the portable terminal 2 b of player B through the server communication unit 31 (Step S 112 ). The progress control unit 331 may transmit the owned point of player B to the portable terminal 2 b of player B through the server communication unit 31 . [0161] The progress control unit 331 may transmit display data for displaying the game screen 700 c which may be used for browsing the game field F, to the portable terminal 2 c of player C through the server communication unit 31 (Step S 113 ). [0162] Then, the display processing unit 251 of the portable terminal 2 b may display the game screen 700 b based on the display data which has been received from the server 3 through the communication unit 21 . The input processing unit 252 of the portable terminal 2 b may accept game region designation in an operable period (Step S 114 ). The display processing unit 251 may store the received owned point of player B, in the storage unit 22 before execution of Step S 114 . [0163] Then, the input processing unit 252 of the portable terminal 2 b may transmit input data which may include a region point correlated with the game region R, to the server 3 through the communication unit 21 (Step S 115 ). [0164] Then, if the input data is received from the portable terminal 2 b of player B, the progress control unit 331 , the point retrieval unit 332 , the correlation unit 333 , and the setting unit 334 in the server 3 may perform the game progress processing (Step S 116 ). Details of the game progress processing will be described later. [0165] Then, the progress control unit 331 may transmit display data for displaying the game screen 800 a which may be used for browsing the game field F, to the portable terminal 2 a of player A through the server communication unit 31 (Step S 117 ). [0166] The progress control unit 331 may transmit display data for displaying the game screen 800 b which may be used for browsing the game field F, to the portable terminal 2 b of player B through the server communication unit 31 (Step S 118 ). [0167] The progress control unit 331 may transmit display data for displaying the game screen 800 c which may be used for causing player C to designate a game region R included in the game field F, to the portable terminal 2 c of player C through the server communication unit 31 (Step S 119 ). The progress control unit 331 may transmit the owned point of player C to the portable terminal 2 c of player C through the server communication unit 31 . [0168] Then, the display processing unit 251 of the portable terminal 2 c may display the game screen 800 c based on the display data which has been received from the server 3 through the communication unit 21 . The input processing unit 252 of the portable terminal 2 c may accept a game region designation in an operable period (Step S 120 ). The display processing unit 251 may store the received owned points of player C, in the storage unit 22 , before execution of Step S 120 . [0169] Then, the input processing unit 252 of the portable terminal 2 c may transmit input data which may include a region point correlated with the game region R, to the server 3 , through the communication unit 21 (Step S 121 ). [0170] Then, if the input data is received from the portable terminal 2 c of player C, the progress control unit 331 , the point retrieval unit 332 , the correlation unit 333 , and the setting unit 334 in the server 3 may perform the game progress processing (Step S 122 ). Details of the game progress processing will be described later. [0171] After that, the above-described processes of Step S 105 to Step S 122 may be executed until each of the portable terminals 2 performs the game region designation the number of times, which may be preset by the server 3 . [0172] Game Progress Processing [0173] FIG. 21 may be a diagram illustrating an example of an operation flow of the game progress processing performed by the progress control unit 331 , the point retrieval unit 332 , the correlation unit 333 , and the setting unit 334 . The game progress processing illustrated in FIG. 21 may be executed in the processes of Steps S 110 , S 116 , and S 122 in FIG. 20 . [0174] Firstly, the point retrieval unit 332 may retrieve the player ID of a player and a region point associated with a region ID, from the input data which has been received from the portable terminal 2 through the server communication unit 31 (Step S 201 ). The point retrieval unit 332 may retrieve region point information associated with the region ID stored in the region point table. In Step S 201 , the point retrieval unit 332 may store the subtracted owned point of the player, in the player table, based on the summation value of region points associated with the region ID included in the input data. [0175] Then, the correlation unit 333 may calculate a region point after addition, and may specify the current corresponding region ID (Step S 202 ). [0176] Then, if the current corresponding region ID may be specified, the setting unit 334 may perform the specifying processing of a point-change target region (Step S 203 ). [0177] Then, the setting unit 334 may determine whether or not the point-change target region may be specified by the specifying processing of a point-change target region (Step S 204 ). [0178] In a case where no point-change target region is specified (No in Step S 204 ), the setting unit 334 may cause the process to proceed to Step S 207 . [0179] In a case where the point-change target region is specified (Yes in Step S 204 ), the setting unit 334 may perform the region-point changing processing (Step S 205 ). [0180] Then, the setting unit 334 may store the region point after the region-point changing processing, as region point information of the region point table for each region ID (Step S 206 ). In a case where the last game progress processing in the executed game is performed, the process of Step S 206 may be executed, and a series of steps may be ended. [0181] The progress control unit 331 may create display data for displaying a game screen which may include the game field F including the corresponding region colored based on the region point information of the region point table (Step S 207 ), and may then end a series of steps. [0182] Hitherto, as described above in detail, the game system performs the region-point changing processing in a domination game. Thus, a first player can have the region points of another player, which may be correlated with a game region R, as the region points of the first player without designating the game region R. Thus, it may be possible to realize a game requiring a player to exercise a strategy, improving the player's interest for the game. In the above descriptions, as an example, the descriptions may be made by using player A, player B, and player C as players participating in the game. However, the number of players participating in the game may not be limited to three. The shape of the game region may be any shape. MODIFICATION EXAMPLE 1 [0183] In receiving processing of game region designation by the input processing unit 252 of the portable terminal 2 , predetermined designation conditions may be associated with a plurality of game regions R included in the game field F which may be used in the game. [0184] FIG. 22A may be a schematic diagram illustrating another example of the game field F used in the game. [0185] In the example of the game field F illustrated in FIG. 22A , a game region Rx which does not function as the point-change target region may be disposed in the game field F. The game system 1 may associate a condition in that, in a case where a player correlates a region point with the game region Rx, a first predetermined point value may be consumed from the owned points of the player, with the game region Rx, as the predetermined designation condition. For example, in the game region information of the game field table, the first predetermined point value may be associated and stored in correlation with the region ID of a game region Rx. In a case where a game region R designated by a player operating an input unit 23 may be the game region Rx, the input processing unit 252 may consume the correlated region point(s) and the first predetermined point value associated with the region ID of the game region Rx, from the owned point of the player, which may be stored in the storage unit 22 . [0186] In this manner, in a case where a game region Rx of which a probability of being included in the predetermined arrangement may be lower than that of another game region R may be a region at an end portion of all game regions R included in the game field F, if a region point may be correlated with the game region Rx by a player, the correlated region point and the first predetermined point value associated with the game region Rx may be consumed from the owned point of the player. [0187] The game region Rx of which a probability of being included in the predetermined arrangement may be lower than that of another game region R may not be limited to the game region Rx illustrated in FIG. 22A . For example, a game region R may be set as the game region Rx, in accordance with the number of other game regions R which may be adjacent to the game region R. In this case, for each game region R, the number of other game regions R which may be adjacent to each game region R may be calculated, and the first predetermined point value may be given a value depending on the calculated value that may be associated with each game region R. That is, in a case where one other game region R may be adjacent to a game region Rx, the first predetermined point value may be 100 points, for the game region Rx. In a case where two other game regions R may be adjacent to a game region Rx, the first predetermined point value may be 50 points, for the game region Rx. The first predetermined point value associated with a game region Rx may be calculated by a predetermined calculation expression (for example, 100/(the number of other game regions R which may be adjacent to the game region Rx)). [0188] Thus, it may be possible to provide a game in which stimulation may be performed such that a case where game region R having a high probability of being included in the predetermined arrangement may be designated by a player occurs relatively frequently, and in which forming a point-change target region or predetermined arrangement may be promoted, and an occurrence of stalemate may be difficult. It may be possible to prevent an occurrence of a situation in which a player having the owned point of a value larger than that of other players correlates a large amount of region points with a game region Rx, in advance, and to prevent reduction of the will of other players to continue the game. The game region Rx may be an example of a first specific region. [0189] In the example of the game field F illustrated in FIG. 22A , a condition relating to the upper limit of the region point correlated with the game region Rx by a player may be associated with the game region Rx, as the predetermined designation condition. For example, in the game region information of the game field table, a second predetermined point value may be associated and stored in correlation with the region ID of the game region Rx. In a case where the game region R designated by a player operating an input unit 23 may be the game region Rx, the input processing unit 252 may control correlation of the region point, so as to cause the summation value of region points of players, which may be correlated with the game region Rx, not to exceed the second predetermined point value. For example, in a case where designation of the game region Rx may be received, if it may be determined that the summation value of region points of players, which may be correlated with the game region Rx exceeds the second predetermined point value, the input processing unit 252 may cancel the received designation input. [0190] Thus, it may be possible to prevent an occurrence of a situation in which a player correlates a large amount of region points with a game region Rx, in advance, which may help to prevent other players from losing the will to continue the game. MODIFICATION EXAMPLE 2 [0191] The progress control unit 331 in the server 3 may change the game field F displayed by display data transmitted to the portable terminals 2 , in accordance with the progress of the game. [0192] FIG. 22B may be a schematic diagram illustrating an example of the game field F used in the game. [0193] In the example of the game field F illustrated in FIG. 22B , a restricted region Rt may be disposed in the game field F. It may not be possible for a player to designate the restricted region Rt at a time of starting the game. In a case where the restricted region Rt may be included in the game field F, the display processing unit 251 in the portable terminal 2 generally does not display the restricted region Rt, and but displays only game regions R included in the game field F. [0194] Then, the progress control unit 331 in the server 3 may determine whether or not a predetermined game-field change condition may be satisfied, in accordance with game region designation of a player who participates in the game. Then, in a case where the predetermined game-field change condition is satisfied, the progress control unit 331 may change some of the restricted regions Rt to game regions R, and may create display data for displaying a game screen including a game field F which may include the changed game region R. The progress control unit 331 may transmit the created display data to the portable terminal 2 . [0195] For example, the predetermined game-field change condition may correspond to a case where the number of times of performing a series of processes in which all players participating in the game performs an input operation in an input operation order exceeds the predetermined number, or to a case where a region point may be correlated with a specific game region (game region and the like which may be adjacent to the restricted region Rt) by a player. The predetermined game-field change condition may correspond to a case where the number of game regions R correlated with a region point by all players participating in the game or by a specific player exceeds the predetermined number of regions, a case where the summation value of region points correlated with all or some of game region R among the game regions R correlated with region points exceeds a third predetermined point value, or a case where a predetermined period elapses from when the game may be started. [0196] The game field F may not be limited to the example illustrated in FIG. 22B . For example, the game field F may include a first sub-game field F 1 , a second sub-game field F 2 , and a restricted region Rt. The first sub-game field F 1 may include a plurality of first game regions R 1 . The second sub-game field F 2 may include a plurality of second game regions R 2 . The restricted region Rt may be disposed between the first sub-game field F 1 and the second sub-game field F 2 . In this case, if the restricted region Rt may be changed to a game region R, the restricted region Rt may be disposed on a game field F so as to cause the first sub-game field F 1 and the second sub-game field F 2 to form one game field F. [0197] In a case where the above-described predetermined game-field change condition is satisfied, the progress control unit 331 may change the predetermined game region R to the restricted region Rt. In this case, in a case where the predetermined game-field change condition may be satisfied, the progress control unit 331 may change at least some of the game regions R to restricted regions Rt, and may create display data for displaying a game screen including a game field F which may include the changed game region R. The progress control unit 331 may transmit the created display data to the portable terminal 2 . The restricted region Rt may be displayed so as to be visually recognizable or not to be visually recognizable. In a case where a region point may be correlated with the game region R which has been changed to the restricted region Rt, the correlated region point may be included in the owned point of a player who correlates the region point. [0198] In a case where the above-described predetermined game-field change condition is satisfied, the progress control unit 331 may change the predetermined game region R to an undesignatable region Ro. The undesignatable region Ro may be a game region in which it may not be possible that a player correlates a region point, and a game region which does not function as the point-change target region. In a case where a region point may be correlated with a game region R which has been changed to the undesignatable region Ro, the correlated region point may be maintained without being changed. The region point correlated with the undesignatable region Ro may be used in the progress of the game (for example, determination of win or lose of the game), similarly to a region point correlated with a general game region R. An undesignatable period in which the predetermined game region R may be changed to the undesignatable region Ro may be set in the game system 1 . In this case, if a predetermined undesignatable period elapses from when the predetermined game region R may be changed to the undesignatable region Ro, the undesignatable region Ro may be brought back into a game region R. [0199] With the above descriptions, it may be possible to provide a game requiring further strategy from a player, in that a game region R on which play can occur may be selected and periodically updated, while the change of the game field F may be predicted. In addition, it may be possible to provide a game in which a player may be prevented, in advance, from associating a large amount of region points with a game region Rx, and in which an a stalemate may be unlikely to occur. MODIFICATION EXAMPLE 3 [0200] In the embodiment, each of a plurality of players may be able to designate a game region R at any time during the operable period corresponding to the player. However, a period or a timing when a player can designate a game region R may not be limited to the operable period. For example, control may be performed such that a timing when a player can designate a game region R has a predetermined time interval, in a period from a start of the game to an end of the game. That is, a player can designate the next game region R after a predetermined time interval from a timing when at least some of the owned points of the player may be correlated with a game region R. In this case, the predetermined time interval may be changed in accordance with the size of the points value of region points associated with a game region R by the player. For example, control may be performed such that the predetermined time interval becomes longer as the value of the point which has been correlated as a region point, with a game region R by a player. Thus, it may be possible to cause region points which can be correlated with game regions R by each player to be uniform. In addition, an occurrence of a situation in which a player who has a large amount of the owned point may be too advantageous may be prevented, and thus it may be possible to maintain the will of a player to continue the game even when that player does not have a large amount of the owned points, to continue the game. It may be possible to provide a game in which considering the amount of a region point correlated with a game region R by a player and an operable period of the player, in accordance with an action of a player as the competition opponent may be required, and strategic characteristics may be required. MODIFICATION EXAMPLE 4 [0201] The game system 1 may progress a game in which game regions included in the game field F may be respectively designated by a plurality of players and thus the game regions R may be correlated with groups to which the plurality of players belongs. [0202] FIG. 23 may be a diagram illustrating another example of the schematic configuration of the game system 1 . As an example, a game in which a plurality of groups (group G 1 , group G 2 , and group G 3 ) to which players participating in the game belong may be correlated with a game region R will be described below. [0203] As illustrated in FIG. 23 , a correlation game such as a domination game, in which a game field F including a plurality of game regions R may be displayed in portable terminals 2 of players who participate in the game and belong to a group G 1 , a group G 2 , and a group G 3 , and the displayed game field F may be used may proceed by the portable terminal 2 and the server 3 constituting the game system 1 . [0204] Each of a plurality of players participating in the game may designate a game region R included in the displayed game field F, in an input operation order. The input operation order may be correlated with the group. For example, in a case where the first in the input operation order may be the group G 1 , each of players belonging to the group G 1 may designate a game region R in the operable period of the first in the input operation order. Similarly, in a case where the second in the input operation order may be the group G 2 , each of the players belonging to the group G 2 may designate a game region R in the operable period of the second in the input operation order. [0205] Then, the server 3 may receive input data from the portable terminal 2 of a player belonging to each group in the input operation order, when each operable period in the input operation order may be ended. Each group in the input operation order may be an example of a first group. The server 3 may calculate the summation value of region points correlated by players belonging to a group in each of a plurality of game regions R, and may correlate the calculated summation value of each of the game regions, as a game point of the group in each of the game regions. [0206] The server 3 sets each of the plurality of game regions R, as a corresponding region of the group, which may be correlated with a region point of a value which may be the largest among region points correlated with the game region R. [0207] The server 3 may specify another corresponding region Ra 1 of the group, which has been previously set, and may be different from the corresponding region Ra 2 of the group, which may be set this time in the input operation order. Then, the server 3 may determine whether or not one or a plurality of game regions R may be disposed between the corresponding region Ra 2 of the group, which has been set, and the specified other corresponding region Ra 1 of the group, in predetermined arrangement. [0208] In a case where it may be determined that one or the plurality of game regions R may be disposed in the predetermined arrangement, the server 3 may determine whether or not all of the determined game regions R may be corresponding regions of another group which may be different from the group of this time in the input operation order. Then, in a case where it may be determined that all of the game regions R disposed in the predetermined arrangement may be the corresponding regions of another group, the server 3 may extract a region point of the group of this time in the input operation order, which may be correlated with the game region R disposed in the predetermined arrangement, and may extract a region point of another group which has the game region R disposed in the predetermined arrangement, as the corresponding region. [0209] The server 3 may replace the extracted region point of the group of this time in the input operation order with the extracted region point of another group, and may store the region points replaced with each other. [0210] In this manner, in a game in which the region-point changing processing may be performed, it may be possible to execute a competition between groups to which a plurality of players belongs, and to improve more interest for the game. Each player belonging to a group has a need to progress the game in cooperation with other players belonging to the group, and thus it may be possible to further promote cooperation in the group. In the embodiment and other modification examples, the region point and the corresponding region may be set for each group, and the region-point changing processing may be performed for each group. [0211] A player belonging to each group may correlate a region point with a game region R, in accordance with an operation condition which has been set for each group. For example, the operation condition may correspond to a case where the summation of region points which can be correlated with a game region R by players belonging to each group, in each operable period, may be equal to or less than the predetermined first conditional value. Additionally or alternatively, the operation condition may correspond to a case where the summation of the number of game regions R which can be correlated with region points by players belonging to each group, in each operable period, may be equal to or less than the predetermined second conditional value. [0212] For example, in a case where the first conditional value may be 1000 points, if the summation value of region points correlated by all players belonging to each group reaches 1000 points in the operable period of each group, it may not be possible that the player belonging to the group correlates a region point with a game region R until the next operable period. In a case where the second conditional value may be 50 pieces, if the summation value of the number of game regions R correlated by all players belonging to each group reaches 50 pieces in the operable period of each group, it may not be possible that the player belonging to the group correlates a region point with a game region R until the next operable period. [0213] The operation condition may correspond to a case where the summation of region points which can be correlated with a game region R by players belonging to each group, for a period from a start of the game to an end of the game, may be equal to or less than a third predetermined conditional value. Additionally or alternatively, the operation condition may correspond to a case where the summation of the number of game regions R which can be correlated with a region point by a players belonging to each group for a period from a start of the game to an end of the game may be equal to or less than a fourth predetermined conditional value, and the like. The first conditional value, the second conditional value, the third conditional value, and the fourth conditional value may vary for each group. [0214] Thus, each player belonging to a group has a need to progress the game in cooperation with other players belonging to the group, and thus it may be possible to further promote cooperation in the group. MODIFICATION EXAMPLE 5 [0215] The progress control unit 331 in the server 3 may associate each player with a player reward in accordance with the region point correlated with a game region R by each player participating in the game. The player reward may be game content, an item, virtual currency, or the like which may be used in another game, another event, and the like. [0216] For example, the progress control unit 331 may store a region point included in the input data transmitted by each player, in the server storage unit 32 . When the game may be ended, the progress control unit 331 calculates the summation value of the region points of the player, which have been stored in the server storage unit 32 . The player reward depending on the calculated summation value may be stored in the server storage unit 32 in association with each player. The summation value may be a summation value of region points for corresponding regions of each player when the game maybe ended. [0217] The progress control unit 331 may associate the group reward with each player, in accordance with the region point correlated with the corresponding region of a group to which each of players participating in the game belongs. The group reward may be game content, an item, virtual currency, or the like which may be used in another game, another event, and the like. The group reward may be different from the player reward. [0218] For example, when the game may be ended, the progress control unit 331 may calculate the summation value of the region points correlated with the corresponding regions of each player, which have been stored in the server storage unit 32 , for each group. The group reward depending on the calculated summation value of the region points of each group may be stored in the server storage unit 32 in association with each player belonging to each group. The summation value may be a summation value of the region points correlated with the corresponding regions of a group to which each of the players belongs, or be a summation value of the region points of each group, which may be correlated with game regions R by each of the players participating in the game, in the middle of executing the game. [0219] Thus, in a group competition in the correlation game such as a domination game, it may be possible to obtain a reward depending on an individual record or a reward depending on the degree of the group participating in the game, in addition to a competition result. Thus, it may be possible to further improve player interest in the game. Because each player participates in the game while simultaneously having to consider a strategy for improving an individual record and a strategy for improving a group record, players' interest may be held for longer and the game may be vitalized. MODIFICATION EXAMPLE 6 [0220] The corresponding region R of a player may be displayed based on predetermined color information associated with the player. However, the predetermined color information may be changed in accordance with the region point of the player, which may be correlated with the corresponding region R, and the corresponding region R may be displayed based on the changed color information. For example, the progress control unit 331 in the server 3 may specify predetermined color information associated with a player. The progress control unit 331 changes brightness, chroma, or hue in the predetermined color information in accordance with the region point of the player, which may be correlated with the corresponding region R of the player. The progress control unit 331 may create display data for displaying a game screen including the game field F which may include the corresponding region R, based on the changed color information. [0221] In the corresponding region R of a player, the predetermined color information associated with the player may be changed in accordance with the region point of another player, which may be correlated with the corresponding region R. The corresponding region R may be displayed based on the changed color information. [0222] In the corresponding region R of a player, predetermined color information associated with the player may be changed in accordance with the region point of the player, which may be correlated with the corresponding region R and the region point of another player. The corresponding region R may be displayed based on the changed color information. For example, a relative point such as a different value between the region point of the player and the region point of another player may be calculated, and predetermined color information may be changed in accordance with the calculated relative point. [0223] Thus, it may be possible to easily visually recognize a region point correlated with a corresponding region R by a player and/or other players, and to determine a game region which may be immediately correlated by the player. [0224] In the portable terminal 2 held by a player, a corresponding region R of the player may be displayed based on first color information, and corresponding regions R of all other players except for the player may be displayed based on second color information. Thus, the player can immediately distinguish the own corresponding region R from corresponding regions R of other players except for the player. The portable terminal 2 held by a player may have a function of performing switching between display of a corresponding region based on color information associated with each of a plurality of players, and display of corresponding regions based on first color information for the player and second color information for all other players. Thus, it may be possible to display a corresponding region in a display form desired by a player. MODIFICATION EXAMPLE 7 [0225] In a case where a predetermined period elapses from a start of the game, the progress control unit 331 in the server 3 may end the game. In a case where the summation value of region points correlated with a game region by players participating in the game exceeds a predetermined value, the progress control unit 331 may end the game. [0226] Thus, the game may be ended at a timing which may not be expected by a player, and thus it may be possible to provide a game further requiring a strategy of a player. MODIFICATION EXAMPLE 8 [0227] The above-described functions of the server processing unit 33 may be executed in the processing unit 25 in the portable terminal 2 . In this case, if various tables may be stored in the storage unit 22 , it may not be necessary that a communication with the server 3 may be performed every time processing may be performed, and the above functions can be realized only by the portable terminal 2 . The game executed in the portable terminal 2 may be a hybrid-game in which the server 3 and the portable terminal 2 handle a portion of the processing. In this case, for example, web display and a native display may be provided. In the web display, the game screen relating to the progress of the game may be displayed in the portable terminal 2 based on display data generated by the server 3 . In the native display, others of a menu screen and the like may be displayed by a native application which may be installed on the portable terminal 2 . MODIFICATION EXAMPLE 9 [0228] The game system 1 may have a configuration of including only a plurality of portable terminals 2 which may be respectively operated by a plurality of players. Each of the plurality of portable terminals 2 may perform wireless communication with other portable terminals 2 by a wireless communication scheme of the IEEE802.11 standards. The plurality of portable terminals 2 may constitute an ad hoc network. In this case, a specific portable terminal 2 among the plurality of portable terminals 2 may function as a host, and may execute the above-described functions of the server 3 . A portable terminal 2 other than the specific portable terminal 2 among the plurality of portable terminals 2 may communicate with the specific portable terminal 2 that executes the functions of the server 3 , and thus the above-described game may be executed. The specific portable terminal 2 functioning as the host may execute both of the functions of the server 3 and the functions of the portable terminal 2 . [0229] The skilled person of the related art can understand that various changes, substitutions, and modifications maybe added without departing from the gist and the scope of the present invention.

A control program for a game device having a storage unit configured to store points associated with players. The game device may receive a request by a player to designate at least a portion of the points associated with the first player as region points of the first player, which may in turn be correlated with a game region designated by the first player. When the first player has the most points for a particular game region, the game region may be set to be a region of the first player. When the first player disposes a first and second game region in a predetermined arrangement, such that the first and second game region has game regions between them, the game regions between the first and second game region may have their point values swapped to put the first player on top.

DESCRIPTION FIELD OF THE INVENTION The present invention concerns improved make-up brushes and more particularly eyelash brushes, that is to say brushes intended to apply a make-up product such as mascara to the eyelashes. BACKGROUND OF THE INVENTION The eyelash brushes known at present consist of a handle whose end carries the brush proper. They are generally made by means of tufts of bristles held between metal wire. Certain eyelash brushes have also been proposed in which these bristles are replaced by hook-shaped bristles of a material such as that sold under the Trade Name "VELCRO". These brushes naturally have constant and well- defined characteristics, both as regards the disposition and distribution of the bristles in space and as regards the suppleness of hardness of the brush. Similarly, the quantity of the make-up product capable of being retained on the brush remains constant for a given make-up product. Now, the requirements of the users of these brushes may vary a very great deal. In fact, the shape, the number, the disposition and the length of the eyelashes may vary considerably from person to person, as may also their thickness and suppleness. Moreover, the make-up products currently on sale are becoming more and more numerous and have very different characteristics of colouring, viscosity etc. Finally, the make-up habits vary enormously from person to person. The invention proposes to overcome these various problems and to supply an improved make-up brush, in particular an eyelash brush, which would be capable of being adapted to the various requirements encountered, whether these requirements are dictated by the user or related to the nature of the make-up product used. Moreover, the invention proposes to supply such a brush which could be of simple design, inexpensive, and easy to make. SUMMARY OF THE INVENTION The present invention provides an improved make-up brush, in particular an eyelash brush, comprising: shaft means; brush means including means regularly distributed around the longitudinal axis of the make-up brush to serve as bristles; and means actuable by the user for varying the diameter of the brush means, at least locally, at said regularly distributed bristle means. Thus, the improved make-up brush according to the invention may adopt at least two stable states, that is to say, a small diameter state where the diametrical dimension of the brush means is minimal and a large diameter state wherein, on the contrary, this dimension is a maximum for at least a part of the length of the brush means at the bristle means. However, in an improved mode of implementation, provision may be made for the brush to be maintained in intermediate states wherein the diametrical dimension of the brush means is intermediate between the maximum dimension and the minimum dimension. In a first mode of implementation of the invention, the brush means carrying or having the regularly distributed bristle means, or at least a part of this brush means, is designed so as to be capable of varying its length under the effect of suitable actuation means and it is this variation of length which produces a variation in the brush diameter by deformation such that this diameter increases when the length decreases, and vice versa. In a first embodiment of this mode of implementation, the brush means may comprise several deformable longitudinal strips distributed in the space around the longitudinal brush axis and interspaced by gaps, each strip carrying at least one row of bristles. The actuation means may then comprise a simple longitudinally movable rod, for example slideable, within the shaft, one of the ends of this rod forming or comprising an actuation element while the other end is connected to one end of the said strips whose other end is fixed in relation to the shaft. Thus by displacing the rod longitudinally in relation to the shaft, a shortening or an extension of the distance separating the ends of the strips carrying the bristles, and therefore a deformation resulting in variation in the diameter of the strips, is produced. The variations are most pronounced around the central portion of the strips which, because of this, assume a domed shape when they are in their maximum diameter state. The strips may advantageously be strips made of a synthetic or elastomeric material, the bristle extending preferably integrally from the strip and being made, for example, together with the latter by injection moulding. By way of example a hollow sleeve, of a generally cylindrical shape, may thus be moulded of an elastomer and provided with bristles set up perpendicularly to the sleeve surface, preferably in the form of regular rows; after moulding, longitudinal gaps are cut into the sleeve to define the longitudinal strips of the sleeve, the gaps preferably not extending up to the ends of the sleeve. It is thus possible to obtain at one and the same time a very important variation in diameter at the level of the central zone of the strips and, simultaneously, a variation in the suppleness of the brush. In a second embodiment, the brush means comprises a bellows provided with successive notches and fins to form a kind of indentation so that the regularly distributed means serving as bristles are formed by the annular teeth of the identations constituted by the bellows. Advantageously, the bellows has one of its own ends mounted at the end of the shaft and is fixed by its other end to the end of an actuator rod capable of being displaced between a sunken position in the shaft, wherein the bellows is elongated and has a reduced diameter, and a position which is partly extracted from the shaft, wherein the bellows is shortened and its diameter increased. Preferably, the fixing of the bellows both at the end nearer the handle and at the other end to the rod is obtained by catch engagement. This embodiment makes it possible, in particular, to cause the height of the teeth and the average space separating the teeth to vary, which correspondingly allows variation of both the quantity of the make-up product contained on the brush and the conditions of wiping the eyelashes. In another mode of implementation, the regularly distributed bristle means may be mounted on sectors or longitudinal elements, for example strips carrying rows of bristles, these sectors being capable of being brought towards or moved away from the geometric brush axis, for instance, by means of a wedging device actuated by a suitable actuator rod. In another mode of implementation, the regularly distributed bristle means may be carried by an elastomer sleeve which is capable of expanding its diameter, the sleeve being mounted on a diameter variation device, for example one of the wedging type. BRIEF DESCRIPTION OF THE DRAWINGS Other advantages and characteristics of the invention will emerge on reading the following description made by way of a non-restrictive example and referring to the attached drawing wherein: FIG. 1 shows a longitudinal cross-sectional view of a first embodiment of an eyelash brush according to the invention, in its minimum diameter state. FIG. 2 shows this brush in its maximum diameter state; FIG. 3 shows the brush proper, in the state shown in FIG. 2; FIG. 4, showing the brush proper in its minimum diameter state, is a longitudinal half section of a brush according to a second embodiment of the invention; and FIG. 5 shows this brush in its maximum diameter state. PREFERRED EMBODIMENTS OF THE INVENTION Reference will first be made to FIGS. 1 to 3. The eyelash brush according to the invention comprises an elongated tubular shaft 1 whose end is fixed in the usual way to a part 2 forming the closure of a container (not shown) for the eyelash make-up product. This closure part 2, which is of an enlarged diameter, has a skirt 3 provided with internal threads 4 for screwing closure part 2 on to the container neck. This closure part 2 also serves as a holding element for the user. The tubular shaft 1 slideably encloses an elongate rod 5 whose top end is fixed to a button 6 having a suitably striated peripheral edge to facilitate gripping by the user. This button is movable between a high position as in FIG. 2, and a low position as in FIG. 1, and may be retained in these extreme positions thanks to slots 7 which are capable of cooperating with inner ribs 8 disposed within a recess 9 in the top of closure part 2. If button 6 is rotated around the longitudinal axis of rod 5, so as to align slots 7 with ribs 8, the ribs 8 may be dropped into the slots 7 and button 6 can thus come nearer to the rest of closure part 2, as shown in FIG. 1. If, on the other hand, the slots 7 are angularly offset relative to the ribs 8, the base of button 6 rests on the tops of ribs 8 and button 6 is thus found in its position remote from closure part 2, as shown in FIG. 2. It will moreover be seen that the end 10 of rod 5 is rounded, for instance in the manner of a rivet head, and of diameter considerably greater than that of rod 5 and substantially the same as that of the end of tubular shaft 1 so that an elastomer sleeve may be disposed between these two ends to form the brush proper (generally designated 11). This sleeve, obtained for instance by injection moulding, has a hollowed out central part allowing the rod 5 to pass therethrough and has been moulded in the configuration shown in FIG. 1. It has, in fact, a generally cylindrical shape and comprises four radial gaps or slits whose length is shorter than the length of the sleeve so that these radial gaps or slits define four longitudinal strips 13 on the sleeve which are not interconnected except at the ends 14 of the sleeve. Each strip 13 has one or several rows of bristles or supple stumps 15 forming the bristles of the brush. In the FIG. 1 configuration, the distance between the rounded end 10 of the rod 5 and the end of shaft 1 is practically equal to the length of sleeve 11 in its released state. If, starting from this state, button 6 is pulled upwards to bring it into the FIG. 2 position, the distance between end 10 and the end of shaft 1 is shortened so that the various strips 13 of sleeve 11 become deformed outwardly by buckling, thus producing a pronounced increase in the brush diameter, this increase being at its maximum approximately midway along the sleeve. It will thus be understood that the brush may be used by a person either in the minimum diameter configuration shown in FIG. 1, or in the maximum diameter configuration shown in FIG. 2 wherein the button 6 has been rotated around its axis to ensure that the configuration is maintained. If the user wishes to return from the FIG. 2 position to that of FIG. 1, she only has to align the slots 7 with the ribs 8 and then the rod 5 moves downwards under the effect of the elastic force of the deformed sleeve 11 which tends to resume its elongated released position having the reduced diameter of FIG. 1. By suitably determining the nature and thickness of the sleeve 11, different degrees of suppleness and user comfort may be obtained; this suppleness moreover varies according as to whether one is in the position of FIG. 1 or that of FIG. 2. This embodiment may, of course, be subject to many variations. Thus, the number of strips may be higher than four, for instance, six or eight. The shape and disposition of the bristles can obviously be altogether different. The actuating mechanism may also vary according to all forms within the skill of the expert designing the brush. Finally, instead of being connected at their ends, the strips could be completely independent by being then connected, by suitable means, to the rod on the one hand and to the shaft on the other hand. Reference will now be made to FIGS. 4 and 5. In this embodiment, the shaft 1 and rod 5 slideable therewithin are retained. However, in this case the rod 5 is extended in a spherical end 16 which is preceded by a notch. The brush proper is constituted by a flexible bellows 17 forming successive annular teeth 18. The bottom rounded end 19 bounded by this bellows 17 has a small internal lip capable of coming into the notch between the end of rod 16 and the body of rod 5 for the purpose of fixing, by catch engagement, between the spherical end 16 and rod 5. At its open other end 20, the bellows also has a notch capable of allowing the fixing by catch engagement of the bellows end 20 against the lower end of hollow shaft 1, and is for this purpose provided with a small catch engagement bead capable of penetrating within this notch. It will therefore be seen that since the bellows 17 is fixed, on the one hand, to the end of shaft 1 and, on the other hand, to the rod end 16 a rising motion of rod 5 produces a shortening of the bellows 17 and therefore an increase in the diameter of the tips of teeth 18 as well as of the depth of the notch separating two successive teeth 18. Moreover, a variation in suppleness of the bellows may be produced in this way. Preferably, the bellows has sufficient elasticity to cause it to resume the elongated reduced diameter portion of FIG. 4 so that such a bellows 17 can be mounted on a device similar to that of FIGS. 1 and 2 with the same means of actuation. Although the invention has been described with reference to special embodiments, it shall be duly understood that it is in no way limited thereto and that various modifications of shape and materials may be brought thereto without thereby departing either from the scope or spirit of the invention.

A make-up brush, in particular an eyelash brush, includes a bellows or longitudinally slit sleeve defining bristles and adapted to be varied in diameter, by variation in length, so as to suit the wishes of a user or the properties of a make-up product to be applied.

REFERENCE TO EARLIER APPLICATIONS This is a continuation-in-part of pending prior U.S. patent application Ser. No. 10/014,991, filed Dec. 11, 2001 by Gregory E. Sancoff et al. for SURGICAL SUTURING INSTRUMENT AND METHOD OF USE. This patent application also claims benefit of now abandoned prior U.S. Provisional Patent Application Ser. No. 60/322,409, filed Sep. 14, 2001 by Frederic P. Field et al. for ENDOSCOPIC SUTURING INSTRUMENT. The two above-identified documents are hereby incorporated herein by reference. FIELD OF THE INVENTION This invention relates to medical instruments and procedures in general, and more particularly to suturing instruments and methods for suturing. BACKGROUND OF THE INVENTION Suturing instruments are typically used to draw together two or more portions of a subject patient (e.g., tissue such as muscle or skin) or to attach an object to the patient (e.g., to attach a piece of surgical mesh to the abdominal wall of the patient during hernia repair surgery). Certain suturing instruments employ a needle that precedes a length of suture material through a subject. For example, U.S. Pat. Nos. 3,470,875; 4,027,608; 4,747,358; 5,308,353; 5,674,230; 5,690,653; 5,759,188; and 5,766,186 generally disclose suturing instruments in which a needle, with trailing suture material, is passed through a subject. U.S. Pat. Nos. 4,890,615; 4,935,027; 5,417,700; and 5,728,112 generally disclose suturing instruments in which suture material is passed through the end of a hollow needle after that needle has passed through a subject. With all of the foregoing devices, a needle must be passed through the subject in order to deploy the suture. This is generally undesirable, since the needle typically leaves a larger hole in the subject than is necessary to accommodate only the suture material. In this respect it should be appreciated that it is generally desirable to alter each portion of the material being sutured as little as possible. A suturing instrument has been devised which permits the suture material itself to pierce the subject without the use of a needle. However, this device does not permit sufficient flexibility with regard to the amount of tension that may be applied to the suture and tissue. More particularly, U.S. Pat. No. 5,499,990 discloses a suturing instrument in which a 0.25 mm stainless steel suturing wire is advanced to the distal end of a suturing instrument, whereupon the distal end of the suturing wire is caused to travel in a spiral direction so as to effect stitches joining together two portions of a subject. After the spiral is formed, the beginning and end portions of the suture may be bent toward the tissue in order to inhibit retraction of the suture wire into the tissue upon removal of the suturing instrument. The stainless steel wire is sufficiently firm to hold this locking set. In addition, after the spiral is formed, the radius of the deployed suture spiral may then be decreased by advancing an outer tube over a portion of the distal end of the instrument. Again, the stainless steel wire is sufficiently firm to hold this reducing set. Unfortunately, however, such a system does not permit sufficient flexibility in all situations with regard to the appropriate amount of tension to be applied to the subject, since the wire is relatively firm (i.e., firm enough to hold its sets). Such a system also does not provide sufficient flexibility with regard to the appropriate type of suture stitch to be applied, since the device is specifically configured to provide only a spiral suture stitch. In contrast to the aforementioned limitations of the suturing instrument of U.S. Pat. No. 5,499,990, it is desirable that a suturing instrument approximate the portions of the material which is to be joined in the correct physiological relationship, and to urge the portions together with an appropriate amount of force. If too much force (or tension) is applied to the suture material, then the subject portions may become necrotic or the sutures may cut through the subject. If too little tension is applied to the suture material, then the healing process may be impaired. U.S. Pat. No. 4,453,661 discloses a surgical instrument for applying staples. The staples are formed from the distal end of a length of wire. The distal end of the wire is passed through a subject, and thereafter contacts a die that causes the wire to bend, thereby forming the staple. The wire is sufficiently firm to take the set imposed by the die. The staple portion is then cut from the wire by a knife. Again, such a system suffers from the fact that it does not permit sufficient flexibility in all situations with regard to the appropriate tension to be applied to the subject, since the attachment is made by a staple which has a predefined geometry and is formed with relatively firm wire. In addition, the system is limited as to the type of fastening which may be applied, since the surgical instrument is limited to only applying wire staples. There is a need, therefore, for a new suturing device that permits minimally disruptive suturing and permits flexibility in the placement, application, and tensioning of the suture material. SUMMARY OF THE INVENTION The invention provides a device for introducing a flexible elongated element through a subject. In one embodiment, the device includes a proximal end and a distal end, as well as an advancement unit for longitudinally advancing the flexible elongated element toward the distal end of the device such that a distal end of the flexible elongated element may pass from the distal end of the device with sufficient force to pass through the subject. The device also includes a securing unit for variably adjusting a securing force applied by the flexible elongated element so as to provide the desired securement to the subject. In further embodiments, the device includes a guide tube for guiding the flexible elongated element through the device, toward the distal end of the device, as well as a rotation unit for rotating the distal end of the device so as to cause the flexible elongated element to wrap around itself, whereby to adjustably apply the securing force to the flexible elongated element. In another aspect of the invention, there is provided a suturing device comprising: a housing; a shaft extending distally from said housing, at least a portion of said shaft being flexible; a pair of opposing jaws located at a distal end of said shaft; a suture drive mechanism located in said housing and adapted to advance suture material through said shaft, through one of said jaws, through a subject to be sutured, and into the other jaw; and a jaw rotation mechanism located in said housing and adapted to rotate said jaws so as to secure the suture material to the subject. In another aspect of the invention, there is provided a suturing device comprising: a housing; a shaft extending distally from said housing; a pair of opposing jaws located at a distal end of said shaft, said opposing jaws being (i) pivotally connected to said distal end of said shaft, and (ii) pivotally connected to an inner yoke movable relative to said distal end of said shaft, whereby movement of said inner yoke in a distal direction causes said opposing jaws to open relative to one another, and movement of said inner yoke in a proximal direction causes said opposing jaws to close relative to one another; a suture drive mechanism located in said housing and adapted to advance suture material through said shaft, through one of said jaws, through a subject to be sutured, and into the other jaw; and a jaw rotation mechanism located in said housing and adapted to rotate said jaws so as to secure the suture material to the subject. In another aspect of the invention, there is provided a suturing device comprising: a housing; a shaft extending distally from said housing, at least a portion of said shaft being flexible; a pair of movable jaws pivotally connected to the distal end of said shaft in opposing relation such that said jaws can open and close relative to one another; a suture drive mechanism located in said housing and adapted to advance suture material through said shaft, through one of said jaws, through a subject to be sutured, and into the other jaw; a jaw rotation mechanism located in said housing and adapted to rotate said jaws so as to secure the suture material to the subject. In another aspect of the invention, there is provided a suturing device comprising: a housing; a shaft extending distally from said housing; a pair of opposing jaws located at a distal end of said shaft; a suture drive mechanism located in said housing and adapted to advance suture material through said shaft, through one of said jaws, through a subject to be sutured, and into the other jaw; a jaw rotation mechanism located in said housing and adapted to rotate said saws so as to secure the suture material to the subject; and a source of suture material located in the device, said suture material comprising (i) a distal portion having properties favorable for penetrating, twisting and cutting operations, and (ii) a proximal portion having properties favorable for driving operations, said source of suture material being located in the device so that said proximal portion is engaged by said suture drive mechanism. In another aspect of the invention, there is provided a suture material, comprising: a distal portion having properties favorable for penetrating, twisting and cutting operations; and a proximal portion having properties favorable for driving operations. In another aspect of the invention, there is provided a method for treating gastroesophogeal reflux disease (GERD), comprising: providing a suturing device comprising: a housing; a shaft extending distally from said housing; a pair of opposing jaws located at a distal end of said shaft; a suture drive mechanism located in said housing and adapted to advance suture material through said shaft, through one of said jaws, through a subject to be sutured, and into the other jaw; and a jaw rotation mechanism located in said housing and adapted to rotate said jaws so as to secure the suture material to the subject; advancing the distal end of the suturing device into a patient's stomach so that the distal end of the suturing device is adjacent to the wall of the stomach below the lower esophageal sphincter (LES); gathering together portions of the stomach wall below the LES with the pair of opposing jaws; operating the suture drive mechanism so as to advance suture material through the gathered-together portions of the stomach wall; and operating the jaw rotation mechanism so as to secure the suture material to the subject and thereby secure together the gathered-together portions of the stomach wall. In another aspect of the invention, there is provided a method for effecting hemostasis, comprising: providing a suturing device comprising: a housing; a shaft extending distally from said housing; a pair of opposing jaws located at a distal end of said shaft; a suture drive mechanism located in said housing and adapted to advance suture material through said shaft, through one of said jaws, through a subject to be sutured, and into the other jaw; and a jaw rotation mechanism located in said housing and adapted to rotate said jaws so as to secure the suture material to the subject; advancing the distal end of the suturing device into a patient adjacent to tissue which would benefit by effecting hemostasis; gathering together portions of the tissue which would benefit by effecting hemostasis with the pair of opposing jaws; operating the suture drive mechanism so as to advance suture material through the gathered-together portions of the tissue; and operating the jaw rotation mechanism so as to secure the tissue and thereby effect hemostasis. BRIEF DESCRIPTION OF THE DRAWINGS These and other objects and features of the present invention will be more fully disclosed or rendered obvious by the following detailed description of the preferred embodiment of the invention, which is to be considered together with the accompanying drawings wherein like numbers refer to like parts, and further wherein: FIG. 1 is a side view of a suturing instrument formed in accordance with the present invention; FIG. 2 is a partial side view, partially in section, of the suturing instrument shown in FIG. 1 ; FIG. 3 is a partial top view, partially in section, of the suturing instrument shown in FIG. 1 ; FIG. 4 is a schematic partial side view showing some of the internal components of the suturing instrument shown in FIG. 1 ; FIG. 4A is a perspective view of a drive barrel assembly incorporated in the suturing instrument shown in FIG. 1 ; FIG. 5 is a perspective view of a wire guide support unit incorporated in the suturing instrument shown in FIG. 1 ; FIG. 6 is a perspective view of the suturing instrument's wire supply cartridge, which includes the wire guide support unit shown in FIG. 5 ; FIG. 7 is a perspective view, partially in section, of the wire supply cartridge shown in FIG. 6 ; FIG. 8 is a perspective rear view of the drive barrel assembly incorporated in the suturing instrument shown in FIG. 1 , with the drive barrel assembly's release lever being shown in its closed position; FIG. 9 is a perspective view of the proximal (i.e., rear) end of the drive barrel assembly shown in FIG. 8 , with the release lever being shown in its open position; FIG. 10 is a perspective view of the proximal (i.e., rear) end of the same drive barrel assembly, with the release lever being shown in its closed position, and with the wire guide and wire guide support unit being advanced relative to the drive barrel assembly (but with the remainder of the wire supply cartridge being removed from view); FIG. 11 is a schematic view taken along the line 11 — 11 of FIG. 4 ; FIG. 12 is a side view of a shaft and an end effector portion of the suturing instrument shown in FIG. 1 ; FIG. 13 is a side view of the end effector portion of the suturing instrument shown in FIG. 1 ; FIG. 14 is a side view, partially in section, of the end effector portion shown in FIG. 13 , with the end effector portion being shown with its cutting bar in its forward (i.e., non-cutting) position; FIG. 15 is a side view, partially in section, of the end effector portion shown in FIG. 14 , but with the end effector portion being shown with its cutting bar in its retracted (i.e., cutting) position; FIG. 16 is a perspective view of the end effector portion of the suturing instrument shown in FIG. 1 ; FIGS. 17A–17J show various steps in a suturing operation conducted with the suturing instrument shown in FIG. 1 ; FIG. 18 is a sectional view showing one possible construction for the suturing instrument's fixed jaw portion and its associated cutting bar; FIG. 19 is a side view showing a piece of wire cut with the apparatus shown in FIG. 18 ; FIG. 20 is a sectional view showing another possible fixed construction for the suturing instrument's fixed jaw portion and its associated cutting bar; FIG. 21 is a side view showing a piece of wire cut with the apparatus shown in FIG. 20 ; FIG. 22 is a side view, partially in section, of the end effector portion of the device, wherein the end effector portion includes a piezoelectric element to aid in wire penetration; FIG. 23A is a schematic diagram of the device's fixed jaw portion, illustrating how the suture wire may sometimes curve as it exits the fixed jaw portion; FIG. 23B is a schematic diagram of a modified form of the device's fixed jaw portion, illustrating how the profile of the device can be modified so as to counteract the aforementioned wire curvature; FIG. 23C is a schematic diagram of a modified form of the device's movable jaw portion, illustrating how the mouth of the movable jaw portion's opening may be enlarged so as to facilitate suture capture; FIG. 24 is a schematic diagram of a modified form of the device, wherein one or more legs have been provided to help stabilize the tissue during suturing; FIG. 25 is a schematic diagram of another modified form of the device, wherein a second set of jaws have been added to the device to help stabilize the tissue during suturing; FIGS. 26–29 a are schematic diagrams of a preferred embodiment of the present invention illustrating a novel procedure to address gastroesophogeal reflux disease (GERD); FIGS. 30–39 are schematic diagrams of modified forms of suturing instruments with two movable jaw portions for gripping tissue; and FIG. 40 is a schematic diagram of a supply suture wire having a softer distal wire portion optimized for tissue penetration, twisting and cutting, and a harder proximal wire portion optimized for driving. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Overview Looking first at FIG. 1 , there is shown a suturing instrument 10 which comprises a preferred embodiment of the present invention. Suturing instrument 10 includes a housing 12 , a handle 14 , a shaft 16 and an end effector 18 . Suturing instrument 10 also includes a wire advance button 20 , a jaw closing actuator 22 , a wire cutting actuator 24 , a left-thumb-actuated rotation button 26 , and a right-thumb-actuated rotation button 28 ( FIG. 3 ). Suturing instrument 10 also includes a wire supply cartridge 30 , as well as a shaft retaining nut 32 . Shaft retaining nut 32 allows shaft 16 to be dismounted from the remainder of the device for cleaning purposes. As will be discussed in further detail below, generally during use, suture wire (comprising wire formed of metal or any other suitable material having the required flexibility and stiffness) is drawn from a winding in wire supply cartridge 30 and is pushed through housing 12 and shaft 16 to end effector 18 , which includes a pair of opposing jaw portions. The jaw portions may be brought together around the material which is to be sutured by actuating jaw closing actuator 22 when the jaw portions are positioned at an appropriate surgical location. The suture wire is driven through housing 12 and shaft 16 to end effector 18 by actuating wire advance button 20 . The suture wire is driven from one jaw portion to the other jaw portion with sufficient force to penetrate the tissue placed between the jaw portions, and the suture wire is permitted to pass through the second jaw portion. The jaw portions are then permitted to separate and move away from the tissue, leaving the suture wire extending from the subject tissue to each of the two jaw portions. Shaft 16 and end effector 18 (together with wire supply cartridge 30 ) may then be rotated with respect to housing 12 and handle 14 by actuating either left-thumb-actuated rotation button 26 or right-thumb-actuated rotation button 28 . This causes the portions of the suture wire that extend from the tissue to be twisted about one another so as to form a closed loop extending through the tissue. It will be appreciated that the size of this closed loop may be adjustably reduced by increasing the degree of twisting in the wire. The twisted loop of suture wire may then be cut off, at end effector 18 , from the remaining portion of the suture wire that extends back through the suturing instrument. Such cutting may be effected by actuating wire cutting actuator 24 . As will be discussed in further detail below, wire supply cartridge 30 may be supplied separately from suturing instrument 10 , with the wire supply cartridge 30 being loaded into suturing instrument 10 prior to commencing a suturing operation. As will also be discussed in further detail below, wire supply cartridge 30 may be disposable, such that the cartridge may be discarded after all of its wire has been used up. Construction Details As shown in FIGS. 2 and 4 , handle 14 provides a cavity that may receive batteries 34 . In other embodiments, the unit may be powered remotely via a power transmission cord or any other source of suitable power. Batteries 34 supply a ground (or negative) potential to a ground connector post 36 ( FIG. 2 ), which in turn communicates with a rotary ground communicator 38 . Rotary ground communicator 38 permits electrical contact to be maintained with ground connector post 36 when rotary ground communicator 38 is rotated with respect to ground connector post 36 , as occurs when shaft 16 and end effector 18 are rotated so as to twist closed suture wire extending through the tissue. Batteries 34 supply a positive potential to wire advance button 20 , and to a first connector post 40 , which in turn communicates with a first rotary electrical communicator 42 . First rotary electrical communicator 42 permits electrical contact to be maintained with first connector post 40 when first rotary electrical communicator 42 is rotated with respect to first connector post 40 . The positive potential from batteries 34 is also supplied (in parallel) to each thumb-activated rotation button 26 , 28 ( FIG. 3 ), and to a second connector post 44 ( FIG. 2 ), which in turn communicates with a second rotary electrical communicator 46 . Again, second rotary electrical communicator 46 permits electrical contact to be maintained with second connector post 44 when second rotary electrical communicator 46 is rotated with respect to second connector post 44 . Each of the connector posts 36 , 40 and 44 may be spring-biased so as to remain in contact with its respective rotary communicator. In view of the foregoing construction, the positive potentials may be switched on by depressing the respective actuator button 20 , 26 , 28 . Handle 14 also includes a cap 48 which may be removed so as to permit insertion of batteries 34 . First rotary electrical communicator 42 is in electrical communication with a wire advance motor 50 shown in FIGS. 2 and 4 . The output shaft of wire advance motor 50 is coupled to a miter drive gear 52 , which is in turn coupled to a miter follower gear 54 . Miter follower gear 54 is coupled to a drive wheel 56 which contacts the suture wire 58 , as will be described in further detail below with reference to FIGS. 5-10 . Second rotary electrical communicator 46 is in electrical communication with a shaft rotation motor 60 ( FIGS. 3 and 4 ), the output of which is coupled to a pinion gear 62 ( FIGS. 4 , 4 A and 11 ) that rotates along an internal gear 64 ( FIGS. 4 and 11 ). As shown in FIG. 3 , left-thumb-actuated rotation button 26 and right-thumb-activated rotation button 28 may be provided to permit the user to use the thumb of either their left hand or their right hand, respectively, so as to actuate shaft rotation motor 60 . In this respect it will be appreciated that, inasmuch as left-thumb-actuated rotation button 26 and right-thumb-actuated rotation button 28 are wired in parallel, shaft rotation motor 60 will rotate in the same direction regardless of which button (i.e., button 26 or button 28 ) may be actuated. Jaw closing actuator 22 ( FIGS. 2 and 4 ) is coupled to a jaw linkage coupler 66 , which in turn contacts a jaw linkage 68 ( FIGS. 2 and 14 ). When jaw closing actuator 22 is pulled toward handle 14 ( FIG. 2 ), jaw closing actuator 22 pivots on its pivot pin 67 ( FIG. 4 ) so as to drive jaw linkage coupler 66 distally, against the force of biasing spring 69 , and so as to cause the jaw linkage 68 to move forward toward the distal end of suturing instrument 10 . This action will in turn cause movable jaw portion 98 to close on fixed jaw portion 96 ( FIG. 17A ), as will hereinafter be discussed in further detail. When jaw closing actuator 22 is subsequently released, biasing spring 69 ( FIG. 4 ) drives jaw linkage coupler 66 proximally, so as to cause jaw linkage 68 to move proximally. This action will cause movable jaw portion 98 to open relative to fixed jaw portion 96 ( FIG. 14 ), as will hereinafter be discussed in further detail. The action of jaw linkage 68 at the distal end of the device is discussed further below with reference to FIGS. 13 and 14 . Wire cutting actuator 24 is coupled to a wire cutting linkage coupler 70 ( FIGS. 2 and 4 ), which in turn contacts a wire cutting linkage 72 ( FIGS. 2 , 14 and 15 ). When wire cutting actuator 24 is pulled toward handle 14 ( FIG. 2 ), wire cutting actuator 24 pivots on its pivot pin 73 ( FIG. 4 ) so as to drive wire cutting linkage coupler 70 proximally, against the force of biasing spring 69 , and so as to cause wire cutting linkage 72 to move proximally, away from the distal end of suturing instrument 10 . This action will in turn cause cutting bar 104 ( FIG. 14 ) to move proximally ( FIG. 15 ) so as to effect wire cutting, as will hereinafter be discussed in further detail. When wire cutting actuator 24 is subsequently released, biasing spring 69 drives wire cutting linkage coupler 70 distally, so as to cause wire cutting linkage 72 to move distally. This action causes cutting bar 104 to move distally, so as to assume the position shown in FIG. 14 . Wire cutting linkage 72 moves adjacent to, and independent of, jaw linkage 68 discussed above. The action of wire cutting linkage 72 at the distal end of the device is discussed further below with reference to FIGS. 14 and 15 . The wire supply cartridge 30 shown in FIG. 1 includes a wire guide support unit 74 , as shown in FIGS. 5–7 . A supply coil of suture wire 58 (comprising wire formed of metal or any other suitable material having the required flexibility and stiffness) may be supplied in the base of cartridge 30 and is fed into the support unit 74 as shown in FIG. 7 . A wire guide 76 surrounds suture wire 58 , from support unit 74 to the distal end of suturing instrument 10 , adjacent to end effector 18 ( FIGS. 5–7 , 14 and 15 ). Wire guide 76 ensures that suture wire 58 does not bend or buckle as the suture wire is pushed through housing 12 and shaft 16 . More particularly, wire guide 76 preferably forms a sufficiently close sliding fit with suture wire 58 such that suture wire 58 cannot bend or buckle as the suture wire is advanced through suturing instrument 10 . At the same time, wire guide 76 is also formed so as to present a minimum of friction to suture wire 58 as the suture were is advanced through the instrument. The foregoing characteristics are important, inasmuch as suture wire 58 is extremely thin and flexible and highly susceptible to bending or buckling in the absence of some sort of lateral support. By way of example but not limitation, where suture wire 58 is formed out of stainless steel and has a diameter of 0.005 inch, wire guide 76 might have an inside diameter of 0.008 inch and an outside diameter of 0.016 inch. In addition, wire guide 76 is preferably formed out of polytetrafluoroethylene (PTFE) or some other relatively lubricious material. Alternatively, the interior of wire guide 76 may be coated with a lubricant so as to facilitate closely-supported, low-friction passage of the suture wire through the wire guide. Further by way of example but not limitation, in one preferred form of the invention, suture wire 58 may comprise 316 LVM stainless steel having a tensile strength of 170 kpsi. Although wire guide 76 extends through support unit 74 ( FIG. 7 ), wire guide 76 has two openings 78 (one on either side of wire guide 76 , only one of which is shown in FIG. 5 ) in the center of support unit 74 . Openings 78 expose a portion of suture wire 58 so that wire drive wheel 56 ( FIG. 8 ) may contact suture wire 58 and urge the suture wire forward toward the distal end of suturing instrument 10 , as will be discussed in detail below with reference to FIGS. 8–10 . As shown in FIGS. 2 , 3 , 4 A and 8 , housing 12 receives a drive barrel assembly 80 that contains the aforementioned motors 50 and 60 , and provides a distally-extending barrel shaft 81 ( FIGS. 4A and 8 ), on the outside of which are located the rotary communicators 38 , 42 and 46 . A recess 82 ( FIG. 4A ) is provided on the distal end of barrel shaft 81 for receiving a coupling pin 84 ( FIGS. 2 and 4 ) which is located on the proximal end of shaft 16 , such that rotation of drive barrel assembly 80 causes rotation of coupling pin 84 and hence shaft 16 . Drive barrel assembly 80 is rotationally held within housing 12 by bearings 86 , as shown in FIGS. 2 and 3 . Looking next at FIGS. 7–10 , wire supply cartridge 30 may be attached to drive barrel assembly 80 by rotating a release lever 87 away from the center of drive barrel assembly 80 ( FIGS. 8 and 9 ), so as to move a carriage 88 relative to drive barrel assembly 80 . Most particularly, release lever 87 rides on a pin 90 , and rotation of release lever 87 from the position shown in FIG. 8 to the position shown in FIG. 9 draws carriage 88 , as well as a wire follower wheel 92 , away from the center of drive barrel assembly 80 . Once wire follower wheel 92 is separated from wire drive wheel 56 by a sufficient distance to expose the drive barrel assembly's central passageway 93 ( FIG. 9 ), wire guide 76 (overlying suture wire 58 ) may be inserted into passageway 93 ( FIG. 10 ), and wire guide support unit 74 ( FIGS. 6 , 7 and 10 ) may be inserted between wheels 56 and 92 ( FIG. 10 ), such that wheels 56 and 92 contact either side of suture wire 58 through openings 78 formed in either side of wire guide 76 . A biasing spring 94 ( FIGS. 8–10 ) is provided on carriage 88 to urge wire follower wheel 92 into close contact with suture wire 58 . In other embodiments, wire follower wheel 92 may also be driven indirectly by wire drive wheel 56 in order to provide additional forces to move suture wire 58 distally (i.e., forward, toward the tool's end effector 18 ). Pinion gear 62 ( FIGS. 4 , 4 A and 11 ) extends distally from drive barrel assembly 80 and engages the housing's internal gear 64 , as shown in FIGS. 4 and 11 . As a result of this construction, when shaft rotation motor 60 is actuated, pinion gear 62 rotates around internal gear 64 , bringing with it the entire drive barrel assembly 80 . This in turn causes shaft 16 to rotate, since shaft 16 is coupled to drive barrel assembly 80 . More particularly, the rotation of drive barrel assembly 80 is transferred to shaft 16 through the shaft's coupling pin 84 ( FIGS. 2 , 4 and 12 ), which is seated in recess 82 ( FIG. 8 ) of drive barrel assembly 80 . End effector 18 (FIGS. 1 and 13 – 16 ) includes the fixed jaw portion 96 and the movable jaw portion 98 . Movable jaw portion 98 is coupled to the aforementioned jaw linkage 68 ( FIG. 14 ) via a jaw linkage pin 100 , such that when jaw linkage 68 is moved distally (i.e., by pulling jaw closing actuator 22 toward handle 14 ), jaw portion 98 is rotated about a pivot pin 102 ( FIG. 13 ) and closes onto fixed jaw portion 96 . Conversely, when jaw linkage 68 is moved proximally (i.e., by the power of biasing spring 69 acting on jaw linkage coupler 66 and hence jaw linkage 68 ), movable jaw portion 98 will open away from fixed jaw portion 96 . It will be appreciated that the force of biasing spring 69 will normally keep movable jaw portion 98 open relative fixed jaw portion 98 ( FIGS. 1 , 13 and 14 ), unless and until jaw closing actuator 22 is activated so as to overcome the bias of spring 69 . Wire cutting linkage 72 ( FIGS. 2 , 3 , 14 and 15 ) is coupled to the cutting bar 104 ( FIGS. 14 and 15 ) that includes a small opening 106 through which suture wire 58 may pass, as will hereinafter be discussed in further detail. Preferably cutting bar 104 is slidably received in a passageway 107 ( FIGS. 14 , 15 , 16 and 17 H) formed in fixed jaw portion 96 . In one position ( FIG. 14 ), cutting bar 104 is positioned in fixed jaw portion 96 such that the cutting bar's opening 106 is aligned with a channel 108 formed in fixed jaw portion 96 , whereby suture wire may be passed from the distal end of wire guide 76 , through channel 108 formed in fixed jaw portion 96 (where it undergoes an approximately 90 degree change of direction), through opening 106 in cutting bar 104 , through a channel extension 108 A formed in fixed jaw portion 96 , and across to movable jaw portion 98 , as will hereinafter be discussed in further detail. However, when wire cutting linkage 72 is moved proximally by pulling wire cutting actuator 24 toward handle 14 , cutting bar 104 is also moved proximally ( FIG. 15 ) so as to cut any suture wire extending from channel 108 (in fixed portion 96 ) into opening 106 (in cutting bar 104 ). In this respect it will be appreciated that it is desirable to form channel extension 108 A with a length greater than channel 108 (see FIGS. 14 and 15 ) so as to prevent the suture wire from being cut in two places (i.e., at channel 108 and again at channel extension 108 A) when cutting bar 104 is moved proximally by pulling on wire cutting actuator 24 . At the same time, however, it should also be appreciated that the fixed jaw portion's channel 108 and channel extension 108 A, and the cutting bar's opening 106 , are all sized, relative to suture wire 58 , so as to provide as much support as possible to the suture wire as it passes through, and out of, fixed jaw portion 96 . It will be appreciated that the force of biasing spring 69 will normally keep cutting bar 104 in its distal position (i.e., with the cutting bar's opening 106 aligned with the fixed jaw portion's channel 108 ), unless and until wire cutting actuator 24 is activated so as to overcome the bias of spring 69 . In view of the foregoing construction, it will be seen that: (1) release lever 87 ( FIGS. 8–10 ) may be activated so as to move wire follower wheel 92 away from, and toward, wire drive wheel 56 so as to permit a full wire supply cartridge 30 (FIGS. 1 and 5 – 7 ) to be loaded into suturing instrument 10 ; (2) activating jaw closing actuator 22 will cause movable jaw portion 98 to close on fixed jaw portion 96 ; (3) activating wire advance button 20 will cause wire drive wheel 56 to advance suture wire 58 through housing 12 and shaft 16 ; (4) activating rotation button 26 and/or rotation button 28 will cause shaft 16 to rotate relative to housing 12 ; and (5) activating wire cutting actuator 24 will cause cutting bar 104 to move proximally so as to sever any suture wire extending from fixed jaw portion 96 . Operation Suturing instrument 10 may be used to apply wire suture 58 to a subject so as to effect a desired suturing operation. By way of example but not limitation, and looking now at FIGS. 17A–17J , suturing instrument 10 may be used to suture together two portions 110 , 112 of a subject which is to be sutured. In a typical case, portions 110 , 112 might comprise two sections of severed tissue which need to be reattached to one another, or two pieces of previously unattached tissue which need to be attached to one another. However, one or the other of the portions 110 , 112 might also comprise artificial mesh or some other object being attached to tissue, etc. In addition, in a typical case, portions 110 , 112 might be located relatively deep within a patient, and might be accessed during a so-called “minimally invasive”, or a so-called “closed surgery”, procedure; however, in other circumstances, portions 110 , 112 might be accessed during a conventional, or so-called “open surgery”, procedure. This later situation might include procedures done at the outer surface of the patient's body, i.e., where portions 110 , 112 comprise surface subjects. In any case, suturing instrument 10 is initially prepared for use by installing batteries 34 into handle 14 , if batteries 34 are not already installed, and by installing wire supply cartridge 30 into the suturing instrument, if a cartridge 30 is not yet installed. As noted above, wire supply cartridge 30 is installed in suturing instrument 10 by (1) moving the drive barrel assembly's release lever 87 to its open position ( FIG. 9 ), so as to move wire follower wheel 92 away from wire drive wheel 56 and thereby expose the barrel assembly's central passageway 93 ; (2) passing the distal end of the cartridge (i.e., the distal end of wire guide 76 ) through drive barrel assembly 80 and shaft 16 until the distal end of wire guide 76 is in communication with the channel 108 formed in fixed jaw portion 96 ( FIG. 14 ), at which point the cartridge's wire guide support unit 74 will be positioned intermediate wire drive wheel 56 and wire follower wheel 92 ( FIG. 2 ); and (3) moving the drive barrel assembly's release lever 87 back to its closed position ( FIG. 8 ), so as to cause wire drive wheel 56 and wire follower wheel 92 to extend through the wire guide's openings 78 and engage suture wire 58 . At this point suturing instrument 10 will be ready for use, with its movable jaw portion 98 being opened away from its fixed jaw portion 96 , and with its cutting bar 104 being in its forward ( FIG. 14 ) position. Next, suturing instrument 10 has its movable jaw portion 98 moved into engagement with its fixed jaw portion 96 (i.e., the jaws 96 , 98 are placed in their “closed” position) by pulling jaw closing actuator 22 toward handle 14 , and then the distal end of suturing instrument 10 is moved adjacent to subject portions 110 , 112 ( FIG. 17A ). In the case of a so-called closed surgical procedure, such positioning will generally involve moving the distal end of the suturing instrument through a cannula and into an interior body cavity; however, it is also envisioned that one might move the distal end of the suturing instrument directly into an otherwise-accessible body cavity, e.g., directly into the colon or esophagus, etc. In the case of a so-called open surgical procedure, such positioning might involve positioning the distal end of the suturing instrument adjacent to more readily accessible subject portions 110 , 112 . In any case, once the distal end of suturing instrument 10 has been placed adjacent to subject portions 110 , 112 , jaw closing actuator 22 is released, such that biasing spring 69 ( FIG. 4 ) will cause movable jaw portion 98 to open away from fixed jaw portion 96 ( FIG. 171B ). Then the distal end of suturing instrument 10 is moved so that its jaws 96 , 98 straddle subject portions 110 , 112 , and then jaw closing actuator 22 is actuated again, by pulling jaw closing actuator 22 toward handle 14 , so as to close movable jaw portion 98 against fixed jaw portion 96 , whereby to capture subject portions 110 , 112 ( FIG. 17C ). Next, wire advance button 20 is activated so as to cause suture wire 58 to be driven forward, out of the distal end of wire guide 76 , through the fixed jaw portion's channel 108 , through opening 106 in cutting bar 104 , through the fixed jaw portion's channel extension 108 A, through subject portions 110 , 112 , and finally through an opening 113 ( FIGS. 14 , 15 and 17 C) formed in movable jaw portion 98 . Suture wire 58 is preferably advanced so that a length 58 A of wire 58 extends approximately 1 centimeter out of the bottom end of movable jaw portion 98 ( FIG. 17C ). In this respect it will be appreciated that, as suture wire 58 leaves fixed jaw portion 96 and engages subject portions 110 , 112 , the fixed jaw portion's channel 108 , the cutting bar's opening 106 and the fixed jaw portion's channel extension 108 A will support the thin suture wire so as to enable the suture wire to penetrate subject portions 110 , 112 . Once this has been done, jaw closing actuator 22 is released so as to permit movable jaw portion 98 to return to its “open” position relative to fixed jaw portion 96 , and then wire advance button 20 is used to pay out additional suture wire 58 as the distal end of suturing instrument 10 is stepped back (e.g., by about a centimeter or so) from subject portions 110 , 112 ( FIG. 17D ). Then jaw closing actuator 22 is used to move jaw portion 98 back into engagement with fixed jaw portion 96 once more ( FIG. 17E ). Next, left-thumb-actuated rotation button 26 , or right-thumb-actuated rotation button 28 , is used to rotate shaft 16 and hence end effector 18 . This causes suture wire 58 to twist on itself, initially creating a relatively large loop 116 ( FIG. 17F ) of suture wire 58 extending from subject portions 110 , 112 toward suturing instrument 10 . However, as rotation button 26 and/or rotation button 28 is used to rotate shaft 16 (and hence end effector 18 ) more and more, the loop 116 of suture material will progressively close down ( FIG. 17G ) so as to form a tight binder for subject portions 110 , 112 . In this respect it will be appreciated that the longer the period of time that end effector 18 is rotated, the greater the amount of twisting of suture wire 58 , and the greater the force holding subject portions 110 , 112 . In this respect it will also be appreciated that suture wire 58 is preferably carefully selected with respect to its flexibility relative to the strength of subject portions 110 , 112 . In particular, suture wire 58 is chosen so as to have a flexibility such that the suture wire will twist, and loop 116 will close down, before subject portions 110 , 112 will undergo substantial deformation and/or tearing. By way of example but not limitation, in practice, it has been found that 0.005 inch diameter stainless steel wire can be used with most types of mammalian tissue such that the suture wire can be twisted closed without causing substantial deformation and/or tearing of the tissue. Once suture wire 58 has been tightened to the desired degree, rotation of shaft 16 and end effector 18 is stopped, i.e., by releasing button 26 or button 28 . Then wire cutting actuator 24 is depressed (e.g., it is pulled back toward handle 14 ) so as to pull cutting bar 104 proximally and thereby sever the suture wire 58 as the suture wire emerges from the fixed jaw portion's channel 108 and enters the cutting bar's opening 106 ( FIG. 17H and FIG. 15 ). This action separates the deployed suture wire extending through subject portions 110 , 112 from the suture wire remaining in wire supply cartridge 30 , wire guide 76 and the fixed jaw portion's channel 108 . Then wire cutting actuator 24 is released, allowing biasing spring 69 to return cutting bar 104 to return to its distal position, and then jaw closing actuator 22 is released, allowing movable jaw portion 98 to move away from fixed jaw portion 96 . Suturing instrument 10 may then be removed from subject portions 110 , 112 which action will pull wire length 58 A from movable jaw portion 98 ( FIG. 171 ). The deployed suture wire 58 may then be pressed down flat against subject portions 110 , 112 , or rounded into a ball, or otherwise operated upon, so as to reduce the profile of, or reduce the tendency to snag on, the deployed suture wire ( FIG. 17J ). It will be appreciated that suturing instrument 10 will have application in a broad range of different suturing operations. More particularly, it will be appreciated that suturing instrument 10 will have application in both “open” and “closed” surgical procedures, with the former including, but not limited to, large entry procedures, relatively shallow procedures, and surface procedures; and with the latter including, but not limited to, surgical procedures where access is gained to an interior structure through the use of a cannula, and surgical procedures where access is gained directly to an internal body cavity without the use of a cannula, e.g., such as a procedure conducted within the colon or the esophagus. It will also be appreciated that suturing instrument 10 will have application where two portions of tissue must be attached to one another (e.g., where two severed pieces of tissue must be re-attached to one another, or where two separate pieces of tissue must be attached to one another, or where two sections of a single piece of tissue must be approximated to one another), and where an object must be attached to the patient (e.g., where surgical mesh must be attached to the patient's abdominal wall during hernia repair surgery, etc.). Among other things, it is believed that suturing instrument 10 will have particular application in the areas of general laparoscopic surgery, general thoracic surgery, cardiac surgery, general intestinal surgery, vascular surgery, skin surgery and plastic surgery. Looking next at FIGS. 18 and 19 , it will be seen that where the fixed jaw portion's channel 108 is disposed so as to be substantially aligned with the center of cutting bar 104 ( FIG. 18 ), suture wire 58 will be cut with a relatively flat leading end 58 B ( FIG. 19 ). However, it has sometimes been found helpful to provide suture wire 58 with a relatively sharp leading point. Such a leading point can help open the subject for the following portion of the suture wire. In addition, such a leading point can help the suture wire penetrate the subject with a substantially straight path, so that the suture wire will reliably enter the movable jaw portion's opening 113 . To this end, it has been found that moving the fixed jaw portion's channel 108 off-center relative to cutting bar 104 ( FIG. 20 ) will cause the leading end 58 B of suture wire 58 to be formed with a relatively sharp tip 58 C ( FIG. 21 ). It is also possible to use suturing instrument 10 to ligate a subject rather than to pass a suture through the subject. For example, suturing instrument 10 might be used to ligate a blood vessel with suture wire 58 . In this case, suturing instrument 10 is deployed so that suture wire 58 will pass around the far side of the subject, rather than through the subject as in the case of the suturing operation of the type described above. By way of example but not limitation, in a typical ligating operation, movable jaw portion 98 is first opened relative to fixed jaw portion 96 . Then suturing instrument 10 is positioned about the subject so that when movable jaw portion 98 is thereafter closed toward fixed jaw portion 96 , the fixed jaw portion's channel 108 and the movable jaw portion's opening 113 will both lie on the far side of the subject. The movable jaw portion 98 is then closed against the fixed jaw portion 96 , and suture wire 58 is passed from fixed jaw portion 96 to movable jaw portion 98 , i.e., around the far side of the subject. The movable jaw portion 98 is then opened, and suture wire 58 is payed out as the instrument is stepped back from the subject. Then the movable jaw portion 98 is again closed against the fixed jaw portion 96 . The shaft of the instrument is then rotated so as to form, and then close down, the ligating loop. Then cutting bar 104 is activated so as to cut the ligating loop from the remainder of the suture wire still in the tool, the movable jaw member 98 is opened, and the instrument is withdrawn from the surgical site. The deployed suture wire 58 may then be pressed down flat against the subject, or rounded into a ball, or otherwise operated upon, so as to reduce the profile of, or reduce the tendency to snag on, the deployed suture wire. As will be appreciated by a person skilled in the art, where instrument 10 is to be used for ligating purposes, fixed jaw portion 96 and movable jaw portion 98 might be formed with a greater longitudinal length so as to facilitate passing the suture wire around the far side of the subject. Furthermore, movable jaw member 98 might be formed with a recess, intermediate its jaw linkage pin 100 ( FIG. 15 ) and its opening 113 , for accommodating the subject, whereby to prevent compressing the subject when movable jaw member 98 is moved into engagement with fixed jaw member 96 . Suture wire 58 may comprise a wire formed out of a metal or any other suitable material having the required flexibility and stiffness. By way of example but not limitation, suture wire 58 may comprise stainless steel, titanium, tantalum, etc. If desired, suture wire 58 may also be coated with various active agents. For example, suture wire 58 may be coated with an anti-inflammatory agent, or an anti-coagulant agent, or an antibiotic, or a radioactive agent, etc. Looking next at FIG. 22 , it is also possible to impart ultrasound energy to the wire in order to make tissue penetration easier. More particularly, because of the small cross-sectional area of the wire and the propensity for the wire to buckle when axially loaded, it is beneficial to be able to advance the wire into tissue with a minimum of load. This can be achieved by appropriately applying ultrasound energy to the wire. A piezoelectric element 200 is placed at the outside radius of the wire guide path 108 at the right angle bend in the fixed jaw portion 96 just before where the wire enters the tissue. The piezoelectric element 200 vibrates at a position along this bend such that it supports the wire in completing the turn but also imparts a component of displacement in the direction of the tissue. Displacement of this kind at ultrasonic frequencies, in addition to the existing wire driving means, would cause the tip of the wire to penetrate the tissue using less force. In addition to reducing the tendency for outright wire buckling, lowering the wire loads will also allow the wire penetration to proceed in a straighter path. Looking next at FIG. 23A , it will be seen that, in some circumstances, the suture wire 58 may exit fixed jaw portion 96 with a curvature, due to the fact that suture wire 58 follows curved channel 108 in fixed jaw portion 96 . In some cases this curvature in the suture wire 58 may be quite modest, so that it may be effectively ignored. However, in other circumstances, this curvature might be large enough to cause the suture wire advancing out of fixed jaw portion 96 to miss the target opening 113 in movable jaw portion 98 . In this case the curvature in suture wire 58 can present a significant problem. However, and looking now at FIG. 23B , it has been found that the profile of the cutting bar's opening 106 may be modified so as to provide a deflecting die which will counteract undesirable curvature in the suture wire and return the suture wire to a straight path as the suture wire exits fixed jaw portion 96 . Alternatively, the profile of the fixed jaw portion's channel 108 may be modified, adjacent to cutting bar 104 , so as to provide a similar deflecting die which will counteract undesirable curvature in the suture wire and return the suture wire to a straight path as the suture wire exits fixed jaw portion 96 . Futhermore, and looking now at FIG. 23C , the mouth of the movable jaw portion's opening 113 may be enlarged to help capture a suture wire deviating from a straight path. Looking next at FIG. 24 , it will be seen that one or more legs 300 may be provided on suturing instrument 10 , wherein legs 300 help stabilize the tissue during suturing. And looking next at FIG. 25 , it will be seen that a grasper 400 , comprising jaws 405 and 410 , may be added to suturing instrument 10 to help stabilize the tissue during suturing. If desired, the end effector 18 of suturing instrument 10 may be constructed so as to have two movable, opposing jaws, rather than one fixed jaw and one movable jaw as described above. Also, if desired, shaft rotation motor 60 and thumb buttons 26 , 28 may be configured so that depressing one button (e.g., button 26 ) will cause end effector 18 to rotate in one direction (e.g., clockwise), and depressing the other button (e.g., button 28 ) will cause end effector 18 to rotate in the opposite direction (e.g., counterclockwise). Significantly, it has been found that the present invention has particular application in a novel procedure to address gastroesophogeal reflux disease (GERD), among others. More particularly, with this novel procedure, suturing instrument 10 may be used to gather tissue below the stomach's lower esophageal sphincter (LES) so as to improve its function and thereby reduce the symptoms of GERD. In one preferred form of the invention, and looking now at FIGS. 26–29 , suturing instrument 10 is inserted into the interior of a patient's stomach so that its end effector 18 is located adjacent to the wall of the LES ( FIG. 26 ), jaw portions 96 and 98 are used to gather together two spaced sections 110 , 112 of the wall of the LES ( FIG. 27 ), and then suture wire 58 is used to secure together, in the manner previously described, the gathered-together portions of the stomach wall below the LES ( FIGS. 28 and 29 ). The foregoing steps may be repeated as many times as is necessary to adequately gather the stomach wall below the patient's LES and thereby improve its function and reduce the symptoms of GERD. In this respect it has also been found that it may be useful to construct suturing instrument 10 in certain ways, or to modify suturing instrument 10 in certain ways, so as to facilitate its use in the aforementioned GERD procedure, among others. Thus, for example, it has been found that the aforementioned GERD procedure may be advantageously carried out by approaching the LES through the esophagus, preferably through the working lumen of an endoscope. To this end, suturing instrument 10 is preferably formed so as to be flexible along its length. This may be accomplished by forming shaft 16 ( FIGS. 1 and 14 ) out of a flexible material, and by forming its internal components (e.g., jaw linkage 68 , wire cutting linkage 72 and wire guide 76 ) out of flexible elements. By way of example but not limitation, shaft 16 may be formed with a plastic, metal-reinforced construction, such as a construction of the sort used to form flexible endoscopes; jaw linkage 68 and wire cutting linkage 72 may be formed out of flexible metal rods; and wire guide 76 may be formed out of polytetrafluoroethylene (PTFE). Alternatively, and looking next at FIG. 29A , a portion of shaft 16 may be removed, e.g., at A, so as to leave a smaller, flexible spine B connecting a distal section C with a proximal section D. If desired, spine B may be formed integral with, and out of the same material as, distal section C and proximal section D; alternatively, spine section B may be formed out of another material, e.g., Nitinol. Furthermore, if desired, the connecting section B could be located along the center axis of shaft 16 , e.g., by making it out of a separate piece of material connected to both distal section C and proximal portion D. This latter construction can be particularly advantageous in that it can be relatively stiff in torsion as to transmit torque, yet flexible in bending along its length. Furthermore, in using suturing instrument 10 in the aforementioned GERD procedure, it has been found that the LES can frequently be difficult to grasp and draw together, due to (i) the angle of attack to the tissue, (ii) the slippery nature of the tissue, and (iii) the variable tones of the tissue. As a result, it has also been found that it can be helpful to provide two movable jaw portions for gripping the tissue. More particularly, and looking now at FIGS. 30–39 , two movable jaw portions 96 A, 98 A may be provided at the distal end of shaft 16 . Jaw portions 96 A, 98 A are pivotally pinned, via pivot pins 100 A and 100 B, respectively, to an outer yoke 16 A secured to the distal end of shaft 16 ( FIG. 31 ). At the same time, jaw portions 96 A, 98 A are also pivotally pinned, via pivot pins 100 C riding in a slot 100 D, to an inner yoke 16 B ( FIG. 33 ). Inner yoke 16 B is movably disposed within outer yoke 16 A and is secured to the end of jaw linkage 68 A. As a result of this construction, when inner yoke 16 B is moved distally by jaw linkage 68 A, jaw portions 96 A, 98 A will open relative to one another ( FIG. 31 ); and when inner yoke 16 B is moved proximally by jaw linkage 68 A, jaw portions 96 A, 98 A will close together ( FIG. 37 ). The foregoing construction is highly advantageous for several reasons, among others: (i) by providing two movable jaw portions, the mouth of the suturing instrument can be enlarged so as to facilitate gripping and drawing together tissue, e.g., such as in the aforementioned GERD procedure, and (ii) by using a single, movable inner yoke 16 B to open and close jaw portions 96 A, 98 A pinned to a fixed outer yoke 16 A, the two jaw portions can be made to reliably open and close to a corresponding and symmetrical extent, thereby ensuring uniform mouth operation at all times. In addition to the foregoing, jaw portions 96 A, 98 A are preferably provided with offset distal teeth (or fangs) 96 B, 98 B, respectively ( FIG. 30 ). These teeth (or fangs) 96 B, 98 B enhance the ability of the jaw portions to grip tissue, particularly hard-to-grip tissue such as the LES during the aforementioned GERD procedure. Inasmuch as jaw portions 96 A, 98 A both move, it can also be advantageous to modify certain aspects of the suturing instrument from the construction previously disclosed. More particularly, with the suturing instrument disclosed above, jaw portion 96 , which delivers suture wire 58 to the tissue, is fixed relative to shaft 16 , and wire guide 76 extends linearly into jaw portion 96 and preferably confronts a stop shoulder ( FIG. 14 ). However, with the embodiment disclosed in FIGS. 30–39 , both jaw portion 96 A and jaw portion 98 A move relative to shaft 16 . As a result, with the construction of FIGS. 30–39 , it is preferred that the distal end of wire guide 76 A ( FIG. 39 ) terminate in jaw portion 96 A in a slightly different manner so that suture wire 58 can be reliably guided into the wire guide path in jaw portion 96 A. At the same time, inasmuch as it is desirable to increase the radius of curvature imposed on suture wire 58 , it is preferred that wire guide 76 A be outboard of pivot pin 100 A, so that wire guide 76 A can “cut the corner” when jaw portion 96 A is in its open position ( FIG. 33 ). To this end, since the distal end of wire guide 76 A may move slightly relative to jaw portion 96 A depending on the pivotal position of jaw portion 96 A, it is preferred that the distal end of wire guide 76 A be provided with a flange 76 B ( FIG. 33 ) which is received in a slot 96 C which is formed in jaw portion 96 A, whereby wire guide 76 A can be attached to jaw portion 96 A with a floating engagement. In order to prevent cutting bar 104 and/or wire cutting linkage 72 from impeding the opening and/or closing of jaw portion 96 A, it is preferred that cutting bar 104 and wire cutting linkage 72 be sized so that they can both be fully withdrawn from jaw portion 96 A when cutting bar 104 is in its withdrawn (i.e., proximal) position. And in one preferred form of the invention, cutting bar 104 and its associated wire cutting linkage 72 are replaced by a single cutting rod 104 A ( FIGS. 37 and 38 ) which extends from housing 12 to the end of shaft 12 . The distal end of cutting rod 104 A is used to selectively intrude across the wire guide path formed in jaw portion 96 A so as to sever suture wire deployed from the suturing instrument. Cutting rod 104 A is preferably formed out of a flexible material, such that cutting rod 104 A can extend into jaw portion 96 A even when intervening tissue should prevent full closure of jaw portion 96 A and 98 A. In the aforementioned GERD procedure, it has been found that where the LES is accessed through the esophagus, wire must be driven a fairly long distance, e.g., from an area proximal to the proximal end of the endoscope (typically located a significant distance from the patient's mouth) to an area distal to the distal end of the endoscope (typically located at the LES). In practice, this is typically a distance of approximately 3 feet for a gastroscope (and up to 5 feet long for a colonoscope, when doing colon procedures, see below). However, it has been found that it can be difficult to drive the suture wire such a long distance. This is because the suture wire is typically chosen for its penetrating, twisting and cutting characteristics, and this typically means using relatively soft wire, e.g., 316L stainless steel wire having a tensile strength of 160 kpsi. Thus, in one form of the invention, it has been found helpful to supply suture wire 59 A ( FIG. 40 ) of two differing characteristics: (i) a softer distal wire portion 59 B optimized for tissue penetration, twisting and cutting, and a harder proximal wire portion 59 C optimized for driving. By way of example, while distal wire portion 59 B might comprise 316L stainless steel with a tensile strength of 160 kpsi, proximal wire portion 59 C might comprise 304 stainless steel with a tensile strength of 430 kpsi. Distal wire portion 59 B might be incorporated with wire supply cartridge 30 during manufacture, or distal wire portion 59 B might be added to wire supply cartridge 30 and/or suturing instrument 10 after proximal wire portion 59 C has been installed in wire supply cartridge 30 . Distal wire portion 59 B may or may not be secured to proximal wire portion 59 C. It should also be appreciated that while suturing instrument 10 uses the aforementioned drive barrel assembly 80 ( FIG. 8 ) to drive suture wire 58 (or suture wire 58 A), other apparatus may be used to drive the suture wire, e.g., a wire drive mechanism such as is disclosed in pending U.S. patent application Ser. No. 10/051,322, filed Jan. 18, 2002 by Frederic P. Field et al. for SURGICAL SUTURING INSTRUMENT AND METHOD OF USE; or a wire drive mechanism such as is disclosed in pending U.S. patent application Ser. No. 10/039,601, filed Oct. 19, 2001 by Frederic P. Field et al. for SURGICAL SUTURING INSTRUMENT AND METHOD OF USE; or a wire drive mechanism such as is disclosed in pending U.S. patent application Ser. No. 10/082,510, filed Oct. 19, 2001 by Frederic P. Field et al. for SURGICAL SUTURING INSTRUMENT AND METHOD OF USE; or any other wire drive mechanism consistent with the present invention. The three aforementioned patent applications are hereby incorporated herein by reference. The foregoing constructions and/or modifications have been found to be particularly advantageous for effecting the aforementioned GERD procedure, particularly when accessing the LES through the esophagus. However, it should also be appreciated that one or more of these constructions and/or modifications may also be applicable to other surgical procedures including, but not limited to, a gastric bypass procedure; hemostasis for peptic ulcer disease; closing perforations within the gastrointestinal tract; fixing stents within the gastrointestinal tract or elsewhere in the body; fixing GERD monitoring apparatus in place within the gastrointestinal tract; closing endoscopic mucosal resection (EMR) sites within the stomach and/or the colon; and in other surgical procedures which will be obvious to those skilled in the art in light of the present disclosure. Modifications It will be appreciated by those skilled in the art that numerous modifications and variations may be made to the above-disclosed embodiments without departing from the spirit and scope of the present invention.

A device is disclosed for introducing a flexible elongated element through at least two portions of a subject. In an embodiment, the device includes a proximal end and a distal end, as well as an advancement unit for longitudinally advancing the flexible elongated element toward the distal end such that a distal end of the elongated element may pass from the distal end of said device with sufficient force to pass through the portions of the subject. The device also includes a securing unit for variably adjusting a securing force applied by the flexible elongated element to secure together the portions of the subject.

[0001] This application claims priority to provisional U.S. Patent Application No. 62/014,060, titled “Mitral Valve Implants for the Treatment of Valvular Regurgitation” and filed Jun. 18, 2014. The entire disclosure of the foregoing priority application is hereby incorporated by reference herein for all purposes. BACKGROUND [0002] 1. Field [0003] The present invention generally provides improved medical devices, systems, and methods, typically for treatment of heart valve disease and/or for altering characteristics of one or more valves of the body. Embodiments of the invention include implants for treatment of mitral valve regurgitation. [0004] The human heart receives blood from the organs and tissues via the veins, pumps that blood through the lungs where the blood becomes enriched with oxygen, and propels the oxygenated blood out of the heart to the arteries so that the organ systems of the body can extract the oxygen for proper function. Deoxygenated blood flows back to the heart where it is once again pumped to the lungs. [0005] The heart includes four chambers: the right atrium (RA), the right ventricle (RV), the left atrium (LA) and the left ventricle (LV). The pumping action of the left and right sides of the heart occurs generally in synchrony during the overall cardiac cycle. [0006] The heart has four valves generally configured to selectively transmit blood flow in the correct direction during the cardiac cycle. The valves that separate the atria from the ventricles are referred to as the atrioventricular (or AV) valves. The AV valve between the left atrium and the left ventricle is the mitral valve. The AV valve between the right atrium and the right ventricle is the tricuspid valve. The pulmonary valve directs blood flow to the pulmonary artery and thence to the lungs; blood returns to the left atrium via the pulmonary veins. The aortic valve directs flow through the aorta and thence to the periphery. There are normally no direct connections between the ventricles or between the atria. [0007] The mechanical heartbeat is triggered by an electrical impulse which spreads throughout the cardiac tissue. Opening and closing of heart valves may occur primarily as a result of pressure differences between chambers, those pressures resulting from either passive filling or chamber contraction. For example, the opening and closing of the mitral valve may occur as a result of the pressure differences between the left atrium and the left ventricle. [0008] At the beginning of ventricular filling (diastole) the aortic and pulmonary valves are closed to prevent back flow from the arteries into the ventricles. Shortly thereafter, the AV valves open to allow unimpeded flow from the atria into the corresponding ventricles. Shortly after ventricular systole (i.e., ventricular emptying) begins, the tricuspid and mitral valves normally shut, forming a seal which prevents flow from the ventricles back into the corresponding atria. [0009] Unfortunately, the AV valves may become damaged or may otherwise fail to function properly, resulting in improper closing. The AV valves are complex structures that generally include an annulus, leaflets, chordae and a support structure. Each atrium interfaces with its valve via an atrial vestibule. The mitral valve has two leaflets; the analogous structure of the tricuspid valve has three leaflets, and opposition or engagement of corresponding surfaces of leaflets against each other helps provide closure or sealing of the valve to prevent blood flowing in the wrong direction. Failure of the leaflets to seal during ventricular systole is known as malcoaptation, and may allow blood to flow backward through the valve (regurgitation). Heart valve regurgitation can have serious consequences to a patient, often resulting in cardiac failure, decreased blood flow, lower blood pressure, and/or a diminished flow of oxygen to the tissues of the body. Mitral regurgitation can also cause blood to flow back from the left atrium to the pulmonary veins, causing congestion. Severe valvular regurgitation, if untreated, can result in permanent disability or death. [0010] 2. Description of the Related Art [0011] A variety of therapies have been applied for treatment of mitral valve regurgitation, and still other therapies may have been proposed but not yet actually used to treat patients. While several of the known therapies have been found to provide benefits for at least some patients, still further options would be desirable. For example, pharmacologic agents (such as diuretics and vasodilators) can be used with patients having mild mitral valve regurgitation to help reduce the amount of blood flowing back into the left atrium. However, medications can suffer from lack of patient compliance. A significant number of patients may occasionally (or even regularly) fail to take medications, despite the potential seriousness of chronic and/or progressively deteriorating mitral valve regurgitation. Pharmacological therapies of mitral valve regurgitation may also be inconvenient, are often ineffective (especially as the condition worsens), and can be associated with significant side effects (such as low blood pressure). [0012] A variety of surgical options have also been proposed and/or employed for treatment of mitral valve regurgitation. For example, open-heart surgery can replace or repair a dysfunctional mitral valve. In annuloplasty ring repair, the posterior mitral annulus can be reduced in size along its circumference, optionally using sutures passed through a mechanical surgical annuloplasty sewing ring to provide coaptation. Open surgery might also seek to reshape the leaflets and/or otherwise modify the support structure. Regardless, open mitral valve surgery is generally a very invasive treatment carried out with the patient under general anesthesia while on a heart-lung machine and with the chest cut open. Complications can be common, and in light of the morbidity (and potentially mortality) of open-heart surgery, the timing becomes a challenge—sicker patients may be in greater need of the surgery, but less able to withstand the surgery. Successful open mitral valve surgical outcomes can also be quite dependent on surgical skill and experience. [0013] Given the morbidity and mortality of open-heart surgery, innovators have sought less invasive surgical therapies. Procedures that are done with robots or through endoscopes are often still quite invasive, and can also be time consuming, expensive, and in at least some cases, quite dependent on the surgeon's skill. Imposing even less trauma on these sometimes frail patients would be desirable, as would be providing therapies that could be successfully implemented by a significant number of physicians using widely distributed skills. Toward that end, a number of purportedly less invasive technologies and approaches have been proposed. These include devices which seek to re-shape the mitral annulus from within the coronary sinus; devices that attempt to reshape the annulus by cinching either above to below the native annulus; devices to fuse the leaflets (imitating the Alfieri stitch); devices to re-shape the left ventricle, and the like. [0014] Perhaps most widely known, a variety of mitral valve replacement implants have been developed, with these implants generally replacing (or displacing) the native leaflets and relying on surgically implanted structures to control the blood flow paths between the chambers of the heart. While these various approaches and tools have met with differing levels of acceptance, none has yet gained widespread recognition as an ideal therapy for most or all patients suffering from mitral valve regurgitation. [0015] Because of the challenges and disadvantages of known minimally invasive mitral valve regurgitation therapies and implants, still further alternative treatments have been proposed. Some of the alternative proposals have called for an implanted structure to remain within the valve annulus throughout the heart beat cycle. One group of these proposals includes a cylindrical balloon or the like to remain implanted on a tether or rigid rod extending between the atrium and the ventricle through the valve opening. Another group relies on an arcuate ring structure or the like, often in combination with a buttress or structural cross-member extending across the valve so as to anchor the implant. Unfortunately, sealing between the native leaflets and the full perimeter of a balloon or other coaxial body may prove challenging, while the significant contraction around the native valve annulus during each heart beat may result in significant fatigue failure issues during long-term implantation if a buttress or anchor interconnecting cross member is allowed to flex. Moreover, the significant movement of the tissues of the valve may make accurate positioning of the implant challenging regardless of whether the implant is rigid or flexible. [0016] In light of the above, it would be desirable to provide improved medical devices, systems, and methods. It would be particularly desirable to provide new techniques for treatment of mitral valve regurgitation and other heart valve diseases, and/or for altering characteristics of one or more of the other valves of the body. The need remains for a device which can directly enhance leaflet coaptation (rather than indirectly via annular or ventricular re-shaping) and which does not disrupt leaflet anatomy via fusion or otherwise, but which can be deployed simply and reliably, and without excessive cost or surgical time. It would be particularly beneficial if these new techniques could be implemented using a less-invasive approach, without stopping the heart or relying on a heart-lung machine for deployment, and without relying on exceptional skills of the surgeon to provide improved valve and/or heart function. SUMMARY [0017] In some embodiments, disclosed herein is an implant for treating mal-coaptation of a heart valve. The implant can include one or more of a shape memory structure, a biocompatible membrane coupled to the structure, a hub placed on the proximal side of the implant and coupled to the membrane, one, two, or more holes or perforations along the edge of the membrane on the proximal side, and a ventricular projection coupled to an anchoring device. The implant can be folded for delivery through a percutaneous catheter. A shape memory structure can include a shape memory spine, such as nitinol or PEEK for example. A part of the ventricular projection, such as the distal tip, can be radiopaque. The anchoring device could be active, or passive. The spine can include features such as microholes and microhooks for coupling to the membrane and tissue. [0018] Also disclosed herein is a steerable catheter that includes one or more of a steerable shaft, a rotatable handle that is coupled to a pullwire placed within the shaft to adjust the bend radius of the distal tip of the shaft depending on the amount of torque applied to the handle. In some embodiments, the diameter of the handle of the catheter is equal to the diameter of the steerable shaft, or no larger than the diameter of the steerable shaft. Also disclosed herein is a delivery catheter comprising one or more of the following: a rotatable handle coupled to a pullwire placed within a torqueable shaft to adjust the bend radius of the distal tip of the shaft of the catheter, a sheath designed to contain the implant when the implant is folded, and distal tip further comprising of locking features that enable coupling of delivery catheter to either a hub of an implant or to an anchor. In some embodiments, the catheter can also include a tearable and disposable funnel to aid in the folding of the implant. In some embodiments, the distal tip further comprises locking tabs which are naturally set to be in the unlocked position. The delivery catheter may be coupled to the annular hub of the implant which has features that accept the locking tabs of the delivery catheter. In some embodiments, a guidewire or another catheter may be inserted within the shaft to push the locking tabs to the companion features on the hub of the implant so that the catheter and the hub are locked. The catheter can also include a loop, such as wire running from the proximal handle to the distal tip such that the tension in the loop may be controlled via control on the handle. The delivery catheter may be coupled to the annular hub of the implant which has a cross pin. A guidewire or another catheter may be inserted within the shaft and the loop of wire is tensioned against the cross-pin and the guidewire such that the delivery catheter is locked to the hub of the implant until the tension on the loop is maintained. [0019] An implant can be operatively coupled to tissue, such as heart tissue, via a first coupling of the anchor to the delivery catheter, and a second coupling of the anchor to the implant hub where torque is applied to the delivery catheter to insert the anchor into the hub and the tissue. The first coupling can be uncoupled to retract the catheter. [0020] In some embodiments, commissure anchors can be delivered by one or more of the following steps: coupling an anchor to a shaft of a catheter, advancing the anchor and the catheter to an anchor site, delivering the anchor such that it engages with the implant and tissue, and uncoupling the anchor from the shaft. The shaft can be torqueable, and the engaging mechanism can apply torque to the shaft so that the anchor engages with the implant and tissue. The anchors can be made of shape memory materials and be compressed into the shaft of a catheter for delivery to the anchor site, where the distal tip of the catheter is shaped such that it pierces tissue. The anchors can be advanced after the delivery catheter first pierces the tissue and subsequently the catheter is retracted leaving the anchor in place. [0021] In some embodiments, disclosed is an implant for treating mal-coaptation of a heart valve. The implant can include one or more of the following: a removable shape memory structure, a biocompatible membrane coupled to the structure, a hub placed on the proximal side of the implant and coupled to the membrane, one, two, or more holes or perforations along the edge of the membrane on the proximal side, and a ventricular projection coupled to an anchoring device. The implant can also include at least one passageway, such as a passageway placed around the annular edge, and/or along the ventricular projection. In some embodiments, a plurality, such as 2, 3, 4, 5, or more anchors are delivered to couple an implant to the heart tissue. A delivery device can have a distal section that includes 1, 2, or more anchors rotationally coupled to a central spinning shaft. A spring-loaded mechanism can apply a pushing force so as to cause the anchors to exit the distal end. In some embodiments, the anchors can be housed in a housing with grooves on the inside diameter such that as the central spinning shaft rotates, the anchors may exit the distal end. The device can include one or more of, for example, a hollow shaft, a pointed end at the end of the hollow shaft, one, two, or more hollow barrels placed within the hollow shaft threaded by a wire, and a pusher at the proximal end such that when a force is applied to the pusher, the barrels exit the hollow shaft one by one. [0022] In some embodiments, disclosed herein is a steerable guidewire, comprising an elongate flexible body, having a longitudinal axis, a proximal end and a distal deflection zone; a control on the proximal end, for controllable deflection of the deflection zone; and a movable deflection element extending from the control to the deflection zone. In some embodiments, no portion of the guidewire has an outside diameter of greater than about 10 French, 8 French, 6 French, or 4 French. The control can have an outside diameter that is no greater than the outside diameter of the body. Rotation of the control about the axis can cause lateral movement of the deflection zone. Rotation of the control in a first direction about the axis can cause proximal retraction of the deflection element. [0023] Also disclosed herein is an implantable coaptation assistance device, comprising a flexible body; a first, concave surface on the body, configured to restrain a posterior leaflet; a second, convex surface on the body, configured to contact an anterior leaflet; an arcuate, peripheral superior edge on the body defining an opening which faces away from the first surface; and a ventricular projection extending away from the body and configured to anchor in the ventricle. The device can also include an anchor on the ventricular projection. The anchor could be active or passive. The device can also include a flexible spine for supporting the arcuate peripheral edge. The spine can be removable in some cases. [0024] Also disclosed herein is an anchoring system for attaching a ventricular projection of an implantable coaptation device. The system can include a shoulder, having an aperture extending therethrough; a helical tissue anchor, extending distally from the hub; a first engagement structure on the anchor, for releasable engagement of a torque shaft; a second engagement structure on the torque shaft, for engaging the anchor; and an implant, having a hub dimensioned to receive the helical anchor through; wherein the torque shaft is configured for rotation to drive the helical anchor into tissue and secure the implant to tissue. The first engagement structure can be an aperture, and the second engagement structure can be a projection. The projection can be laterally moveable into and out of the aperture, such as in response to axial movement of an elongate element within the torque shaft. [0025] In some embodiments, a steerable guidewire is provided. The steerable guidewire can include an elongate flexible body, having a longitudinal axis, a proximal end and a distal deflection zone. The steerable guidewire can include a control on the proximal end, for controllable deflection of the deflection zone. The steerable guidewire can include a movable deflection element extending from the control to the deflection zone. In some embodiments, no portion of the guidewire has an outside diameter of greater than about 10 French. In some embodiments, no portion of the guidewire has an outside diameter of greater than about 6 French. In some embodiments, no portion of the guidewire has an outside diameter of greater than about 4 French. In some embodiments, the control has an outside diameter that is no greater than the outside diameter of the body. In some embodiments, rotation of the control about the axis causes lateral movement of the deflection zone. In some embodiments, rotation of the control in a first direction about the axis causes proximal retraction of the deflection element. [0026] In some embodiments, an implantable coaptation assistance device is provided. The implantable coaptation assistance device can include a flexible body. The implantable coaptation assistance device can include a first, concave surface on the body, configured to restrain a posterior leaflet. The implantable coaptation assistance device can include a second, convex surface on the body, configured to contact an anterior leaflet. The implantable coaptation assistance device can include an arcuate, peripheral superior edge on the body defining an opening which faces away from the first surface. The implantable coaptation assistance device can include a ventricular projection extending away from the body and configured to anchor in the ventricle. [0027] In some embodiments, the implantable coaptation assistance device can include an anchor on the ventricular projection. In some embodiments, the implantable coaptation assistance device can include an active anchor. In some embodiments, the implantable coaptation assistance device can include a passive anchor. In some embodiments, the implantable coaptation assistance device can include a flexible spine for supporting the arcuate peripheral edge. In some embodiments, the spine is removable. [0028] In some embodiments, an anchoring system for attaching a ventricular projection of an implantable coaptation device is provided. The anchoring system can include a shoulder, having an aperture extending therethrough. The anchoring system can include a helical tissue anchor, extending distally from the hub. The anchoring system can include a first engagement structure on the anchor, for releasable engagement of a torque shaft. The anchoring system can include a second engagement structure on the torque shaft, for engaging the anchor. The anchoring system can include an implant, having a hub dimensioned to receive the helical anchor through. In some embodiments, the torque shaft is configured for rotation to drive the helical anchor into tissue and secure the implant to tissue. In some embodiments, the first engagement structure is an aperture, and the second engagement structure is a projection. In some embodiments, the projection is laterally moveable into and out of the aperture. In some embodiments, the projection is laterally moveable into and out of the aperture in response to axial movement of an elongate element within the torque shaft. [0029] In some embodiments, an implantable coaptation assistance device is provided. The implantable coaptation assistance device can include a coaptation assist body comprising a first coaptation surface, an opposed second coaptation surface, each surface bounded by a first lateral edge, a second lateral edge, an inferior edge, and a superior edge. The implantable coaptation assistance device can include a ventricular projection extending from the inferior edge. The implantable coaptation assistance device can include a first support extending through at least a portion of the coaptation assist device between the superior edge and the ventricular projection. The implantable coaptation assistance device can include a second support extending through at least a portion of the coaptation assist body between the first lateral edge and the second lateral edge. The implantable coaptation assistance device can include a passageway extending through at least a portion of the coaptation assist device sized to accept a steerable catheter therethrough. In some embodiments, the first support has a first configuration wherein the first support is generally linear and a second configuration wherein the first support is curved. In some embodiments, the first and second support are configured to permit percutaneous insertion of the implantable coaptation assistance device. [0030] In some embodiments, the passageway extends through at least a portion of the coaptation assist device between the superior edge and the ventricular projection. In some embodiments, the steerable catheter comprises a distal tip configured to curve. In some embodiments, a handle of the steerable catheter is rotated to cause the distal tip to curve. In some embodiments, the first support comprises a shape memory material. In some embodiments, the first support is bonded to the coaptation assist body. In some embodiments, the coaptation assist body comprises a lumen sized to accept at least a portion of the first support. In some embodiments, the first support is removable. In some embodiments, the first support extends from the superior edge to the ventricular projection. In some embodiments, the passageway extends through at least a portion of the coaptation assist body between the first lateral edge and the second lateral edge. In some embodiments, the second support comprises a shape memory material. In some embodiments, the second support is bonded to the coaptation assist body. In some embodiments, the coaptation assist body comprises a lumen sized to accept at least a portion of the second support. In some embodiments, the second support is removable. In some embodiments, the second support extends from the first lateral edge to the second lateral edge. In some embodiments, the first support is coupled to the second support. In some embodiments, the first support and the second support are coupled to a removable hub, the removable hub projecting from a surface of the coaptation assist body. [0031] In some embodiments, a kit comprising is provided. The kit can include an implantable coaptation assistance device. The implantable coaptation assistance device can include a coaptation assist body comprising a first coaptation surface, an opposed second coaptation surface, each surface bounded by a first lateral edge, a second lateral edge, an inferior edge, and a superior edge. The implantable coaptation assistance device can include a ventricular projection extending from the inferior edge. The implantable coaptation assistance device can include a passageway extending through at least a portion of the coaptation assist device sized to accept a steerable catheter therethrough. The kit can include a steerable catheter. In some embodiments, the steerable catheter is configured to pass through the mitral valve and curve toward the ventricular tissue, wherein the implantable coaptation assistance device is configured to be passed over the steerable catheter toward the ventricular tissue. [0032] In some embodiments, the passageway extends through at least a portion of the coaptation assist device between the superior edge and the ventricular projection. In some embodiments, the steerable catheter comprises a distal tip configured to curve. In some embodiments, a handle of the steerable catheter is rotated to cause the distal tip to curve. In some embodiments, the passageway extends through at least a portion of the coaptation assist body between the first lateral edge and the second lateral edge. [0033] In some embodiments, a method of using an implantable coaptation assistance device is provided. The method can include the step of inserting a coaptation assist body toward a heart valve. In some embodiments, the coaptation assist body comprising a first coaptation surface, an opposed second coaptation surface, each surface bounded by a first lateral edge, a second lateral edge, an inferior edge, and a superior edge, a ventricular projection extending from the inferior edge. The method can include the step of manipulating a first support to cause the coaptation assist body assume a curved configuration. In some embodiments, the first support extending through at least a portion of the coaptation assist device between the superior edge and the ventricular projection. The method can include the step of manipulating a second support to cause the coaptation assist body assume a curved configuration. In some embodiments, the second support extending through at least a portion of the coaptation assist body between the first lateral edge and the second lateral edge. [0034] In some embodiment, manipulating a first support comprises releasing the coaptation assist body from a delivery catheter. In some embodiment, manipulating a second support comprises releasing the coaptation assist body from a delivery catheter. The method can include the step of guiding the coaptation assist body over a steerable catheter. The method can include the step of passing a steerable catheter from the ventricular projection toward the superior edge prior to inserting the coaptation assist body toward a heart valve. The method can include the step of moving a distal portion of the steerable catheter to curve around the posterior leaflet. The method can include the step of passing the coaptation assist device over the curve of the steerable catheter. In some embodiments, the steerable catheter is removed after the ventricular projection engages with ventricular tissue. In some embodiments, the steerable catheter remains in place as the ventricular projection is advanced toward the ventricular tissue. The method can include the step of removing the first support from the coaptation assist body. The method can include the step of removing the second support from the coaptation assist body. The method can include the step of engaging the ventricular projection with ventricular tissue. In some embodiments, the method is performed percutaneously. BRIEF DESCRIPTION OF THE DRAWINGS [0035] FIG. 1A-1F schematically illustrate some of the tissues of the heart and mitral valve, as described in the Background section and below, and which may interact with the implants and systems described herein [0036] FIG. 2A illustrates a simplified cross-section of a heart, schematically showing mitral valve function during diastole. [0037] FIG. 2B illustrates a simplified cross-section of a heart, schematically showing mitral valve function during systole [0038] FIGS. 3A-3B illustrate a simplified cross-section of a heart, schematically showing mitral valve regurgitation during systole in the setting of mal-coaptation of the mitral valve leaflets. [0039] FIG. 4A illustrates a stylized cross section of a heart, showing mitral valve mal-coaptation in the settings of functional mitral valve regurgitation. [0040] FIG. 4B illustrates a stylized cross section of a heart, showing mitral valve mal-coaptation in the settings of degenerative mitral valve regurgitation. [0041] FIG. 5A illustrates an embodiment of the coaptation assistance device. [0042] FIG. 5B illustrates the various cross-sections the support structure may have along the section A-A of FIG. 5A [0043] FIG. 5C illustrates the various shapes of the anchors at the distal end of the ventricular projection. [0044] FIG. 5D illustrates non-limiting examples of ranges of dimensions of the coaptation assistance device. [0045] FIG. 5E illustrates a table of non-limiting examples of variations (materials, range of dimensions) of the support structure. [0046] FIG. 5F illustrates an embodiment of the distal end of the ventricular projection. [0047] FIG. 5G illustrates the position of the coaptation assistance device may be maintained by utilizing the shape of the coaptation assistance device to pinch the native posterior leaflet. [0048] FIG. 5H illustrates an embodiment of how the coaptation assistance device may be secured through the posterior leaflet from the ventricular side. [0049] FIG. 6A illustrates a steerable catheter. [0050] FIG. 6B illustrates the position of the steerable catheter of FIG. 6A in the heart. [0051] FIG. 7A illustrates a delivery catheter. [0052] FIG. 7B illustrates an embodiment of a locking mechanism that locks the delivery catheter to the annular hub. [0053] FIG. 7C illustrates another embodiment of a locking mechanism that locks the delivery catheter to the annular hub. [0054] FIG. 7D illustrates the coupling of the coaptation assistance device, the delivery catheter, and a guidewire or steerable catheter. [0055] FIGS. 8A-8D illustrate how the coaptation assistance device is folded and pulled into an implant sheath and delivered into the heart through the femoral access. [0056] FIGS. 8E-8G illustrate how the delivery catheter and the implant sheath are placed so that the ventricular projection of the coaptation assistance device may be anchored. [0057] FIG. 8H illustrates the coaptation assistance device that is fully open and the delivery catheter positioned over the annular hub for anchoring the annular hub to the annulus. [0058] FIG. 8I illustrates an embodiment of an anchor that may be used to anchor the annular hub. [0059] FIG. 9A illustrates a method to anchor the coaptation assistance device adjacent to the commissures via holes in the frame of the coaptation assistance device. [0060] FIG. 9B illustrates the top view of the anchor and crossbar of FIG. 9A . [0061] FIG. 10A illustrates another embodiment of the delivery catheter having multiple lumens and connections to the implant. [0062] FIG. 10B illustrates a cross section of the delivery catheter shown in FIG. 1 OA. [0063] FIGS. 11A-B illustrate various alternative embodiments of anchors. [0064] FIG. 11C illustrates a delivery tube through which the anchors 11 A and 11 B may be delivered. [0065] FIG. 11D illustrates how the anchor of FIG. 11B may appear after the anchoring process is completed. [0066] FIG. 12 illustrates a spineless implant design (figure is shown with a structure 1220 which is later withdrawn from the implant). [0067] FIGS. 13A-B illustrate the initial stages of the delivery procedure for the spineless implant. [0068] FIGS. 14A-B illustrate various types of anchoring methods for spineless implants. [0069] FIG. 15A illustrates an embodiment of an anchor catheter enabled to deliver multiple anchors. This figure also illustrates multiple anchor designs. [0070] FIG. 15B illustrates another embodiment of an anchor catheter enabled to deliver multiple anchors. [0071] FIGS. 15C-D illustrate how the anchors in 15 B may be coupled to the tissue. [0072] FIG. 16A illustrates another embodiment of an anchor catheter enabled to deliver multiple anchors. [0073] FIGS. 16B-C illustrate how the tool in FIG. 16A may be used to deliver multiple anchors. [0074] FIG. 17A illustrates another embodiment of a spineless implant. [0075] FIGS. 17B-E illustrate how the embodiment of FIG. 17A may be anchored. DETAILED DESCRIPTION [0076] The devices, systems and methods described within this disclosure are generally for the treatment of mitral valve regurgitation (MR). Mitral valve regurgitation occurs when the mitral valve does not prevent the backflow of blood from the left ventricle to the left atrium during the systolic phase. The mitral valve is composed of two leaflets, the anterior leaflet and the posterior leaflet, which coapt or come together during the systolic phase to prevent backflow. There are generally two types of mitral valve regurgitations, functional and degenerative regurgitations. Functional MR is caused by multiple mechanisms including abnormal or impaired left ventricular (LV) wall motion, left ventricular dilation and papillary muscle disorders. Degenerative MR is caused by structural abnormalities of the valve leaflets and the sub-valvular tissue including stretching or rupture of the chordae. Damaged chordae may lead to prolapsing of the leaflets which means that the leaflets bulge out (generally into the atrium), or become flail if the chordae become torn, leading to backflows of blood. As will be described below, the devices, system and methods in this disclosure provide a new coaptation surface over the native posterior valve such that the backward flow of blood is minimized or eliminated. [0077] Referring to FIGS. 1A-1D , the four chambers of the heart are shown, the left atrium 10 , right atrium 20 , left ventricle 30 , and right ventricle 40 . The mitral valve 60 is disposed between the left atrium 10 and left ventricle 30 . Also shown are the tricuspid valve 50 which separates the right atrium 20 and right ventricle 40 , the aortic valve 80 , and the pulmonary valve 70 . The mitral valve 60 is composed of two leaflets, the anterior leaflet 12 and posterior leaflet 14 . In a healthy heart, the edges of the two leaflets oppose during systole at the coaptation zone 16 . [0078] The fibrous annulus 120 , part of the cardiac skeleton, provides attachment for the two leaflets of the mitral valve, referred to as the anterior leaflet 12 and the posterior leaflet 14 . The leaflets are axially supported by attachment to the chordae tendinae 32 . The chordae, in turn, attach to one or both of the papillary muscles 34 , 36 of the left ventricle. In a healthy heart, the chordae support structures tether the mitral valve leaflets, allowing the leaflets to open easily during diastole but to resist the high pressure developed during ventricular systole. In addition to the tethering effect of the support structure, the shape and tissue consistency of the leaflets helps promote an effective seal or coaptation. The leading edges of the anterior and posterior leaflet come together along the zone of coaptation 16 , with a lateral cross-section 160 of the three-dimensional coaptation zone (CZ) being shown schematically in FIG. 1E . [0079] The anterior and posterior mitral leaflets are dissimilarly shaped. The anterior leaflet is more firmly attached to the annulus overlying the central fibrous body (cardiac skeleton), and is somewhat stiffer than the posterior leaflet, which is attached to the more mobile posterior mitral annulus. Approximately 80 percent of the closing area is the anterior leaflet. Adjacent to the commissures 110 , 114 , on or anterior to the annulus 120 , lie the left (lateral) 124 and right (septal) 126 fibrous trigones which are formed where the mitral annulus is fused with the base of the non-coronary cusp of the aorta ( FIG. 1F ). The fibrous trigones 124 , 126 form the septal and lateral extents of the central fibrous body 128 . The fibrous trigones 124 , 126 may have an advantage, in some embodiments, as providing a firm zone for stable engagement with one or more annular or atrial anchors. The coaptation zone CL between the leaflets 12 , 14 is not a simple line, but rather a curved funnel-shaped surface interface. The first 110 (lateral or left) and second 114 (septal or right) commissures are where the anterior leaflet 12 meets the posterior leaflet 14 at the annulus 120 . As seen most clearly in the axial views from the atrium of FIGS. 1C , 1 D, and 1 F, an axial cross-section of the coaptation zone generally shows the curved line CL that is separated from a centroid of the annulus CA as well as from the opening through the valve during diastole CO. In addition, the leaflet edges are scalloped, more so for the posterior versus the anterior leaflet. Mal-coaptation can occur between one or more of these A-P (anterior-posterior) segment pairs A1/P1, A2/P2, and A3/P3, so that mal-coaptation characteristics may vary along the curve of the coaptation zone CL. [0080] Referring now to FIG. 2A , a properly functioning mitral valve 60 of a heart is open during diastole to allow blood to flow along a flow path FP from the left atrium toward the left ventricle 30 and thereby fill the left ventricle. As shown in FIG. 2B , the functioning mitral valve 60 closes and effectively seals the left ventricle 30 from the left atrium 10 during systole, first passively then actively by increase in ventricular pressure, thereby allowing contraction of the heart tissue surrounding the left ventricle to advance blood throughout the vasculature. [0081] Referring to FIGS. 3A-3B and 4 A- 4 B, there are several conditions or disease states in which the leaflet edges of the mitral valve fail to oppose sufficiently and thereby allow blood to regurgitate in systole from the ventricle into the atrium. Regardless of the specific etiology of a particular patient, failure of the leaflets to seal during ventricular systole is known as mal-coaptation and gives rise to mitral regurgitation. [0082] Generally, mal-coaptation can result from either excessive tethering by the support structures of one or both leaflets, or from excessive stretching or tearing of the support structures. Other, less common causes include infection of the heart valve, congenital abnormalities, and trauma. Valve malfunction can result from the chordae tendinae becoming stretched, known as mitral valve prolapse, and in some cases tearing of the chordae 215 or papillary muscle, known as a flail leaflet 220 , as shown in FIG. 3A . Or if the leaflet tissue itself is redundant, the valves may prolapse so that the level of coaptation occurs higher into the atrium, opening the valve higher in the atrium during ventricular systole 230 . Either one of the leaflets can undergo prolapse or become flail. This condition is sometimes known as degenerative mitral valve regurgitation. [0083] In excessive tethering, as shown in FIG. 3B , the leaflets of a normally structured valve may not function properly because of enlargement of or shape change in the valve annulus: so-called annular dilation 240 . Such functional mitral regurgitation generally results from heart muscle failure and concomitant ventricular dilation. And the excessive volume load resulting from functional mitral regurgitation can itself exacerbate heart failure, ventricular and annular dilation, thus worsening mitral regurgitation. [0084] FIG. 4A-4B illustrate the backflow BF of blood during systole in functional mitral valve regurgitation ( FIG. 4A ) and degenerative mitral valve regurgitation ( FIG. 4B ). The increased size of the annulus in FIG. 4A , coupled with increased tethering due to hypertrophy of the ventricle 320 and papillary muscle 330 , prevents the anterior leaflet 312 and posterior leaflet 314 from opposing, thereby preventing coaptation. In FIG. 4B , the tearing of the chordae 215 causes prolapse of the posterior leaflet 344 upward into the left atrium, which prevents opposition against the anterior leaflet 342 . In either situation, the result is backflow of blood into the atrium, which decreases the effectiveness of left ventricle compression. [0085] FIG. 5A illustrates an embodiment of a coaptation assistance device 500 . The coaptation assistance device 500 can include a coaptation assistance body 515 . The coaptation assist body 515 can include a first coaptation surface 535 . The first coaptation surface 535 can be disposed toward a mal-coapting native leaflet, in the instance of a mitral valve, the posterior leaflet when implanted. The coaptation assist body 515 can include a second coaptation surface 540 . The second coaptation surface 540 can be opposed to the first coaptation surface 535 as shown in FIG. 5A . The second coaptation surface 540 can be disposed toward a mal-coapting native leaflet, in the instance of a mitral valve, the anterior leaflet when implanted. The first coaptation surface 535 and the second coaptation surface 540 can be bounded by a first lateral edge and a second lateral edge. The first coaptation surface 535 and the second coaptation surface 540 can be bounded by an inferior edge and a superior edge 545 . [0086] The first coaptation surface 535 and the second coaptation surface 540 are two sides of the same implant structure forming the coaptation assistance body 515 . The shape of the coaptation assistance body 515 may be characterized generally, in some embodiments, by the shape of the superior edge 545 , the shape of the first coaptation surface 535 , and the second coaptation surface 540 . [0087] The coaptation assistance device 500 can include a ventricular projection 525 as shown in FIG. 5A . The ventricular projection 525 can extend from the inferior edge of the coaptation assistance body 515 . The ventricular projection 525 can be placed within the left ventricle when implanted. The ventricular projection 525 can provide an anchoring mechanism. The distal end 530 of the ventricular projection 525 generally provides the anchoring mechanism. [0088] The distal end 530 of the ventricular projection 525 may have different shapes as shown in FIG. 5C . FIG. 5C shows five embodiments of the distal end 530 . It is noted that more variations are possible and they are not limited to the five embodiments shown in FIG. 5C . Generally, and in other embodiments, there are two types of anchors. Examples of passive anchors are shown in embodiments 555 . 1 through 555 . 4 in FIG. 5C . Passive anchors rely on entrapment behind and/or interference with the chordae. With respect to the passive anchors, in some embodiments, the largest dimension or the dimension responsible for entanglement (usually the width) with the chordae may range from 10 mm to 40 mm, such as 25 mm. [0089] Distal end 555 . 1 includes one or more prongs. The prongs can be an elongate rod which extends from a central hub as shown. In the illustrated embodiment, four prongs extend from the central hub. In other embodiments, one or more prongs extend from the central hub. The prongs can extend at an angle from the central hub, thereby increasing the surface area of the distal end 530 . Distal end 555 . 2 can be generally rectangular, rectangular, generally square, square, generally diamond shaped or diamond shaped. The distal end 555 . 2 can include one or more cut outs. The cut outs can increase the ability to grip tissue. In the illustrated embodiment, four cutouts are formed in the distal end. In other embodiments, one or more cut outs are provided. [0090] Distal end 555 . 3 includes one or more prongs. The prongs can be an elongate rod which extends from a central hub as shown. In the illustrated embodiment, two prongs extend from the central hub. In other embodiments, one or more prongs extend from the central hub. The prongs can extend at a right angle from the central hub, thereby increasing the surface area of the distal end 530 . [0091] Distal end 555 . 4 includes one or more barbs. The barbs can extends from a central hub as shown. The barbs can extend back toward the central hub. In the illustrated embodiment, three or more barbs extend from the central hub. In other embodiments, one or more barbs in one or more directions are provided. [0092] Distal end 555 . 5 includes one or more prongs, and is similar to the configuration shown as distal end 555 . 1 . Distal end 555 . 5 is an example of an active anchor. Active anchors may have features such as sharp points, barbs, or screws that may couple to the ventricular tissue. Active anchors may require a driving force, such as a torque, to embed within the tissue. Either passive or active anchors may be made of implant grade biocompatible materials such as silicone, PEEK, pebax, polyurethane. [0093] The size of the coaptation assistance device 500 is described in detail in FIG. 5D . This figure shows the top view and front view of the coaptation assistance body 515 of the coaptation assistance device 500 . The three parameters “x”, “y” and “z” shown in the figure characterize the coaptation assistance device 500 . Non-limiting examples of ranges and magnitudes of these variables x, y, and z are shown in the “Dimension Table” in the figure. [0094] The coaptation assistance device 500 can include a support structure 505 . The support structure 505 can be referred to as a spine. The support structure 505 can define, at least in part, the shape of the coaptation assistance device 500 . [0095] Returning back to FIG. 5A , the support structure 505 is shown by dotted lines. In some embodiments, the support structure 505 is made of a shape memory material such as but not limited to nitinol (NiTi), polyether ether ketone (PEEK) or other stiff polymer or fatigue resistant metal. The use of shape memory materials enables advantages described herein. For example, one advantage of a shape memory material is that its superelastic properties helps the coaptation assistance device 500 maintain its shape and functionality as a coaptation assistance device as the heart contracts and dilates and exerts pressure on the coaptation assistance device 500 . Another example of an advantage is that a shape memory material lends itself to percutaneous delivery methods which will be described herein. [0096] The support structure 505 can include one or more section. In some embodiments, the support structure 505 includes one section. In some embodiments, the support structure 505 includes two sections. In some embodiments, the support structure 505 includes three or more sections. In some embodiments, one or more sections of the support structure 505 can include one or more subsection. In the embodiment shown in FIG. 5A , the support structure 505 includes two sections: a first section 505 . 2 and a second section 505 . 1 . [0097] The first section 505 . 2 can extend through at least a portion of the coaptation assistance device 500 between the superior edge 545 and the ventricular projection 525 . In some embodiments, the first section 505 . 2 can extend through the entire length between of the coaptation assistance device 500 between the superior edge 545 and the ventricular projection 525 . In some embodiments, the first section 505 . 2 extends from a location between the superior edge 545 and the inferior edge of the coaptation assistance body 515 . In some embodiments, the first section 505 . 2 extends from a location between the inferior edge of the coaptation assistance body 515 and the ventricular projection 525 . In some embodiment, the first section 505 . 2 extends along the coaptation assistance body 515 and continues on to support the ventricular projection 525 . [0098] The second section 505 . 1 can extend through at least a portion of the coaptation assist body 515 between the first lateral edge and the second lateral edge. In some embodiments, the second section 505 . 1 can extend through the entire length between of the first lateral edge and the second lateral edge. In some embodiments, the second section 505 . 1 extends from a location between the superior edge 545 and the inferior edge of the coaptation assistance body 515 . In some embodiments, the second section 505 . 1 extends from a location closer to the superior edge 545 than the inferior edge of the coaptation assistance body 515 . In some embodiments, the second section 505 . 1 extends from the first lateral edge toward the second lateral edge. In some embodiments, the second section 505 . 1 extends from the second lateral edge toward the first lateral edge. In some embodiments, the second section 505 . 1 extends along a section between the first lateral edge and the second lateral edge. In some embodiments, the second section 505 . 1 extends along the edge of the coaptation assistance device 500 . [0099] In some embodiments, the first section 505 . 2 and the second section 505 . 1 of the support structure 505 may be one integral piece or unitary structure. In some embodiments, the first section 505 . 2 and the second section 505 . 1 of the support structure 505 are separate components. In some embodiments, the first section 505 . 2 and the second section 505 . 1 may be two separate sections joined together by methods such as but not limited to crimping and laser welding. [0100] In some embodiments, the first section 505 . 2 is integrated within the coaptation assistance body 515 as described herein. In some embodiments, the first section 505 . 2 in integrated within the ventricular projection 525 as described herein. In some embodiments, the first section 505 . 2 is removable from the coaptation assistance body 515 as described herein. In some embodiments, the first section 505 . 2 is removable from the ventricular projection 525 as described herein. In some embodiments, the second section 505 . 1 is integrated within the coaptation assistance body 515 as described herein. In some embodiments, the second section 505 . 1 is removable from the coaptation assistance body 515 as described herein. In some embodiments, the first section 505 . 2 can have a first zone that is generally oriented substantially parallel to a longitudinal axis of the body 515 , and a second zone that is generally oriented substantially perpendicular to the longitudinal axis of the body 515 as illustrated. [0101] The support structure 505 that supports the shape of the ventricular projection 525 may have various cross sections as shown by section AA in FIG. 5A and illustrated in detail in FIG. 5B . In FIG. 5B , five embodiments of the cross-section are shown; however, it is noted that the embodiments of the cross section of the support structure 505 are not limited to these five. Cross-section 550 . 1 is circular or generally circular. Cross-section 505 . 2 is circular or generally circular. Cross-section 550 . 1 can have a larger cross-sectional area than cross-section 550 . 2 . Cross-section 550 . 3 comprises a plurality of circular or generally circular cross-sections. In the illustrated embodiment, seven circular or generally circular cross-sections collectively form the cross-section 550 . 3 . In other embodiments, two or more circular or generally circular cross-sections collectively form the cross-section 550 . 3 . Cross-section 550 . 3 can be in the form of a cable. Cross-section 550 . 4 is rectangular or generally rectangular. Cross-section 550 . 5 is rectangular or generally rectangular. Cross-section 550 . 4 can have a larger cross-sectional area than cross-section 550 . 5 . [0102] It is also noted that the first section 505 . 2 and the second section 505 . 1 may have different cross-sections as well. Each cross-section or embodiment shown in FIG. 5B may have certain advantages such as some cross sections may bend easily in one direction and not in another. Some other cross sections may have higher reliability properties than others. The characteristics of each type of cross-section is described along with the ranges and non-limiting possible dimensions of the cross section in Table 2 in FIG. 5E for two different materials nitinol and PEEK. Although various configurations are presented in Table 2, in some embodiments, cross-sections 550 . 4 and 550 . 5 can be utilized for both materials. [0103] When the coaptation assistance device 500 is placed within the heart, the coaptation assistance device 500 is such that, in some embodiments, the ventricular projection 525 will generally be placed within the left ventricle as shown in FIG. 5G . The ventricular projection 525 provides a mechanism to anchor the coaptation assistance device 500 using the structure of the ventricles. An example of positioning of the coaptation assistance device 500 over the posterior leaflet is illustrated in FIG. 5G . [0104] Bearing in mind that other examples of positioning are possible and are discussed elsewhere within this disclosure, in this particular example, the coaptation assistance device 500 is illustrated with a ventricular projection 525 that has a curved shape. The ventricular projection 525 and/or the first support 505 . 2 may be composed of shape memory materials, in which case the curved shape is retained after implantation. The curved shape may enable the coaptation assistance device 500 to stay in position as engages to the native posterior leaflet 14 . [0105] FIG. 5F shows an embodiment of a passive anchor for the ventricular projection 525 . In this embodiment, a tube 560 running along the length of the ventricular projection 525 terminates in two tubes 565 . 1 and 565 . 2 , at the distal end of the coaptation assistance device 500 . The coaptation assistance device 500 may be delivered to the left side of the heart with straightening wires such that the two tubes 565 . 1 and 565 . 2 are approximately straight as shown by the dotted lines 565 . 1 and 565 . 2 (Position A) indicating that the straightening wires are in an advanced state. In some embodiments, the two tubes 565 . 1 and 565 . 2 may be made of shape memory material including but not limited to polyurethane, silicone, polyethylene, pebax and nylon. Without the straightening wires, the two tubes 565 . 1 and 565 . 2 may have a default shape that may be curled or coiled as shown by the solid lines 565 . 1 and 565 . 2 (Position B) in FIG. 5F . [0106] After the implant is appropriately delivered and placed in the heart, the straightening wires may be withdrawn allowing the two tubes 565 . 1 and 565 . 2 to assume their default shape (Position B). The two tubes 565 . 1 and 565 . 2 may provide anchoring support due to entanglement with the chordae. The advantage of this type of anchoring is that the straightening wires may be advanced back into the two tubes 565 . 1 and 565 . 2 , straightening out the two tubes 565 . 1 and 565 . 2 and causing the two tubes 565 . 1 and 565 . 2 to disentangle from the chordae structure should it become necessary to reposition the coaptation assistance device 500 due to unsatisfactory placement. Although the example above describes two tubes 565 . 1 and 565 . 2 , it will be understood that there may be one, two, or more tubes. [0107] Yet another embodiment of anchoring the coaptation assistance device 500 is illustrated in FIG. 5H . An active anchor may be coupled to the distal end of the ventricular projection 525 . After delivery of the implant, the active anchor may be driven through the posterior leaflet to couple to the coaptation assistance device 500 at the annular (atrial) section as shown. Methods to position and drive the anchors will be discussed herein. [0108] In another embodiment, the tips of the ventricular projection 525 may be radiopaque or echogenic to aid in placement and anchoring of the coaptation assistance device 500 while the coaptation assistance device 500 is being placed percutaneously. In such a procedure, fluoroscopic or ultrasound imaging modalities may be used to visualize the heart and the coaptation assistance device 500 . [0109] Returning back to FIG. 5A , in another embodiment, the coaptation assistance device 500 can include a hub 510 . The hub 510 can have one or more purposes. One purpose can be to serve as an anchoring device as discussed herein. Another purpose can be to provide a mechanism to deliver the coaptation assistance device 500 percutaneously as discussed herein. In some embodiments, a hub (not shown) may be present at the distal end of the coaptation assistance device 500 . The hub can be located at the end of the ventricular projection 525 . The ventricular hub may be placed at the very distal tip of the distal end 530 of the ventricular projection 525 . To distinguish the two hubs, the hub 510 on the proximal side will be called simply the “hub”, the “annular hub” or the “proximal hub”. The hub at the distal tip of the ventricular projection will specifically be called the “ventricular hub”. [0110] Still referring to FIG. 5A , the coaptation assistance body 515 of the coaptation assistance device 500 may be made of various biocompatible materials such as expanded polytetrafluoroethylene (ePTFE). This material provides the coaptation surface against which the anterior leaflet will close. The coaptation assistance body 515 of the coaptation assistance device 500 can be coupled to the support structure 505 such that the shape of the support structure 505 gives the general shape of the coaptation assistance device 500 . [0111] The shape of the coaptation assistance device 500 may be further supported by one or more ribs 546 (not shown). There may be one, two, or more ribs 546 . The ribs 546 may be made of various materials such as but not limited to suture, polypropylene, nylon, NiTi cable, NiTi wire and PEEK. The process of coupling the coaptation assistance body 515 of the coaptation assistance device 500 to the support structure 505 and/or the ribs 546 (if ribs 546 are present) is described herein. [0112] In some methods of manufacturing, the process may commence by slipping polyethylene (PE) tubes on the support structure 505 and/or the ribs 546 (if ribs 546 are present). This combination is placed between two ePTFE sheets after which heat and pressure are applied. The ePTFE bonds with the PE tubes due to pores in the ePTFE material into which the polyethylene material of the tube may melt into, creating a mechanical bond. Similarly, the PE tube material may melt into microholes in the support structure 505 and/or the ribs 546 when heat and compression are applied. The microholes in the support structure 505 and/or the ribs 546 may be deliberately placed to improve the bonding. [0113] In a variation of the process described above, PE sheets may be placed where no PE tubes may be present. In this variation, just as described above, a similar process of heat and compression is applied and a more uniform composite structure may be generated. In a further embodiment, the support structure 505 and/or the ribs 546 may have features such as microholes that couple the ePTFE membrane. The micro-hole diameters may be in the range of 0.005″ to 0.030″, for example. [0114] In a variation on the type of materials that may be used to make the coaptation assistance body 515 of the coaptation assistance device 500 , other materials such as but not limited to sponge material, polyurethane, silicone, bovine or porcine pericardium may be utilized. Bonding processes may include but may not be limited to heat bonding, suturing and gluing. [0115] Continuing to refer to FIG. 5A , in some embodiments, the coaptation assistance device 500 has perforations or slots 520 . There may be one or multiple such perforations or slots 520 . These perforations 520 can serve the purpose of providing sites where anchors may be placed as discussed herein. [0116] One of the advantages of the coaptation assistance device 500 is that the coaptation assistance device 500 may be folded into a smaller structure. The coaptation assistance device 500 can be delivered percutaneously through a delivery catheter. In some embodiments, the support structure 505 is made of a shape memory material. When the coaptation assistance device 500 is unfolded inside the heart, the desired shape of the coaptation assistance device 500 is regained. Many embodiments now describe the various methods, devices and systems that are used to deliver the coaptation assistance device 500 into the heart. [0117] In some methods of use, the first support has a first configuration wherein the first support 505 . 2 is generally linear and a second configuration wherein the first support 505 . 2 is curved. In some methods of use, the first support 505 . 2 and the second support 505 . 1 are configured to permit percutaneous insertion of the coaptation assistance device 500 . [0118] The first few steps in the delivery procedure can be similar to those that are known in the art. The body of the patient is punctured for example in the lower torso/upper thigh area (groin) to get access to the femoral vein. Generally a trans-septal sheath and needle are inserted into the inferior vena cava and advanced up to the atrial septum, at which point a trans-septal puncture is performed and the trans-septal sheath is advanced into the left atrium. The needle is removed and the trans-septal sheath now provides access to the left atrium. More details about the above steps may be found in publicly available medical literature. [0119] The method can include various steps including those that are now described. The ventricular projection 525 of the coaptation assistance device 500 can be generally be placed within the left ventricle. It may be advantageous to guide the coaptation assistance device 500 to this location using various guiding techniques. For example a simple guidewire may be placed inside the trans-septal sheath and guided into the left ventricle by first entering the left atrium and going through the mitral valve. However, simple guidewire may not provide sufficient accuracy in placement of the ventricular projection 525 . [0120] In some embodiments, a method of placing a guidewire inside a steerable sheath may be used. The steerable sheath with a guidewire may be advanced through the trans-septal sheath and subsequently advanced through the mitral valve into the left ventricle where the steering ability of the steerable sheath would give additional support to position the guidewire appropriately. After the guidewire is placed, the steerable sheath requires to be removed prior to delivery of the coaptation assistance device. This method, although providing a more accurate positioning of the guidewire, involves an extra step of removing the steerable sheath. To improve on this process in terms of reducing the number of steps needed to perform the implantation, a various embodiments of a steerable sheath are disclosed herein. Small Diameter Steerable Catheter [0121] Referring to FIG. 6A , a small diameter steerable catheter 600 is illustrated. In some embodiments, the diameter 615 of a handle 610 of the steerable catheter 600 can be equal or substantially equal to the diameter 620 of the body 605 of the steerable catheter 600 . The steerable catheter 600 can have within it a pullwire 625 . When the handle 610 is rotated, for example in the direction of the arrow 632 , the distal portion of the steerable catheter 600 moves along arrow 635 from the linear position 630 to the curved position 640 . The curved position 640 may be beneficial to position the ventricular projection 625 as discussed herein. When the handle 610 is rotated, for example in the opposite direction of the arrow 632 , the distal portion of the steerable catheter 600 moves along from the curved position 640 to the linear position 630 . The linear position 630 of the steerable catheter 600 is shown by dotted lines, not to be confused with the pullwire 625 which is also shown in dotted lines. The linear position 630 may be beneficial for insertion or retraction of the steerable catheter 600 from the anatomy. [0122] In some embodiments, the diameter of the handle 610 can be equal to the diameter of the body 605 . This can be advantageous as the coaptation assistance device 500 may slide over the handle 610 and/or the body 605 smoothly after the steerable catheter 600 is placed in the ventricle. In some embodiments, the steerable catheter 600 can include an extension 612 at the proximal end which extends from the handle 610 . The extension 612 can be a wire or other elongate structure. The purpose of the extension 612 is to aid in the loading of other catheters or devices while allowing a physician or other operators to retain control of the steerable catheter 600 . Subsequent to loading of the other catheters or devices on the extension 612 , the steerable catheter 600 is utilized to guide the other catheters or devices. The length of the extension 612 can match or exceed the length of the catheter or device that is being loaded such that during the process of loading and delivering the other catheter or device, control of the steerable catheter 600 is retained. [0123] In some embodiments, the extension 612 may be coupled to the handle 610 only when necessary. For example if during a procedure, the medical team decides that a longer catheter is necessary, the extension 612 may be coupled to the handle 610 . Coupling mechanisms may include but are not limited to a threaded junction, a compression fit, or other mechanisms. [0124] Non-limiting examples of dimensions of the various subcomponents in some embodiments (the body 605 , handle 615 , extension 612 ) can be as follows: the diameter 620 of the body 605 may range from 2 to 10 Fr, such as 4 Fr, between about 2 Fr and about 6 Fr, between about 3 Fr and about 5 Fr, or less than 10 Fr, 9 Fr, 8 Fr, 7 Fr, 6 Fr, 5 Fr, 4 Fr, 3 Fr, or 2 Fr. The handle 610 length may range in some cases from about ½″ to about 2″, such as about 1″, the handle linear travel (for pullwire activation) may range in some cases from about ⅛″ to about 3″, such as about ¾″. [0125] During the implantation process, some methods involve the guidewire or guidewire and steerable sheath. In some methods, the steerable catheter 600 may be advanced through the femoral access. Since the handle 610 is outside the patient's body, it may be rotated such that the distal portion of this steerable catheter 600 is placed in an appropriate position under the posterior leaflet. The extension 612 can be attached to the proximal end of the handle 610 to allow subsequent loading of the coaptation assistance device 500 and delivery catheter 700 prior to insertion into the trans-septal sheath 650 , described herein. This delivery catheter 700 may then be used as a guide for introducing the coaptation assistance device 500 as will be explained herein. [0126] FIG. 6B illustrates the placement of the steerable catheter 600 in the heart. An embodiment of the trans-septal sheath 650 is shown. The left atrium 655 , left ventricle 660 , the posterior leaflet 665 of the mitral valve and the anterior leaflet 670 of the mitral valve are also shown. The steerable catheter 600 is shown going through the mitral valve and being positioned under the posterior leaflet 665 . It may be now appreciated how having the ability to deflect the distal potion of steerable catheter 600 can be advantageous so that an appropriate position of the coaptation assistance device 500 may be achieved. The distal portion of the steerable catheter 600 is able to curve under the posterior leaflet 665 as shown. In some methods, the next general step after placing the steerable catheter 600 is to deliver the coaptation assistance device 500 to the heart. Further embodiments are now described with regards to methods and devices to achieve delivery. [0127] Delivery Catheter [0128] Referring to FIG. 7A , a delivery catheter 700 is now described. The function of the delivery catheter 700 is to carry the coaptation assistance device 500 to the heart. The shaft body 710 of the delivery catheter 700 can be torqueable and deflectable. The shaft body 710 is shown by the cross hatched lines. The delivery catheter 700 can include a handle 730 . The handle 730 can have rotation mechanisms, for example pull wires etc. The rotation mechanism can deflect and steer the shaft body 710 . Distal to the handle 730 is an implant sheath 725 which as explained herein may carry the coaptation assistance device 500 to the heart. In some embodiments, and even more distal to the implant sheath 725 is a tear away funnel 720 . The tear away funnel 720 can facilitate the folding of the coaptation assistance device 500 . In some embodiments, the most distal end of the shaft body 710 has features that may lock the shaft body 710 to the coaptation assistance device 500 so that the coaptation assistance device 500 may be transported to the heart and placed appropriately. The locking process and features are now described in relation to FIGS. 7B , 7 C and 7 D. [0129] Referring to FIG. 7D , the delivery catheter 700 and the coaptation assistance device 500 can have matching features that enable them to be locked temporarily. In some embodiments, the delivery catheter 700 includes one or more distal locking tabs 705 . The coaptation assistance device 500 can include the annular hub 510 as described herein. The distal locking tabs 705 of the delivery catheter 700 may couple with features in the annular hub 510 of the coaptation assistance device 500 as will be explained herein. [0130] In some methods, the steerable catheter 600 or other guiding wires or catheters may be advanced through the ventricular projection 525 and/or anchoring mechanism 530 . In some embodiment, the anchoring mechanism 530 can have a hole or passageway in the center to allow the steerable catheter 600 to pass through, as shown in FIG. 7D . The steerable catheter 600 can pass from the anchoring mechanism 530 to the annular hub 510 . Other paths through the coaptation assistance device 500 are contemplated. The steerable catheter 600 can pass from the anchoring mechanism 530 to the annular hub 510 and further to the delivery catheter 700 . [0131] Referring to FIG. 7B , the tip of the delivery catheter 700 is shown in a magnified view. The annular hub 510 of coaptation assistance device 500 is also shown. Distal locking tabs 705 may be made of some shape memory material such as nitinol. The natural position of the locking tabs 705 is set such that they bend inwards and towards each other as illustrated in FIG. 7A . In some methods, a guidewire or a catheter such as steerable catheter 600 can be inserted into the annular hub 510 and between the distal locking tabs 705 , and the distal locking tabs 705 can be pushed out against the annular hub 510 . The annular hub 510 is designed with matching pockets 740 such that the distal locking tabs 705 fit into these pockets 740 . As long as the steerable catheter 600 is present to force the distal locking tabs 705 outwards into the pockets 740 , the tip of the delivery catheter 700 remains locked to the annular hub 510 . Other locking mechanisms are possible and one such alternative is now described in FIG. 7C . [0132] Referring to FIG. 7C , the annular hub 510 can include a cross-pin 745 . The cross-pin 745 can be a solid piece that goes across the annular hub 510 and is held in place by methods that are known in the art. The delivery catheter 700 can include a loop of wire or suture 750 . The suture 750 which may loop around an object such as a guidewire or the steerable catheter 600 within the annular hub 510 . The suture 750 may extend into the handle 730 of the delivery catheter 700 . The handle 730 may have a mechanism which controls the tension of the suture 750 . By controlling the tension, the coaptation assistance device 500 can be pulled against and held securely to the distal end of the delivery catheter 700 . When steerable catheter 600 is retracted past the level of the cross-pin 745 , the loop 755 of the suture 750 can slip over the cross-pin 745 , thereby releasing the cross-pin 745 and the coaptation assistance device 500 . [0133] Delivery Procedure [0134] FIGS. 8A-8D show a method of delivery. In some methods, the implant sheath 725 and the funnel 720 are advanced over the coaptation assistance device 500 . The implant sheath 725 and the funnel 720 can be advanced over the coaptation assistance device 500 after the delivery catheter 700 is locked with the coaptation assistance device 500 . The shape of the funnel 720 aids in the coaptation assistance device 500 closing or folding in on itself. The advancement of the implant sheath 725 and the funnel 720 is shown in FIGS. 8A and 8B . The arrow 760 in FIG. 8A indicates how the coaptation assistance device 500 is pulled into the funnel 720 . Once the coaptation assistance device 500 is within the implant sheath 725 , the funnel 720 is removed. In some embodiments, the funnel 720 is removed by pulling on a tab 715 , thereby splitting the funnel 720 , shown in FIG. 8C . The funnel 720 and the tab 715 can be then discarded. In some methods, the implant sheath 725 containing the coaptation assistance device 500 can be advanced over the guidewire or the steerable catheter 600 . To reiterate, the advantage of the design of the steerable catheter 600 becomes evident as the coaptation assistance device 500 can glide smoothly over the steerable catheter without having any difficulty due to different size diameters of the handle 610 and the body 605 . The implant sheath 725 can be inserted into the trans-septal sheath 650 as shown FIG. 8D . [0135] The system of the coaptation assistance device 500 and the implant sheath 725 is advanced until it exits the trans-septal sheath 650 as shown in FIG. 8E . The delivery catheter 700 is deflected such that the implant sheath 725 is positioned between the leaflets of the mitral valve, which is shown in FIG. 8E . The implant sheath 725 is placed between the chordae 765 (“P2” location). Once the implant sheath 725 attains this position, the delivery catheter 700 is held in place and the implant sheath 725 is retracted slowly, causing the coaptation assistance device 500 to start exiting the implant sheath 725 as illustrated in FIG. 8F . It is to be noted that the steerable catheter 600 or an equivalent guide wire is still in place under the posterior leaflet and can still be actively adjusted or deflected using the control handle 610 . In some methods, as the delivery catheter 700 is advanced, the coaptation assistance device 500 is pushed out, following the path of the steerable catheter 600 until the distal end 530 of the ventricular projection 525 is coupled to the ventricular tissue. This is illustrated in FIG. 8G . While the coaptation assistance device 500 is being pushed out, the implant sheath 725 can be retracted. In some methods, rotational adjustments may be made to the delivery catheter 700 to ensure appropriate placement. Anchoring [0136] Once the coaptation assistance device 500 is open, the method can include the step of anchoring the coaptation assistance device 500 on the atrial aspect of the mitral valve namely, on the on the mitral valve annulus. Several embodiments now describe the methods and systems to achieve anchoring. [0137] A support structure 505 made of a shape memory material can be advantageous. As the coaptation assistance device 500 opens, the coaptation assistance device 500 assumes the shape that was intended due to the action of the shape memory material. The shape of the coaptation assistance device 500 , as described herein, can be intended to provide a new coaptation surface so that regurgitant flows are reduced or eliminated. Returning back to the explanation of the delivery and anchoring process, the delivery catheter 700 , which can be still coupled to the annular hub 510 of the coaptation assistance device 500 , may now be manipulated (rotationally and axially) to position the coaptation assistance device 500 appropriately over the posterior leaflet of the native valve. In an embodiment, the support structure 505 of the coaptation assistance device 500 may have features which may attach to the tissue. In some embodiments, these features are passive hooks. In some methods, these features engage the annulus such that the coaptation assistance device 500 may be held in place while anchoring is commenced. FIG. 8H shows the state of the delivery catheter 700 with the implant sheath 725 retracted and the shaft body 710 still coupled to the annular hub 510 . [0138] An embodiment of an anchor 800 is illustrated in detail in FIG. 8I . The anchor 800 may be coupled to the delivery catheter 700 and/or the coaptation assistance device 500 in various ways. The annular hub 510 may have a cross-pin 512 . The cross-pin 512 can provide a site about which a helical structure 815 of the anchor 800 may wrap around as shown. The anchor 800 can have a shoulder 805 . The shoulder 805 may fit around the shaft body 710 of the delivery catheter 700 . The shoulder 805 may have features such as windows 810 which can lock the distal locking tabs 705 of the delivery catheter 700 . The distal locking tabs 705 of the delivery catheter 700 can lock when a pin, guidewire or a catheter such as the steerable catheter 600 is present within the shaft body 710 of delivery catheter 700 . In some methods, the anchor 800 can be preloaded onto the coaptation assistance device 500 and locked in place with the delivery catheter 700 during the process of mounting the coaptation assistance device 500 onto the delivery catheter 700 . This can occur prior to when the coaptation assistance device 500 is pulled into the implant sheath 725 and being readied for insertion into the femoral vein. Returning back to FIG. 8H , torque can be applied to the shaft body 710 such that the anchor 800 is driven into the tissue. To provide feedback whether the anchor 800 is secured appropriately, fluoroscopic markers may be present on the anchor 800 . The markers may be located at the proximal end. These markers may inform the medical team about how far the anchor 800 may have travelled towards the annular hub 510 and may be informative about when the anchor 800 is securely in place. In some embodiments, to ensure that appropriate torque is applied, the torque level at the handle 730 may spike as the anchor 800 bottoms out on the annular hub 510 . This increased torque level may be felt at the handle 730 providing feedback that appropriate torque has been applied. The central guidewire or the steerable catheter 600 can be retracted. This causes the distal locking tabs 705 to fall back from the windows 810 of the anchor 800 , thus unlocking the delivery catheter 700 and the anchor 800 . This can cause the releasing the coaptation assistance device 500 . The delivery catheter 700 and steerable catheter 600 may now be completely retracted. Commissure Anchoring [0139] Several embodiments illustrate the commissure anchoring. One such embodiment is shown in FIG. 9A . The delivery catheter 700 (not shown) has been retracted and an anchor catheter 900 has been advanced through the femoral access. The anchor catheter 900 is torqueable. One or more anchor catheters 900 can be provided. The distal tip of the anchor catheter 900 may have one or more features to lock the anchors in place during the delivery of the anchor. In FIG. 9A , the distal tip has a cut-out 905 which may receive a portion of the helical anchor 915 . The anchor catheter 900 may also have central pin 920 . The central pin 920 can have a pointed end on the distal tip. In some embodiments, the central pin 920 can have the ability to be retracted. [0140] FIG. 9A shows a loop 910 . The ends (not shown) of the loop 910 may travel to the handle of the anchor catheter 910 or some length therebetween such that the tension of the loop 910 may be controlled. The loop 910 go over a crossbar 917 or other portion which forms the proximal part of the helical anchor 915 . The top view of the helical anchor 915 with the crossbar 917 is shown in FIG. 9B . While outside the body, prior to entry into the trans-septal sheath (not shown), the helical anchor 915 may be placed adjacent to the central pin 920 . The loop 910 may be arranged in such a manner that when tension is applied to the loop 910 , the loop 910 keeps the helical anchor 915 , and the central pin 920 locked in place. In FIG. 9A , this arrangement is retracted so that the cutouts 905 receive the proximal portion of the helical anchor 915 . Keeping the loop 910 in tension, the entire arrangement is advanced into the trans-septal sheath. [0141] Once in the desired location within the body, the anchor catheter 900 is adjusted so that the distal end of the anchor catheter 900 is positioned over a commissure hole 520 . The central pin 920 and the helical anchor 915 are advanced such that the central pin 920 first pierces the tissue after going through a commissure hole 520 . Torque is applied to the anchor catheter 900 and the helical anchor 915 pierces the tissue. The helical anchor 915 anchors the support structure 505 or frame of the coaptation assistance device 500 to the tissue. After the helical anchor 915 is in place, the central pin 920 is retracted. The retraction of the central pin 920 can allows the loop 910 to slip over the crossbar 917 of the helical anchor 915 , thereby releasing the anchor 915 . This process can be repeated for the other commissure site to anchor both extreme projections of the coaptation assistance device 500 . Alternative Anchoring Techniques [0142] FIG. 10A shows an alternative anchoring technique in another embodiment. In this embodiment, a delivery catheter 1000 may have multiple lumens 1040 . The delivery catheter 1000 may have a cross-section as shown in FIG. 10B . The lumens 1040 may carry individual torqueable drive shafts. Each drive shaft can be locked onto an anchor as the case is for shafts 1020 and 1030 or onto the annular hub 510 as is shown for shaft 1010 . Each torqueable shaft 1010 , 1020 , 1030 may have the design of the anchor catheter 900 illustrated in FIG. 9A . The delivery catheter 1000 may have a central lumen 1050 through which a guidewire or the steerable catheter 600 may pass. The multiple torqueable drive shafts 1010 , 1020 , 1030 , a guidewire or the steerable catheter 600 along with the coaptation assistance device 500 can all be loaded and retracted into the implant sheath of the delivery catheter 1000 prior to entry into the trans-septal sheath. This entire arrangement can be advanced and the same procedure as explained herein can be followed to place the coaptation assistance device 500 . The advantageous aspect of this arrangement is that the anchoring process may be accomplished without the need to retract the anchor catheter multiple times, reloading the anchors and reentering the body. Alternative Designs for Anchors [0143] While some anchors have been described herein, other alternative embodiments are contemplated. FIG. 11A shows an anchor with grappling hooks. FIG. 11B shows an anchor that resembles an umbrella. In both embodiments, the anchors may be made of a shape memory material. In both embodiments, the anchors may be loaded into a delivery catheter such as the delivery catheter illustrated in FIG. 11C . [0144] Locking mechanisms such as those described herein may be used to lock the anchors to the delivery catheter. The delivery catheter may have a pointed end so that the delivery catheter may be guided to an appropriate location and initially pierce the tissue. After the delivery catheter is placed at an appropriate location and the initial piercing is accomplished, one or more of the anchors may be advanced and set in place. This step is followed by unlocking and retracting the delivery catheter. [0145] FIG. 11D is an illustration of how the umbrella anchor of FIG. 11B may look after it has been set into the tissue to anchor the coaptation assistance device 500 . Due to the natural unstressed shape of the anchor, when deployed in the tissue over the coaptation assistance device 500 , the deformed shape would have an effective spring-force on the face of the coaptation assistance device 500 , ensuring a good foothold. Spineless Implants [0146] The coaptation assistance device 500 described in FIGS. 5A-F can include the support structure 505 . The support structure 506 can be made of shape memory material as described herein. In some embodiments of the coaptation assistance device, another configuration is contemplated. This configuration can be called the spineless coaptation assistance device to indicate that the support structure is removed after placement of the coaptation assistance device in the heart. Both types of coaptation assistance devices can have certain advantages. The spineless coaptation assistance device may be advantageous due to fewer components and materials and no possible metal fatigue. [0147] FIG. 12 shows an embodiment of the spineless coaptation assistance device 1200 . The spineless coaptation assistance device 1200 can include a tube or a passageway 1210 . The passageway 1210 can be placed around the annular edge. This passageway 1210 can be called the annular tube. The spineless coaptation assistance device 1200 can include a tube or passageway 1212 along the ventricular projection. This passageway 1212 can be called the ventricular tube. [0148] The profile of the passageway 1210 can be shown towards the ends of the annular tube. Although a circular profile is illustrated, the tubes or passageways 1210 , 1212 may have other profiles including but not limited to oval and flat. [0149] The support structure 1210 . 1 , 1210 . 2 , 1210 . 3 is shown by dotted lines except at the annular edges where the support structures 1210 . 1 and 1210 . 3 protrude. The support structure 1210 . 1 , 1210 . 2 , 1210 . 3 may have three distinct sections, where 1210 . 1 and 1210 . 3 are placed in the annular tube and 1210 . 2 is placed in the ventricular tube. The support structure 1210 . 1 , 1210 . 2 , 1210 . 3 can be coupled within a spine hub 1220 . In some embodiments, the support structure 1210 . 1 , 1210 . 2 , 1210 . 3 may be distinct and separate sections. In some embodiments, the support structure 1210 . 1 , 1210 . 2 , 1210 . 3 may be joined together by using one of various methods such as, but not limited to, crimping and laser welding. This arrangement of the support structure 1210 . 1 , 1210 . 2 , 1210 . 3 and the coaptation assistance device 1200 allows the support structure 1210 . 1 , 1210 . 2 , 1210 . 3 to be extracted from the coaptation assistance device 1200 . In some methods, the support structure 1210 . 1 , 1210 . 2 , 1210 . 3 is extracted by applying a pulling force on spine hub 1220 . More detail about the coaptation assistance device 1200 , and the procedure to deliver and anchor the coaptation assistance device 1200 , will be provided herein. Delivery Procedure of the Spineless Implant [0150] FIGS. 13A and 13B illustrate the delivery procedure of the coaptation assistance device 1200 . FIG. 13A shows the coaptation assistance device 1200 of FIG. 12 . FIG. 13A shows an additional feature, an anchor site 1300 . This anchor site 1300 will be described in greater detail herein. [0151] The steerable catheter 600 can inserted into the coaptation assistance device 1200 . The steerable catheter 600 can be inserted from the distal tip of the ventricular projection 1212 . The steerable catheter 600 can exits from an exit aperture 1335 . A delivery catheter 1320 can be provided. The delivery catheter 1320 can include a torqueable shaft 1310 . The delivery catheter 1320 can include a hub locking feature 1330 that couples with a hub anchor 1300 . In FIG. 13A , the hub locking feature 1330 is shown as a screw. Other locking mechanisms explained herein may be utilized. [0152] FIG. 13B illustrates more detail with regard to the delivery catheter 1320 . The distal tip of the delivery catheter 1320 can include a funnel 1360 . Proximal to the funnel 1360 , an implant introducer 1340 may be present. At the very proximal end, the delivery catheter 1320 may have a handle 1370 . [0153] The steerable catheter 600 can be threaded through the coaptation assistance device 1200 as described herein. The funnel 1360 can be inserted on to the distal tip of the delivery catheter 1320 . The coaptation assistance device 1200 can be locked in place using the locking feature 1330 , such that the hub anchor 1300 is connected to the torqueable shaft 1310 . [0154] The steerable catheter 600 can be threaded through an angled side port 1350 on the implant introducer 1340 . The coaptation assistance device 1200 and the steerable catheter 600 can be pulled through the funnel 1360 by retracting the delivery catheter 1320 . With continued retraction, the coaptation assistance device 1200 will fold upon itself within the implant introducer 1340 . Once the implant is in the introducer 1340 , the funnel 1360 is removed and discarded. The funnel 1360 may be designed such that it may be easily removed. Designs for the funnel include but are not limited to the peel away design (shown previously in FIGS. 8A-8C ) or a clamshell design ( FIG. 13B ). [0155] The delivery catheter 1320 along with the implant introducer 1340 can be advanced over the steerable catheter 600 until the implant introducer 1340 couples with the hub of the trans-septal sheath 650 . At this point, the implant introducer 1340 may not be able to advance further but the coaptation assistance device 1200 itself can be advanced into the trans-septal sheath. The next several steps are similar to that shown in FIGS. 8E through 8G , except in this example, no implant sheath is used. The coaptation assistance device 1200 is placed over the posterior leaflet and the ventricular projection 1212 is placed in the left ventricle. The steerable catheter 600 can be retracted allowing the ventricular projection 1212 to curl or coil under P2. Once the ventricular projection 1212 is anchored, the hub anchor 1300 can be rotated or otherwise activated. The hub anchor 1300 can anchor the proximal side of the coaptation assistance device 1200 to the annulus. The torqueable shaft 1310 can retracted. After additional anchoring, which will be explained herein, the hub locking feature 1330 is retracted pulling the support structure 1210 . 1 , 1210 . 2 , 1210 . 3 along with it. The coaptation assistance device 1200 may now be operational in the left heart without the support structure 1210 . 1 , 1210 . 2 , 1210 . 3 . Anchoring Procedure for Spineless Implant [0156] FIG. 14A shows an embodiment for anchoring the coaptation assistance device 1200 . As no rigid structure such as the support structure 1210 . 1 , 1210 . 2 , 1210 . 3 can be present after implantation, the coaptation assistance device 1200 may need additional anchors. In some embodiments, the coaptation assistance device 1200 may utilize closely spaced anchors. In some embodiments, the coaptation assistance device 1200 may utilize additional and closely spaced anchors than a similar coaptation assistance device with a support structure 505 , described herein. FIG. 14A shows an embodiment of anchors 1400 , which may be used to couple the coaptation assistance device 1200 and the tissue. FIG. 14B shows another embodiment. In FIG. 14B , a suture or tape 1410 is used to “sew” the coaptation assistance device 1200 to the tissue. The suture or tape 1410 may be made of one of several materials including, but not limited to, polypropylene or nylon. Several embodiments describing how the multiple anchors are placed are now explained herein. [0157] FIG. 15A shows an embodiment of an anchor catheter 1500 that delivers multiple anchors. Several anchors 1510 , including anchor 1510 . 1 and anchor 1510 . 2 , are stacked within the anchor catheter 1500 . Although FIG. 15A shows two anchors 1510 . 1 and 1510 . 2 stacked within the anchor catheter 1500 , more or fewer anchors may be stacked. Each anchor 1510 may include a coil section 1550 . The coil section 1550 can include a pointed end 1570 . The anchor 1510 may include an anchor head 1560 . The anchor head 1560 may have one of several cross sections shown by 1545 . 1 , 1545 . 2 , 1545 . 3 and 1545 . 4 in FIG. 15A . Other cross sections are possible. [0158] To initially load the anchor catheter 1500 , the anchors 1510 are loaded onto a central shaft 1520 of the anchor catheter 1500 . The central shaft 1520 and the anchors 1510 may have a matching cross section such that the anchors 1510 may be rotationally coupled to the central shaft 1520 . At the proximal end of the anchor catheter 1500 , a spring 1540 can be included. This spring 1540 provides a pushing force such that as the central shaft 1520 is rotated, the anchors 1510 exit the distal end of the anchor catheter 1500 in the direction of arrow 1550 . As the anchors 1510 exit, the anchor 1510 can engage with the coaptation assistance device 1200 and the tissue to couple the coaptation assistance device 1200 to the tissue. The rotation of the central shaft 1520 may be controlled by an operator such as a doctor. In some embodiments, the central shaft 1520 is coupled to a torqueable wire (not shown) which may be coupled at the proximal end to a handle (not shown). In some embodiments, the torqueable wire may be controlled manually. In some embodiments, the torqueable wire may be controlled via an electric motor. Other methods to impart a rotational motion to the central shaft 1520 are contemplated. A feature that is not shown in the FIG. 15A is the ability to steer and position the distal end of the anchor catheter 1500 . As one anchor 1510 is delivered, the distal tip may need to be repositioned to deliver the next anchor 1510 . A steering mechanism such as pull wires may be included to steer the distal tip of the anchor catheter 1500 . [0159] FIG. 15B shows another embodiment of an anchor catheter 1600 that delivers multiple anchors. FIG. 15B shows only the distal tip of an anchor catheter 1600 . The anchor catheter 1600 can include multiple anchors 1610 such as 1610 . 1 and 1610 . 2 . Although the anchor catheter 1600 shows five anchors, more or fewer anchors 1610 may be loaded at any one time. The anchor catheter 1600 may have a central shaft 1630 . The anchor catheter 1600 can include threads such as 1620 on the inside of the housing 1605 . These threads 1620 can house the coils of the anchors 1610 as shown. To initially load the anchor catheter 1600 , the anchors 1610 are inserted into the housing 1605 . The anchors 1610 are inserted onto the central shaft 1630 . As described previously, the cross-section of the central shaft 1630 may match the cross-section of the anchors 1610 so that the anchors 1610 may be mounted on the central shaft 1630 . The rotation of the central shaft 1630 may be controlled by a torqueable cable (not shown) which may couple the central shaft 1630 to a handle (not shown) of the anchor catheter 1600 . The operator such as a doctor may control the rotation. In some embodiments, the torqueable wire may be controlled manually. [0160] In some embodiments, the torqueable wire may be controlled via an electric motor. As the central shaft 1630 rotates, the threads will force the anchors 1610 to exit the anchor catheter 1600 and engage with the coaptation assistance device 1200 and the tissue to couple the coaptation assistance device 1200 and the tissue together. The anchor catheter 1600 may also have pull wires to steer the distal tip of the anchor catheter 1600 so that as one anchor 1610 is delivered, the anchor catheter 1600 may be positioned to deliver the next anchor 1610 . [0161] FIG. 15B illustrates a central suture 1635 . The central suture 1635 can include a ball 1640 coupled to the end of the central suture 1635 . FIGS. 15C and 15D illustrate how the central suture 1635 and ball 1640 may be used. The ball 1640 can sit in a pocket inside the first anchor 1610 . 1 . The central suture 1635 can connect the first anchor 1610 . 1 to the second anchor 1610 . 2 and others anchors 1610 (not shown in the figure). This arrangement may provide the ability to use the central suture 1635 as a guide wire to return back to an anchor 1610 after the anchor 1610 has been screwed into the tissue 1645 . The operator may wish to return to the anchor 1610 to reposition or adjust the anchor 1610 . In addition, if one or more anchors 1610 came loose, the central suture 1635 may provide a tether for the loose anchors 1610 , therefore preventing embolic events. [0162] FIG. 16A-C shows another embodiment of an anchor catheter 1700 that delivers multiple anchors. The anchor catheter 1700 can have a hollow shaft. The hollow shaft can be pointed at the distal end which may be used to pierce the coaptation assistance device 1200 and tissue. Multiple anchors 1710 such as 1710 . 1 , 1710 . 2 may be arranged within the hollow shaft of the anchor catheter 1700 . The anchors 1710 can be hollow barrels. [0163] A suture 1720 may be threaded through the anchors 1710 as shown. The suture 1720 may be secured to the first anchor 1710 . 1 by arranging the suture 1720 to exit the second anchor 1710 . 2 and enter the first anchor 1710 . 1 through a side aperture 1740 . The suture 1720 may then be secured by means of a knot as depicted in dotted lines within the first anchor 1710 . 1 . The suture 1720 in the other anchors 1710 , except the first anchor 1710 . 1 , may appear as illustrated for the anchor 1710 . 2 . The anchors 1710 , except the first anchor 1710 . 1 have a portion of their walls cut out. The cut outs can aids in better trapping the anchors within the tissue, similar to a toggle-bolt. At the proximal end of the anchor catheter 1700 , a feature such as a pusher tube 1750 may be present to cause the anchors 1710 such as 1710 . 1 and 1710 . 2 to exit the anchor catheter 1700 at the distal end. The pusher 1750 may be attached to a handle (not shown) so as to enable an operator such as a doctor to deposit one or more anchors 1710 when appropriate. The arrow 1760 indicates the direction of the push. [0164] FIG. 16B-C illustrates how the anchor catheter 1700 of FIG. 16A may operate. In FIG. 16B , the anchor catheter 1700 is advanced through the coaptation assistance device 1200 through a slot such as described by 520 in FIG. 5A . The anchor catheter 1700 then pierces the tissue 1645 . The operator pushes the first anchor 1710 . 1 out of the anchor catheter 1700 , depositing the anchor 1710 . 1 within the tissue. Once the first anchor 1710 . 1 is deposited, the rest of the anchors 1710 are deposited as illustrated in FIG. 16C . In FIG. 16C , the anchor catheter 1700 is pulled out of the tissue after depositing the first anchor 1710 . 1 in order to enter a second location. At the second location, the anchor catheter 1700 can deposit the second anchor 1710 . 2 . This process is continued until desired to secure the coaptation assistance device 1200 to the tissue. After the last anchor 1710 is delivered, a cutter (not shown) can be advanced inside the anchor catheter 1700 to cut the suture 1720 , leaving behind the anchors 1710 . [0165] In some embodiments, the anchors 1710 may be radio opaque or they may be covered by a radio graphic marker. During the process of delivery of the anchors 1710 , the radio opaque markers may be visualized if a fluoroscope is used. This may help in spacing the anchors 1710 around the annulus of the coaptation assistance device 1200 . [0166] In some embodiments, the MR is assessed while securing the coaptation assistance device 1200 and the pitch and/or the location of the sewing action is determined according to the presence or absence of the MR. [0000] Spineless Implant with Annular Tube [0167] FIG. 17A illustrates another embodiment of a spineless coaptation assistance device 1800 . In this embodiment, the support structure 1810 may only traverse down the ventricular projection 1820 . A tube or passageway 1830 may be present around the annular edge of the coaptation assistance device 1800 . Instead of utilizing a support structure 1810 to maintain the shape of the coaptation assistance device 1800 , an anchor catheter 1850 can be inserted into the tube 1830 as shown in FIG. 17B . In FIG. 17B , the anchor catheter 1850 can be a deflectable anchor catheter. [0168] FIG. 17B also shows a first site 1860 . 1 where an anchor such as that described by 1560 in FIG. 15A can be delivered. At this site 1860 . 1 and all anchor sites 1860 , the tip of the anchor catheter 1850 would be deflected by controls located outside the body. The anchors (not shown) may be delivered securing the coaptation assistance device 1800 to the tissue. The tip of the anchor catheter 1850 may be radio opaque which may then be visualized during the anchor delivery process. The visualization of the tip may be utilized to locate the anchors around the annulus of the coaptation assistance device 1800 . FIG. 17B illustrates a first anchor location 1860 . 1 and FIG. 17C illustrates a second anchor location 1860 . 2 . After the appropriate number of anchors are delivered, the anchor catheter 1850 is retracted completely as shown in FIG. 17D . Finally the support structure 1810 can be removed as shown in FIG. 17E . [0169] In a variation of the embodiment shown in FIGS. 17A-17E , the support structure 1810 may not be limited only to the ventricular projection; it may also be inserted through the annular tube 1830 such that a desired shape may be maintained. The support structure can be a shape memory material. Utilizing a support structure around the annular tube 1830 may result in an anchor catheter which may have relatively simpler control mechanisms compared to the anchor catheter 1850 used for the coaptation assistance device 1800 described in FIG. 17A . [0170] It is contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments disclosed above may be made and still fall within one or more of the inventions. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with an embodiment can be used in all other embodiments set forth herein. 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 inventions. Thus, it is intended that the scope of the present inventions herein disclosed should not be limited by the particular disclosed embodiments described above. Moreover, while the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described and the appended claims. Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as “inserting a coaptation assist body proximate the mitral valve” includes “instructing the inserting of a coaptation assist body proximate the mitral valve.” The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “approximately”, “about”, and “substantially” as used herein include the recited numbers, and also represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, 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.

The invention relates in some aspects to a device for use in the transcatheter treatment of mitral valve regurgitation, including steerable guidewires, implantable coaptation assistance devices, anchoring systems for attaching a ventricular projection of an implantable coaptation device, a kit, and methods of using an implantable coaptation assistance device among other methods.

TECHNICAL FIELD This invention relates to blades for removing material (e.g., snow, dirt, ash) from surfaces. BACKGROUND Traditional shoveling of material or debris involves lifting and throwing material, pushing or some combination of pushing and throwing using a shovel or other apparatus. The following patent(s) disclose various shovels (U.S. Pat. Nos. 5,906,060; 1,206,235; 1,232,361; 2,460,560; 2,598,952, 2,772,490; 2,846,785; 2,852,872; 2,484,409 and 5,271,169). Material is removed from surfaces by sliding the blade across the surface, collecting the material on the blade and then moving the material to a desired location and tilting or lifting the blade to remove the material from the blade. Existing shovels or blades sometimes lose all forward momentum when encountering surface irregularities. This results in lost efficiency and requires increased effort and time by the operator. SUMMARY According to the first embodiment of the invention comprising a blade is provided. The blade may include a handle, an elongated member, and a blade body. The elongated member may have a first end and a second end spaced apart from the first end. The handle may be configured to receive the first end of the elongated member. The blade body may be configured to receive the second end of the elongated member. The blade body may include a first surface, a second surface, a first side, a second side, a first edge, a second edge, and a first runner. The second surface may be disposed opposite the first surface. The first side may have a first profile and the second side may have a second profile, with the second side disposed opposite and substantially parallel to the first side. The first edge may extend between the first side and the second side. The second edge may be spaced apart from the first edge and may extend between the first side and the second side. The first runner may be attached to the first side, the first runner having a first runner profile at least partially defined by the first profile and the first runner extending beyond the second edge. The blade may have a second runner attached to the second side, the second runner having a second runner profile at least partially defined by the second profile and the second runner extending beyond the second edge, the second runner disposed substantially parallel to the first runner. The blade may have a blade body profile for a blade body runner attached to the blade body, the blade body runner having a blade body runner profile at least partially defined by the blade body profile and the blade body runner extending beyond the second edge, the blade body runner disposed substantially parallel to the first runner. The first runner profile may have an arcuate profile that substantially matches the first profile, a portion of the first runner may not be in plane with the second surface, and a portion of the first runner may not be in plane with the second edge. The second runner profile may have an arcuate profile that substantially matches the second profile, a portion of the second runner may not be in plane with the second surface, and a portion of the second runner may not be in plane with the second edge. The blade body runner profile may have an arcuate profile that substantially matches the blade body profile, a portion of the blade body runner may not be in plane with the second surface, and a portion of the blade body runner may not be in plane with the second edge. According to the second embodiment of the invention comprising a blade body is provided. The blade body may include a first surface, a second surface, a first side, a second side, an edge, and a first runner. The second surface may be disposed opposite the first surface. The first side may have a first profile and the second side may have a second profile, with the second side disposed opposite and substantially parallel to the first side. The first surface and second surface may define an edge extending between the first side and the second side. The first surface and second surface may define a blade body profile. The first runner may be attached to the first side, the first runner having a first runner profile at least partially defined by the first profile and the first runner extending beyond the edge. The blade body may have a second runner attached to the second side, the second runner having a second runner profile at least partially defined by the second profile and the second runner extending beyond the second edge, the second runner disposed substantially parallel to the first runner. The blade body may have a blade body runner attached to the blade body, the blade body runner having a blade body runner profile at least partially defined by the blade body profile and the blade body runner extending beyond the edge, the blade body runner disposed substantially parallel to the first runner. The first runner profile may have an arcuate profile that substantially matches the first profile, a portion of the first runner may not be in plane with the second surface, and a portion of the first runner may not be in plane with the edge. The second runner profile may have an arcuate profile that substantially matches the second profile, a portion of the second runner may not be in plane with the second surface, and a portion of the second runner may not be in plane with the edge. The blade body runner profile may have an arcuate profile that substantially matches the blade body profile, a portion of the blade body runner may not be in plane with the second surface, and a portion of the blade body runner may not be in plane with the edge. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of elements of the blade. FIG. 2 is an exploded perspective view of elements of the blade with runners. FIG. 3 is a perspective view of elements of the blade with runners. FIG. 3A is a cross-section of elements of the blade with runners. FIG. 3B is a side view of elements of the blade with runners. FIG. 4 is a perspective view of an embodiment of the blade with integral runners. FIG. 5 is a perspective view of elements of the blade with the embodiment of attached runners. FIG. 5A is a perspective view of an existing blade with the embodiment of attached runners. DETAILED DESCRIPTION As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention that may be embodied in various and alternative forms. The figures are not necessarily to scale; some features may be exaggerated or minimized to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the present invention. Referring to the drawings in detail wherein like elements are indicated by like numerals, there is shown a blade 102 that may include an elongated member 104 ; a blade body 106 ; a first side 108 ; a first profile 110 ; a second side 112 ; a second profile 114 ; a first edge 116 ; a second edge 118 ; a first runner 202 ; a first runner profile 204 ; a second runner 206 ; and a second runner profile 208 . FIG. 400 depicts an embodiment of the invention. See FIGS. 1, 2, 3, 3A, 3B, and 4 . The elongated member 104 may have a first end 124 and a second end 126 spaced apart from the first end 124 and an elongated body extending therebetween. The second end 126 of the elongated member 104 receives the blade body 106 . The blade body 106 has a first side 108 that follows the first profile 110 of the blade 102 . The first profile 110 may be defined by a substantially continuous section having a constant radius of curvature. In at least one embodiment, the first profile 110 may be defined by a linear section or a substantially non-continuous section having varying radii of curvature such that it is not piecewise continuous. The blade body 106 has a second side 112 that follows the second profile 114 of the blade 102 . The second profile 114 may be defined by a substantially continuous section having a constant radius of curvature. In at least one embodiment, the second profile 114 may be defined by a linear section or a substantially non-continuous section having varying radii of curvature such that it is not piecewise continuous. The first runner 202 may abut the first side 108 . The first runner 202 and the first side 108 may be substantially aligned with the first runner profile 204 substantially following the first profile 110 . Traditionally, the first surface 120 is the concave surface of the blade body 106 whereas the second surface 122 is the convex surface of the blade body 106 . The first profile 110 and the first runner profile 204 may substantially follow the second surface 122 or in some embodiments, the first profile 110 is vertically offset from the first runner profile 204 . The offset between the first profile 110 and the first runner profile 204 also offsets the first runner 202 from the first surface 120 and/or the second surface 122 reducing the contact between the blade body 106 and the surface being shoveled. The second runner 206 may abut the second side 112 . The second runner 206 and the second side 112 may substantially aligned with the second runner profile 208 substantially following the second profile 114 . The second profile 114 and the second runner profile 208 may substantially follow the second surface 122 or in some embodiments, the second profile 114 is vertically offset from the second runner profile 208 . The offset between the second profile 114 and the second runner profile 208 also offsets the second runner 206 from the first surface 120 and/or the second surface 122 reducing the contact between the blade body 106 and the surface being shoveled. The blade body profile 302 is substantially defined by the second surface 122 . The blade body runner profile 304 may substantially follow the blade body profile 302 . The blade body runner 306 may be substantially aligned with the blade body runner profile 304 . The blade body profile 302 and the blade body runner profile 304 may substantially follow the second surface 122 or in some embodiments the blade body profile 302 is vertically offset from the blade body runner profile 304 . The offset between the blade body profile 302 and the blade body runner profile 304 also offsets the blade body runner 306 from the first surface 120 and/or the second surface 122 reducing the contact between the blade body 106 and the surface being shoveled. The first surface 120 and the second surface 122 define the first edge 116 , wherein the first edge 116 extends between the first side 108 and the second side 112 . The first surface 120 and the second surface 122 define the second edge 118 , wherein the second edge 118 extends between the first side 108 and the second side 112 . The first edge 116 and the second edge 118 are spaced apart and disposed opposite one another. Traditionally, the first edge 116 is closest to the handle or the “trailing edge” and the second edge 118 is the “scraping” or “leading” edge of the blade body, which contacts the material first and the surface where the material resides. The first runner 202 extends ahead of the direction of scraping of the second edge 118 . When a surface irregularity is encountered the first runner 202 traverses the surface irregularity reducing or avoiding impact with the second edge 118 . The second runner 206 extends ahead of the direction of scraping of the second edge 118 . When a surface irregularity is encountered second runner 206 traverses the surface irregularity reducing or avoiding impact with the second edge 118 . The blade body runner 306 extends ahead of the direction of scraping of the second edge 118 . When a surface irregularity is encountered blade body runner 306 traverses the surface irregularity reducing or avoiding impact with the second edge 118 . The extension of the runners (first runner 202 , second runner 206 , and/or blade body runner 306 ) beyond the second edge 118 allows the blade body 106 to traverse surface irregularities when clearing material from irregular surfaces, while allowing the second edge 118 to maintain contact with the surface being cleared. When a surface irregularity is encountered by at least one the runners (first runner 202 , second runner 206 , and/or blade body runner 306 ) the runners slide up the raised surface allowing the second edge 118 (the “scraping edge”) to easily transition to the new surface. The second edge 118 on a blade with runners contacts raised surfaces for a shorter duration of time than the second edge 118 on a blade without runners. Without the runners (first runner 202 , second runner 206 , and/or blade body runner 306 ) extending beyond the second edge 118 , the second edge 118 would impact the irregularity, hampering the movement of the blade body 106 . The user would be required to lift and reposition the blade on the new surface and reinitiate momentum. The irregularity may also be a gap between resilient surfaces (metal, concrete, etc.) whereby the second edge 118 falls into the gap, hampering momentum when the second edge 118 contacts the other resilient surface. With the extension of the runners (first runner 202 , second runner 206 , and/or blade body runner 306 ) beyond the second edge 118 , the second edge 118 will not fall into the gap because the runners (first runner 202 , second runner 206 , and/or blade body runner 306 ) will “traverse” the gap between resilient surfaces without a hampering of the momentum of blade body 106 . The vertical offset of the runners (first runner 202 , second runner 206 , and/or blade body runner 306 ) from the first surface 120 and/or the second surface 122 , and the extension of the runners (first runner 202 , second runner 206 , and/or blade body runner 306 ) beyond the second edge 118 may allow the blade body 106 to traverse surface irregularities when clearing material from irregular surfaces and keep the second edge 118 in contact with the surface when clearing material from flat surfaces. Referring to FIG. 4 , the first embodiment 402 , the components may be integrally formed to the blade body. The integrally formed components for this embodiment may be: the blade body 106 ; the first side 108 ; the first profile 110 ; the second side 112 ; the second profile 114 ; the first edge 116 ; the second edge 118 ; first surface 120 ; the second surface 122 ; the first runner 202 ; the first runner profile 204 ; the second runner 206 ; the second runner profile 208 ; the blade body profile 302 ; the blade body runner profile 304 ; and the blade body runner 306 . Referring to FIG. 5 and FIG. 5A , the second embodiment 502 the components may be added to an existing blade body. The components to be added on to an existing blade may be: the first runner 202 ; the first runner profile 204 ; the second runner 206 ; the second runner profile 208 ; the blade body runner profile 304 ; and the blade body runner 306 . In the second embodiment the edge 504 is the second edge 118 “scraping edge” of the first embodiment. While exemplary embodiments are described above, it is not intended that these embodiments describe all possible forms of the invention. Rather, the words used in the specification are words of description rather than limitation, and it is understood that various changes may be made without departing from the spirit and scope of the invention. Additionally, the features of various implementing embodiments may be combined to form further embodiments of the invention.

A blade is provided having runners on the blade that extend forward of the blade's leading edge. These runners traverse surface irregularities allowing the blade to avoid colliding with surface irregularities.

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 60/78731,740 filed on Oct. 31, 2005, the contents of which are incorporated herein by reference. FIELD OF INVENTION The present invention relates generally to a manufacturing process and a resulting apparatus which results in a completely hydrogel polymer device that maintains lumen patency which allows for numerous applications, particularly, catheters and stents. BACKGROUND OF THE INVENTION Generally, the common approaches utilized in the art to fabricate a product from hydrolyzed PAN entail typically coagulating a single layer or heavily plasticizing a solvent based formula hydrolyzed PAN, in order that it may be molded or extruded by conventional thermoplastic extrusion or injection molding methods. Unfortunately, do to limitations, these materials and related processes are not reliable and often lead to inconsistencies in production and/or components. As referenced in U.S. Pat. No. 6,232,406 and in fact improvements so noted in U.S. Pat. No. 4,943,618 are probably not necessary when manufacturing a product with the disclosed process. Many types of devices are available and generally well known in the art of catheter design and construction which exhibit various curved and coiled end geometrical configurations for anchorage while others rely on material and polymer characteristics to increase performance and patient comfort. It is also generally known that some devices can be particularly difficult to implant, and withdraw. Unfortunately these designs do not minimize migrations and their lubricous coatings, which will erode off, do not diminish patient comfort, and encrustation. In a typical modality, conventional thermoplastic polyurethane Ureteral Stent or Catheter is likely to migrate due to physiological or peristaltic organ and or muscle movement. Thereafter the device may become dislodged from its location rendering it ineffective. Additionally, after a relatively short period of time urine salts for example typically adhere to the coated and uncoated devices diminishing flow, and comfort, increasing patient pain and jeopardizing device integrity. The disclosed invention will alleviate these unacceptable complications. SUMMARY OF INVENTION It is the object of the invention to provide a stent or catheter fabricated in a manner totally comprised of a hydrogel capable of becoming structural in its final configuration having a cross sectional area that increases with hydration, while maintaining mechanical integrity. It is a further object of the invention to provide a catheter or stent that incorporates a manufacturing process that results in an end product that is stable, will not erode and will exhibit tensile strengths and elongations that allow use in applications where typical thermoplastic devices are currently used. Said devices immediately exhibit lubricous surface characteristics when wetted with any aqueous media and provide increased resistance to biological complications once implanted. Substantial mechanical characteristics are exhibited by a fully hydrated device, which can be loaded with colorants, radiopacifiers and fillers. The present invention relates generally to the field of catheters used to maintain flow in the urinary system for example and in particular a configuration that maintains an atraumatic passage where the structural hydrogel composition provides comfort, placement and mechanical advantage. Hydrolyzed polyacrylicnitrile (PAN) polymers produced utilizing the present method result in a superior end product when produced with the disclosed process. Use of this method overcomes inconstancies in present formulations and devices made in accordance with the instant process yield a 100% hydrogel composition stent, catheter or hybrid version which may can be implanted with a substantially smaller diameter and then hydrated into a predictable larger, softer size within a controllable period of time. The catheter or hybrid will also be relatively rigid for ease of placement and track-ability. The present invention relates generally a manufacturing process which results in a completely hydrogel polymer device that maintains lumen patency which allows for numerous applications. Catheters and stems are particular examples, and their composition, mechanical characteristics, and the significantly unique ability to conduct and allow fluids to pass from one end to the other without physiological rejection, inflammation, or manifestation of complications due to implant or otherwise undesirable outcomes when used for ambulatory and or therapeutic interventions is the purpose of the invention. Accordingly, a ureteral stent is provided having anchorage that will not migrate, exhibits resistance to encrustation and facilitates ease of implant and withdrawal. In general, the placement of the structural hydrogel, ureteral stent or catheter creates in a path from which fluids can be reliably conducted from one end to the other, which requires no significant clinical follow up due to device migration, encrustation or related patient comfort issues. BRIEF DESCRIPTION OF THE DRAWINGS Advantages of the present invention will be apparent from the following detailed description of exemplary embodiments thereof, which description should be considered in conjunction with the accompanying drawings, in which: FIG. 1 is a configuration of a Stent or catheter consistent with the present invention, showing a predominant longitudinal representation and views of anchorage methods at corresponding ends. Said anchorage may be but are not limited to barbell, or trumpet profiles at one or both ends of a device. FIG. 2 . is an example of the invention as applied to stenting a Ureter with predominate anchorage at distal ends in the bladder and kidney respectively maintaining placement location. FIG. 3 , step ( 1 ) discloses the basic function of the process where by after depositing the first layer, that deposition is rinsed with water essentially coagulating the hydrogel in places on the mandrel. Then the hydrogel component is rinsed and then dried either on mandrel, or can be removed from mandrel and exchanged to a smaller or larger mandrel for an additional effect. Thereafter a concurrent layer can be added. FIG. 3 , step ( 2 ) discloses the basic function of the process thereafter step ( 1 ) whereby concurrent layers fuse together; inherently due to for example the solvent concentration in the concurrent outer layer and effect on the inner first layer now dehydrated for proceeding with step ( 2 ). Additionally, when and where required an adhesive can be absorbed by the dehydrated layer and or preloaded into the concurrent layer which would be extremely valuable when applying the hydrgel to other dissimilar surfaces. FIG. 4A , a front view, 4 B, a side view, 4 C a rear view & 4 D, the opposing side view disclose and details the aspects of the process. FIGS. 4A & B, specifically exhibit that multiple devices can be produced simultaneously whereby hydrogel in a semi-fluid form of a specific viscosity is pumped or otherwise transported thru a manifold and out an orifice of specific size, at a specific temperature and flow rate. Additionally FIGS. 4A & B show that in setting up the process configuration, mandrel size, distance form the manifold outlet and mandrel speed both in RPM and in line speed is coordinated to the aforementioned hydrogel characteristics. FIGS. 4C & D further identifies variations in the process whereby multiple materials can be deployed in a single process yielding one product with several materials included. FIGS. 5A & B discloses aspects of the process whereby, mandrel design and specification can be modified in many ways contributing to end product design and performance criteria and characteristics. For example, instead of a straight uniform mandrel, FIG. 5A indicates a “barbell” shaped mandrel that allows for an as cast profile in process whereby the deposition of hydrogel conformingly coats the mandrel in process. FIG. 5B discloses a method for enhancing density and or product characteristics for example by removing dehydrated deposition from mandrel in step and transferring to either a small mandrel whereby add tonal layers may exhibit greater potential compression, become denser, effect dug delivery or wicking gradients and or provide different elongation than otherwise in the same or other devices of same or similar material. Similarly, a dehydrated deposition can be transferred to a larger mandrel for further modification in process. In this manner a hydrated deposition can be dehydrated onto the larger mandrel and processed further thereafter. FIG. 6 is a stress/strain graph of a sample processed in accordance with the disclosed process. The low load with respect to high elongation is demonstrated. FIGS. 7A , B, C, D, E, F &G are examples of Hybrid compositions that are possible due to the disclosed process. FIGS. 8A & B are examples of compositions that are possible due to the disclosed process whereby force and aqueous gradients maybe directed. FIGS. 9A & 9B are configurations of a Stent or catheter consistent with the present invention; showing a predominant longitudinal representation and views of anchorage methods at corresponding ends. Said anchorage may be but are not limited to barbell, or trumpet profiles at one or both ends of a device. FIG. 10 is a section according to the invention illustrated to show the change in annular cross sectional area that can be expected proportional to the volume of fluid absorbed. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS A Stent or catheter or composite of the structural hydrogel and a metal, plastic or other component, and process for producing the same is illustrated herein. The finished device as disclosed is comprised of 100% Hydrogel polymer which is stable and structural in its final composition, not requiring a substrate or scaffold to maintain composition or mechanical characteristics. Referring now to the drawings, particularly in FIG. 1 , there is generally indicated the stent of the present invention. As illustrated in FIG. 1 , the body of the stent 1 is displayed, along with the uretral lumen 3 and the outward radial forces 2 . The trumpet or barbell distal end for anchorage with radiopacifier fill 4 is also shown. In FIG. 2 , the path urine travels through the body is shown. How the urine 5 will flow from the kidney, 6 through the anchorage in the kidney, 8 through the ureter, 7 through the anchorage of the ureter 9 and into the bladder 10 . The urine will then flow 12 through the urethra 11 . FIG. 3 displays the process of making the hydrogel stent. In step 1 , the composition of the hydrogel 13 that is desired is passed through the syringe body or reservoir 14 and subsequently through a needle 16 to form the first layer 17 which will be held in place by the mandrel 15 . In step 2 , the process is repeated to form the second layer 20 around the first layer 19 and both held in place by the mandrel. FIG. 4A the front view of the stent producing process. The adjustable process parameters of temperature, pressure and viscosity 21 and a reservoir of hydrogel in solvent solution 23 then the variable of process parameter flow rate 22 . This will then go through the manifold outlet diameter 24 that allows for stents of various diameters to be created. The length of the stent can also be varied by the distance deposition filament 26 . The mandrel RPM or line speed 25 can be varied and multiple stents can be received by the multiple mandrels 27 . FIG. 4B shows the side view of the stent producing process. The reservoir of material 28 goes through the Outlet ID 30 which travels through a set distance 29 of the length of stent where a lead dimension is set 31 . The mandrel 32 will hold a set deposition thickness 35 while rotating a set RPM 33 and coming out of the process at a certain line speed 34 . FIG. 4C shows the end view of the stent producing process with reservoirs of material A 36 and material B 37 . These two materials then flow through the flow direction valve 38 . A mandrel 39 then holds in place where the deposition 40 will come from. FIG. 4D shows a side view from the opposite side of 4 B shows the reservoir of material 41 with a material A 42 and material B 43 that make up the inner layer of the stent 44 . FIG. 5A shows how the second layer will be attached to the first with a Mandrel dimension A 45 holding in place the subsequent outer layer 46 around the inner layer 47 with a variable mandrel length 48 and a mandrel dimension B 49 . FIG. 5B shows the two step process of how the mandrel holds the structure of the stent as it comes through. In step 1 , the variable mandrel diameter 53 with a deposit layer on the mandrel 50 is then dehydrated 51 onto a mandrel 88 . The second step to create a smaller diameter stent is shown in step 2 with a smaller mandrel 54 with a smaller dehydrated stent 52 . FIG. 6 is a graph depicting how much the stent can stretch based on the weight of the load applied to it. FIG. 7A shows a view of what the end of a finished structural hydrogel device 55 would look like with an embedded weave composition 56 of the final stent. FIG. 7B shows a cross section of the finished stent with an inner layer 58 , an outer layer 57 a coil form 59 and a hydrogel tip 60 . The flow of fluid through the stent is also shown 61 . FIG. 7C shows the same cross section with a variable diameter of both the inner layer 63 and the outer layer 62 with the same outward flow 64 . FIG. 7D shows how a catheter or stein can possibly be filled with medication that will flow into the bloodstream when the bloodstream has a lower concentration than the catheter or stent. The potential inflation of the outer layer 67 of the catheter shaft 66 of a low profile integral balloon 68 is displayed. FIG. 7E shows a more detailed side view of the potential expansion for drug refilling purposes. The optional inflation 69 with a thin wall of the balloon 70 with an optional drug reservoir 72 is shown more clearly. FIG. 7F shows an end view of what the catheter or stent will look like when expanded. The increased diameter of the stent 71 with the force that is exerted outwards by the fluid flowing through 73 is displayed. FIG. 7G shows what the ends of the devices will look like if expanded. A solid core 74 with multiple layers of radiopaque filled hydrogel forming a tip 75 with the layers required by the process 76 . A potential adhesive 77 could also be implemented. FIG. 8A shows three potential configurations of A 78 , B, 79 and C 80 . These configurations depict different potential forces that may be applied depending on the volume and amount of flow of liquid through the device. FIG. 8B shows how drugs may be delivered through diffusion 81 if that option is pursued. FIG. 9A shows an interior cross sectional view of the final device while FIG. 9B shows what the outside of the final device will look like. FIG. 10 shows the variable diameters of the outer layer with the interior diameter 83 and exterior diameter 84 when the device is fully hydrated 86 . The same is shown for the inner layer with the interior diameter 85 and the exterior diameter 84 when the device is fully hydrated 87 . In the preferred embodiment, a Physician skilled in the ability can be expected to implant and retrieve a Structural Hydrogel Device in the same manner as a thermoplastic device. A Structural Hydrogel Ureteral Stent or catheter can be implanted transuretheraly or percutaneously from the kidney into the Ureter considerably smaller in diameter and once wetted immediately lubricous while hydrating, and increasing in corresponding volume. This instant process ideally can be used to fabricate an entity, device or product which exhibits a reversible function, ideally infinitely where the material can be dehydrated and re-hydrated as required. In that sense, the primary mechanism of the process is that the first or inner layer material is deposited fully hydrated and then subsequently dehydrated as a part of the process, see step ( 1 ) FIG. 3 , FIGS. 4A & B. Then a sequential layer is added whereby the solvent in the second layer solution that allows the hydrogel to be in a semi-liquid phase will interact with the dehydrated first or inner layer beneath and a covalent interface will be achieved, see step ( 2 ) FIG. 3 , FIGS. 4A & B. This material defined as a hydrogel, is in its semi-fluid phase before solidification, and used as a raw material in the disclosed process. Furthermore different concentrations of solids or fillers in the hydrogel material can be deposited by for example controlling several reservoirs flowing into one manifold with one unique outlet, see FIGS. 4C & D. Additionally, mandrels used for initial processing, may be removed to create additional effects. For example a larger OD mandrel will result in a thinner dehydrated wall when preparing for a concurrent layer. Similarly, a smaller OD mandrel, no mandrel or a combination of diameters could be used for additional desired effects, see FIGS. 5A & B. Conversely, the disclosed (reversible dehydration/hydration lamination) process provides a novel advantageous alternative when designing or fabricating products made from raw materials such as hydrolyzed PAN type materials that need to exhibit excellent mechanical characteristics while maintaining low percent solids, see FIG. 6 . One of the most valuable attributes of the disclosed process allows processing from solvent-based hydrogel solutions that result in a structural hydrogel device exceeding the performance of coagulated hydrolyzed PAN products and components. Therefore the disclosed process exceeds the limitation of materials such as hydrolyzed PAN but also includes any formulation that exhibits a reversible function whereby the material can be dehydrated and re-hydrated. In that manner, the disclosed process allows the layering and or lamination of layers in accordance with the disclosed process resulting in a laminated structural hydrogel of predominately low solids and high corresponding aqueous content that will exhibit significant mechanical characteristics such that a stable product can be produced. Subsequently, this novel process allows the lamination of subsequent concurrent layers that in a final configuration provide the enhanced mechanical characteristics that result in 100% structural hydrogel products as well as hybrid versions, see FIGS. 7A , B, C, D, E, F & G. Although one primary advantage of the disclosed process is the ability to adhere one hydrogel layer to another hydrogel layer or other surface material, and that the lamination of such layers together results in and benefit from the compression of the outer layers or at least the integration of the outer layer to the associated inner layer; one can incorporate or produce a hybrid by for example incorporating a braid or fabric between layers, see FIG. 7A . Therefore the disclosed process results in the revolutionary never before claim of adhering one hydrogel layer to another hydrogel layer, which as disclosed is the primary influence resulting in the superior mechanical and biocompatibility performance characteristics of the as called structural hydrogel product or device. A hybrid device for example utilizing a structural hydrogel distal tip manufactured in accordance with the disclosed process, and adhered to or processed directly onto a conventional metal, TPE/TPU device surface, such as for example a catheter where the hydrogel is not a coating but an integral component, see FIGS. 7B & C could diminish complications related to implantation. Furthermore, a hybrid device utilizing a structural hydrogel design manufactured in accordance with the disclosed process can be engineered with different percent concentrations of solids in a specific layer, or segmented or positioned specifically along the axis of a catheter shaft for example. In this manner radiopaque media can be placed where it is desired, or a denser matrix can be produced in specific layers or segment along the axis, providing a differential gradient that would promote diffusion or conduction enhancing drainage, or providing a specific drug delivery barrier, see FIGS. 8A & B. Otherwise, current processing of hydrolyzed PAN and alike hydrogels is limited to only primarily coagulation of freely poured or molded gel, typically into a sheet form where further processed including secondary operations that include many methods of cross-lonking such as exposure to radiation, freeze/thaw methods, and modifications to the polymer chemistry, as well as using hot acid to enhance its hydrophylicity and or primers that are required to attach coatings to an intended substrate. This dangerous, expensive and marginally successful operation is not required with the disclosed process which produces a low solids and therefore correspondingly highly hydrophilic product. Thermoplastic extrusion processes are possible with many hydrogel formulae, in order to make them perform like conventional TPE and TPU's. Although thermoplastic extrusion typically results in components and products that exhibit adequate mechanical characteristics, thermoplastic extrusion of for example hydrolyzed PAN does not yield a component or product that exhibits a large aqueous content compared to product manufactured from the disclosed process. Furthermore, for example extruding hydrolyzed PAN requires loading the polymer resin with large amounts of plasticizers, and when radiopacifers are added the end product contains a much higher percent of solid than exhibited by products manufactured with the disclosed process, diminishing the hydrophilicity, and bio-compatibility. The advantages therefore are that the disclosed process which doesn't require thermoplastic processing (although it can be extruded or molded); doesn't require post processing to enhance hydrophylicity, and isn't sensitive to variations in the base polymer chemistry can be used to cost effectively derive products which will exhibit a much higher level of aqueous absorption and related bio-compatibility which is paramount and related while exhibiting the required mechanical characteristics, which if not achieved, the device or product application wouldn't be possible. To achieve this bio-compatibility and in accordance with the benefits of the disclosed process a catheter for example might be produced with several layers whereby the last layer is void of but all previous layers would be filled with radiopacifiers, see FIG. 9 . In this manner human tissue does not come into contact with the radiopaque filler medias as would devices produced of or conventional hydrogels, TPE or TPU's. Also drug delivery systems and attempts to force the change in volume resulting in for example predetermined radial forces can be exhibited by adding or not adding fillers or generally the specification of the percent of hydrogel solids in a given layer or layers as illustrated in FIG. 8 .

The present invention relates generally a manufacturing process which results in a completely hydrogel polymer device that maintains lumen patency which allows for numerous applications. Catheters and stents are particular examples, and their composition, mechanical characteristics, and the significantly unique ability to conduct and allow fluids to pass from one end to the other without physiological rejection, inflammation, or manifestation of complications due to implant or otherwise undesirable outcomes when used for ambulatory and or therapeutic interventions is the purpose of the invention.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to a dental prophylaxis angle (prophy angle), and in particular to a disposable prophy angle having a disposable prophy cup. 2. Description of the Prior Art It is well known in the prior art to use disposable prophy angles having disposable prophy cups for performing dental procedures by a dentist or hygienist. These prophy angles are driven by a motorized dental handpiece. They are usually connected to the handpiece by inserting a nose section of the handpiece into the angle and connecting it to a drive shaft of the angle. The primary purpose of using a prophy angle is to enable the hygienist to reach more easily the various surface areas of the teeth. The main obstacles in this procedure are the hygienists hands, visibility, access and the size of the angle itself. The prophy cups are shaped to hold a desired amount of abrasive medium (paste) which is used to clean and polish the teeth. The prior art teaches of ways to automatically feed the paste or, in other cases, to preload a definitive amount of paste. Upon performing the procedure, the prophy cup and angle are subject to contamination and infection from saliva and blood of the patient. The high cost of sterilizing these items, in terms of money and time, has made the use of reasonably priced disposable angles very practical. Another advantage in using disposable mechanisms is to eliminate the need for the dentist or hygienist having to actually handle the components during sterilization. But most importantly, is to reduce the danger from incomplete sterilization, whereby the bacteria and infection are then transferred from one patient to another. Since every hygienist can consume thousands of disposable prophy angles each year, it is very important that they be reasonably priced. Most of the disposable prophy angles are manufactured from plastic material or inexpensive metals. Usually the plastic materials are of different grades and types depending on whether the component parts are designed to be gears, shafts or housings. Although they are used but a single time, the prior art recognizes the need for ruggedness and durability in disposable angles. It is also imperative that they not break or splinter during use. As stated above, the primary purpose of the prophy angle is to more easily reach the various surfaces of the teeth. Unfortunately the designs of the prior art locate the main gear reduction in the head section of the prophy angle. This creates a bulkiness where it is least desired. This also demands that the housing leading to the head be larger than necessary. It also makes the weight of the prophy angle heavier at the distal end causing a balancing problem. These designs limit the length of the housing and therefore bring the hygienists hands closer to the mouth of the patient. This causes the patient to experience more discomfort, creates a visibility problem and leads to fatique of the hygienist's hands. It is well known in the prior art that "splatter" is a problem that happens when the paste is not handled correctly by the prophy cup. There are numerous patents which address this problem. Some seek a solution in the design of the cup, while others attempt to solve the problem by providing a shield or some similar type barrier. The present invention seeks to improve upon the prior art. Accordingly, a need will be seen for a prophy angle which will alleviate these problems and accomplish the desired end result. A discussion of the prior art, of which the present inventor is aware, and the distinctions from the present invention is provided below. U.S. Pat. No. 5,433,605 issued to Strobl, Jr. on Jul. 18, 1995, discloses an adjustable prophy angle of which the angle can be adjusted from the standard 90° to improve accessibility. The bulkiness of the angle appears to remain, if not worse, and the visibilty is not seen to be improved. U.S. Pat. No. 5,219,285 issued to Meller et al. on Jun. 15, 1993, discloses a disposable right angle which utilizes a three piece construction with one of the pieces being made of metal to increase durability. The metal component is insertable through the housing which increases the bulkiness of the angle. U.S. Pat. No. 5,040,978 issued to Falcon et al. on Aug. 20, 1991 shows a dental prophy angle having a single snap-on retention mechanism that is integral with the housing for retaining the prophy cup rotating member and providing smooth rotation of the cup. This is an excellent illustration of the prior art and the effort that has been made to make the angles easy to assemble. Although this feature is of importance, it does not make the access any easier nor reduce the visibility problem. U.S. Pat. No. 4,544,356 issued to Gardella et al. on Oct. 1, 1985 teaches the use of a main shaft and a secondary shaft, but rather than utilizing a gear mechanism this patent uses a reciprocating cam to impact a reciprocating action to the cup. No attempt is made here for any gear reduction. None of the above inventions and patents, either singly or in combination, is seen to describe the instant invention as claimed. SUMMARY OF THE INVENTION Accordingly, the above problems and difficulties are obviated by the present invention which provides for a disposable prophy angle to be used in association with motorized dental handpieces. More particularly, the present invention is comprised of four major sections, a sleeve, a neck, a head and a prophy cup attachment. The main inventive concept of the present invention being the utilization of a gear ratio system at a relative distance from the head. This gear ratio taking place in the sleeve section, which has the largest cross sectional area. A secondary shaft, leading from the location of the gear ratio, needs to be only a fraction of the size of the main drive shaft. This allows the neck section to be thinner, thereby allowing greater visibility for the hygienist. Also, by having the gear ratio take place in the sleeve section, the heaviest portion of the prophy angle is in the handle. This will create a more balanced prophy angle, one that will be easier for the hygienist to control, cause less fatigue, give better access, and it will also help to keep the hands of the hygienist out of and away from the patients's mouth. The working member of the prophy angle is a prophy cup which is different than the prior art, in that it will have a plurality of concentric rings disposed within the inner cup, which will help eliminate splatter. These rings will have varying levels of abrasivity; the most abrasive being at the deepest portion of the cup. The rings being made of materials such as cloth or felt. As an option, the inner core of the cup may have a multitude of relatively short bristles for increased abrasion. The density and type of material of the bristles a function of the abrasivity. The gearing in the head section will have a greater surface area of contact. Since the gear ratio has already been performed in the sleeve section, the cup will exhibit less wobbling and less vibration, because the central axis of the head end will be shorter in length than comparable devices. Indirectly this also will have an effect in the reduction of splatter. The part of the prophy cup that is in contact with the tooth surface is a molded rubber. During the dental procedure it is often desired and necessary to change the cup texture. The types of rubber used to make the cups can range from relatively soft to sandpaper hard. It is also appreciated that in lieu of the hygienist changing cups, that they can be factory installed with ratings such as soft, medium and hard. An important object of the present invention is to provide a prophy angle that is inexpensive to manufacture and that is totally disposable. Another object of the present invention is to provide a prophy angle that will have greater access to tooth surface as well as gingival tissue. Still another object of the present invention is to provide a gear ratio closer to the hands for greater balance, thereby causing less fatigue and stress to the hands of the hygienist. The major benefit, in providing this gear reduction, is that less air is required to drive the system. Beyond any economical considerations, less air means less vibration and increased frequency of rotation at the head end of the cup, thereby less movement of the cup. This will allow the cup to glide over the teeth more easily, thereby causing more effective surface polishing and better elimination of plaque. An object of the present invention is to make a prophy angle that will give the hygienist greater range of visibility during the procedure and also reduce vibration to the hands. Another object of the invention is to impart to the prophy angle a true spin concentricity which will minimize wobble and thereby reduce splatter from the paste medium. A further object of the invention is to provide a prophy cup that will have varying levels of abrasion created by a plurality of concentric rings made from cloth or felt materials. Still another object of the invention is to provide a prophy cup that will have an inner core made from varying densities of nylon bristles. These and other objects of the present invention will become readily apparent upon further review of the following specification and drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a longitudinal sectional view showing the disposable prophy angle with prophy cup mounted therein. FIG. 2 is a front elevational view of the main and secondary gears taken on lines A--A of FIG. 1. FIG. 3 is a longitudinal cross sectional view of the neck section. FIG. 4 is a cross sectional view of the neck section taken on lines B--B of FIG. 3. FIG. 5 is a cross sectional view of the head section and the relationship of the driving and driven gears. FIG. 6 is an elevational cross sectional view of a symmetrical prophy cup. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to the drawings, and in particular to FIG. 1, reference numeral 20 indicates a disposable dental prophylaxis (prophy) angle of the present invention. The angle 20 includes a sleeve section 21, a tapered neck section 22, a head section 23 and a prophy cup 24. Sleeve section 21, having means 79 for snap-fitting into neck section 22 and neck section 22 having similar means 79 for snap-fitting into the head section 23. The lower head section 23 also having means 79 for opening and closing head section 23. Conventional means for connecting the sections are well known in the art. These connections can also be made by bonding the mating surfaces by suitable adhesives, sonic welding or other known techniques. Sleeve section 21 is comprised of a thin outer shell made from a disposable plastic material, a plastic that is FDA approved such as a polycarbonate resin like that marketed under the General Electric trademark LEXAN. Sleeve section 21 has a generally cylindrical elongated passageway 25 therein, and an opening 26 of sufficient diameter to accept the nose portion of a conventional dental handpiece (not shown). The handpiece is usually air or electrically driven and connected to a dental unit. Located in close proximity to opening 26 is a standard "T" shaped keyslot (not shown) for securing the dental handpiece in place. It is presumed that this mounting means can be adapted to accept a variety of handpieces, without deviating from the intent of the present invention. Integrally interposed within passageway 25 are support struts 28. Struts 28 provide stability to sleeve 21, thereby eliminating the need for a thicker shell. Each strut 28 will have an orifice 63 leading to a conduit 64, for allowing the hygienist to periodically add dental oil for lubrication. This will be important on units designed to be permanent and thereby autoclaved, however even on disposable angles 20 it may be desired to decrease friction from time to time. An integrally interposed 360° stop 29 is positioned to orient the dental handpiece and insure that it will be properly inserted within sleeve section 21. Transversing longitudinally through passageway 25 is a main drive shaft 30, which has a proximal end 31 and a distal end 32. Proximal end 31 having a main drive gear 33 integrally connected to it. As shown in FIG. 2, drive gear 33 has internal teeth. Distal end 32 of drive shaft 30 connects with the drive input of the dental handpiece. Struts 28 and stop 29 both provide support, stabilization and alignment for drive shaft 30. Struts 28 and stop 29 being molded from the same type of plastic as sleeve section 21. Drive shaft 30 and drive gear 33 are generally made from a different grade of plastic. Gears usually require more flexibility and therefore a plastic such as an acetal copolymer available under the Celanese trademark CELCON as well as many others can be used. The exterior surface of sleeve section 21 can have rubber soft pads 42 dispersed to help reduce vibration to the hands of the hygienist. These pads 42 can be manufactured as part of the prophy angle 20 or else can be removably placed on sleeve section 21. As depicted in FIGS. 3 and 4, neck section 22 is elongated 20 and tapered (quite significantly in respect to other conventional prophy angles) and has a cross sectional shape that is flat on the top and bottom surfaces 65 and 66 while having elliptical side surfaces 67. Neck section 22 is made from the same plastic as sleeve section 21. The elongated tapering shape allows the hygienist to have greater visibility and also increases the comfort level of the patient. The interior of neck section 22 is a hollow chamber 34. Interposed within chamber 34 are neck struts 68 which are integral with neck section 22 and in addition to supporting neck section 22 also provide support for an optional stability tube 74 that will further eliminate vibration in the system. Neck struts 68 have a shape mirroring the hollow chamber 34. Stability tube 74 passes longitudinally through the chamber 34 and provides the support and alignment of a secondary shaft 37. Shaft 37 moves longitudinally through tube 74 and has a first end 38 integrally connected to a secondary gear 39. Secondary gear 39 having externally mounted teeth for meshing with drive gear 33, as shown in FIGS. 1 and 2, whereby secondary shaft 37 will have the same rotational direction as main drive shaft 33. A main inventive concept of the present invention is in providing this gear ratio away from head section 23. Second end 40 of secondary shaft 37 having a spirally shaped driving gear 41 extending from the neck 22. Spiral driving gear 41 having teeth that gradually narrow from the outer extremity to the inner core. The advantages of this will be stated later. Neck section 22 having orifices 63 for introducing oil which is a necessity for reusable prophy angles. The oil flows through conduits 64 for lubricating secondary shaft 37. It is to be appreciated that the slim and elongated shape of neck section 22, and the distribution of the gearing ratio to sleeve section 21, allows for a more balanced angle 20 with the weight closer to the hygienist's hands. This will help to reduce stress and fatigue. Head section 23 and its relationship to neck section 22 and prophy cup 24 are best described by FIG. 5. Head section 23 is made from the same disposable plastic as sleeve section 21. It is critical for the exterior surface of the head 23 to be extremely smooth so as to eliminate possible irritations with 5 the inner membranes of the mouth and tongue. The design of the present invention enhances this concept as rounded head section 23 and neck section 22 are not only smooth but smaller than conventional disposable prophy angles. Within head section 23 is a cavity 43. The bottom of head section 23 having a snap fitting means 79 to allow access. An opening 44 is defined in the lower portion of head section 23. A rotating mandrel 45 is seated within cavity 43. Mandrel 45 having a central axis pole 46 integrally fixed to it, with axis pole 46 extending both upwardly and downwardly from mandrel 45. The top part 47 of axis pole 46 is rotatively positioned within a recess 48 in the inner shell of head 23. Insuring proper alignment and spatial positioning of mandrel 45 is a hollow cylindrical sheath 75 that extends downwardly to the upper portion of mandrel 45, which has a spirally shaped bevel driven gear 49 therein. Gear 49 is put into direct engagement with the spirally shaped driving gear 41 of secondary shaft 37. The result being a greater contact surface between gear teeth 41, 49. The greater gear surface area means a reduction in weight, more spin and less energy expenditure. Driving gear 41 approaches driven gear 49 at a right angle but maintains a 3600 groove, whereby gears 41, 49 are locked throughout the rotation. Mandrel 45 has a cup-like shape with tapering concentric sides 50. The bottom surface 35 of mandrel 45 is integrally connected to a circular boss 36 by a concentric slot 69. Slot 69 maintains boss 36 in a generally parallel spatial relationship to bottom surface 35. Mandrel 45 is located in head section 23 maintaining proper position within head 23 by boss 36 and concentric slot 69. Boss 36 having a diameter larger than cup opening 44 and thereby forming a seal with cup opening 44. Slot 69 having a friction fit with the perimeter of cup opening 44. At the bottom of axis pole 46 is an integrally connected receiving button 53 which has a rounded shape and designed for mounting of a disposable prophy cup 24. Heat caused by friction, when combined with vibration, is a major factor of increased splattering. The present invention is designed to eliminate harmful vibration. An improved design incorporates a circular channel 51 defined within concentric slot 69. A plurality of ball bearings 52 are dispersed within slot 69 in frictionless contact with central axis pole 46. FIG. 1 illustrates the relationship of prophy cup 24 to head section 23 with particular emphasis on the mounting of cup 24 to receiving button 53. As shown in FIG. 6, the top side of cup 24 has an adapter portion 72 containing a rounded aperture 54 therein for friction fitting over the button 53. Cup 24 having a conically shaped portion 73 with an exterior concentric surface 55. The inner surface 70 of the conically shaped portion having a bore 56. The inner surface 70 having defined therein a plurality of concentric rings. The rings increasing in abrasivity as they are disposed closer to the inner core of cup 24. The preferred embodiment depicts three such rings, an inner ring 58 of greatest abrasivity, a middle ring 59 of lesser abrasivity, and an outer ring 60 having the least amount of abrasivity. The materials for the rings are selected from various cloth and felt materials. The manner in which they are implanted into cup 24 is by conventional methods such as adhesives or heat treating. At the inner core of cup 24 are a multitude of nylon bristles 77, each having tips 78 at their distal ends. Tips 78 being made of nylon or felt material. The densities in which bristles 77 are dispersed is a direct function of the desired abrasiveness of cup 24. The concentricities allow the hygienist to maneuver the working part of cup 24 into and over areas that would be very difficult to cover without concentricities 58-60. A major benefit of the concentric ring design is in reducing, if not totally eliminating "splattering". Splattering is caused by the non-true torque of cup 24 combined with cup design and the ability or inability of cup 24 to hold the paste. Often at high speeds cup 24 has a tendency to wobble. The gear reduction being performed away head section 23 plus the large surface area of contact between driving gear 41 and driven gear 49 also tends to reduce the wobbling effect. Exterior cup surface 55 having a portion nearest bore opening 71 which has a scored surface 61 for better abrasive qualities between prophy cup 24 and the gingival tissue. The abrasivity of scored surface 61 being varied depending upon the tenaciousness of the plaque. Encircling about adapter portion 72 and cup 24 is a circumferential groove 62 for application of a removal tool which may be available but not herein disclosed. Prophy cup 24 is made of a molded rubber such as butyl rubber, but it is acknowledged that there are many excellent molded rubbers that can be used. The texture of cup 24 will vary during the procedure. It is anticipated that cup 24 can be augmented by impregnations around the outer perimeter with cloth, felt or sponge materials that are sometimes beneficial in removing tenacious plaque and stains. In cleaning a patient's teeth and gums, a hygienist applies a cleaning compound to the surface of the prophy cup and then applies the rotating prophy cup 24 to the patient's teeth. It is most important that the hygienist have the best vision possible, as working in the confines of a patient's mouth is already a difficult task. The preferred embodiment of the disposable prophy angle 20 and the prophy cup 24 described above, provides a distinct advance in the field of prophylaxis procedures. It provides a means for positioning the main gearing away from the head of the angle, thus reducing the size and weight of head end 23. By using the present invention's secondary shaft arrangement, the neck section 22 can be substantially reduced. Both of these improvements aid the visibiltiy and balance of the angle 20. The present disclosure includes that contained in the appended claims, as well as that of the foregoing description. Although this invention has been described in its preferred form with a certain degree of particularity, it is understood that the present disclosure of the preferred form has been made only by way of example and that numerous changes in the details of construction and the combination and arrangement of parts may be resorted to without departing from the spirit and scope of the invention. LEGEND 20 Prophy angle 21 Sleeve section 22 Neck section 23 Head section 24 Prophy cup 25 Passageway in sleeve section 26 Opening in passageway for contra-angle 28 Support strut 29 360° Stop 30 Main drive shaft 31 Proximal end of main drive shaft 32 Distal end of main drive shaft 33 Main drive gear 34 Hollow chamber in neck section 35 Bottom Surface 36 Circular Boss 37 Secondary shaft 38 First end of secondary shaft 39 Secondary gear 40 Second end of secondary shaft 41 Spiral driving gear 42 Rubber pads on outer surface of neck section 43 Cavity inside head section 44 Cup opening 45 Mandrel 46 Central axis pole 47 Top portion of central axis pole 48 Recess 49 Driven gear on top surface of mandrel 50 Tapered concentric side surface of mandrel 51 Circular Channel 52 Ball bearings 53 Receiving button 54 Circular aperture 55 Outer concentric surface of conical cup 56 Bore within the conical cup 58 Inner concentric ring 59 Middle concentric ring 60 Outer concentric ring 61 Scored surface of 55 62 Circumferential groove 63 Orifice 64 Conduit 65 Top flat surface of neck section 66 Bottom flat surface of neck section 67 Elliptical side surfaces of neck section 68 Neck struts 69 Concentric Slot 70 Inner surface of conical cup 71 Bore opening 72 Adapter portion of prophy cup 73 Conically shaped portion of prophy cup 74 Stabilizer tube 75 Cylindrical sheath 77 Nylon bristles 78 Bristle tips 79 Means for snap-fitting sections together

A disposable right angle dental handpiece comprising a plastic housing having a sleeve, a tapered neck, a head and a disposable prophy cup. The cup being removably coupled to a driven rotating member located in the head section for simultaneously cleansing the surface of the teeth as well as the surrounding tissue and gingival crevice. The sleeve having an elongated opening for receiving a power drive from a dental unit. A gear ratio mechanism located in the sleeve, rather than in the head section, for increasing the shaft speed by a factor of two to three times. A gear to gear arrangement in the head section for transferring the directional rotation from the drive shaft to the prophy cup. The prophy cup comprising a flexible body having a cavity therein with a plurality of concentric rings made of cloth or felt material for holding the cleansing paste and also to avoid splattering.

CROSS REFERENCE TO A RELATED APPLICATION This application is a continuation in part of application Ser. No. 540,505, filed Jan. 13, 1975 and now Pat. No. 3,935,858. SUMMARY OF THE INVENTION This invention relates to an orthopedic device for immobilizing a body part of a patient and will have specific but not limited application to a knee, ankle or wrist immobilizer which is of universal application to accommodate patients of varying size. The immobilizer includes a flexible cover which extends around the body part of the patient. A pair of stays are detachably connected to the cover and positioned one on one side and one on the other side of the body part. The stays may also carry belts or similar securement means by which the cover of the immobilizer is secured about the body part. The position of the pair of stays by being detachably connected to the immobilizer cover can be varied so as to accommodate the particular size of the patient. Accordingly, it is an object of this invention to provide a body part immobilizer which is of universal application to accommodate patients of different size. Another object of this invention is to provide a wraparound immobilizer for the knee, ankle, wrist or other body part in which stays are adjustably applied to the cover of the immobilizer. Still another object of this invention is to provide an immobilizer which is for a body part of a patient and which includes detachable stays positioned on the sides of the body part and carrying means for securing the cover about the body part. Other objects of this invention will become apparent upon a reading of the invention's description. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a plan view of a knee immobilizer shown in detached form. FIG. 1A is a detailed view of that portion of FIG. 1 within broken line circle 1A. FIG. 2 is a plan view of the knee immobilizer showing the stays thereof detached from the immobilizer. FIG. 3 is a perspective view of the knee immobilizer shown applied about the knee of a patient and as viewed from one side. FIG. 4 is also a perspective view of the immobilizer shown applied about the knee of the patient and viewed from the opposite side. FIG. 5 is a fragmentary cross sectional view taken along line 5--5 of FIG. 1. FIG. 6 is a plan view of a wrist immobilizer. FIG. 7 is a plan view of the wrist immobilizer showing a stay thereof detached from the immobilizer. FIG. 8 is a perspective view of the wrist immobilizer shown applied about the wrist of a patient. FIG. 9 is a plan view of an ankle immobilizer shown with the fore stay pad detached. FIG. 10 is a perspective view of the ankle immobilizer showing the stays and fore stay pad detached from the immobilizer. FIG. 11 is a perspective view of the ankle immobilizer shown applied about the ankle of a patient. DESCRIPTION OF THE PREFERRED EMBODIMENTS The preferred embodiments illustrated are not intended to be exhaustive or to limit the invention to the precise forms disclosed. They are chosen and described in order to best explain the principles of the invention and its application and practical use to thereby enable others skilled in the art to best utilize the invention. The immobilizer shown in FIGS. 1-5 includes a flexible cover 10. Cover 10 includes an upper edge 12 and a parallel lower edge 14, as well as side edges 16 and 18. To accommodate the anatomical shape of a patient's leg 20, side edges 16 and 18 preferably taper from upper edge 12 to lower edge 14 with the cover assuming a trapezoidal appearance when in planar form. Also each side edge 16 and 18 may be formed with a cut-out 22 to accommodate the knee cap of the patient. Cover 10 may be formed of any one of a variety of materials, such as a polyvinyl foam construction, having a looped pile material 24 applied to its outer surface. A fixed stay 26 is positioned midway between side edges 16 and 18 and extends from upper edge 12 to lower edge 14 of the cover. Stay 26 is secured in position by being sewn or otherwise appropriately affixed to cover 10. Stay 26 is shaped to generally conform to the anatomical curvature of the back of the leg at the knee. Also connected to cover 10 are a pair of detachable stays 30 and 32. Stays 30 and 32 are located to the inside and outside of the knee when the immobilizer is secured about the patient as shown in FIGS. 3 and 4. Each stay 30 and 32 includes an encasement 34 to which a plurality of hook or similar type securement members 36 are attached to one side. Hook members 36 are designed so as to engage and interlock with the loop pile material 24 of cover 10 and serve to connect stays 30 and 32 to the cover. Hook members 36 of stays 30 and 32 and loop pile material 24 of cover 10 may be of the cooperating interlocking type sold under the well known trademark "Velcro". Stays 30 and 32 are connected to cover 10 by having their hook members 36 pressed into engagement with loop pile material 24 of the cover. Rings 38 and straps 40 are also secured to stays 30 and 32 for the purpose of securing cover 10 about the knee of the patient. In FIGS. 3 and 4 the immobilizer is shown attached to leg 20. Cover 10 is wrapped around the knee with stay 26 being positioned to the rear or back of the knee and with side edges 16 and 18 in a juxtaposed or overlapping arrangement, depending upon the size of the patient. Stays 30 and 32 are applied to the cover at selected locations on the inside and outside of the knee, thus providing lateral rigidity to the immobilizer. The free end portions of straps 40 are inserted through rings 38 and return bent so that the hook members 42 of each strap can be pressed into interlocking engagement with the pile material 44 extending along the remainder of the strap. By utilizing loop pile material with cover 10 and hook member attachments with stays 30 and 32, the stays can be easily removed from and reapplied to the cover in adjusting the immobilizer to accommodate a particular size patient. The interlocking adherence between hook members 36 of stays 30 and 32 and the loop pile material of cover 10 is of sufficient strength to enable the cover to be secured about the patient's knee through the use of rings 38 and straps 40. While it is preferred that stays 30 and 32 of the immobilizer also carry the means for securing cover 10 about the knee of the patient, it is to be understood that such securement means whether straps, rings or buckles can be sewn directly to cover 10 with detachable stays 30 and 32 serving only as rigidifying means. The immobilizer shown in FIGS. 6-8 includes a flexible cover 50 having looped pile material 52 applied to its outer surface. A pair of stays 54 and 56 are connected to cover 50. Stay 56 is detachable and includes an encasement 58 to which a plurality of hooks 59 are attached to one side. Stay 54 is preferably sewn to cover 50 but if desired can be of a similar detachable construction as stay 56. Stay 56 carries straps 60 and stay 54 carries rings 62 for securing the immobilizer about the wrist of the patient as shown in FIG. 8 with the straps being inserted through the rings and return bent to have hook 64 carried by the straps pressed into locking engagement with pile material 66 extending along the straps. Strap 68 of hook material serves to secure tab 70 about the hand of the patient. The hooks 59 of stay 56 allow the stay to be pressed into interlocking engagement with cover material 52 and selectively located to accommodate the wrist of the patient. The immobilizer shown in FIGS. 9-11 includes a cover 80 having looped pile material 82 applied to its outer surface. Cover 80 has a center opening 84 to accommodate the heel 85 of the patient. A pair of detachable stays 86 and 87 are connected to cover 80 and located at the inside and outside of the foot when the immobilizer is applied to the patient's ankle. Stays 86 and 87 are bent to a desired anatomical configuration and each includes an encasement 88 to which a plurality of hooks 90 are attached to one side. Each stay carries one or more straps 92 and one or more rings 94 for securing the immobilizer about the ankle of the patient as shown in FIG. 11. A fore stay pad 96 is applied over the front of the ankle with side edges 98 of cover 80 preferably overlapping the pad and straps 92 passing through loops 100 of the pad. Straps 92 are also inserted through rings 94 and return bent with the hooks 90 carried by the straps being pressed into interlocking engagement with material 82 of the cover and similar material forming the outer side of stay encasements 88. In the wrist and ankle immobilizer embodiments of FIGS. 6-11, pile material 52 and 82 and hooks 59 and 90 may be of the cooperating interlocking type sold under the trademark "Velcro." It is to be understood that the invention may be applied to various types of body part immobilizers and is not to be limited to the details above given but may be modified within the scope of the appended claims.

A wraparound immobilizer for a body part of a patient, such as the knee, ankle or wrist, in which the inside and outside stays which assist in immobilizing the body part are adjustable to accommodate the size of the patient. Additionally, the stays may carry the attachment straps by which the immobilizer is secured about the body part.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates, in general, to intravenous catheter insertion devices, and in particular relates to a catheter insertion device incorporating a simple lever and clip structure which will safely lock a catheter hub of a catheter assembly to a normally disposable cannula housing and guard structure and which, in a simple mode, enables separation of the catheter hub from the cannula assembly or structure upon retraction and protective guarding of the used cannula. Specifically, an aspect of the invention resides in providing the lever release clip for a safety catheter which upon unlocking and releasing of the catheter hub concurrently pushes the catheter hub off a nose guard of the cannula assembly, while enabling a physician or clinical personnel to release the catheter by employing only one hand. The invention is further adapted to enable separation between the catheter hub of a flexible catheter and the needle or cannula arrangement of a catheter insertion device by simply manipulating a lever arranged on a cannula structure or nose guard thereof by simply pushing against a push-tab element. The utilization of clinical apparatus in which pointed hollow needles or cannulas are employed in order to puncture the skin of a patient, and especially catheters utilizing such needles to effectuate venipunctures, is well known in the medical art and is widely practiced by physicians and clinical personnel for the purpose of injecting fluids and drugs directly into the bloodstream of patients. Additionally, during surgical operations or procedures it may be frequently required that whole blood transfusions and parenteral fluids be administered to a patient undergoing such surgical procedures. Basically, as is well known and has been employed for a considerable length of time, the introduction of such fluids into the cardiovascular systems of patients has necessitated the forming of a venipuncture utilizing a hollow rigid needle having a proximal attachment site for a fluid connection which is adapted to interconnect the needle with a source of intravenously administered fluids. The foregoing method of administering fluids to patients through venipuncture has been subject to some rather serious problems in the administration of fluids to patients in this medical technology. Thus, a primary concern which had to be addressed resided in the inherent rigidity of the needle, the latter of which is normally constituted of surgical-quality steel, and while inserted into the vein of a patient necessitated the needle to be maintained for reasons of safety in a fixed position at the general site of the venipuncture throughout the duration of fluid administration or transfusion, whereby such a procedure could conceivably consume a considerable length of time. In addition to the foregoing, at times it has been necessary to periodically draw blood samples and/or successively administer intravenous fluids to a patient, thus requiring the patient to be subjected to a series or plurality of venipuncture, each administered at a specific time and at different sites on the body, resulting in a relatively traumatic experience for patients in view of such repeated and somewhat painful and unpleasant venipunctures. In order to ameliorate or possibly even eliminate the foregoing problems in the medical technology, it has been more recently the practice to introduce a flexible tubular catheter of a low-friction material, such as a silastic or Teflon into the vein of a patient and to permit the catheter tube to remain in such a position over lengthier periods of time for purposes of; for example, periodically administering fluids, including parenteral fluids, blood/plasma transfusions, medications in liquid form and also for the collection of blood samples and the like. In this manner, the previously encountered trauma, extravasation, and infiltration caused by repeated venipuncture have been largely avoided, and the danger and discomfort to a patient of leaving a rigid needle in the body for a prolonged period of time has been generally overcome. Thus, in order to position the distal end of such a flexible catheter tube within the body cavity of a patient, such as a vascular cavity or vein, there is normally employed a cannula or hollow sharp-tipped needle for the purpose of forming the venipuncture. Thereafter, the flexible catheter tube, which is telescopically and slidably coaxially mounted on the outer circumference of the cannula or hollow needle so as to extend sleeve-like thereabout is advanced along the length of the needle into the vein subsequent to the needle having formed the venipuncture. Thereafter, the needle is adapted to be withdrawn from the interior of the catheter tube, while permitting the latter to remain within the body of the patient at the site of the venipuncture, and the needle is suitably discarded. Inasmuch as the needle which has been previously positioned in the body of the patient upon forming the venipuncture may have been exposed to infectious agents; for instance, such as a patient infected with the Acquired Immune Deficiency Syndrome (AIDS) which is frequently or practically always ultimately fatal in nature, or other dangerous infectious conditions such as hepatitis, there is present the danger or hazard that the clinical personnel may inadvertently or accidentally jab or stick themselves with the used needle after withdrawal from the body of the patient, with the possibility of infection or even death resulting therefrom. Heretofore, in order to release the structure which contains the used retracted needle or cannula from a lock on a catheter hub, the latter of which remains attached to a flexible catheter tube extending into the site of the puncture in the patient's body, it was frequently necessary for the clinician or physician to employ both hands in order to implement the separating operation between the catheter hub and used cannula structure so as to enable the subsequent attachment of a complementary Luer lock fitting to the Luer lock lug on the catheter hub for enabling the introduction of quantities of a parenteral fluid, supply of blood/plasma, or other medications to the patient in an intravenous procedure. Frequently, this necessitated that the clinical personnel was required to carry out, almost simultaneously or in rapid succession, two or three procedural steps, rendering the steps difficult to implement without the use of both hands, and possibly, upon occasion, even necessitating that one of the steps be delayed pending the completion of preceding steps in the separating of the catheter and cannula components. 2. Discussion of the Prior Art Thus, U.S. Pat. No. 4,762,516 to Luther et al. discloses the retraction of a used needle or cannula into a protective housing. However, this necessitates the further procedure of having to release a catheter while essentially employing two hands. Although other publications disclose various structures and methods for releasing catheters and their catheter hub structures from cannula assemblies while the cannulas have been retracted into a clinical personnel-protective environment, none disclose the employment of simple operative structure, such as a lever-clip device, which will enable locking of the catheter to the cannula assembly and also facilitate pushing the cannula hub off the housing or nose/guard components for the cannula when the latter is in its retracted position. SUMMARY OF THE INVENTION Accordingly, in order to facilitate a one-handed separation and relative manipulation of the catheter and cannula components of the intravenous catheter insertion device; especially the detachment from the catheter of the structure and elements containing the used cannula or hollow needle which was previously employed in forming the venipuncture, while permitting the catheter and thereto attached catheter hub, the latter of which comprise a part of a Luer lock lug or fitting, to remain in position at the site of the venipuncture, pursuant to the invention there is utilized a novel lever and clip arrangement which is positioned intermediate a housing for the containment of the cannula or needle, and including a nose guard projecting into the catheter hub, through the implementation of a simple one-handed manipulation of the lever and clip arrangement. This, in essence, renders simple the process of separating the catheter and cannula housing components by enabling a user to grip the housing structure containing the retracted used cannula and with one or more fingers of the same hand to manipulate the lever and clip so as to effectuate the release and pushing off of the catheter hub in a single motion. Accordingly, it is an object of the present invention to provide a novel lever and clip arrangement enabling the separation of a safety catheter hub from a disposable cannula assembly. Another object of the present invention is to provide a simple lever and clip structure mountable on the components of the intravenous catheter insertion device comprising a catheter hub of a safety catheter assembly and housing a nose guard structure adapted to receive a needle or cannula for forming the venipuncture in a patient, and whereby upon a simple manipulation of a clip or lever on the device which is operable with one hand of a user holding the device, it is possible to separate the components thereof to enable removal of the cannula and related components in a protective state while permitting the therefrom released and pushed-off catheter hub and thereto attached catheter extending into the venipuncture in the patient's body to remain in place. BRIEF DESCRIPTION OF THE DRAWINGS The foregoing and other objects and advantages of the invention may now be more readily ascertained from the following detailed description of various embodiments of the inventive device, taken in conjunction with the accompanying drawings; in which: FIG. 1 illustrates an intravenous catheter injection device incorporating a lever and release clip structure pursuant to the invention; FIG. 2 illustrates the device of FIG. 1 in the process of being locked into operative position; FIG. 3 illustrates the device of FIG. 1 in the process of the catheter hub being released from the cannula structure upon retraction of the cannula; FIGS. 4a through 4f illustrate various successive steps in respectively the operation and assembly of the lever and release clip structure pursuant to the inventive device; FIG. 5 illustrates a rear view of the lever and release clip; FIG. 6 illustrates a front view of the lever and release clip; FIG. 7 illustrates a side view of the lever and release clip; FIG. 8 illustrates a sectional view taken along Line 8--8 in FIG. 5; FIGS. 9 and 10 illustrate a catheter insertion arrangement in, respectively, operative and cannula-retracted positions thereof; FIG. 11 illustrates a modified version of a lever and release clip structure on a catheter insertion device; FIG. 12 illustrates the catheter insertion device of FIG. 11 in the process of being locked; FIG. 13 illustrates the device of FIG. 11 in the process of being unlocked so as to separate the catheter hub from a nose guard portion of the device; FIGS. 14a through 14c illustrate sequential steps in the assembly of the lever and release clip of FIG. 11; FIGS. 15, 16 and 17 illustrate, respectively, front, side and sectional views of the lever and release clip utilized in the embodiment of FIG. 11, FIG. 17 being a sectional view taken along Line 17--17 in FIG. 15; FIGS. 18 and 19 illustrate perspective views of another version of a catheter insertion device pursuant to the invention in, respectively, operative and cannula-retracted positions thereof; FIG. 20 illustrates another embodiment of a catheter insertion device utilizing a lever and clip structure; FIGS. 21 and 22 illustrate the device of FIG. 20 in, respectively, catheter locking and unlocking modes; FIG. 23 illustrates a front view of the combined lever and clip and cannula guard structure utilized in the catheter device embodiment of FIG. 20; FIG. 24 illustrates a sectional view taken along Line 24--24 in FIG. 23; FIG. 25 illustrates a further modified catheter insertion device pursuant to the invention; and FIGS. 26 and 27 illustrate the catheter device of FIG. 25 in, respectively, the catheter locking and unlocking modes thereof. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Referring in more specific detail to FIG. 1 of the drawings, there is illustrated an intravenous catheter insertion device 10 incorporating a catheter (not shown) having a cannular needle 12 projecting therefrom, wherein the needle is generally of surgical steel construction adapted to be inserted into the vein of a patient in the shown extended position thereof. The insertion device 10 includes a guard 14 and a housing 16, and wherein the structure thereof includes a nose section 18 comprising a snap-in nose 20. A lever and release clip 22 is mounted at the leading end of the guard 14 and, as shown in FIG. 2 of the drawings, the hub 26 of the catheter is adapted to be attached to the housing 16 in a locked position. In order to ensure that the locking position has been ascertained, an audible "click" may be generated upon locking. At this point the catheter hub 26 is locked in place, with the extended cannula 12 passing therethrough in extended position ready for venipuncture, and the catheter hub will not separate from the cannula assembly without any deliberate actions being imparted thereto by a physician or clinician. This, in essence, imparts a degree of a "fail-safe" operation to the catheter insertion device. Upon the cannula 12 having been fully retracted into the protective housing 16, in order to separate the catheter and its catheter hub 26 from the remaining insertion structure, so as to remain in the vein of the patient, as is illustrated in FIG. 3 of the drawings, a user would push back and then down on the lever clip 22 with one finger, releasing the catheter hub 26 and concurrently pushing the latter off the nose guard and housing. It is also possible for the user of the catheter insertion device 10 to merely push off and release the catheter hub 26 by pushing forward somewhat harder on the clip tab 30 and, in the event the user is implementing a difficult catheter insertion into a patient, it is possible for him or her to release the catheter hub 26 prior to locking so as to impart a more sensitive "feel" to the insertion of the cannula 12 into the vein of the patient. Referring to FIGS. 4a through 4c, there are shown successive steps in the assembly of the lever and release clip 22 of FIG. 1. As shown in FIG. 4a, the lever-clip 22 is snapped onto the nose guard piece 18; and in FIG. 4b the properly oriented catheter hub 26 is then snapped onto the lever-clip and nose guard assembly. FIG. 4c illustrates the entire arrangement in the assembled and operatively locked condition thereof. In order to release the catheter and its catheter hub 26 from the remaining cannula structure, as discussed with regard to FIG. 3 of the drawings, FIG. 4d illustrates the nose guard 18 being locked over the cannula point, with the cannula 12 or hollow needle (not shown) being in the fully retracted or guarded position within the housing structure 16. Thereafter, as shown in FIG. 4e of the drawings, the user or clinical personnel pushes downwardly on the lever clip 22 in the direction of arrow A, thereby both releasing and pushing off the catheter hub 26 as shown in the directions of arrows B. Thereafter, with the catheter hub 26 and the attached catheter tube remaining in place, the latter having its leading or free end inserted into the vein of the patient, the cannula assembly comprising the nose guard 18, the housing 16 and lever clip 22 is removed and discarded. As shown in FIGS. 5 through 8, the lever release clip 22 is constituted from a molded plastic material, preferably of a relatively soft plastic, such as polyethylene, having the nose guard formed thereon, in order to prevent any damage to the catheter hub Luer lock lugs during assembly therewith. This catheter insertion device 10, in essence, both releases and pushes off the catheter hub 26 when finger pressure is applied to the top of the lever clip 22, although the device is also capable of facilitating somewhat modified methods of catheter release; for instance, such as by pushing against and deflecting of the lever clip. Referring to FIGS. 9 and 10, there are shown perspective views of a catheter insertion device 40, in which, as shown in FIG. 9, the cannula 42 projects from a nose guard 44 of a unitary structure, and extends from a housing 46, as known per se. upon a lever clip 48 which is mounted on the nose guard 44 being tilted, as shown by arrow A in FIG. 10, the catheter hub (not shown) can be separated from the cannula assembly by simply pulling back on the lever clip or tab 44 of the nose guard. This tab portion 44 of the nose guard can be molded with an integral hinge to facilitate this type of function. Referring to the catheter insertion device 50 in the embodiment of FIG. 11, in this instance there is also illustrated a modified version of a lever clip 56 wherein the catheter hub 52 is introduced into the lever clip opening and over the nose guard portion 54 as in the embodiment of FIG. 1 of the drawings. As shown in FIG. 12, this locking action is effected by pushing the lever clip 56 somewhat forwardly, generating an audible "click" to provide indication of such locking action having been implemented. Conversely, in order to release the catheter hub 52 with the catheter tube from the cannula structure subsequent to locking, a user would simply pull back and/or down on the lever clip 56 as shown in the direction of arrow A in FIG. 13, thereby pushing the catheter hub off the nose. Other lever motions can of course also be contemplated herein. As shown in FIG. 14a through 14c, there are disclosed the successive steps in the assembly of the lever clip 56 of the device 50 of FIG. 11. In FIG. 14a the lever clip 56 is oriented and snapped onto a rib formed on the nose guard portion 54 of the cannula structure. An unoriented catheter hub 52 is then pressed into place on the nose guard, as shown in FIG. 14b; and thereafter as shown in FIG. 14c, the entire catheter arrangement is in an assembled and operatively locked condition. Illustrated in FIGS. 15 through 17 of the drawings is the configuration of the lever clip 56 showing the latter to be an essentially plate like structure having a central aperture 60 whereby, upon pulling back and/or pushing down on the lever-like structure of the lever clip, the catheter hub 52 is either pushed off or released from the nose guard portion 54 of the catheter insertion device 50. This particular lever clip structure does not require that the Luer lock lugs on the catheter hub 52 be oriented inasmuch as it pushes on the body of the hub and not on the lugs which are employed for forming a Luer lock connection subsequent to the withdrawal and detachment of the cannula structure. Inasmuch as this construction does not hold or release the Luer lock lugs on the catheter hub, any method which is currently employed for the release of the catheter can be utilized in addition to the above-described "one-finger" technique as shown in FIGS. 12 and 13 of the drawings. Referring to the embodiment of FIGS. 18 and 19, illustrating in perspective view two positions of a catheter insertion device 70, whereby in FIG. 18 the cannula 72 is shown extended from the nose guard 74 and, in FIG. 19, is protectively retracted therein and into housing 76. This structure permits a user to utilize the same "one-handed" catheter separation techniques as previously mentioned, with the so-called push-tab/guard 78 being unlocked only when the nose guard 74 is locked thereby permitting pushing off of the catheter hub by exerting continuing finger pressure on the push tab 78. As illustrated in FIG. 20 of the drawings, this is a somewhat modified version 80 of the previous devices with the exception being that the lever-clip arrangement 82 is integrally formed with the nose and guard structure 84. Hereby, the operation of locking the catheter hub 86 to the cannula structure as in FIG. 21 is identical to that as described with regard to FIG. 1, with an audible "click" noise signifying that a locking action has taken place. Conversely, as shown in FIG. 22, after locking of the catheter hub 86, the latter can be disengaged by any method currently employed as hereinbefore described. In addition, a user can pull back slightly on the push-tab 88 on the nose guard so as to disengage the catheter hub 86 from the cannula structure; in effect, providing for a "one-handed" operation. As shown in FIGS. 23 and 24, the guard and snap-in nose portion 82 having the projecting lever 82 thereon are integrally molded, using a living hinge 90 to enable the lever portion, as shown in FIGS. 21 and 22, to be resiliently tilted in opposite directions so as to cause the contacting lower projecting end portion 92 thereof to be able to push the catheter hub 86 away from and off the remaining cannula structure, as shown in FIG. 22 of the drawings. Similarly, as shown in FIGS. 25 through 27, the lever and structure 100 of this catheter device 102 is a simple one-piece or unitarily molded nose guard 104 having a protruding member 106 in the form of a tiltable lever whereby, as shown in FIG. 26, the forward movement thereof enables the catheter hub 108 to be locked into position onto the nose portion 110 of the cannula assembly 112, and with the extension of the telescoping arrangement 114, 116 for receiving the retracted cannula to be smooth and chatter-free in operation through the employment of a suitable lubricous plastic material. The unlocking action for separating the catheter hub 108 and its attached catheter tube from the remaining cannula structure, whereby the cannula has been retracted into its protective position, can be implemented in a manner as described hereinbefore by simply pulling back upon the tiltable lever 106 as shown in FIG. 27. The user may also pull back slightly on the push tab 120 on the nose guard 104 to disengage the catheter hub 108 from the disposable cannula structure pursuant to the inventive "one-handed" operation of the device. While there has been shown and described what are considered to be preferred embodiments of the invention, it will, of course, be understood that various modifications and changes in form or detail could readily be made without departing from the spirit of the invention. It is, therefore, intended that the invention be not limited to the exact form and detail herein shown and described, nor to anything less than the whole of the invention herein disclosed as hereinafter claimed.

A catheter insertion device incorporating a simple lever and clip structure which will safely lock a catheter hub of a catheter assembly to a normally disposable cannula housing and guard structure and which, in a simple mode, enables separation of the catheter hub from the cannula assembly or structure upon retraction and protective guarding of the used cannula. Specifically, an aspect resides in providing the lever release clip for a safety catheter which upon unlocking and releasing of the catheter hub concurrently pushes the catheter hub off a nose guard of the cannula assembly, while enabling a physician or clinical personnel to release the catheter by employing only one hand. A further embodiment is adapted to enable separation between the catheter hub of a flexible catheter and the needle or cannula arrangement of a catheter insertion device by simply manipulating a lever arranged on a cannula structure or nose guard thereof by simply pushing against a push-tab element.

BACKGROUND OF THE INVENTION The present invention relates to a drug delivery matrix coating, to an implantable device comprising the drug delivery matrix coating, to a method for making the drug delivery matrix coating and to a method for applying the drug delivery matrix coating to a stent. Stents are typically implanted within a vessel in a contracted state and expanded when in place in the vessel in order to maintain patency of the vessel to allow fluid flow through the vessel. Typically, implantation of such stents is accomplished by mounting the stent on the balloon portion of a catheter, positioning the stent in a body lumen, and expanding the stent to an expanded state by inflation of a balloon within the stent. The stent can then be left in place by deflating the balloon and removing the catheter. Because of the mechanical strength that is required to properly support vessel walls, stents are typically constructed of metallic materials. However, it is frequently desirable to provide localized pharmacological treatment of a vessel at the site being supported by the stent. It is convenient to employ the stent as a vehicle for drug delivery. The metallic materials are not capable of carrying and releasing drugs. Polymeric materials capable of absorbing and releasing drugs typically do not fulfill the structural and mechanical requirements of a stent, especially when the polymeric materials are loaded with a drug, since drug loading of a polymeric material diminishes the structural and mechanical properties of the polymeric material. Since it is often useful to provide localized therapeutic pharmacological treatment of a vessel at the location being treated with the stent, it is desirable to combine such polymeric materials with existing stent structures to provide a stent with the capability of absorbing therapeutic drugs or other agents, for placement and release of the therapeutic agents at a specific intravascular site. One solution historically used has been coating a stent's metallic structure with a polymeric material in order to provide a stent capable of both supporting adequate mechanical loads as well as delivering drugs. Techniques typically used to join polymers to metallic stents include dipping, spraying and conforming processes. However, these techniques have tended to introduce other problems into the stent products. Other problems with drug delivery matrix coatings include marginal adhesion to a substrate such as a metal substrate, insufficient elongation of the coating resulting in cracks, and limited and sub-optimal solvent choices that result in difficult application of the coating and poor manufacturability. SUMMARY OF THE INVENTION The present invention relates to a copolymer of carboxylic acid in a layer as applied in a drug releasing implant. The carboxylic acid copolymer may be in a matrix having a drug or in a primer or in a diffusion barrier. One embodiment of the present invention includes a drug delivery coating. The drug delivery coating comprises a matrix comprising one or more co-polymers of ethylene comprising the reaction products of carboxylic acid containing unsaturated monomers. The drug delivery coating also includes a drug contacting the matrix. The drug delivery coating has a strong adhesion due to Van der Waals interaction resulting from carboxylic acid bonding of the coating to the material being coated. One other embodiment of the present invention includes a stent. The stent comprises a tubular main body. The stent also comprises a coating that is adhered to the tubular main body. The coating comprises one or more co-polymers of ethylene wherein the co-polymers include a carboxylic acid moiety. The carboxylic acid moiety comprises one or more of acrylic acid, methacrylic acid, maleic acid, itaconic acid and all combinations and esters of these monomers. The coating deforms to a degree that accommodates stent deformation and, as a result, is resistant to cracking and delamination. The coating adheres to stents comprised of materials such as stainless steel. Another embodiment of the present invention includes a drug delivery system. The drug delivery system comprises a tubular main body and a first coating that overlays the tubular main body. A drug is incorporated into the first coating. A coating comprising one or more co-polymers of ethylene with a carboxylic acid moiety overlays the first coating. The carboxylic acid moiety is one or more of acrylic acid, methacrylic acid, maleic acid, itaconic acid and all combinations and esters of these monomers. For some embodiments, the first coating is biodegradable. Another embodiment of the present invention includes a method for improving manufacturability of a drug delivery system used with a medical device. The method comprises providing a medical device with a main body and providing a coating comprising cross-linkable co-polymers of ethylene with carboxylic acid. The method also includes applying the coating to the main body of the medical device. The drug delivery coating of the present invention adheres to a metal substrate and has an elongation comparable to a metal or polymeric substrate. The drug delivery coating is soluble in a ternary blend. The ternary blend eases application of the coating to a medical device surface, such as a stent. The ternary blend also improves manufacturability as compared to polymeric drug delivery systems not using the ternary blend. DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates a perspective view of one embodiment of the stent of the present invention. FIG. 2 illustrates a cross-sectional view of one embodiment of the drug delivery matrix of the present invention, wherein a drug is positioned within a polymeric matrix. FIG. 3 a illustrates a cross-sectional view of another embodiment of the drug delivery matrix of the present invention wherein a polymeric matrix overlays a drug-containing matrix. FIG. 3 b illustrates a cross-sectional view of another embodiment of the drug delivery matrix of the present invention wherein the polymeric matrix overlays the drug-containing matrix. DETAILED DESCRIPTION One embodiment of the present invention comprises an array of matrix drug delivery coatings 42 usable as drug delivery coatings for stents 40 , namely metal stents and polymeric stents, such as are illustrated, in one embodiment, in FIG. 1 . While a roll is shown in FIG. 1, it is understood that the coating may be a sheath or a thin coat for other implant embodiments. The array of matrix coatings comprises one or more cross-linkable co-polymers of ethylene, —(C 2 H 4 )— that comprises one or more carboxylic acid moieties. The carboxylic acid moieties are, for some embodiments, unsaturated monomers or unsaturated co-monomers. The unsaturated monomers or co-monomers are one or more of acrylic acid, methacrylic acid, maleic acid, itaconic acid and all combinations and esters of these monomers. The carboxylic acid co-monomer content is at least about 5% by weight and not more than about 50% by weight of the polymer. The carboxylic co-monomer content is, for some embodiments, in a range of about 15 to 40% by weight of the polymer. The acid groups are, for some embodiments, partially neutralized. For other embodiments, the acid groups are fully neutralized using sodium hydroxide, potassium hydroxide, ammonia, and the like. The term “ionomers” as used herein refers to polymers with acid groups that are neutralized with metal cations. The term “matrix polymer” as used herein refers to a polymer capable of forming a coating on a surface of a medical apparatus and providing a network for containing a drug. The matrix polymer has functional moieties capable of crosslinking by hydrogen bonds to other moieties within the matrix polymer and crosslinking to any other moieties derived from the medical apparatus to enhance the strength and toughness of the coating. Adhesion is enhanced by Van der Waals interaction resulting from carboxylic acid bonding of the coating to the medical apparatus. The term “elongation” as used herein refers to a percent elongation to break or an amount of strain the polymer can endure before rupturing. Another embodiment of the present invention includes the matrix drug delivery coating of the present invention and a drug. For some embodiments, such as is illustrated at 20 in FIG. 2, the polymer comprising the coating acts as a drug eluting matrix. The drug 22 is incorporated within the drug eluting matrix 24 . For some embodiments, the drug is a particulate which is dispersed within the drug eluting matrix 24 . For other embodiments, the drug is dissolved within the matrix 24 . The drug delivery coating acts as a barrier to rapid diffusion of the drug through the coating and to a treatment site. The drug delivery coating has a thickness ranging from about 0.1 to 3.0 mils, when applied to a stent. Because diffusion and drug release are delayed by the coating, the coating is usable for releasing drugs to a treatment site after a time interval of no or negligible drug release. The coating of the present invention is usable with multiple drug delivery matrices in order to orchestrate drug release. In one embodiment, the coating, as shown in cross-section in FIG. 2, overlays a surface 26 , such as a stent surface. With this embodiment, the coating functions as a drug release coating. For another embodiment which is not shown, the coating is drug free and does not function as a drug release coating. For some embodiments, the coating made with co-polymers of ethylene is a primer layer or a diffusion barrier. As a primer layer, the coating adheres to the surface of a stent. The primer layer also has functional moieties for crosslinking to a matrix polymer. For some embodiments, the primer layer is a dispersion of ethylene acrylic acid (EAA), such as Primacor 5980, available from Dow-Corning Corp. in Midland, Mich. or MICHEMPRIME 4983R, available from Michelman of Cincinnati, Ohio, or which is a dispersion that is capable of providing carboxyl moieties to the surface. As a primer layer, the coating of the present invention deforms to a degree that accommodates stent deformation, such as stent strut deformation. As a result, the coating is resistant to cracking and delamination and provides both elongation and high adhesion. For some embodiments, a drug is incorporated in the primer or the diffusion barrier. Typically, the drug concentration for these embodiments is lower if the matrix layer is present. Thus, the coating of the present invention accomplishes what many other polymers cannot perform. Thermosets such as epoxies, polyesters, phenolics, polyimide, as well as conventional thermoplastics such as vinyl chloride, cellulosics, styrene, methyl methacrylate and thermoplastics such as PEEK, PPS, polysulfone, polycarbonate, Mylar, unless the strain occurs above the polymer's glass transition temperature, do not elongate and adhere to a degree that makes them acceptable coatings for stent devices. For other embodiments, the polymer comprising the coating is positioned to provide a diffusion limiting barrier for a drug reservoir, such as a micro-depot 17 , shown in FIG. 3 a . The micro-depot 17 is defined by a divot formed at the surface 14 of the stent 13 . This embodiment is illustrated generally at 10 in FIG. 3 a . A coating illustrated at 12 overlays a stent surface 14 . For some embodiments, the coating 12 includes drugs and for other embodiments, the coating 12 is drug-free. The polymer overcoat 16 of the present invention overlays the coating 12 . The coating matrix includes one or more of poly(ethylene-acrylic acid), EAA, poly(ethylene-vinyl alcohol), poly(ethylene vinyl acetate), poly n-butyl methacrylate, poly(ethylene oxide) or a polyurethane elastomer such as Bionate 80A, manufactured by Polymer Technology Group of Berkeley, Calif. Bionate 80 is a polycarbonate-urethane and is a thermoplastic elastomer formed as a reaction product of a hydroxyl terminated polycarbonate, an aromatic diisocyanate, and a low molecular weight glycol which is used as a chain extender. The overcoat 16 includes one or more of EAA, ethylene-methacrylic acid (EMAA), and other ethylene, acrylic acid-based materials. For other embodiments such as is illustrated at 30 in FIG. 3 b , the polymer overcoat 16 functions as a cover over a drug-only layer 32 or a drug/non-drug mixture layer, which is not shown. The coat may be biodegradable but there may be non-biodegradable coats, as well. One layer of this type is a layer that comprises a drug and a biodegradable material such as phosphatidylcholine. Other suitable biodegradable materials include linear aliphatic polyesters like polyglycolide and polylactide from poly(alpha-hydroxyacetic acids), poly(orthoesters), polyanhydrides, polysaccharides, poly(ester amides), tyrosine-based polyarylates or polyiminocarbonates or polycarbonates, poly(D,L-lactide-urethane), poly(beta-hydroxybutyrate), poly(e-caprolactone), poly[bis(carboxylatophenoxy)phosphazene], poly(amino acids), pseudo-poly(amino acids), and copolymers derived from amino acids and non-amino acids. As the biodegradable layer degrades, the drug is released. For other embodiments, the matrix polymer coats a medical device such as a stent as shown at 40 in FIG. 1 but the polymer acts as a primer, and is free of drugs. For these embodiments, the matrix polymer 42 coats surfaces that are regarded as difficult to coat, such as stainless steel. Stainless steel is regarded as a difficult to coat metal because stainless steel has an outer surface that is trivalent chromium oxide, which provides a less reactive surface than other metal oxides. It is the interactions between metal oxides on the substrate and functional groups on the polymer that provide the adhesive force. For some embodiments, the polymer coating formulation of the present invention also includes one or more of a surfactant, a colorant, and one or more plasticizers or mixtures of these materials. Some of the co-polymer coating embodiments of the present invention comprise co-polymers that are soluble in ternary blends comprising toluene, a chlorinated solvent, and a lower alcohol. The ternary blends of toluene, chlorinated solvents, and lower alcohols, are usable to dissolve and to apply the polymer or polymer/drug blend to a stent. For example, a blend of 15% trichloroethane, 15% 2-propanol and 70% toluene is usable to dissolve a coating polymer manufactured by Dow Chemical, PRIMACOR 5980. For some embodiments, the polymer coating formulation is dissolved at an elevated temperature. The use of these ternary blends renders the coating application process easier in that a coating has a viscosity that eases application and uniformity of thickness. Specifically, solvents dissolve the polymer to make a coating solution. Surfactants are added to improve substrate wetting. Surfactants are also added to prevent foaming. Plasticizers increase elongation at the expense of hardness and tensile strength. The co-polymers are neutralized in a volatile or a non-volatile base. The copolymers are dispersed in water and in co-solvents such as the ternary blends that are described. Specifically, the co-solvents include the ternary blends of toluene, chlorinated solvents and lower alcohols. In one particular example, a coating of the present invention is made with a PRIMACOR 5980I, which is manufactured by Dow Chemical of Midland, Mich. The PRIMACOR 5980I is an ethylene acrylic acid copolymer, EAA, that adheres to metals and other polar substrates. The PRIMACOR 5980I has the physical properties described in Table 1. TABLE 1 Physical Properties Test Method Values (SI) Resin Properties Weight Percent Comonomer Dow Method 20.5 Melt Index, g/10 min ASTM D 1238 300 Melt Flow Rate, g/10 min ASTM D 1238 13.8 Density, g/cc ASTM D 792 0.958 DSC Melting Point, F (C) Dow Method 171 (77) Vicat Softening Point, F (C) ASTM D 1525 108 (42) Molded Part Properties Ultimate Tensile, psi (Mpa) ASTM D 638 1400 (10) Ultimate Elongation, % ASTM D 638 390 Tensile Modulus, 2% secant, psi (MPa) ASTM D 638 4800 (33) Hardness, Shore D ASTM D 2240 50 One other polymer formulation usable in the coating formulation of the present invention is provided in an ammonia neutralized aqueous dispersion at 25% solids, manufactured by Michelman Inc. The product name is Michem Prime4983 R. The Michem Prime 4983R product includes EAA solids in a percent of 25% non-volatiles. Dow Primacor 5980i is also usable. The specific gravity is 0.98 to 1.00. The particle size is about 0.03 micron. The viscosity is about 50 to 400, as measured with a No. 2 spindle. The hardness, as measured by ASTM test D-5, is about 54 sd. This Michem Prime 4983R dispersion is, for some embodiments, blended in a concentration that is less than 40% w/w, and is preferably within a range of 5 to 20% w/w with a co-solvent and, optionally, with a drug component. This dispersion is applied by standard coating application techniques such as spray coating or dipping, at substantially room temperature. When used as a primer, an addition of about 20 to 50 micrograms of coating material per stent is typically used. As a matrix with drug, about 50 to 500 micrograms per stent are applied to each stent. If used as a diffusion limiting barrier coat, a quantity of about 50 to 500 micrograms of material are applied to each stent. Once the coating is applied to a stent, the coating and stent are baked at low temperature, 120 degrees to 150 degrees F., for a period of time that is sufficient to drive off the solvents and any volatile amine. Coating and heating produces a conformal coating on the device. For some embodiments, the coating is dried at room temperature, rather than being subjected to baking. Another embodiment of the present invention includes a stent or other implantable medical device made with the coating of the present invention. The medical device comprises a main body comprising a material such as stainless steel, nickel, gold, chrome, nickel titanium alloy, platinum, other metals, silicone, polyethylene, other polyolefins, polyesters, other plastics, glass, polyurethane, acetal, polyamide, and polyvinyl chloride. Medical devices include catheters, microcatheters, wires, wound drains and dressings, arteriovenous shunts, gastroenteric tubes, urethral inserts, laparoscopic equipment, pellets and implants. The medical devices are made for some embodiments with coating alone. For other embodiments, the medical devices deliver drugs through the drug delivery coating. The drug delivery coating of the present invention substantially eliminates problems of marginal substrate adhesion, insufficient elongation resulting in cracks and limited and sub-optimal solvent choices resulting in difficult application and poor manufacturability. The carboxylic acid groups of the ethylene polymer impart a high adhesion to the coating so that the coating strongly adheres to metal. The ethylene content insures sufficient elongation of the coating to accommodate the strain associated with stent expansion. An ability to neutralize the acid groups with a volatile or permanent counter ion provides water dispersibility properties to the coating. The water dispersibility is compatible with organic co-solvents such as 2-propanol or methyl ethyl ketone to aid in substrate wetting and improved application properties. The acid groups that are not ionically neutralized in the dried film are usable to associate with amine groups on a drug, such as Actinomycin D, and to retard its release. Thus, the drug delivery coating of the present invention resists wet abrasion. The coating remains coherent without cracks despite flexing when applied to substantially inert surfaces that are difficult to coat, such as stainless steel. This performance is an improvement over other coatings which do not display optimal properties when applied to stainless steel. Due to a high ethylene content, the hydrophobic nature of the dry film retards the transport of drug molecules, which tend to be functionalized and have some hydrophilic character. Examples of such active ingredients include antiproliferative substances as well as antineoplastic, anti-inflammatory, antiplatelet, anticoagulant, antifibrin, antithrombin, antimitotic, antibiotic, antioxidant, and combinations thereof. A suitable example of an antiproliferative substance includes actinomycin D, or derivatives and analogs thereof (manufactured by Sigma-Aldrich 1001 West Saint Paul Avenue, Milwaukee, Wis. 53233; or COSMEGEN available from Merck). Synonyms of actinomycin D include actinomycin, actinomycin IV, actinomycin I1, actinomycin X1, and actinomycin C1. Examples of suitable antineoplastics include paclitaxel and docetaxel. Examples of suitable antiplatelets, anticoagulants, antifibrins, and antithrombins include sodium heparin, low molecular weight heparin, hirudin, argatroban, forskolin, vapiprost, prostacyclin and prostacyclin analogs, dextran, D-phe-pro-arg-chloro-methylketone (synthetic antithrombin), dipyridamole, glycoprotein IIb/IIIa platelet membrane receptor antagonist, recombinant hirudin, thrombin inhibitor (available from Biogen), and 7E-3B® (an antiplatelet drug from Centocore). Examples of suitable antimitotic agents include methotrexate, azathioprine, vincristine, vinblastine, fluorouracil, adriamycin, and mutamycin. Examples of suitable cytostatic or antiproliferative agents include angiopeptin (a somatostatin analog from Ibsen), angiotensin converting enzyme inhibitors such as CAPTOPRIL (available from Squibb), CILAZAPRIL (available from Hoffman-LaRoche), or LISINOPRIL (available from Merck); calcium channel blockers (such as Nifedipine), colchicine, fibroblast growth factor (FGF) antagonists, fish oil (omega 3-fatty acid), histamine antagonist, LOVASTATIN (an inhibitor of HMG-CoA reductase, a cholesterol lowering drug from Merck), monoclonal antibodies (such as PDGF receptors), nitroprusside, phosphodiesterase inhibitors, prostaglandin inhibitor (available form Glazo), Seramin (a PDGF antagonist), serotonin blockers, steroids, thioprotease inhibitors, triazolopyrimidine (a PDGF antagonist), and nitric oxide. Other therapeutic substances or agents which may be appropriate include alpha-interferon, genetically engineered epithelial cells, and dexamethasone. While the foregoing therapeutic agents have been used to prevent or treat restenosis, the drugs are provided by way of example and are not meant to be limiting, since other therapeutic drugs may be developed which are equally applicable for use in the present invention. The treatment of diseases using the therapeutic agents described as well as dosage rates are known. For some embodiments, a selected drug is intimately mixed with the polymeric coating material of the present invention in order to uniformly disperse the therapeutic drug in the polymeric material. For other embodiments, the drug is incorporated into a matrix such as a biodegradable polymer matrix. The specific method of uniformly dispersing the therapeutic drug in the polymer is variable, and depends upon the stability of the therapeutic drug to thermal processing. Ethylene and acrylic acid, for example, are co-polymerized by free radical techniques to form an essentially linear polymer. However, ethylene is not “crosslinked” by the acid co-polymer. The acid groups randomly placed along the chain hydrogen bond to each other. The acid groups crosslink each other, not the ethylene groups. For some embodiments, the therapeutic drug is uniformly dispersed in the polymeric material by coextruding small solid particles of the drug with the polymer material. The specific method of uniformly dispersing the therapeutic drug in the polymer varies and depends upon the stability of the therapeutic drug to thermal processing. The therapeutic drug is uniformly dispersed in the polymeric material by coextruding small solid particles of the selected therapeutic drug with the selected polymeric material. This extrusion device includes a hopper into which the polymeric material and small particles of selected therapeutic drug are added together, and into which a porosigen is also added, if desired. The extruder also typically includes a lead screw that drives and that intimately mixes the ingredients together, to uniformly disperse the small particles of the therapeutic drug, and if desired, a porosigen as well, in the polymeric material. The barrel of the extruder is heated by temperature controlled heaters surrounding the barrel in stagers. A motor and associated gears are provided to drive the lead screw, and a cooling system is also typically provided. This method of intimately mixing the therapeutic drug and polymeric material yields a relatively high and uniformly distributed loading of the therapeutic drug in the polymer. While a loading of the therapeutic drug is currently no more than about 40% by weight, depending upon the specific application and interaction of the polymer with the drug, drug loadings as high as 70% by weight have been achieved by this method. A preferable concentration range is 5 to 20% by weight. The drug loaded polymer is extrudible into an appropriate shape, or can be subsequently calendered to produce a drug loaded polymer film having a smooth surface, with the therapeutic drug uniformly distributed in the film. A polycarbonate-urethane material such as Bionate 80 is very hygroscopic. Pellets of Bionate 80 are dried by a process such as forced air dehumidifying dryer at 82 degrees C. for at least about 4 hours prior to extrusion or injection molding. Bionate 80 pellets are typically filtered during extrusion, through filters such as a 350 mesh filter and two 500 mesh filters. Extrusion equipment is set with a cross head temperature of about 200 degrees C. to 215 degrees C. to initiate the flow. Once flow is established, the cross head temperature is decreased until steady, viscous flow is achieved. Extrusion conditions for the polycarbonate-urethane material are typically within the following ranges: Conditions Temperature (C) Temperature (F) Barrel-Zone 1 200-215 390-420 Barrel-Zone 2 193-230 380-445 Barrel-Zone 3 193-230 380-445 Die 200-215 390-420 Melt Temperature 191-221 375-430 Extruder Configuration Parameter Value Length to Diameter Ratio 24:1 Compression Ratio 2.5:1 to 3.5:1 Cooling Water Temperature 18-20 degrees C. The particles of the desired therapeutic drug are formed to have a maximum cross-sectional dimension of about 10 microns. An average particle size of less than 10 microns and a uniform distribution of the particles of the therapeutic drug in the polymeric material provide a therapeutically effective amount of the therapeutic drug in the layer of the polymeric material to be applied to the structure of the stent, since the layer of polymeric material typically is as thin as 25 microns. The size and distribution of the particles of the therapeutic drug affect the physical properties of the polymer. In other embodiments, the therapeutic drug is compounded with the polymer by calendering the ingredients, such as in a two roll mill, for example. This method yields a relatively high and uniformly distributed loading of the therapeutic drug in the polymer. The matrix coating is applicable to the surface of a stent using methods such as dipping, spraying, flowing, rolling and brushing. Thickness of the coating ranges from about 0.1 to about 3 mils. The thickness is adjustable by adjusting viscosity of the coating material prior to application. Thickness is also adjustable by applying multiple coating layers. 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. Modifications and variations of the above-described embodiments of the invention are possible 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.

A coated stent is provided including a coating comprising one or more co-polymers of ethylene with carboxylic acid wherein the carboxylic acid co-monomer content is 5-50 wt%.

SEQUENCE LISTING An attached Sequence Listing (i. Name: SEQ_LISTING, ii. Date of Creation: Nov. 18, 2015, and iii. Size: 1 KB) is submitted herewith. FIELD OF THE INVENTION The invention concerns the use of the PAT nonapeptide for the manufacturing of a drug in the treatment or the prevention of neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, Huntington's disease or amyotrophic lateral sclerosis. BACKGROUND OF THE INVENTION The neurodegenerative diseases affect progressively the brain function and more generally the nervous system. The process involved consists generally in a deterioration of the functioning of the nervous cells, in particular the neurons, leading to the cellular death. The consequence for the patient is a progressive alteration, usually irreversible, of the nervous functions which can induce his death. The clinical outcome can be either some damages of the psychic function, leading to dementia such as in Alzheimer's or Pick's disease, or motor abnormalities such as in amyotrophic lateral sclerosis or Parkinson's disease, or the combination of both such in Huntington's chorea disease or Creutzfeldt-Jacob's disease. Alzheimer's disease (AD) is the most known and spread of the neurodegenerative diseases. It is characterized by memory loss and sometimes by disorders of reasoning, organization, language and perception. It is widely admitted that the AD symptoms arise from an increase of the production or accumulation of a specific protein (β-amyloid) in the brain, which leads to the death of nervous cell. Increasing age is the greatest know risk factor for AD. Approximately 30 millions of people in the world are affected by AD. Population ageing suggests that the economic burden caused by AD disease will become increasingly important. Parkinson's disease (PD) is the second most common neurodegenerative disorder in the United States and approximately 1-2% of worldwide population older than 65 years suffers from this progressive disease (Dorsey E R. et al. Neurology 2007; 68: 384). The predominant motor symptoms of PD including slow movement, resting tremor, rigidity and gait disturbance are caused by the loss of dopaminergic neurons in the substantia nigra. Although the etiology of PD remains so far unknown, both genetic and environmental factors appear to play a role (Paisan-Ruiz C. et al. Neuron. 2004; 44: 595 and Vila M. and Przedborski S. Nat. Med. 2004; Suppl 10: S58). Huntington's disease (HD) is an autosomal dominant inherited and progressive neurodegenerative disease that affects approx. 30,000 individuals in the US (about 200,000 individuals are at risk) (Harper P S. Hum. Genet. 1992; 89: 365). HD is clinically characterized by abnormal involuntary movements, behavioral disturbance, cognitive dysfunction and psychiatric disease. Massive loss of GABAergic medium spiny neurons (MSNs) of the striatum occurs in the HD brain together with enlargement of the ventricles and a corresponding shrinkage of the overlying cortex. MSNs of the striatum project into various regions of the CNS and are the key drivers of the progression of degenerative process that involves the remainder of the basal ganglia and subsequent dissemination including cortex and substantia nigra (Andric J. et al. Neurosci. Lett. 2007; 416: 272 and Frank S et al. Neurology. 2004; 62: A204). Dopamine, glutamate and γ-aminobutiric acid (GABA) are thought to be the most affected neurotransmitters in HD (Gunawardena S. et al. Arch. Neurol. 2005; 62: 46). Amyotrophic lateral sclerosis (ALS) is an adult-onset neurodegenerative disorder characterized by selective motor neuron death. Both upper motor neurons in the motor neuron cortex and lower motor neurons in the brainstem and in the ventral horn of the spinal cord are affected. Patients develop a progressive muscle phenotype characterized by spasticity, hyperreflexia, fasciculations, muscle atrophy and paralysis. ALS is usually lethal within 3 to 5 years after diagnosis, only 5-10% of patients survive beyond 10 years. There are approximately 140,000 new cases diagnosed worldwide each year. In most cases (90%) there is no family history of ALS. However a clear family history is present in 10% of patients who then suffer from familial ALS. Although the familial ALS is in almost all cases inherited in an autosomal dominant way, autosomal recessive and X-linked forms exist. Mutations in more than 10 different genes are known to cause familial ALS. Many mechanisms have been suggested to play a role in the pathogenesis and disease progression. These include amongst others neuronal excitotoxicity, mitochondrial dysfunction, deregulated autophagy, axonal transport dysfunction and refraction (Cudkowicz M E Ann. Neurol. 1997 41, 210-221). Albeit, there is currently no treatment leading to the AD recovery, there are 2 types of drugs which can decrease its symptoms and slow down its evolution. EP236684A, DE 3805744A and EP296560A disclose drugs based on acetylcholinesterase inhibitors: galantamine, rivastigmine and donepezil respectively. EP392059A discloses a drug containing memantine which is a NMDA receptor antagonist. All these drugs have received a marketing authorization to treat AD. However, the treatment only affects the symptoms. Several studies have shown that these drugs slow down only in a modest way the progression of cognitive symptoms as well as erratic behaviors in some patients. Moreover, half of the patients who received these drugs do not respond to these treatments. Finally, these drugs induce several undesirable effects such as nausea, diarrhea, hepatic disorders etc. . . . . Thus, there is an urgent need for drugs with a new mechanism of action different from the aforementioned drugs. Several projects are being explored currently. Few examples are mentioned hereafter. The secretase inhibitors block the transformation process of the β-amyloid protein precursor (known as “APP”) into the β-amyloid protein and thus permit to slow down its dangerous accumulation in the brain. Among these inhibitors is the tramiprosate (ALZHEMED®) which was tested in a phase II clinical study (Aisen P S et al. Neurology 2006; 28: 1757). Another inhibitor, the scillo-cyclohexanehexol, was tested in animals successfully (MacLarin J A et al. Nat. Med. 2006; 12: 801). These molecules interact with β-amyloid proteins during their formation and prevent them from agglomerating and from forming small aggregates, which destroy nervous cells by settling as solid plaques. However, they already cause important damage during their formation. Other treatments such as ubiquitin (compound naturally produced in the brain) induce the disappearance of β-amyloid protein before its reaches high accumulation in the brain (Taddei N. et al. Neurosci. Lett. 1993; 151: 158). However, the ubiquitin rates remain insufficient in patients which suffer from Alzheimer's disease. Another interesting method is the immunological approach. WO 94/06476A discloses a new type of drug which has a target different from the molecules cited previously: Etanercept (ENBREL®), which is a fusion protein directed against the TNF-α pro-inflammatory cytokine A recent pilot study was carried out over a 6 months period and showed encouraging results in term of cognitive improvement (Tobinick E. CNS Drugs 2009; 23: 713). In addition to the fact that the project is at a preliminary phase at the clinical level, the administration of the product ENBREL® was carried out by perispinal route in order to circumvent the problem linked to its incapacity to pass across the blood-brain barrier (BBB) (Griffin S. Newspaper of Neuroinflammation; 2008; 5: 3). However, this route of administration is burdensome and painful for the patient and requires a certain number of precautions: it must be carried out in hospitals. The presence of the blood-brain barrier (BBB) restricts strongly the passage of molecules such as ENBREL® from the plasma into the cerebral extracellular medium: very few drugs designed in laboratories, cross this barrier to treat brain diseases. Limited therapeutic options are available to PD, HD and ALS patients as only symptomatic treatments have received marketing authorizations so far. The major challenge for clinical development of new drug entities in neurodegenerative disorders lies in the difficulty to identify and hit disease-relevant targets that will beneficially interfere with complex physiopathological mechanisms. Moreover such therapeutic agent must cross the BBB and reach diseased regions of the central nervous system. U.S. Pat. Nos. 4,900,755 and 6,238,699 disclose an oral formulation for the controlled release of the combination of levodopa/carbidopa (SINEMET®). This treatment compensates for the loss of dopaminergic neurons that occurs in PD brains. Carbidopa, a decarboxylase inhibitor, prevents peripheral metabolism of levodopa, the precursor of dopamine, outside of the brain. In the brain levodopa is broken down into dopamine which increases dopamine concentration in the striatum. Levodopa, dopamine precursor is used because the natural neurotransmitter does not cross the BBB. Tetrabenazine (XENAZINE®) is an oral dopamine-depleting agent that treats chorea associated with HD. Dopamine is required for fine motor movement, so the inhibition of its transmission is efficacious for hyperkinetic movement. Tetrabenazine is a reversible human vesicular monoamine transporter type 2 inhibitor. It acts within the basal ganglia and promotes depletion of monoamine neurotransmitters serotonin, norepinephrine, and dopamine from stores. It also decreases uptake into synaptic vesicles (Guay D. Am. J. Geriatr. Pharmacother. 2010; 8: 331). Finally, riluzole (RILUTEK®) is the only approved treatment for ALS which increases lifespan by only 2-3 months after 1.5 years of treatment, and is effective at delaying the use of assisted mechanical ventilation in bulbar patients (Miller R G et al. Neurology 2009; 73: 1218 and Bellingham M C. CNS Neurosci. Ther. 2011; 17: 4). Pharmacological properties of riluzole include an inhibitory effect on glutamate release mediated by inactivation of voltage-dependent sodium channels and by its ability to interfere with intracellular events that follow transmitter binding at excitatory amino acid receptors. Although these drugs reduce cognitive or motor symptoms and improve quality of life, they fail to modify or halt disease progression. Their long-term use is associated with side-effects that often require treatment arrest. Therefore, there is a need for drugs which should at the one hand be sufficiently effective to treat AD, PD, HD or ALS and on the other hand cross the BBB. The Applicant objective is to develop a drug capable to treat of Alzheimer's disease and other neurodegenerative disorders without presenting the disadvantages of the existing treatments. The Applicant has found, in a fortuitous way, due to the work already carried out with this molecule, that a peptide analog of thymulin hormone has an interesting potential in the prevention and the treatment of AD, PD, HD and ALS. We know since the late 1950's the central role played by the thymus in the differentiation of T-cells, responsible in particular of transplant rejection and implicated in the immune defense against the viruses and some bacteria. The hormone secreted by the thymus was then identified as a peptide of 9 amino-acids: the thymulin (Pleau J M et al. Immunol. Lett, 1979; 1:179; Amor et al, Annals Rheum. Dis. 1987; 46: 549). The thymulin effects on the immune system were shown to be zinc-dependent. Indeed, zinc confers to the thymulin a tetrahedral conformation which corresponds to the active form of the molecule. In the absence of zinc, thymulin is no longer active on the immune system. Work was undertaken specifically on a nonapeptide called “PAT” having the sequence of amino-acids Glu-Ala-Lys-Ser-Gln-Gly-Gly-Ser-Asp (EAKSQGGSD). The application WO 03/030927A reports that several derivatives of thymulin, such as the PAT nonapeptide presents analgesic and anti-inflammatory properties, and can treat in pain including neurogenic pain. More recently, the application WO 2009/150310A describes specifically the use of the PAT nonapeptide in the treatment of autoimmune diseases such as rheumatoid arthritis, and intestinal bowel diseases (IBD) such as Crohn's disease and hemorrhagic rectocolitis. SUMMARY OF THE INVENTION The present invention refers to the use of the PAT nonapeptide corresponding to the formula (I): EAKSQGGSD or one of its pharmaceutically acceptable salts in the preparation of a drug in the treatment and the prevention of neurodegenerative diseases, in particular Alzheimer's disease Parkinson's disease, Huntington's disease and amyotrophic lateral sclerosis. The PAT peptide is administered to the human or the animal at a dose ranging between 0.1 and 50 mg; and preferably between 1 and 10 mg. By “pharmaceutically acceptable salt”, one understands as example and in a nonrestrictive way acetate, sulfate or hydrochlorate. The invention also relates to the use of a compound of formula (I) in which one or more amino-acids are in the D configuration. The pharmaceutical composition of the invention can be administered by parenteral, topical, oral, perlingual, rectal or intraocular route. The preferred administration route is the parenteral route, and in particular the cutaneous (s.c.), intranasal, intra-peritoneal (i.p.) or intravenous (i.v.) routes. It can also be considered a topical route, in particular transderrmal, such as for example, as a patch, pomade or gel. During an experiment carried out for the invention, it was shown that the PAT nonapeptide displays a biological activity when it is administered by intracerebroventricular (i.c.v.) route—which bypasses the BBB, and also by parenteral route (intra-peritoneal). This latter mode of administration highlights the fact that the product crosses the BBB and reaches the brain. To cross the BBB, persons skilled in the art know that the molecular and physicochemical properties of the molecule must fulfill the 5 criteria described by Lipinski et al. (1997). Adv Drug Del Rev 23: 3-25 (amongst them a low molecular weight, its hydrophobicity, its charge etc. . . . ). Yet, we were surprised to notice that the PAT peptide, which does not fulfill all these criteria, crosses the BBB. The formulations to be administered by parenteral route contain a solvent allowing the solubilization of a peptide such as the PAT peptide; this solvent can be selected among the water for injection or physiological saline solution, optionally with preservative agents (such as cresol, phenol, benzyl alcohol or methylparaben) and/or buffer agents, and/or isotonic adjuvants and/or surfactants well-known by persons skilled in the art. One of the preferred administrations is the subcutaneous (s.c.) route. The injectable form by subcutaneous route according to the invention contains the PAT peptide dissolved in an appropriate solvent, with if necessary other excipients such as those cited previously. One of the injectable subcutaneous forms according to the invention contains a polymer which allows a slow diffusion of the PAT peptide during the time course (period up to 30-40 days). In order to achieve that, PAT peptide is dissolved in an appropriate solvent such as a physiological saline solution, and mix with appropriate polymers such as the polyethylene glycols, polyvinyl pyrrolidones and polyacrylamides. BRIEF DESCRIPTION OF THE DRAWINGS Other advantages and characteristics of the invention will become clear upon reading the following examples. Reference is made to the appendix drawings in which: FIG. 1 shows the results obtained from Y-maze test in mice having received by (i.c.v.) intracerebroventricular route either the ScAβ (“scrambled”) peptide or the Aβ 25-35 peptide, and also by intra-cerebroventricular (i.c.v.) route an inert (V) vehicle or the PAT peptide. The evaluated parameter is the spontaneous alternation expressed as a percentage; FIGS. 2A and 2B show the results obtained from passive avoidance test; the treated groups are identical to those of FIG. 1 ; in FIG. 2A is measured the latency time (in seconds) to enter into the dark compartment; and in FIG. 2B is measured the latency time to escape (in seconds); FIG. 3 shows the results obtained from Y-maze test under the same conditions as for FIG. 1 , except that the PAT peptide and the inert (V) vehicle are injected by intra-peritoneal (i.p.) route; FIGS. 4A and 4B show the results obtained from passive avoidance test carried out such as for FIG. 2 except that the PAT peptide and the inert (V) vehicle are injected by intra-peritoneal (i.p.) route; in FIG. 4A is measured the latency time (in seconds) to enter into the dark compartment; and in FIG. 4B is measured the latency time to escape (in seconds). FIGS. 5A and 5B show the results obtained from in vitro tests performed with rat primary dopaminergic neurons; in FIG. 5A is depicted the quantitative representation of the protective effect of PAT on the survival of TH-positive dopaminergic neurons exposed to 6-hydroxydopamine (6-OHDA) injury and pre-treated with vehicle (V), survival promoting brain derived neurotrophic factor (BDNF) or increasing concentrations of PAT (0.1 to 1000 nM). The evaluated parameter is the survival of TH-positive dopaminergic neurons (% of control condition, Ctrl). FIG. 5B show examples of microscopic aspect of neurons in control culture conditions (control), injured by 6-OHDA or pretreated with 10 nM PAT before 6-OHDA application are given. FIGS. 6A and 6B show the results obtained from in vitro tests performed with rat primary GABAergic medium spiny neurons; in FIG. 6A is depicted the quantitative representation of the protective effect of PAT on the survival of GAD67-positive GABAergic neurons exposed to glutamate injury and pre-treated with vehicle (V), survival promoting brain derived neurotrophic factor (BDNF) or increasing concentrations of PAT (0.1 to 1000 nM). The evaluated parameter is the survival of GAD67-positive GABAergic neurons (% of control condition, Ctrl). FIG. 6B shows examples of microscopic aspect of medium spiny neurons in control culture conditions (control), injured by glutamate or pretreated with 10 nM PAT before glutamate application are given. DETAILED DESCRIPTION OF THE INVENTION In FIGS. 1 to 4B , one-way ANOVA followed by Dunnett's post hoc test was applied to the results: (*) means that the results are significant with a probability of <0.0001; (**) with a p<0.01 vs. ScAβ+V treatment group; (#) with a p<0.05 vs. (Aβ25-35+V) treatment group and (##) with a p<0.01 vs. (Aβ25-35+V) treatment group. In FIGS. 5A-5B and 6A-6B , statistical significance was determined by applying one-way ANOVA followed by Dunnett's test to the results: (*) means that the results were significant with a probability of <0.005 vs. 6-OHDA or glutamate condition respectively. Example 1 Alzheimer's Model in Mice—Spontaneous Alternation Test Experimental Protocol The Swiss OF-1 (Depré, St Doulchard, France) mice were 7-9 weeks old from and weigh 32±2 g. They were dispatched into several groups and placed in plastic cages. They had free access to food and water, except during the behavioral experiments, and were maintained in an environment controlled (23±1° C., 40-60% of moisture) with light/darkness cycles of 12 hrs (light on at 8:00 am). The experiments were carried out between 9:00 am and 5:00 pm, in a room of experimentation. The mice were acclimated during 30 minutes before the beginning of the experiment. All the protocols followed the directives of the European Union dating of Nov. 24, 1986. Treatment The PAT peptide (5 μg) synthesized by Polypeptide (Denmark) was solubilized in distilled water and was administered by intra-peritoneal (i.p.) route in a volume of 100 μl (by 20 g of body weight) or by intra-cerebroventricular (i.c.v.) route at the same time as the amyloid peptide. The β [25-35] amyloid peptide called Aβ 25-35 and the Aβ25-35 “scrambled” peptide—called Sc.Aβ—were purchased from Genepep (France). They were resuspended in sterile distilled water at a concentration of 3 mg/ml and were preserved at 20° C. until their use. Before being injected, the peptides were subjected to an aggregation at 37° C. during 4 days. They are administered by i.c.v route in a final volume of 3 μl per mouse. The animals were tested at Day 7 after the injection. In a first set of experiments, the mice received intracerebral (i.c.v.) administration of either water, or PAT nonapeptide (5 μg) at the same time than the ScAβ peptide or the Aβ 25-35 peptide (9 nmol). After a 7-days period, their performance in the spontaneous alternation test was evaluated. The numbers of animals per group were respectively 10 and 11. In a 2 nd set of experiments, the same test was performed, except that the PAT peptide was administered by intra-peritoneal (i.p.) route. Test Course—Measured Parameters We placed each mouse, which was not familiar with the device, at an end of a Y-maze (3 arms of 50 cm length and separated from 60°) and we let it move freely during 8 minutes. The number of entries in each arm, including the possible returns in the same arm, was counted visually. An entry was counted when the forelegs of the animal came at least 2 cm in the arm. An alternation was counted when an entry was made in all the 3 arms during successive tests. The number of total possible alternations was then the total number of entries minus 2 and the percentage of alternations was calculated as: (counted alternations/total of possible alternations)×100. The animals making less than 8 entries in 8 minutes were discarded from the experimental groups. No animal was excluded in this study. The compounds were administered 30 minutes before the session. Results The results are shown in FIG. 1 and FIG. 3 for the i.c.v. and i.p. administration routes, respectively. As expected, when the Aβ 25-35 peptide was administered, the symptoms of Alzheimer's disease were induced. Administration of the control ScAβ peptide had no effect. As expected, we observed that in FIG. 1 (i.c.v. route) when the ScAβ peptide was administered to the mice (which do not show any symptom of Alzheimer's disease) the co-administration of the PAT peptide had no effect. In contrast, co-administration of PAT peptide with the Aβ 25-35 peptide (thus the mice reproduce memory symptoms) exerted a significant neuroprotective effect on learning deficits induced by the Aβ 25-35 peptide. In FIG. 3 (i.p. route), we also noticed a neuroprotective effect of the PAT peptide and this effect was very significant for the dose of PAT peptide between 1 and 3 mg/kg of body weight. Example 2 Alzheimer's Model in Mice—Passive Avoidance Test Experimental Protocol: The information relative to the mice, the peptides, their administration and the treatment groups are similar to those of Example 1. Test Course. Tested Parameters The compounds were administered 30 minutes before the test. This test allowed the evaluation of the long term non-spatial memory. The device in the test consisted of an enlightened compartment having white PVC walls (with width/length/height dimensions of 15-20-15 cm respectively); an obscure compartment having black PVC walls (with same dimensions) and a grid on the ground. A trap door separated the 2 compartments. A lamp of 60 W was positioned 40 cm above and lightens the white compartment during the experiment. On the grid, random electric shocks of 0.3 mA were delivered to the mice legs during 3 seconds from a random power generator (Lafayette Instruments, USA). The 1 st phase of the experiment called “training” was carried out first. The trap door was closed at the beginning of the exercise. Each mouse was placed in the white compartment. The trap door was lifted after 5 seconds. When the mouse entered into the dark compartment and touched the grid with all its legs, the trap door was closed and the random electric shock was delivered on the legs during 3 seconds. The latency time before the entry into the dark compartment and the number of counts were recorded. The number of counts did not differ between the groups, indicating that the sensitivity to the electric shock was not affected by the type of administration route i.e. here i.c.v. or i.p. (not shown results). The animals for which the latency time was out the range of 3-30 seconds were discarded from the experiment. The attrition rates accounted for less than 2% of the animals and were independent of the treatment. The 2 nd phase of the experiment called “retention” was carried out 24 h after the 1 st phase (“training”). Each mouse was placed again in the white compartment. The trap door was raised after 5 seconds. The latency time of entry into the dark compartment was recorded during a 300 seconds period. The number of entries and the time of escape (time spent going back into the white compartment) were measured during a 300 seconds period. Results The results are presented in FIGS. 2 ( 2 A and 2 B) for the administration by i.c.v. route; and in FIGS. 4 ( 4 A and 4 B) for the administration by i.p. route. The FIG. 2 —administration by i.c.v. route—shows clearly that the injection of the PAT peptide (5 μg) by i.c.v. route in mice having received the Aβ 25-35 peptide (the latter reproducing training deficits) improved the 2 criteria tested when they were compared to mice having received water distilled (V) only. Thus, by using this animal model of Alzheimer's disease, it was demonstrated that the PAT peptide presented at a significant neuroprotective effect. Again, in FIG. 4 —administration by i.p. route—a neuroprotective effect of PAT peptide was observed. As in the spontaneous alternation test, the neuroprotective effect of the PAT was observable for a dose higher than 0.3 mg/kg of body weight. Thus, the use of the 2 animal models of Alzheimer's disease shows that the PAT peptide is an interesting and promising candidate to treat and prevent cerebral lesions related to the training deficit. Example 3 Cellular Model of Parkinson's Disease—Survival of Rat Primary Dopaminergic Neurons after 6-Hydroxydopamine Injury 6-hydroxydopamine (6-OHDA) is a selective catecholaminergic neurotoxin that is not only used as a pharmacological agent able to trigger PD-like stigmata (Sauer H. and Oertel W H Neuroscience 1994; 59: 401 and Cass W A et al. Brain Res. 2002; 938: 29) but also likely corresponds to a natural dopaminergic catabolite that accumulates in PD-affected brains and that appears to strongly contribute to this pathology (Jellinger K. et al. J. Neural. Transm. 1995; 46: 297). For this reason, 6-OHDA-induced dopaminergic neurotoxicity in mice is widely used as a model for PD research. Because 6-OHDA also induces neurodegeneration of dopaminergic neurons in vitro, it provides a useful model of PD. In this in vitro test mesencephalic dopaminergic neurons are exposed to 6-OHDA injury. Neuroprotective effect of a test compound is evaluated by pre-incubating the mesencephalic neurons for 1 h before the 6-OHDA application. After 24 h of intoxication, viable dopaminergic neurons are visualized and quantified by staining with a monoclonal Anti-Tyrosine Hydroxylase (TH) antibody. Tyrosine Hydroxylase is the first and rate-limiting enzyme involved in the biosynthesis of catecholamines like dopamine and norepinephrin from Tyrosine and has a key role in the physiology of adrenergic neurons. Tyrosine hydroxylase is commonly used as a marker for dopaminergic neurons, which is particularly relevant for research in Parkinson's disease. Brain derived neurotrophic factor (BDNF) is used as a positive control that has been shown to reduce the 6-OHDA-induced neurodegeneration in vitro (Riveles K et al. Neurotoxicology 2008; 29: 421). Experimental Protocol Rat dopaminergic neurons were cultured as described by Schinelli et al. J. Neurochem. 1988; 50: 1900 and Visanji N P et al. FASEB J. 2008; 22: 2488. Briefly, the midbrains obtained from 15-day old rat embryos (Janvier, France) were dissected under a microscope. The embryonic midbrains were removed and placed in ice-cold medium of Leibovitz (L15) containing 2% of Penicillin-Streptomycin (PS) and 1% of bovine serum albumin (BSA). The ventral portion of the mesencephalic flexure, a region of the developing brain rich in dopaminergic neurons, was used for the cell preparations. The midbrains were dissociated by trypsinisation for 20 min at 37° C. (Trypsin EDTA 1X). The reaction was stopped by the addition of Dulbecco's modified Eagle's medium (DMEM) containing DNAase I grade II (0.1 mg/ml) and 10% of fetal calf serum (FCS). Cells were mechanically dissociated by 3 passages through a 10 ml pipette. Cells were then centrifuged at 180×g for 10 min at +4° C. on a layer of BSA (3.5%) in L15 medium. The supernatant was discarded and the cell pellets were re-suspended in a defined culture medium consisting of Neurobasal (Invitrogen) supplemented with B27 (2%), L-glutamine (2 mM) and 2% of PS solution and 10 ng/ml of BDNF and 1 ng/ml of Glial-Derived Neurotrophic Factor (GDNF). Viable cells were counted in a Neubauer cytometer using the trypan blue exclusion test. The cells were seeded at a density of 40 000 cells/well in 96 well-plates (pre-coated with poly-L-lysine) and maintained in a humidified incubator at 37° C. in 5% CO2/95% air atmosphere. Half of the medium was changed every 2 days with fresh medium. Treatment On day 6 of culture, the medium was removed. The PAT peptide (10 mg) synthesized by Polypeptide (Denmark) was solubilized in distilled water. PAT (concentrations ranging from 0.1 nM to 1 μM) or BDNF (50 ng/mL i.e. 2 nM) were solved in culture medium (containing 0.1% DMSO) and then pre-incubated with mesencephalic neurons for 1 hour before the 6-OHDA application. One hour after test compound incubation, 6-OHDA was added to a final concentration of 20 μM diluted in culture medium still in presence of compound or BDNF for 24 hours. Each condition was tested on one culture mesencephalic dopaminergic neurons but 6 independent replicates. End Point Evaluation: Measurement of Total Number of TH-Positive Neurons After 24 hours of intoxication, cells were fixed by a solution of 4% paraformaldehyde in PBS, pH=7.3 for 20 min at room temperature. The cells were washed again twice in PBS, permeabilized and non-specific sites were blocked with a solution of PBS containing 0.1% of saponin and 1% FCS for 15 min at room temperature. Then, cells were incubated with monoclonal anti-tyrosine hydroxylase (TH) antibody produced in mouse at dilution of 1/10,000 in PBS containing 1% FCS, 0.1% saponin, for 2 hours at room temperature. These antibodies were revealed with Alexa Fluor 488 goat anti-mouse IgG at the dilution 1/800 in PBS containing 1% FCS, 0.1% saponin, for 1 h at room temperature. For each condition, 20 pictures per well were acquired (representing 80% of the total surface of the well) using ImageXpress (Molecular device) equipped with a LED at 10× magnification. All images were acquired with the same conditions. The number of TH-positive neurons was automatically analyzed using MetaXpress software (Molecular device). Data were expressed in percentage of control conditions (no intoxication, no 6-OHDA=100%) in order to express the 6-OHDA injury. All values were expressed as mean+/−SEM (s.e.mean) (n=6 wells per condition per culture). Results The results are depicted in FIGS. 5A and 5B . FIG. 5A shows quantitative representation of the effect of PAT on the survival of TH-positive dopaminergic neurons injured by 6-OHDA. FIG. 5B shows examples of microscopic aspect of mesencephalic neurons in control culture conditions, injured by 6-OHDA or pretreated with 10 nM PAT before 6-OHDA application. As previously shown in the literature, the survival of TH-positive dopaminergic neurons exposed to 6-OHDA was reduced by 31% compared to cells maintained in control culture conditions. Pretreatment with BNDF neurotrophic factor fully protected TH-positive neurons from 6-OHDA-induced cell death. Pre-incubation of dopaminergic neurons with PAT resulted in a dose-dependent protection against 6-OHDA injury. 100% survival levels were achieved with a concentration of PAT as low as 10 nM. Under these conditions PAT was as potent as BNDF. The potent neuroprotective activity of PAT was obvious when looking at the microscopic aspect of dopaminergic neurons as illustrated in FIG. 5B . Exposure to 6-OHDA resulted in a strong reduction of TH-positive neurons per well compared to control culture conditions due to cell death. Treatment with PAT restored the number of viable TH-positive neurons per well to a level similar to control conditions. Example 4 Cellular Model of Huntington's Disease— Survival of Rat Primary Gabaergic Medium Spiny Neurons after Glutamate Injury GABAergic medium spiny neurons (MSNs) in the striatum represent the mostly affected cell population in HD brain. Being the main neuronal cell type of the striatum (85% in humans), GABAergic MSNs play a central role in the clinical manifestation of HD. GABA is viewed as the neurotransmitter that inhibits spontaneous involuntary movements, therefore loss of GABAergic MSNs is responsible for chorea development and other involuntary movements. The exquisite vulnerability of MSNs of striatum to degeneration in HD is caused by glutamate excitotoxicity that leads to neuronal dysfunction and death. Excessive activation of NMDA glutamate receptors is observed in post-mortem HD brain tissue (Kumar P. et al. Pharmacol. Rep. 2010; 62: 1). Because glutamate is toxic to GABAergic striatal neurons in vitro, it provides a useful model of HD (Freese A et al. Brain Res. 1990; 521: 254). In this in vitro test, GABAergic MSNs are exposed to glutamate injury. Neuroprotective effect of a test compound is evaluated by pre-incubating MSNs for 1 h before the glutamate application. After 24 h of intoxication, viable GABAergic neurons are visualized and quantified by staining with a monoclonal anti-Glutamic Acid Decarboxylase antibody (specific for isoform GAD67). Glutamic acid decarboxylase is the first and rate-limiting enzyme involved in the biosynthesis of GABA from glutamic acid in higher brain regions. Brain derived neurotrophic factor (BDNF) is used as a positive control given that it has been identified as a factor required for the maturation and survival of MSNs (Ivkovic S et al. J. Neurosci. 1999; 19: 5409). Experimental Protocol: The information relative to the preparation of mesencephalic rat neurons, the culture conditions and treatment of cells are similar to those of Example 3. Treatment On day 13 of culture, the medium was removed. The PAT peptide (10 mg) synthesized by Polypeptide (Denmark) was solubilized in distilled water. PAT (concentrations ranging from 0.1 nM to 1 μM) or BDNF (50 ng/mL i.e. 2 nM) were solved in culture medium (containing 0.1% DMSO) and then pre-incubated with MSNs for 1 hour before the glutamate application. One hour after test compound incubation, glutamate was added to a final concentration of 10 μM diluted in culture medium still in presence of compound or BDNF for 20 min. After 20 min, glutamate was washed and fresh culture medium with BNDF or test compound was added for additional 24 h. Each condition was tested on one culture mesencephalic GABAergic neurons but 6 independent replicates. End Point Evaluation: Measurement of Total Number of GAD67 Positive Neurons After 24 hours of intoxication, cells were fixed with a cold solution of ethanol (95%) in acetic acid (5%) for 5 min. The cells were washed again twice in PBS, permeabilized and non-specific sites were blocked with a solution of PBS containing 0.1% of saponin and 1% FCS for 15 min at room temperature. Then, cells were incubated with monoclonal anti-GAD67 antibody produced in mouse at dilution of 1/200 in PBS containing 1% FCS, 0.1% saponin, for 2 hours at room temperature. These antibodies were revealed with Alexa Fluor 488 goat anti-mouse IgG at the dilution 1/400 in PBS containing 1% FCS, 0.1% saponin, for 1 h at room temperature. For each condition, 30 pictures per well were acquired (representing 80% of the total surface of the well) using ImageXpress (Molecular device) equipped with a LED at 20× magnification. All images were acquired with the same conditions. The number of GAD67-positive neurons was automatically analyzed using MetaXpress software (Molecular device). Data were expressed in percentage of control conditions (no intoxication, no glutamate=100%) in order to express the glutamate injury. All values were expressed as mean+/−SEM (s.e. mean) (n=6 wells per condition per culture). Results The results are depicted in FIGS. 6A and 6B . FIG. 6A shows quantitative representation of the effect of PAT on the survival of GAD67-positive neurons injured by glutamate. FIG. 6B shows examples of microscopic aspect of GAD67-positive GABAergic MSNs in control culture conditions, injured by glutamate or pretreated with 10 nM PAT before glutamate application. As expected, the survival of GAD67-positive MSN exposed to glutamate was reduced by 38% compared to cells maintained in control culture conditions. Pretreatment with BNDF neurotrophic factor protected GAD67-positive neurons from glutamate-induced cell death to some extent (81% cell survival). Pre-incubation of GABAergic neurons with PAT resulted in a dose-dependent protection against glutamate injury. Survival levels above 90% were achieved with concentrations of PAT starting from 10 nM. PAT was in average more potent than BNDF in tested conditions. The potent neuroprotective activity of PAT was obvious when looking at the microscopic aspect of GABAergic neurons as illustrated in FIG. 6B . Exposure to glutamate resulted in a strong reduction of GAD67-positive neurons per well compared to control culture conditions due to cell death. Treatment with PAT restored the number of viable GAD67-positive neurons per well to a level similar to control conditions. Thus the use of established cellular models of Parkinson's and Huntington's disease shows that PAT exerts a potent protective effect on injured neurons. In addition, PAT reduces cognitive decline in a mouse model of Alzheimer's disease. All together this peptide proves to be an interesting and promising candidate to treat and prevent neurodegenerative disorders with highly unmet medical needs.

A PAT nonapeptide of formula EAKSQGGSD (SEQ ID NO: 1) can be used to treat or prevent neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, Huntington's disease and amyotrophic lateral sclerosis. Pharmaceutical compositions containing the PAT nonapeptide can be formulated for administration by parenteral route, including the subcutaneous, intraperitoneal, intravenous or intranasal routes.

FIELD OF THE INVENTION [0001] The present invention relates to menu plan generation. BACKGROUND TO THE INVENTION [0002] People have constraints upon the food that they may eat if they are to remain healthy or, for instance, lose weight, both in qualitative and quantitative terms. For instance, persons wishing to lose weight restrict their calorie intake whereas coeliacs disease sufferers must avoid gluten. These people face the problem of obtaining a diet that is not monotonous but which meets their dietary constraints. The provision of a varied diet assists a person in adhering to their dietary regime resulting in an improvement in the effectiveness of the diet, for instance achieving body size reduction more quickly. SUMMARY OF THE INVENTION [0003] It is an aim of the present invention to provide a system for providing varied sequences of items. For example, a system whereby people having dietary constraints can be provided with a varied diet. [0004] According to the present invention, there is provided a method of providing a varied array of items, the method comprising: — [0005] creating a database of item definitions, each item definition including a value for a predetermined parameter; [0006] determining a set of constraints, including a target value for said predetermined parameter; and [0007] selecting item definitions from the database in dependence on said set of constraints to produce an array, having at least two dimensions of a predetermined number of item identifiers, in a manner adapted to produce variety in said array. [0008] Preferably, the set of constraints is determined by receiving the results of a questionnaire, validating the results of the questionnaire and storing constraints derived from said results in association with said person. More preferably, said questionnaire comprises a hypermedia document form and is received in an http request. [0009] Preferably, the method includes transmitting said array of item identifiers by email. [0010] Preferably, said selection of items comprises populating a template data structure, representing a grid having a rows and a columns, with values such that the total of the values for each column equals said target value. More preferably, the values for each row of one column are selected randomly from a set of predetermined value distributions, the value total for each member of the set being the same. Yet more preferably, said selection of item identifiers comprises populating an item data structure, representing a grid having rows and columns, with item identifiers wherein each item identifier identifies an item having the parameter value in the corresponding element of said template data structure. Still mote preferably, the method comprises generating a data set of identifiers of acceptable items by retrieving identifiers for items meeting said constraints from said database, wherein the item data structure is populated from said data set. [0011] According to the present invention, there is provided a method of providing a varied diet, the method comprising: — [0012] creating a database of meal definitions, each meal definition including a value for a nutritional parameter; [0013] determining a set of dietary constraints affecting a person, including a target value for said nutritional parameter; [0014] selecting meal definitions from the database in dependence on said set of dietary constraints to produce a menu plan for said person for a predetermined number of days in a manner adapted to produce variety in said menu plan; and [0015] transmitting the menu plan. [0016] According to the present invention, there is also provided a method of reducing the size or weight of a person, the method comprising: [0017] creating a database of meal definitions, each meal definition including a value for a nutritional parameter; [0018] determining a target value for said nutritional parameter in dependence on measured physical characteristics of a person; [0019] selecting meal definitions from the database in dependence on said target value to produce a menu plan for said person for a predetermined number of days in a manner adapted to produce variety in said menu plan; [0020] transmitting the menu plan to said person; and [0021] ingestion of foodstuffs by said person in accordance with said menu plan so as to effect a reduction in the size or weight thereof. [0022] It will be appreciated that the degree of variety achievable in the menu plan will be a function of the size of the database and the dietary constraints imposed. [0023] Preferably, there is a random aspect to the selection of the meal definitions. However, a more deterministic, e.g. cyclic, selection scheme could be employed to ensure variety. [0024] Preferably, the size or weight reducing method includes selecting said meal definitions in dependence on an additional dietary constraint, said target value and said additional dietary constraint being members of a set of dietary constraints for said person. [0025] Preferably, said target value is determined by weighing and measuring the height of the person to whom the varied diet is to be provided. [0026] Preferably, the set of dietary constraints is determined by receiving the results of a questionnaire for a person, validating the results of the questionnaire and storing dietary constraints derived from said results in association with said person. More preferably, said questionnaire comprises a hypermedia document form and is received in an http request. [0027] Preferably, said menu plan is transmitted by email. [0028] Preferably, said selection of meal definitions comprises populating a template data structure, representing a grid having days along one axis and meals along another axis, with nutritional values for meals such that the total of the nutritional values for each day equals said target value. [0029] Preferably, the nutritional values for the meals of one day are selected randomly from a set of nutritional value distributions, the nutritional value total for each member of the set being the same. [0030] Preferably, said selection of meal definitions comprises populating a meal data structure, representing a grid having days along one axis and meals along another axis, with meal identifiers wherein each meal identifier identifies a meal having the nutritional parameter value in the corresponding element of said template data structure. [0031] Preferably, a data set of identifiers of acceptable meals is generated by retrieving identifiers for meals meeting said constraints from said database and the meal data structure is populated from said data set. [0032] According to the present invention, there is provided a process for reducing the body weight of a person comprising: [0033] (a) defining a plurality of candidate meals including lunches and dinners; [0034] (b) calculating a single numerical value for each candidate meal, the single numerical value being dependent on at least the caloric and fat content of each such meal; [0035] (c) calculating a target numerical value allotted per day for the person based on at least the person's current body weight and desired weight loss; [0036] (d) selecting meals from the plurality of candidate meals to produce a menu plan for the person for a predetermined number of days, such that the total of the numerical values for the meals selected for each day is less than or equal to the target numerical value and such that a variety of meals are included in the menu plan; [0037] (e) ingesting the meals from the menu plan; and [0038] (f) repeating at least step (e) until the desired weight loss is achieved. [0039] Preferably, the process further comprises the person selecting certain food items which must be included in the meals of the menu plan and employing a programmable computer to produce a menu plan in conformance with these selections. [0040] Preferably, the process further comprises the person designating at least some of the candidate meals as “eating out,” “ready” and “recipe meals” and employing a programmable computer to produce a menu plan in conformance with these selections. [0041] According to the present invention, there is provided data processing system for providing a multi-day menu plan for a person to assist the person in body weight reduction comprising: [0042] data storage means for storing candidate meal definitions and numerical values associated with each candidate meal dependent on at least the caloric and fat content of each such candidate meal; [0043] data server means for obtaining information from the person over the internet including weight information and food preferences and for transmitting the menu plan back to the person; and [0044] data processing means for calculating a target daily numerical value for the person based on at least the person's current body weight, and for selecting meals from the plurality of candidate meals to produce a multi-day menu plan such that the total of the numerical values for the meals selected for each day is less than or equal to the target numerical value, such that a variety of meals are included in the menu plan, and such that the food preferences obtained from the person are included in the menu plan. [0045] It will be appreciated that where the present invention is applied to slimming, the slimming may be non-therapeutic. BRIEF DESCRIPTION OF THE DRAWINGS [0046] [0046]FIG. 1 is a data flow diagram illustrating a system according to the present invention; [0047] [0047]FIG. 2 is a diagram illustrating a web server and a computer for generating menu plans; [0048] [0048]FIG. 3 is a flowchart illustrating a menu plan preparation program; [0049] [0049]FIG. 4 illustrates a table of valid daily nutritional parameter distributions; [0050] [0050]FIG. 5 illustrates a nutritional parameter template grid; [0051] [0051]FIG. 6 illustrates a menu grid; [0052] [0052]FIG. 7 is a more detailed flowchart of step s 7 of FIG. 3; [0053] [0053]FIG. 8 is a more detailed flowchart of step s 8 of FIG. 3; [0054] [0054]FIG. 9 is a more detailed flowchart of step s 9 of FIG. 3; [0055] [0055]FIG. 10 is a more detailed flowchart of step s 10 of FIG. 3; [0056] [0056]FIG. 11 is a more detailed flowchart of step s 14 of FIG. 3; [0057] [0057]FIG. 12 is a more detailed flowchart of step s 16 of FIG. 3; and [0058] [0058]FIG. 13 is a more detailed flowchart of step s 18 of FIG. 3. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0059] An embodiment of the present invention will now be described, by way of example, with reference to the accompanying drawings. [0060] Referring to FIG. 1, a system according to the present invention employs a data capture stage 1 for capturing information relating to the dietary constraints of a person 2 . The captured data is transmitted to a menu plan generation stage 3 which generates a set of meal definitions for a predetermined period, e.g. a fortnight, in dependence on the captured data using a database of meals 4 . The resultant set of meal definitions is then communicated to the person 2 . [0061] The capture stage 1 may comprise machine reading of a paper questionnaire and the resultant set of meal definitions communicated to the person 2 as a printed document. [0062] Referring to FIG. 2, the data capture stage 1 is effected by a web server machine 5 and the menu plan generation stage 3 is performed by a dedicated computer 6 . [0063] The web server machine 5 has a web server process 7 running on it. First and second CGI (Common Gateway Interface) programs 8 , 9 can be run by the web server process 7 for processing the contents of, respectively, a questionnaire form web page and a “member” login form page. [0064] The questionnaire form web page is provided so that people can become members and asks for the following information:— [0065] given and family names; [0066] title; [0067] address, including postal code; [0068] e-mail address; [0069] telephone number; [0070] sex; [0071] date of birth; [0072] height; and [0073] current weight. [0074] credit card details. [0075] The people filling in the form will have weighed themselves and measured their heights. [0076] Additionally, the questionnaire form includes checkboxes and radio buttons so that the prospective member can answer the following questions:— [0077] Are they?— [0078] diabetic; [0079] vegetarian; [0080] Jewish requiring kosher food; [0081] Muslim requiring halal food. [0082] Do they suffer from coeliac disease? [0083] Do they have any of the following allergies?— [0084] nut allergy; [0085] wheat allergy; [0086] dairy allergy. [0087] Do they prefer?— [0088] no milk; [0089] skimmed milk; [0090] semi-skimmed milk. [0091] Do they prefer?— [0092] low fat spread; [0093] margarine high in polyunsaturated fats; [0094] butter. [0095] Would they prefer to avoid?— [0096] alcohol; [0097] red meat; [0098] fish. [0099] and select three items from:— [0100] chocolate; [0101] cheese; [0102] crisps (US: chips); [0103] biscuits (US cookies); [0104] bread; [0105] wine; [0106] beer; [0107] spirits; [0108] chips (US: french fries); and [0109] ice cream [0110] as “must have” items. [0111] The questionnaire form also allows the prospective member to enter:— [0112] the number of times (0, 1-2, 3-5, 6-9, 10-14) that they would like to eat out (“eating out” meals) during a fortnight and the types of food they would like to each on such occasions (burgers, curries, grills, jacket potatoes, pizzas, roast dinners. salads, sandwiches, stir-frys); [0113] the number of times that they wish to cook main meals (“recipe” meals) during a fortnight (0, 1-2, 3-5, 6-9, 10-14) and for how many people; [0114] the number of heat-only prepared main meals (“ready” meals) that they would like during a fortnight (0, 1-2, 3-5, 6-9, 10-14). [0115] Finally, many people like to start each day with the same breakfast and the questionnaire form allows the prospective member to indicate this and choose the type of breakfast required (toast and marmalade, cereal, cereal and toast, cooked). [0116] When the form is submitted by a person becoming a member, the first CGI program 8 validates the data and, if it appears valid, e.g. wine as a “must have” does not conflict with a desire to avoid alcohol, stores it in a respective file 10 in an XML format. [0117] The “member” login form page includes boxes for the member to enter their unique username and password. When the “member” login form is submitted by a member, the second CGI program 9 validates the username and password and, if they are correct, stores the unique username in a respective file 10 . [0118] The web server machine 5 is connected to a menu plan generation machine 6 by a local area network 11 . [0119] The menu plan generation machine 6 supports a database 12 , a configuration program 13 , a web server interface program 14 , a menu plan generation program 15 and an e-mail program 16 . [0120] The database 12 comprises tables containing member details, meal definitions and a points distribution table 20 (FIG. 4). These points are allocated to food items on the basis of nutritional parameters determined by measurement and analysis of the food items, in this case the calorie and fat content of the food (See EP-A-0859981). The points distribution table 20 contains a plurality of distributions, i.e. allocations of points to breakfast, lunch, evening meal, snack and milk, for each of a range of daily points targets. [0121] Meal definitions are loaded into the database 12 by means of the configuration program 13 which provides an administration user interface. The meal definitions include fields identifying main ingredients types, e.g. fish, red meat, chicken, and the types of diet, e.g. halal, vegetarian, nut-free, for which they are suitable, whether they are generally applicable and the points value. Some restricted diet items, e.g. gluten-free biscuits, are not appropriate for people not requiring a gluten-free diet. However, others, such as Spaghetti Neapolitano, are specifically suitable for vegetarians but are also more widely suitable. [0122] The web server interface program 14 periodically reads the contents of the files 10 . [0123] If a file 9 contains full user details, the web server interface program 14 stores the user details in the database 12 and generates a username and initial password. The username and initial password are sent to the web server machine 5 which sends them to the new member in an HTML page and stores them for subsequent validation of logins by the member. [0124] If the file 10 contains only a username, the web server interface program 14 passes the username to the menu plan generation program 15 . [0125] The menu plan generation program 15 obtains the member's details from the database 12 using the username and then generates a menu plan for a fortnight on the basis of the member's details and the time of year or festivals, e.g. Christmas or Shrove Tuesday, occurring during the period for which the menu plan is being generated. The completed menu plan is sent to the requesting member in an e-mail by means of the e-mail program 16 . [0126] When the web server interface program 14 stores new member's details in the database 12 , it allocates a points target to the new member on the basis of their BMI (Basal Metabolic Rate) and their activity level. The BMI is determined from the member's height, weight, age and sex. For example, a person allocated 22 points may eat food whose “points” values add up. to 22 points in any one day. This value will need to be recalculated as the member reports back weight or activity level changes. [0127] Referring to FIG. 3, when a menu plan is to be generated for a member, the menu plan generation program 15 queries the database 12 to obtain a valid meal data set containing all of the meal definitions which are appropriate for the member, according to the questionnaire answers given by the member and the current season (step S 1 ). [0128] A valid points distribution data set is then generated by querying the points distribution table 20 for records for the appropriate total points, the appropriate “milk” point and the appropriate breakfast points, if the member has specified that the same breakfast is required every day (step s 2 ). If the result is an empty set, e.g. because there are no suitable breakfasts, an error is reported (step s 5 ) and the process terminates. [0129] Referring to FIG. 5, a 14×4 points template grid 21 , i.e. 14 days by breakfast, lunch, evening meal, and snacks is populated randomly from the rows returned in step s 2 (step s 6 ). [0130] Once the template grid 21 has been populated, a 14×4 menu grid 22 (FIG. 6) is populated with meal ids using the points template grid 21 as a guide. [0131] The first stage of this process is to attempt to meet the member's requirements for “eating out” evening meals (step s 7 ). [0132] Referring to FIG. 7, it is first determined whether the member wishes to eat out at all (step s 101 ). If not, the process terminates. However, if the member does want to eat out, a first day is chosen according to the maximum (2, 5, 9, 14) of the range selected by the member for “eating out” meals and a predetermined algorithm (step s 102 ). Then any suitable meals are extracted from the data set obtained at step s 1 and placed in a random order. A suitable meal here will be one with the points value specified in the corresponding location of the points template grid 21 . The list is then searched from the top to the bottom for a meal that has not already been picked and which has a different main ingredient to those on the preceding and succeeding days, if any. If a meal is found (step s 103 ), its id is added to the menu grid 22 in the appropriate location (step s 104 ). It is then determined whether the maximum of member's desired range for “eating out” meals has been reached (step s 105 ). If so, the process terminates, otherwise it is determined whether there are any mote days to which an “eating out” evening meal could be allocated (step s 106 ). If not, the process terminates, otherwise the next day is selected according to the aforementioned algorithm (step s 107 ). [0133] If a suitable meal is not found at step s 103 , the process moves directly to step s 106 . [0134] Next, an attempt is made to meet the member's requirements for “recipe” meals, i.e. meals to be prepared for or by the member and which ate provided to the member with a recipe (step s 8 ). The recipes may be for more than one person, for instance if the member's family members are all to have the meal. [0135] Referring to FIG. 8, it is first determined whether the member wishes to have any “recipe” meals (step s 201 ). If not, the process terminates. However, if the member does want to have “recipe” meals, a first day is chosen according to the maximum (2, 5, 9, 14) of the range selected by the member for “recipe” meals and a predetermined algorithm (step s 202 ). Then any suitable meals are extracted from the data set obtained at step S 1 and placed in a random order. A suitable meal here will be one with the points value specified in the corresponding location of the points template grid 21 . The list is then searched from the top to the bottom for a meal that has not already been picked and which has a different main ingredient to the main meals on the preceding and succeeding days, if any. If a meal is found (step s 203 ), its id is added to the menu grid 22 in the appropriate location (step s 204 ). It is then determined whether the maximum of member's desired range for “recipe” meals has been reached (step s 205 ). If so, the process terminates, otherwise it is determined whether there are any more days to which an “recipe” evening meal could be allocated (step s 206 ). If not, the process terminates, otherwise the next day is selected according to the aforementioned algorithm (step s 207 ). [0136] If a suitable meal is not found at step s 203 , the process moves directly to step s 206 . [0137] After the recipe meals have been added, an attempt is made to meet the member's requirements for ready meals, i.e. meals that simply need to be reheated (step s 9 ). [0138] Referring to FIG. 9, it is first determined whether the member wishes to any “ready” meals (step s 301 ). If not, the process terminates. However, if the member does want “ready” meals, a first day is chosen according to the maximum (2, 5, 9, 14) of the range selected by the member for “ready” meals and a predetermined algorithm (step s 302 ). Then any suitable meals are extracted from the data set obtained at step S 1 and placed in a random order. A suitable meal here will be one with the points value specified in the corresponding location of the points template grid 21 . The list is then searched from the top to the bottom for a meal that has not already been picked and which has a different main ingredient to the main meals on the preceding and succeeding days, if any. If a meal is found (step s 303 ), its id is added to the menu grid 22 in the appropriate location (step s 304 ). It is then determined whether the maximum of the member's desired range for “ready” meals has been reached (step s 305 ). If so, the process terminates, otherwise it is determined whether there ate any more days to which an “ready” evening meal could be allocated (step s 306 ). If not, the process terminates, otherwise the next day is selected according to the aforementioned algorithm (step s 307 ). [0139] If a suitable meal is not found at step s 303 , the process moves directly to step s 306 . [0140] Any remaining gaps for evening meals in the menu grid 22 are then filled with meals which are not specifically “eating out”, “recipe” or “ready” meals (step s 10 ). [0141] Referring to FIG. 10, the first day without an evening meal allocated to it is selected first (step s 401 ). Then any suitable meals are extracted from the data set obtained at step s 1 and placed in a random order. A suitable meal here will be one with the points value specified in the corresponding location of the points template grid 21 . The list is then searched from the top to the bottom for a meal that has not already been picked and which has a different main ingredient to the main meals on the preceding and succeeding days, if any. If a meal is found (step s 402 ), its id is added to the menu grid 22 in the appropriate location (step s 403 ), otherwise an error is reported (step s 11 in FIG. 3) and the menu plan generation process terminates. If a meal has been added at step s 403 , it is determined whether there are any more days to which an evening meal needs to allocated (step s 404 ). If not, the process terminates, otherwise the next day is selected according to the aforementioned algorithm (step s 405 ). [0142] If the member has specified that they want the same breakfast each day (step s 12 ), the breakfast elements the menu grid 22 are populated with the relevant meal type (step s 13 ). If the member has not specified that they want the same breakfast each day (step s 12 ), the breakfast elements of the menu grid 22 are populated with breakfasts with the appropriate points values (step s 14 ). [0143] Referring to FIG. 11, the first day is selected first (step s 501 ). Then any suitable breakfasts are extracted from the data set obtained at step s 1 and one is selected at random. A suitable breakfast here will be one with the points value specified in the corresponding location of the points template grid. If the range of available breakfasts is sufficiently large, a different breakfast is preferably selected for each day, as in the case of the main meals. If a breakfast is found (step s 502 ), its id is added to the menu grid 22 in the appropriate location (step s 503 ), otherwise an error is reported (step s 15 in FIG. 3) and the menu plan generation process terminates. If a breakfast has been added at step s 503 , it is determined whether there are any more days to which a breakfast needs to be allocated (step s 404 ). If not, the process terminates, otherwise the next day is selected according to the aforementioned algorithm (step s 505 ). [0144] After the breakfasts have been dealt with, the lunch elements of the menu grid 22 are filled randomly with meals with the appropriate points value whilst avoiding the situation where the lunch and evening meal of a day have the same main ingredient (step s 16 ). [0145] Referring to FIG. 12, the first day is selected first (step s 601 ). Then any suitable lunches are extracted from the data set obtained at step S 1 and placed in a random order. A suitable lunch here will be one with the points value specified in the corresponding location of the points template grid 21 . After randomisation, the list is sorted so that lunches with the same main ingredient as the evening meal for the day are moved to the bottom of the list. The lunch at the top of the list is selected if it does not have the same main ingredient for the main meal of the same day. If a suitable lunch is found (step s 602 ), its id is added to the menu grid 22 in the appropriate location (step s 603 ), otherwise an error is reported (step s 17 in FIG. 3) and the menu plan generation process terminates. If a lunch has been added at step s 603 , it is determined whether there are any more days to which a lunch needs to be allocated (step s 604 ). If not, the process terminates, otherwise the next day is selected according to the aforementioned algorithm (step s 605 ). [0146] Finally, the snack elements of the menu grid 22 are filled randomly with meals with the appropriate points value (step s 18 ). [0147] Referring to FIG. 13, the first day is selected first (step s 701 ). Then any suitable snacks are extracted from the data set obtained at step s 1 and one is selected at random. A suitable snack here will be one with the points value specified in the corresponding location of the points template grid. If a suitable range of snacks are available, a different snack is selected for each day such that no day has a snack and a main meal with the same main ingredient. If a suitable snack is found (step s 702 ), its id is added to the menu grid 22 in the appropriate location (step s 703 ), otherwise an error is reported (step s 19 in FIG. 3) and the menu plan generation process terminates. If a snack has been added at step s 703 , it is determined whether there are any more days to which a snack needs to be allocated (step s 704 ). If not, the process terminates, otherwise the next day is selected according to the aforementioned algorithm (step s 705 ). [0148] In each of steps s 7 , s 8 , s 9 , s 10 , s 14 , s 16 and s 18 , the meals are randomly chosen from the relevant subset of the valid means data set. However, a weighting is applied to meals according to whether they contain a “must have” item which the member has specified. Consequently, meals including “must have” items are more likely to be selected. [0149] When a menu plan has been successfully generated, a email containing the menu plan, including any recipes for “recipe” meals and any milk items, which are constant across the period of the menu plan, is generated and sent to the member using the email program 16 (step s 20 ). [0150] On receiving the email, the member eats the meals specified therein over the two-week period covered by it and achieves a weight loss thereby. [0151] It will be appreciated that many modifications can be made to the embodiment described above. For example, the menu plan could be presented to the member as a web page or as a printed document. [0152] In another embodiment, menu plan generating program 15 produces one or more grocery order messages, in dependence on the menu plan and information in the database 12 , and sends them to respective stores. Stores receiving these messages make up the orders and send them to the member who requested the menu plan on which the orders were based. [0153] By limiting the grids to one day, the present invention can be employed to provide ad hoc menu plan suggestions for one day. For instance, a member would request a web page with a button labelled, for example, “What shall I eat today” and radio buttons for selecting “eat out”, “recipe”, “ready” or “any” for the evening meal. Clicking on the button would cause a CGI program to populate a one-day menu grid, using a method substantially as described above but with the radio button selections overriding any preference for evening meal types in the database 12 , and present the result to the user as a web page. [0154] Alternatively, the menu plans could be produced cyclically, e.g. fortnightly, for a member and stored rather than being sent in one transmission. The user would then request the current day's menu plan using a web browser.

A method of providing a varied sequence of items, e.g. a varied diet, involves determining constraints and establishing a parameter target value. This informaiton is then used to populate a two dimensional grid representing items in varied arrangement.

FIELD OF THE INVENTION [0001] The present invention relates to improved solubilizing agents/solvents for organic ultraviolet (UV) filters and the use of these materials in cosmetically acceptable products for improved protection against UV radiation as well as cosmetic formulations which can better protect the user against UV radiation. BACKGROUND OF THE INVENTION [0002] It has been known for a long time that certain amounts of ultraviolet content, in particular, that which is associated with natural and artificial light sources (UV-A 320 to 390 nm; UV-B 280 to 320 nm; UV-C 100 or 200 to 280 nm), lead to damage to the human skin. [0003] UV-A radiation chiefly has the effect of ageing of the skin (thinning of the epidermis and degeneration of connective tissue, and pigment disorders), while UV-B and UV-C lead to sunburn and skin cancer. [0004] Leisure activities which have changed in recent years with longer periods in the open air and, in particular, extensive sunbathing to achieve the “healthy tan” have, however, against the background of medical findings and the awareness of the lack of natural protection mechanisms of the skin by pigment formation and solar acclimatization by thickening of the horny layer, shifted the need for adequate protection against intensive UV radiation. It has been intensified significantly by the discussion of the decrease and thinning of the Antarctic ozone hole and the associated increase in the intensity of UV-A and UV-B radiation on the earth's surface. [0005] This becomes clear from the increasing turnovers in recent years of products with high sun protection factors (SPFs). These are primarily still the conventional sun protection formulations (sun milk sun oil) with the primary intended use of sunbathing, but increasingly also the so-called care products for the face, body and hair, such as day and night creams, conditioners, lotions, (hydro, lipo) gels, (lip)sticks and sprays, pharmaceutical formulations and to a small extent products of decorative cosmetics, which are predominantly commercially available in the form of oils and liquid, cream-like or ointment/paste-like W/O and O/W emulsions. [0006] As stated above, UV-B radiation can cause tanning and bums, rather than UV-A radiation. Prior art sun protection compositions therefore predominantly comprise only filters which protect against UV-B radiation. Since the effects/side effects of a suntan/sunburn are not immediately and clearly perceptible, the skin is exposed to radiation for significantly longer than would be appropriate. [0007] However, the skin is therefore predominantly exposed unprotected to UV-A radiation. The problem is thus that UV-A radiation penetrates into the skin and causes long-term damage, even though it does not cause immediately detectable actions. [0008] Medical findings in recent years have clearly demonstrated that not only UV-B radiation but also UV-A radiation is harmful to the skin. It has been demonstrated that enzymes which repair cells damaged by UV-B radiation are inhibited in their activity and thus UV-A radiation indirectly promotes skin cancer. By deeper depth of penetration, UV-A radiation can even cause changes in the blood vessels. [0009] Moreover, UV-A radiation is the origin of most photodermatoses, such as sun allergies: small red blisters which appear on the arms and neckline during first exposure to sun and are accompanied by severe itching. In the long term, with abuse of the sun, they can cause skin cancer. [0010] UV-A rays are, therefore, almost more dangerous than UV-B rays, since they issue no alarm signal, such as sunburn. When their damage is noticed, it is already too late. [0011] With increased exposure to the sun, an increase in various infectious skin diseases, such as mycoses or herpes, has been found. [0012] This increase is based on the ability of the UV rays to weaken the immune system of the skin, thus to reduce its capacity to react and to reduce the defense against causes of infections, such as, for example, herpes virus or skin fungi. It is assumed nowadays that the phenomenon of photoimmunosuppression also plays a significant role in the development of skin cancer. [0013] For sun protection of naked, uncovered skin and hair (bleaching, embrittlement), particularly of the face and lips, sun protection compositions, which ensure adequate and lasting protection over the entire harmful UV spectrum, are therefore in demand. [0014] Such broad-band sun protection compositions can comprise a combination of correponding organic UV-A and UV-B filters. [0015] By these there are to be understood organic substances which are liquid or crystalline at room temperature and which are capable of absorbing ultraviolet rays and of releasing the energy absorbed again in the form of longer-wavelength radiation, e.g., heat. To establish a sufficiently high sun protection factor, however, correspondingly high contents of these filters must be used. [0016] During lasting exposure of the skin to sun, the protection should be renewed at regular intervals of approximately one to four hours. The same applies during sports activity, in order to compensate the decrease in protection, i.e., loss of the filter substances by bathing, perspiration or mechanical abrasion by clothing or hand towels. [0017] Only the regular use of light protection products with a high SPF and a broad absorption spectrum both against UVA and against UVB rays allows an effective protection. Furthermore, because of the increased incident solar radiation in some regions, sun protection formulations, which have a greatly increased light protection factor, are increasingly required. [0018] The light protection factor LPF or also SPF is a coefficient that expresses the ability of a product to prevent sunburn by the sun. Light protection with a factor of 60 therefore protects against the occurrence of sunburn for twice as long as a product with factor 30, and correspondingly 3 times as long as a product with factor 20. [0019] These higher light protection factors are in most cases generated by an increase in the concentration of UV filter substances in the formulation. [0020] Since 1995, light protection factors have been measured by the same international standard (COLIPA), which allows comparison between the various manufacturers. [0021] Given these frequent uses over large areas, it is not ruled out that the high-dosed filters (approximately 3 to 30 wt. % of the formulation) are applied to the skin in gram quantities. [0022] However, these amounts of filter substances must have been dissolved and incorporated into the formulation in a homogeneous and stable manner. [0023] Oily components that have a good dissolving power for the filter substances are often used to dissolve these substances. Certain ester oils, inter alia, are thus also employed. Aliphatic benzoic acid esters are a class of compounds used here. A typical representative of this class of compounds is the compound Tegosoft® TN (C 12-15 -allyl benzoate), which has been employed particularly frequently as a solvent for UV filter substances. [0024] Nevertheless, the dissolving power of the established compounds often is not sufficient to dissolve relatively large amounts of UV filter substances. [0025] This increase in concentration is therefore problematic in practice, or under certain circumstances even impossible. [0026] Incompletely dissolved UV filter contents in the end product can put the stated SPF in doubt under certain circumstances. Even if the solution properties of the sun protection filter initially still exist in their entirety, under storage conditions, which are extreme but relevant in practice, precipitation of the filters and, therefore, a loss in action can nevertheless occur. [0027] In view of the above discussion, there is a need to overcome these disadvantages and to provide cosmetic formulations which have a particularly high dissolving power for UV filters. SUMMARY OF THE INVENTION [0028] The present invention obviates the problems mentioned above by utilizing new solubilizing agents/solvents for dissolving organic UV filters. [0029] The inventive compounds are distinguished by their particularly high dissolving power for organic crystalline UV-A and UV-B filters. At the same time, the inventive compounds have a comparatively high content of aromatic groups in the molecule. [0030] It is now known from the prior art that the introduction of aromatic groups, such as, e.g., phenyl radicals, into a molecular skeleton often results in a significant increase in the melting point, so that the compounds are solid at room temperature. In some cases, compounds with a high aromatic content have melting points of greater than 100° C., which means that incorporation into cosmetic formulations is made very difficult. Surprisingly, in spite of their comparatively high content of aromatic groups, the compounds according to the invention are liquid at room temperature or have a low melting point of less than 70° C. [0031] Due to their low melting point, the substances according to the invention can be incorporated into cosmetic formulations at low processing temperatures below the boiling point of water which are preferred in the cosmetics industry. The compounds according to the invention, which are solid at room temperature, can also advantageously be employed in combination with liquid compounds, therefore it is possible for liquid mixtures to be obtained. [0032] These properties make the compounds according to the invention suitable ingredients of cosmetic formulations. [0033] The present invention therefore relates to a method for dissolving organic UV filter which comprises the utilization of compounds of the general formula (I) wherein R,R′ are the same or different and are H, a C 1-5 -hydrocarbon radical, or a —O—C 1-5 -Oxhydrocarbon radical, R 1 , R 2 , R 3 are the same or different and are H, or a C 1-5 -hydrocarbon radical, X,Y are the same or different and are —O—; —O—C(O)—; or —(O)C—O, A is A α which is —O—C(O)—O—; A β which is R 4 —CH 2 C(CH 2 —) 3 —, or A γ which is —C(H)— isopropyl, where R 4 ═R 4 } =—CH 3 ; R 4 ε =—[CH 2 —CH(R 1 )] e —(Y) d —(CH 2 ) c -Ph(R) a , a,b are the same or different and are 1 to 5, c,k are the same or different and are 0 to 5, d,h are the same or different and are 0 or 1, e,g are the same or different and are 0 or 1, f is 0 or 1, m is 1 to 3, and n=0 or 1, as solubilizing agents/solvents for dissolving said organic UV filters. [0046] The present invention also relates to the use of these solubilizing agents/solvents for dissolving organic UV filters for the preparation of cosmetic formulations. [0047] The present invention furthermore relates to cosmetic formulations with improved sun protection factor comprising organic UV filters dissolved in the improved solubilizing agents/solvents. DETAILED DESCRIPTION OF THE INVENTION [0048] As stated above, the present invention provides a method in which organic UV filters can be dissolved using the compound described above by formula (I) as well as cosmetic formulations that include the same. [0049] Organic UV filters that can be co-used according to the invention are, for example, the compounds listed below (FDA registration name in parentheses): Filter FDA registration name Ethylhexyl methoxycinnamate Octinoxate Benzophenone-3 Oxybenzone Octocrylene Butyl-methoxydibenzoylmethane Avobenzone Ethylhexyl salicylate Octisalate Homobornyl salicylate Homosalate Phenylbenzimidazole-sulfonic acid Phenylbenzimidazole- sulfonic acid Benzophenone-4,-5 Sulisobenzone Ethylhexyl dimethyl-PABA Padimate O 4-Aminobenzoic acid PABA Butyl methoxycinnamate Cinoxate Benzophenone-8 Dioxybenzone Menthyl anthranilate Menthyl anthranilate 4-Methylbenzylidene-camphor Ethylhexyl-triazone PEG-25 PABA Isoamyl p-methoxycinnamate Diethylhexyl-butamido-triazone Drometrizole-trisiloxane Camphor-benzalkonium methosulfate Terephthalyidene-dicamphor-sulfonic acid Benzylidene-camphor-sulfonic acid 3-Benzylidene-camphor Diethylbenzylidene-malonate-dimethicone Methylene-bis-benzotriazolyl- tetramethylbutylphenol Bis-ethylhexyloxyphenol-methoxyphenyl- trazine Disodium phenyl-dibenzimidazole-tetrasulfonate Polyacrylamidomethyl-benzylidene-camphor [0050] The most widely used chemical sun protection compositions comprise, for example, p-aminobenzoic acid (PABA), PABA esters (glyceryl PABA, amyldimethyl PABA and octyldimethyl PABA), benzophenone derivatives (oxybenzone und sulisobenzone), cinnamates (octyl methoxycinnamate and cinoxate), salicylates (homobornyl ethyl salicylate) and anthranilates (see, for example, Pathak Madhu, “Sunscreens: Topical and Systemic Approaches for Protection of Human Skin Against Harmful Effects of Solar Radiation”, Continuing Medical Education Series, J. Am. Acad. Dermat, 7: 3 (September 1982) p. 285, 291). [0051] Three representative UV-A or UV-B filters were chosen as representatives for testing the dissolving power for crystalline UV filters in the substances described. These are benzophenone-3 (2-hydroxy-4methoxy-benzophenone) und butyl-methoxydibenzoylmethane as two UV-A filters and methylbenzyliden camphor as a UV-B filter. [0052] The dissolving power of conventional ester oils for these three compounds is not satisfactory in most cases. A compound with an above-average dissolving power for UV filter substances is Tegosoft® TN already mentioned, which is therefore also widely established as an ingredient for sun protection formulations. [0053] It has now been found that the dissolving power of the compounds according to the invention not only is comparable to that of Tegosoft® TN, but in many cases also significantly exceeds this. [0054] The required cosmetic formulations with a particularly high dissolving power for UV filters can be readily realized in this manner. [0055] Suitable carriers for the preparation of such sun protection formulations include lanolin, glyceryl stearate, cocoa butter, sorbitan sesquioleate, propylene glycol, isopropyl myristate, petrolatum and acrylic polymers. Mixtures of two or more of these substances can furthermore be used. These substances are known in the prior art as “dermatologically suitable”, i.e., they cause or promote no adverse reactions on the skin of the user. [0056] The amount of the carrier must merely be sufficient to achieve a uniform distribution on application to the skin, so that adequate covering of the skin with the UV-absorbing material is ensured. [0057] The oily formulations described above, by themselves or in the form of water-in-oil (W/O) emulsions, can be incorporated into topical sun protection compositions, and furthermore introduced into diverse cosmetic products, such as, for example, lipstick, eye shadow, make-up, moisturizing cream, rouge and further care products, in order to form cosmetics which protect the user's skin underneath against the harmful actions of UV radiation. These materials can be mixed with the cosmetic base composition by known mixing methods. [0058] Further constituents of cosmetic formulations which comprise the compounds of the invention maybe so-called auxiliaries. These auxiliaries are well-known in the prior art and are added in order to fulfill their own functions. The preferred auxiliaries include substances such as thickeners, softeners, superfatting agents, agents for water resistance, emollients, wetting agents and surface-active substances, as well as preservatives, antifoams, perfumes and mixtures thereof or any desired further compatible ingredients which are conventionally used in cosmetics. [0059] The compounds according to the invention are to be obtained by a simple route by esterification of suitable substituted carboxylic acids with the correspondingly suitable alcohols or by transesterification of carboxylic acid esters with suitable alcohols. [0060] In this procedure, mono- and dicarboxylic acids or their esters are reacted with alcohols with aromatic substituents, or carboxylic acids with aromatic substituents or their esters are reacted with branched and unbranched, optionally also aromatic mono- and polyalcohols. [0061] Alternatively, instead of the carboxylic acid esters organic carbonates, such as diethyl carbonate, can also be used. The preparation is carried out by the conventional procedures known from the literature for esterification or transesterification reactions. [0062] The following examples are provided to illustrate the present invention and to demonstrate that the inventive compounds can be used as a solubilizing/solvent for dissolving organic UV filters. EXAMPLE 1 [0000] Preparation of Compound 1: [0063] 379.9 g of the alcohol 1-phenoxy-2-propanol were initially introduced into the reaction vessel together with 320.1 g of benzoic acid, 4.2 g of p-toluenesulfonic acid and 0.7 g of hypophosphorous acid. After the mixture had been heated up to 160° C., a vacuum of 400 mbar was applied. After 1.5 h, the vacuum was increased to 200 mbar, and was increased to 30 mbar in further steps. The temperature was then increased to 180° C. After the acid number had reached a value of <15, the mixture was neutralized with potassium hydroxide solution and the product was subjected to a steam treatment. The product was then dried in vacuo at 150° C. After cooling, the product was filtered. [0064] The product was in the form of a slightly yellowish clear liquid with a purity of 90% (GC). The yield was 95%, based on the alcohol. EXAMPLE 2 [0000] Preparation of Compound 2: [0065] 129.7 g of the alcohol 1-phenoxy-2-propanol were initially introduced into the reaction vessel together with 50.3 g of diethyl carbonate. After the mixture had been heated up to 110° C., 0.9 g of isopropyl titanate was added. The mixture was now heated slowly up to 240° C. and the ethanol formed was distilled off over a distillation column. [0066] After 4 h, the mixture was cooled to approx. 160° C. and a vacuum of 100 mbar was applied. The vacuum was lowered to 10 mbar in the course of 2.5 h and the further ethanol formed was distilled off until no further distillate was formed. The product was subjected to a steam treatment and then dried at 150° C. in vacuo. After cooling, the product was filtered. [0067] The product was in the form of a clear liquid with a purity of 89% (GC). The yield was 93%, based on the alcohol. EXAMPLES 3-8 [0068] The preparation of compounds 3 to 8 was carried out analogously to Examples 1-2. [0069] The following provides the structural formulas of the compounds produced in Examples 1-8: [0070] These compounds are defined by the general formula (I) wherein: TABLE 1 Compound R/R′ R 1 /R 2 /R 3 X/Y A a/b c/k d/h e/g f m/n 1 H/H CH 3 /—/H — 5/5 0/0 1/1 1/0 0 1/1 2 H/H CH 3 /CH 3 /H —O—/—O— A α 5/5 0/0 1/1 1/1 1 1/1 3 H/H — — A α 5/5 3/3 0/0 0/0 1 1/1 4 H/H H/H/H — 5/5 3/3 1/1 1/1 0 1/1 5 H/H — — A α 5/5 1/1 0/0 0/0 1 1/1 6 H/— — Aβwhere R 4 = R4 δ 5/— 0/— 1/— 0/— 1 3/0 7 H/— — A β where R 4 = R 4 ε 5/— 0/— 1/— 0/— 1 3/0 8 H/H CH 3 /—/CH 3 Aγ 5/5 0/0 1/1 1/0 1 1/1 EXAMPLE 9 [0071] Test for the dissolving power of crystalline UV filters: [0072] Three representative crystalline UV-A or UV-B filters were chosen as representatives for determination of the solubility of UV filter substances. These are: Benzophenone-3(=2-hydroxy-4-methoxy-benzophenone) (UV-A filter) 4-Methylbenzylidene-camphor (UV-B filter) Butyl-methoxy-dibenzoylmethane (UV-A filter) [0076] For the determination of the dissolving power of these three UV filter substances, in each case a particular amount (50 g) of one of the compounds according to the invention was initially introduced into the dissolving vessel and temperature-controlled at 22° C. 1 wt. % of a UV filter was added and the mixture was stirred until this amount had dissolved completely and homogeneously. This operation was repeated until the maximum amount of the UV filter which can be dissolved had been exceeded. For complete dissolving, a relatively long stirring time of several hours was often necessary at higher concentrations. [0077] Once the maximum concentration has been roughly determined in this manner, the test was repeated with smaller weights of the UV filter for fine determination of the concentration range around this maximum concentration. [0078] The compound Tegosoft® TN was used as a reference. [0079] Results of the solubility determinations: Benzophenone- 4-Methylbenzylidene- Butyl-methoxy- Compound 3 camphor dibenzoylmethane 1 31 30.7 16.5 2 19.7 24.3 9.5 3 18.5 23.5 9.0 4 25.0 23.9 9.5 5 29.3 27.0 8.8 8 24.5 29.4 15.6 Tegosoft ® 12.7 22.0 12.1 TN [0080] As can be seen from the above values, the dissolving power of the compounds according to the invention was significantly better than the dissolving power of Tegosoft® TN in many cases. EXAMPLE 10 [0081] Examples of cosmetic formulations: [0082] The compounds according to the invention were employed as a constituent of cosmetic formulations. A water-in-oil (W/O) and an oil-in-water (O/W) cream were chosen for this by way of example. [0000] A) Standard Test Recipe W/O (W/O Sun Cream) [0083] Preparation: [0084] Batch size: in each case 100 g [0085] 1. Melt the constituents of phase A in a glass beaker at 80° C. and transfer to a glass beaker. [0086] 2. Bring the constituents of phase A to a controlled temperature of 80° C. in a drying cabinet. [0087] 3. Dissolve the constituents of phase B in a glass beaker. [0088] 4. Stir in phase B slowly while stirring with an MIG stirrer (500 rpm) and then homogenize for 3 minutes at 1,400 rpm. [0089] Standard Test Recipe W/O 1: [0090] With Tegosoft® TN as the solvent for the UV filter benzophenone-3 (12 % based on the mixture with Tegosoft® TN). Standard test recipe W/O % A ISOLAN ® PDI 3.0 Castor Wax 0.5 Microwax W 80 0.5 Tegosoft ® TN 22.85 Benzophenone-3 3.15 (Total oily phase 30%) B MgSO 4 *7H 2 O 1.0 Water 68.95 Bronopol 0.05 [0091] Standard Test Recipe W/O 2: [0092] With compound 1 as the solvent for the UV filter benzophenone-3 (12 % based on the mixture with compound 1). [0093] This standard test recipe served to check whether the recipe constituent Tegosoft® TN can be replaced without problems by a comparable amount of compound 1 in standard test recipe W/O 1 without fundamentally changing the properties of the standard test recipe. Standard test recipe W/O % A ISOLAN ® PDI 3.0 Castor Wax 0.5 Microwax W 80 0.5 Compound 1 22.85 Benzophenone-3 3.15 (Total oily phase 30%) B NaCl 1.0 Water 68.95 Bronopol 0.05 [0094] Standard Test Recipe W/O 3: [0095] With compound 1 as the solvent for the UV filter benzophenone-3 (24 % based on the mixture with compound 1). [0096] This standard test recipe served to check whether the content of the UV filter benzophenone-3 can be significantly increased in the standard test recipe compared with the standard test recipe W/O 2 without fundamentally changing the properties of the standard test recipe. Standard test recipe W/O % A ISOLAN ® PDI 3.0 Castor Wax 0.5 Microwax W 80 0.5 Compound 1 19.76 Benzophenone-3 6.24 (Total oily phase 30%) B NaCl 1.0 Water 68.95 Bronopol 0.05 [0097] As has been seen from the preparation and checking of the abovementioned recipes, it was possible both for the recipe constituent Tegosoft® TN to be replaced without problems by a comparable amount of compound 1 in standard test recipe W/O 1 and for the content of the UV filter benzophenone-3 in the standard test recipe to be increased significantly, without fundamentally changing the properties of the standard test recipe. [0000] B) Standard Test Recipe O/W (O/W Sun Cream) [0098] Preparation: [0099] Batch size: in each case 100 g [0100] 1. Heat the constituents of phase A to 80° C. in a 400 ml glass beaker. [0101] 2. Heat the constituents of phase B to 80° C. in a 250 ml glass beaker. [0102] 3. Add phase B to phase A and then homogenize with an ESG bar for 2 minutes. [0103] 4. Cool to 50 to 60° C. in a water bath, while stirring, add phase C and homogenize again for 1 minute. [0104] 5. Cool to <30° C. in a water bath, while stirring. [0105] Standard Test Recipe O/W 1: [0106] With Tegosoft® TN as the solvent for the UV filter methylbenzylidene-camphor (20% based on the mixture with Tegosoft® TN). Standard test recipe O/W % A TEGO ® Care 215 2.5 TEGIN ® M 1.0 TEGO ® Alkanol 18 2.0 TEGOSOFT ® TN 11.6 Methylbenzylidene-camphor 2.9 (Total oily phase 20%) B Glycerol 3.0 Water 76.5 CA 24 ® 0.1 C Keltrol F ® 0.4 [0107] Standard Test Recipe O/W 2: [0108] With compound 1 as the solvent for the UV filter methylbenzylidene-camphor (20% based on the mixture with compound 1). This standard test recipe served to check whether the recipe constituent Tegosoft® TN can be replaced without problems by a comparable amount of compound 1 in standard test recipe O/W 1 without fundamentally changing the properties of the standard test recipe. Standard test recipe O/W % A TEGO ® Care 215 2.5 TEGIN ® M 1.0 TEGO ® Alkanol 18 2.0 Compound 1 11.6 Methylbenzylidene-camphor 2.9 (Total oily phase 20%) B Glycerol 3.0 Water 76.5 CA 24 ® 0.1 C Keltrol F ® 0.4 [0109] Standard test recipe O/W 3: [0110] With compound 1 as the solvent for the UV filter methylbenzylidene-camphor (30% based on the mixture with compound 1). This standard test recipe served to check whether the content of the UV filter methylbenzyliden camphor can be significantly increased in the standard test recipe compared with standard test recipe W/O 2 without fundamentally changing the properties of the standard test recipe. Standard test recipe O/W % A TEGO ® Care 215 2.5 TEGIN ® M 1.0 TEGO ® Alkanol 18 2.0 Compound 1 10.15 Methylbenzylidene-camphor 4.35 (Total oily phase 20%) B Glycerol 3.0 Water 76.5 CA 24 ® 0.1 C Keltrol F ® 0.4 [0111] As has been seen from the preparation and checking of the abovementioned recipes, it was possible both for the recipe constituent Tegosoft® TN to be replaced without problems by a comparable amount of compound 1 in standard test recipe O/W 1 and for the content of the UV filter methylbenzylidene-camphor in the standard test recipe to be increased significantly, without fundamentally changing the properties of the standard test recipe. [0112] By the preparation of the six recipes listed above it has thus been possible to demonstrate that it was possible to increase the amount of UV filter in the recipes by virtually 100% by using the compounds according to the invention. [0113] While the present invention has been particularly shown and described with respect to preferred embodiments thereof, it will be understood by those skilled in the art that the foregoing and other changes in forms and details may be made without departing from the spirit and scope of the present invention. It is therefore intended that the present invention not be limited to the exact forms and details described and illustrated, but fall within the scope of the appended claims.

The invention relates to the use of compounds of the general formula (I) wherein R,R′═HC 1-5 -hydrocarbon radical, —O—C 1-5 -oxyhydrcarbon radical and are identical or different R 1 , R 2 , R 3 ═H, C 1-5 -hydrocarbon radical and are identical or different, X,Y═—O—; —O—C(O)—; —(O)C—O— and are identical or different, A=A α =—O—C(O)—O—; A β =R 4 —CH 2 C(CH 2 —) 3 , Aγ=—C(H)isopropyl, R 4 ═R 4 δ =—CH 3 ; R 4 ε =—[CH 2 —CH(R 1 )] e -(Y) d —(CH 2 ) c -Ph(R) a , a,b=1 to 5 and are identical or different, c,k=0 to 5 and are identical or different, d,h=0 or 1 and are identical or different, e,g=0 or 1 and are identical or different, f=0 or 1, m=1 to 3, n=0 or 1, as solubilizing agents/solvents for dissolving organic UV filters.

A claim for domestic priority is made herein under 35 U.S.C. §119(e) to U.S. Provisional App. Ser. No. 60/673,114 filed on Apr. 20, 2005 and U.S. Provisional App. Ser. No. 60/689,215 filed on Jun. 10, 2005, the entire disclosures of which is incorporated herein by reference. BACKGROUND The present invention relates to devices for producing food products in a continuous fashion. Particularly, the present invention is directed to the art of food production for the home and other small scale production settings. Generally, large scale food production equipment that mold, cook, and fill food products are known in the art. Because this type of equipment is purposefully designed for large scale continuous production, the equipment is usually bulky, heavy, and expensive. However, the need for continuous food production equipment not only exists for large scale production facilities but for the common household as well. Existing food cookers for the common household require a significant amount of user intervention. The user must individually apply a food mixture to a hot plate and meticulously observe the mixture such that it cooks thoroughly without burning. This process is inconvenient for the user because it is time consuming and must be repeated for each individual serving of food. In addition, it is often the case when such single serve equipment can produce inconsistent results based on the inattention of the user. For one reason or another, the user may become distracted or simply forget how long the mixture has been cooking. This results in either under or overcooked food. Therefore, for the reasons discussed above, it is the objective of the present invention to provide certain improvements in the art of continuous food cooking devices. SUMMARY OF THE INVENTION The present invention sets forth multiple novel improvements to the art of household food cooking devices. These improvements involve the consistency, volume, speed, and convenience with which food may be made in the home. The invention described herein is a device that is portable, simple to use, and is capable of producing food items in a continuous fashion. The continuous food cooker generally includes a housing, a mixture hopper for receiving a food mixture, a hot roller assembly for forming and cooking the mixture, a hot roller drive assembly for driving the hot roller assembly, and a cutter assembly for cutting the produced food item. In a first embodiment, the mixture hopper is disposed above the housing. The mixture hopper includes a reservoir and a synchronized mixture dispensing cam that is rotatably mounted at a lower region of the reservoir. The mixture dispensing cam meters the flow of uncooked food mixture into the hot roller assembly and dispenses the mixture in sync with the hot roller drive assembly. The mixture is cooked as it enters a cooking zone and passes through a channel between the hot rollers. The produced food item exits along a dispensing tray attached to the housing of the continuous food cooker. When the continuous food cooker is not in use, the dispensing tray may be folded in an upright closed position. As the cooked mixture glides along the dispensing tray, it passes under a cutter assembly. When the food item has reached the desired length, the user may depress a cutter to slice off a portion of the food item. In a second embodiment the hot rollers are detachable from the hot roller assembly for cleaning and maintenance. In a third embodiment the hot rollers, the roller journals, and one carrying handle are integrated so as to provide a convenient and aesthetic means of removing and replacing the detachable hot rollers. In a fourth embodiment the hot rollers include a plurality of rectangular surface features that protrude along a cylindrical outer skin of the rollers (e.g. for producing waffles). In a fifth embodiment the hot rollers are substantially smooth along a cylindrical outer skin of the rollers (e.g. for producing pancakes, bread, or cooking bacon). In a sixth embodiment the hot rollers include a plurality of depressed surface features that are recessed along a cylindrical outer skin of the rollers (e.g. for producing cookies). In a seventh embodiment the hot rollers include a plurality of strip-like longitudinally oriented surface features (e.g. for grilling sandwiches or toasting bread). BRIEF DESCRIPTION OF THE DRAWINGS The invention may take form in certain structures and components, several embodiments of which will be discussed in detail in this specification and illustrated in the accompanying drawings. In the drawings: FIG. 1 is a perspective view of a first embodiment of the continuous food cooker invention. FIG. 1A is a horizontal sectional view of the first embodiment of the continuous food cooker through the hot roller assembly and the hot roller drive assembly. FIG. 2 is a vertical sectional view of the first embodiment of the continuous food cooker through the hot roller assembly illustrating the cooking zone in and around the channel between the hot rollers. FIG. 2A is a perspective view of the first embodiment of the continuous food cooker illustrating the operation of the continuous food cooker. FIG. 2B is a perspective view of the first embodiment of the continuous food cooker illustrating the compact configuration of the continuous food cooker. FIG. 3 is a frontal elevation view of a second embodiment and a third embodiment of the continuous food cooker illustrating the removable hot roller assembly and hopper. FIG. 4 is a perspective view of a roller design used in a fourth embodiment of the continuous food cooker. FIG. 4A is a side elevation view of the roller design shown in FIG. 4 . FIG. 5 is a perspective view of a roller design used in a fifth embodiment of the continuous food cooker. FIG. 5A is a side elevation view of the roller design shown in FIG. 5 . FIG. 6 is a perspective view of a roller design used in a sixth embodiment of the continuous food cooker. FIG. 6A is a side elevation view of the roller design shown in FIG. 6 . FIG. 7 is a perspective view of a roller design used in a seventh embodiment of the continuous food cooker. FIG. 7A is a side elevation view of the roller design shown in FIG. 7 . DETAILED DESCRIPTION With reference to FIG. 1 , a first embodiment of a continuous food cooker 10 is shown which generally comprises a frame or housing 12 , a food mixture hopper 14 , a hot roller assembly 16 , a hot roller drive assembly 18 and a cutter assembly 20 . The housing generally includes a base 22 , a top panel 24 , a rear panel 26 , a left and right side panel 28 , 30 , and a forward facing fold down dispensing tray 32 . The dispensing tray has two positions, an upright closed position and an open position. When the dispensing tray 32 is in the upright closed position, a hot roller cavity area 34 is defined directly behind the dispensing tray 32 . Generally, the hot roller assembly 16 is located in the upper portion of the hot roller cavity area 34 . In addition, the cutter assembly 20 is located in the forward facing region of the hot roller cavity 34 . The housing may be formed of a light weight plastic material, yet resilient enough to withstand high temperature. The base, the top panel, the rear panel and the side panels may all be formed together in a one-piece type construction. In addition, a pair of handles 29 may be fastened to side panels 28 , 30 . The handles 29 provide a convenient gripping area for transporting the continuous food cooker. The mixture hopper 14 generally includes a reservoir 36 , a removable lid 38 , a pair of downward projecting support members 40 , and a mixture dispensing cam 42 . A food mixture 2 may be placed in the reservoir 36 . The mixture dispensing cam 42 is located at a lower region of the reservoir 36 and serves as a valve for metering the flow of the food mixture 2 . The mixture dispensing cam 42 has a longitudinal dispensing slot 44 , a timing gear 46 , a driven end 48 , and a free end 50 . In the first embodiment, the timing gear 46 is operatively attached or connected to the hot roller assembly 16 such that when the hot roller assembly 16 is in motion, it is synchronized with the mixture dispensing cam 42 via the timing gear 46 . Also, the mixture hopper 14 may be formed of translucent plastic material such that it is easy for the user to determine what the level is of the food mixture 2 . The pair of downward projecting support members 40 engage the top panel 24 of the housing 12 of the continuous food cooker 10 . The downward projecting support members 40 engage the top panel 24 of the housing 12 such that the food mixture 2 is dispensed through the dispensing slot 44 in alignment with the hot roller assembly 16 . Now with reference to FIG. 1A , the hot roller assembly 16 is shown. In the first embodiment, the hot roller assembly 16 generally includes a first and a second hollow hot roller 52 , 54 . Each roller has a driven end 56 and a free end 58 . The hot roller assembly 16 also includes heating elements 60 along with a plurality of roller journals 62 . The first and second hot rollers 52 , 54 are aligned in a parallel configuration in close proximity to one another such that a mixture channel 53 is defined between them. The roller journals 62 act to capture the driven ends 56 and the free ends 58 of the first and second hot rollers 52 , 54 . The heating elements 60 may be fixed either to the internal hollow portion of the rollers 52 , 54 or they may be fixed to an internal support wall of the hot roller cavity 34 . However, fixing the heating elements 60 to the rollers 52 , 54 will require the use of a slip ring in order to maintain an electrical connection with the heating elements 60 . Preferably, the heating elements 60 are fixed with respect to the hot roller cavity 34 such that a slip ring is not necessary thereby reducing the associated cost. In addition, more uniform heating of the hot rollers 52 , 54 occurs when the heating elements 60 are stationary and the hot rollers 52 , 54 are permitted to rotate about the heating elements 60 . The heating elements 60 are appropriately sized such that when electricity is passed through them, adequate heat is generated in order to heat the rollers 52 , 54 and cook the mixture 2 as it passes through the channel 53 . Driven ends 56 of the rollers 52 , 54 are driven by the hot roller drive assembly 18 . The hot roller drive assembly 18 generally comprises a motor 64 , a reduction unit 66 and a gear train 70 . The motor 64 is coupled to a reduction unit 66 which acts to reduce the speed and increase the torque of the motor 64 . The reduction unit 66 includes an output shaft 68 . The output shaft 68 may be directly coupled to the first roller 52 or may be coupled to the first hot roller 52 through a series of gears. In the first embodiment, the output shaft 68 is directly connected to the first roller 52 . The second hot roller 54 is driven off of the output shaft through a gear train 70 . The first hot roller 52 and the second roller 54 rotate in opposite directions such that if the first hot roller 52 is rotating in a clockwise direction, the second hot roller 54 is rotating in a counter clockwise direction. It is also important that the hot rollers rotate at the same rate of speed. Otherwise, the food items will become distorted as they are cooked. Now with reference to both FIGS. 1 and 1A , the cutter assembly 20 is shown. The cutter assembly 20 generally comprises a cutter portion 72 , a cutter surface 74 , a cutter handle 76 , a pair of tracks 78 and a biasing element 80 . In the first embodiment, the cutter portion 72 is slidably engaged in the tracks 78 . The tracks 78 are vertically oriented in a forward region of the hot roller cavity 34 . The tracks 78 are disposed on either side of the hot roller cavity and provide a method of mounting the cutter portion 72 . The cutter portion 72 effectively has two positions, an upper and a lower position. The biasing elements 80 maintain the cutter portion 72 in the upper position. When the user desires to cut off a portion of the food item, the user pushes directly down on the handle portion 76 of the cutter portion 72 until slicing all the way through the food item. Now with reference to FIGS. 1A , 2 , and 2 A, one cycle of operation of the continuous food cooker 10 will be discussed. After mixing the appropriate ingredients to form a food mixture 2 , the food mixture is placed in the reservoir of the mixture hopper 14 . By way of example only, and for the purposes of explaining one cycle of operation, the food mixture may be a pancake or waffle batter mixture. At this point, the food cooker 10 is plugged in and activated. Upon activating the continuous food cooker, the hot roller drive assembly 18 causes the first and second hollow hot rollers 52 , 54 to rotate. As the first and second hot rollers 52 , 54 are rotating, the heating elements 60 are receiving power and radiating heat. The hot rollers 52 , 54 may operate at temperatures of approximately 900° F. in order to adequately cook the mixture 2 . At this point, the mixture hopper 14 is placed on the top panel 24 of the housing 12 . As the mixture hopper engages the housing 12 , the timing gear 46 of the batter dispensing cam 42 engages one of the gears of the gear train 70 of the hot roller drive assembly 18 . The mixture dispensing cam 42 will begin to rotate upon engaging the timing gear 46 . As the longitudinal dispensing slot 44 of the mixture dispensing cam 42 rotates into a vertical orientation, the mixture will flow through the longitudinal dispensing slot 44 . As the mixture 2 flows through the longitudinal dispensing slot 44 , it drips down into the channel 53 of the hot roller assembly 16 . As shown in FIG. 2 , a cooking zone 53 a is formed around the channel 53 . The cooking zone 53 a begins along a horizontal plane defined by the axis of rotation of both of the hot rollers 52 , 54 and extends upward along the outer surface of the hot roller 53 , 54 to an angle α approximately 45 degrees from the horizontal plane. The mixture 2 is initially “flash cooked” as it comes into contact with the hot outer surface of the hot rollers 52 , 54 and continues to cook by conductive heat transfer from the hot rollers into the central area of the channel 53 . The hot rollers 52 , 54 rotate at a rate appropriate to cook the mixture 2 without leaving it doughy or burnt. With reference to FIG. 2A , a waffle 4 is made in a continuous fashion as it progresses through the hot roller cavity 34 and out the front of the continuous food cooker 10 gliding along the dispensing tray 32 . The user may elect to create a waffle as long or short as they desire. Once the waffle has reached a length of their preference, the user can apply pressure to the cutter portion 72 of the cutter assembly 20 , pushing in a downward direction to engage the cutter surface 74 with the waffle 4 . The user may repeat the cutting process as the waffles continue to be produced by the continuous food cooker until the user has as many waffles as he or she desires. When the user has finished using the continuous food cooker machine, they may power it off and store any unused mixture by applying the removable lid to the hopper 14 and placing the hopper in a refrigerated area. In addition, the user of the continuous food cooker 10 may elect to remove the hot rollers 52 , 54 (as in the process described below with reference to FIG. 3 ) in order to clean the hot rollers 52 , 54 and the hot roller cavity 34 of the continuous food cooker 10 . Now with reference to FIG. 2B , the continuous food cooker 10 is shown in its compact configuration. The compact configuration allows the continuous food cooker 10 to be stored or transported with ease. As shown in FIG. 5 , the dispensing tray 32 is in the upright closed position, the hopper 14 is engaged on the housing 12 , and the removable lid 38 is attached. In this configuration, the continuous food cooker 10 consumes a limited amount space such that it may be stored in a typical overhead or under the counter kitchen cabinet. In addition to its compact design, the use of resilient plastic materials in fabrication allow the continuous food cooker 10 to be lightweight and transported with minimal effort or inconvenience. Now with reference to FIG. 3 , a second embodiment and a third embodiment of the continuous food cooker 200 , 300 is shown. In particular, the mixture hopper 214 , 314 and the hot rollers are removeable from the housing 212 , 312 for the purposes of cleaning and maintenance. Also, the hopper 214 , 314 may be removed from the top panel 224 , 324 of the housing 212 , 312 simply by lifting the hopper 214 , 314 in an upward motion. When uncooked food mixture remains and the user wishes to store the unused food mixture, the user may apply the removable lid 228 , 338 to the hopper 214 , 314 before refrigerating the food mixture. In a third embodiment of the continuous food cooker 300 , one of the carrying handles 329 may be integrated with the free end 358 of the hot rollers 352 , 354 and the roller journals 362 . As shown in FIG. 3 , the user of the continuous food cooker 300 may grip handle 329 and in one outward pulling motion remove the hot rollers 352 , 354 from the housing 312 as a one piece assembly. Now with reference to FIGS. 4 through 7 , a series of different rollers may be used in the continuous food cooker invention for cooking, forming, grilling or toasting various types of food. In order to accommodate a variety of foods and food texture preferences, the rollers may be equipped with a multitude of different surface features. With reference to FIG. 4 , a fourth embodiment of the continuous food cooker may have rollers 452 , 454 having a plurality of rectangular protrusions 455 as surface features. The protrusions 455 of the fourth embodiment shown in FIG. 4 extend perpendicularly outward from a cylindrical outer skin 457 . Naturally, any number of surface features may be arranged along the cylindrical outer skin to form a desired pattern. The rollers 452 , 454 of the fourth embodiment are very similar to the rollers 52 and 54 of the first embodiment. By way of example, the rectangular protrusions 455 of the fourth embodiment would be particularly useful in forming and cooking waffles. In this case, as the mixture flows between the rollers 452 , 454 , and takes on certain impressions created by the rectangular protrusions 455 . Thus, the resulting waffle would have the characteristic grid-like square depressions on either side of the waffle. With reference to FIG. 4A , a side elevation view of a driven end 456 of the rollers 452 , 454 is shown. FIG. 4A clearly illustrates the arrangement of the rectangular protrusion 455 in eight rows formed along the longitudinal axis of the rollers 452 , 454 . Now with reference to FIG. 5 , a fifth embodiment of the rollers 552 , 554 is shown. In this case, the rollers 552 , 554 have no surface features along a cylindrical outer skin 557 . In fact, as the food mixture enters the channel between the rollers 552 , 554 , the resulting cooked food product will have a very smooth surface on either side of the food product. By way of example, this embodiment of the rollers 552 , 554 may be used in making pancakes or cooking bacon. In addition, one particular advantage of using the continuous food cooker to cook bacon using the rollers 552 , 554 is that it results in healthier bacon with less fat, grease, and oil as compared to conventional methods of cooking bacon. Pressure exerted onto the bacon as it passes between the heated rollers 552 , 554 not only facilitates the cooking of the bacon, but also serves to squeeze out excess oil, fat and other greases that are a result of the cooking process. In the case of cooking thin sliced meat products (such as bacon, chicken, or steak), the user may opt to remove the hopper and manually feed the strips of meat into and between the rollers 552 , 554 . FIG. 5A shows a side elevation view of a driven end 556 of the rollers 552 , 554 clearly illustrating that there are no surface features in this particular embodiment. Now with reference to FIG. 6 , a sixth embodiment of the continuous food cooker utilizing a pair of rollers 652 , 654 is shown. In this embodiment, the rollers 652 , 654 are particularly suited for cooking doughy-type products such as cookies. The surface features of the rollers 652 , 654 consist of circular or oval-like depressions 655 in a cylindrical outer skin 657 of the roller 652 , 654 . As before, any number of depressions 655 may be arranged along the outer skin 657 . To further illustrate the depressions 655 in the rollers 652 , 654 , FIG. 6A illustrates the side elevation view of a driven end of the rollers 652 , 654 . The dashed lines shown in FIG. 6A would represent the overall width and depth of the depressions 655 in a cross-sectional view of the rollers 652 , 654 . In this embodiment, the rollers 652 , 654 may be located in close proximity to one another such that the cylindrical outer skin 657 of each roller would be nearly touching the other. In addition, the two rollers 652 , 654 would be synchronized such that the depressions 655 come into alignment within the cooking zone as the two rollers rotate. By maintaining a very close tolerance between the two rollers 652 , 654 any amount of trimming required about the perimeter of the cooked food product, such as a cookie, would be reduced to a minimum. With reference to FIG. 7 , a seventh embodiment of the rollers 752 , 754 is shown. In the seventh embodiment, the rollers 752 , 754 have a plurality of longitudinally oriented strips or grooves 755 . The strips 755 may either protrude outward from a cylindrical outer skin 757 or they may be recessed. The rollers 752 , 754 of the seventh embodiment would be particularly suited for gripping harder surface-type food products such as in toasting or grilling sandwiches, subs, or slices of bread. To further illustrate the surface features 755 of the rollers 752 , 754 , FIG. 7A shows a side elevation view of a driven end 756 of the rollers 752 , 754 . As shown in FIG. 7A , the surface features or strips 755 protrude outwardly from the cylindrical outer skin 757 . Lastly, it should be noted that yet other embodiments of the continuous food cooker may incorporate a hot roller adjustment assembly for adjusting the mixture channel to accommodate various types of food items. The adjustment assembly could be manually operated by rotating a threaded drive screw or could be automatic such that the mixture channel automatically increases or decreases in size to maintain a fixed amount of pressure exerted between the hot rollers and onto the food item being cooked. This automatic method of adjustment could be accomplished by hingedly suspending one of the hot rollers in parallel configuration to the other while having a biasing element, such as an extension spring, maintain tension between the rollers. Furthermore, additional embodiments of the continuous food cooker provide for a hot roller drive assembly that includes a hot roller speed adjustment assembly using a rheostat, pulse width modulator, or transmission having different gear ratios. Finally, any of the embodiments described above may also include a temperature adjustable hot roller heater element for adjusting the cooking temperature depending on the food item or user preference. Several exemplary embodiments have thus been described. Modifications and alterations may occur to others upon reading and understanding the proceeding detailed description. It is intended that the exemplary embodiments be construed as including all such modifications and alterations insofar as they come within the scope of the appended claims or equivalence thereof.

The present invention relates to a portable household food cooker capable of receiving a food mixture and producing food items in a continuous fashion. The continuous food cooker generally includes a housing and a hopper. The hopper is disposed above the housing for receiving the food mixture and for dispensing the food mixture into the cooker. The continuous food cooker also includes a hot roller assembly for forming and cooking the food mixture, a hot roller drive assembly operatively attached to at least one roller, and a cutter for cutting the produced food item at a desired length. The hot roller assembly includes at least one rotatable roller and at least one heating element for heating the at least one roller. The at least one roller and the at least one heating element are disposed internally to the housing.

This is a continuation of application Ser. No. 07/935,516 now abandoned, filed on Sept. 8, 1992, now abandoned, which is a continuation of Ser. No. 07/438,863, filed on Nov. 20, 1989, now U.S. Pat. No. 5,157,603 which is a division of Ser. No. 267,713 filed on Nov. 11, 1988, now U.S. Pat. No. 4,933,843, which is a continuation of Ser. No. 928,170, filed Nov. 6, 1986, now abandoned. BACKGROUND AND SUMMARY OF THE INVENTION The present invention relates generally to microsurgical and ophthalmic systems and more particularly to a programmable control system and console for operating microsurgical instruments. Present day ophthalmic microsurgical systems provide one or more pneumatically operated (fluid pressure operated) surgical instruments connected to a control console. The control console provides the fluid pressure signals for operating the instruments and usually includes several different types of human actable controllers for controlling the fluid pressure signals supplied to the surgical instruments. Usually included is a foot pedal controller which the surgeon can use to control a surgical instrument. The conventional console also has push button switches and adjustable knobs for setting the desired operation characteristics of the system. The conventional control system usually Serves several different functions. For example, the typical ophthalmic microsurgical system has both anterior and posterior segment capabilities and may include a variety of functions, such as irrigation/aspiration, vitrectomy, microscissor cutting, fiber optic illumination, and fragmentation/emulsification. While conventional microsurgical systems and ophthalmic systems have helped to make microsurgery and ophthalmic surgery possible, these systems are not without drawbacks. Microsurgical and ophthalmic systems are relatively costly and are often purchased by hospitals and clinics for sharing among many surgeons with different specialities. In eye surgery, for example, some surgeons may specialize in anterior segment procedures, while other surgeons may specialize in posterior segment procedures. Due to differences in these procedures, the control system will not be set up in the same manner for both. Also, due to the delicate nature of this type of surgery, the response characteristics or "feel" of the system can be a concern to surgeons who practice in several different hospitals, using different makes and models of equipment. It would be desirable to eliminate the differences in performance characteristics between one system and the next, while at the same time providing enough flexibility in the system to accommodate a variety of different procedures. The prior art has not met these objectives. The present invention greatly improves upon the prior art by providing a programmable and universal microsurgical control system, which can be readily programmed to perform a variety of different surgical procedures and which may be programmed to provide the response characteristics which any given surgeon may require. The control system is preprogrammed to operate in a variety of different modes to provide a variety of different procedures. These preprogrammed modes can be selected by pressing front panel buttons. In addition to the preprogrammed modes, each surgeon can be provided with a programming key, which includes a digital memory circuit loaded with particular response characteristic parameters and particular surgical procedure parameters selected by that surgeon. By inserting the key into the system console jack, the system is automatically set up to respond in a familiar way to each surgeon. For maximum versatility, the console push buttons and potentiometer knobs are programmable. Their functions and response characteristics can be changed to suit the surgeons' needs. An electronic display screen on the console displays the current function of each programmable button and knob as well as other pertinent information. The display screen is self-illuminating so that it can be read easily in a darkened operating rooms. More specifically, the microsurgical control system of the invention is adapted for controlling fluid pressure controlled microsurgical instruments. The term "fluid pressure", unless otherwise specified, includes both positive pressure and negative pressure (vacuum), as well as pneumatic imputations. The microsurgical control system comprises a means for providing fluid pressure couplable to the microsurgical instrument for delivering a fluid pressure signal to the instrument. A manually actuable controller is coupled with the means for providing fluid pressure for adjusting the fluid pressure signal in response to human actuation. A digitally programmed electronic circuit coupled to the controller selectively alters the manner in which the controller responds to human actuation. Further, in accordance with the invention, the microsurgical control system includes a console and means on the console for connecting to at least one microsurgical instrument. The console has an electronic display screen and a plurality of manually actuable controllers disposed thereon at locations corresponding to predetermined regions of the display screen. The system includes a menu generating means coupled to the display screen for writing predetermined human readable messages at the predetermined regions of the display screen. A procedure control means is coupled to the connecting means for defining and providing a plurality of predetermined and selectable surgical procedures for controlling the inset. A procedure selection means is coupled to the procedure control means and is responsive to the human actuable controller, for causing the procedure control means to perform a selected one of the plurality of procedures. Still further in accordance with the invention, the control means includes a means for defining predetermined and selectable surgical procedures. The defining means includes a jack on the console and at least one memory circuit removably connected to the jack, for storing parameters used to define the surgical procedures. For a more complete understanding of the invention, its objects and advantages, reference may be had to the following specification and to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is a perspective view of the microsurgical system of the invention; FIG. 2 is a front view of the system console showing the front panel layout in greater detail; FIG. 3 is a system block diagram of the electronic control system of the invention; FIG. 4 is a detailed schematic diagram illustrating the processor and related components of the electronic control system; FIG. 5 is a detailed schematic diagram illustrating the reset and watchdog circuits of the electronic control system; FIG. 6 is a detailed schematic diagram illustrating the system bus structure of the electronic control system; FIG. 7 is a detailed schematic diagram illustrating the dual UART circuit of the electronic control system; FIG. 8 is a detailed schematic diagram illustrating the memory circuits of the electronic control system; FIG. 9 is a detailed schematic diagram illustrating the key memory circuits of the electronic control system; FIG. 10 is a detailed schematic diagram illustrating the digital potentiometer circuits of the electronic control system; FIG. 11 is a detailed schematic diagram illustrating the foot controller pedal circuitry of the electronic control system; FIG. 12 is a detailed schematic diagram illustrating the interrupt request handling circuitry of the electronic control system; FIG. 13 is a detailed schematic diagram illustrating the video circuitry of the electronic control system; FIG. 14 is a detailed schematic diagram also illustrating the video circuitry of the electronic control system; FIGS. 15-17 are detailed schematic diagrams illustrating the analog peripheral control circuitry of the electronic control system; and FIGS. 18 through 31 depict various menus displayable on the display screen of the invention. DESCRIPTION OF THE PREFERRED EMBODIMENT Referring first to FIGS. 1 and 2, a microsurgical control system 10 is provided having a foot pedal assembly 24 according to the present invention. The control system 10 includes a system console 12 which has an upwardly and inwardly sloping front panel 14 and at least one removable access door 254 in one of the side panels. On the front panel 14 is an electronic display screen 16, a plurality of push button switches or touch sensitive pads 18 and a plurality of "endless" digital potentiometer knobs 20. The push buttons 18 and knobs 20 are actuable by the surgeon or nurse to select various different modes of operations and functions used in various surgical procedures. The console 12 also includes a cassette eject button 36, an irrigation pinch valve 37, and a power on/off switch 38. The electronic display screen 16 is controlled by a computer to provide one or more different menus or messages which instruct the operator as to the function of the buttons 18 and knobs 20 for the particular mode selected. The display screen 16 may be conceptually divided into display screen regions 22 with the buttons 18 and knobs 20 being positioned at locations around the periphery of the screen 16 corresponding to the regions 22. By virtue of the location of the buttons 18 and knobs 20 adjacent the screen 16, for example, a message in the upper left-hand comer of the screen 16 is readily understood by the operator as referring to the upper left most button. This arrangement allows the indicated function of each button 18 and knob 20 to be readily changed. The use of an electronic display screen 16 also permits the buttons 18 and knobs 20 to be labeled in virtually any language. The microsurgical control system 10 is adapted for use with a number of different surgical instruments. As shown in FIG. 1, a fiber optic illumination instrument 214 is coupled to the console 12 via fiber optic cable 212. Also illustrated is a fragmentation emulsification instrument 28 coupled to the console 12 through an electrical cable 30. The instrument 28 is also coupled to a collection container or cassette 100 through an aspiration tube 31. A cutting instrument 32 is also shown which is coupled to the console 12 through tubing 34 and to the cassette 100 through tubing 35. The cutting instrument 32 may be a guillotine cutter for vitrectomy procedures, or it may be a microscissors inset for proportionate and multiple cutting. However, when the microscissors instrument is used, the instrument is not connected to the cassette 100. While certain microsurgical instruments have been illustrated in FIG. 1, it will be understood that the microsurgical control system 10 can be used with other similarly equipped instruments. In general, any of the microsurgical instruments are actuated or controlled by fluid pressure (positive pressure or negative pressure). However, it should be appreciated that other suitable types of control signals may be used in the appropriate application. To provide irrigation/aspiration capabilities, the control system 10 further includes the removable cassette 100 which may be inserted into a cassette slot 102 in the console 12. The cassette 100 has a passageway opening 148 to which an aspiration tube from an aspiration instrument may be connected. The console 12 also includes a plurality of couplers 40 to which surgical instruments described above may be attached. Above each coupler 40 is a light emitting diode 42 which is illuminated when the instrument connected to the associated coupler 40 is activated. To store the operating parameters of a particular microsurgical operation, the control system 10 electrically communicates with a digitally encoded memory key K21. The memory key K21 includes an integrated memory circuit which stores the operating parameters for a particular surgical procedure. The console 12 receives the key K21 through a slot J21. Suitable types of memory keys K21 are commercially manufactured by Data Key Inc., Burnsville, Minn. However, it should be appreciated that other suitable means for accessing specifically assigned memory locations may be used in the appropriate application. A further description of the control system may also be found in the following commonly owned patent applications which were filed on even date herewith, and which are hereby incorporated by reference: Scheller, et al U.S. patent application Ser. No. 06/928,265, entitled "Collection Container For Ophthalmic Surgical Instruments" now U.S. Pat. No. 4,775,897; Scheller, et al U.S. patent application Ser. No. 06/927,827, entitled "Illumination System For Fiber Optic Lighting Instruments now U.S. Pat. No. 4,757,426; and Scheller U.S. patent application Ser. No. 06/927,807, entitled "Foot Pedal Assembly For Ophthalmic Surgical Instrument" now U.S. Pat. No. 4,837,857. Referring now to FIG. 3, a system overview of the microsurgical control system will be presented. The control system of the presently preferred embodiment centers around a microprocessor 310, such as a Motorola 6809. Connected to the reset terminal of the microprocessor is a reset logic circuit 312 and watchdog circuit 314. Reset logic circuit 313 performs the power on reset and manual reset functions, while the watchdog circuit monitors the operation of the microprocessor and causes it to be reset in the event it should enter an endless software loop or wait state. The details of the reset logic and watchdog circuits will be discussed below in connection with FIG. 5. Microprocessor 310 communicates with a processor address bus PAn and with a processor data bus PDn. In the presently preferred embodiment, the address and data bus structure is divided into two parts, one part for addressing the kernel of the machine and the other part for addressing the higher level system components. The kernel provides most of the peripheral device-independent functions and gives the control system its default or start up characteristics. The higher level system portion gives the control system the capability of being programmed to handle a variety of different surgical procedures with response characteristics tailor fit to a particular surgeon. As seen in FIG. 3, the processor address bus PAn and the processor data bus PDn both branch forming two portions. The resulting four branches are buffered in buffers 316, 318, 320 and 322. Buffers 316 and 318 address the kernel of the machine on address bus An and data bus Dn. Buffers 320 and 322 address the system portion of the machine on address bus BAnSYS and on data bus BDnSYS. In order to select whether the kernel portion or the system portion is to be addressed by microprocessor 310 and in order to maintain control over the direction of data flow, a buffer control circuit 324 is provided. Buffer control circuit 324 is responsive to address lines A11-A15 of address bus An. It provides a plurality of control signals coupled to buffers 318 and 322 for selecting which of the two data buses (Dn or BDnSYS) are active and for controlling the direction of data flow. Thus by addressing buffer control circuit 324, microprocessor 310 can selectively address either the kernel portion or the system portion of the invention. The bulk of the kernel appears generally at 326 and includes EPROM 328 and nonvolatile RAM 330. EPROM 328 contains the kernel operating system program instructions while nonvolatile RAM 330 contains the default data values used to define the system's default operating parameters. Also coupled to the kernel is dual UART (DUART) 332 which provides serial communication with microprocessor 310 via ports A and B. These ports my be accessed in order to monitor the microprocessor machine states during software debugging and programming and may also be used to connect to an external computer system for use in loading updated software into the machine and for testing the system. If desired, either or both of the ports can be connected to modem circuits for remote communication with the system via telephone lines. This feature would permit software updates to be made without requiring the unit to be shipped back to the factory. Also part of the kernel 326 is a peripheral decoding circuit 334 which is coupled to address bas An and which provides a plurality of board select signals BOARDn and a plurality of chip select signals CSn, which microprocessor 310 can activate to select a particular peripheral controller board or to select a particular peripheral controller chip. These will be discussed more fully below. The system portion of the invention is illustrated generally at 336. The system portion communicates with the system bases BAnSYS and BDnSYS. Included in the system portion are a plurality of universal memory sites 338 which can contain random access memory chips programmed to contain alternate response characteristics which differ from the default characteristics stored in RAM 330. Also provided is EEROM 340 which is an electrically erasable ROM used to store the calibration arrays for determining the response of the pneumatic systems or fluid pressure controlled systems of the invention. The values stored in EEPROM 340 represent calibration values preferably set and stored at the factory. Because an electrically erasable ROM is used, these values can presently preferred embodiment, this reprogramming is not available to the end user, but would normally be performed by a qualified technician via the serial ports A and B of dual UART 332. The microfiche appendix provides one example of a suitable program which could used in the control console according to the present invention. This microfiche appendix is hereby incorporated by reference. Each of the universal memory sites 338, as well as EEROM 340, EPROM 328 and nonvolatile RAM 330 include a memory select control input MSn. Control circuit 324, under microprocessor control, provides the memory select signals used to activate a particular memory device. In addition to these memory devices, the invention also has the capability to address a removable memory device which can be removably connected to a jack accessible on the exterior of the system console. This removable memory device or key memory 342 may be programmed by the end user for storing parameters used to define particular surgical procedures and particular response characteristics desired by a given surgeon. Although the key memory devices may be implemented in a variety of different package configurations, the presently preferred configuration is in the form of a removable electronic key. The key has a plurality of electrical contacts connected to a nonvolatile electrically alterable memory chip which is encapsulated in the body of the key. When the key is inserted into the jack on the system console and turned, the encapsulated memory chip is coupled to the key memory space 342 of the system portion of the circuit. The particular parameters and surgical procedures stored in the key memory are then accessible to microprocessor 310 to override the default parameters stored in nonvolatile RAM 330. It should be noted, however, that the key is only necessary to override the default values, and that the system may be operated without the key using the default values. In order to provide an interface between the human operator and the control system, several human actuable controllers are provided. These controllers include a plurality of "endless" digital potentiometers 20 and associated buffering circuitry 344 to which the front panel potentiometer knobs 20 are connected. In one embodiment according to the present invention, these digital potentiometers are Hewlett Packard Model HEDS7501 controllers. The signals generated by these potentiometers are related to specific operating parameters by the software. Accordingly, it should be that this feature permits multiple uses to be made of these potentiometers for different surgical procedures. As will be seen in connection with FIGS. 18-31, the display screen 16 is used to display an indication of the special operating parameters for these potentiometers. The digital potentiometers are connected to the system data bus BDnSYS and are selected by activation of certain of the chip select lines (CS2-CS4). The foot controller pedal 24 coupled to foot control circuitry 346 also provides human actuable control via the system data bus. In addition, push buttons 18 likewise provide human actuable control. These buttons are coupled through push button interface circuitry 348 to the system data bus. Like the digital potentiometer circuitry, the foot control circuitry and the push button interface circuitry are selected by certain of the chip select lines. The foot controller is selected by chip select lines CS13-CS15, and the push button circuits are selected by CS8-CS9. The human actuable controllers, i.e. the digital potentiometers, the foot controller pedal and the push button monitor switches, may be considered as peripheral devices. In addition to these peripheral devices, the microsurgical control system 10 also includes several analog peripheral devices, i.e. the fluid pressure actuated surgical implements. To simplify the illustration in FIG. 3, these analog peripherals and their associated control circuitry have been designated generally by block 350. The microsurgical control system also includes a video monitor 352 which defines display screen 16 and on which human readable messages are displayed. As will be more fully explained below, monitor 352 displays a series of different menus which identify the current function of each of the monitor switches 18 and digital potentiometers 20. In addition, the menus also provide certain other information to the surgeon, such as the operating parameter values selected by the appropriate rotation of the digital potentiometers. The video monitor is supplied with horizontal and vertical sync signals and a video signal via signal processor circuit 354. Signal processor circuit 354 receives the 10 MHz. clock signal from oscillator 356 as well as the vertical and horizontal sync signals from CRT controller 358. Each of the pixel locations on monitor 352 has one or more corresponding memory cell locations within video RAM circuit 360. The video RAM circuit is a dual ported memory circuit which can be directly accessed by both the monitor via the shift register (SR) interface circuit 362 and which may be accessed by the microprocessor via buffer 364. The presently preferred video screen has a 256 by 512 pixel resolution. Data to be displayed on monitor 352 is input through buffer 364 to video RAM 360 during a first half of the microprocessor machine cycle. During the second half of the machine cycle, the data is converted to a video signal and written to the monitor for display. As illustrated in FIG. 3, the monitor circuit defines a separate buffer data bus BDnVID, which is coupled to the system data bus BDnSYS through buffer 366. Because many of the peripheral devices are interrupt handled devices, a system timer and interrupt request circuit 368 is provided. When a peripheral device needs attention of the microprocessor, it generates an interrupt which is handled by the interrupt request circuit 368, causing the appropriate microprocessor interrupt to be generated. Circuit 368 also generates a system timer which is coupled to a speaker 370 to produce a periodic audible beeping tone. The audible beeping tone is presently tied to the aspiration function. It provides a tone which periodically beeps at a rate proportional to the aspiration rate. The audible beeping tone provides a continuous audible indication of the aspiration rate so that the surgeon does not need to look away from the surgical situs in order to determine the aspiration level. Having given an overview of the microsurgical control system, a more detailed analysis of the circuit will now be presented. The detailed schematic diagrams of FIGS. 4-17 have been provided with the customary pin designations where applicable. In these detailed schematic diagrams, many of the interconnecting leads and buses have been omitted for clarity; and it will be understood that the circuits with like pin designations share common signal lines and buses. Referring now to FIG. 4, microprocessor 310 is illustrated. In FIG. 4, microprocessor 310 is also designated U1. The kernel address buffer 316 comprises two buffer circuits U27 and U28 which may be LS245 integrated circuits. The kernel data buffer 318 is implemented using buffer circuit U2 which may also be a LS245 integrated circuit. The DIR terminal of circuit U2 is responsive to the DIRKER* control signal and the E* terminal is responsive to the SELKER* control signal. The SELKER* control signal selects the kernel data bus as the active bus and the DIRKER* control signal controls the data flow direction. These control signals are generated by the buffer control circuit 324 which includes circuits U9 and U10, both programmable array logic chips, such as PAL16L8 integrated circuits. These circuits are coupled to the A11-A15 address lines and decode these lines to produce the control signals indicated in FIG. 4. Among the control signals provided are memory select signals MSN (MS0-MS7). These signals are used to select which of the memory chips is being accessed by microprocessor 310. Also illustrated in FIG. 4 is EPROM 328 and nonvolatile RAM 330. These memory circuits are also designated U5 and U6, respectively. EPROM 328 may be a 2764 integrated circuit, while nonvolatile RAM 330 may be an HM6264-15 integrated circuit. As illustrated, EPROM 328 is enabled by MS7 memory select signal while RAM 330 is enabled by the MS0 memory select signal. Also illustrated in FIG. 4 is peripheral decode circuit 334, which is also designated U7. This circuit may be a PAL20L10 integrated circuit. It provides the function selection and board selection by decoding address lines A4-A15. In addition to providing the BOARDn control signals (BOARD0-BOARD1), U7 also provides several other control signals indicated, including a control signal for operating dual UART 332. In addition to circuit U7, the peripheral decode circuit 334 also comprises circuit U8, shown in FIG. 6. Circuit U8 may be an LS154 integrated circuit which decodes address lines A0-A3 and provides a plurality of chip select signals CSn (CS0-CS15). As illustrated, circuit U* is enabled by the BOARD0* signal from U7. Referring now to FIG. 5, the reset logic circuits 312 and watchdog circuit 314 are illustrated. The reset logic circuits provide an output at circuit U43 which is designated MPURST*. This signal is coupled to microprocessor 310 (FIG. 4) to provide a reset signal to the microprocessor. The reset circuits include a power on reset circuit 372 which couples to the reset logic circuit 374. The power on reset circuit provides a reset signal a sufficient time after powerup to ensure that the microprocessor is properly operating. Reset logic circuit 374, in addition to providing the microprocessor reset signal MPURST*, also provides hardware reset signals HDRST and HDRST* for resetting the peripheral devices connected to the system. This arrangement allows the microprocessor to be reset, to change memory banks for effecting different operations, for example, without requiring the hardware reset of the peripheral devices. The reset functions may be instigated by soft-ware control or by manually operated reset push buttons. The reset logic circuits 312 include a reset button control logic circuit 376 through which manual reset of both the microprocessor and the system can be accomplished using switches SW1 and SW2. Watchdog timer circuit 314 is a resettable timer circuit. During normal operation, the microprocessor, acting through control signal WATCHDOGRST*, resets or reinitializes the watchdog circuit every 40 to 50 milliseconds. The watchdog reset control signal WATCHDOGRST* is provided by the dual UART 332, shown in FIG. 7. As long as the watchdog circuit is periodically reinitialized, it will not affect operation of the microprocessor. However, if not reinitialized after approximately 200 to 300 milliseconds, watchdog circuit 314 produces an output signal which causes the microprocessor reset signal MPURST* to be generated. One purpose of the watchdog circuit is to reset the microprocessor and the system in the event the microprocessor loses program control due to a power surge or dropout. This is implemented by requiring the microprocessor to periodically generate the watchdog reset control signal as one of its many functions. If program control is lost, the microprocessor will not generate this control signal, whereupon the watchdog circuit 314 will cause a reset. Another use for the watchdog circuit is in switching between memory banks. The control system of the invention employs several memory banks, which are discussed more fully below. These memory banks may be programmed to contain different sets of instructions, operating parameters, and the like. Normally, the microprocessor would operate based on instructions contained in one or more of the memory banks, with the remaining banks containing different instructions held in reserve for other users. For example, the memory banks may be programmed to display operating instructions in a variety of different languages: English, French, German, Japanese and so forth. In order to switch from one bank to another, the microprocessor executes program instruction code which appropriately changes the default memory to be selected. The microprocessor then purposefully fails to reinitialize the watchdog circuit, causing a reset to occur. When the reset occurs, the machine state reinitializes with the newly selected memory bank in place of the previously selected one. Also, if desired, hardware switches or jumpers may be used to determine which memory banks are active upon power up. Also illustrated in FIG. 5, is the indicator driver circuitry 378 which is used to illuminate the LED indicators 42 above the couplers 40 on the front panel of console 12. Referring now to FIG. 6, the system address buffers 320 and system data buffer 322 are illustrated. System address buffers 320 are designated U29 and U30 while system data buffer is designated U3. Like the kernel data buffer 318, the system data buffer 322 has its DIR and E* terminals connected to control lines DIRSYS* and SELSYS* which are provided by buffer control circuit 324. FIG. 7 illustrates the dual UART circuitry 332 in greater detail. As illustrated, the dual UART circuitry includes a dual UART chip U4 which may be a 2681 integrated circuit. This circuit provides the various control signals indicated, including the watchdog reset control signal previously discussed. The dual UART circuit 332 provides two ports Port A and Port B, both complying with the RS232 standard. Although the uses of these two ports are many, one use is in loading new programs into the memory of the system. One of the ports can be connected to a remote terminal to receive commands, while the other terminal can be used to input the program to be loaded. In this fashion, the state of the machine can be monitored during the program loading procedure. FIG. 8 depicts the universal memory sites 338 of the invention. These universal memory sites may be provided with either RAM or ROM, depending upon the desired application. The universal memory sites are presently illustrated as circuits U64-U68, which may be implemented using 2764 integrated circuits. As illustrated, each of these circuits is coupled to one of the memory select lines MSn (MS2-MS6). Also illustrated in FIG. 8 is EEROM ROM 340, also designated U69. This circuit may be implemented using a DS1216 electrically erasable ROM circuit. As illustrated, the EEROM 340 is coupled to the MS1 memory select line. Also illustrated for convenience is the system bas 380 to which the universal memory sites 338 and EEROM 340 are connected. The key memory control circuitry is illustrated in FIG. 9. When the key K21 is inserted into jack J21, the key memory 342 is coupled to the KAn and KDn address and data bases. These buses are buffered through to the BAnSYS and BDnSYS system bases as illustrated. When the user physically turns the key in which the key memory 342 is encapsulated, a grounding signal is established with integrated circuit U32 (FIG. 12); and the KEY* signal enables the key memory 342 through Schmidt trigger 382. With reference to FIG. 10, the digital potentiometer control circuits 344 are illustrated in detail. Presently four digital potentiometers are illustrated, although it will be recognized that a greater or fewer number may also be employed. Each of the digital potentiometers is coupled to a programmable array logic (PAL) circuit, designated U18-U21. These PALS or logic array circuits are used to encode the signals from the potentiometers in order to provide an input signal which may be readily counted by counter circuitry which is internal to the microprocessor. Additionally, it should be noted that while these potentiometers may continue to be endlessly turned in one direction or the other, the counter will not go below a zero value or go above its maximum value. These logic array circuits are coupled to the system bus BDnSYS as illustrated. Each logic array is activated by a given chip select line CSn (CS2-CS5). Each logic array provides a system interrupt request signal on the lead designated SYSIRQ*. When any one of the "endless" digital potentiometers is turned, the corresponding array logic circuit issues a system interrupt request which is handled by the interrupt request circuit 368 shown in FIG. 12. Preferably the value of each digital potentiometer is stored in a software variable and is updated each time the setting of the potentiometer is changed. FIG. 11 depicts the foot control pedal circuitry 346. The foot control pedal 24 is coupled by fiber optic cable 26 to the system console. A group of programmable array logic circuits designated U23, U24, U25 and U26 (FIG. 12) decode the foot pedal slide position settings indicative of the degree of rotation of the pedal about its generally horizontal axis of rotation. In addition to these values, the foot pedal also has an on/off switch which indicates that the foot pedal is in the fully up position. The foot pedal also has similar on/off switches which indicate when the foot switch has been moved to the right and left positions. These switches provide control signals via Schmidt triggers 384 designated FPUP, FPR and FPL. FIG. 11 also illustrates the push button interface circuitry 348, comprising integrated circuits U11 and U12. The interface circuitry can be implemented using LS245 integrated circuits. The push buttons 18 (FIG. 1) are connected to jacks J6. Also connected to the interface circuitry 348 are the three control signals FPL, FPR and FPUP which are produced by the foot pedal switches discussed above. The circuits U11 and U12 couple all of the switches to the system bus BDnSYS. The human actuable controllers are all transition detection interrupts peripheral devices. When the actuator setting is changed, a transition occurs which causes an interrupt signal to be generated. FIG. 12 illustrates the interrupt handling circuitry 368. The interrupt request handling circuit 368 includes integrated circuit U50 which may be an MC6840 integrated circuit. This circuit produces the system timer interrupt SYSFIRQ* which occurs every 40 to 50 milliseconds and is used for event counting and for resetting the watchdog circuit 314. This circuit also provides the audible beeping tone for driving speaker 370. Circuit 368 also includes logic gates 386 which are coupled to the foot pedal control signals FPUP, FPUR, FPR, FPRR, FPL and FPLR. The logic gates provide the system interrupt request signal SYSIRQ* which is coupled to U50 as shown. FIGS. 13 and 14 illustrate the video portion of the control system. The video circuitry includes CRT controller 358 which may be a 6845 integrated circuit. The CRT controller is illustrated in FIG. 14 bearing the designation U47. Coupled to the CRT controller is data bus buffer U51 which buffers the system data bus BDnSYS to the video data bus BDnVID. The CRT controller provides the vertical and horizontal sync signals VSYNC and HSYNC, as well as other control signals as indicated. The video RAM memory circuits 360 are illustrated in FIG. 13. They are coupled to the video address bus VAn and also to the video data buses UBDn and LBDn. Buffers 364 comprising circuits U34 and U35 provide the buffering between these data buses and the system video data bus BDnVID. Circuits U34 and U35 may be LS245 integrated circuits. The DIR terminal of those circuits are mutually coupled to the DIRSYS control line. In order to access video RAM 360, the microprocessor writes data to buffers 364 during a first half of the microprocessor machine cycle. This data is written to the display monitor screen during the second half of the machine cycle. A ten MHz. oscillator 356 provides the timing signal at which the video screen is refreshed during each other half cycle. Data is read from video RAM 360 into shift register (SR) interface circuits 362. This data is then shifted out at the ten MHz. rate into video signal processor circuit 354. The shift register interface circuits may be LS166 integrated circuits and are designated as U33 and U36 in FIG. 13. The signal processor circuit 354 is designated U58 and may be implemented using a PAL16R4 integrated circuit. The output of signal processor circuit 354 provides the video and corresponding horizontal and vertical sync signals for driving the video monitor 352. Video RAM 360 is addressed using multiplexers U48, U49, U52 and U53, which are all implemented using LS157 integrated circuits. These multiplexers are in turn controlled by the timing and decoding circuitry 388 shown in FIG. 14. Timing decoding circuit 388 includes U38 which provides decoding for the video signal and U39 which provides timing for the system. FIGS. 15, 16 and 17 depict the analog peripheral control circuitry which was designated generally by block 350 in FIG. 3. As noted above, many of the microsurgical implements are operated by fluid pressure signals. The control system console includes venturi pressure arrangement for providing the pneumatic signals used to control the surgical implements. The circuitry illustrated in FIGS. 15, 16 and 17 interfaces the microprocessor with the analog controlled valves (not shown) used to provide the specific pneumatic signals required by the surgical implements and by various pneumatically operated peripheral devices. In this regard, the presently preferred embodiment employs an illumination system with light dimming capabilities provided by a pneumatically controlled movable carriage. The analog peripheral control circuitry of FIGS. 15, 16 and 17 allow the microprocessor to control this light dimming device. In addition, the cassette 100 for collecting aspiration fluids is also controlled by the analog circuitry. The cassette employs a light emitting diode and phototransistor pair for sensing the level of fluid within the cassette. This sensing mechanism provides an indication to the microprocessor of when the cassette is nearly full and needs to be replaced. The cassette is provided with a resilient-walled passageway which is blocked by squeezing action of a solenoid plunger operated by microprocessor 310. In addition to these functions, the analog circuitry also controls the BIPOLAR power used for cauterizing. Referring more specifically to FIG. 15, the analog peripheral control circuitry couples to the microprocessor via the SYSAn and SYSDn system buses via jack J1. Interrupt requests from the analog devices are processed through logic gates U20 to provide interrupt request signal IRQ*. These two buses are buffered through buffers U4 and U5 while the interrupt request signals are buffered through U15. Referring to FIG. 16, which is a continuation of the schematic diagram of FIG. 15, the buffers U4 and U15 couple to the data bus D of the analog control circuitry, while buffer U5 couples to the address bus A of the analog control circuitry. The light dimming pneumatic controller is coupled to the control circuit via jack J2 and the cassette interface at jack J3. The BIPOLAR control circuitry is illustrated in FIG. 17. In operation, the nurse or surgeon inserts cassette 100 into cassette slot 102, depressing it until it is locked into place. The act of sliding the cassette into place causes the aspiration vacuum system to be connected to the vacuum port of the cassette. The tubing for an aspiration instrument may then be inserted into the opening 148. At this time, the other surgical instruments are connected to the front panel couplers 40 as required. The fiber optic illumination instrument 214 is plugged into the fiber optic coupler 210. The system power switch 38 is then turned on, which causes powerup reset circuit 372 to reset microprocessor 310 after the appropriate time delay. In the presently preferred embodiment, the microprocessor controlled microcomputer system powers up in the initial function selection mode with the display screen 16 appearing as in FIG. 18. In this initial selection mode, only two of the switches 18a and 18b are active. The remaining push buttons and potentiometer knobs have no effect. In the screen region 22a, adjacent button 18a, appears the message "Anterior". In the screen region 22b, adjacent button 18b, appears the message "Posterior". By depressing button 18a, the front panel display changes to display the anterior segment menu which provides the several different surgical procedures shown in FIG. 19. In addition to the surgical procedures offered on the menu, the user may also select information or help screens or the user may select return, which returns to the initial selection screen. By pressing the button 18i adjacent the menu entry entitled "IRR ONLY", the screen displays a submenu which is illustrated in FIG. 20. This menu, in turn, offers other selections. Note that the IRR ONLY message is highlighted or emphasized in FIG. 20 and that two additional functions namely IRR PRIME and ASP PRIME, are added. FIGS. 21-24 illustrate the appearance of the display screen when the remaining selections are made from the menu of FIG. 19. With reference to FIGS. 21-24, it is seen that certain of the potentiometer knobs 20 have been made active and that adjacent each active knob there is a human readable indication of the function and current setting. In FIG. 23, for example, the cutting rate is indicated at 300 cpm, while the aspiration rate is indicated at 50 mm Hg. Also shown in the display screen in FIG. 23, is the message indicating the actual aspiration vacuum level, as opposed to the maximum setting provided by the ASP potentiometer knob. The remaining Figures relate to other functions provided by the control system and various menu levels of procedures selected from the initial selection menu of FIG. 18. From the foregoing, it will be seen that the menus displayed on the screen change depending upon the selections made by the user. While the menus illustrated are in the English language, the invention is capable of displaying these menus in other languages as well, using the bank switching techniques previously described. In addition, the particular default setting of cutting rate aspiration vacuum, diathermy power, fragmentation power, etc. can be unique to each different surgeon who uses the control system, merely by inserting that surgeon's preprogrammed key into the jack on the system console. While many of the functions are the same from menu to menu, certain groups of functions are mutually exclusive. The IRR ONLY, IRR/ASP and VITREOUS modes are mutually exclusive modes for the menu shown in FIG. 19. When one of these modes is in operation and a different one is selected, it automatically cancels the previous selection. Repressing the same mode switch a second time causes the mode to be cancelled. This allows other modes which may function simultaneously to be selected individually. For example, in the extracapsular mode, the user could select IRR ONLY and BIPOLAR allowing the foot pedal to control both of these functions. However, either function could be then eliminated by simply repressing its designated push button. In the phacoemulsification mode, IRR ONLY, IRR/ASP, PHACO, and VITREOUS, FRAGMENTATION and SCISSORS are also mutually exclusive functions. BIPOLAR, ILLUMINATION and AIR EXCHANGE then become individually selected functions which can be used (in any combination) with one of those three principle functions, i.e. VIT, FRAG, and SCISSORS. In all anterior segment procedures, both the IRR PRIME and ASP PRIME are illuminated. These allow the nurse or surgeon to reprime any of the lines without the need to access the surgeon's foot pedal. All posterior segment screens or menus, eliminate the IRR PRIME since continuous irrigation is generally used by the posterior segment surgeon. The RETURN selection is continuously displayed to allow the user to traverse the menu screens without requiring the system to be shut off and reinitialized. The INFORMATION control button is a shift key which allows the user by depressing it to then select whichever modes information is desired. For example, if the user is in the extracapsular mode of FIG. 19 and depresses the information button while also depressing the IRR ONLY button, information about the IRR ONLY mode will be displayed on the screen. With respect to the posterior segment menus (e.g., FIGS. 25-31), the selection of FRAGMENTATION preferably automatically cancels BIPOLAR, ILLUMINATION and/or AIR EXCHANGE modes since these are not used in conjunction with the fragmenter. Returning to a SCISSORS or VITREOUS mode thereafter requires the reinitialization of any of these modes desired. Also whenever VITRECTOMY and AIR EXCHANGE are selected together, the CUT RATE display will be extinguished and the AIR PRESSURE display illuminated and controlled by the appropriate potentiometer knob. Under such circumstances, the cutter will continue to function normally. Should the user require a change in cutting rate, the AIR EXCHANGE control is simply turned off to eliminate the cutting rate display in order to access the appropriate knob. The AIR EXCHANGE function can then be reinitiated. In addition to the front panel controls, the foot pedal is also capable of controlling certain of the functions. Table I below describes the foot pedal functions for different surgical modes. TABLE I______________________________________Mode Left Down Right______________________________________Anterior(Extracap &Phaco)IRR ONLY -- on/off --IRR/ASP Reflux IRR ONLY, -- on/off, linear 1 cycle aspirationPHACO Reflux IRR, ONLY on/off on/off, linear (momentary) 1 cycle aspirationVITREOUS Reflux IRR ONLY, -- on/off, cutting & 1 cycle linear aspirationBIPOLAR on/off -- -- (momentary)PosteriorVITREOUS -- linear on/off aspiration cutting (intermittent)FRAG- -- -- on/offMENTATION fragmentation (momentary)SCISSORS -- proportion proportionate/ or speed multicut (intermittent)BIPOLAR on/off -- -- (momentary)FIBEROPTIC -- -- --AIR EX- -- -- --CHANGE______________________________________ While the invention has been described in connection with its presently preferred embodiment, it will be understood that the invention is capable of certain modification and change without departing from the spirit of the invention as set forth in the appended claims.

The control system is programmable by the user by inserting a preprogrammed key into the system console. The key changes the default values normally used by the control system to those values selected by a particular surgeon. The control console thus emulates the performance characteristics of a wide variety of different types of microsurgical control systems, leaving the surgeon free to perform the operation without having to adjust to a new or unfamiliar system. The display screen is self-illuminating and provides a plurality of control menus generated by data stored in computer memory circuits. By bank switching the memory circuits, the display can be caused to appear in a wide variety of different languages.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates to sterilizing lamps and, more specifically, to a photocatalytic lamp, which is comprised of a lamp body, and a photocatalyst covering formed of a photocatalyst-coated breathing base material, which has a plurality of protruding flow guide portions that define with the periphery of the lamp body a respective buffer zone adapted to buffer the flowing of air. [0003] 2. Description of the Related Art [0004] Following fast development of industries and increase of the number of motor vehicles, the problem of air pollution becomes more and more series in most countries around the world. In order to breathe clean air, air conditioners, air purifiers, ventilators with wire gauze filters and the like may be used. However, these devices can simply remove solid matters from air. In recent years, various nanostructured photocatalysts have been developed for use with ultraviolet light sources to sterilize air. When a photocatalyst radiated by ultraviolet light, oxygen and water in air are caused to react and to produce negative oxygen ions and hydroxide free radicals. When encountered organic substances in air, negative oxygen ions transfer electrons to organic substances, and hydroxide free radicals catch electrons from organic substances. During the process, organic substances are caused to decompose into carbon dioxide and water. By means of the aforesaid chemical reaction, photocatalysts cause an oxidation to kill germs in air. [0005] Various photocatalytic sterilizing products have been commercialized. However, the structural or space arrangement between the catalyst (for example, TiO 2 ) and the light source (for example, ultraviolet lamp) affects the sterilizing effect. [0006] FIGS. 1A-1C show a photocatalytic lamp according to the prior art. This structure of photocatalytic lamp is comprised of an UV lamp tube 11 and a photocatalyst coating 12 covered on the surface of the UV lamp tube 11 . Because the photocatalyst coating 12 covers the whole area of the surface of the UV lamp tube 11 (except the base at each end of the lamp tube), less amount of UV energy passes out of the photocatalyst coating 12 , resulting in a low photocatalyst ionizing (activating) effect. There are other related prior art patents, which include U.S. Pat. Nos. 6,135,838 and 6336998. Further, because the photocatalyst coating 12 is smoothly covered on the surface of the UV lamp tube 11 , currents of air pass over the surface of the photocatalytic lamp rapidly, resulting in a short air and photocatalyst contact time. Therefore, this design of photocatalytic lamp is less effect in killing germs in air. [0007] In order to extend the contact time of catalyst with air, another structure of photocatalytic lamp is developed. According to this design, the photocatalytic lamp comprises an UV lamp body and a photocatalytic light guide. The photocatalytic light guide is a formed of a panel like a honeycomb in structure. However, this design of photocatalytic lamp is still not satisfactory in function because the photocatalyst at the rear end of the photocatalytic light guide cannot receive sufficient radiation of ultraviolet light from the UV lamp body. [0008] There is still known another structure of photocatalytic lamp, which uses a photocatalyst filter as covering means for the lamp. The photocatalyst filter is a substrate having openings in it. Due to the formation of the openings in the substrate, the structural strength of the photocatalyst filter is weakened. Further, when passing through the area around the openings in the substrate, air tends to be disturbed, forming a turbulent flow of air, which causes noises. SUMMARY OF THE INVENTION [0009] The present invention has been accomplished under the circumstances in view. It is the main object of the present invention to provide a photocatalytic lamp, which kills germs in air by means of a photocatalytic effect. It is another object of the present invention to provide a photocatalytic lamp, which has buffer zones to buffer the flowing of circulating air. [0010] To achieve these and other objects of the present invention, the photocatalytic lamp comprises a lamp body, and a photocatalyst covering surrounding the lamp body. The photocatalyst covering comprises a breathing base material, and a photocatalyst in the breathing base material. The breathing base material has protruding flow guide portions each defining with the periphery of the lamp body a respective buffer zone adapted to buffer the flowing of circulating air. In one embodiment of the present invention, the flow guide portions extend in radial direction. In another embodiment of the present invention, the flow guide portions extend in axial direction. BRIEF DESCRIPTION OF THE DRAWINGS [0011] FIG. 1A is an elevational view of a photocatalytic lamp according to the prior art. [0012] FIG. 1B is a cross-sectional view in an enlarged scale of the photocatalytic lamp shown in FIG. 1 . [0013] FIG. 1C is a longitudinal view in section in an enlarged scale of a part of the photocatalytic lamp shown in FIG. 1 . [0014] FIG. 2A is a schematic drawing showing the structure of a photocatalytic lamp according to the present invention. [0015] FIG. 2B is a schematic drawing showing an alternate form of the photocatalytic lamp according to the present invention. [0016] FIG. 3 is a schematic drawing showing a circulation of air through one buffering zone in the photocatalytic lamp according to the present invention. [0017] FIG. 4 is a perspective view of another alternate form of the photocatalytic lamp according to the present invention. [0018] FIG. 5 is a perspective view of still another alternate form of the photocatalytic lamp according to the present invention. [0019] FIG. 6 is a schematic drawing of still another alternate form of the photocatalytic lamp according to the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0020] Referring to FIGS. 2A and 2B , a photocatalytic lamp is shown comprising a lamp body 2 and a photocatalyst covering 3 formed of a breathing base material 31 attached with a photocatalyst and covered on the surface of the lamp body 2 . The breathing base material 31 is a thin sheet member selected from any of a variety of materials including non-woven fabric, polymeric sheet material, metal netting, filter paper, ceramics, and sponge. The photocatalyst can be obtained from any of a variety of oxide compounds such as TiO 2 , ZnO, SnO 2 , SrTiO 3 , WO 3 , Bi 2 O 3 , and Fe 2 O 3 . The best choice is TiO 2 . Most preferably, TiO 2 is selected. [0021] The aforesaid photocatalyst can be mixed in the breathing base material 31 during the fabrication of the breathing base material 31 . Alternatively, the photocatalyst can be coated on the surface of the breathing base material 31 . [0022] Referring to FIG. 3 and FIG. 2A , unlike the smooth tube-like conventional designs, the photocatalyst covering 3 is shaped like a corrugated tube having a plurality of protruded flow guide portions 32 . Each protruded flow guide portion 32 defines with the periphery of the lamp body 2 a flow buffer zone 33 . When currents of air pass through the photocatalyst covering 3 either from direction A or direction B, the buffer zones 33 buffer the flowing speed of currents of air, and at the same time, the radiation of light from the lamp body 2 excites the photocatalyst at the breathing base material 31 of the photocatalyst covering 3 , producing an ionized effect to sterilize air. [0023] The aforesaid lamp body 2 can be formed of a lamp tube lamp bulb, or LED (light emitting diode) having a wavelength within 200˜800 nm. Preferably, the lamp body 2 is formed of a UV (ultraviolet) lamp tube, UV lamp bulb, or UV LED (light emitting diode). [0024] In the embodiment shown in FIG. 3 , the lamp body 2 is formed of a UV lamp tube, which emits UV light to kill germs in air and to excite the photocatalyst at the breathing base material 31 of the photocatalyst covering 3 , achieving a photodissociation effect. Because the buffer zones 33 buffer the flowing speed of air and because currents of air are continuously circulated through the photocatalyst covering 3 , the invention effectively kill germs in air and remove bad smell from air. [0025] The protruded flow guide portions 32 may be variously embodied. According to the embodiments shown in FIGS. 2A and 4 , the protruded flow guide portions 32 are arranged in parallel around the periphery of the lamp body 2 . According to the embodiment shown in FIG. 2B , the protruded flow guide portions 32 are spirally connected in series around the periphery of the lamp body 2 . According to the embodiment shown in FIG. 5 , the protruded flow guide portions 32 extend in axial direction, and are arranged in parallel around the periphery of the lamp body 2 . [0026] FIG. 6 shows still another alternate form of the present invention. According to this embodiment, the lamp body 2 is formed of a lamp bulb, and the photocatalyst covering 3 comprises a plurality of protruded flow guide portions 32 arranged in parallel around the periphery of the lamp body 2 . [0027] Further, the photocatalyst covering 3 may be used with an existing lamp tube (or lamp bulb). Because the breathing base layer 31 admits air and light, the photocatalyst covering 3 does not block the light of the lamp tube (or lamp bulb), and the photocatalytic lamp provides sufficient illumination when sterilizing air. [0028] A prototype of photocatalytic lamp has been constructed with the features of FIGS. 2 ˜ 6 . The photocatalytic lamp functions smoothly to provide all of the features discussed earlier. [0029] Although particular embodiments of the invention have been described in detail for purposes of illustration, various modifications and enhancements may be made without departing from the spirit and scope of the invention. Accordingly, the invention is not to be limited except as by the appended claims.

A photocatalytic lamp is constructed to include a lamp body and a photocatalyst covering surrounding the lamp body, the photocatalyst covering being formed of a photocatalyst-coated breathing base material, which has a plurality of protruding flow guide portions that define with the periphery of the lamp body a respective buffer zone adapted to buffer the flowing of air.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to video games. More specifically, the present invention relates to a game program for realizing a role playing game (hereinafter referred to as RPG) which changes a development of a story forming the game on a screen according to an operational input by a player. 2. Description of the Related Art A video game using cards, such as playing cards is known. In addition, RPGs, using cards have been put in practical use. An RPG using cards makes cards for generating predetermined effects in a game such as magic cards and power-up cards to appear. A character in the game uses each of these cards as one of items that the character can use. However, in the above-mentioned card game, an ordinary card game using cards is simply played on a screen, thus, although it is convenient in progressing the game, amusement more than that inherent in the card game cannot be offered to a player. In addition, in the RPG using cards, card items simply appear as either weapon items or protection items that have been used frequently in the RPG. Thus, originality and amusement arising from using cards cannot be offered to a player. SUMMARY OF THE INVENTION The present invention has been devised in view of these problems, and it is an object of the present invention to provide a game program for enabling a player to play an RPG using cards having originality and amusement, a recording medium having the game program stored therein, a method of processing story developments in an RPG and a game apparatus. In order to solve the above-mentioned problems, according to an aspect of the present invention, a game program for causing a computer to execute a role playing game which changes a development of a story forming the game on a screen according to an operational input of a player is provided. The game program causes the computer to execute a displaying procedure for displaying a group of cards on the screen; a selecting procedure for selecting one of the displayed cards according to an operational input of the player; and a determining procedure for determining a development of the story according to a selected card. Therefore, the computer executes processing in accordance with the game program to display the group of cards on the screen and one of the cards is selected by an operational input of the player, whereby the story in the RPG is developed in various ways. Thus, originality and amusement of the RPG using cards can be offered to the player. In addition, according to another aspect of the present invention, the game program causes the computer to display the cards in a scene for selecting a course of a character appearing in the game, and, determine the course of the character in the game according to the selected card. Therefore, when a card is selected by the operational input of the player, a course of the character is determined in various ways according to the selected card. Thus, a story is developed in various ways for each player. In addition, according to another aspect of the present invention, the game program causes the computer to display the cards in a scene for selecting an action of a character appearing in the game, and, determine an action of the character in the game according to the selected card. Therefore, when a card is selected by the operational input of the player, an action of the character is determined in various ways according to the selected card. Thus, a story is developed in various ways. In addition, according to another aspect of the present invention, a scenario of the story is determined according to the selected card. Therefore, when a card is selected by an operational input of a player, a scenario of the story changes according the selected card. Thus, the story is surely developed in various ways. In addition, according to another aspect of the present invention, the game program causes the computer to execute a procedure for having the character virtually obtain a group of cards corresponding to different scenarios, respectively. Moreover, in the determining procedure, a scenario corresponding to any of the selected cards is determined as a scenario of the story. Therefore, after the character virtually obtains a group of cards corresponding to different scenarios, respectively, a scenario of the story is determined at the point when any of the cards is selected. The story thereafter is developed in accordance with the determined scenario. In addition, according to another aspect of the present invention, the game program causes the computer to execute the obtaining procedure in the first scene of the role playing game. Therefore, a development of the story varies for each player from the start of the role playing game, and thus, amusement of the RPG is increased. In addition, according to other aspects of the present invention, the game program causes the computer to read a program recorded in a recording medium, whereby effects similar to those described above can be realized. In addition, according to other aspects of the present invention, the game program causes the computer to execute processing in steps to be written, whereby effects similar to those described above can be realized. Therefore, processing steps to be written are executed using hardware such as a general-purpose computer or a general-purpose game apparatus. Consequently, a story development technology in the role playing game of the present invention can be easily implemented using the hardware. Other objects and advantages besides those discussed above shall be apparent to those skilled in the art from the description of preferred embodiments of the invention which follows. In the description, reference is made to accompanying drawings, which form a part hereof, and which illustrate an example of the invention. Such an example, however, is not exhaustive of the various embodiments of the invention, and therefore reference is made to the claims which follow the description for determining the scope of the invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a block diagram showing an overall configuration of a game apparatus to which an embodiment of the present invention is applied; FIG. 2 is a main flow chart showing processing procedures of a CPU; FIG. 3 illustrates an example of display of a player character in the form of a card; FIG. 4 illustrates examples of display of a scenario card; FIG. 5 is a flow chart showing details of exemplary processing for game developments based on a scenario; FIG. 6 illustrates examples of display of a geographical feature (obstacle geographical feature) card; FIGS. 7A and 7B illustrate examples of display of a PC card and a wild card; FIG. 8 illustrates examples of display of an item card; FIG. 9 is a flow chart showing details of exemplary processing of a battle screen; FIG. 10 illustrates examples of display of an enemy card; FIG. 11 illustrates examples of a trick card; FIG. 12 illustrates examples of a magic card; and FIG. 13 illustrates an example of a screen of an entire game screen. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Embodiments of the present invention will be hereinafter described with reference to the accompanying drawings. Further, in the following descriptions, the case in which the present invention is applied to a game machine for home use will be explained as an example. FIG. 1 is a block diagram showing a configuration of a game apparatus in accordance with this embodiment of the present invention. As shown in the figure, this game apparatus 1 includes, for example, a game machine main body 2 , a keypad 3 , a memory card 4 , a TV set 5 and a CD-ROM 6 . The game machine main body 2 is composed of, for example, a CPU 8 (Central Processing Unit), an ROM (Read Only Memory) 18 , an RAM (Random Access Memory) 9 , an HDD (Hard Disk) 10 , an interface unit 11 , a sound processing unit 12 , a graphics processing unit 13 , a CD-ROM (Compact Disc Read Only Memory) drive 14 , a detachable CD-ROM 6 and a communications interface 15 , which are connected to each other via a bus 7 . The CPU 8 sequentially executes a program stored in the RAM 9 to perform processing for progressing a game based on a basic program such as a boot program and an OS (Operating System) stored in the ROM 18 . In addition, the CPU 8 controls operations of each of components 9 to 15 in the game machine main body 2 . The RAM 9 is used as a main memory of the game machine main body 2 and stores a program and data required for progress of a game, which are transferred from the CD-ROM 6 . In addition, the RAM 9 is also used as a work area in executing a program. That is, a program storage area 91 , a data storage area 92 , a work area 93 and the like are allocated to the RAM 9 . A program and data to be stored in the program storage area 91 and the data storage area 92 are read from the CD-ROM 6 by a CD-ROM drive 14 in accordance with control of the CPU 8 and transferred to the RAM 9 . Various kinds of data required during progress of a game are temporarily stored in the work area 93 . A game program and data received from an external network 17 via the communications interface 15 and a communications line 16 are stored in the HDD 10 . The detachable keypad 3 and the memory card 4 are connected to the interface unit 11 . The interface unit 11 controls exchanges of data between the keypad 3 and the memory card 4 that are in the outside of the game machine main body 2 and the CPU 8 and the RAM 9 . Further, the keypad 3 is provided with direction keys and various buttons. A player operates these keys and buttons to execute inputs required for progress of a game, such as an instruction to move and an instruction to operate to the player's own character. In addition, the memory card 4 saves data indicating a state of progress of a game. The sound processing unit 12 performs processing for reproducing sound data such as BGM (Background Music) and sound effects corresponding to a state of progress of a game in accordance with an instruction from the CPU 8 and outputs the sound data to the TV set 5 as a voice signal. The graphics processing unit 13 performs three-dimensional graphic processing in accordance with an instruction from the CPU 8 and generates image data corresponding to a state of progress of a game. The graphics processing unit 13 adds a predetermined synchronization signal to the generated image data to output the data to the TV set 5 as a video signal. The CD-ROM drive 14 drives the CD-ROM 6 set in the game machine main body 2 in accordance with an instruction from the CPU 8 and transfers a program and data stored in the CD-ROM 6 to the RAM 9 via the bus 7 . The communications interface 15 is connected to the external network 17 via the communications line 16 and performs processing for exchanging a program and data with the external network 17 in accordance with an instruction from the CPU 8 . The CD-ROM 6 stores a program and data (game program 6 a ) required for progress of a game. The CD-ROM 6 is driven by the CD-ROM drive 14 , whereby the stored program and data are read. The program and data read from the CD-ROM 6 are transferred to the RAM 9 from the CD-ROM drive 14 via the bus 7 . The TV set 5 is provided with a display screen 51 consisting of a CRT (Cathode Ray Tube) or the like for displaying an image corresponding to a video signal from the graphics processing unit 13 and a speaker 52 for outputting voices corresponding to a voice signal from the sound processing unit 12 . Usually, a television receiver is used as the TV set 5 . In this embodiment in accordance with the above-mentioned configuration, when a game is started, the CPU 8 secures an area for storing information in the RAM 9 , whereby the program storage area 91 , the data storage area 92 , the work area 93 and the like are secured in the RAM 9 . Then, upon receiving a game starting request, the CPU 8 reads information required for a game to be started from the CD-ROM 6 into the RAM 9 , whereby a game program is stored in the program storage area 91 and various kinds of data are stored in the data storage area 92 . The CPU 8 executes processing indicated in a flow chart of FIG. 2 in the first place based on the game program stored in the program storage area 91 . That is, the CPU 8 executes character determination processing first (step S 1 ). This character determination processing is processing for determining a character of the player among a group of characters and causes the display 51 to display a group of (e.g., seven) questions consisting of a group of choices, respectively. When selection of any choice is completed in response to all the questions, a specific character is determined as a character of the player (player character PC), and the player character PC is displayed on the display 51 as a card as shown in FIG. 3 . That is, in this embodiment, unlike an ordinary RPG, the player character PC appears in the form of a card instead of appearing as a personified character. Further, this processing of step S 1 is only executed when an RPG in accordance with this embodiment is played for the first time. When the game is subsequently started, processing is started regarding the selected character as a player character PC (card) based on saved data stored in the memory card 4 . In addition, on the display 51 , display is divided into an upper and lower part. In the lower part of the screen, a player character PC in the form of a card is mainly displayed, and an enemy character and other characters in the form of a card, which appear in the following description, are mainly displayed in the upper part of the screen. Subsequently, after setting “0” in a counter C for counting the number of cleared scenarios (step S 2 ), scenario obtaining processing is executed (step S 3 ). A player character PC meets a character operated by a computer in a predetermined place (e.g., a town) and obtains information concerning a certain scenario by the character, whereby a scenario card for the scenario can be obtained. Therefore, the number of available scenario cards varies according to the number of characters that the player character PC meets. In addition, in this scene, the player may propose that a character the player character PC meets be a comrade of the player character PC. In this way, it becomes possible to increase the number of allies. Here, scenario cards are associated with scenarios forming a different development and a story, respectively. Next, scenario selection processing is executed (step S 4 ). In this scenario selection processing, the scenario card obtained in step S 3 is used. As shown in an example of FIG. 4, scenario cards 511 , 512 and 513 obtained by the player character PC are displayed on the display 51 . Any one of the three scenario cards 511 , 512 and 513 is selected according to operation of the keypad 3 by the player. When any one of the scenario cards is selected, game development processing based on the scenario to be described later is executed (step S 5 ), and then if the scenario is cleared by this game development processing, a value of the counter C is incremented (step S 6 ). Further, whether the scenario is cleared or not is determined by whether a mission is accomplished or not as described later. A mission provided for each scenario in this context includes tasks such as defeating a boss monster of an opponent or finding a predetermined item. When game processing based on the scenario ends in accordance with operation of the keypad 3 by the player and progress of a game, in the two remaining scenario cards among the above-mentioned three scenario cards 511 , 512 and 513 , game development processing based on a scenario corresponding to any one of the cards is started (step S 7 ). Then, if the scenario is cleared by this game development processing, a value of the counter C is incremented (step S 8 ). In addition, when a game based on the scenario ends, game development processing based on a scenario of the remaining one scenario card among the above-mentioned three scenario cards 511 , 512 and 513 is executed (step S 9 ). If the scenario is cleared in this game development processing, a value of the counter C is incremented (step 10 ). Subsequently, it is determined whether or not the number of scenarios required for clearing the stage is cleared based on the value of the counter C (step S 11 ). If the number of scenarios required for clearing the stage is not cleared, the processing of step S 3 and subsequent steps is repeated. Further, scenario cards of the number required for clearing a stage or more (e.g., five) are obtained before starting the stage and an arbitrary three scenario cards among them are cleared, whereby the stage may be cleared. Then, if the number of scenarios required for clearing the stage is cleared (step S 11 ; YES), it is determined whether or not the stage cleared this time is a final stage among all the stages set in this RPG (step S 12 ). If it is not the final stage and stages that should be cleared still remain, the processing moves to the next stage (step S 13 ) and processing of step S 2 and subsequent steps is repeated. In addition, here, the processing may return to step S 1 instead of step S 2 . In this way, it becomes possible for a player to play using a different player character for each stage. That is, the same processing as in the above-mentioned step S 2 to step S 12 is performed in each stage, and games are developed by stories based on three types of scenarios corresponding to three scenario cards. Then, when all the games based on the three types of scenarios corresponding to the three scenario cards are cleared, the processing moves to the next stage. Finally, when all the stages set in this RPG are cleared, the determination in step S 12 is YES, and the game is completely performed. FIG. 5 is a flow chart showing details of exemplary game development processing based on scenarios to be executed in the above-mentioned steps S 5 , S 7 and S 9 . First, course selection processing (selection processing of a transit card) is executed (step S 31 ). In this course selection processing (selection processing of a transit card), a group of transit cards are displayed on the display 51 . On the surface of each of the transit cards, a figure indicating “climb a ladder”, “go up the stairs”, “open a door” or the like is displayed. The player selects a transit card corresponding to an action that the player wishes a character to take among the displayed transit cards by operation of the keypad 3 . Thus, game processing is executed according to the selected transit card and the RPG progresses. Subsequently, a geographic feature card relating to the selected transit card is displayed on the display 51 . Examples of the geographic feature card are shown in 514 , 515 and 516 of FIG. 6 . Figures indicating “passage where a skeleton is lying”, “cave”, “lake” or the like are displayed on displaying surface of these geographic feature cards. The player instructs the player character PC to take any action with respect to a geographic feature card displayed on the screen. In addition, in the case of a certain geographic feature card, an enemy character appears simultaneously with it. In this case, a battle is started. Battle processing will be described in detail later. In a scene in which the player character PC does not encounter an enemy (scene other than a battle), the player executes selection processing for selecting any one of PC (player character) cards and wild cards with respect to the displayed geographic feature card (step S 37 ). These cards are PC (player character) cards and wild cards that the player character PC owns virtually, with which a player character PC determines an operation on a game. Here, as specific examples of the wild card, there are cards indicating “advance”, “look out over”, “try at any rate” and the like. On the other hand, as specific examples of the PC (player character) card, there are cards indicating “run away”, “check well”, “medical herb”, “jump”, “release a trap”, “open a lock”, “thrust”, “cut”, “release an arrow”, “magic of fire”, “magic of water” and the like. One of a group of cards consisting of PC cards and a group of cards consisting of wild cards is displayed on a lower part 537 of the screen as shown in FIG. 13 according to an operation of the player. Then, the player operates the keypad 3 to select one of the cards, whereby an action of the player character PC is determined. For example, in a geographic feature card indicating a certain place (a cave, a hole opened in a large tree, or the like), a “look out over” card being a wild card is used. Then, a geographic card indicating a treasure box is displayed. Here, a “check well” card being a PC (player character) card is used. Then, it is displayed on the screen that releasing of a trap and opening a lock are required to open this treasure box. Thus, “release a trap” and “open a lock” cards being PC (player character) cards are used, whereby the treasure box is opened and items inside the treasure box are displayed on the screen. Subsequently, a “try at any rate” card being a wild card is used, whereby the items in the box can be obtained. Here, as available items, there are money and a key 521 , a knife 522 , a protector 523 , a pot 524 and the like shown in FIG. 8 . Any player character PC is selected by an operation of the keypad 3 to have the player character PC to hold the obtained items, whereby the obtained item can be used. In addition, if it is not particularly necessary to take a specific action such as “check well” with respect to the displayed geographical feature, an “advance” card being a wild card is used, whereby the processing advances to the next geographical feature card (transit card). That is, when selection of a transit card is executed in step S 31 , a geographical card relating to the selected transit card is displayed on the display 51 (step S 32 ). Subsequently, it is determined whether or not an enemy character has appeared simultaneously with the appearance of this geographical feature card (step S 33 ) and, if an enemy character has appeared, processing of a battle screen to be described later is executed (step S 34 ). Thereafter, in this processing of battle screen, it is determined whether or not the player character PC has attained a mission set on the scenario (step S 35 ) and, if the mission has not been attained, the processing of step S 31 and subsequent steps is repeated. Then, if the player character PC has attained the mission set on the scenario, it is determined that the scenario is cleared (step S 36 ). In addition, if it is determined that an enemy character has appeared as a result of the determination in step S 33 , processing for selecting a wild card or a PC card is executed (step S 37 ). In the processing for selecting a wild card or a PC card, as shown in FIGS. 7A and 7B, the computer causes the display 51 to display PC cards 520 or wild cards 517 to 519 . Here, the wild cards 517 , 518 and 519 showing examples indicate “advance”, “look out over” and “try at any rate”, respectively, and the PC card 520 is a card indicating “open a lock”. That is, in an ordinary RPG, a player character PC takes an action on a screen according to an operation of the keypad 3 , whereas, in the RPG in accordance with this embodiment, a player character PC is not made to take an action on the screen. Instead, the PC cards and wild cards 517 to 520 are selected, whereby it is assumed that the player character PC has taken an action corresponding to the selected card. Thus, the game processing is executed according the selected PC cards or the wild cards 517 to 520 and the RPG progresses. Then, in step S 38 , it is determined whether or not selection of the next wild cards or PC cards is necessary. If it is necessary, the processing of step S 37 and subsequent steps is repeated. If it is unnecessary, the processing advances to the above-mentioned step S 35 . FIG. 9 is a flow chart showing details of the above-mentioned processing of a battle scene (step S 34 ). In this processing of a battle scene, processing of encounter with an enemy is executed first (step S 341 ). That is, when any geographical feature card is selected in the above-mentioned processing of step S 32 , any of enemy cards 525 to 528 shown in FIG. 10 as examples may be displayed on the display 51 , whereby it is assumed that the player character PC has encountered an enemy character. Next, processing of mutual attacks is executed (step S 342 ). In this processing of mutual attacks, the computer causes the display 51 to display trick cards 529 to 532 shown in FIG. 11 or magic cards 533 to 536 shown in FIG. 12 . Then, for example, with the trick cards 529 to 532 displayed, any of them is selected by operation of the keypad 3 . When a trick card is selected, numerals in a range set in the trick card in advance are sequentially displayed at a high speed on the card. Then, when buttons are operated on the keypad 3 at the timing when any of the numerals is displayed, the numeral is determined as a value of attacking power of the player character PC. The determined value of attacking power of the player character PC is compared with a value of an enemy character card that is an object of attack of the player character PC at that point, whereby a result of the battle is determined. Moreover, if a result of the battle is determined in this way, subtraction processing is performed with respect to a life point set in the player character PC (card) in advance and a life point set in the enemy character (card) in advance. Next, it is determined whether or not the life point set in the player character PC (card) in advance or the life point set in the enemy character (card) has become “0” (step S 343 ). If any of the life points has become “0”, it is determined whether or not it is the life point of the player character PC (card) (step S 344 ) and, if it is the life point of the player character PC (card), the card is turned over to be displayed (step S 345 ). In addition, if it is not the life point of the player character PC (card) but the life point of the enemy character (card), the enemy character (card) is eliminated (step S 346 ). After turning over the player character card (step S 345 ) and after eliminating the enemy character (step 346 ), processing returns to that in FIG. 5, step 35 . Further, although the case in which the present invention is realized with a game machine for home use as a platform is described in this embodiment, the present invention may be realized with a general-purpose computer such as a personal computer or an arcade game machine as a platform. Moreover, a program and data for realizing the present invention are stored in a CD-ROM, which is used as a recording medium in this embodiment. However, a recording medium is not limited to a CD-ROM and may be a DVD (Digital Versatile Disc), other computer readable magnetic and optical recording media or a semiconductor memory. Furthermore, a program and data for realizing the present invention may be provided in the form of being preinstalled in a storage device of a game machine or a computer in advance. In addition, a program and data for realizing the present invention may be in the form of being downloaded from another apparatus on the network 17 connected by the communications interface 15 shown in FIG. 1 via the communications line 16 to the HDD 10 and used. In addition, the program and the data may be in the form of being recorded in a memory on another apparatus side on the communications line 16 and sequentially stored in the RAM 9 if necessary via the communications line 16 and used. In addition, a form of providing a program and data for realizing the present invention may be such that the program and the data is provided as a computer data signal superimposed on a carrier wave from another apparatus on the network 17 . In this case, the other apparatus on the network 17 is requested from the communications interface 15 via the communications line 16 to transmit the computer data, and the transmitted computer data signal is received and stored in the RAM 9 . It is also possible to realize the present invention in the game apparatus 1 using the program and the data stored in the RAM 9 in this way. As described above, according to the present invention, any of a group of cards displayed on a screen is selected according to an operational input by a player, whereby a story in an RPG can be developed in various ways according to the selected card. Thus, it becomes possible to offer the player originality and amusement of an RPG using cards. The present invention is not limited to the above embodiments and various changes and modifications can be made within the spirit and scope of the present invention. Therefore, to apprise the public of the scope of the present invention the following claims are made. The present disclosure relates to subject matter contained in priority Japanese Application No. 2001-087448, filed on Mar. 26, 2001, the contents of which is herein expressly incorporated by reference in its entirety.

A game program realizes a role playing game using cards with originality and amusement. In processing for selecting a scenario, a character is solicited to obtain three scenario cards in advance. Any of the scenario cards is selected from the three scenario cards according to operation of a player. When any of the scenario cards is selected, game development processing based on a scenario of the selected scenario card is executed. Subsequently, it is determined if conditions for clearing a scenario, for which the game development processing is executed, defined in the scenario in advance are met. The game development processing based on the scenario continues to be executed until the conditions for clearing the scenario are met. When the conditions for clearing the scenario are met, games based on scenarios of the remaining two scenario cards are developed.

TECHNICAL FIELD [0001] The present invention relates to a deodorizing agent comprising a dry cell of a microorganism as an active ingredient, which has a deodorizing effect on an odor substance, particularly, ammonia, trimethylamine, methyl mercaptan, hydrogen sulfide, fatty acid including propionic acid and n-butyric acid and the like. The present invention also relates to a deodorizing method comprising contacting the deodorizing agent with an odor substance. BACKGROUND ART [0002] Conventionally, various offensive odor sources have been deodorized by chemical treatment methods using a deodorizing agent, physical treatment methods comprising use of an absorbent or burning an offensive odor substance (e.g., JP-A-2001-519, JP-A-2001-522, JP-A-2001-157706), and biological treatment methods comprising degrading an offensive odor substance with a microorganism and the like (e.g., JP-B-2810308). [0003] The principle of a microbiological deodorizing method which decomposes an odor component using a particular group of microorganisms is decomposition by microorganisms of an odor substance that becomes the source of an offensive odor. In this method, the microorganism that decomposes an odor substance is a viable cell, and the odor substance is decomposed by the metabolic action of the viable cell. [0004] In the method of physically adsorbing an odor component with an absorbent such as activated carbon and the like, the principle is adsorption of an odor component within the micropores of the absorbent. However, the adsorption ability per unit weight varies, and an odor component once adsorbed may be problematically desorbed. [0005] In addition, zeolites and the like used for deodorizing cannot be reused and are difficult to be treated, posing a serious environmental problem as evidenced by the pressing need for final disposal sites and the like. DISCLOSURE OF THE INVENTION [0006] Offensive odors caused by excreta etc. produced during the breeding of domestic animals and indoor breeding of pet animals such as dogs, cats, and the like have become a big problem in recent years. An object of the present invention is to provide a deodorizing agent capable of deodorizing an offensive odor, particularly a typical odor substance from the aforementioned excreta such as ammonia, trimethylamine, methyl mercaptan, hydrogen sulfide, fatty acid including propionic acid and n-butyric acid and the like, and a deodorizing method using the deodorizing agent. [0007] The present inventors have found that dry cells of various bacteria (e.g., bacteria belonging to the genus Escherichia , bacteria belonging to the genus Brevibacterium , bacteria belonging to the genus Bacillus and the like) widely used for the industrial production of amino acids, nucleic acids, and the like can effectively eliminate odor substances such as ammonia, trimethylamine, methyl mercaptan, hydrogen sulfide, fatty acid including propionic acid and n-butyric acid and the like, by acting on an offensive odor substance, which resulted in the completion of the present invention. [0008] That is, the present invention provides a deodorizing agent comprising a dry cell of a microorganism selected from the group consisting of bacteria belonging to the genus Escherichia , bacteria belonging to the genus Brevibacterium and bacteria belonging to the genus Bacillus as an active ingredient, and particularly the above-mentioned deodorizing agent wherein the deodorizing agent deals with at least one kind of odor substance selected from the group consisting of ammonia, trimethylamine, methyl mercaptan, hydrogen sulfide, and fatty acid including propionic acid and n-butyric acid. [0009] The present invention also provides a deodorizing method comprising contacting the above-mentioned deodorizing agent with an odor substance. DETAILED DESCRIPTION OF THE INVENTION [0010] The offensive odor substance as referred to in the present invention is free of any particular limitation and is typically an odor substance from excreta of pet animals such as a dog, cat and the like due to indoor breeding or excreta when domestic animals such as cattle, pigs, chicken and the like are bred. More specifically, it is an odor substance of ammonia, hydrogen sulfide, trimethylamine, acetaldehyde, methyl mercaptan, fatty acid including propionic acid, n-butyric acid, n-valeric acid, iso-valeric acid and the like. The bacteria belonging to the genus Escherichia , bacteria belonging to the genus Brevibacterium and bacteria belonging to the genus Bacillus to be used in the present invention are bacteria for amino acid fermentation or nucleic acid fermentation, and have an ability to produce amino acids or nucleic acids when sugar sources such as starch, molasses and the like are used as main starting materials, various nutrients necessary for the growth of useful microorganisms are added, and the microorganism is placed under optimal pH, temperature and aeration management. Preferably, cells after various fermentations are used. [0011] As regards the amino acid fermentation microorganism, the amino acid produced by the fermentation microorganisms can be, for example, glutamic acid, lysine, arginine, phenylalanine, a branched chain amino acid (e.g., valine, leucine, isoleucine) and the like, with particular preference given to lysine, arginine and phenylalanine fermentation microorganisms. As regards the nucleic acid fermentation microorganism, 5′-inosinic acid, guanosine and inosine fermentation microorganisms are preferable. To be more specific, the fermentation microorganism of glutamic acid can be, for example, Brevibacterium flavum ATCC 14067. The fermentation microorganism of lysine can be, for example, Escherichia coli FERM BP-5252 and Brevibacterium flavum ATCC 21475. The fermentation microorganism of arginine can be, for example, Brevibacterium flavum FERM BP-6894. The fermentation microorganism of phenylalanine can be, for example, Escherichia coli FERM BP-3853, Brevibacterium lactofermentum FERM BP-4160 and Bacillus subtilis FERM BP-609. The fermentation microorganism of valine can be, for example, Brevibacterium lactofermentum FERM BP-1763. [0012] In the present invention, a dry cell means a dead cell substantially free of water, which sometimes contains residual medium components, filter aids and the like. By the phrase “substantially free of water” is meant that the water content is not more than 15 wt %, preferably not more than 10 wt %. [0013] The dry cell can be produced by any suitable technique but is generally produced in the following manner. [0014] According to a known method, a cell is cultured in a culture medium managed to have pH, temperature and aeration suitable for each fermentation. Upon completion of the fermentation, the cell, which can be sterilized with heating or not sterilized, is collected by centrifugation or filtration. [0015] The obtained cell, either as is or, for example, re-suspended in water, physiological saline, a suitable buffer near neutral and the like, is then subjected to the subsequent drying step. [0016] The cell may be dried by any method, and, for example, industrially known spray drying, ventilation drying, lyophilization, vacuum drying and the like can be mentioned in that regard. The dry cell to be used in the present invention can be obtained by subjecting a cell of a microorganism to such treatments. The spray drying, ventilation drying, lyophilization, vacuum drying and the like can be performed under conditions generally known to those of ordinary skill in the art. In the spray drying, for example, the obtained cell is re-suspended at a cell concentration of about 5-25 wt % and dried at a temperature of 100-300° C. In the ventilation drying, for example, the obtained cell is applied in a wet state at a temperature of 100-700° C. In the lyophilization, for example, the obtained cell is re-suspended in water at a cell concentration of about 5-25 wt %, and the suspension is lyophilized. In vacuum drying, for example, the obtained cell is treated in a wet state at a temperature of 50-100° C. in vacuo (e.g., not more than 53 kPa). The above-mentioned conditions are mere examples and are not limitative. In spray drying, ventilation drying and the like, sterilization with heating may be or may not be performed before harvesting. In lyophilization and the like, however, sterilization with heating and the like are performed before harvesting so as to obtain a dead cell. [0017] A dry cell of a microorganism for amino acid fermentation or nucleic acid fermentation can be used as it is as a deodorizing agent or can be formulated with one or more other components into a deodorizing preparation. Additives such as various sugars (e.g., lactose, glucose and the like), polysaccharides (e.g., starch, cellulose and the like), various proteins (e.g., casein and the like), various salts (e.g., calcium carbonate and the like), and the like may be present in the deodorizing preparation. The deodorizing agent or preparation may be in any form and, for example, powder, granule, tablet, capsule and the like can be mentioned in that regard. The deodorizing preparation can be produced by conventional means for formulating-preparations. [0018] The deodorizing agent or preparation can be used as it is or upon mixing with sawdust, zeolite, wood pieces, papers, activated carbon and the like. [0019] As a deodorizing method of using the deodorizing agent of the present invention, the deodorizing agent and an odor substance are brought into contact with each other. [0020] For example, when an odor substance is gaseous and fills a room and the like, the deodorizing agent may be placed in the room. [0021] The amount of the thus prepared deodorizing agent based on the amount of a dry cell itself is preferably about 0.1 to 5 w/v %, when ammonia concentration per space volume is 500 ppm. With this amount of deodorizing agent, the ammonia in a room can be deodorized to an ammonia concentration that barely allows sensing by a person. EXAMPLES [0022] The present invention is explained in more detail in the following Examples, which are not to be construed as limitative. Example 1 [0000] Preparation of Dry Cell from Lysine Fermentation Culture Medium [0023] Lysine fermentation using L-lysine producing bacteria Escherichia coli FERM BP-5252 was performed in the following medium: Glucose 100 g/L, ammonium sulfate 60 g/L, KH 2 PO 4 1 g/L, MgSO 4 .7H 2 O 0.4 g/L, FeSO 4 .7H 2 O 10 mg/L, MnSO 4 .4H 2 O 8.1 mg/L, biotin 300 μg/L, thiamine hydrochloride 200 μg/L, soybean protein acid hydrolysate (total nitrogen content 3.2%) 35 ml/L, L-methionine 200 mg/L, calcium carbonate 50 g/L, pH 7.0. [0024] The L-lysine producing bacterial strain was inoculated to the above-mentioned medium, and cultured at 36° C. for 72 hr. After completion of the lysine fermentation, the fermentation broth was sterilized with heating. The heat sterilization condition was 120° C., 2 minutes. Thereafter, the sterilization liquid was separated by centrifugation into a heavy liquid containing the cell and a light liquid. The obtained cell-containing liquid contains the cell in a proportion of about 4 to 20 wt %. This was further concentrated under reduced pressure to give a cell concentration liquid having a cell content of about 15 to 25 wt %. The obtained cell concentration liquid was spray dried at a hot wind temperature of 150 to 250° C. to give a dry cell having a water content of 2 to 10 wt %. Example 2 [0000] Ammonia Deodorizing Effect of Dry Cell of Lysine Fermentation Microorganism [0025] The dry cell of lysine fermentation microorganism obtained in Example 1 was used. In 3 L bags controlled to have an ammonia gas concentration of 500 ppm were independently placed an activated carbon powder (1 g) and a dry cell of lysine fermentation microorganism (dry lysine cell, 5 g), and the gas concentration in the bags was determined 2, 5, 10, 30 and 60 minutes later by a gas detector. The gas concentration in the bag without deodorizing treatment was also determined. TABLE 1 Lapse of time (min.) Sample 2 5 10 30 60 Dry lysine cell 400 250 140 20 <10 Activated carbon powder 200 170 140 80 60 No addition 500 500 500 480 440 (unit: ppm) Example 3 [0000] Deodorize Effect of Dry Cell of Lysine Fermentation Microorganism on Trimethylamine [0026] The dry cell of lysine fermentation microorganism obtained in Example 1 was used. In 3 L bags controlled to have a trimethylamine gas concentration of 50 ppm were independently placed an activated carbon powder (1 g), and a dry cell of lysine fermentation microorganism (dry lysine cell, 5 g), and the gas concentration in the bags was determined 2, 5, 10, 30 and 60 minutes later by a gas detector. The gas concentration in the bag without deodorizing treatment was also determined. TABLE 2 Lapse of time (min.) Sample 2 5 10 30 60 Dry lysine cell 13 11 4 <1 Not measured Activated carbon powder 7 3 2 1 <1 No addition 50 50 49 49 48 (unit: ppm) Example 4 [0000] Preparation of Dry Cell from Phenylalanine Fermentation Culture Medium [0027] Phenylalanine fermentation using L-phenylalanine fermentation bacteria Brevibacterium lactofermentum FERM BP-4160 was performed in the following medium: Sucrose 2%, potassium phosphate 0.1%, magnesium sulfate 0.04%, ferrous sulfate 0.001%, manganese sulfate 0.01%, ammonium acetate 0.4%, soybean protein acid hydrolysate (as total nitrogen) 0.2%, L-tyrosine 0.04%, biotin 1000 μg/L and vitamin B 1 100 μg/L. [0028] The L-phenylalanine producing bacterial strain was inoculated to the above-mentioned medium, and the cells were cultured at 31° C. for 24 hr. [0029] After the completion of the phenylalanine fermentation, a filter aid was added to the fermentation broth, and the mixture was thereafter separated by a compression type filtration separator into a filtration residue containing the cell and a light liquid. The obtained filtration residue contained the cells in an amount of about 20 to 50 wt %, which was aeration dried with hot air at a temperature of 150 to 600° C. to give a dry cell having a water content of 2 to 10 wt %. Example 5 [0000] Deodorizing Effect of Dry Cell of Phenylalanine Fermentation Microorganism on Ammonia [0030] The dry cell of phenylalanine fermentation microorganism obtained in Example 4 was used. In 3 L bags controlled to have an ammonia gas concentration of 500 ppm were independently placed an activated carbon powder (1 g), and a dry cell of phenylalanine fermentation microorganism (dry phenylalanine cell, 5 g), and the gas concentration in the bags was determined 2, 5, 10, 30 and 60 minutes later by a gas detector. The gas concentration in the bag without deodorizing treatment was also determined. TABLE 3 Lapse of time (min.) Sample 2 5 10 30 60 Dry phenylalanine cell 90 60 30 10 <10 Activated carbon powder 100 80 60 30 20 No addition 500 500 500 480 480 (unit: ppm) Example 6 [0000] Preparation of Dry Cell from Phenylalanine Fermentation Culture Medium [0031] Phenylalanine fermentation using L-phenylalanine fermentation bacteria Bacillus subtilis FERM BP-609 was performed in the following medium: Glucose 2%, potassium phosphate 0.1%, magnesium sulfate 0.04%, ferrous sulfate 0.002%, manganese sulfate 0.002%, soybean protein acid hydrolysate (as total nitrogen) 0.2%, L-tyrosine 0.02%, L-tryptophan 0.02%. [0032] The L-phenylalanine producing bacterial strain was inoculated to the above-mentioned medium, and the cells were cultured at 30° C. for 24 hr. After the completion of the phenylalanine fermentation, a filter aid was added to the fermentation broth, and the mixture was thereafter separated by a compression type filtration separator into a filtration residue containing the cell and a light liquid. The obtained filtration residue contained the cells in an amount of about 20 to 50 wt %, which was aeration dried with hot air at a temperature of 150 to 600° C. to give a dry cell having a water content of 2 to 10 wt %. Example 7 [0000] Deodorizing Effect of Dry Cell of Phenylalanine Fermentation Microorganism on Acetic Acid [0033] The dry cell of phenylalanine fermentation microorganism obtained in Example 6 was used. In 3 L bags controlled to have an acetic acid gas concentration of 50 ppm were independently placed an activated carbon powder (1 g), and a dry cell of phenylalanine fermentation microorganism (dry phenylalanine cell, 5 g), and the gas concentration in the bags was determined 2, 5, 10, 30 and 60 minutes later by a gas detector. The gas concentration in the bag without deodorizing treatment was also determined. TABLE 4 Lapse of time (min.) Sample 2 5 10 30 60 Dry phenylalanine 6 5 3 2 1 cell Activated carbon 1 <1 Not Not Not powder measured measured measured No addition 51 50 50 50 40 (unit: ppm) Example 8 [0000] Comparison of Deodorizing Effect of Dry Cells of Lysine Fermentation Microorganism and Yeast on Ammonia [0034] The dry cell of lysine fermentation microorganism obtained in Example 1 was used. As a control for comparison, a dry cell of yeast (dry beer yeast manufactured by KIRIN BREWERY CO., LTD.) was used. In 3 L bags controlled to have an ammonia gas concentration of 500 ppm were independently placed an activated carbon powder (1 g), dry yeast cell (5 g) and a dry cell of lysine fermentation microorganism (dry phenylalanine cell, 5 g), and the gas concentration in the bags was determined 2, 5, 10, 30 and 60 minutes later by a gas detector. The gas concentration in the bag without deodorizing treatment was also determined. TABLE 5 Lapse of time (min.) Sample 2 5 10 30 60 Dry lysine cell 20 <10 Not Not Not measured measured measured Dry yeast cell 120 100 40 <10 Not measured Activated carbon 200 170 140 80 60 powder No addition 500 500 500 480 440 (unit: ppm) Example 9 [0000] Deodorizing Effect of Dry Cell of Lysine Fermentation Microorganism on Ammonia in Broiler Dropping [0035] The dry cell of lysine fermentation microorganism obtained in Example 1 was used. Broiler litter (chaff) (250 g) was mixed with 1% lysine fermentation cell and 3% of zeolite (commercially available), respectively, and the mixture was mixed well with 750 g of broiler dropping. The gas concentration was determined 4, 6, 8 and 10 days later by a gas detector. The gas concentration in the bag without deodorizing treatment was also determined. TABLE 6 Lapse of time (min.) Sample 4 6 8 10 Dry lysine cell 5 17 130 260 Zeolite 11 43 189 305 No addition 5 60 254 396 (unit: ppm) [0036] From the above-mentioned Examples 2, 3, 5, 7, 8 and 9, it has been confirmed that, by contacting amino acid fermentation or nucleic acid fermentation cells with an offensive odor substance, the concentration of the offensive odor substance was reduced, thus demonstrating a deodorizing effect. [0037] While the reason for the deodorizing effect of a dried cell of a particular bacterium on an offensive odor substance is not clear, it is postulated that a dried cell surface is charged by drying the cell, and then becomes electrically bonded to the charged offensive odor substance. On the other hand, cells are aggregated by drying, forming micropores in the cake (lump), as a result of which a deodorizing effect is achieved based on physical adsorption, like activated carbon and the like. Consequently, the dried cell electrically and physically adsorbs the offensive odor substance, and therefore, the deodorizing agent of the present invention exhibits a remarkable effect as compared to activated carbon. [0038] From the above results, the deodorizing effect is considered to be achieved by drying an amino acid or nucleic acid fermentation cell irrespective of the drying method. [0039] According to the deodorizing agent and the deodorizing method of the present invention, particularly an offensive odor caused by excreta etc. produced during the breeding of domestic animals and indoor breeding of pet animals such as dogs, cats, and the like can be effectively deodorized. Since the amino acid and nucleic acid fermentation cells after deodorizing are organic materials, they can be beneficially burned or reused as a fertilizer and the like. [0040] While some of the embodiments of the present invention have been described in detail in the above, it will, however, be evident for those of ordinary skill in the art that various modifications and changes may be made to the particular embodiments shown without substantially departing from the novel teaching and advantages of the present invention. Such modifications and changes are encompassed in the spirit and scope of the present invention as set forth in the appended claims. [0041] This application is based on a patent application No. 004839/2004 filed on Jan. 9, 2004 in Japan, the contents of which are hereby incorporated by reference.

The present invention provides a deodorizing agent and a deodorizing method capable of effectively deodorizing an offensive odor substance caused by, for example, animal excreta. The deodorizing agent and method utilize a dry cell of a microorganism selected from the group consisting of bacteria belonging to the genus Escherichia , bacteria belonging to the genus Brevibacterium , and bacteria belonging to the genus Bacillus , as an active ingredient.

BACKGROUND OF THE INVENTION This invention relates generally to knot tying mechanisms, and specifically to a knotter for use in crop baling machines. In conventional crop balers, hay, straw and similar crop material that has been previously cut, windrowed or swathed, is picked up from the ground by a pickup and fed in successive batches or charges into an elongated bale chamber in timed sequence with a reciprocating plunger. The plunger compresses the material into bales and, at the same time, gradually advances the bales toward the outlet of the bale chamber. As the bales reach a predetermined length as controlled by a metering device, a bale tying mechanism is actuated which wraps cord, twine or other flexible tying material around the bale and secures the ends of the material together. Typically, a knotter is mounted on the bale chamber adjacent a slot therein, the knotter including a twine holder, a rotatable billhook, and various other component parts which interact to form a knot in the twine portions. During the baling operation, the leading strand of the twine is held by the twine holder and extends forwardly across a twine retainer finger and a billhook and then in front of the bale. The twine retainer finger supports the strand so that it does not bear forcefully against the billhook. A needle is involved in completing the encirclement of twine around the bale and, when advancing, the needle lays a trailing strand across the twine retainer finger, billhook and twine holder. A twine finger captures these strands of twine and positively positions the strands against the heel of the billhook. Thus, there are presented in a certain zone a pair of twine portions or strands lying alongside each other and these portions are twisted into a bight by the billhook and a portion thereof is pulled through the bight to form a double overhand knot. On completion of the operation of the knotter, the twine finger returns to the initial position. The removal of the tied knot from the billhook involves mechanical stripping by a movable member which normally embodies a knife operable to cut the twine from the twine supply so that the tied bale is complete in itself. The tying mechanism thus includes several components working in a precisely timed relationship so that theoretically the mechanism ties one knot for each bale and prepares the twine for the succeeding bale. Those of skill in the art will generally agree that the knotter is one of the most complex components of a baler, and, therefore, one of the most difficult to understand and maintain. A great deal of research and experimentation has been, and still is on a continuing basis, undertaken by individuals and corporations in an effort to improve knotters and reduce their sensitivity. Examples of these efforts abound in the prior art. Recently, a novel knotter has been developed which exhibits exceptional structural simplicity and highly reliable operational characteristics. This new knotter is disclosed in co-pending Patent Application Ser. No. 916,313. The instant application is directed to improvements in the above-identified knot tying mechanism which substantially advance its performance characteristics. In particular, the knotter disclosed in the 916,313 application includes a planar twine disc declined relative to the twine being presented to the twine-gripping area of the disc by the needle. This angle of twine presentation contributed to an incidence of mistie which, though acceptable, was not within a preferable range. SUMMARY OF THE INVENTION It is an object of the instant invention to provide a knotter having an improved twine disc attitude relative to the twine being presented to the twine-gripping area by a baler needle. It is another object of the invention to provide a knotter with a twine disc rotatable about a central fixed hub with a billhook shaft extending through the fixed hub and operably engaged therewith so that rotation of said billhook shaft causes a corresponding rotation of said twine disc. It is another object of the instant invention to provide a knot tying mechanism which is more compact than that heretofore known. It is a further object of the instant invention to provide a knot tying mechanism which is less susceptible to malfunction due to crop particle accumulation. It is a still further object of the instant invention to provide a knot tying mechanism wherein the billhook shaft extends through the fixed hub of a rotatable twine disc at an angle relative to the plane of the twine disc. It is an even still further object of the instant invention to provide a knot tying mechanism for a crop baler which has improved operational characteristics due to the positional relationship between the twine holding area of the twine disc and the billhook. These and other objects are attained according to the instant invention by providing a knot tying mechanism with improved operational capabilities. A twine disc rotatably mounted about a central fixed hub is angularly arranged to position the twine-gripping area for better acceptance of twine from the needle and thereby reduce the incidence of misties due to inadequate gripping. A billhook shaft extends through the fixed hub to properly support the billhook adjacent the twine-gripping area, and to transmit rotational power from the shaft to the twine disc. BRIEF DESCRIPTION OF THE DRAWINGS The advantages of this invention will become apparent upon consideration of the following detailed disclosure of the invention, especially when it is taken in conjunction with the accompanying drawings wherein: FIG. 1 is a schematic top plan view of a crop baler equipped with a pair of knotters according to the instant invention; FIG. 2 is a schematic sectional view of the bale chamber and associated parts of the baler of FIG. 1; FIG. 3 is a schematic sectional view of one knotter according to the instant invention; FIG. 4 is a plan view of the knotter of FIG. 3 taken along lines 4--4 thereof; FIG. 5 is a top plan view of the knotter of FIG. 3 taken along lines 5--5 thereof. FIG. 6 is a schematic view of the drive means for the pair of knotters shown in FIG. 1; FIG. 7 is a schematic sectional view of the drive means of FIG. 6, taken along lines 7--7; FIG. 8 is a cross sectional view of the billhook and shaft taken along lines 8--8 of FIG. 9; FIG. 9 is a bottom axial view of the billhook; FIG. 10 is a side elevational view of the movable jaw of the billhook; FIG. 11 is a plan view of the movable jaw of the billhook; FIG. 12 is a top plan view of the twine retainer fingers of the knotter mechanisms; FIG. 13 is a side elevational view of the twine retainer fingers of FIG. 12, taken along lines 13--13; FIG. 14 is a top plan view of the twine disc and twine retainer fingers of the knotter of the instant invention; FIG. 15 is a sectional view of the twine disc and twine retainer fingers taken along lines 15--15 of FIG. 14; FIG. 16 is a top plan view of the support frame of the knotter; FIG. 17 is a side elevational view of the support frame of FIG. 16; FIG. 18 is a schematic representation of the knotter hub in position relative to the twine disc and support frame; FIG. 19 is a top plan view of the hub, taken along lines 19--19 of FIG. 18; FIGS. 20 through 30 schematically illustrate the billhook as it progresses through the successive angular operating positions in the formation of a knot (i.e. at 0 degrees, 90 degrees, 180 degrees, 270 degrees, 360 degrees, 450 degrees, 540 degrees, 630 degrees and 720 degrees, respectively); FIG. 31 is a diagram illustrating the knotter drive; and FIG. 32 shows schematically a knot formed with the knotter of the instant invention. DESCRIPTION OF THE PREFERRED EMBODIMENT A typical agricultural baler, generally designated 10, is shown in FIGS. 1 and 2 to include a wheel supported chassis upon which are mounted a pickup mechanism 11, a feeder mechanism 12 and a bale chamber 13. As cut crop material is picked up from the ground, it is fed in successive batches or charges into the inlet of the bale chamber 13 and the batches of material are compressed into bales 14 by a reciprocating plunger 16 which also advances the bales along the chamber 13 toward an outlet 17 in the direction of arrow 18. As can perhaps best be seen in FIG. 2, a primary portion or length 20 of twine or flexible material 21 extends across a bale chamber 13 in the path of the leading end of each bale 14 from a supply reel or container 22 and passes through the eye of a needle 23 with the primary portion 20 of the twine 21 being held in a knotter 24 mounted on a top wall of the bale chamber 13. The baler carries a pair of identical knotters 24 and each knotter is arranged to cooperate with a needle 23 whereby a pair of needles also has to be provided. A main drive shaft 30 (FIGS 2, 6 and 7) is rotatably journalled in support 31 on the upper wall of the bale chamber 13 at a distance thereabove and transversely of the baling chamber 13. This main drive shaft 30 is intermittently actuated by a conventional trip mechanism 32 which includes a starwheel 33 arranged to engage the bale of hay or other material as it is being formed, whereby it is rotated about a shaft 34 as the bale 14 moves along chamber 13. The shaft 34 is operatively coupled to a trip lever 36 which itself is connected to a clutch mechanism 37 mounted on the main shaft 30. One half of the clutch mechanism 37 is driven continuously through a chain or sprocket drive transmission from an intermediate shaft on the baler, only a sprocket 38 thereof being shown in FIGS. 2 and 6. The diameter of the starwheel 33 and the transmission ratio between the shaft 34 and the trip lever 36 are such as to allow the formation of a bale of predetermined length before the trip mechanism actuates the clutch mechanism 37, whereupon the main shaft 30 is driven to initiate the tying of a knot by each knotter. The main shaft 30 has a crank arm 39 attached thereto at its end opposite to the clutch mechanism 37, the arm 39 being connected by a pitman or link 40 to a needle frame 41 which carries the pair of needles 23 (FIG. 2). The needle frame 41 is pivotally mounted on the bale chamber 13 by bearings 42. The bale chamber 13 has a pair of longitudinal slots in its lower wall for accommodating the needles 23 when pivoted to their full throw position. No further elaboration will be given concerning the structural details of the trip mechanism 32 and the needle frame and drive mechanism as these details are sufficiently well known in the art. Operatively, upon actuation of the clutch mechanism 37, the main shaft 30 is driven, and the needles 23 move from the rest position (indicated by full lines in FIG. 2) to their full throw position (shown partially in phantom lines in FIG. 2) to wrap the respective lines 21 around the bottom and trailing end of the bale 14 and place the secondary portions 43 of the twines 21 in the respective knotters 24. Each twine 21 loops back over the needle 23 to the reel 22 in the full throw position, thereby leaving a new primary portion or length of twine 21 across the path of the next bale to be formed. As each needle 23 returns to its rest position, the ends of each primary and secondary portion, 20 and 43, are twisted and tied together by the knotter 24, with a secondary portion 43 being severed during the tying operation. The entire knotting or tying operation takes place between successive strokes of the baler plunger 16. The main shaft 30 also has attached thereto a single conical gear segment 50 having teeth 51 over only about 1/3 of its circumference. The gear teeth 51 are arranged to mesh with the teeth of a conical gear 52 which is mounted on one end of a stub shaft 53 on the other end of which is mounted a sprocket 54. The shaft 53 is journalled in a support 56. A chain 57 engages the sprocket 54 and sprockets 58 and 59 of the respective knotters 24. As already stated, the two knotters 24 are identical and, therefore, only one will be described in further detail in relation to the associated needle 23 and other components. By way of general introduction to the knotter structure, attention is directed to the cross sectional view of FIG. 3 where the basic component parts, and their interrelationships can be seen. Each knotter 24 is mounted to the top wall of the bale case 13 adjacent an elongate aperture 60 slightly rearwardly of twine guide rollers 61 (see FIGS. 3 and 4). The knotter includes a base or a support frame 62, a generally circular twine disc 63 rotatably mounted by a central hub 64 fixed to support frame 62, a billhook 66 including elongate shaft 115 extending angularly through, and rotatably supported by, hub 64, and a worm gear 67 fixed to the billhook shaft in meshing engagement with internal gear teeth 97 on twine disc 63. As mentioned above, and clearly seen in FIG. 3, for example, the twine disc 63 is maintained at an angle θ 1 relative to the bale case 13. Though further discussion will be given below, it should be appreciated at this time that θ 1 is an acute angle and allows for a better placement of the twine in the twine-gripping area of the twine disc by the needle 23. Also, as can be seen in FIG. 3, the billhook shaft 115 is positioned at angle θ 2 relative to the twine disc 63. The angular relationship between the shaft 115 and the twine disc permits the billhook 66 to be situated properly for the knot tying operation. Following is a more detailed description of the structural configuration of the knotter 24 and the important interrelationships among the parts. The support frame 62 (generally seen in FIGS. 3, 4 and 5, and more specifically in FIGS. 16, 17 and 18) includes a generally horizontal bottom plate 70 which is adapted to be removably affixed to the top wall of bale chamber 13. A twine disc support plate 71 is attached to bottom plate 70 at an angle relative to the plane thereof equal to angle θ 1 . A cylindrical bearing sleeve 72 is also supported by the bottom plate 70, adjacent support plate 71. As can be seen best in FIG. 16, support plate 71 has a recess 73 cut therein adjacent bearing sleeve 72 to provide operational clearance for the worm gear 67. A plurality of apertures are provided in the bottom plate 70 (not numbered) for the convenient attachment thereof to the bale case 13. Also, as can be perhaps best seen in FIG. 16, threaded apertures 74 and 76 are provided in the support plate 71 for the attachment of hub 64. It should be readily realized by one of skill in the art that the support frame 62 may be constructed of individual elements, or cast as a single unitary structure, or any combination thereof. Referring now to FIGS. 3, 4 and 5 generally, and 14 and 15 specifically, the twine disc 63 itself comprises a unitary structure with three generally circular flanges or discs 80, 81 and 82 which are laterally spaced one above the other in such a manner as to define respective slots or grooves 83 and 84 (FIG. 15). The flanges 80, 81 and 82 are generally circular in shape and of the same size, and each flange has at its periphery six equispaced notches 86. The notches 86 are generally rectangular in shape and of a depth which is substantially smaller than the difference between the radius of the flanges 80, 81 and 82 and a radius of the central opening 87. Thus, the grooves 83 and 84 still have an effective depth even at the location of the notches 87. The leading and trailing edges 88 and 89, with respect to the direction of rotation 90, of each notch 86 are directed generally radially of the twine flanges 80, 81 and 82 with the outer end of the leading edge 88 cut away to allow the twine readily to enter the notch. Adjacent notches 86 and the three flanges 80, 81 and 82 are slightly offset relative to each other so that the notches 86 in one flange are slightly in advance (with respect to the direction of rotation 90) of the corresponding notches 86 in the flange immediately above. Thus, associated notches 86 in the flanges 80, 81 and 82 define grooves 91 through 96 (FIGS. 5 and 14) which are inclined rearwardly with respect to the direction of rotation 90 at an angle of about 60 degrees relative to the planes of the flanges. All edges of the twine holder flanges 80, 81 and 82 are rounded so as to avoid inadvertent cutting of the twine during operation. As can be clearly seen in FIGS. 3, 14 and 15, the twine disc 63 is formed with a central opening 87. On the bottom portion thereof, around the interior periphery thereof, are a continuous series of gear teeth 97. These teeth are of uniform size and, as will be seen below, are adapted to intermesh with the worm gear 67 on the billhook shaft. Also, it should be noted in FIG. 15 that the twine disc 63 includes a circular step 99 on the internal portion of flange 80. In the assembled knotter, as seen in FIG. 3, the step 99 is engaged by retainer ring 108 on hub 64 to hold the twine disc 63 in position. Attention is now directed generally to FIGS. 3 and 5, and specifically to FIGS. 18 and 19 for a description of the hub 64. A semi-circular block member 100 is formed with an upper substantially annular retaining ring 108 which protrudes beyond the normal periphery of the block member, and a lower substantially annular recess 109 which is of sufficient depth and height to allow clearance for the teeth 97 on the rotatable twine disc 63. A recess slot 103 is formed along one edge of the block member 100 to permit clearance, in the assembled knotter, for the billhook shaft and worm gear. An arm 101 is affixed to the upper surface of the block member and extends angularly away therefrom to support bearing sleeve 102. A brief view of FIG. 3 shows that the relationship between the bearing sleeve 102, bearing sleeve 72 on support frame 62 and the billhook shaft 115 is such that the alignment shown in FIG. 3 is maintained. A pair of orifices 104 and 105 are formed through the block member 100 and are adapted to receive bolts 106 and 107, respectively (see FIGS. 3 and 5), for holding the hub in a fixed position relative to support frame 62. Thus, it can be seen that the hub 64 is affixed solidly to the support frame 62 in such a manner as to prevent the twine disc 63 from undergoing any lateral or vertical movement, yet permitting free rotation thereof. The knotter further includes a billhook 66 with which is associated a hollow billhook shaft 115 (best seen in FIGS. 3 and 8) rotatably journalled in sleeve sections 116 and 117 of the respective bearing sleeves 72 and 102. The billhook shaft 115 supports at one end the associated driving sprocket 59. The billhook 66 comprises a fixed jaw 118 positioned at about 90 degrees relative to the axis of the billhook shaft 115 opposite to the sprocket 59. The fixed jaw 118 has an elongated body 119 which is wider than it is thick as seen in FIGS. 8 and 9. The transition between the shaft 115 and the jaw body 119 comprises smoothly curved and rounded surfaces 120, thus avoiding any sharp edges which might sever the twine. The fixed jaw 118 has a bent tip portion 121. The transition between the body 119 and the tip portion 121 also comprises smoothly curved and rounded surfaces 122. At the side facing the billhook shaft 115, and adjacent the tip portion 121, the fixed jaw comprises a recess or notch 123 arranged for receiving a crochet hook 124 on movable jaw 126 of the billhook 66 (see FIGS. 10 and 11). At the junction of the fixed jaw 118 and the billhook shaft 115, the fixed jaw is provided with an elongated slot 127 through which the movable jaw 126 extends and in which it is pivotally mounted by a pivot pin 128. The movable jaw 126 has at one end a heel portion 129 which acts as a cam follower with respect to the roller cam 132 (see FIGS. 3 and 4) as the billhook shaft 115 is rotated. The heel portion 129 is generally rectangular as seen in FIG. 11 with its operative, cam follower surface 132 being convex as seen in FIG. 10. The heel portion 129 is smoothly integrated with the remainder of the movable jaw 126. The movable jaw 126 further comprises a curved portion 133 which serves as a twine guiding surface and which extends from the heel portion 129 to approximately midway along the jaw, i.e., to the point where the movable jaw 126 extends through the slot 127 in the fixed jaw 118. On the side facing the fixed jaw 118, the movable jaw 126 has a transition surface 134 between the curved portion 133 and the crochet hook 124. The crochet hook 124 on the movable jaw 126 and the notch or recess 123 in the fixed jaw 118 cooperate to grip, and hence maintain, the twine when the latter is positioned between the open jaws and the movable jaw 126 has been moved to its closed position. The movable jaw 126 has a tip portion 136 extending in a similar manner to the tip portion 121 of the fixed jaw 118. Furthermore, the central portion of the jaw 126 includes, on the opposite side to the fixed jaw 118, a shoulder 137 for preventing the entrapment of a section of twine between the movable jaw 126 and the slot 127 through a central portion of the fixed jaw 118 which would interfere with the proper operation of the billhook 66 in tying a knot, or prevent the release of a tied knot from the billhook. The movable jaw 126 further includes a recess or notch, 138 in the opposite side to the fixed jaw 118 at a location slightly offset relative to the pivot 128. A mechanism for spring loading the movable jaw 126 is provided inside the hollow billhook shaft 115 whereby the jaw is urged to the closed position. Referring to FIG. 3, the mechanism comprises an adjustable screw-threaded stop member 141, a compression spring 142 abutting at one end the adjustable stop member 141 and at the other end an abutment member 143 engaging a retainer pin 144. The retainer pin 144 comprises an elongate stem 146 extending coaxially with the billhook shaft 115 and an angled end 147 adapted for engagement with the notch or recess 138 in the movable jaw 126. The billhook shaft 115 carries intermediate the sleeve sections 116 and 117 a worm gear 67 with a single spiral tooth for driving the twine disc 63. Bearing sleeves 72 and 102 are so arranged so to maintain the worm gear 67 in driving engagement with teeth 97 on the internal periphery of twine disc 63. With the worm gear fixed in position on shaft 115, it can be seen that rotation of sprocket 59 causes a fixed rotational response in the twine disc 63. The fixed transmission ratio between the billhook shaft 115 and the twine disc 63 is 12/1 and the various components are arranged so that the shaft and discs rotate in the same direction. As best seen in FIGS. 3, 4 and 5, a further support member 150 is provided on base 62 with a pivot 151 at one side of the twine disc 63 for pivotally mounting a pair of twine retaining fingers 152 and 153, which are integrally connected at one end. The twine finger mechanism is shown in detail in FIGS. 12 and 13. The fingers 152 and 153 extend from the pivot 151 in a transverse direction across the twine disc 63 and extend in part into the grooves 83 and 84, respectively. Each finger 152 and 153 has a curved edge 154 opposite the pivot which edge acts as a twine guide, assisting in the positioning of the secondary portion 43 of the twine in the groove 91 as seen in FIG. 5. The edge 154 partly defines a generally hooked end 156 of the finger which, at least in the upper finger 152, as shown in FIGS. 12 and 13, has a straight edge 157 which also acts as a twine guide. The edges of the fingers 152 and 153 facing towards twine disc 63 and extending between the flanges thereof each comprise a flat section 158 and a curved section 159, separated by a curved section 160 of a smaller radius than section 159. The fingers 152 and 153 are resiliently urged into grooves 83 and 84 by a leaf spring 161 (see FIGS. 3, 4 and 5). The leaf spring 161 is secured at one end adjacent the pivot 151 to the upturned edge of support member 150 and extends in the direction of the fingers and contacts the same between ears 162 and 163 adjacent edge 154 of the twine fingers. An adjustable screw 164 (see FIG. 5), mounted on support member 150, contacts leaf spring 161 intermediate its ends to provide adjustment of the pressure exerted by the spring on the fingers 152 and 153. Projecting from support member 150 in a rearward direction and closely adjacent the underside of flange 82 of twine disc 63 is a knife blade 166 (best seen in FIGS. 3, 5 and 16) having a cutting edge facing in a direction opposite to the direction of rotation 90 of the twine disc 63. The knife blade 166 is adjustably and releasably mounted to facilitate adjustment and either sharpening or replacement should this become necessary. A first stationary twine guide 170 (see FIGS. 4 and 5) is affixed to support frame 62 adjacent a side of the twine disc 63. Twine guide 170 includes a pair of parallel spaced apart plates 171 and 172 which extend partially into the grooves 83 and 84, respectively, of twine disc 63 and terminate forwardly in guide edges 173 and 174. A curved guide extension 176 is affixed to the twine guide 170 and directed forwardly and away from the knotter mechanism. Guide extension 176 and guide edges 173 and 174 cooperate to direct twine inwardly toward a twine gripping area, best seen in FIG. 5, defined by groove 91 and the twine retaining fingers 152 and 153. Guide 170 terminates rearwardly in a pair of spaced apart twine disc cleaners 177 and 178 which extend into the grooves 83 and 84 respectively to remove any material therein and direct it away from the knot tying mechanism. Projecting from the upturned edge of support member 150 in a rearwardly direction partially above the twine disc 63 is a second stationary twine guide 180. This second twine guide 180 comprises a guide surface 181 operable to guide twine towards the twine gripping area of groove 91. Having thus described the components of the knotter constructed in accordance with the invention, the operation thereof will now be described in greater detail with reference to FIGS. 20 through 31. The sequence of operation of the mechanism will be described with reference to FIG. 31 illustrating the various characterizing angular positions of main shaft 30. During operation, the baler is moved across a field and crop material, such as hay, to be baled is picked up from the ground with the pickup mechanism 11 and is delivered thereby to the feeder mechanism 12 which in turn feeds the crop material in successive batches or charges into the bale chamber 13 in timed sequence with the reciprocating baler plunger 16. The plunger 16 compresses the crop material into a bale 14 and at the same time gradually advances the bale towards the outlet 17 of the baling chamber in the direction of arrow 18. As long as the clutch mechanism 37 is not actuated, all components of the knotters 24 are in their rest position. This means that needles 23 are in their lowermost dwell position as shown in full lines in FIG. 2, while the billhook 66 projects downwardly as seen in FIG. 4. As already mentioned, a primary portion 20 of twine 21 extends from a supply reel 22 across the bale chamber 13 in the path of the leading end of the bale 14 being formed and passes through the eye of the needle 23, with the free end of the primary portion being supported in the twine disc 63 of the associated knotter 23, bearing in mind that two knotters are employed, whereby each bale 14 is bound by two pieces of twine. The free end of the primary portion 20 of the twine 21 is received in a groove 92 of the twine disc 63 and passes across the top of the twine disc 63 and down into the next groove 91 (arising from the knotting operation in relation to the previous bale) and is firmly held in position by the retainer fingers 152 and 153 in cooperation with the flanges 80, 81 and 82. As a bale 14 is being formed and moved along the bale chamber 13, the star wheel 33 is rotated thereby and as the bale reaches a predetermined length, the metering wheel 33 actuates the clutch mechanism 37, whereupon the main shaft 30 is rotated through 360 degrees by the chain and sprocket drive mechanism. During the first 180 degrees of rotation of the shaft 30 (referenced by number 186 in FIG. 31) the crank arm 39, the pitman 40 and the needle frame 41 are pivoted whereby the needles 23 move from their lowermost rest position, when the main shaft 30 is at point 187 in FIG. 31, to their highest, full throw, positions (phantom lines in FIG. 2) when the main shaft 30 is at reference 188. Simultaneously, as is known in the art, the baler plunger 16 is moving towards its extreme material compressing position. The needles 23 move upwardly through the baling chamber 13 and through slots (not shown) in the face of the plunger 16, whereby the plunger holds the crop material to be baled away from the needles 23 but enabling a smooth and unobstructed passage of the needles 23 through the bale chamber 13 and preventing bending and/or breakage of the needles 23. During the next 180 degrees of rotation (referenced 189 in FIG. 31) of the main shaft 30, the needles 23 are retracted and returned to their rest or dwell positions at reference 187 of the main shaft 30. At the same time, the plunger 16 is retracted. During the initial movement (reference 190 in FIG. 31) over 120 degrees of the main shaft 30 feed teeth 51 of the gear segment 50 are not in mesh with the teeth of the conical gear 52, whereby the actual knotting mechanism is not operated. During the initial movement 190 of the shaft 30, each needle 23 carries the end of the secondary twine portion 43 of the twine 21 from the position shown in full lines in FIG. 2 around the bottom and trailing end of the bale 14 to the position shown in phantom lines in FIG. 2. At the position 191 of the main shaft 30, the tip of each needle 23 projects through the aperture 60 in the bale chamber top wall and at a location generally forwardly of the associated knotter 24 and slightly offset to the left relative to the billhook 66 thereof and relative to the center of the twine disc 63. At that moment, the needle 23 places the end of the secondary twine portion 43 in the groove 91 positioned above and slightly rearwardly of the billhook 66 and adjacent the primary end portion 20 already positioned therein. At that moment, the secondary twine portion 43 is substantially perpendicular to the plane of the twine disc 63 within groove 91 at the apex of the V defined by the stationary guide members 170 and 180. Hence, the twine portion 43 is readily located in the groove 91. The end of the secondary twine portion 43 is held against the trailing edge 89 of the notches 86 while the end of the primary portion 20 is held against the leading edge 88 thereof. The guide edge 181 of stationary guide 180, guide extension 176 and guide edges 173 and 174 of stationary guide 170, and edges 154 of twine retainer fingers 152 and 153 thus cooperate with the edges of the twine disc flanges 80, 81 and 82 in guiding the end of the secondary twine portion 43 into the appropriate position in groove 91. Gear segment 50 meshes with the conical gear 52 at the position 191 of the main shaft 30, whereby the billhook shaft 115 and the twine disc 63 start rotating in the proper direction. The transmission ratios are such that for a 60 degree rotation of the main shaft 30, the billhook shaft 115 is rotated through 360 degrees and the twine disc 63 is rotated through only 30 degrees. As the twine disc 63 is rotated over said 30 degrees in the direction 90, the ends of the primary and secondary twine portions 20 and 43 held in the groove 91 are caused to move in the same direction and towards the twine retainer fingers 152 and 153. The guide edges 157 on the twine retainer fingers wedge the twine portions between ssaid fingers and the flanges 80, 81 and 82. After no more than 15 degrees of rotation of the twine disc 63, the end of the twine portions 20 and 43 are strongly caught and held between the fingers and the flanges and only can slide therebetween under a substantial load. This firm grasp on the two portions of twine is held over about 30 degrees of rotation of the twine disc 63, i.e., until the main shaft 30 has reached the position 192. Thereafter, the ends of the twine portions 20 and 43 are moved between the sections 160 of the retainer fingers and the flanges which increases the area of contact between the various components and the twine so that the grasp on these ends is further increased to the extent that the ends can no longer slide between the components. The free end of the primary twine portion 20, which initially was held between the flanges and the sections 160 on the twine fingers, moves past the sections 160 substantially at the same moment as the ends of the twine portions 20 and 43 moved between the flanges and the twine retainer fingers at the location of the hooked ends 156 of the fingers. As the twine holder 63 is rotated over the first 30 degrees of its movement, i.e., when the main shaft 30 is rotated from the position 191 to the position 188, the billhook shaft 115 is rotated over a first full cycle of 360 degrees. The primary twine portion 20 extends, as shown in FIG. 3, between the groove 91 and the twine retaining edge or roller 61 of the aperture 60 and the bale chamber top wall when the main shaft 30 is in the position 191. At the same time, the secondary twine portion 43 extends between the same groove 91 and a further forwardly positioned lower point, which normally is defined by the trailing end of the bale of crop material in the bale chamber 13. Thus, both twine portions 20 and 43 normally have a slightly different position when the main shaft is in the position 191. During the first 90 degrees rotation of the billhook shaft 115, the billhook 66 engages both twine portions 20 and 43 from below and from the right (FIG. 20) and causes them to slide from the tip 121 of the fixed jaw 118 towards the base thereof over the forward surface 196 (FIG. 21), thus the twine portions are urged to move in front of the billhook 66. During the next 90 degree rotation of the billhook shaft 115 (90-180 degree movement), the twine portions 20 and 43 slide further towards and arrive at, the base or heel of the billhook 66 so that said strands are now positioned rearwardly of the billhook 66 and engage the rear edge 197 of the movable jaw 126 (FIG. 22). The twine portions 20 and 43 are maintained behind the billhook 66 during its movement from the 90 degree position to the 180 degree position by the notches 86 forming the groove 91 in which the portions are located which are still positioned rearwardly of the billhook, thus holding the twine portions 20 and 43 in a substantially rearwardly and upwardly inclined position and at an angle relative to the billhook 66. The heel portion 132 of the movable jaw 126 engages the roller cam 131 during the latter part of the rotational movement of the billhook shaft 115 from the 90 degree to the 180 degree position. This causes the movable jaw 126 to open against the resilient force of the spring 142 but this does not result in the ends of the twine portions 20 and 43 being caught between the jaws as is usual at this stage in conventional knotters. This is because the upper parts of the twine portions 20 and 43 are positioned rearwardly of the opened jaw 126 as already explained. The opening of jaws 118 and 126 at this stage does serve a useful purpose, however, in that the movable jaw 126 positively urges the upper parts of the said twine portions into the relative groove 91 which is now positioned adjacent the billhook 66 and towards the base thereof. This is especially so during the continued movement of the billhook 66 beyond the 180 degree position. Thus, during the first cycle the billhook 66 positively assists in properly positioning the twine portions 20 and 43 relative to the twine disc 63 by positioning them about the billhook so that they can be held in the disc in a desired manner. Continued rotation of the billhook shaft 115 from the 180 degree position to the 270 degree position causes both twine portions 20 and 43 to slide over the rear edge 197 of the movable jaw 126 in the direction of the pivot pin 128 and the shoulder 137 (FIGS. 10 and 23). Both twine portions 20 and 43 are now held behind the billhook 66 at the right-hand side thereof. Simultaneously, the movable jaw 126 is again closed under the resilient pressure of spring 142 as soon as the heel portion 132 disengages the roller cam 131. Continued rotation of the billhook shaft 115 from the 270 degree position to the 360 degree position causes the twine portions 20 and 43 further to slide along the billhook 66 so as to engage the shoulder 137 of the movable jaw 126 (FIG. 24). Thus, on completion of the first cycle (360 degrees) of the billhook 66 both twine portions 20 and 43 extend from above the billhook along the right-hand side of the base thereof, behind the rear edge 197 of the movable jaw 126, and over the leading edge of surface 119 of the fixed jaw 118. The lower strands portions project in a forwardly inclined direction over the respective tip portions 121 and 136 of the jaws 118 and 126. This enables the billhook 66, upon continued rotation beyond the 360 degree position, (i.e. during its second cycle) to catch again both twine portions 20 and 43 from below and from the rear thereof as seen in FIG. 24. The billhook 66 is thus operated during its first full cycle of 360 degrees (movement of the main shaft 30 from the position 191 to the position 188) to bring the twine portions 20 and 43 closely parallel and adjacent to each other so that they are in the best possible condition for a knot to be tied during the next cycle of the billhook 66. At the end of the first cycle of the billhook 66, each needle 23 has reached its full throw position and is at the point of returning to its fully retracted or dwell position. The needles 23 reach their dwell position when the main shaft 30 returns to its position 187. During this movement, each needle 23 carries a further portion of twine 198 down the trailing end of the formed bale and this twine portion 198 becomes the primary twine portion for the next bale to be formed. When the main shaft 30 has reached the position 199, the gear segment 50 passes beyond the conical gear 52, whereby drive to the knotters 24 is interrupted. Thus, further rotation of the main shaft 30 from the position 199 to the position 187 merely completes the retraction of the needles 23 to their dwell positions. As the main shaft 30 moves from the position 188 to the position 192 the billhook shaft 115 is rotated over the first 180 degrees of its second cycle (the actual knot-tying cycle). During the first 90 degrees of this cycle the tips 121 and 136 of the billhook jaws hook behind and below the twine portions 20 and 43 from the right hand side and the latter begins to slide over the surface 196 of the fixed jaw 118 (FIG. 25). Further rotation of the billhook 66 from the 90 degree position to the 180 degree position of the second cycle causes the lower parts of the twine portion 20 and 43 to slide further over the surface 196 of the fixed jaw 118 towards the base thereof (FIG. 26). Simultaneously, the heel 129 of the movable jaw 126 hooks behind the upper parts of the twine portion 20 and 43 thus causing them to slide in the direction of the base of the billhook 66 over the curved section 133 of the movable jaw 126. Continued rotation of the billhook shaft 115 toward the 180 degree position results in a loop being formed around the billhook 66 (FIG. 26). As the loop is being complete, the heel 129 contacts the roller cam 131 for the second time which opens the jaws 118 and 126 and the twine portions 20 and 43 are now in a position relative to the billhook 66 in which they can enter the open jaws as seen in FIG. 29. This is because the groove 91 holding the twine portions has now reached a position closer to the billhook and slightly to the right thereof. At the same time, the groove 92 reaches a position in which the end of the primary twine portion 20 previously held thereby is released. As the heel 129 moves off the roller cam 131 during movement of the billhook shaft 115 from the 180 degree position to the 270 degree position, the jaw 126 is closed due to the action of the spring 142, whereupon the twine portions 20 and 43 are firmly clamped in the billhook jaws 118 and 126 (FIGS. 27 and 30). During the loop-forming part of the cycle a substantial tensile force is exerted on the twine portions 20 and 43 causing them gradually to slip a limited amount between the flanges 80, 81 and 82 and the associated twine retaining fingers 152 and 153. This is necessary in order to provide a certain length of twine with which to form a knot, the appropriate length being determined by the curvature of the surface 133 of the movable jaw 126 and being sufficient not only to enable the knot to be tied but also for the knot to be loose enough (but not too loose) for it to be pulled from the billhook. This length of twine is longer than on conventional knotters. During the movement of the main shaft 30 from the position 192 to the position 199, the billhook 66 is rotated from its 180 degree position to its 360 degree position of the second cycle during which movement the loop of twine slides towards the tip of the billhook 66 with the ends of the twine portions 20 and 43 still clamped between the jaws 118 and 126. Also, the twine disc 63 is rotated further, thereby moving the ends of the twine portions to the sections 160 of the retainer fingers 152 and 153 so that, as explained, the grasp on the twine portions is increased substantially to the extent that the ends are no longer allowed to slide in between the various components even under an increased tensile load. As the twine disc 63 moves on its next following rest position (which is reached with the main shaft 30 in position 199), the groove 91 holding the twine portions 20 and 43 moves past the fixed knife blade 166, whereby both portions of twine are severed, leaving the formed bale 14 independent as such although the looped ends of the twine portions are still retained on the billhook 66 (FIG. 28). The cutting of the primary twine portion 20 gives rise to a short piece of twine and if this does not fall from between the discs 80, 81 and 82 during the formation of the subsequent bales, the twine disc cleaners 177 and 178 will remove it. A clean cut of twine portions 20 and 43 is obtained as at the moment of cutting, these portions are firmly held in the twine disc 63 by the finger sections 160 as described above. The billhook 66 thus moves to its rest position in timed sequence with the tail ends of the twine portions 20 and 43 being cut. In this position, the jaws 118 and 126 extend generally downwardly and rearwardly toward and adjacent, or even partially through, the aperture 60 in the top wall of the bale chamber 13. As stated, the loop just formed is still retained in the billhook 66 with the severed tail ends still clamped therebetween. The tail ends are more or less firmly clamped between the jaws 118 and 126 under the action of the spring 142, with the crochet hook 124 of the movable jaw 126 resting in the notch 123 of the fixed jaw 118. The subsequent strokes of the bale plunger 16 cause the wrapped bale 14 to move further rearwardly along the bale chamber 13, thereby also causing the loop to be pulled off the billhook 66 over the severed tail ends of the twine portions 20 and 43 and to tighten the loop around the tail ends. At this moment the knot is actually completed. The tail ends of the twine portions 20 and 43 are finally also released under the increasing tensile load exerted thereupon by the rearward movement of the bale in the chamber 13. Depending upon the shape, dimensions and adjustment of the billhook 66, as is generally known in the art, the knot so formed will be an overhand knot or bow knot the latter being illustrated in FIG. 32, as reference number 200. As the main shaft 30 approaches the position 199, the tail end 198 of the primary twine portion for the next bale, which is held in the next following groove 96 and which extends over the the top of the twine disc 63, engages the section 160 of the fingers 152 and 153, so that when a tensile load is exerted on the twine during the formation of the following bale, said tail end is firmly held and does not slip. At the same time that the twine disc 63 reaches its rest position, the next following groove 96 is brought into position at the apex of the V formed by the twine guide 170 and 181 for receiving the primary twine portion 198 for the next bale of which portion is held in the groove 91 and extends over the uppermost flange 80, down through the groove 96 to the needle 23 and then to reel 22, a guide surface 181 of the twine guide 180 and the guide edge 172 and 174 of the twine guide 170 assisting in the positioning of the twine portion 198. In typical prior art knotters a twine finger is required to place the twine in the correct position to engage the billhook and a stripping finger or the like is required to pull the cut twine ends off the billhook jaws. With the present invention, however, the twine finger and twine stripper and drive means therefor are not necessary due to the particular arrangement of the twine holder relative to the billhook and due to the fact that the billhook has a twine "assembling" cycle (the first cycle) in addition to a knotting cycle. Furthermore, the normal movable knife blade for cutting twine after a knot has been tied, has been replaced by a simple stationary knife with the relative movement required for the cutting operation being provided by the rotation of the twine holder. This further simplifies the structure. It will be seen that the cam roller 131 is relatively large and as it is contacted by the heel 129 of the movable jaw 126 over a small angular part of each cycle of movement of the billhook 66, the rotational movement of the roller is also small, wear is equally spread over the roller surface, thus minimizing surface deterioration. The location of the roller 131 relative to the billhook 66 is such that it does not present a trap for the twine portions 20 and 43 as it would if it were positioned on a heel of the movable jaw 126 as in known knotters. FIGS. 20 and 24 show that the twine portions 20 and 43 are substantially parallel to the billhook jaws at the start of the cycle of the billhook. FIG. 26 shows that the loop formed in the twine portions 20 and 43 is substantially at right angles to the position of these portions at the start of the cycle, whereby the twine portions have to move over a relatively large distance between these positions and the length of the curved section 133 of the movable jaw reflects this, the length being three to four times greater than known billhooks. From the foregoing it will be understood by those skilled in the art that a knotter according to the instant invention is a simple design, whereby it is simple to manufacture, assemble, and adjust. The structure is very reliable and requires only a minimum of attention once it has left the factory. Field adjustments, if required at all, are readily accomplished and can be made by the average operator whereby extensive harvesting delays are avoided. Variations in twine and the use of different types of twine only require minimum adjustments, if any at all. The number of oscillating and complicated parts and of complicated drive means such as cams and cam followers, has been reduced to minimum and most of the moving parts have rotational movement only. The remaining oscillatory components are small in size and have only small displacement. For this and other reasons, the inertia forces are less critical and hence the speed of operation of the knotter, and hence the baler, can be increased substantially. Increased knotter speed does not adversely affect the quality of the knot tied by the knotter because, as described, an entire cycle of operation is devoted to establishing the proper position of the portions of twine to be tied and a further entire cycle is devoted to tying the actual knot. In most known balers, the maximum baling speed is 90 strokes per minute of the bale plunger but upwards of 130 strokes per minute can be accommodated by a knotter in accordance with the present invention. Within reason, the plunger speed of operation is unlimited and the only restraint is that imposed by the knotter which normally only has one cycle of 360 degrees in which to perform the knotting operation and which is completed in between two subsequent plunger strokes so that the speed of the moving parts is high so that inertia and other factors become significant and detract from the consistent tying of acceptable knots. Conventional knotters normally have a main drive arrangement for each knotter installed on the baler. As the baler usually employs two knotters, then two main drive means are required. However, two or more knotters according to the present invention can be driven by a simple, single main drive arrangement. Due to the simple design and the reduced number of moving parts, it is possible to significantly reduce the number of greasing nipples per knotter. Conventional knotters normally have six or seven greasing nipples, but a knotter according to the present invention requires only one or two. Also, due to the design of the knotter, the operation of the knotting mechanism will be affected to a lesser extent, if at all, by the vibrations of the baler, the tension in the twine, the jarring of the baler as it moves through a field, variation in the crop conditions such as tough or resilient crop causing the baler twine to jump about, and moisture, dirt, crop debris and the like, all subjecting the components to abrasion. The angle of the billhook shaft relative to the bale chamber is advantageous for the reason that the billhook is positioned extremely close to the bale. Thus, a shorter loop of twine around the bale and thus also a higher bale density is obtained in that the bale is found tighter and does not expand to take up slack in the twine band. The chosen inclination of the billhook shaft, and also the billhook, relative to the bale chamber is also advantageous in that the load on the twine as the knot is pulled off the bale hook is reduced. By extending the billhook shaft 115 through the twine disc 63 an important breakthrough in efficiency has been attained. It is thereby possible to incline the twine disc relative to the top of the bale case while maintaining the proper billhook attitude. The twine disc 63 is located very nearly perpendicular to the twine path provided by movement of needles 23, thus providing a larger contact area between the twine and the disc grooves, and a decrease in misties due to gripping failures. In the embodiment shown, the twine disc angle, θ 1 , is advantageously about 15 degrees. The angle between the billhook shaft 115 and the twine disc 63, θ 2 , is chosen to be about 45 degrees also. Of course, these angles may vary; however, the figures given represent the optimum arrangement now known. Finally, it will be also understood by those skilled in the art that the cost of a knotter according to the invention and the cost of the field delays and servicing are reduced substantially in comparison with costs of a conventional knotter. While a specific embodiment of the invention has been illustrated and described, it will be apparent to those skilled in the art that various alterations and modifications in the construction and arrangement of components can be made.

A knot tying mechanism with improved operational capabilities is disclosed. A twine disc rotatably mounted about a central fixed hub is angularly arranged to position the twine-gripping area for better acceptance of twine from the needle and thereby reduce the incidence of misties due to inadequate gripping. A billhook shaft extends through the fixed hub to properly support the billhook adjacent the twine-gripping area, and to transmit rotational power from the shaft to the twine disc.

RELATED APPLICATION This application claims priority of U.S. Provisional Application Ser. No. 60/116,799 filed Jan. 21, 1999. FIELD OF THE INVENTION The subject invention generally relates to the field of detecting halitosis or bad breath and, more particularly, to an improved method for measuring the concentration of sulfides within the mouth of a subject to determine the presence and extent of halitosis activity. BACKGROUND OF THE INVENTION Halitosis, commonly known as bad breath, is a common concern for many people. The most common source of halitosis is thought to be the tongue. Gram negative, anaerobic bacteria are prone to proliferate in the papilla structure at the posterior or rear of the tongue. The papilla form a multitude of niches or irregularities which are favored breeding grounds for the anaerobic bacteria as they simulate non-oxygenated micro environments. The anaerobic bacteria break down specific components such as amino acids found in the saliva generating or producing sulfur containing metabolic by-products. These sulfur containing by-products are volatile and have been implicated as the major cause of odor and/or halitosis. It is interesting to note that these same bacteria which are associated with the causation of halitosis are often the same bacteria considered as the etiological agent for periodontal disease. The detection and diagnosis of halitosis has traditionally involved self-monitoring which is typically accomplished by breathing into one's own hand and then sniffing the trapped contents or a person suspecting that they have halitosis can utilize another person to sample their breath and render a subjective diagnosis. Devices or monitors for the detection of halitosis are known in the art. U.S. Pat. No. 4,823,803, to Nakamura, issued Apr. 25, 1989, discloses a device for testing human exhalation for halitosis. Other prior art devices are known for analyzing a subject's breath for volatile sulfur emissions. U.S. Pat. No. 5,275,161, hereby incorporated by reference, assigned to the same assignee as the subject invention, discloses a method and apparatus for electro-chemically detecting and quantifying sulfide levels in gingival sulci to determine the presence and extent of gingivitis and periodontal disease in a subject. The method disclosed therein employs a probe which is inserted into the sulcus and which includes a miniature sulfide measuring electrode and a reference electrode. U.S. Pat. No. 5,628,312 also assigned to the same assignee as the subject invention, discloses a probe for diagnosing periodontal disease by the concentration of sulfides present which includes a sulfide responsive measuring electrode and a reference electrode joined by a salt bridge to assure electrical continuity between the sulfide responsive electrode and the reference electrode. Accordingly, it would be advantageous and desirable to have a method for diagnosing the presence and extent of halitosis activity on the surface of a subject's tongue by measuring the concentration of sulfides thereon. SUMMARY OF THE INVENTION There is disclosed a method for diagnosing the presence and extent of halitosis activity in a subject by measuring the concentration of sulfides present on the surface of the subject's tongue. The method includes the step of assaying fluid disposed on the surface of the tongue for the concentration of sulfides therein. There is also disclosed a method for diagnosing the presence and extent of halitosis activity in the mouth of a subject by measuring the concentration of sulfides present on the surface of the subject's tongue including the steps of providing a sulfide responsive probe. A preferred probe includes a housing having a tip configured to probe the surface of the tongue, a measuring electrode and a reference electrode operative to establish an electrical potential therebetween when the tip is contacted with a sulfide containing fluid wherein the electrical potential generated is proportional to the concentration of sulfides in the fluid. There is also disclosed a method for diagnosing the presence and extent of halitosis activity on the surface of a subject's tongue by measuring the concentration of sulfides thereon including the steps of providing a dual electrode probe having a sulfide-responsive measuring electrode and a reference electrode, providing a voltage indicator for generating a data readout reflective of the strength of the electrical potential between the sulfide-responsive measuring electrode and the reference electrode, and electrically connecting the sulfide-responsive measurement electrode and the reference electrode to the voltage indicator. The probe is then positioned in contact with the surface of the subject's tongue such that both electrodes are in contact with the surface of the tongue and the fluid disposed thereon wherein the fluid bridges the electrodes to cause a potential between the sulfide-responsive measurement electrode and the reference electrode, whereby the magnitude of the potential corresponds to the concentration of the sulfides in the fluid. The method further includes the steps of reading the data readout provided by the voltage indicator which is indicative of the concentration of sulfides on the surface of the tongue and comparing the data readout with a predetermined standard to determine the extent of halitosis. BRIEF DESCRIPTION OF THE DRAWINGS The following detailed description is best understood with reference to the following drawings in which: FIG. 1 is a depiction of a probe structured in accordance with the present invention; FIG. 2 is an enlarged, cross-sectional view of a portion of the probe of FIG. 1; FIG. 3 is an enlarged, cross-sectional view of a portion of the probe of FIG. 1; FIG. 4 is a graph depicting sulfide levels on the surface of a subject's tongue treated with artificial saliva; FIG. 5 is a graph depicting sulfide levels on the surface of a subject's tongue treated with 0.12% chlorhexidine; FIG. 6 is a graph depicting sulfide levels on the surface of a subject's tongue treated “back to back” with a first commercially available product and a second commercially available product; FIG. 7 is a graph depicting sulfide levels on the surface of a subject's tongue treated with a third commercially available product; and FIG. 8 is a graph depicting sulfide levels on the surface of a subject's tongue treated with a fourth commercially available product. DETAILED DESCRIPTION OF THE INVENTION The present invention is directed to a halitosis probe for measuring the sulfide concentration of fluids disposed in the mouth or oral cavity, specifically on the surface of the tongue. Suitable probes include those disclosed in either U.S. Pat. No. 5,275,161 and/or U.S. Pat. No. 5,628,312 both incorporated herein by reference. Referring to FIGS. 1 and 2, a typical probe structure 20 in accordance with the principles of the present invention is shown. The probe 20 includes a housing 22 which can be disposable having a dimension and shape configured to contact or probe various regions of the surface of the tongue and also which contains a sulfide-responsive sensing electrode 24 . The probe 20 further includes a reference electrode 26 supported by the housing 22 or by an optional disposable second housing portion 23 . Referring to FIGS. 1 and 3, the reference electrode 26 is immersed within a salt pellet 28 to control the chemical environment. The reference electrode 26 is kept in electrical contact with the sulfide-responsive sensing electrode 24 through a salt bridge 30 . An aperture 25 is disposed within the probe assembly 20 to provide direct electrical contact to the salt bridge when hydrated. As shown in U.S. Pat. Nos. 5,275,161 and/or 5,268,312, the sulfide-responsive measuring electrode 24 and the reference electrode 26 are connected to respective, electrically conductive leads 38 . The leads 38 are in electrical communication with an electro-chemical analyzer 40 which may operationally include a sound generator 42 in communication therewith. In operation, the probe 20 is disposed so that a tip portion 32 thereof is in contact with the fluid layer disposed on the subject's tongue so that the sulfide-responsive electrode 24 contacts the fluid. The reference electrode 26 is also in electrical communication with the fluid, via the salt bridge 30 . An electrical potential is developed between the sulfide-responsive electrode 24 and the reference electrode 26 and this electrical potential is proportional to the sulfide concentration in the fluid. The electro- 163 chemical analyzer is operative to sense the potential between the electrodes 24 , 26 and to provide a display which is directly indicative of, or correlatable with, sulfide concentration. Since, in some instances, it is difficult for a practitioner to observe a visual display while properly positioning the probe 20 on the tongue, the sound generator 42 may be utilized in combination with the electro-chemical analyzer 40 . The sound generator 42 produces an audible signal which is indicative of the potential generated between the electrodes 24 , 26 . Referring to FIG. 2, the sulfide-responsive measuring electrode 24 is most preferably fabricated from a material which undergoes an electro-chemical reactivation with the sulfide ion. One particularly preferred material comprises silver sulfide and, accordingly, the electrode 24 may be simply comprised of a fine sulfided silver wire 34 with an insulator 35 disposed therebetween. In other instances, the electrode 24 may comprise a wire, such as a stainless steel wire, coated with silver. Other metals reactive with sulfide may be similarly employed, for example, antimony. The reference electrode 26 is disposed in an electro-chemical relationship with the sulfide-responsive electrode 24 and must be employed in order to provide a potential indicative of a sulfide ion concentration. In a preferred embodiment, the reference electrode 26 is disposed in the probe 20 . One particularly preferred reference electrode 26 comprises a silver-silver chloride electrode, typically provided by disposing a chloride coating on a silver wire 34 . In some instances, the chloride coating will be disposed to cover a substantial length of the wire, and in other instances, the wire will be insulated along substantially all of its length and will have a body of silver chloride disposed so as to cover a free end of the wire. All such configurations may be employed in the practice of the present invention. The reference electrode 26 is disposed within the pellet 28 of a salt, such as potassium chloride. The pellet 28 of potassium chloride can be partially covered by the material of the housing 22 , and preferably has a major portion of its free surface covered by a moisture impervious material, such as a layer of epoxy resin. In accordance with another feature of the present invention, as shown in FIG. 3, there is provided a hydration layer 36 on the probe 20 , in the region of the reference electrode 26 , sulfide-responsive electrode 24 and salt bridge 30 . The hydration layer 36 comprises a smooth, open structured, over-coated layer which assures the maintenance of hydrated conditions between the electrodes 24 , 26 and salt bridge 30 and allows for wider tolerances in the fabrication of the salt bridge 30 . A number of different materials may be utilized for the hydration layer 36 . One preferred material involves cellulose acetate. Other embodiments of the hydration layer 36 may similarly be prepared from a variety of polymers such as cellulose acetate-butyrate, vinyls and the like. In use, once the probe 20 is hydrated, the probe 20 is ready for insertion into the mouth of the subject and for contact with the surface of the subject's tongue. The probe 20 is inserted so that it comes into contact with the fluid layer overlying the tongue. The electrolytes within the fluid layer will cause an electrical potential to develop between the electrodes 24 , 26 , the magnitude of which corresponds to the concentration of sulfide in the fluid. After measurement of the tongue, a portion of or all of the probe 20 may be discarded as the probe 20 is preferably made of or constructed of disposable materials. While one particular configuration of the probe 20 has been illustrated, it will be appreciated that in accordance with the principles disclosed herein, other configurations may be implemented. The present invention can be utilized to record localized measurements of sulfide concentrations on the surface of the tongue for day-to-day variations, variations within a single day, for the effect of normal activities (eating, drinking), and for the effective treatment modalities, such as mouthwashes, as illustrated in the examples set forth below. Additionally, as sulfide concentrations are not necessarily uniform over the entire surface of the tongue, the probe of the present invention can be utilized to detect points and/or regions of the surface of the tongue which may be “hot spots” where sulfide production is located or unusually high. EXAMPLES The following examples are presented in order to demonstrate the utility of the present invention. EXAMPLE 1 Example 1 demonstrates the ineffectiveness of an artificial saliva product for altering the sulfide concentrations on the surface of a tongue of a subject. Referring to FIG. 4, the sulfide concentrations taken over time are displayed as a function of signal strength in millivolts. Baseline data was obtained from the tongue of an experimental subject. Five measurements from the surface of the tongue including rear center, rear left, rear right, left side, and right side were obtained. One measurement from underneath the tongue was also obtained. The measurements were then repeated immediately following the subject's rinsing for thirty seconds with a commercially available artificial saliva product. The subject then brushed their tongue with a toothbrush dipped into the artificial saliva product and the six measurements were immediately taken again. Five hours after the initial rinse with the artificial saliva product, the six measurements were again repeated. The data obtained in this example demonstrate the uniformity and repeatability of sulfide measurements obtained utilizing the probe of the present invention. The artificial saliva product, as expected, had no effect on the sulfide concentrations measured on the surface of the subject's tongue. EXAMPLE 2 In this example, the effectiveness of the bactericide chlorhexidine for the reduction of sulfide levels on the surface of a subject's tongue was analyzed. It was predicted that chlorhexidine would be effective in the reduction of sulfide levels on the surface of the tongue as it is known that chlorhexidine is retained by oral tissue. As in Example 1, measurements of the sulfide levels on the surface of the tongue and from the underside of the tongue were obtained utilizing the probe of the subject invention. Referring to FIG. 5, the results of the chlorhexidine experiment are shown. Baseline data was obtained from the surface of the tongue and from underneath the tongue as described in Example 1. The measurements were then repeated immediately following a thirty second rinse of the subject's tongue in 0.12% chlorhexidine. The subject then brushed their tongue with a toothbrush which had been dipped into the 0.12% chlorhexidine solution. As shown in FIG. 5, two of the five measurements from the surface of the tongue are reduced significantly. After a one hour and twenty minute time delay following the initial chlorhexidine rinse, the measurements were repeated and four of the five measurements from the surface of the tongue were reduced considerably. The fifth measurement had also been significantly reduced. After a four hour delay following the initial chlorhexidine rinse, the six measurements were repeated. Four of the five measurements from the surface of the tongue were found to be lower than those recorded at the one hour and twenty minute time point. The fifth measurement was higher than that recorded at the one hour and twenty minute interval but was considerably lower than the initial measurement. The data obtained in this example was found to be consistent with the documented modality or action of chlorhexidine. That is, there is no immediate reduction in sulfide concentration; however, after the passage of a period of time, the retained chlorhexidine residue destroys contacted bacteria thus shutting down the production of sulfides by the bacteria. As the time progresses, more and more bacteria are destroyed at some sites while at other sites the bacteria is able to proliferate once again. This example demonstrates the utility of the probe of the present invention in obtaining sulfide concentrations which are correlatable to the action of a known bactericide. EXAMPLE 3 In Example 3, a first and a second commonly available commercial oral hygiene product were administered in a “back-to-back” fashion. Referring to FIG. 6, the data obtained in this example are illustrated. As in Example 1, measurements of the concentration of sulfides on the surface of the tongue and underneath the tongue were obtained utilizing a probe in accordance with the present invention. A baseline was established by obtaining five measurements of the surface of the subject's tongue and one measurement from underneath the subject's tongue. Immediately thereafter, the subject brushed and rinsed with the first product and then the six measurements were immediately obtained. Then, following a twenty minute time period, the six measurements were repeated. Then, the subject rinsed with the second product for thirty seconds and the six measurements were taken. Three of the five measurements of the sulfide concentration were found to be significantly lower with the other two being slightly reduced. The subject then brushed with the second product and the measurements were again repeated. All measurements on the surface of the tongue were significantly reduced. After a period of four hours from the initial brush and rinse with the first product, four of the five measurements from the surface of the tongue remained significantly lowered while one of the measurements had increased to the level seen immediately after the rinse with the second product. Based on this “back-to-back” comparison, the first product was found to be ineffective for reducing the sulfide concentrations on the surface of the subject's tongue, the second product was found to have an immediate effect which could be increased by mechanically manipulating the surface of the tongue by brushing. After 4 hours, there was evidence that bacterial generation of sulfides were recurring. EXAMPLE 4 In this example, another product comprising a third commonly available commercial oral hygiene product was tested as shown in FIG. 7 . Measurements were obtained as in Example 1. A baseline was established by taking five measurements of the sulfide concentration from the surface of the subject's tongue. One measurement was taken from underneath the tongue. The subject then rinsed with the product, and the six measurements were repeated thirty seconds thereafter. All five surface measurements indicated a significant lowering of the sulfide concentrations. The subject then brushed with a toothbrush which had been dipped in the product and the measurements were immediately repeated thereafter. Very little additional reduction of sulfide concentration was found. Five hours after the initial rinse, the measurements were repeated. Two of the five surface measurements were found to remain very low. The remaining three of the five signals had begun to increase approaching the initial baseline values. The product tested appears to produce an immediate significant reduction of sulfide production. Some of the sulfide production areas were kept sulfide free for more than five hours. Other areas were found to again produce sulfide within this time interval. EXAMPLE 5 In this example, a product comprising a fourth commonly available commercial oral hygiene product was tested for its ability to lower sulfide concentrations on the surface of a subject's tongue as shown in FIG. 8 . Measurements were taken as described for the previous examples utilizing a probe in accordance with the present invention. A baseline measurement was obtained and thereafter the subject rinsed twice with the product. Thirty seconds after the second rinse, the six measurements were immediately taken. It was found that all five surface sulfide concentrations had been considerably reduced. Five hours after the rinse, the measurements were repeated and all five of the surface sulfide concentration measurements indicated that all five sulfide concentration measurements were considerably reduced. The product tested in this example demonstrated an immediate and significant reduction of sulfide production. Even five hours after the initial treatment, sulfide production remained very low and sulfide production had not been reestablished. The foregoing examples demonstrate the ability of the probe of the present invention to be utilized for obtaining measurements of the sulfide levels on the surface of the tongue. These measurements can be used for the diagnosis of halitosis and to assess the effectiveness of treatments for halitosis. In view of the teachings presented herein, other modifications and variations of the present inventions will be readily apparent to those of skill in the art. The foregoing drawings, discussion, and description are illustrative of some embodiments of the present invention, but are not meant to be limitations on the practice thereof. It is the following claims, including all equivalents, which define the scope of the invention. Any patents or publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains. These patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference.

A method and apparatus for diagnosing the presence and extent of halitosis activity are disclosed. A method includes assaying for the presence of sulfides on the surface of a subject's tongue in order to determine the concentrations of sulfides in the fluids.

CONTINUITY This is a divisional of U.S. patent application Ser. No. 315,950, filed Sep. 30, 1994, now U.S. Pat. No. 5,628,546. TECHNICAL FIELD This invention relates to chairs for patients undergoing treatment, and more particularly, to dental patient' chairs. BACKGROUND OF THE INVENTION Dental patient's chairs come in a variety of types, styles, and sizes. Traditional dental patients' chairs are adjustable, typically by means of a simple pivot between the seat and the backrest which allows for simple articulation of the back as it rotates about the pivot. Such traditional chairs are, however, problematic for a number of reasons. First, it is typically important that the patient's head does not move relative to the headrest. Any time movement of a traditional dental chair is desired, the backrest pivots about an axis common to the seat. Upon pivoting the backrest, a person typically must move anywhere from a few to several inches in the chair in order to be seated squarely on the seat cushion with the backrest in the proper supporting position. Necessarily, the position of the patient's head relative to the headrest will change. This requires the treating physician to readjust the headrest. Further, with respect to the patient's head, the patient's jaw and skull relative to the patient's backbone must be oriented in an optimal position for the dentist, oral surgeon or other treating physician to access the areas of the mouth. If the head and jaw move relative to the patient's backbone during adjustment of the chair, the patient may not be able to open his or her mouth sufficiently or there may be some other impediment to accessing the mouth areas. A primary problem with respect to traditional dental patients' chairs is that the pivot axis, particularly a simple pivot between the backrest and the seat, is not coincident with the axis of the human body "pivot." Therefore, the person's body and the seat when articulating will not remain in constant, identical contact with one another. One attempt to solve this problem has been to try to locate the axis of the chair pivot close to the axis that is assumed to be where rotation of the upper torso takes place relative to the lower body. This, however, creates two problems. First, this would require a large hinge mechanism on the chair well above the seat cushion level that would get in the way of the patient getting in and out of the chair. Perhaps more importantly, the human body does not pivot like a simple hinge. Rather, the human body has one hinge between the upper legs and the pelvic bone, and a second hinge between the lower part of the backbone and that same pelvic bone. This creates a complex hinge mechanism that must be dealt with in a sophisticated way. An overriding consideration in today's medical profession, including the dental profession, is contamination. With the ever-increasing presence of serious diseases, such as AIDS, hepatitis, and the like, contamination has become particularly important. A major problem with respect to any dental patient's chair is the need for the treating physician to adjust the chair manually. For example, the physician is typically required to manipulate a variety of manually controlled switches or buttons, such as to adjust the headrest, backrest, or even the light used in treating the patient. Each time such an adjustment is required, the treating physician must put down the instruments, and readjust the particular piece of equipment. Any contamination on the treating physician's gloves will contaminate any of these various manually operated adjustments. These same adjustments are those that are typically not thought of when sterilization takes place between patients, as compared to the physician's instruments and the like. Another important consideration is the patient's comfort and sense of security. The patient should not feel that he or she is sliding up and down in the seat in an uncontrolled manner, particularly where critical angles of inclination are involved. This occurs when a simple pivot, described above, is used in a patient's chair. Some attempts have been made to place a sliding mechanism in the backrest portion of a chair to allow for the back to move when the seat is being reclined. Once again, however, this does not recognize the complex pivot that occurs in the human body. In addition, any mechanisms added to the backrest of the chair will create an impediment to the doctor performing work on the patient. In designing a dental patient's chair, the backrest should be kept as thin as possible so the doctor can have maximum patient positioning freedom while keeping his knees and legs free to get close to his patient. There is a need, therefore, to provide a dental patient's chair that can be completely and fully manipulated without the need of the treating physician to touch any part of the chair with his or her hands. There is a further need to develop a dental patient's chair that pivots in the same complex manner as the human body so that when the chair is reclined, the human body will follow both the backrest and the seat in the exact same manner. This would eliminate any need for the patient to readjust him or herself in the chair, and would maintain the head in the relatively same position on the headrest. The present invention relates to a dental patient's chair that is fully and completely adjustable by the use of a unique foot control system that eliminates the need to manipulate any hand-operated control knobs or levers. The present invention also involves a sophisticated linkage assembly which allows the seat to pivot and move in the same manner as the human body when the human body articulates about the complex pivot created at the pelvic bone, the upper legs, and the lower part of the backbone. This allows the patient's body to remain in the same position relative to the backrest and the seat of the patient's chair as the chair is articulated in a variety of positions. Other advantages, features, and objects of the invention will become more apparent from the detailed description of the invention that follows. BRIEF DESCRIPTION OF THE DRAWINGS Preferred embodiments of the invention are described below with reference to the accompanying drawings, which are briefly described below. FIG. 1 is a side elevation view of a dental patient's chair according to the present invention; FIG. 2 is a side elevation view of the dental patient's chair of FIG. 1 showing the various linkage mechanisms of the chair; FIG. 3 is a side elevation view of the dental patient's chair of FIG. 1 with a portion of the linkage broken away to show a drive mechanism for adjusting the chair; FIG. 4 is a side elevation view of the dental patient's chair of FIG. 1 in a lowered position; FIG. 5 is a side elevation view of the dental patient's chair of FIG. 1 showing the chair in a fully inclined position; FIG. 6 is an exploded view of the linkage assemblies of the present invention; FIG. 7 is a side elevation view of the headrest assembly; FIG. 8 is a side elevation view of the headrest assembly in an alternate position; FIG. 9 is a top view of a foot control apparatus according to the present invention; FIG. 10 is a side elevation view of the foot control apparatus of FIG. 9; FIG. 11 is a partial bottom view of the foot control apparatus of FIG. 9; FIG. 12 is a sectional, exploded view of some of the components of the foot control apparatus shown in FIG. 11; FIG. 13 is a bottom view of the foot control apparatus of FIG. 9 without the base; FIG. 14 is an exploded side elevation view of the components of the foot control apparatus of FIG. 13. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS This disclosure of the invention is submitted in furtherance of the constitutional purposes of the U.S. Patent Laws "to promote the progress of science and useful arts" (Article 1, Section 8). FIG. 1 shows a dental patient's chair 20 generally comprising a backrest assembly 22, a seat assembly 24, a footrest assembly 26, an armrest assembly 28, a linkage assembly 30, a lift mechanism 32, and a base or platform 34. The dental patient's chair is operated solely and exclusively by a programmable foot control apparatus 200 which can be positioned anywhere on the ground at the rear end of the dental patient's chair. Ideally, it will be positioned for convenient operation by the treating physician. The foot control apparatus emits an infrared signal which is transmitted to and received by a PC board 160 mounted inside of the dental patient's chair. The chair shown in FIG. 1 includes a breakaway portion to show where the PC board 160 may be located. FIGS. 2 through 6 show more specifically the various features of the dental patient's chair. The seat assembly 24 includes a seat frame 36 which is moved through a variety of horizontal and vertical positions as the chair articulates because of the main linkage assembly 30. The frame comprises side members 36 which are attached to one another by a cross bar 37. (FIG. 6 shows left and right components of the chair that are mirror images of one another by adding an "a" or a "b" designation to the component number). A pair of arm posts 38 are rigidly coupled to the frame 36. A pair of armrests 39 are coupled, in turn, to the arm posts 38. The seat frame 36 moves generally relative to the main or reference frame 40. The reference frame comprises side members 40, which are secured together by a cross brace 41 and a tubular cross member 47. The seat frame 36 is attached to the reference frame 40 solely by means of a butterfly linkage member 42 and a boomerang-shaped linkage member 44. The main frame further comprises upstanding arms 46 which are fixedly coupled to the ends of tubular cross member 47. The top ends of arms 46 pivotally couple the backrest assembly thereto at triangular shaped brackets 50. A pair of push bars 48 are coupled at one end to the triangular pieces 50 and pivotally coupled at opposite ends to the butterfly linkage members 42. When the chair is articulated, the push bars 48 urge the lower portion of the butterfly bars 42 toward the front of the chair, which causes the top portion of the butterfly linkage members 42 to move the seat in a rearward position. The boomerang linkage member 44 moves the seat in an upward position as the seat frame 36 moves relative to the reference frame 40. The butterfly and boomerange members are different lengths and pivotally mounted in the manner shown so that the seat tilts when the it moves between the forward/rearward and upward/downward directions. The backrest assembly 22 is coupled to the seat frame assembly 24 by means of a pair of triangular-shaped brackets 50 which are interconnected to one another by means of a cross bar (unnumbered), as shown in FIG. 6. A banana-shaped bracket 51 is fixedly coupled to the cross bar and the triangular-shaped mounting brackets 50. A pair of support stays 53 are cantilevered from the banana bracket 51 and provide a support basis for the backrest cushion 52 (FIG. 2). An adjustable headrest assembly 56 is inserted in between the stays 53 and secured in a relative position by means of a coupling member 54 which includes a ratchet mechanism 55. The headrest assembly includes a tongue portion 58 which is inserted through the coupling member 54, as the tongue member is inserted between the stays 53. The footrest assembly 26 is pivotally coupled to the seat frame 36 by means of a pair of cam links 60. The footrest assembly 26 comprises a pair of parallel mainframe members 64 attached to one another by a cross member 65. A pair of bearing wheels 66 are rotatably attached to the reference frame 40 for engaging the cam surface 62 of the cam links 60. Each of the cam links 60 includes a cam surface 62 for engaging the bearing wheels 66. As the seat frame 36 moves relative to the reference frame 40, the cam surface 62 engages the bearing wheel, which will change the orientation of the footrest assembly 26. The reference frame 40 is vertically supported by means of a height adjustment assembly 32 which comprises essentially a parallelogram linkage. This height adjustment assembly specifically comprises a main vertical support member 68 and a pair of parallelogram support arms 70. The main vertical support member 68 and the parallelogram arms are pivotally coupled, on one end, to upstanding mounting brackets 72 on one end, and to a lower portion of the reference frame 40 on opposite ends. A vertical drive means in the form of a screw jack assembly 74 is used to move the chair vertically. The screw jack assembly 74 comprises a motor or drive means 76 which rotates a threaded extension portion 78. The motor is mounted to the base by means of a motor bracket 80 which is pivotally coupled to a base plate mount 82. A threaded coupling 86 is pivotally mounted, in turn, to a pair of flanges 84 which extend down from the main vertical support member 68. As the screw jack assembly rotates the threaded portion 78, the threaded coupling 86 is drawn toward the motor 76, which causes the parallelogram linkage to lower the dental patient's chair in a vertical position. The inclining and reclining of the seat chair is actuated by a seat drive means in the form of a second screw jack assembly, which comprises a motor 92 which rotates a screw or threaded extension portion 94. The motor 92 is pivotally secured by means of a motor mounting bracket 96 to a mounting member 98 attached to the cross bar of the backrest assembly 22. The threaded extension portion 94 is threadably inserted into a threaded coupling 100 which is secured, in turn, to a coupling mount attached to the cross bar 37 of the seat frame 36. When it is desired to move the chair into an inclined position, the screw jack assembly 90 rotates the threaded portion 90 which draws the coupling 100 toward the motor 92. This causes the butterfly linkage member 42 and the boomerang-shaped linkage member 44 to rotate (counterclockwise as shown in FIG. 2). This causes the seat frame 36 to move simultaneously in backward and upward directions relative to the reference frame 40 in a manner which replicates the movement of the human body upon articulation. The specific degree and amount of vertical and horizontal movement of the seat frame 36 depends upon the lengths of the butterfly and boomerang linkage members. These have been determined by computer-simulation of the exact articulation of the human body. With reference to FIG. 4, the various pivot points are disclosed. The lower parallelogram linkage, which allows for the vertical movement of the chair, is defined by pivot points 110, 112, 114 and 116. The boomerang-shaped member 44 is pivotally mounted to the reference frame at pivot point 118, and pivotally mounted to the seat frame at pivot point 120. The butterfly linkage member 42 is pivotally coupled to the reference frame 40 at pivot point 126 . The butterfly member is further pivotally coupled on one end to the push bar 48 at pivot point 122 and at an opposite end at pivot point 124 on the seat frame. The backrest assembly rotates about pivot point (on triangular shaped piece 50 just above point 130 in FIG. 4) when the backrest is rotated relative to the seat frame assembly. FIG. 7 shows one possible position of the headrest assembly 56. The headrest assembly includes a headrest cushion 140 which is pivotally secured to a dual pivot member 42 at pivot point 144. The dual pivot member 142 is coupled, in turn, to the tongue member 58 of the headrest assembly at pivot point 46. In the position shown in FIG. 7, the headrest assembly is at an extended position for a tall person. FIG. 8 shows an alternative position of the headrest assembly 56 with the headrest cushion 140 being articulated at pivot point 144 to allow the tongue 58 to be inserted into the seat cushion area 52 and to allow the dual pivot member 142 to be articulated down. In the position shown in FIG. 8, the headrest assembly 56 can be adjusted to suit a small person or child. FIG. 9 shows a foot control apparatus according to the present invention. The foot control apparatus includes an outer shell 202 and a plurality of apertures 204, 206, 208, which allow infrared beams to be transmitted to receiving devices in the dental patient's chair. The foot control apparatus includes four main areas, A, B, C, and D, on the top surface of the shell 202. By manipulating the foot control apparatus (discussed below), the dental patient's chair is fully and completely adjustable without the need for the treating physician to adjust any hand-operated control mechanisms. FIG. 11 shows a bottom view of a portion of the foot control assembly. A trapezoid-shaped piece 210 is mounted to the underside of the shell 202. The trapezoid piece provides an lower horizontal surface (since the foot control has a curved outer surface) which enables an even vertical force to be placed upon the other members of the foot control apparatus. A pair of spring steel members 212, 214 are mounted in a crosswise fashion to the underside of the trapezoid-shaped piece 210 by means of a fastener 216. The extreme ends of the spring steel members 212, 214 provide the means for creating the actuating force or forces to operate the foot control apparatus. A resilient spacer 218 is positioned under the trapezoid-shaped piece 210 to allows the cover to tilt in its mounted position. As shown in FIGS. 13 and 14, the footrest assembly further comprises a circuit board 224 which is attached to the base 230 of the foot control apparatus through a spacer 222. A plurality of switches (not shown) are coupled to the circuit board. A plurality of fasteners 226 are inserted through the circuit board 224 through the spacer 220 and threadedly received by the base 230. A battery (not shown), which provides power to the circuit board and the infrared emitter (not shown), is held by a retaining clip 228 mounted to the base 230. A removable cover 231 is secured to the exposed, bottom side of the base 230 by means of a fastener 232. The cover 230 can be removed to provide access to the battery storage area. A plurality of rubber feet 234 are further attached to the bottom surface of the base 230. When pressure is applied to any location of the outer edge of the cover, the cover will tilt and contact one or more switches mounted on the circuit board. That is, the spring arms will actuate one or more of the switches. This will case the microcomputer in the foot control to send a signal, preferably an infra red signal or signals, to the receiver on the patient's chair. These switches may be timer switches so that a tap or series of taps on a location of the edge of the cover will cause a particular signal to be sent from the foot control to the receiver on the patient's chair. The foregoing are but examples of the various signals that may be generated by the foot control and the various ways for actuating switches on the circuit board inside the foot control assembly. In compliance with the statute, the invention has been described in language more or less specific as to structural and methodical features. It is to be understood, however, that the invention is not limited to the specific features shown and described, since the means herein disclosed comprise preferred forms of putting the invention into effect. The invention is, therefore, claimed in any of its forms or modifications within the proper scope of the appended claims appropriately interpreted in accordance with the doctrine of equivalents.

A dental patient's chair which is fully and completely adjustable which includes a foot control system that eliminates the need to manipulate any hand-operated control knobs or levers. The dental patient's chair includes a linkage assembly which allows the seat to pivot and move in the same manner as the human body when the human body articulates about the complex pivot created at the pelvic bone, the upper legs, and the lower part of the backbone. The dental patient's chair allows the patient's body to remain in the same position relative to the backrest and the seat of the patient's chair as the chair is articulated in a variety of positions.

FIELD OF THE INVENTION The present invention finds applicability in the field of electrocardiograms; and more specifically placing leads on a patient prior to taking an electrocardiogram. BACKGROUND OF THE INVENTION 1. Background Information Most 12-lead EKG requires specifically trained personnel to place nine separate electrodes that adhere to specific areas of the patient's body. A wire to a monitor connects each electrode. Electrical activity of the heart is transformed into a wave form via a computer and displayed on a screen or recorded on graph paper in 12 different views or “leads”. The leads are various combinations of the electrodes. An alarm system signals when a lead is missing or malfunctioning. The placement of leads in a 12-lead EKG is described in U.S. Pat. No. 5,184,620 to Cudahy, the contents of which are incorporated herein in their entirety. The leads show views of the heart in two planes. The frontal plane view uses different combinations of electrodes L 1 , L 2 and L 3 to create six different leads. The horizontal plane view uses each of the precordial electrodes V 1 - 6 to create six different leads. Together, there are a total of twelve leads. This describes the routine 12-lead EKG most commonly used. A standard 12-lead electrocardiogram (EKG) provides a comprehensive picture of the heart's electrical activity. Each lead provides a different view. The six limb leads originate from three electrodes placed on the patient's arms and left leg. The limb electrodes are marked with abbreviations: LL (left leg), RA (right arm), and LA (left arm). They provide the basis for the three standard limb leads and the three augmented limb leads. The three standard limb leads (I, II, and III) represent the difference in bipolar electrical potential between two of the limb electrodes, as follows: (one electrode is positive, one is negative) lead I: right arm (−)/left arm (+) lead II: right arm (−)/left leg (+) lead III: left arm (−)/left leg (+) The three argmented limb leads (AVR, AVL and AVF) use the same three electrodes as the standard limb leads I, II and Im to measure the unipolar electrical potential in one electrode in reference to the other two electrodes: lead AVR: right arm (+) in reference to left arm (−), left leg (+) lead AVL: left arm (+) in reference to right arm and left leg lead AVF: left leg (+) in reference to left arm and right arm. For a horizontal view from the heart to an electrode placed on the chest, one looks to the six precordial leads (V 1 and through V 6 ). For an accurate lead recording on the ECG, one needs to place the chest electrodes correctly. One starts by finding the proper landmarks for V 1 —fourth intercostal space, right sternal border-because this position will be your guide for placing the other chest electrodes. To place the electrode for V 1 , one follows these steps: First, palpate the jugular notch (a depression). Move inferiorly and palpate the solid manubrium. Continue to move inferiorly and feel the angle of Louis (sternal angle), which is at the top of the sternal body. Directly to the right of the angle of Louis is the second right rib. Below the second right rib is the second intercostal space. Move your fingers down, palpating the next two ribs. Below the fourth rib and to the right of the sternal body is the fourth intercostal space. Place the V 1 electrode here. Then place V 2 through V 6 as follows: V 2 : fourth intercostal space, left sternal border V 3 : midway between V 2 and V 4 V 4 : fifth intercostal space, left midclavicular line V 5 : same level as V 4 at anterior axillary line V 6 : same level as V 4 at left midaxillary line. The lead placement must be precise within a few centimeters, requiring knowledge and skill. The education and training of personnel is time consuming and expensive. The procedure may only be available where there are trained personnel. There is variability in placement between personnel and each new procedure, leading to variability in readings. The placement of each lead or electrode in the designated anatomical position often requires repeated attempts. This limits the use of the 12-lead EKG in emergency settings. Multiple pieces of equipment (electrodes, clips, wires, etc.) and connection sites carry the risk of damage, loss of improper use and the knowledge to detect and correct the problem. In addition, extra pieces of equipment must be available and functional in each setting used. The additional training and equipment add costs. 2. Prior Art Patents Beitler (U.S. Pat. No. 5,782,238) discloses a flexible multiple electrode lead EKG device for patient-attachment. There are switches on the electrodes for activating the proper electrode. The device is weighted for attachment rather than through adhesion. Wilk (U.S. Pat. No. 5,257,631) teaches an electrocardiographic device which is coextensive with the chest of the patient being tested. The device is weighted and attached by straps. Cudahy (U.S. Pat. No. 5,184,620) teaches an electrode pad having a plurality of electrode sites. The electrode placement device is held in place by adhesive. The configuration of the Cudahy device does not allow for accurate placement of the device across the chest because of the lack of a visual guide relative to the body. The following patents also show multiple electrode EKG devices for hooking a patient to an electrocardiograph instrument. Sem-Jacobsen 3,954,100 Imram 5,327,888 Rotolo 5,445,149 Feingold 4,233,987 None of the prior art patents show the unique features of the electrode placement device as described by the herein disclosed invention. SUMMARY OF THE INVENTION The herein described invention is designed to facilitate electrode placement by eliminating single lead electrode placement habitually resorted to in the prior art. The herein disclosed invention requires no special skill to use, thereby eliminating the cost of training personnel and eliminates the need for skilled personnel. This in turn allows the device to be used in a much wider variety of settings such as cardiac stress testing, operating rooms, radiological suites, in the field, ambulance, emergency rooms, catheterization laboratories, outlying facilities, doctors offices, geriatric centers, and other care provider settings. Variability in readings is largely minimized. There is a great decrease in time required to place the device, which allows for use in emergency settings. The number of parts and pieces of equipment are reduced and most are disposable. The design allows a cost savings as no material is wasted in construction of a triangle (e.g., a square or rectangle cut in half), as opposed to configurations currently in use. The choice of adapters (provided along with the device) allow the device to be universally used with almost any EKG machine. The device could be used as well with an electronic system which would allow for remote readings. Described another way, the electrode placement device is to be used for taking an electrocardiogram and, preferably, has a triangular applicator to be applied to the chest of a patient prior to taking an electrocardiogram. The device is sized to fit the patient and the top portion of the device is straight across to ensure accurate placement of the device. The device is in the shape of a triangle and has electrodes placed therein. The device can be placed on the patient during an emergency situation and kept on that patient in the ambulance, in the emergency room, operating room and recovery room. The device can be described comprehensively as being a disposable electrode lead placement device intended to be applied by a doctor, nurse or technician to a patient's chest for the purpose of facilitating EKG readings on the patient's heart. One of the contacts or electrodes of the device is marked on the front portion of the device and clearly visible externally thereof, such that the doctor, nurse or technician may quickly position that one electrode at an approximately correct predetermined location on the patient's chest and then align the straight top edge of the device substantially in a horizontal plane, such that the remaining contacts in the array of prepositioned contacts on the device are thereby disposed in a substantially correct alignment with respect to respective locations in the patient's chest from which the EKG readings are to be taken. The disposable device has a plan outline which is substantially triangular and includes a right angle corner, and wherein a contact is disposed adjacent to the right angle corner. The device is intended to be maintained on the patient's chest for a time interval from an initial emergency situation through treatment until recovery, such that a datum is established for the patient, and such that any deviation from that datum may be quickly observed. The device can be used in a method of obtaining early EKG readings from a patient in an emergency situation and thereafter taking periodic EKG readings on the patient and readily detecting any significant differences in the EKG readings indicative of a particular problem being experienced by the patient during diagnosis, treatment and recovery. This method includes the steps of providing a disposable device in a sterile package, the package providing indicia and instructions externally thereon, such that an emergency medical technician may quickly position the device on the patient's chest in an approximately desired location. An adhesive is provided on the back portion of the device along with providing a peel-off protective layer for the device. With the problems attendant to use of conventional electrodes, the herein disclosed invention has the following objectives: to provide a device which makes placement of EKG electrodes simple and accurate. to provide a relatively-inexpensive disposable device for use with an electrocardiogram (EKG) device which is inexpensive. to produce an electrode placement EKG device which is easy to use. to produce an electrode placement EKG device which requires no special training for use. to provide an electrode placement EKG device with universal applicability. to provide an electrode placement EKG which is “fail safe”. These and other objects of the present invention will become apparent from a reading of the specification taken in conjunction with the enclosed drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of the electrode placement device of this invention. FIG. 2 is a disassembled (exploded perspective) view thereof. FIG. 3 is a perspective view thereof with part of the device cut-away to show its interior. FIG. 4 is an enlarged sectional view of the interior of the device as viewed from the cut-away of FIG. 3 . FIG. 5 is a view showing the electrode placement device applied to the chest of a male patient. FIG. 6 is a view showing the electrode placement device applied to the chest of a female patient. FIG. 7 is a view of the packet (sterile package) in which the EKG electrode placement device is supplied. FIG. 8 is a view of removing the electrode placement device from the packet. FIG. 9 is a view showing the protective peel-off cover being removed from the adhesive layer of the electrode placement device. FIG. 10 is a view showing the lead placement device over the chest of a patient. FIG. 11 is a view of the electrode positions of a 9-lead electrode positioning device. The leads are placed on positions V1-V6, and at the three corners of the triangle. FIG. 12 is a view of the lead placement device attached to the EKG recording unit, using an adapter (if necessary). DESCRIPTION Referring to FIGS. 1 and 2, the electrocardiogram (EKG) electrode placement device 10 has three layers (best shown in FIG. 2 ); a peel-off protective cover 12 , an electrode containing layer 14 and the top surface cover 16 . The contact surface 17 of the electrode containing layer 14 has a coating of adhesive 26 and at the electrode surface 19 there is a conductive coating 21 . The adhesive coating 26 and the conductive coating 21 are best shown in FIGS. 3 and 4. Referring to FIG. 2, all of the electrodes (or contacts) 18 are attached to leads 20 ; however, for ease of illustration not all of the electrodes 18 are shown with leads. As best shown in FIG. 12, all of the leads 20 will be ganged together and fitted to a terminal connector 22 . The electrode containing layer 14 has the adhesive coating 26 and a conductive coating 21 on the surface of the electrodes 18 . In a preferred embodiment, nine leads are employed in the device. The placement of leads to the electrodes is clearly set forth in FIG. 11 . With reference to FIGS. 3 and 4, the placement of electrodes 18 within the device is illustrated. Each electrode 18 is attached to a lead 20 which in turn is attached to a terminal 22 (best shown in FIG. 11 ). In actuality, the device can be conceptualized as having four layers, namely, the protective cover 12 , the adhesive layer 26 , the electrode retaining layer 14 , and the top surface cover 16 . A conductive layer 21 covers the electrode surface. FIGS. 5 and 6 are views illustrating the position of the electrode placement device on the male chest (FIG. 5) and the female chest (FIG. 6 ). FIG. 7 is a view of the external surface of the packet 24 with instructions for use. The EKG electrode placement device 10 is shown fitted to the patient prior to being removed for use. This simplifies use for all users of the device. FIGS. 8 to 10 show the steps to be taken for applying the electrode placement device 10 : removing the device from packet 24 (FIG. 8 ); removing the protective peel-off cover 12 from the adhesive layer (FIG. 9 ); and placing the device on the chest of patient (FIG. 10 ). The electrode placement device 10 is applied by first applying the right arm point 30 to the chest, then the left arm point 31 to the chest and then pressing the top surface cover 16 and electrodes 18 to the chest. This will adhere the electrodes 18 in their proper place for EKG reading. Once the electrode placement device 10 is applied to the chest, the terminal connector 22 is attached to the connector 28 of the EKG unit (FIG. 12 ). Readings can then begin. With reference to FIG. 11, the relative positions of the electrodes as applied to the chest are shown. These are conventional placement points. The device has nine electrodes 18 ; however, the device 10 could be fashioned to have twelve or more electrodes. Technically speaking, the technician applying the device would use the right and left outer borders of the clavicles, where they meet the shoulders as the upper border of the device and the lower left corner should lie within the last three ribs on the anterior axillary line, with the left border being perpendicular to the upper border. The preferred device of this invention is in the shape of an isosceles or equilateral triangle. The sensing units or electrodes 18 of the “multi-electrode device” 10 of this invention are embedded between two triangle-shaped pieces of material in correct anatomical positions for electrode placement. The triangles and sensing electrodes units are made from materials commonly used and described below, under “options”. The underside of the device, which will be in contact with the skin, will allow a small exposed area of each sensing unit to come into direct contact with the skin. There will be a type of gel commonly used and described below to enhance conductivity between the skin and sensing unit. There will be a type of adhesive on the underside of the device that is in contact with the skin made from a commonly used material described below. Each sensing unit or electrode will be permanently attached to a wire, and the wires will exit the triangle “multi-electrode” either bound in a single cable or separate. The inventor conceptualizes the electrode placement device of this invention to be disposable. There will be a combination of connectors and cables that will allow for universal connections to most monitors and electrocardiogram machines. The package containing the device as well as the device itself will have illustrations to show exactly where to place the device on the patient. In using the electrode placement device of this invention, a triangle is preferred because of the cost savings in the material. An isosceles or equilateral triangle is not mandatory; any triangle will do. The sizes will be “S, M, L” (small, medium, large). The diagram of the body will be printed on the front of the device (also on the package) so that use of the product will be easy to use by the most inexperienced technician. In an emergency, the Emergency Medical Technicians (EMT's) are eager to get the patient to the Emergency Room (ER). They don't take the time, presently, to apply the “buttons” or suction cups for an Electrocardiogram (EKG). It takes too long and requires training and skill. They have to get the patient to the ER quickly. The herein disclosed invention remedies this problem, and the device is easy to use and can be used in emergency situations. The leads of the inventive device are sandwiched between the two layers of material. The material is soft and flexible. A cover sheet (on the back) is lifted off by the nurse or “tech” to expose the adhesive and electrodes, and the device is positioned on the patient's chest. The adhesive is in contact with the patient's skin. It is just like the adhesive used on the present disposable “buttons”. The individual leads can be surrounded by perforations so that they can be moved for more accurate placement. The device will interface via an adapter with any EKG machine. There are four or five standard machines. The short wires coming off of the device will be bundled into a connector and, through an adapter 28 , to the EKG. Or the connector may be fitted to a particular EKG. The preferred number of electrodes used in the device of this invention is nine, however, more or fewer electrodes could be used. In using the device, it is only necessary for the device to be fitted in a proximate position. (Of course, the more precise, the better.) The important thing is to be consistent, to establish a database for future readings with that particular patient. The device stays in place. There are no leads or (“buttons”) to be moved around. It's the differences (from previous readings) which are important. If not positioned right, peel it off and re-position it. Or toss it away and use another one. For adults, male or female, the device would be sized accordingly: S=90-140 pounds M=140-180 pounds L=180+pounds For children we would need around 4 or 5 different sizes. Sizes for male and female don't vary too much, except for large breasted females. The “buttons” on the leads could be in a perforated area which could be popped out to reposition a particular “button” if necessary. By convention there are now 12 leads being used. But in the field, around three are applied. With 12 leads, you would get much more information on the condition of the patient's heart. The inventive device is described with nine leads but could be fashioned to contain more leads. The herein described invention contemplates a comprehensive method of use. This is possible since the electrode placement device can remain in place from the time that the emergency medical technician places the device on the patient (1) during an emergency, (2) in the ambulance, (3) in the emergency room, (4) in the operating room, (5) in the intensive care unit and in the (6) recovery room. This is a major advantage since the EKG readings will be consistent. Variability of readings due to placing and replacing electrodes will be eliminated. In a preferred embodiment of the present invention, the electrodes (contacts or sensing elements) 18 may be chlorodized silver or copper/nickel alloys. The conducting gel may be hypoallergenic, solid or wet. The material for the “triangles” may be foam latex free, fabric (+/−non-woven, +/−stretchable), and hypoallergenic, ventilated, vinyl tape, fluid resistant. The adhesive is diaphoretic and high “tack”. Other variations or options comprise perforations around the sensing unit in various shapes and sizes, allowing them to stay adhered to the patient while the extra adhesive material is removed (for prolonged use of the electrodes), color coding in various ways, alternative for use on the back instead of the chest, various adult and pediatric sizes, adaptations to allow for veterinary use, pull-tabs, lead or cable lock design, and/or x-ray translucent materials. It will be appreciated by those skilled in the art that many advantages accrue from the use of the electrode placement device of the present invention, as follows: 1) The device is disposable. This eliminates a potential source of patient-to-patient infection. 2) The device is relatively inexpensive. 3) The device follows the standard lead pattern which is built in. Although this feature is not necessarily critical, variations of configuration of electrodes is possible. 4) The device has a universal adaptor which can be used anywhere in the world. 5) The device comes in a package with easy to use instructions and a placement diagram. 6) No special skill or training is required to use the device. 7) The device is faster and easier to use than conventional devices. 8) Using the device of this invention eliminates variability in placement and replacement. 9) The triangular configuration uses less material (from a cost standpoint). 10) The device of this invention is easy to use in emergency medical situations. 11) The device can be kept in place even with the patient going into the emergency room or operating room. 12) The device could also be used for regular periodic exams as well as for stress tests. 13) The device is sized to fit the patient. 14) The device can be used in the field as well as the office. Obviously, many modifications may be made without departing from the basic spirit of the present invention. Accordingly, it will be appreciated by those skilled in the art that within the scope of the appended claims, the invention may be practiced other than has been specifically described herein.

Disclosed is an electrode placement with a series of electrodes disposed therein to be used for a one-step placement of electrodes. The device is shaped to allow it to be positioned and placed on a patient so that accurate placement of electrodes is achieved.

FIELD OF THE INVENTION The present invention relates to a device for collecting a sample of exfoliated cells from a colorectal mucosal surface of a human subject, to a kit comprising said device and to methods of colorectal cell sampling using said device. BACKGROUND OF THE INVENTION Sporadic colorectal cancer (CRC) is one of the most frequently occurring and deadly of the oncological diseases affecting people in developed Western countries. It predominantly affects people over the age of 50. A serious obstacle to early diagnosis of CRC is the absence of early, readily identifiable clinical manifestations in the majority of cases. It is only in the advanced stages of the disease, when larger tumours have formed, resulting in pain, bleeding and symptoms of obstruction, that the disease is readily diagnosed. However, the late stages of the disease are also associated with invasive or metastatic tumours. Thus, detection of colorectal tumours prior to the advanced stages of the disease would greatly increase the chances of successful surgical intervention and overall survival rates. In the absence of early, readily identifiable clinical indications, the search for suitable CRC screening methods has continued for decades. Unfortunately, there is presently no CRC screening technique that combines low invasiveness, simplicity and low cost with high sensitivity and specificity. Two methods of screening for CRC are flexible colonoscopy/sigmoidoscopy and faecal occult blood testing (FOBT) [Rennert, G. Recent Results Cancer Res. 2003; 163: 248-253, Atkin, W. Scand. J. Gastroenterol. (Suppl.) 2003; 237: 13-16, Walsh, J. M. and Terdiman, J. P. JAMA 2003; 289: 1288-1296]. However, both of these methods have significant drawbacks. Flexible colonoscopy/sigmoidoscopy is regarded as a precise and reliable diagnostic procedure, however, its invasiveness, cost and requirement for skilled and experienced specialists to carry out the procedure make its use in routine screening impractical. The same is true for recently introduced computed tomographic colonography (virtual colonoscopy). FOBT is cheap and simple, however, it produces unacceptably high rates of both false negative and false positive results. Despite these limitations, FOBT is presently the screening method of choice. Alternative methods of diagnosing CRC based upon a direct indicator of tumour presence have been investigated. One indicator that has been identified is analysis of exfoliated colonocytes. Exfoliation of colonocytes (i.e. spontaneous detachment of cells from orderly organized epithelial layer of colonic mucosa) is an important cell renewal mechanism in the human gut [Eastwood, G. L. Gastroenterology 1977; 41: 122-125]. Cytological analysis of colonocytes obtained from colonic or rectal washings (i.e. by irrigation of the colorectal mucosa) was carried out approximately 50 years ago [Bader, G. M. and Papanicolau, G. N. Cancer 1952; 5: 307-14]. This work showed that morphologically distinct exfoliated neoplastic cells could be detected in CRC patients. However, the method of obtaining these samples (an invasive colonic lavage procedure) suffered from the same disadvantages as sigmoidoscopy/colonoscopy, and required detailed cytological analysis of the sample once obtained. The prevailing approach to obtaining samples of exfoliated epithelial cells has been to isolate them from human faeces. Human faeces were identified as a source of such cells, as the exfoliated cells of the colonic epithelium can be excreted in conjunction with other faecal matter. The first attempts to use colonocytes isolated from human faeces for diagnostic and research purposes were started about 15 years ago by P. P. Nair and his colleagues. They claimed to be able to recover thousands of “viable” exfoliated cells from a few grams of dispersed faecal material using an isolation procedure based on density gradient centrifugation [Iyengar, V. et al., FASEB J 1991; 5: 2856-2859, Albaugh, G. P. et al., Int. J. Cancer 1992; 52: 347-350]. However, these ambitious claims have generated substantial doubts due to the low likelihood of the presence of well-preserved colonocytes in an aggressive anaerobic environment such as that found in the faeces. Furthermore, morphological evidence presented in their 1991 reference was unconvincing. P. P. Nair and members of his group maintain the validity of their approach [Nair, P. et al., J. Clin. Gastroenterol. 2003; 36(5 Suppl.) S84-S93], but have not produced any practical advances based on the outcomes of their studies. However, despite the lack of practical advances by P.P. Nair and his colleagues, the use of human stool for diagnostic and research purposes remains an active research area as it is not associated with any invasive intervention. A number of groups have undertaken attempts to isolate colonocyte-derived genetic material (DNA) from human stool samples in order to develop diagnostic procedures employing molecular biomarkers of malignancy. Whilst DNA directly isolated from homogenized faeces can be amplified and analysed for the presence of cancer-associated genetic alterations, the absence of a highly reliable single molecular biomarker for cancer resulted in the use of multiple molecular markers reflecting a number of genetic alterations known to be present in malignant cells at relatively high frequencies. Several approaches proposing simultaneous detection of multiple mutations in the APC, K-ras and p53 genes combined with microsatellite marker analysis have been described [Ahlquist, D. A. et al., Gastroenterology 2000; 119: 1219-1227, Dong, S. M. et al., J. Natl. Cancer Inst. 2001; 93: 858-865, Rengucci, C. et al., Clin. Cancer Res. 2001; 93: 858-865, Traverso, G. et al., N. Engl. J. Med. 2002; 346: 311-320]. Methylation changes in faecal DNA have also been considered as a potential diagnostic marker [Muller, H. M. et al., Lancet 2004; 363: 1283-1285]. Although detection of colorectal tumours by multi-target molecular assays appears to be feasible, the validity of these methods for screening purposes remains questionable due to the high cost and relative complexity of laboratory procedures involved. The search for CRC molecular markers in DNA extracted from homogenized stool samples has overshadowed the importance of the initial collection/isolation of exfoliated colonocytes. It is, however, apparent that homogenized stool is a difficult material for human DNA extraction. In particular, the abundance of bacteria in faeces can interfere with colonocyte DNA recovery procedures, and rapid mammalian DNA damage and degradation occur in the presence of anaerobic bacterial flora of the human colon. The development of approaches based upon exfoliated colonocyte isolation has been slow partially due to a surprising lack of knowledge on cell exfoliation in the gut both in normal physiological conditions and in disease. The current views on colonocyte exfoliation are still affected by an old and unproven hypothesis implying “obligatory” exfoliation of nearly all differentiated colonocytes upon their migration to the luminal epithelium from the colonic crypts (i.e. it is presumed that there should be millions of colonocytes present in faecal matter because the cell proliferation rate of colonic epithelium is high and all cells are eventually exfoliated). It is, however, becoming clear that programmed cell death or apoptosis in situ is at least as important as exfoliation [Hall, P. A. et al., J. Cell Sci. 1994; 107: 3569-3577, Barkla, D. H. and Gibson, P. R. Pathology 1999; 31: 230-238, Ahlquist, D. A. et al., Hum. Pathol. 2000; 31: 51-57]. The relationship between these two major mechanisms of cell removal from colonic mucosa may undergo significant changes in colorectal neoplasia [Ahlquist, D. A. et al. (supra)]. Indeed, it is now proven that normal regulatory pathways leading cells to apoptosis are severely deregulated in malignant tumours [Bedi, A. et al., Cancer Res. 1995; 55: 1811-1816, LaCasse, E. C. et al., Oncogene 1998; 17: 3247-3259, Jass, J. R. Gastroenterology 2002; 123: 862-876, Oren, M. Cell Death Differ. 2003; 10: 431-442, Boedefeld, W. M. 2nd et al., Ann. Surg. Oncol. 2003; 10: 839-851] resulting in a greatly reduced apoptotic potential of cancer cells. At the same time, tumour cell adhesion is known to diminish dramatically as cancer progresses [Yamamoto, H. et al., Cancer Res. 1996; 56: 3605-3609, Haier, J. and Nicolson, G. L. Dis. Colon Rectum 2001; 44: 876-884, Leeman, M. F. et al., J. Pathol. 2003; 201: 528-534]. The latter phenomenon is important for metastatic spread, however in colorectal neoplasia, combined suppression of apoptosis and decrease in intercellular adhesion/communication greatly increases the chances of malignant cell shedding from the surface of growing tumours. If this is the case, exfoliated tumour cells, some of which can probably retain proliferative potential, should differ from their normal (non-tumour) exfoliated counterparts in: i) being more abundant due to facilitated exfoliation from the tumour surface; and ii) having much greater “survival” capacity, in particular due to higher resistance to the lack of oxygen [Graeber, T. G. et al., Nature 1996; 379: 88-91]. Upon exfoliation, these cells enter a relatively well oxygenated “mucocellular layer” that separates the colonic mucosa from the faecal contents of the gut and permanently moves distally with the flow of faeces [Ahlquist, D. A. et al. (supra)]. The importance of the mucocellular layer providing an interface between colorectal mucosa and faecal contents of the gut has not been understood until recently. Experimental studies indicated that good quality DNA could be easily obtained from the surface of rat faeces and used for further amplification and gene mutation analysis [Loktionov, A. and O'Neill, I. K. Int. J. Oncol. 1995; 6: 437-445]. These early experiments suggested that DNA extracted from colonocytes isolated from human stool surface (stool surface can be regarded as a fraction of mucocellular layer excreted with faeces) could be used for molecular analysis. A method of exfoliated cell isolation from human whole stool samples by washing cells off the surface of cooled faeces and collecting them by immunomagnetic separation procedure has been developed [Loktionov, A. et al., Clin. Cancer Res. 1998; 4: 337-342]. Although work in this direction was initially planned in terms of developing a molecular diagnostic assay for CRC, it emerged that a simple quantitative analysis of colonocyte-derived DNA from human stool surface could be used for CRC diagnosis and screening since the relative DNA amount in CRC patients was much higher compared to healthy individuals. Other authors have also reported higher amounts of either exfoliated cells [Dutta, S. K. et al., Gastroenterology 1995; 108 (Suppl.): A463] or DNA [Villa, E. et al., Gastroenterology 1996; 110: 1346-1353] in dispersed or homogenized stool samples obtained from CRC patients, however the differences between healthy people and cancer patients observed in those studies were not large enough to be considered diagnostically valid. By contrast, Loktionov et al (supra) were able to show the existence of a striking difference between CRC patients and healthy individuals employing a calculated index relating to the amount of DNA extracted from cells isolated from the stool surface to stool weight (stool DNA index or SDNAI). The SDNAI-based diagnostic method is described in U.S. Pat. No. 6,187,546. Although the technique and results of its initial trials apparently highlighted a very efficient, simple and inexpensive approach to CRC screening, it had a number of substantial faults (apparent difficulties of whole stool handling and especially impossibility of the procedure standardization) preventing its commercialization and serious introduction into clinical practice. It has also become clear that relatively small numbers of well-preserved cells can be obtained from human stool surface using this technique [Bandaletova, et al., APMIS 2002; 110: 239-246]. These problems, difficulty of standardization being the crucial one, cause serious doubts with regard to using exfoliated colonocytes isolated from stool samples for wide scale CRC screening. There is a good body of evidence indicating that the mucocellular layer covering human rectal mucosa is particularly rich in well-preserved exfoliated colonocytes. In addition, the cellular content of this layer in CRC patients appears to be much higher than in healthy individuals primarily due to greatly increased presence of highly resistant malignant colonocytes. Therefore CRC patients' tumour cells, which are much better adapted to autonomous existence, should quantitatively dominate the rectal exfoliated cell pool. Several recent reports describing distal (e.g. anal) implantation of persisting exfoliated cells from removed colorectal tumours [Jenner, D. C. et al., Dis. Colon Rectum 1998; 41: 1432-1434, Wind, P. et al., Dis. Colon Rectum 1998; 41: 1432-1434, Isbister, W. H. Dig. Surg. 2000 ; 17 : 81 - 83 , Hyman, N. and Kida, M. Dis. Colon Rectum 2003; 46: 835-836, Abbasakoor, F. et al., Ann. R. Coll. Surg. Engl. 2004; 86: 38-39] strongly corroborate this hypothesis. Direct access to the rectal mucosa is possible by routine digital rectal examination with an examiner's gloved finger. However, although one can achieve a contact with the rectal mucocellular layer by employing this simple manipulation, significant losses of material and simultaneous contamination with irrelevant squamous epithelium of the anal canal are inevitable during the removal of the finger from the rectum. Smears prepared from gloves used for rectal examination have shown well-preserved colonocytes, combined with a high level of contamination by cells of the squamous epithelium. There is thus a great need for direct collection of exfoliated epithelial cells from the surface of rectal mucosa without the problems of material loss and serious contamination with other tissue elements at the stage of removal of the cell-collecting surface from the rectum. Such cells could be used not only for quantitative cell and DNA analysis, but also investigated for the presence of additional cancer biomarkers (e.g. proteins) and finally assessed immunohistochemically and cytologically. SUMMARY OF THE INVENTION According to a first aspect of the invention, there is provided a colorectal cell sampling device comprising: a colorectal insertion member having a distal, insertion end, a proximal end and a closable interior cavity; a flexible membrane having an outer, cell sampling surface and an inner surface, wherein said membrane is sealingly attached to the distal, insertion end of said insertion member and held within the interior cavity; such that, in use, pressurisation of the interior cavity to at least a first elevated pressure causes the membrane to emit from the distal end of said insertion member to make contact with the colorectal mucosal surface and pressurisation of the interior cavity to a second reduced pressure causes the membrane to invert and return to the interior cavity of said insertion member. The device overcomes the difficulties with digital sampling by holding the flexible membrane within the insertion member both on insertion and withdrawal so that there is no material loss and the sample is not contaminated by cells from other surfaces (e.g. the squamous epithelium). By sampling the mucosal surface directly, the device overcomes the difficulties associated with whole stool sampling including, the unpleasant nature of the work, the low concentration of cells obtainable, the high levels of contamination with faecal matter (especially bacteria), and especially method standardization difficulties related to such problems, for example, great variability of stool size and consistency. Although the device is invasive, it is far less invasive than the devices currently used for colonoscopy/sigmoidoscopy, and does not require operation by a skilled and highly trained operator. The device may even be self-administered. The reduced level of invasiveness and the absence of complication risk are likely to lead to greater patient acceptance. These advantages should in turn allow for more sampling to be carried out, and at a lower cost. In a preferred embodiment of the invention, the flexible membrane is expandable and is constructed from an elastic material. More preferably, the flexible membrane is constructed from a nitrile, latex or rubber based substance. In a preferred embodiment of the invention, the closable interior cavity of the insertion member is closed. In a preferred embodiment of the invention, the cell sampling device further comprises means for pressurisation of the interior cavity, wherein said means are attached to the proximal end of the insertion member. Preferably, said means for pressurisation of the interior cavity are attached to the cell sampling device via a valve (e.g. a self-sealing valve) present at the proximal end of the insertion member. It will be appreciated that the means for pressurisation of the interior cavity may comprise any means suitable for applying a fluid (e.g. liquid or gas) to the flexible membrane. Preferably, the means for pressurisation of the interior cavity comprise a source of compressed air, a syringe or a pump (e.g. bulb). Preferably, the means for pressurisation of the interior cavity comprise a source of compressed air which comprises a mechanical device capable of delivering a pre-defined quantity of a first elevated pressure and a second reduced pressure to the cell sampling device. This embodiment has the advantage of accurately regulating the pressure inside the insertion member and the mechanical device has the advantage of being re-used with an indefinite number of disposable colorectal cell sampling devices. More preferably, the means for pressurisation of the interior cavity comprise a syringe. The use of a syringe, allows for both simple operation, and for a fixed volume of air to be pumped into the flexible membrane (preferably at least a ten fold increase in the volume of air present in the flexible membrane). For example, in an embodiment of the invention where a 100 ml syringe is attached at the proximal end of the insertion member, the plunger of said syringe could initially be set at the 70-90 ml mark. A pre-defined quantity of a first elevated pressure could therefore be applied by pushing the plunger to its maximum extent (e.g. to the 0 ml mark) which would fill the flexible membrane with an air volume of 70-90 ml. A pre-defined quantity of a second reduced pressure could then subsequently be applied by pulling the plunger of the syringe back to its maximum extent (e.g. to the 100 ml mark) which would draw the membrane into the interior cavity of the insertion member. In a preferred embodiment of the invention, the syringe would be supplied with one or more retention features (e.g. snap locations) to mark the plunger positions of the syringe at each stage during use (e.g. one position prior to insertion, one during insertion and one after withdrawal). The advantage of the means for pressurisation of the interior cavity being a syringe is that the colorectal cell sampling device may be adapted to fit onto commonly available and disposable laboratory and hospital equipment. In a preferred embodiment of the invention, the surface area of the outer, cell sampling surface of said flexible membrane is reproducibly controllable. This allows for a fixed surface area to be brought into contact with the colorectal mucosal surface being sampled, thereby providing a quantifiable collection of exfoliated cells which is correlated with the amount present on the surface of the colorectal mucosa. Preferably, the surface area is controlled by the means for pressurisation of the interior cavity. This allows for a fixed surface area to be brought into contact with the mucosal surface being sampled. In a preferred embodiment of the invention, the insertion member is adapted to engage with a rectal access tube. This embodiment has the advantage of allowing a rectal access tube and an obturator, such as an olive shaped obturator (a conjoined rectal access tube and obturator is commonly known as a proctoscope) to be inserted first to open the rectal cavity followed by withdrawal of the obturator prior to insertion of the sampling device of the invention. The sampling device could then remain held in position with the rectal access tube for whatever period of time was required to obtain a sample. The obturator would then be replaced once the sampling device is removed and the obturator and rectal access tube would be withdrawn together. In a preferred embodiment of the invention, the insertion member is configured to allow self-insertion. In such an embodiment, the insertion member is inserted together with a rectal access tube and therefore eliminates the need for an obturator (e.g. the insertion member has a rounded distal, insertion end). This embodiment provides the advantage that the sampling device of the invention may be self-administered, for example, patients will be easily able to sample exfoliated cells from their rectal mucosa. In this embodiment, it is envisaged that the insertion member and rectal access tube are inserted and removed together and only separated upon removal. In a preferred embodiment of the invention, the flexible membrane forms a receptacle when held within the interior cavity of said insertion member, such that fluid may be added. This embodiment of the invention would allow for reagents to be added to the sampling device after a sample has been obtained without the need to transfer the sample to a separate receptacle, thereby losing some of the material from the sample. In a preferred embodiment of the invention, the interior cavity of the insertion member is provided with adhesion means. This embodiment of the invention has the effect of drawing the flexible membrane towards the walls of the interior cavity of the insertion member once a sample has been obtained and application of the second reduced pressure has drawn the flexible membrane into the interior cavity of the insertion member. This feature has the advantage of providing a stable receptacle when filled with liquid. In a preferred embodiment of the invention, the insertion member is adapted to engage with a sealing means to seal said receptacle. This would allow the sampling device, containing the sample, to be stored and transported prior to further analyses being carried out on the sample. Preferably, the sealing means is a threaded cap. A threaded cap has the advantage of sealing the receptacle to prevent loss of sample and also allows removal for further analysis. In the embodiment wherein the cell sampling device comprises means for pressurisation of the interior cavity, said means are preferably detachable from the insertion member. This has the advantage of converting the sampling device into a compact assay vial which may be conveniently transported and stored with many other compact assay vials for subsequent screening reactions. In a second aspect of the invention, there is provided a kit for collecting a sample from a colorectal mucosal surface of a human subject, which comprises a colorectal cell sampling device as defined herein and a rectal access tube and optionally an obturator. The use of a rectal access tube provides both for more comfortable insertion of the sampling device, and prevents contact between the sampling device and any surface other than the mucosal surface to be sampled. The use of an obturator in addition to the rectal access tube, may ease the discomfort of inserting the rectal access tube. In a preferred embodiment of the invention, the kit may additionally comprise a lubricant, such as a lubricating jelly (e.g. K-Y jelly). This has the advantage of providing greater comfort during insertion of the obturator or cell sampling device of the invention. In a preferred embodiment of the invention, the obturator is disengaged from the rectal access tube after insertion of the conjoined obturator and rectal access tube into the rectal cavity. In a preferred embodiment of the invention, the kit further comprises sealing means, such as a threaded cap, to engage with the insertion member. In a preferred embodiment of the invention, the kit further comprises one or more reagents, such as a buffer. The use of a buffer allows for the preparation of the sample prior to further analysis. In a preferred embodiment of the invention, the buffer may be present in the threaded cap (e.g. as a blister packet), such that securing the cap to the insertion member releases the buffer into the receptacle (e.g. by piercing the blister packet) to suspend the cells present on the sampling surface of the flexible membrane prior to further analysis. In a preferred embodiment of the invention, the buffer is a cell-lysis buffer which has the advantage of providing a key step prior to DNA extraction. In an alternatively preferred embodiment of the invention, the buffer is a cell-preserving medium which has the advantage of allowing enhanced cytological, biochemical and immunohistochemical analyses on the resultant cell sample. Preferably, the cell-preserving medium is supplemented with one or more cell culture components (e.g. nutrients and antibiotics). It will be further appreciated by the person skilled in the art that any of the devices or kits previously described are suitable for sampling exfoliated epithelial tissue (e.g. colonocytes) from the surface of human colorectal mucosa. In a third aspect of the invention there is provided a method of quantitative sampling of exfoliated cells from a colorectal mucosal surface of a human subject without contaminating the sample by contacting other body surfaces comprising the steps of: bringing a sampling device comprising a sequestered cell sampling surface into proximity with the colorectal mucosal surface to be sampled, without making prior contact with any other body surface; contacting the cell sampling surface with the colorectal mucosal surface such that a sample is obtained from the mucosal surface; and removing the sampling device and sample from proximity with the mucosal surface without the sequestered cell sampling surface or sample making contact with any other body surface. This method encompasses the key steps of directly sampling exfoliated cells from a mucosal surface, and ensures that the sample is not contaminated by the cell sampling membrane making contact with other body surfaces. Contamination is avoided by sequestering the sampling surface, wherein sequestering may be defined as isolating or setting apart the sampling surface prior to bringing it into contact with the colorectal mucosal surface or after collecting cells from the colorectal mucosal surface. In a fourth aspect of the invention there is provided a method of sampling exfoliated cells from a colorectal mucosal surface of a human subject, comprising the steps of: inserting a colorectal cell sampling device according to the invention into the rectal cavity and bringing said device into proximity with a colorectal mucosal surface without the outer, cell sampling surface of the flexible membrane making prior contact with any other body surface; pressurising the interior cavity to at least a first elevated pressure so that the flexible membrane emits from the distal end of the sampling device; contacting the colorectal mucosal surface with the outer, cell sampling surface of said membrane such that a sample of exfoliated cells is obtained from the colorectal mucosal surface; applying a second reduced pressure to the interior cavity so that the flexible membrane inverts and the sample present on the cell sampling surface of said membrane returns to the interior cavity of the cell sampling device; and removing the cell sampling device from proximity with the colorectal mucosal surface and withdrawing said device from the rectal cavity without the membrane or sample making contact with any other body surface. It will be appreciated that the cell sampling device may additionally require a rectal access tube either alone or together with an obturator. Thus, in a preferred embodiment of the invention, the method additionally comprises the steps of: inserting a conjoined colorectal cell sampling device according to the invention and a rectal access tube into the rectal cavity; and removing said sampling device and sample from the rectal access tube. In a preferred embodiment of the invention, the method additionally comprises the steps of: inserting a conjoined rectal access tube and an obturator into the rectal cavity; withdrawing the obturator from the rectal access tube prior to inserting a sampling device; removing the sampling device and sample; replacing the obturator via the rectal access tube; and withdrawing the conjoined rectal access tube and obturator from the rectal cavity. In a fifth aspect of the invention there is provided a method of sampling exfoliated cells from a colorectal mucosal surface of a human subject, comprising the steps of: inserting a rectal access tube and an obturator into the rectal cavity via the anal canal; withdrawing the obturator from the rectal access tube; inserting a colorectal cell sampling device according to the invention into the rectal cavity via the rectal access tube, without the flexible membrane of the sampling device making contact with any other body surface; pressurising the interior cavity to at least a first elevated pressure so that the flexible membrane emits from the distal end of the sampling device; contacting the colorectal mucosal surface with the outer, cell sampling surface of said membrane; obtaining a sample of exfoliated cells from the colorectal mucosal surface; applying a second reduced pressure to the interior cavity so that the flexible membrane inverts and the sample present on the cell sampling surface of said membrane returns to the interior cavity of the cell sampling device; withdrawing the cell sampling device from the rectal cavity via the rectal access tube, without the flexible membrane of the sampling device contacting any body surface; replacing the obturator via the rectal access tube; and withdrawing the rectal access tube and obturator from the rectum via the anal canal. It will be appreciated that while the rectal access tube remains inserted in the rectal cavity, a further cell sampling device of the invention may be introduced into the rectal cavity. For example, the first cell sampling device may be introduced which comprises a cell-lysis buffer to allow DNA extraction and analysis (e.g. quantitation) of any sampled cells. Thereafter, a second cell sampling device may be introduced which comprises a cell-preservation medium to allow cytological, biochemical and immunohistochemical analysis of any sampled cells. In an alternative aspect of the invention, there is provided a sampling device for collecting a sample from a mucosal surface located within a rectal cavity of a subject, comprising: a substantially cylindrical body, which has an open cavity at the distal end and a closable cavity at the proximal end; a flexible membrane held within the substantially cylindrical body which forms a seal separating the open distal cavity from the closable proximal cavity; the two surfaces of the membrane being the proximal surface and the distal surface; and means for inflation and deflation, wherein the means for inflation can increase the internal fluid pressure of the closable proximal cavity when closed causing the membrane to evert from the distal end of the substantially cylindrical body until the distal surface of the membrane contacts the mucosal surface to be sampled; and the means for deflation can decrease the fluid pressure of the closed proximal cavity causing the membrane to invert so that the membrane is held within the substantially cylindrical body after the distal surface of the membrane has contacted the mucosal surface to be sampled. In a preferred embodiment of the invention, the deflation means is the valve. This embodiment of the invention would be particularly suitable for use with an elastic membrane where the internal pressure in the closable proximal cavity is greater than that outside the cavity. In a preferred embodiment of the invention, the deflation means comprises the syringe connected to the valve. In a second alternative aspect of the invention, there is provided a method of sampling exfoliated cells from a mucosal surface located within the rectal cavity of a human subject, comprising the steps of: bringing a sampling device according to the invention into proximity with a mucosal surface without the sampling membrane making prior contact with any other body surface; increasing the internal pressure of the closed proximal cavity so that the flexible membrane everts from the distal end of the sampling device; contacting the mucosal surface with the distal surface of the membrane such that a sample of exfoliated cells is obtained from the mucosal surface; decreasing the internal pressure of the closed proximal cavity so that the flexible membrane inverts, and it and the sample are held within the open distal cavity; and removing the device and sample from proximity with the mucosal surface without the membrane or sample making contact with any other body surface. In a preferred embodiment of the invention, the method comprises the steps of: attaching a source of compressed air to the valve, and increasing the internal pressure of the closed proximal cavity by opening the valve; or attaching a syringe to the valve and increasing the internal pressure of the closed proximal cavity by inserting the plunger. In a preferred embodiment of the invention, the method comprises the steps of: decreasing the internal pressure of the closed proximal cavity by opening the valve; or decreasing the internal pressure of the closed proximal cavity by withdrawing the plunger. In a preferred embodiment of the invention, the method comprises the steps of: adding a cell lysis buffer or cell preserving medium to the open distal cavity of the sampling device; and sealing the open distal cavity of the sampling device. In a third alternative aspect of the invention, there is provided a method of sampling exfoliated cells from a mucosal surface located within the rectal cavity of a human subject, comprising the steps of: inserting a rectal access tube and an obturator into the rectal cavity via the anal canal; withdrawing the obturator from the rectal access tube; inserting a sampling device according to the invention into the rectal cavity via the rectal access tube, without the flexible membrane of the sampling device making contact with any other body surface; connecting the sampling device to a means for inflation; increasing the internal pressure of the closed proximal cavity so that the flexible membrane everts from the distal end of the sampling device; contacting the rectal mucosa with a fixed surface area of the sampling surface; obtaining a sample of exfoliated cells from the surface of rectal mucosa; decreasing the internal pressure of the closed proximal cavity so that the flexible membrane inverts, and it and the sample are held within the open distal cavity; withdrawing the sampling device from the rectal cavity via the rectal access tube, without the flexible membrane of the sampling device contacting any body surface; replacing the obturator via the rectal access tube; withdrawing the rectal access tube and obturator from the rectal cavity via the anal canal; adding a cell lysis buffer or cell preserving medium to the open distal cavity; and sealing the open distal cavity of the sampling device. In a fourth alternative aspect of the invention, there is provided a method of screening and diagnosis for colorectal cancer which comprises any of the methods set out above and further comprising recovering the collected sample from the sampling device and performing an analysis on the sample. In a preferred embodiment of the invention, the analysis is selected from DNA quantitation, DNA extraction followed by its quantitation and optional molecular analysis, cytological/cytochemical investigation and biochemical tests. It is to be noted that the accuracy of screening by any of these methods will be improved by the provision of a sample with low levels of contaminants and a high concentration of cells taken from the colorectal mucosal surface being sampled. BRIEF DESCRIPTION OF THE FIGURES The invention will now be described, by way of example only, with reference to the accompanying drawings in which: FIG. 1 shows a cross-sectional view of a cell sampling device of the invention. FIG. 2 shows a schematic representation of a cell sampling device of the invention wherein the means for pressurisation comprise a syringe. FIG. 3 shows a schematic representation of a cell sampling device of the invention wherein the means for pressurisation comprise a source of compressed air. FIG. 4 shows the components required for sampling exfoliated cells from a colorectal mucosal surface of a human subject. FIG. 5 shows an example of a method of sampling exfoliated cells from a colorectal mucosal surface of a human subject using any of the devices shown in FIGS. 1-4 . FIG. 6 shows an example of the steps which may follow the method depicted in FIG. 5 . DETAILED DESCRIPTION OF THE INVENTION Description of Cell Sampling Embodiments The cell sampling device of FIG. 1 is designed for insertion into a rectal cavity. The device comprises a substantially cylindrical insertion member 1 with an interior cavity 3 , closed at the distal insertion end 2 by a flexible and resilient membrane 4 which is sealingly attached to the member 1 at the distal end 2 . In the position shown in FIG. 1 , the membrane 4 is held within the cavity 3 , and is adapted to emit from the cavity 3 when the cavity 3 is pressurised by means 7 (shown in more detail in FIG. 2 ). The membrane 4 has a cell sampling surface 5 which in the rest position shown in FIG. 1 is the inner surface, but when the membrane emits is the outer surface, and an opposing surface 6 which in the rest position is the outer surface, but which becomes the inner surface when the membrane emits. The membrane is made of nitrile, latex or a rubber based substance. At the proximal end 34 , the cavity 3 is closed by a self-sealing valve 18 , to which the pressurisation means 7 is adapted to be attached. The embodiment of the invention wherein the means for pressurisation of the interior cavity 7 is an integrated syringe is shown in FIG. 2 which schematically also shows the steps necessary to sample exfoliated cells from a colorectal mucosal surface of a human subject ( FIGS. 2A-2D ). FIG. 2A shows a representation of the cell sampling device prior to insertion into a rectal cavity. The syringe 7 is attached to an insertion member 1 substantially as described in FIG. 1 . The syringe has a plunger 23 which sealingly slides along a barrel 32 of the syringe 7 to alter the volume within an inner chamber 33 of the syringe 7 . The plunger 23 of the syringe 7 is set such that 70 ml of air is present within the chamber 33 of the syringe 7 . FIG. 2B shows a representation of the cell sampling device once inserted into a rectal cavity. The plunger 23 of the syringe has been fully depressed which causes the flexible membrane 4 to inflate to a volume of 70 ml. The inflated flexible membrane 4 then makes contact with the colorectal mucosal surface of a human subject such that any exfoliated cells are transferred to the outer surface of the flexible membrane 4 . FIG. 2C shows a representation of the cell sampling device once exfoliated cells have been sampled and prior to removal from a rectal cavity. The plunger 23 of the syringe 7 is retracted such that 80 ml of air is present within the chamber of the syringe 7 . This therefore creates a reduced pressure within the chamber which causes the flexible membrane 4 to be drawn back into the interior cavity of the insertion member 1 and adhere firmly to the side walls of the insertion member 1 . The amount of reduced pressure may be pre-quantified by the presence of two snap fit retention features 24 (only one of which is shown in FIG. 2C ). The snap fit features 24 are arms present on the plunger 23 of the syringe 7 which locate into holes on the barrel 32 of the syringe 7 . The purpose of the snap fit features 24 is to prevent withdrawal of the plunger 23 from the syringe 7 . FIG. 2D shows a representation of the cell sampling device after removal from the rectal cavity and prior to cell analysis. The distal, insertion end of the insertion member 1 is provided with a thread which is adapted to receive a 20 mm diameter threaded screw cap 8 . The cap 8 may have a blister packet containing a buffer such that upon screwing the cap 8 to the insertion member 1 , the buffer is released into the receptacle formed by the deflated flexible membrane 4 . After the cap 8 has been screwed to the insertion member 1 , the syringe 7 may be detached from the insertion member 1 to allow the insertion member 1 to be converted to a compact assay vial which, along with a plurality of other vials, may be packaged and sent to a laboratory for cell analysis. The embodiment of the invention wherein the means for pressurisation of the interior cavity 7 is a source of compressed air is shown in FIG. 3 . This figure schematically shows a mechanical device 9 which is a pump operated by an electrical motor (not shown) capable of delivering repeated doses of a first elevated pressure followed by a second reduced pressure upon activation of the trigger 14 . The mechanical device 9 is capable of attachment to an insertion member 1 substantially as described in FIGS. 1 and 2 by way of a click-fit locator 16 present on the mechanical device 9 which co-operates with a locating lug 17 on the insertion member 1 . A self-sealing valve 18 is present on the insertion member 1 to ensure pressure is maintained within the insertion member 1 upon disconnection from the mechanical device 9 . The insertion member 1 comprises vanes 19 which are designed to engage with a proctoscope and is threaded 20 at the distal insertion end in order to receive a threaded cap 8 having a blister packet 21 containing buffer. The mechanical device 9 is intended to be battery powered and may be re-charged by a power supply through a charging jack 12 . The mechanical device 9 comprises an air intake filter 25 , a rubberised handle 13 and also has an on-off switch 15 and light emitting diodes 10 and 11 which indicate when the device 9 is ready and when the cycle of first and second pressure applications are complete. In use, a user holds the mechanical device 9 by the rubberised pistol type handle grip 13 and attaches the device 9 to an insertion member 1 . The insertion member is then inserted into the rectal cavity where it engages with a proctoscope using the vanes 19 which enables an improved penetration consistency. A first elevated pressure is applied by the user by pressing the trigger 14 which causes air to be drawn into the mechanical device 9 through the air intake filter 25 which is then compressed and causes the flexible membrane to emit from the distal end of the insertion member 1 to make contact with the colorectal mucosal surface. A second reduced pressure is then applied by the user by pressing the trigger 14 a second time which causes the flexible membrane to return to the interior cavity of the insertion member 1 . Once cell sampling has been completed, the insertion member 1 is disengaged from the proctoscope and the mechanical device 9 is detached from the insertion member 1 and the pressure within the insertion member 1 is maintained by way of the self-sealing valve 18 . A threaded cap 8 having a buffer containing blister packet 21 may then be screwed to a thread 20 on the insertion member 1 causing buffer to be released into the receptacle formed by the deflated flexible membrane. The mechanical device 9 can then be re-used by attachment to subsequent insertion members 1 . Components Required for the Touch-Print Cell Sampling Technique The components required for sampling exfoliated cells from a colorectal mucosal surface of a human subject are presented in FIG. 4 . i) Access to the rectal mucosa can be achieved by the use of a rectal access tube 29 , which can be a modification of an existing instrument for rectal examination (e.g. rectoscope 22 ). The rectal access tube 29 consists of a rigid tube (with a handle) equipped with an obturator 30 providing an olive-shaped end and uninterrupted surface facilitating introduction of the rectal access tube 29 through the anal canal into the rectum. ii) The cell sampling device 1 shown in FIG. 4 is substantially as described in FIG. 1 and has an external diameter compatible with the internal diameter of the rectal access tube, i.e. in the range of 15-20 mm. iii) A source of compressed air 7 serves to provide a means for pressurisation of the interior cavity. The means for pressurisation 7 may comprise a syringe (as described in FIG. 2 ), an air pump (as described in FIG. 3 ) or a compressed air mini-container (mini-cylinder). Air pressure inside the cell-sampling device can be limited/ controlled by either using a fixed air volume (simple syringe solution) or by reaching a fixed air pressure level (a precision valve would be needed for this purpose). iv) A bottle or tube with a specific buffer 35 (different buffers should be used for different purposes, such as DNA or RNA extraction or cell isolation/separation for further analysis). v) A hermetic lid 8 for the cell-sampling device (needed for cell/protein lysis reactions if immediate DNA or RNA extraction is performed, for cell isolation procedures and, especially, for storage/transportation of the material if it is not immediately used, e.g. transportation from surgery/clinic to laboratory). The components required for the procedure can be developed to be used as a disposable kit, which should include all the listed components except the compressed air source, which can be used repeatedly. Description of the Touch-Print Cell Sampling Technique (Rectal Manipulations) FIG. 5 shows an example of the touch-print cell sampling technique to sample exfoliated cells from a colorectal mucosal surface of a human subject using any of the devices shown in FIGS. 1-4 . This procedure is simple and no special training in proctology or endoscopy is required for the operator to carry it out. It can be performed by any qualified medical professional (GP, nurse etc.) at a local surgery or patient's home or it may even be self-administered by the patient. FIG. 5A schematically illustrates a cross-section of the anatomy of the human rectum 28 , anal canal 26 and colorectal mucocellular layer 27 . It should be noted that any contact of the cell-sampling device with squamous epithelium of anal canal can result in both material loss and contamination of the sample with squamous epithelium of the anal canal. The procedure commences with introduction of a rectoscope-like rectal access tube 29 with an obturator 30 in place into the rectum 28 ( FIG. 5B ). An appropriate lubricant can be used for the introduction procedure to facilitate it and to diminish patient's discomfort, which can be caused by this initial stage of the procedure. Once the rectal access tube 29 is introduced ( FIG. 5C ) and the obturator 30 has been removed, direct access to rectal mucosa is achieved and the mucocellular layer 27 opens. The insertion member 1 is introduced to the rectal access tube 29 so that the upper edge of the insertion member is located just above the edge of the rectal access tube ( FIG. 5D ). A first elevated pressure is applied which inflates the collecting flexible membrane in order to contact the membrane with the rectal mucocellular layer 27 to provide touch-print cell sampling ( FIG. 5E ). The device is left in this position for approximately 10-15 seconds to achieve better adhesion of exfoliated cells and cell-derived materials of the mucocellular layer to the collecting membrane. FIG. 5F shows the application of a second reduced pressure which deflates the flexible membrane and causes it to return to its initial position with collected material 31 on the outer, cell sampling surface. The insertion member 1 is removed from the rectal access tube 29 and taken for further manipulations and analyses. The obturator 30 (a new re-lubricated one can be used) is reinstalled into the rectal access tube 29 , and the tube 29 is removed from the rectum 28 (see FIG. 5G ). The complete procedure (rectal manipulations) should take no more than a couple of minutes. Processing of Collected Cells. FIG. 6 shows an example of the steps which may follow the method depicted above for FIGS. 5A-5G which should be completed immediately after cell collection to avoid drying of the cell collection membrane. Step (a) shows cell-sampling device 1 with exfoliated cells 31 on the cell-collecting flexible membrane after cell collection. The top compartment of the cell-sampling device is filled with a fixed volume of a specific buffer 35 which lyses or suspends the exfoliated cells (Step (b)). Different cell lysis buffers or cell preserving mediums can be used for DNA or RNA extraction procedures, special buffers/mediums should be used for applications requiring cell isolation. The cell-sampling device is prepared for sample transport or storage by being hermetically closed with a secure threaded cap 8 (step (c)) but it will be appreciated that when the threaded cap has a buffer containing blister packet then step (b) can be omitted. The device can then be stored or transported for further downstream procedures for screening/diagnostic and/or research purposes (step (d)). Analysis of Samples It should be stressed that the technique provides a much higher degree of standardization in comparison with other existing approaches. The use of a standard device with standard air pressure/volume, standard area of inflated collection membrane (contact area with rectal mucocellular layer can vary, but this variation is negligible compared to other ways of obtaining exfoliated cells, e.g. stool-based techniques) and standard amount of buffer added after the cell sampling procedure create very favourable conditions for comparative analysis of either cell numbers or amounts of cell-derived substances (e.g. DNA). (a) Analysis of Samples for the Purpose of Colorectal Cancer Screening Colorectal cancer screening implies wide, population-based (age-defined) assessment of individuals presenting no complaints to reveal asymptomatic (in most instances—early) cases of the disease, timely treatment of which can reduce mortality caused by the condition. One necessary requirement for the method is its simultaneous applicability for thousands/millions of people. i) Given that there are strong indications of considerably higher amounts of colonocytes and colonocyte-derived DNA in rectal mucocellular layer of colorectal cancer patients compared to tumour-free individuals, it is very likely that the technique of direct sampling of exfoliated colonocytes and colonocyte-derived materials can provide a simple screening test for colorectal cancer based on the direct quantitation of -the amount of DNA extracted from the cells. For this approach the initial buffer used just after cell sampling should be a cell lysis buffer used for the selected DNA extraction procedure. The addition of the buffer should provide efficient cell lysis and preservation of the DNA-containing material during transportation to a dedicated laboratory and (probably) some period of storage. The DNA extraction method should be selected on the basis of its applicability for high throughput analysis, i.e. it should be compatible with multichannel liquid handling robotic systems. Exact values for DNA quantities defining “positive”, “negative” and “doubtful” results of the test should be determined in clinical trials. ii) Similar initial steps of DNA extraction can be applied for the analysis of molecular markers of colorectal cancer. Cells sampled by the touch-print procedure should provide a much better quality DNA compared to currently employed techniques of DNA extraction from stool samples. PCR amplification of this DNA can be done without precise quantitation of its amount. Multi-target molecular analysis is considered as an option in colorectal cancer screening, however it may be more time-consuming and expensive compared to direct quantitative analysis. At the same time DNA extracted for direct quantitation can certainly be used for PCR amplification in further diagnostic analysis of quantitatively “positive” or “doubtful” cases. iii) In case of a need for specific isolation of colonocytes from cells of other types, separation methods (e.g. immunomagnetic or density gradient separation) can be applied to achieve a higher purity of colonocyte cell population for the analysis. For this purpose some cell-preserving media containing antibiotics (some bacterial presence in the collected material is impossible to avoid) and mucolytic agents can be applied. Isolated colonocytes can then be used for different types of analysis such as DNA extraction and quantitation, DNA extraction followed by PCR amplification, cancer molecular and biochemical marker analysis, cytological/cytochemical assessment, and direct cell counting (doubtful in terms of screening due to low speed and high cost). (b) Colorectal Cancer Diagnosis Diagnostic use of tests is focused on individuals presenting some specific complaints or already identified as sufferers from a condition. Target groups of patients are much smaller than those expected for screening purposes. i) Direct DNA quantitation can be applied in individuals presenting complaints indicating possible colorectal conditions. ii) DNA extraction followed by PCR amplification and molecular analysis can be useful both for confirmation of the initial diagnosis and for advanced diagnostic procedures (assessment of cancer aggressiveness, sensitivity to chemotherapy for metastatic tumours, prognosis etc.). iii) Cell isolation can be used for both further molecular/biochemical analysis and cytological investigation (tumour cells with specific morphological features) can be easily found among exfoliated colonocytes in CRC patients.

A device for collection of exfoliated cells from the rectal mucosa comprises a hollow, cylindrical body having an inflatable and invertible flexible membrane attached to one end thereof. Applying positive pressure to inflate the membrane after the device is inserted, preferably through a rectal access tube, into the rectum causes exfoliated cells to be collected on the surface of the membrane. Before removal of the device, negative pressure is applied and the membrane, along with the collected sample of exfoliated cells, is deflated, inverted and withdrawn into the body of the device, thereby avoiding contact of the collected sample with body surfaces or the rectal access tube as the device is removed from the rectum.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a Continuation of application Ser. No. 12/801,332 filed Jun. 3, 2010, which is a Divisional of application Ser. No. 12/318,844 filed Jan. 9, 2009, which is a Divisional of application Ser. No. 11/826,292 filed Jul. 13, 2007, which is a Continuation of application Ser. No. 11/245,027 filed Oct. 7, 2005, which is a Divisional of application Ser. No. 10/913,485 filed Aug. 9, 2004, which is a Divisional of application Ser. No. 10/093,699 filed Mar. 11, 2002, which is a Continuation of PCT/CH00/00563 filed Oct. 18, 2000, which claims priority from German Patent Application. No. 199 50 204.8 filed Oct. 19, 1999 and German Patent Application. No. 299 19 053.6 filed Nov. 3, 1999. BACKGROUND OF THE INVENTION [0002] 1. Field of Invention [0003] The invention relates to an interdental treatment device that includes an electrically powered vibrating head. [0004] 2. Description of Related Art [0005] For teeth-cleaning purposes nowadays use is made either of conventional manual toothbrushes or of electric toothbrushes, in the case of which a movable brush head can be motor-driven from the handle. Electric toothbrushes usually achieve a more intensive cleaning action than the manual toothbrushes, but they have the disadvantage that they are relatively bulky and expensive and may damage the gums and subject the tooth enamel to pronounced abrasion. SUMMARY OF THE INVENTION [0006] An object of the present invention is to provide a cost-effective vibrating toothbrush which corresponds, in size, approximately to the conventional manual toothbrushes and nevertheless allows a better cleaning action than the latter. [0007] This object is achieved according to the invention by a toothbrush including a vibrating head part, a mechanical vibratory device in at least one of the head and a neck, and a power supply, preferably in the handle. [0008] Since a mechanical vibratory device which causes the head part to vibrate is accommodated in a front head part of the toothbrush, or in a neck-part region adjacent to the head part, the neck part connecting the head part to the handle, and is operatively connected to a power source, preferably accommodated in the handle, via electrical connections running in the neck part, vibration-damping means preferably being provided in order to prevent vibration transmission to the handle, this achieves the situation where the vibrations which effect the improved cleaning action are produced predominantly in the head part and can only be felt to a slight extent in the handle, as a result of which comfortable handling of the toothbrush is achieved. A further advantage of the toothbrush according to the invention is that there is no need for any mechanical drive means to be led through the flexible neck part to the vibratory device. It is merely the electrical connections, designed as wires, cables or electrically conductive plastic tracks, which run through the neck part. [0009] Preferred developments of the toothbrush according to the invention form the subject matter of the dependent claims. BRIEF DESCRIPTION OF THE DRAWINGS [0010] The invention will now be explained in more detail with reference to the drawing, in which, purely schematically: [0011] FIG. 1 shows a side view, partially in section, of a first exemplary embodiment of a toothbrush according to the invention and of a handle-closure part separated from one another (without a battery); [0012] FIG. 2 shows a bottom view, partially in section, of a second exemplary embodiment of a toothbrush according to the invention in the assembled state; [0013] FIG. 3 shows a side view, partially in section, of the toothbrush according to FIG. 2 and the closure part separated from one another (without a battery); [0014] FIG. 4 shows a side view of a third exemplary embodiment of a toothbrush according to the invention in the assembled state; [0015] FIG. 5A shows a front part of the toothbrush according to FIG. 4 with different embodiments of exchangeable interdental treatment heads; and [0016] FIGS. 5B-D show different embodiments of exchangeable interdental treatment heads. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0017] Both the toothbrush illustrated in FIG. 1 and that according to FIGS. 2 and 3 each have a handle 1 , a front bristle-carrying head part 3 and a neck part 4 , which connects the head part 3 to the handle 1 . The bristles combined to form clusters of bristles 6 are anchored in a bristle carrier 5 and form a possibly profiled brushing surface with their free ends. In the embodiment illustrated, the bristle carrier 5 with the clusters of bristles 6 is positioned, in a manner which is known per se and thus is not described in any more detail, on a retaining part 2 of the head part 3 such that it can be exchanged. [0018] The neck part 4 is provided with neck-part zones 7 which are made of an elastically relatively compliant material component and provide for, or additionally increase, the elasticity of the neck part 4 , with the result that, during use of the interdental treatment device, the head part 3 can be forced back resiliently in the case of forces acting in the direction of the brushing surface. If appropriate, the neck-part zones 7 are designed as notches which extend over part of the neck circumference and are filled with elastically compliant material (e.g. with thermoplastic elastomer). Of course, it would also be quite conceivable for the form and number of neck-part zones to be different. It is also conceivable to have a flexible neck zone without using elastic material components, e.g. by providing constrictions or by way of a bellows. [0019] Integrated in the front head part 3 , or in that region of the neck part 4 which is adjacent to the head part 3 , is a mechanical vibratory device 10 , by means of which vibrations which effect or enhance the teeth-cleaning action may be imparted to the head part 3 . The vibratory device 10 can be connected to an electric power source, accommodated in the handle 1 , via electrical connections running in the neck part 4 , as is described herein below. The already mentioned neck-part zones 7 made of an elastically compliant material act here as means which damp the vibration between the vibrating head part 3 and the handle 1 , with the result that the vibratory action is produced, in particular, in the head part and is only transmitted to the handle 1 to a slight extent. This means that only slight vibrations can be felt in the handle 1 during the teeth-cleaning operation, and the toothbrush is thus comfortable to handle. Conversely, however, it is also advantageous that the vibration produced is not damped by the handle 1 and can act to full effect in the head part 3 . Instead of the neck-part zones 7 consisting of elastically compliant material, however, other vibration-damping means would also be conceivable; it is not absolutely necessary to use an elastic material. The damping may also be achieved, using a basic material, by the neck part being configured in a particular form, for example by the presence of a bellows/accordion part, etc. [0020] Accommodated in the handle 1 is a sheath or sleeve 20 which extends in the longitudinal direction of said handle and is made of electrically conductive material. Both the handle 1 and the sleeve 20 are open to the rear, this forming a cavity 21 which can be closed from the rear by a closure part 22 and into which it is possible to insert a battery 25 , in the exemplary embodiment illustrated a commercially available, non-rechargeable cylindrical battery, with a defined power (e.g. 1.5 V) as the power source for the vibratory device 10 . It would also be possible, however, for a button cell or for a rechargeable storage battery to be used as the power source. [0021] A spring contact 29 for the positive pole 30 of the battery 25 (see FIG. 2 ) is fitted in the sleeve 20 , on a transverse wall 28 , and is connected to the vibratory device 10 via an electric line 31 , a switch 32 , which is installed in the sleeve 20 and can be actuated from the outside of the handle 1 , and an electric line 33 running in the neck part 4 . The electrical connection can be interrupted by means of the switch 32 . [0022] The closure part 22 is provided with a threaded stub 22 a made of an electrically conductive material and can be screwed into the handle 1 and/or into the sleeve 20 by way of said threaded stub. The threaded stub 22 a is provided with a contact surface 22 b which, with the closure part 22 screwed in, comes into abutment against the negative pole 35 of the battery 25 inserted into the sleeve 20 . The negative pole 35 is electrically connected to the vibratory device 10 via the threaded stub 22 a, the sleeve 20 itself and a line 34 , which connects the sleeve 20 to the vibratory device 10 and runs in the neck part 4 . [0023] Instead of being transmitted via the electrically conductive sleeve 20 , it would also be possible for the power from the negative pole 35 to be transmitted in some other way, for example using wires or an electrically conductive plastic. [0024] In the exemplary embodiment illustrated in FIG. 1 , the vibratory device 10 comprises a vibratory element 11 ′ which functions preferably in the manner of a vibratory armature, can be electrically connected directly to the power source via the lines 33 , 34 and, with the power source connected, is made to vibrate. [0025] In the case of the toothbrush variants illustrated in FIGS. 2 and 3 , the vibratory device 10 comprises a vibratory element 11 in the form of an eccentric, which produces mechanical vibrations and can be rotated about an axis located in the longitudinal direction of the toothbrush, and also comprises a drive which is arranged directly adjacent and is designed as a micromotor 15 . The vibratory element 11 is connected to the shaft 15 a of the micromotor 15 , which can be electrically connected to the power source via the lines 33 , 34 . The micromotor 15 and the eccentric may be accommodated as a structural unit in a housing 12 . [0026] Instead of an eccentric which can be driven in rotation, it would also be possible to have a vibratory element 11 which can be driven in a translatory manner. [0027] It would be possible, in the case of the toothbrush according to the invention, to arrange the bristle-carrying head part 3 such that it can be moved in relation to the neck part 4 in order for the latter, in the case of vibrations produced by means of the vibratory device 10 , to be made to move in relation to the rest of the toothbrush. [0028] The electric lines 31 , 33 , 34 could also be realized by electricity-conducting plastic tracks. [0029] The switch 32 , which connects or interrupts the lines 31 , 33 , may also be, for example, a magnetic switch. [0030] The preferred configuration of the switch 32 , however, contains a pulse switch arranged on a printed circuit board as well as further electronic components which store the switching state. [0031] It is also possible, however, for the electrical connection between the battery 25 and the vibratory element 11 ′ ( FIG. 1 ) or the drive 15 ( FIGS. 2 and 3 ) to be produced or interrupted not by the switch 32 , but by the closure part 22 , which can be screwed into the handle 1 and/or into the sleeve 20 or connected to the same in a bayonet-like manner, being turned (i.e. the switch 32 is dispensed with in the case of such a configuration). [0032] Instead of the rear closure part 22 being screwed to the handle 1 , it would, of course, also be possible to have some other type of releasable connection (e.g. plug-in connection, bayonet connection, etc.) and a corresponding configuration of the contact part interacting with the negative pole 35 . [0033] It would also be possible for the closure part 22 to be in a form which is quite different to that illustrated in the drawing. For example, the closure part could be provided with a set-down surface or a foot part and thus serve as an element on which the toothbrush can be set down. [0034] The toothbrush illustrated in FIG. 4 corresponds essentially to that according to FIGS. 2 and 3 ; the same parts, once again, have the same designations. According to FIG. 4 , the vibratory device 10 is arranged directly in the front head part 3 . In this exemplary embodiment, the sleeve 20 is dispensed with; the battery 25 is connected directly to the vibratory device 10 via the lines 33 , 34 . It is also the case with this device that use is preferably made of an exchangeable carrier 5 which can be positioned on a retaining part 2 of the head part 3 , e.g. in the manner of a snap-in connection. The capacity for changing the bristle carrier 5 provided with the clusters of bristles 6 is particularly advantageous since the interdental treatment device provided with the vibratory device 10 can be used irrespective of the service life of the bristles, which is usually even shorter than the service life of the battery 25 . [0035] As can be seen from FIG. 5 , it is possible, instead of the bristle carrier 5 or 5 a, which forms part of a conventional brush head and is provided with respective clusters of bristles 6 or 6 a, to position other, optionally different carriers or adapters 5 b to 5 d on the retaining part 2 , these being provided with different interdental brushes 6 b, 6 c or interdental treatment parts 6 d for effective cleaning of the spaces between the teeth. The interdental brush 6 b may be designed, for example, as a helical brush made of coated wire with plastic filaments twisted in. The interdental brush 6 c comprises bristles which, together, form a cluster tip. The treatment part 6 d may be designed, for example, as a plastic element which has a tip and may preferably be provided with an abrasive coating for removing plaque and tartar from the spaces between the teeth. Of course, it would also be possible to use any other desired treatment heads. [0036] It is also the case with the variant according to FIGS. 4 and 5 that the bristle carrier 5 could be configured such that a vibration-induced movement in relation to the retaining part 2 were possible. [0037] For the introduction of the vibratory device 10 , the connecting lines 33 , 34 and further electronic components, it is possible for the toothbrush according to the invention, or the housing thereof, to be produced in two parts and for the two parts to be welded in a water-tight manner once the abovementioned parts have been positioned therein. [0038] It is also possible, however, for the toothbrush according to the invention to be produced by injection molding preferably involving two or more components. The abovementioned parts are advantageously positioned as a unit in an injection molding made of a first material component and then encapsulated in the second material component (or in the further material component) by injection molding. It is not necessary here for full encapsulation to take place. Certain parts may be exposed, as a result of which it is possible to achieve an esthetic effect. [0039] It would also be possible, however, for the abovementioned electronic components to be inserted into a ready molded handle 1 . [0040] Since it is not only the vibratory element 11 , 11 ′ itself but also the drive, i.e. the micromotor 15 , which are arranged in the front head part 3 , or in the directly adjacent front region of the neck part 4 , it is not necessary for any mechanical drive means to be led through the flexible neck part 4 in order to connect the micromotor to the vibratory element 11 . It is only the electric lines 33 , 34 (wires, cables or electrically conductive plastic tracks) which run through the neck part 4 . [0041] According to the invention, use is made of a mechanical vibratory device 10 which has a diameter of less than 15 mm, preferably less than 6 mm, and is less than 35 mm, preferably less than 20 mm, in length. This ensures that the toothbrush may be of ergonomic configuration and is easy to handle. The toothbrush according to the invention may correspond, in size, more or less to the conventional manual toothbrushes, which makes them more straightforward to handle in comparison with the commercially available, considerably larger electric toothbrushes, even though this toothbrush achieves a cleaning action which is comparable with that of the known electric toothbrushes, but is gentler than the latter. Moreover, the toothbrush according to the invention is straightforward and cost-effective to produce. [0042] It is nevertheless also possible for the vibratory device according to the invention to be integrated in conventional electric toothbrushes.

An interdental treatment device, such as a toothbrush, includes a handle configured to accommodate an electric power source, a head carrying an interdental treatment tool, and a neck between the handle and the head. The head or neck includes a mechanical motorized vibratory device, including a drive which causes the head to vibrate. Electrical connections are operably connected to the mechanical vibratory device and the electric power source to power the mechanical vibratory device via the electrical connections. In various embodiments, a switch may be operably connected to at least one of the electrical connections to interrupt power from the power source to the mechanical motorized vibratory device. In various embodiments, a vibration-damping structure dampens vibration transmission from the head to the handle.

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority, pursuant to 35 U.S.C. §119(e), to U.S. Provisional Application Ser. No. 60/738,361 filed on Nov. 17, 2005, the content of which is incorporated herein in its entirety. FIELD OF THE INVENTION The present invention generally relates to methods for manipulating bacterial growth using a quorum sensing molecule. In particular, the present invention provides methods for the selective inhibition of bacterial growth in a biofilm. The present invention also relates to methods of treating or protecting against dental caries and infective endocarditis. BACKGROUND OF THE INVENTION A biofilm is a complex aggregation of microorganisms marked by the secretion of a protective and adhesive matrix. Biofilms are also often characterized by surface attachment, structural heterogeneity, genetic diversity, complex community interactions, and an extracellular matrix of polymeric substances. Single-celled organisms generally exhibit two distinct modes of behavior. The first is the familiar free floating, or planktonic, form in which single cells float or swim independently in some liquid medium. The second is an attached state in which cells are closely packed and firmly attached to each other and usually a solid surface. The change in behaviour is triggered by many factors, including quorum sensing, as well as other mechanisms that vary between species. When a cell switches modes, it undergoes a phenotypic shift in behavior in which large suites of genes are up- and down-regulated. Biofilms are usually found on solid substrates submerged in or exposed to some aqueous solution, although they can form as floating mats on liquid surfaces. Given sufficient resources for growth, a biofilm will quickly grow to be macroscopic. Biofilms can contain many different types of microorganisms, e.g. bacteria, archaea, protozoa and algae; each group performing specialized metabolic functions. However, some organisms will form monospecies films under certain conditions. The biofilm is held together and protected by a matrix of excreted polymeric compounds called EPS. EPS is an abbreviation for either extracellular polymeric substance or exopolysaccharide. For the purpose of this application, EPS will mean exopolysaccharide. This matrix protects the cells within it and facilitates communication among them through biochemical signals. Some biofilms have been found to contain water channels that help distribute nutrients and signalling molecules. This matrix is strong enough that under certain conditions, biofilms can become fossilized. Bacteria living in a biofilm usually have significantly different properties from free-floating bacteria of the same species, as the dense and protected environment of the film allows them to cooperate and interact in various ways. One benefit of this environment is increased resistance to detergents and antibiotics, as the dense extracellular matrix and the outer layer of cells protect the interior of the community. In some cases antibiotic resistance can be increased 1000 fold (Stewart and Costerton 2001). Biofilms are ubiquitous. Nearly every species of microorganism, not only bacteria and archaea, have mechanisms by which they can adhere to surfaces and to each other. Biofilms can be found on rocks and pebbles at the bottom of most streams or rivers and often form on the surface of stagnant pools of water. Biofilms are important components of food chains in rivers and streams and are grazed by the aquatic invertebrates upon which many fish feed. Biofilms grow in hot, acidic pools in Yellowstone National Park (USA) and on glaciers in Antarctica. In industrial environments, biofilms can develop on the interiors of pipes, which can lead to clogging and corrosion. Biofilms on floors and counters can make sanitation difficult in food preparation areas. Biofilms can also be harnessed for constructive purposes. For example, many sewage treatment plants include a treatment stage in which waste water passes over biofilms grown on filters, which extract and digest organic compounds. In such biofilms, bacteria are mainly responsible for removal of organic matter (BOD); whilst protozoa and rotifers are mainly responsible for removal of suspended solids (SS), including pathogens and other microorganisms. Slow sand filters rely on biofilm development in the same way to filter surface water from lake, spring or river sources for drinking purposes. One widely recognized health problem associated with biofilms is that they are present on the teeth of most animals, where they may become responsible for tooth decay. In addition to tooth decay, biofilms have also been found to be involved in a wide variety of microbial infections in the body, by one estimate 80% of all infections (NIH 2002). Infectious processes in which biofilms have been implicated include common problems such as urinary tract infections, catheter infections, middle-ear infections, gingivitis, coating contact lenses, and less common but more lethal processes such as endocarditis, infections in cystic fibrosis, and infections of permanent indwelling devices such as joint prostheses and heart valves. (Lewis 2001, Parsek and Singh 2003). Such bacterial infections are a persistent problem in human health. Outside of the body there are several means used to control reservoirs of infection including chemical disinfectants and forms of high-energy electromagnetic radiation e.g. ultraviolet light and X-rays. Although effective at controlling environmental populations, they cannot be used to treat bacterial pathogens once infection has occurred. To date, the only treatment that is known to be effective is antibiotics. The way antibiotics generally works is to take advantage of the variant metabolic pathways that exist between humans and bacteria, thereby, differentially affecting bacterial cells. They have two big drawbacks. First, they are not specific against any one type of bacteria and can damage commensal or beneficial bacteria resulting in new pathologies. Second, bacteria have readily evolved to become resistant to antibiotics. Since antibiotics are not beneficial to the bacteria, they can be neutralized without a loss of any critical functions. In addition, antibiotics are not very effective against a bacterial infection that has formed a biofilm. Therefore, there still exists a need for an improved method to treat biofilm-related bacterial infections as well as to manage the formation of biofilms. SUMMARY OF THE INVENTION The present invention is based on the unexpected discovery that the growth rate of bacterial cells has a dose-dependent response to quorum sensing molecules, and that at high dosages, the quorum sensing molecules actually induce cell death. Based on this discovery, and the knowledge that some quorum sensing molecules are species specific, a method for manipulating a selected bacterial population is developed in the present invention. Accordingly, in one aspect, the present invention provides a method for selectively manipulating a growth rate of the selected bacterium, comprising the step of contacting the selected bacterium with a predetermined amount of a quorum sensing molecule to effect a change in the growth rate of the selected bacterium, wherein the quorum sensing molecule is species specific, and the change in the growth rate is dependent on the amount of quorum sensing molecule in a dose-dependent fashion. A method according to this aspect of the present invention may be applied to a wide range of bacterial species including, but not limited to Streptococci, Staphylococci , and Bacilli . For example, gram-positive bacteria are excellent targets because they have peptide-based, species specific quorum sensing systems. Although the method of the present invention is a general method that may be applied to a wide range of microbial organisms, in order to facilitate a full and complete understanding of the present invention, the following exemplary discussion of S. mutans quorum sensing is provided. Quorum Sensing (QS) As used herein, the term “quorum sensing” refers to the ability of bacteria to communicate and coordinate behavior via signaling molecules, or “quorum sensing molecules.” Throughout this application, the abbreviations QS and QSM will be used to stand for Quorum Sensing and Quorum Sensing Molecule, respectively. The purpose of QS is to coordinate certain behaviour or actions between bacteria of the same kind, depending on their number. For example, opportunistic bacteria, such as Pseudomonas aeruginosa can grow within a host without harming it, until they reach a certain concentration. Then they become aggressive, their numbers sufficient to overcome the host's immune system and form a biofilm, leading to disease. QS was first observed in Vibrio fischeri , a bioluminiscent bacterium that lives as a symbiont in the light-producing organ of the Hawaiian bobtail squid. When V. fischeri cells are free-living, the cells are sparsely distributed and the QSM, also known as the autoinducer, is at low concentration and thus cells do not luminesce. In the light organ of the squid, the cells are highly concentrated (about 10 11 cells/ml) and the QSM alters the gene expression pattern to induce transcription of luciferase, leading to bioluminescence. Processes possibly regulated or partially regulated by QS systems in E. coli include cell division. In other species such as Pseudomonas aeruginosa quorum-related processes include biofilm development, exopolysaccharide production, and cell aggregation. Streptococcus pneumoniae uses QS to become competent. Quorum Sensing in S. mutans The bacterium S. mutans is one of the primary etiologic agents of tooth decay (Loesche, 1986). These bacteria first adhere to the smooth surface of teeth along with other early colonizing bacteria. Attachment and subsequent growth on the surface is marked by a physiological change where the bacteria undergo a significant alteration in gene regulation to convert from a planktonic (or free living) state to a biofilm (a community adhered to a surface) state. Particularly striking is the formation of extensive structures composed of EPS. Although the bacteria eventually become sessile, the biofilm continues to grow until the structures become so large that they begin to slough off, with the newly planktonic bacteria repeating the biofilm cycle. One early step in this biofilm formation process is the adherence of S. mutans to teeth followed by a dramatic increase in cell density. S. mutans has at least two distinct cell-cell communication systems collectively referred to as QS systems. Each QS system shares a general mechanism where the cell secretes an autoinducing molecule. When the population density of the cell and the concentration of the autoinducer reach a critical threshold, the cell can sufficiently bind to and hence sense the autoinducer. The effect of binding is a cascade of changes in gene regulation. Of the two known QS systems, the one that activates competence (the ability to take up new genetic material) is best understood. The current paradigm dictates that once the quorum threshold is achieved, then genes involved in uptake and processing of extracellular DNA (transformation) become activated. One current model for control of streptococcal competence through QS is outlined in FIG. 1 . This system relies in part on a pair of proteins that make up a two component signal transduction system (TCSTS) which relies on a transmembrane sensor and an intracellular response regulator. The pathway is initiated by the expression of the comC gene which encodes a 46 amino acid polypeptide of which the first 25 amino acids represent a signal/secretion domain. This domain is believed to be cleaved off by the ComA/B antiporter that secretes the mature 21 amino acid peptide, henceforth called CSP (competence stimulating peptide). It is believed that when the density of cells and the concentration of CSP reaches a critical threshold, there is sufficient interaction of CSP with the two component transmembrane sensor, ComD. Upon binding of CSP to ComD, the intracellular domain becomes phosphorylated. Consequently, this phosphate group is specifically donated to the ComE response regulator protein. Phosphorylated ComE appears to be able to activate certain promoters by binding to a consensus site −70 to −50 bp upstream of the target genes transcriptional start. All of the aforementioned com genes seem to be upregulated including an additional gene, comX, which encodes an alternative sigma factor called ComX. ComX is purported to activate all the late corn genes including all of the structural genes that are required for the bacteria to uptake and incorporate DNA. Competence QS system and S. mutans Attachment Streptococcus mutans ability to colonize the smooth surface of teeth is strongly enhanced in the presence of dietary sucrose. Although sucrose is used as a preferred fermentable carbon source, it is also the primary substrate of a group of glycosyltransferases. Amongst these enzymes is a group of three homologous glucosyltransferases (GTF) which are also necessary for efficient colonization (Loesche, 1986). All three GTFs transfer a glucose moiety from sucrose to a growing polysaccharide chain of glucose subunits (glucans). In addition, they all share at least 50% amino acid sequence identity, with GTFB and GTFC being greater than 75% identical. All three GTFs function extracellularly and acquire their substrate, sucrose, from the oral cavity (reviewed in Banas and Vickerman, 2003). In addition, each GTF can be distinguished by the glycosidic linkage of its glucan product. GTFB forms primarily α-1-3 glucosidic linkages (mutan) that are insoluble while GTFD creates primarily α-1-6 glucosidic linkages (dextran) that are soluble. GTFC forms a mixture of both types of glucosidic linkages. While dextran is believed to be an important component of the biofilm-structure and can readily be metabolized by extracellular dextranases, mutan is believed to be essential for adherence and is very persistent, being a very poor metabolic substrate. Hence, the formation of mutan can be considered both a critical and committed step; one where sucrose a preferred carbon source is irreversibly utilized for attachment. Once initial attachment has occurred, specific adhesins are utilized for more permanent anchoring of the bacteria to the surface of the tooth. This obviates the need for further mutan production. (Goodman and Gao, 2000). The gtfB and gtfC genes have coding sequences of 4.4 kb and 4.1 kb respectively. They are found in tandem repeat with only 198 bps separating their coding sequences; gtfD is unlinked. The former two genes are believed to be the product of gene duplication; this would account for their genetic arrangement and sequence similarity. The fact that the two coding sequences have been known to recombine under non-native conditions to create a hybrid gene suggests that this tandem arrangement was intentionally retained for biological function. One pathway of gtf regulation that has yet to be explored is through quorum sensing. It has been previously shown that gtfB and gtfC possess independent promoters but are both coordinately regulated in a growth phase dependent fashion; both gtfB and gtfC expression are strongly induced at low cell densities and strongly repressed at high cell densities (Goodman and Gao, 2000), the hallmark of QS. In view of the foregoing discussion, it becomes clear that QS is important in the development of biofilms. Therefore, based on the discovery of the present invention, it becomes possible to develop strategies for controlling biofilm by disrupting the QS pathways. Accordingly, in another aspect of the present invention, a method for treating or protecting against a condition associated with the attachment of S. mutans to teeth of a subject is provided. A method according to this aspect of the present invention generally comprises the step of administering to the subject a composition containing CSP in an amount effective to reduce the presence of S. mutans on teeth, wherein the effective amount is dependent on the level of reduction desired based on a dose-response relationship between a growth rate of S. mutans and CSP. Because sucrose may stimulate the growth of non-targeted bacteria, therefore, in some embodiments, the composition may further comprise sucrose. Alternatively, the composition may further comprise an orally acceptable carrier, an anti-caries agent, or any other suitable dental care ingredients commonly used in the art. Moreover, because it is an unexpected discovery of the present invention that an overdose of CSP may induce cell death, in some embodiments, the amount of CSP is preferably greater than 1 mg/ml. A treatment or protection method according to the present invention has at least the following advantages. A method of the present invention is selective with respect to the target bacterium, and does not undesirably disturb the remaining microflora. The addition of sucrose will stimulate the growth of other non-targeted microbes to enhance the selective pressure against the targeted bacterium, providing a natural-selection based approach to eliminate the targeted bacterium, thereby, reducing the risk of side-effects associated with using a foreign compound. Furthermore, because QSM is a natural molecule produced by the bacterium, the likelihood of the bacterium developing a resistance is greatly reduced. Other aspects and advantages of the invention will be apparent from the following detailed description and the appended claims. BRIEF DESCRIPTION OF DRAWINGS FIG. 1 is the postulated regulation of gtf genes by the competence pathway. FIG. 2 is the peptide sequence of CSP using the one-letter amino acid abbreviation from amino terminus to carboxyl terminus. FIG. 3 shows the bar graph of the data from an in vitro attachment assay presented as the percentage of attached bacteria versus optical density of the total (attached and unattached) bacteria. FIGS. 4A and 4B are graphs of the data from an in vivo transcriptional fusion assay of the growth phase-dependent expression of gftB (Panel A) and gftC (Panel B) genes in S. mutans , presented as optical density and luciferase activity versus time (hours). FIG. 5 is an image of a Western blot showing the overexpression of GTFB in the mutant of S. mutans lacking the CSP. FIG. 6 is schematic representation of an in vitro attachment competition assay between the gftBCD (glucosyltransferase (gtf)-negative) mutant and wild-type S. mutans. FIG. 7 is an image of a Western blot showing the negative effect of CSP on the GTFB expression in S. mutans. FIG. 8 is a bar graph of the data from a transcription fusion assay to determine the effect of CSP on gtfB gene expression in S. mutans presented as percent luminescence versus concentration of CSP. FIG. 9 is a bar graph of the percent of S. mutans that sticks to a surface in the presence of CSP and in the presence or absence of sucrose. FIG. 10 shows the putative ComE binding sites in the upstream regions of gftB and gftC. FIG. 11 is an image of an electromobility shift assay gel. Lane 1 is gtfC promoter DNA; Lane 2 is gtfC promoter DNA with E. coli cleared lysate added; and Lane 3 is gtfC promoter DNA with E. coli cleared lysate containing S. mutans ComE. FIG. 12 shows temporary growth inhibition of S. mutans wild-type strains UA140 (A) and UA159 (B) by CSP. DETAILED DESCRIPTION Compositions The compositions of this invention minimize the attachment of S. mutans to teeth, and thus minimize the negative consequences such as dental caries and endocarditis that can result from this attachment. Since other early colonizing oral bacteria rely on their own gtf genes for efficient adherence and are not affected by the presence of CSP, such non-pathogenic bacteria will gain a competitive advantage over S. mutans . In one embodiment, the composition comprises between about 0.05 and 30% (w/w) of CSP. It is to be understood all peptides and proteins having the same or similar function as the CSP peptide encoded by the sequence shown in FIG. 2 (SEQ ID NO: 1) are considered to be functional equivalents of this peptide and are also included within the scope of this invention. Accordingly, the terms “ S. mutans CSP” and “CSP” as used herein encompass the CSP of S. mutans and all functional equivalents thereof. The CSP-containing compositions of this invention include sucrose. It was discovered that the negative effect of CSP on S. mutans is enhanced by the addition of sucrose. That is, since S. mutans is in direct competition with other early bacterial colonizers of the smooth surface of teeth and since many oral streptococci utilize similar glucosyltransferases to facilitate attachment, the combination of CSP and sucrose will specifically reduce the efficiency of S. mutans adherence while enhancing the ability of other non-pathogenic bacteria to more efficiently compete for the bare supergingival pellicle. Indeed, individuals that are edentate are devoid of S. mutans . Hence, CSP treatment should eventually lead to the surgical elimination of S. mutans from the oral cavity. As used herein, the term “oral diseases” refers to diseases and disorders affecting the oral cavity or associated medical disorders that are caused by the attachment of S. mutans to a subject's teeth. Oral disorders include, but are not limited to, dental caries; periodontal diseases (e.g., gingivitis, adult periodontitis, early-onset periodontitis, etc.); mucosal infections (e.g., oral candidiasis, herpes simplex virus infections, oral human papillomavirus infections, recurrent aphtous ulcers, etc.); oral and pharyngeal cancers; and precancerous lesions. The term “subject” refers to any animal, including mammals and humans. The composition of this invention may further include one or more of anti-caries agents in addition to CSP. It is contemplated that various anti-caries reagents well known in the art can be included in the compositions and medicaments of the present invention and include, but are not limited to: (1) substantially water insoluble noncationic antimicrobial agents, including but not limited to, Xylitol, triclosan, halogenated diphenyl ethers, benzoic esters; sesquiterpene alcohols (e.g., farnesol, nerolidol, bisabolol, and santalol), halogenated carbanilides, phenolic compounds including phenol and its homologs, mono-, poly-alkyl and aromatic halophenols, resorcinols (e.g., hexyl resorcinol), catechols (e.g., 2,2′-methylene bis (4-chloro-6-bromophenol), and bisphenolic compounds; (2) non-steroidal anti-inflammatory drugs (NSAIDs), which can be characterized into five groups: (1) propionic acids (e.g., ibuprofen, indoprofen, ketoprofen, naproxen, benoxaprofen, flurbiprofen, fenoprofen, fenbufen, pirprofen, carpofen, oxaprozin, pranoprofen, miroprofen, tioxaprofen, suprofen, alminoprofen, tiaprofen, fluprofen, and bucloxic acid); (2) acetic acids (e.g., ketorolac, indomethacin, sulindac, tolmetin, zomepirac, diclofenac, fenclofenac, alclofenac, ibufenac, isoxepac, furofenac, tiopinac, zidometacin, acematacin, fentiazac, clidanac, oxpinac, and fenclozic acid); (3) fenamic acids (e.g., mefenamic acid, meclofenamic acid, flufenamic acid, niflumic acid, and tolfenamic acid): (4) biphenylcarboxylic acids (e.g., diflunisal and flufenisal); and (5) oxicams (e.g., piroxicam, sudoxicam and isoxicam); (3) histidine-rich polypeptides (“HRPs,” also referred to as histatins), such as histatin-based peptides disclosed in U.S. Pat. Nos. 4,725,576; 5,912,230; 5,885,965; 5,631,228; 5,646,119; and 5,486,503, each of which is incorporated herein by reference; (4) fluoride reagents including sodium fluoride, stannous fluoride, amine fluorides, and monosodiumfluorophosphate; (5) casein; (6) plaque buffers such as urea, calcium lactate, calcium glycerophosphate, and strontium polyacrylates; (7) non-immunogenic amino acid segments of proline-rich proteins that inhibit the adhesion of disease-causing microorganisms to tooth surfaces, as described in U.S. Pat. No. 5,013,542, incorporated herein by reference. The active ingredient can be derived from segmenting a natural or synthetic, proline-rich protein, to provide a non-immunogenic ingredient. The non-immunogenic amino acid segment can be obtained by various techniques, such as by cloning, or by synthesizing analogs of the natural molecules or their segments by chemical means. The non-immunogenic amino acid segment can also be obtained enzymatically or by cleaving the proline-rich protein derived from human saliva by the enzyme trypsin; (8) antibodies against S. mutans , including intact molecules as well as functional fragments thereof, such as monoclonal IgG antibodies that specifically bind an antigen on the surface of S. mutans , including the following antibodies disclosed in U.S. Pat. No. 6,231,857, incorporated herein by reference: the hybridoma deposited with the American Type Culture Collection as ATCC No. HB12559 (designated SWLA1), the hybridoma deposited with the American Type Culture Collection as ATCC No. HB 12560, (designated SWLA2), and the hybridoma deposited with the American Type Culture Collection as ATCC No. HB 12258 (designated SWLA3). and (9) other pharmaceutically acceptable vehicles, diluents and additives such as antioxidants, buffers, bactericidal antibiotics and solutes which render the formulation isotonic in the intended recipient; and aqueous and non-aqueous sterile suspensions which may include suspending agents and thickening agents and liposome-based drug delivery systems commonly known in the art. Oral Formulations The compositions of this invention can be added to a variety of formulations suitable for delivery of the composition to the oral cavity, including, but not limited to, mouthwash solutions, abrasive dentifrice gels, nonabrasive dentifrice gels, denture washes or soaks, denture adhesives or cements, chewing gums, and soft drinks. In order to provide such formulations, a composition of this invention is combined with one or more orally acceptable carriers and/or excipients, or packed in a hydrophobic-delivery vehicle such as liposomes or any other hydrophobic delivery vehicle commonly known in the art. Formulations including, but not limited to, mouth washes, abrasive or nonabrasive dentifrices, chewing gums, soft drinks, and other orally acceptable compositions comprising CSP according to this invention can be prepared by any method known to persons skilled in the art. In general, methods of manufacturing anti-caries oral compositions comprise combining an orally acceptable carrier and an effective amount of CSP that can inhibit the expression of glucosyltransferases. An exemplary procedure for preparing an anti-caries oral composition in a gel formulation is provided in Example 9. A variety of carriers and excipients can be used to formulate the compositions of this invention and are well known to those skilled in the art. Such orally acceptable vehicles for purposes of this invention include, but are not limited to, water, ethanol, humectants such as polypropylene glycol, glycerol and sorbitol, gelling agents such as cellulose derivatives (e.g., Methocel, carboxymethylcellulose (CMC 7MF) and Klucel HF), polyoxypropylene/polyoxyethylene block copolymers (e.g., Pluronic F-127, Pluronic F-108, Pluronic P-103, Pluronic P-104, Pluronic P-105 and Pluronic P-123), colloidal magnesium aluminosilicate complexes such as Veegum, and mucoprotein, thickening agents such as Carbopol 934, gel stabilizers such as silicon dioxides (e.g., Cab-O-Sil M5 and polyvinylpyrrolidone) sweeteners such as sodium saccharin and other approved flavors, preservatives such as citric acid, sodium benzoate, cetylpyridinium chloride, potassium sorbate, methyl and ethyl parabens, detergents such as sodium lauryl sulfate, sodium cocomonoglyceride sulfonate, sodium lauryl sarcosinate and polyoxyethylene isohexadecyl ether (Arlasolve 200), and approved colors. Because human oral cavity contains saliva that is constantly being swallowed, therefore, an oral formulation preferably contains a sufficient amount of CSP to maintain an effective concentration of CSP in the oral cavity for a predetermined amount of time. Similarly, in other applications where the target environment may dilute the CSP to below effective amount, a higher concentration of CSP in the delivery vehicle is desired. For instance, an amount of CSP to account for dilution by saliva is preferably in the range of 0.1 mg/ml to 10 mg/ml. Medicaments Medicaments of this invention comprise CSP in an amount effective to reduce the attachment of S. mutans to teeth. An “effective amount” of CSP is the amount of compound that, when administered to a subject in need of treatment or prophylaxis, is sufficient to reduce the attachment of S. mutans to teeth and therefore, to treat or prevent conditions associated with the attachment of S. mutans to teeth. In one embodiment, the medicament comprises between about 0.05 and 30% (w/w) of CSP. As used herein, the term “medicament” includes any type of medicament for administration to the oral cavity. In one embodiment the medicament can be a single dosage containing (1) CSP alone, (2) CSP in admixture with at least one additional agent effective against a condition associated with the attachment of S. mutans to teeth such as those described herein (3) CSP in admixture with sucrose, or (4) CSP in admixture with sucrose and at least one additional agent effective against a condition associated with the attachment of S. mutans to teeth. Alternatively the medicament can be a kit with one or more dosage forms containing (1) CSP alone, (2) CSP and at least one additional agent effective against a condition associated with the attachment of S. mutans to teeth in admixture or in separate containers (3) CSP and sucrose in admixture or in separate containers, or (4) CSP, sucrose and at least one additional agent effective against a condition associated with the attachment of S. mutans to teeth, wherein the CSP, sucrose, and agent can be provided in separate vials or in admixture in any combination. Method of Treatment In general, dental caries and infective endocarditis may be prevented by contacting the oral cavity of a subject with an amount of S. mutans CSP effective to reduce or inhibit expression of the glucosyltransferase genes (gtfB and gtfC) either directly or indirectly, thereby reducing the attachment of S. mutans to the subject's teeth. In one embodiment, the CSP is formulated as an orally acceptable medicament as described herein comprising a carrier and an effective amount of CSP. As used herein, the term “treating” is intended to mean at least the mitigation of a condition associated with the attachment of S. mutans to teeth in a subject, such as a human, that is affected at least in part by the condition, and includes, but is not limited to, modulating and/or inhibiting the condition; and/or alleviating the condition. As used herein, the term “prophylaxis” is intended to mean at least preventing a condition associated with the attachment of S. mutans to teeth from occurring in a mammal, particularly when the mammal is found to be predisposed to having the condition but has not yet been diagnosed as having it. With respect to treatment regime of CSP, whether alone or in combination with one or more additional anti-caries caries agents, one of ordinary skill in the art will recognize that a therapeutically effective amount will vary with the condition to be treated, its severity, the treatment regimen to be employed, the pharmacokinetics of the agent used, as well as the patient (animal or human) treated. An exemplary regime of an anti-caries composition or medicament of this invention is application of the composition or medicament to the oral cavity of the subject every time the subject eats a food containing sucrose. For example, people generally eat foods with sucrose from one to three times a day. According to this embodiment, a subject would apply a composition or medicament of this invention to the oral cavity from one to three times daily soon after consuming a sucrose-containing food or beverage as part of a routine oral hygiene program to inhibit or treat dental caries or as a program to prevent endocarditis. Since S. mutans is in direct competition with other early bacterial colonizers of the smooth surface of teeth and since many oral streptococci utilize similar glucosyltransferases to facilitate attachment, the presence of sucrose in any formulation of CSP should prove synergistic. Accordingly, the presence of sucrose in any CSP formulation or medicament of this invention will enhance the ability of glucosyltransferase dependent commensal bacteria to adhere. Thus, the combination of CSP and sucrose should both inhibit S. mutans attachment as well as facilitate the attachment of non-pathogenic bacteria, thus reducing the useable surface area and opportunity for S. mutans attachment. The plaque resulting from the attachment of non-pathogenic bacteria is benign and acts a barrier for subsequent S. mutans attachment. The foregoing aspects and features of the invention are further illustrated by the results of the examples discussed below. The examples are not to be construed as limiting of the invention in anyway. Thus, various modifications are possible within the scope of the invention. EXAMPLES Materials and Methods 1) Cultures The results were obtained using two strains of S. mutans : GS5, its derivative GS5-gtfBCD (Hanada, N, Kuramitsu, H. K., Infection and Immunity, 57:2079-2085 (1989)), NG8 and its derivative NG8-comC (Li, Y-H et al., J. of Bact. 183:897-908 (2001)). In each assay the corresponding wild-type strain was used as a control for each mutant. However, where ascertainable, no difference between the two wild-type strains namely NG8 and GS5 was observed. The bacteria were cultured in liquid or solid Todd Hewitt medium at 37° C. with 5% CO2 without agitation. The horse serum was added to 5% where indicated. 2) Transcriptional Fusions The fusion constructs and the transcription assay were previously described (Goodman, S. D. and Gao, Q., Plasmid 43:85-98 (2000)). Briefly, the constructs comprised the upstream regions of the gtfB and gtfC genes fused to the promoterless coding sequence of the firefly luciferase gene and inserted into the plasmid vector pVA838, a shuttle plasmid capable of propagating in both E. coli and S. mutans marked with erythromycin resistance. The plasmids were introduced into S. mutans GS5 by electroporation and the resulting erythromycin resistant strains were grown in liquid cultures and collected at various optical densities. The reporter gene (luciferase) expression was detected by measuring luminescence upon the addition of luciferin (the substrate for luciferase), see Goodman, S. D. and Gao Q. Plasmid 42:154-157 (1999), incorporated herein by reference. 3) Attachment Assay The bacteria were grown in liquid cultures to the desired optical density. 20 ml of the cultures were then transferred into Petri dishes and sucrose added to the final concentration of 2%. The incubation was resumed for one hour, after which the liquid fraction was withdrawn and the fresh medium was added into which the layer of attached cells was scraped. The percentage of the attached bacteria was determined as the ratio of the optical densities of the attached to the total (a sum of attached and unattached) bacteria. 4) Competition Assay The gtfBCD mutant (erythromycin-resistant) and the wild-type S. mutans were mixed at an initial ratio of 1:1000. The resulting liquid culture was grown to the optical density of 0.1 (the peak of GTF activity and maximum attachment). At this optical density 20 mL of the bacteria were placed into the Petri dish containing sucrose and allowed to attach. After one hour 10 mL (one half) of the unattached bacteria were transferred into another Petri dish, diluted 1:1 with fresh medium and allowed to attach. The dilutions assured that the culture maintains a high level of gtf expression characteristic of the low cell density. The transfer was performed a total of three times. After the final attachment period the free bacteria were collected, diluted and plated on solid medium to get individual colonies. The colonies were then picked and tested for erythromycin resistance by streaking on solid medium containing erythromycin. The ratio of sensitive and resistance colonies was calculated to determine the resulting ratio of the mutant to wild-type bacteria. 5) Western Blotting For the Western blotting, the bacteria were incubated to the desired optical density, subjected to the freeze-thaw cycle and mixed with the sample loading buffer. The samples were heated at 100° C. for 15 minutes and subjected to the PAGE. The number of cells per lane of the gel was kept constant at 10 8 cells. The western blotting was performed in accordance with a standard procedure (Sambrook, J. and Russel D. W. Molecular Cloning, a laboratory manual, 3 rd ed. Cold Spring Harbor Laboratory Press, NY, 2001). Briefly, after PAGE the samples were transferred onto the nitrocellulose membrane and the latter subjected to the standard ELISA procedure. The anti-GTFB mouse monoclonal antibody was previously characterized (Fukushima, K., Okada, T., Ochiai, K., Infection and Immunity 61:323-328 (1993), incorporated herein by reference). The secondary antibody (HRP-linked goat anti-mouse) and the detection reagents were purchased from Cell Signaling Technology (Beverly, Mass.). 6) Addition of CSP to Bacterial Cultures Synthetic CSP was dissolved in water to the concentration of 1 mg/mL as described in Li, Y-H et al., J. of Bact., 183:897-908 (2001). The cultures were grown in Todd Hewitt Broth (THB) supplemented with 5% horse serum. CSP was added to the cultures at the time of diluting the overnight culture (time zero of the culture growth) to a designated concentration between 1 and 8 mcg/mL. The incubation then continued up to the optical density where the expression of GTF is maximal (OD 650=0.1). The cultures where then collected and used in Western blotting with anti-glucosyltransferase (gtf) antibody. A parallel Western blot was run with an anti-fructosyltransferase (ftf) antibody. The levels of FTF do not vary significantly during the growth of the culture. Cultures were also used for transcriptional fusion assays and for attachment assays. 7) Cloning and Expression of the S. mutans ComE Coding Sequence into E. coli The DNA sequence of the comE gene is in the public domain and has a genbank accession number of AE015016.1. Oligonucleotides designed to be complimentary to the end points of the coding sequence were used to PCR amplify the intact coding sequence using S. mutans GS-5 chromosomal DNA as a template. The amplicon was then ligated into the Invitrogen (Carlsbad, Calif.) expression vector (pCR®T7TOPO®) according to the protocol of the manufacturer. In this genetic construction, comE is under the control of the plasmid's endogenous inducible promoter. E. coli strains either possessing the original plasmid or one with the new comE containing construction were grown to exponential growth and were treated with isopropylthiogalactoside which induces expression of the comE gene but only in this plasmid based system. After one hour of continued incubation, each culture was harvested, and lysed with lysozyme (0.4 mg/ml). Cell debris was pelleted by centrifugation and the remaining supernatant or cleared lysates were used for subsequent electromobility shift assays. 8) Electromobility Shift Assays with ComE Lysates Electromobility shift assays (EMSA) were performed as described in Goodman et al., J. of Bact. 181:3246-3255 (1999). EMSA measures the extent of complexes formed at equilibrium between specific DNA sequences and proteins by the change in the rate of migration of the protein-DNA complex during gel electrophoresis as compared to the uncomplexed DNA. Complexed DNA migrates more slowly. For these experiments, a PCR DNA amplicon containing the promoter of gtfC and inclusive of the region from −89 to +103 (relative to the start of transcription designated as +1; the putative ComE site is located at −11 to +22) was used as the substrate for EMSA. Lysates of equivalent protein concentrations were used as the source of protein and added at 1:20 (v/v) to the reaction. Conditions for the formation of complexes and subsequent EMSA were performed as stated in Goodman et al., supra. 9) Techniques for detecting and quantitatively identifying S. mutans include bacterial culture with selective media using either broth or agar plate systems, and polymerase chain reaction techniques. (Ellen, R. P., Oral Sci. Rev. 8: 3-23 (1976); Igarashi et al., Oral Microbiol. and Immunol. 11: 294-298 (1996); U.S. Pat. No. 5,374,538; U.S. Pat. No. 4,692,407, each of which is incorporated herein by reference). Human dental caries may also be detected by changes in translucency, color, hardness or X-ray density of teeth. (U.S. Pat. No. 6,231,857, incorporated herein by reference). Example 1 An in vitro assay was performed as described in Materials and Methods to determine whether glucosyltransferases and their substrate (sucrose) are required for the S. mutans attachment to a smooth surface. The results are shown in FIG. 3 , which shows that glucosyltransferases and sucrose are required for the S. mutans attachment. It was observed that when sucrose was added to the medium, the wild-type S. mutans readily attached to the surface of a Petri dish. The attachment was evidenced by the clearance of the substantial number of bacteria from the liquid medium and the presence of the increasing number of bacteria in the mucous layer synthesized on the surface of the Petri dish. After an hour-long incubation, up to 60% of bacterial cells were localized to the layer. On the contrary, the gtf-deficient mutant of S. mutans formed no such layer and less than 5% of cells were cleared from the liquid medium. In addition, the data demonstrate that the ability to attach is maximal during late-lag phase, decreases to 10% by the mid-log phase and falls below 5% as the culture reaches the stationary phase. Example 2 A transcriptional fusion assay was performed as described in Materials and Methods. The results are shown in FIGS. 4A and 4B . After the S. mutans culture was diluted, the expression was low in the stationary phase but rose rapidly as bacteria progress through the lag phase. The gtfB and gtfC expression peaked at the end of the lag phase prior to the exponential growth. The expression declined dramatically during the phase of exponential growth and returned to the low levels when the S. mutans culture reached the stationary phase. In addition, the data show that the two genes have separate functional promoters but are nevertheless regulated in the similar fashion. This example demonstrates the growth phase-dependent expression of gtfB and gtfC genes in S. mutans . This pattern reflects the role of these genes in the early events in the life of an S. mutans culture (e. g., at the time of the initial colonization of a tooth surface). Example 3 This example illustrates the role of CSP in regulating the gtfB gene. FIG. 5 is an image of a Western blot analysis using a monoclonal antibody against GTFB. As shown by FIG. 5 , the normal pattern of GTFB expression is disrupted in the mutant S. mutans lacking the competence stimulating peptide (CSP). In the mutant S. mutans , the GTFB expression remained high throughout the growth of the culture. In contrast, in the wild-type, the amount of the protein was maximal in late lag phase and then dropped dramatically by the end of the exponential phase. Example 4 An in vitro competition assay was performed to demonstrate that the glucosyltransferase (gtf)-deficient mutant of S. mutans fails to attach to the surface in the presence of sucrose even when gtf-positive bacteria are present. The wild-type and mutant bacteria were mixed at an initial ratio of 1:1000. The unattached cells are periodically withdrawn and placed into a fresh dish. As shown in FIG. 6 , after only three such passages the proportion of gtf-deficient bacteria in the supernatant increased 250-fold (from 1:1000 to 1:4). These results demonstrate that the GTF-expressing bacteria adhere to the surface while the GTF-deficient cells mostly remain in the liquid medium despite the fact that the glucans are available for attachment. Example 5 A Western blot analysis was performed to determine the effect of CSP on the level of GTFB expression. As shown in FIG. 7 , panel 1 , CSP has a direct negative effect on the level of GTFB expression in the wild-type S. mutans . When CSP was added to the fresh cultures at the time of dilution, the peak expression of GTFB was lowered proportionally to the amount of peptide added. As a control, the same blot was analyzed with antibody specific to FTF, where it was observed that CSP has no effect on FTF expression ( FIG. 7 , panel 2 ). Example 6 The transcriptional fusion assay was performed to determine whether CSP inhibits the expression of the gtfB gene of S. mutans. S. mutans culture was first diluted from overnight cultures. The expression was low but rose rapidly as the bacteria progressed through the lag phase. When the expression peaked at the end of the lag phase prior to the exponential growth, the cells were challenged with increasing concentrations of CSP for an incubation period of 10 minutes and assessed for luminescence, the measure of reporter gene expression. As shown in FIG. 8 , increasing concentrations of CSP increased the magnitude of repression. This example therefore demonstrates that CSP can inhibit the expression of at least the gtfB gene of S. mutans . The effect of CSP is consistent with repression at the level of transcription. Example 7 An in vitro assay was performed to determine whether CSP can inhibit the attachment of S. mutans to a smooth surface. When sucrose was added to the medium, the wild-type S. mutans readily attached to the surface of a Petri dish. The attachment was evidenced by the clearance of the substantial number of bacteria from the liquid medium and the presence of the increasing number of bacteria in the mucous layer synthesized on the surface of the Petri dish. S. mutans grown to an optical density consistent with the transition between lag and exponential growth for maximal expression of gtfB and gtfC was utilized. As shown in FIG. 9 , after an hour-long incubation up to 51% of bacterial cells were localized to the layer. On the contrary, when bacteria were challenged with CSP at 8 □g/mL for 10 minutes prior to incubation on Petri dishes, S. mutans formed much less of a layer (less than 8%). This example therefore demonstrates that CSP can inhibit the attachment of S. mutans to a smooth surface. Example 8 The putative regulatory pathway controlling the glucosyltransferase (gtf) gene expression is illustrated in FIG. 1 . The competence stimulating peptide (CSP) is cleaved off of a larger peptide which is the product of the comC gene. CSP is extruded into the extracellular milieu by the specific transporter ComAB (the two components are the products of the genes comA and comB). The extracellular concentration of CSP increases with the increase in cell density. When the concentration reaches a threshold, CSP activates its specific receptor ComD. ComD in turn activates a response regulator ComE by phosphorylation. ComE modulates gene expression by binding to its target sites in the regulatory regions on the DNA. ComE regulator has been studied in a related species of the genus Streptococci: S. pneumoniae . In that system it has been shown that ComE interacts with its specific binding sites in the upstream regions of several genes and operons: comC, comX (an alternative sigma factor, a transcription factor), comAB, and comED. (Lee, M. S. and Morrison, D. A., J. of Bact., 181:5004-5016 (1999)). The inventors have shown that the putative ComE binding sites exist in the upstream regions of both gtfB and gtfC FIG. 10 . In both gtfB and gtfC, promoter regions the ComE box can be found at −11 base of the promoter region. In FIG. 10 , capital letters represent actual DNA sequence for gtfB and gtfC while they represent conserved sequence in a ComE consensus derived from the genus streptococcus . Lower case letters are less conserved DNA sequence. The letter W represents either an adenine or thymidine base pair. The asterisk (*) represents a potential one base pair gap in the DNA sequence alignment. This result points at the likelihood that CSP regulates gtf expression via the ComE pathway. As evidence of this model, E. coli cleared lysates either possessing ComE or lacking ComE were used in an electromobility shift assay (EMSA) to assess the capacity of these lysates to bind to the gtfC promoter region that contains the streptococcal ComE box FIG. 11 . Lysates that did not possess expressed ComE failed to form complexes with the gtfC promoter despite possessing a plethora of other E. coli proteins. It is believed that it is the ComE protein which is the only component that distinguishes these two lysates and creates the complex. Example 9 This (tab) example provides an exemplary procedure for preparing a formulation comprising CSP according to this invention. Water, sodium saccharin, sodium benzoate and dyes are combined in a first container and the container is place in an ice bath. When the temperature reaches 6° C., a gelling agent is added. The contents are mixed slowly until the gelling agent is dissolved, and then the solution is heated to 70° C. Into a second container is added glycerin, and then Cab-O-Sil M5 is sprinkled in with mixing. CSP is then added and mixing is continued to a smooth paste. The paste is then heated in a water bath with mixing to a temperature of 70° C. The contents of the first container are added to the second container and blended together until the batch is homogenous while maintaining a 70° C. temperature. A flavoring agent is then added, mixing is stopped, and the formulation allowed to settle for approximately one hour. If necessary, the formulation can be refrigerated overnight to remove air bubbles. CSP can be produced in either of two ways. It is naturally secreted during exponential growth of S. mutans . Fermentation of the bacteria will result in the media being saturated with CSP. Spent or conditioned media can then be further purified or used directly. Alternatively, the peptide can be synthesized according to automated peptide synthesis procedures known in the art, such as the well known Merrifield method, as described in Merrifield, R. B. J. Am. Chem. Soc. 85:2149 (1963); and Merrifield, R. B. Science, 232:341 (1986), each of which is specifically incorporated herein by reference. Example 10 This example provides an example of a mouthwash formulation according to this invention containing CSP. Ingredient Amount (% w/w) CSP 0.5-2.0 Glycerol (humectant) 6.0 Pluronic F-108 1.0 Sodium saccharin (sweetener) 0.3 Deionized Water q.s. Flavors 1.0 100.0  Example 11 This example provides another example of a mouthwash formulation according to this invention containing CSP. Ingredient Amount (% w/w) CSP 0.5-3.0 Ethanol, USP 5.0 Pluronic F-108 2.0 Glycerol (humectant) 10.0  Sorbitol (humectant) 10.0  Sodium saccharin (sweetener) 0.2 Deionized Water q.s. Flavors 0.2 100.0  Example 12 This example provides another example of an abrasive dentifrice gel formulation according to this invention containing CSP. Ingredient Amount (% w/w) CSP 2.0-10.0 Fumed Silica (abrasive) 55.0  Sodium Lauryl Sulfate (detergent) 1.5 Glycerol (humectant) 10.0  Carboxymethylecellulose (gelling agent) 2.0 Sorbitol (humectant) 10.0  Sodium saccharin (sweetener) 0.2 Deionized Water q.s. Perservative  0.05 Flavors 1.0 100.0  Example 13 This example provides an example of a chewing gum formulation according to this invention containing CSP. Ingredient Amount (% w/w) CSP  1.0-11.0 Gum Base 21.3 Sucrose 48.5-58.5 Corn Syrup (Baume 45) 18.2 Flavors  1.0 100.0  Example 14 This example provides an example of a nonabrasive gel dentifrice formulation according to this invention containing CSP. Ingredient Amount (% w/w) CSP 0.05-30.0 Sorbistat (preservative)  0.15 Deionized Water q.s. Silicon Dioxide (gel stabilizer) 1.0 Pluronic F-127 (gelling agent) 20.0  Sodium Saccharin 0.2 Flavors 1.5 100.0  Example 15 This example provides another example of a nonabrasive gel dentifrice formulation according to this invention containing CSP. Ingredient Amount (% w/w) CSP 5.0 (dry basis) Distill water q.s. Sodium Saccharin (sweetener) 0.20 Sodium Benzoate (preservative) 0.30 FD&C Blue #1 (0.1% aq. soln.) 0.27 D&C Yellow #10 (0.5% aq. soln.) 0.50 Gelling agent 18.00  Glycerol (Humectant) 20.00  FCab-O-Sil M5 (Silicon Dioxide) 1.0  100.0   Example 16 This example provides an example of a soft drink formulation according to this invention containing CSP. Ingredient Distilled Water Carbon Dioxide Sucrose Flavors Colors Caffeine Acidulants Preservatives Potassium Sodium CSP Example 17 This example provides an example of a candy formulation according to this invention containing CSP. Ingredient Distilled Water Leavening agents Stabilizers Thickeners Sucrose Flavors Colors Acidulants Preservatives Antioxidants CSP Example 18 This example shows the dose-dependent response of S. mutans ' growth rate versus the amount of CSP administered. Previously, it was assumed that quorum sensing may be an on/off type of switching event wherein when the quorum sensing molecule reaches a certain threshold, a new behavior is turned off and vice versa. The inventors have unexpectedly discovered that the QS regulated gene expression is not an all-or-nothing type of system, but actually has a dose-dependent response. The inventors have demonstrated in this example that at higher concentrations of CSP, the growth of the S. mutans culture slowed down. At 8 μg/ml (4 μM) we see the desired inhibition of the gtf genes. At a 100-fold higher concentration (400 μM), CSP inhibits the growth of a S. mutans culture by 50%. At a 400-fold higher concentration (1.6 mM) the cell division stops and cells begin to die (see FIG. 12 ). The microscopic observation of the culture treated with high concentrations of CSP revealed some overly large cells. This suggested that CSP inhibited cell fission. The live-dead stain further demonstrated that the overly large cells were dead. The experiment was performed in a 96-well plate with triplicate wells for each treatment. Cell density was measured by using a plate reader (BioRad). The experiment was repeated three times. Numbers represent the average of the triplicate samples from one representative experiment. Variations between experiments were within 20%. These experiments were designed to mimic the conditions of the dental hygiene regimen. Specifically, the bacteria were “pulsed” with CSP. The peptide was added for a mere 10 minutes, washed away and the incubation continued in the fresh medium. In this set-up the inhibitory effect persisted for a long time and became undetectable only after 16 hours of the culture growth. Competition experiments have also shown that a mere 3-hour advantage is sufficient to ensure that a resident species in a biofilm will out compete the newcomer. Although the present invention has been described in terms of specific exemplary embodiments and examples, it will be appreciated that the embodiments disclosed herein are for illustrative purposes only and various modifications and alterations might be made by those skilled in the art without departing from the spirit and scope of the invention as set forth in the following claims.

Methods for selectively manipulating a growth rate of a selected bacterium comprising the step of contacting the selected bacterium with a predetermined amount of a quorum sensing molecule to affect a change in the growth rate of the selected bacterium, wherein the quorum sensing molecule is species specific, and the change in the growth rate is dependent on the amount of quorum sensing molecule in a dose-dependent fashion. Also provided are methods for treating or protecting against bacterial infections by utilizing the dose-dependent response of bacterial quorum sensing systems. The methods can be applied to a wide range of bacteria species including Streptococci, Staphylococci , and Bacilli . Compositions, medicaments and oral formulations for use with the methods are also disclosed.

FIELD OF INVENTION This invention relates to improvements in lightweight collapsible support structures in the nature of easels, book rests, book ends or similar articles that upon unfolding and erection provide upstanding inclined or substantially vertical support or abutment surfaces for display purposes or for supporting or anchoring articles such as pads, books or similar items. BACKGROUND TO THE INVENTION Lightweight collapsible structures useful for a variety of purposes have been disclosed in a number of U.S. patents and Canadian patents exemplified by the following: U.S. Pat. No. 433,635 issued August 1890; U.S. Pat. No. 844,066 issued February 1907; U.S. Pat. No. 1,875,460 issued September 1932; U.S. Pat. No. Re. 21,371 issued February 1940; U.S. Pat. No. 2,587,316 issued February 1952; Canadian Pat. No. 312,291 issued June 1931; Canadian Pat. No. 315,615 issued Sept. 29, 1931; Canadian Pat. No. 641,733 issued May 1962. This invention relates to improvements in such collapsible structures but particularly of the nature disclosed in my U.S. Pat. No. 3,990,669 which issued Nov. 9, 1976 and the Canadian counterpart, Canadian Pat. No. 1,010,008 issued May 10, 1977. OBJECTS OF THE INVENTION The principal object of this invention is to provide an improved, self-sustaining, lightweight collapsible support structure including several hingedly interconnected panels adapted upon being extended from a folded state to assume a substantially independent upright stable configuration presenting a principal surface of generally planar configuration from several panels either inclined or supported substantially vertically for display purposes or as a support abutment surface for pads or books or the like. It is another very important object to provide an improved collapsible support structure of the type described which folds compactly for storing or for shipping or carrying but upon being unfolded and extended and deposited upon a suitable supporting surface assumes a stable configuration. Still another object is to provide a support structure of minimal components readily unfolded and extended into its stable configuration and vice versa. Still another important object is to provide a support structure which can be produced in several configurations for particular uses each having an overall appearance that is pleasing. Still another object is to provide support structures capable of being fabricated from stiff lightweight sheet materials using fundamental manufacturing steps and apparatus which ensure efficiency in production. FEATURES OF THE INVENTION The principal feature of this invention resides in providing in a collapsible self-sustaining support structure having a substantial measure of rigidity derived from sheet-like panel portions hingedly interconnected along their common abutting edges to define fold axes for limited swinging movement towards and away from one another, a central panel portion flanked by hingedly interconnected side panel portions which are arranged to be supported in substantially fully extended upstanding side-by-side relation in which the central panel portion has a uniform generally quadrilateral perimetral configuration with its uppermost edge having an extent greater than the extent of its lowermost edge, the central and side panel portions flanking same each presenting hingedly interconnected ledge panel portions along their respective lowermost edges in side-by-side relation with the configuration of the lowermost edges being such that the hingedly inter-connected ledge panel portions are foldable in unison into a generally horizontal disposition only when the aforementioned central and side panel portions are in substantially fully extended side-by-side relation. The aforementioned structure provides a relationship of panels whose relative positions can be fixed or secured against displacement through the manipulations outlined and when deposited upon a flat supporting surface is sufficiently rigid and stable so as to support or accommodate articles for display or books or in certain embodiments serve as book ends. It is also a feature within the structure embodying the invention to provide through selected dimensioning of the principal central panels a range of self-sustaining configurations useful for a variety of purposes as earlier mentioned. Still another feature resides in providing multiple or compound fold axes between the principal central panels and associated side or gusset panels whereby upon collapse and folding of the panel portions one upon the other one section can be received within the other whereby compactness may be readily achieved. Still another feature resides in providing structures of the type indicated which can be cut or struck from a single sheet of suitable material with fold lines defining fold axes inscribed or impressed therein whereby jointing, bonding or interconnecting of only a minimum number of panel portions is required. These and other objects and features are to be found in the following description to be read in conjunction with the accompanying sheets of drawings in which: DRAWINGS FIG. 1 is a perspective view of one preferred form of support structure embodying the invention in extended erect stable disposition illustrating one arrangement of three forwardly facing inclined panel portions with the lowermost locking ledge panel portions extending forwardly. FIG. 2 is a perspective view of the support structure of FIG. 1 taken from a point to the rear and to the left below the support structure as viewed in FIG. 1. FIG. 3 is a perspective view of the support structure of FIGS. 1 and 2 with the outermost side panel portions and associated ledge panel portions folded over upon each other and upon the central panels illustrating the fully collapsed position of same. FIG. 4 is a plan view of a flattened sheet of suitable material having a perimetral configuration and impressed or inscribed with lines defining fold axes from which the support structure of FIGS. 1, 2 and 3 is derived. FIG. 5 is an end elevational view of the support structure of FIG. 1 taken from the right side thereof. FIG. 6 is a perspective view of the second preferred form of support structure embodying the invention in fully extended erect stable disposition. FIG. 7 is a perspective view of the embodiment of FIG. 6 taken from a point to the rear and to the right below same. FIG. 8 is a plan view of a flattened sheet of suitable material having a perimetral configuration and impressed or inscribed with fold axes from which the support structure of FIGS. 6 and 7 is derived. FIG. 9 is a perspective view of the support structure of FIGS. 6 and 7 with the outermost side panel portions and associated ledge panel portions folded over upon each other and upon the central panels illustrating the fully collapsed position. FIG. 10 is a perspective view of still another preferred form of support structure embodying the invention which is similar to the support structure illustrated in FIGS. 6 to 9 inclusive except that the arrangement of three forwardly facing panel portions extends substantially vertically in the fully erect stable dispostion and with the forwardly presented ledge formation at substantially right angles to the aforementioned panel portions. FIG. 11 is a perspective view of the embodiment of FIG. 10 taken from a point to the rear and left below same. FIG. 12 is a plan view of a flattened sheet of suitable material having a perimetral configuration and impressed or inscribed with fold axes from which the support structure of FIGS. 10 and 11 is derived. FIG. 13 is a perspective view of the support structure of FIGS. 10 and 11 with the extended outermost side panels and associated ledge panel portions folded over upon each other in the manner indicated by the arrows and upon the central panels illustrating the fully collapsed disposition thereof. DESCRIPTION OF THE INVENTION The several embodiments of the support structures illustrated in FIGS. 1 to 13 inclusive, when unfolded and secured in the preferred configuration against collapse and deposited upon a suitable supporting surface are independently self-sustaining notwithstanding that they can be readily folded up compactly as illustrated in FIGS. 3, 9 and 13 respectively. All embodiments illustrated and described are intended to be cut from a single stiff sheet of suitable material such as polyethylene or equivalent plastic sheeting or from suitable stiff cardboard sheeting. Where desired the panel portions may take the form of stiff rigid perimetral inserts encased in suitable plastic sheeting or like material with the respective fold axes of such composite article being defined by several thicknesses of such sheeting formed together by sealing or by stitching or otherwise adhered. The fold axes or hinged interconnections are coincident with the panel portion edges. According to the preferred approach which utilizes suitable stiff plastic sheeting the fold axes are defined by impressing or inscribing lines in such plastic sheeting in the die cutting operation. This leaves a minimal number of joints to be fabricated by heat sealing or by using appropriate adhesives. The Embodiment of FIGS. 1 to 5 inclusive The embodiment of FIGS. 1 to 5 inclusive is preferably derived from a one-piece layout or blank having the configuration illustrated in FIG. 4. The blank of FIG. 4 includes a centrally located first panel portion 10 flanked by side panel portions 12 and 14 of opposite symmetry, along each of panel portions 10, 12 and 14 are presented integral ledge panel portions 16, 18 and 20 along lowermost edges 22, 24 and 26 respectively. Central panel portion 10 has a uniform generally quadrilateral configuration with uppermost edge 28 thereof having a greater extent than lowermost edge 22 such that side edge formations separating the respective associated central and side panel portions and ledge panel portions generally indicated at 30, 32 are angled convergingly downwardly respectively and are constituted by pairs of impressed or inscribed fold lines indicated at 34a, 34b, 36a and 36b in FIG. 4. Hingedly connected along uppermost edge 28 constituted by an impressed or inscribed fold line as indicated in FIG. 4 is a second central panel portion 42 adapted to support first mentioned central panel portion 10 in upstanding relation as may be better understood from FIG. 2 of the drawings. The hinged connection of the two central panel portions 10 and 42 allows for swinging movement of the central panel 10 with respect to the central panel 42 first forwardly from a next adjacent folded position to an inclined position, and then reversely when the structure is to be collapsed. The preferred embodiment reveals a hinged connection along uppermost edge 28, whereas this connection may be omitted to provide a gap or slot therebetween for the reception of a flap or cover by means of which a pad can be anchored against dislodgement. Central panel 42 is flanked by and hingedly connected to generally triangularly shaped side panel portions or gussets 44 and 46 which present along their respective hypotenuses as at 48 and 50 anchoring panel portions 52 and 54 which are adapted to be secured in abutting relation against the respective rear surfaces side panel portions 12 and 14 as best seen in FIG. 2 of the drawings. The hinged connections extending along side edges of central panel portion 42 and flanking side panel portions 44 and 46 as indicated generally at 56 and 58 in FIG. 4 comprise separated pairs of fold lines in the case of hinge connections 56 as at 60a, 60b, 60c and 60d and in the case of hinge connection 58 as at 62a, 62b, 62c and 62d. The hinged connections 56 and 58 so defined have an extent so as to embrace the enclosed central panel portions 10 and 42 and associated side panel and gussets when the support structure is collapsed as revealed by FIG. 3 of the drawings. Also such hinged connections 56 and 58 add stability derived from the assumed column or shaping when the article is extended into the fully erect position revealed by FIG. 2. It will be observed from the layout or blank of FIG. 4 from which the article of FIGS. 1, 2, 3 and 5is derived that by joining panel portions 52 and 54 to the rear surfaces of panel portions 12 and 14 along their abutting surface shown particularly in FIG. 2 that alignment of lower deges 22, 24 and 26 of panel portions 10, 12 and 14 respectively can be established only when they are arranged in substantially fully extended coplanar side-by-side relation emphasized in FIGS. 1, 2, and 5 of the drawings. In such fully extended side-by-side relation ledge panel portions 16, 18 and 20 can be folded in unison about their common respective edges or fold axes 22, 24 and 26 which secures panel portions 10, 12 and 14 respectively in substantially fully extended coplanar relation against collapse thereby inherently preserving the erect configuration, which structure so defined has a loading capability, and resists deformation when deposited upon a suitable supporting surface. The support structure of FIGS. 1 to 5 inclusive is intended to carry an opened book supported lowermost on a suitable sponge pad 70 or the like mounted upon ledge panel portions 18 and 20 which sponge pad tends to prevent the cover of the book and pages from closing. Ledge portions 18 and 20 are provided with notches 72 and 74 respectively which notches are adapted to cooperate with notches 76 and 78 respectively presented by side panel potions 12 and 14 in that elastics can be looped around the respective side panel 12 and ledge panel 18 and side panel 14 and ledge panel 20 and anchored in the aforementioned respective notches to hold the leaves or pages from flipping over. The Embodiment of FIGS. 6 to 9 Inclusive It will be understood, having regard to the embodiment of the invention illustrated in FIGS. 6 to 9 inclusive, that a modification to the pattern or layout of FIG. 4 may be undertaken without departing from the concept presented by FIGS. 1 to 5. This may be understood first by considering the blank of FIG. 8 which includes the first central panel portion 80 flanked by and hingedly connected to side panel portions 82 and 84 each presenting hingedly inter-connected ledge panel portions 86, 88 and 90 lowermost respectively. Fold axes formations indicated generally at 92 and 94 of FIG. 8 separate panel portions 80 from side panel portions 82 and 84 respectively with the uppermost edge 96 of central panel portion 80 constituting a fold axis of perimetral extent greater than the perimetral extent of lowermost edge 98a but provided with a slotted arrangement as at 98b. Lowermost edge 98a defining the fold axis between central panel portion 80 and ledge panel portion 86 in the fully extended disposition is aligned with the fold axes 100 and 102 of ledge panel portions 88 and 90 respectively. Central panel portion 80 is hingedly connected along the unslotted portion of uppermost edge 96 to a second central panel potion 104 flanked by gussets 106 and 108 along hinged connections 110 and 112 respectively in the same manner as described in relation to the embodiment of FIGS. 1 to 5 exclusive. Gussets 106, 108 present securing panel portions 118 and 120 separated by fold lines 114, 116 respectively which are adapted to be secured to panel portions 82 and 84 respectively of central panel portion 80 as best seen in FIG. 7. Upon erection of the embodiment of FIGS. 6 to 9 inclusive from the collapsed state of FIG. 9 to that of FIGS. 6 and 7 the panel portions are extended to the point where panels 80, 82 and 84 approach fully extended substantial coplanarity and fold axes 98a, 100 and 102 of ledge portions 86, 88 and 90 move into alignment for swinging in unison forwardly to secure all panel portions against collapse and so preserve the erect condition of the unit with panel portions 80, 82 and 84 inclined rearwardly from lowermost to uppermost edges and with the slot 98b uppermost serving as an aperture for anchoring a note book or pad by its cover to incline downwardly when resting upon same. The Embodiment of FIGS. 10 to 13 Inclusive FIGS. 10 to 13 inclusive disclose still another preferred embodiment of the invention. FIG. 12 illustrates the layout blank used to fabricate the articles depicted in FIGS. 10, 11 and 13 and as with the embodiment of FIGS. 6 to 9 inclusive the layout blank includes a first central panel portion 120 flanked by and hingedly connected to side panel portions 122 and 124 each provided lowermost with ledge panel portions 126, 128 and 130 respectively. The uppermost perimetral edge 150 defines a fold axis along which a second central panel portion 132 is hingedly connected to first central panel portion 120. Central panel portion 132 is also flanked by side panel portions or gussets 134 and 136 carrying outermost connecting panel portions 138, 140 respectively, the fold axes defined by hinge formations 142 and 144 corresponding to those earlier described in connection with the first preferred embodiment of FIGS. 1 to 5 inclusive at 30 and 32 and the fold axes or hinges indicated at 146 and 148 reflecting a structure similar to those indicated at 56 and 58 of the embodiment of FIGS. 1 to 5 inclusive. The erect support structure depicted in FIGS. 10 and 11 is achieved by securing connecting panels 138 and 140 to the rear surfaces of side panel portions 122 and 124 respectively, as best seen in FIG. 11. So erected, such structure presents front panel portions 120, 122 and 124 in substantially perpendicular relation to the composite forwardly extending ledge formation comprising ledge portions 126, 128 and 130. This is achieved by selecting a dimension for front central panel portion 120 measured vertically that is less than as indicated at "a" in FIG. 12. The corresponding dimension of rear central panel portion "b" is distinguished from the measurements "a" and "b" of FIGS. 4 and 8 where "a" exceeds "b". The collapsed configuration of the embodiment of FIGS. 10 to 12 and the direction of folding for that arrangement is as revealed in FIG. 13 by arrows 152 and 154. In other respects the preferred embodiment of FIGS. 10 to 13 is fabricated and operates in a manner similar to that described in relation to the embodiments of FIGS. 1 to 5 inclusive and 6 to 9 inclusive. It is emphasized that the substantially fully extended coplanarity achieved in accordance with the embodiments illustrated among the principal panel portions 10, 12 and 14 of FIG. 1 80, 82 and 84 of FIG. 6 and 120, 122 and 124 of FIG. 10 is a limit position and provides automatic alignment of the integral fold axes presented by the respective ledge panel portions which are adapted only in such limit position to move in unison to project forwardly and thereby secure the extended disposition of the respective principal panel portions and associated supporting panel portions to lock same against collapse and impart stability when the article support is deposited upon a suitable support surface. While the preferred embodiments of the invention have been described and illustrated persons skilled in this field can make variations of alterations in the disclosed structures without departing from the spirit and scope of the invention as defined in the appended claims.

The invention relates to improvements in lightweight collapsible support structures in the nature of easels, book rests and the like which are self sustaining in a predetermined fully erected configuration, presenting in the fully erected configuration a multiplicity of forwardly facing panels upstanding in a rearwardly inclined or substantially vertical position to provide support surfaces for the displaying, supporting or anchoring of articles such as pads, books or the like and further presenting forwardly extending ledge portions from the bottom edges of such abutment surfaces, said ledges serving to rigidify and stabilize the erect configuration of these structures against collapse, but so adapted as to be foldable into a position allowing for such structures to be compactly folded up and collapsed for storage or for carrying when not in use.

CROSS-REFERENCES TO RELATED APPLICATIONS [0001] This is a continuation-in-part of U.S. patent application Ser. No. 10/995,600 (Attorney Docket No. 022356-000220US), filed on Nov. 22, 2004, which was a continuation of U.S. patent application Ser. No. 10/135,135 (Attorney Docket No. 022356-000210US), filed on Apr. 30, 2002, now U.S. Pat. No. 6,821,275, which was a continuation of U.S. patent application Ser. No. 09/631,040 (Attorney Docket No. 022356-000200US), filed on Aug. 1, 2000, now U.S. Pat. No. 6,413,256, and also claims the benefit of U.S. Provisional. Patent Application No. 60/555,777 filed Mar. 24, 2004, the full disclosures of which are incorporated herein by reference. BACKGROUND OF THE INVENTION Field of the Invention [0002] The present invention relates to the field of electrosurgery, and more particularly to systems and methods for ablating, cauterizing and/or coagulating body tissue using radio frequency energy. More in particular, the systems utilize voltage threshold means for controlling the voltage applied to tissue in a cycle-to-cycle manner. [0003] Radio frequency ablation is a method by which body tissue is destroyed by passing radio frequency current into the tissue. Some RF ablation procedures rely on application of high currents and low voltages to the body tissue, resulting in resistive heating of the tissue which ultimately destroys the tissue. These techniques suffer from the drawback that the heat generated at the tissue can penetrate deeply, making the depth of ablation difficult to predict and control. This procedure is thus disadvantageous in applications in which only a fine layer of tissue is to be ablated, or in areas of the body such as the heart or near the spinal cord where resistive heating can result in undesirable collateral damage to critical tissues and/or organs. [0004] It is thus desirable to ablate such sensitive areas using high voltages and low currents, thus minimizing the amount of current applied to body tissue. BRIEF SUMMARY OF THE INVENTION [0005] The present invention is a method and apparatus for treating tissue using an electrosurgical system. The system includes an electrosurgical system having an RF generator, a treatment electrode electrically coupled to the RF generator and positioned in contact with target tissue to be treated, and a spark gap switch positioned between the RF generator and the target tissue. The spark gap includes a threshold voltage and is configured to prevent conduction of current from the RF generator to the tissue until the voltage across the spark gap reaches the threshold voltage. [0006] A method according to the present invention includes the steps of using the RF generator to apply a voltage across the spark gap switch, the spark gap switch causing conduction of current from the RF generator to the target tissue once the voltage across the spark gap reaches the threshold voltage. BRIEF DESCRIPTION OF THE DRAWINGS [0007] FIG. 1 is a cross-sectional side elevation view of a first embodiment of an ablation device utilizing principles of the present invention. [0008] FIG. 2 is an end view showing the distal end of the device of FIG. 1 . [0009] FIG. 3 is a graphical representation of voltage output from an RF generator over time. [0010] FIG. 4A is a graphical representation of voltage potential across a body tissue load, from an ablation device utilizing voltage threshold ablation techniques as described herein. [0011] FIG. 4B is a graphical representation of voltage potential across a body tissue load, from an ablation device utilizing voltage threshold ablation techniques as described herein and further utilizing techniques described herein for decreasing the slope of the trailing edge of the waveform. [0012] FIGS. 5A through 5D are a series of cross-sectional side elevation views of the ablation device of FIG. 1 , schematically illustrating use of the device to ablate tissue. [0013] FIG. 6A is a cross-sectional side view of a second embodiment of an ablation device utilizing principles of the present invention. [0014] FIG. 6B is an end view showing the distal end of the device of FIG. 6A . [0015] FIGS. 7A and 7B are cross-sectional side elevation view of a third embodiment of an ablation device utilizing principles of the present invention. In FIG. 7A , the device is shown in a contracted position and in FIG. 7B the device is shown in an expanded position. [0016] FIG. 8A is a perspective view of a fourth embodiment of an ablation device utilizing principles of the present invention. [0017] FIG. 8B is a cross-sectional side elevation view of the ablation device of FIG. 8A . [0018] FIG. 9A is a perspective view of a fifth embodiment of an ablation device utilizing principles of the present invention. [0019] FIG. 9B is a cross-sectional side elevation view of the ablation device of FIG. 9A . [0020] FIG. 10 is a cross-sectional side elevation view of a sixth ablation device utilizing principles of the present invention. [0021] FIG. 11A is a perspective view of a seventh embodiment of an ablation device utilizing principles of the present invention. [0022] FIG. 11B is a cross-sectional side elevation view of the ablation device of FIG. 11A . [0023] FIG. 11C is a cross-sectional end view of the ablation device of FIG. 11A . [0024] FIG. 12A is a perspective view of an eighth embodiment of an ablation device utilizing principles of the present invention. [0025] FIG. 12B is a cross-sectional side elevation view of the ablation device of FIG. 12A . [0026] FIG. 13A is a cross-sectional side elevation view of a ninth embodiment of an ablation device utilizing principles of the present invention. [0027] FIG. 13B is a cross-sectional end view of the ablation device of FIG. 13A , taken along the plane designated 13 B- 13 B in FIG. 13A . [0028] FIG. 14A is a cross-sectional side elevation view of a tenth embodiment of an ablation device utilizing principles of the present invention. [0029] FIG. 14B is a front end view of the grid utilized in the embodiment of FIG. 14A . [0030] FIG. 15A is a cross-sectional side elevation view of an eleventh embodiment. [0031] FIG. 15B is a cross-sectional end view of the eleventh embodiment taken along the plane designated 15 B- 15 B in FIG. 15A . [0032] FIG. 15C is a schematic illustration of a variation of the eleventh embodiment, in which the mixture of gases used in the reservoir may be adjusted so as to change the threshold voltage. [0033] FIGS. 16A-16D are a series of drawings illustrating use of the eleventh embodiment. [0034] FIG. 17 is a series of plots graphically illustrating the impact of argon flow on the ablation device output at the body tissue/fluid load. [0035] FIG. 18 is a series of plots graphically illustrating the impact of electrode spacing on the ablation device output at the body tissue/fluid load. [0036] FIG. 19 is a schematic illustration of a twelfth embodiment of a system utilizing principles of the present invention, in which a spark gap spacing may be selected so as to pre-select a threshold voltage. [0037] FIG. 20 is a perspective view of a hand-held probe corresponding to the invention with a voltage threshold mechanism at the interior of a microporous ceramic working surface. [0038] FIG. 21 is a sectional view of the working end of the probe of FIG. 20 . [0039] FIG. 22 is a greatly enlarged cut-away schematic view of the voltage threshold mechanism and microporous ceramic working surface of FIG. 21 . [0040] FIG. 23 is a cut-away schematic view of an alternative voltage threshold mechanism with multiple spark gaps dimensions. [0041] FIG. 24 is a cut-away schematic view of an alternative voltage threshold mechanism with a microporous electrode. [0042] FIG. 25 is a sectional view of an alternative needle-like probe with a voltage threshold mechanism at it interior. [0043] FIG. 26 is a sectional view of an alternative probe with a voltage threshold mechanism at it interior together with an exterior electrode to allow functioning in a bi-polar manner. DETAILED DESCRIPTION OF THE INVENTION [0044] Several embodiments of ablation systems useful for practicing a voltage threshold ablation method utilizing principles of the present invention are shown in the drawings. Generally speaking, each of these systems utilizes a switching means that prevents current flow into the body until the voltage across the switching means reaches a predetermined threshold potential. By preventing current flow to tissue until a high threshold voltage is reached, the invention minimizes collateral tissue damage that can occur when a large amount of current is applied to the tissue. The switching means may take a variety of forms, including but not limited to an encapsulated or circulated volume of argon or other fluid/gas that will only conduct ablation energy from an intermediate electrode to an ablation electrode once it has been transformed to a plasma by being raised to a threshold voltage. [0045] The embodiments described herein utilize a spark gap switch for preventing conduction of energy to the tissue until the voltage potential applied by the RF generator reaches a threshold voltage. In a preferred form of the apparatus, the spark gap switch includes a volume of fluid/gas to conduct ablation energy across the spark gap, typically from an intermediate electrode to an ablation electrode. The fluid/gas used for this purpose is one that will not conduct until it has been transformed to conductive plasma by having been raised to a threshold voltage. The threshold voltage of the fluid/gas will vary with variations in a number of conditions, including fluid/gas pressure, distance across the spark gap (e.g. between an electrode on one side of the spark gap and an electrode on the other side of the spark gap), and with the rate at which the fluid/gas flows within the spark gap—if flowing fluid/gas is used. As will be seen in some of the embodiments, the threshold voltage may be adjusted in some embodiments by changing any or all of these conditions. [0046] A first embodiment of an ablation device 10 utilizing principles of the present invention is shown in FIGS. 1-2 . Device 10 includes a housing 12 formed of an insulating material such as glass, ceramic, siliciumoxid, PTFE or other material having a high melting temperature. At the distal end 13 of the housing 12 is a sealed reservoir 20 . An internal electrode 22 is disposed within the sealed reservoir 20 . Electrode 22 is electrically coupled to a conductor 24 that extends through the housing body. Conductor 24 is coupled to an RF generator 28 which may be a conventional RF generator used for medical ablation, such as the Model Force 2 RF Generator manufactured by Valley Lab. A return electrode 30 is disposed on the exterior surface of the housing 12 and is also electrically coupled to RF generator 28 . [0047] A plurality of ablation electrodes 32 a - 32 c are located on the distal end of the housing 12 . Ablation electrodes 32 a - 32 c may be formed of tungsten or any conductive material which performs well when exposed to high temperatures. In an alternative embodiment, there may be only one ablation electrode 32 , or a different electrode configuration. A portion of each ablation electrode 32 a - 32 c is exposed to the interior of reservoir 20 . Electrodes 22 and 32 a - 32 c , and corresponding electrodes in alternate embodiments, may also be referred to herein as spark gap electrodes. [0048] FIGS. 5A through 5D illustrate the method of using the embodiment of FIG. 1 . Referring to FIG. 5A , prior to use the reservoir 20 is filled with a fluid or gas. Preferably, an inert gas such as argon gas or a similar gas such as Neon, Xenon, or Helium is utilized to prevent corrosion of the electrodes, although other fluids/gases could be utilized so long as the electrodes and other components were appropriately protected from corrosion. For convenience only, the embodiments utilizing such a fluid/gas will be described as being used with the preferred gas, which is argon. [0049] It should be noted that while the method of FIGS. 5A-5D is most preferably practiced with a sealed volume of gas within the reservoir 20 , a circulating-flow of gas using a system of lumens in the housing body may alternatively be used. A system utilizing a circulating gas flow is described in connection with FIGS. 15A-15B . [0050] The distal end of the device 10 is placed against body tissue to be ablated, such that some of the electrodes 32 a , 32 b contact the tissue T. In most instances, others of the electrodes 32 c are disposed within body fluids F. The RF generator 28 ( FIG. 1 ) is powered on and gradually builds-up the voltage potential between electrode 22 and electrodes 32 a - 32 c. [0051] Despite the voltage potential between the internal electrode 22 and ablation electrodes 32 a - 32 c , there initially is no conduction of current between them. This is because the argon gas will not conduct current when it is in a gas phase. In order to conduct, high voltages must be applied through the argon gas to create a spark to ionize the argon and bring it into the conductive plasma phase. Later in this description these voltages may also be referred to as “initiating voltages” since they are the voltages at which conduction is initiated. [0052] The threshold voltage at which the argon will begin to immediately conduct is dependent on the pressure of the argon gas and the distance between electrode 22 and surface electrodes 32 a - 32 c. [0053] Assume P 1 is the initial pressure of the argon gas within reservoir 20 . If, at pressure P 1 , a voltage of V 1 is required to ignite plasma within the argon gas, then a voltage of V>V 1 must be applied to electrode 22 to ignite the plasma and to thus begin conduction of current from electrode 22 to ablation electrodes 32 a - 32 c. [0054] Thus, no conduction to electrodes 32 a - 32 c (and thus into the tissue) will occur until the voltage potential between electrode 22 and ablation electrodes 32 a - 32 c reaches voltage V. Since no current flows into the tissue during the time when the RF generator is increasing its output voltage towards the voltage threshold, there is minimal resistive heating of the electrodes 32 a - 32 c and body tissue. Thus, this method relies on the threshold voltage of the argon (i.e. the voltage at which a plasma is ignited) to prevent overheating of the ablation electrodes 32 a , 32 b and to thus prevent tissue from sticking to the electrodes. [0055] The voltage applied by the RF generator to electrode 22 cycles between +V and −V throughout the ablation procedure. However, as the process continues, the temperature of the tip of the device begins to increase, causing the temperature within the reservoir and thus the pressure of the argon to increase. As the gas pressure increases, the voltage needed to ignite the plasma also increases. Eventually, increases in temperature and thus pressure will cause the voltage threshold needed to ignite the plasma to increase above V. When this occurs, flow of current to the ablation electrodes will stop ( FIG. 5D ) until the argon temperature and pressure decrease to a point where the voltage required for plasma ignition is at or below V. Initial gas pressure P 1 and the voltage V are thus selected such that current flow will terminate in this manner when the electrode temperature is reaching a point at which tissue will stick to the electrodes and/or char the tissue. This allows the tip temperature of the device to be controlled by selecting the initial gas pressure and the maximum treatment voltage. [0056] The effect of utilizing a minimum voltage limit on the potential applied to the tissue is illustrated graphically in FIGS. 3 and 4 A. FIG. 3 shows RF generator voltage output V RF over time, and FIG. 4A shows the ablation potential V A between internal electrode 22 and body tissue. As can be seen, V A remains at 0 V until the RF generator output V RF reaches the device's voltage threshold V T , at which time V A rises immediately to the threshold voltage level. Ablation voltage V A remains approximately equivalent to the RF generator output until the RF generator output reaches 0 V. V A remains at 0 V until the negative half-cycle of the RF generator output falls below (−V T ), at which time the potential between electrode 22 and the tissue drops immediately to (−V T ), and so on. Because there is no conduction to the tissue during the time that the RF generator output is approaching the voltage threshold, there is little conduction to the tissue during low voltage (and high current) phases of the RF generator output. This minimizes collateral tissue damages that would otherwise be caused by resistive heating. [0057] It is further desirable to eliminate the sinusoidal trailing end of the waveform as an additional means of preventing application of low voltage/high current to the tissue and thus eliminating collateral tissue damage. Additional features are described below with respect FIGS. 14A-18 . These additional features allow this trailing edge to be clipped and thus produce a waveform measured at the electrode/tissue interface approximating that shown in FIG. 4B . [0058] Another phenomenon occurs between the electrodes 32 a - 32 c and the tissue, which further helps to keep the electrodes sufficiently cool as to avoid sticking. This phenomenon is best described with reference to FIGS. 5A through 5D . As mentioned, in most cases some of the electrodes such as electrode 32 c will be in contact with body fluid while others (e.g. 32 a - 32 b ) are in contact with tissue. Since the impedance of body fluid F is low relative to the impedance of tissue T, current will initially flow through the plasma to electrode 32 c and into the body fluid to return electrode 30 , rather than flowing to the electrodes 32 , 32 b that contact tissue T. This plasma conduction is represented by an arrow in FIG. 5A . [0059] Resistive heating of electrode 32 c causes the temperature of body fluid F to increase. Eventually, the body fluid F reaches a boiling phase and a resistive gas/steam bubble G will form at electrode 32 c . Steam bubble G increases the distance between electrode 22 and body fluid F from distance D 1 to distance D 2 as shown in FIG. 5B . The voltage at which the argon will sustain conductive plasma is dependent in part on the distance between electrode 22 and the body fluid F. If the potential between electrode 22 and body fluid F is sufficient to maintain a plasma in the argon even after the bubble G has expanded, energy will continue to conduct through the argon to electrode 32 c , and sparking will occur through bubble G between electrode 32 c and the body fluid F. [0060] Continued heating of body fluid F causes gas/steam bubble G to further expand. Eventually the size of bubble G is large enough to increase the distance between electrode 22 and fluid F to be great enough that the potential between them is insufficient to sustain the plasma and to continue the sparking across the bubble G. Thus, the plasma between electrodes 22 and 32 c dies, causing sparking to discontinue and causing the current to divert to electrodes 32 a , 32 b into body tissue T, causing ablation to occur. See FIG. 5C . A gas/steam insulating layer L will eventually form in the region surrounding the electrodes 32 a , 32 b . By this time, gas/steam bubble G around electrode 32 c may have dissipated, and the high resistance of the layer L will cause the current to divert once again into body fluid F via electrode 32 c rather than through electrodes 32 a , 32 b . This process may repeat many times during the ablation procedure. [0061] A second embodiment of an ablation device 110 is shown in FIGS. 6A and 6B . The second embodiment operates in a manner similar to the first embodiment, but it includes structural features that allow the threshold voltage of the argon to be pre-selected. Certain body tissues require higher voltages in order for ablation to be achieved. This embodiment allows the user to select the desired ablation voltage and to have the system prevent current conduction until the pre-selected voltages are reached. Thus, there is no passage of current to the tissue until the desired ablation voltage is reached, and so there is no unnecessary resistive tissue heating during the rise-time of the voltage. [0062] As discussed previously, the voltage threshold of the argon varies with the argon pressure in reservoir 120 and with the distance d across the spark gap, which in this embodiment is the distance extending between electrode 122 and ablation electrodes 132 a - 132 c . The second embodiment allows the argon pressure and/or the distance d to be varied so as to allow the voltage threshold of the argon to be pre-selected to be equivalent to the desired ablation voltage for the target tissue. In other words, if a treatment voltage of 200V is desired, the user can configure the second embodiment such that that voltage will be the threshold voltage for the argon. Treatment voltages in the range of 50V to 10,000V, and most preferably 200V-500V, may be utilized. [0063] Referring to FIG. 6A , device 110 includes a housing 112 formed of an insulating material such as glass, ceramic, siliciumoxid, PTFE or other high melting temperature material. A reservoir 120 housing a volume of argon gas is located in the housing's distal tip. A plunger 121 is disposed within the housing 112 and includes a wall 123 . The plunger is moveable to move the wall proximally and distally between positions 121 A and 121 B to change the volume of reservoir 120 . Plunger wall 123 is sealable against the interior wall of housing 112 so as to prevent leakage of the argon gas. [0064] An elongate rod 126 extends through an opening (not shown) in plunger wall 123 and is fixed to the wall 123 such that the rod and wall can move as a single component. Rod 126 extends to the proximal end of the device 110 and thus may serve as the handle used to move the plunger 121 during use. [0065] Internal electrode 122 is positioned within the reservoir 120 and is mounted to the distal end of rod 126 such that movement of the plunger 121 results in corresponding movement of the electrode 122 . Electrode 122 is electrically coupled to a conductor 124 that extends through rod 126 and that is electrically coupled to RF generator 128 . Rod 126 preferably serves as the insulator for conductor 124 and as such should be formed of an insulating material. [0066] A return electrode 130 is disposed on the exterior surface of the housing 112 and is also electrically coupled to RF generator 128 . A plurality of ablation electrodes 132 a , 132 b etc. are positioned on the distal end of the housing 112 . [0067] Operation of the embodiment of FIGS. 6A-6B is similar to that described with respect to FIGS. 5A-5B , and so most of that description will not be repeated. Operation differs in that use of the second embodiment includes the preliminary step of moving rod 126 proximally or distally to place plunger wall 123 and electrode 122 into positions that will yield a desired voltage threshold for the argon gas. Moving the plunger in a distal direction (towards the electrodes 132 a - 132 c ) will decrease the volume of the reservoir and accordingly will increase the pressure of the argon within the reservoir and vice versa. Increases in argon pressure result in increased voltage threshold, while decreases in argon pressure result in decreased voltage threshold. [0068] Moving the plunger 126 will also increase or decrease the distance d between electrode 122 and electrodes 132 a - 132 c . Increases in the distance d increase the voltage threshold and vice versa. [0069] The rod 126 preferably is marked with calibrations showing the voltage threshold that would be established using each position of the plunger. This will allow the user to move the rod 126 inwardly (to increase argon pressure but decrease distance d) or outwardly (to decrease argon pressure but increase distance d) to a position that will give a threshold voltage corresponding to the voltage desired to be applied to the tissue to be ablated. Because the argon will not ignite into a plasma until the threshold voltage is reached, current will not flow to the electrodes 132 a , 132 b etc. until the pre-selected threshold voltage is reached. Thus, there is no unnecessary resistive tissue heating during the rise-time of the voltage. [0070] Alternatively, the FIG. 6A embodiment may be configured such that plunger 121 and rod 126 may be moved independently of one another, so that argon pressure and the distance d may be adjusted independently of one another. Thus, if an increase in voltage threshold is desired, plunger wall 123 may be moved distally to increase argon pressure, or rod 126 may be moved proximally to increase the separation distance between electrode 122 and 132 a - 132 c . Likewise, a decrease in voltage threshold may be achieved by moving plunger wall 123 proximally to decrease argon pressure, or by moving rod 126 distally to decrease the separation distance d. If such a modification to the FIG. 6A was employed, a separate actuator would be attached to plunger 121 to allow the user to move the wall 123 , and the plunger 126 would be slidable relative to the opening in the wall 123 through which it extends. [0071] During use of the embodiment of FIGS. 6A and 6B , it may be desirable to maintain a constant argon pressure despite increases in temperature. As discussed in connection with the method of FIGS. 5A-5D , eventual increases in temperature and pressure cause the voltage needed to ignite the argon to increase above the voltage being applied by the RF generator, resulting in termination of conduction of the electrodes. In the FIG. 6A embodiment, the pressure of the argon can be maintained despite increases in temperature by withdrawing plunger 121 gradually as the argon temperature increases. By maintaining the argon pressure, the threshold voltage of the argon is also maintained, and so argon plasma will continue to conduct current to the electrodes 132 a , 132 b etc. This may be performed with or without moving the electrode 122 . Alternatively, the position of electrode 122 may be changed during use so as to maintain a constant voltage threshold despite argon temperature increases. [0072] FIGS. 7A and 7B show an alternative embodiment of an ablation device 210 that is similar to the device of FIGS. 6A and 6B . In this embodiment, argon is sealed within reservoir 220 by a wall 217 . Rather than utilizing a plunger (such as plunger 121 in FIG. 6A ) to change the volume of reservoir 220 , the FIGS. 7A-7B embodiment utilizes bellows 221 formed into the sidewalls of housing 212 . A pullwire 226 (which may double as the insulation for conductor 224 ) extends through internal electrode 222 and is anchored to the distal end of the housing 212 . The bellows may be moved to the contracted position shown in FIG. 7A , the expanded position shown in FIG. 7B , or any intermediate position between them. [0073] Pulling the pullwire 226 collapses the bellows into a contracted position as shown in FIG. 7A and increases the pressure of the argon within the reservoir 220 . Advancing the pullwire 226 expands the bellows as shown in FIG. 7B , thereby decreasing the pressure of the argon. The pullwire and bellows may be used to pre-select the threshold voltage, since (for a given temperature) increasing the argon pressure increases the threshold voltage of the argon and vice versa. Once the threshold voltage has been pre-set, operation is similar to that of the previous embodiments. It should be noted that in the third embodiment, the distance between electrode 222 and ablation electrodes 232 a - c remains fixed, although the device may be modified to allow the user to adjust this distance and to provide an additional mechanism for adjusting the voltage threshold of the device. [0074] An added advantage of the embodiment of FIG. 7A is that the device may be configured to permit the bellows 221 to expand in response to increased argon pressure within the reservoir. This will maintain the argon pressure, and thus the threshold voltage of the argon, at a fairly constant level despite temperature increases within reservoir 220 . Thus, argon plasma will continue to conduct current to the electrodes 132 a 132 b etc and ablation may be continued, as it will be a longer period of time until the threshold voltage of the argon exceeds the voltage applied by the RF generator. [0075] FIGS. 8A through 13B are a series of embodiments that also utilize argon, but that maintain a fixed reservoir volume for the argon. In each of these embodiments, current is conducted from an internal electrode within the argon reservoir to external ablation electrodes once the voltage of the internal electrode reaches the threshold voltage of the argon gas. [0076] Referring to FIGS. 8A and 8B , the fourth embodiment of an ablation device utilizes a housing 312 formed of insulating material, overlaying a conductive member 314 . Housing 312 includes exposed regions 332 in which the insulating material is removed to expose the underlying conductive member 314 . An enclosed reservoir 320 within the housing 212 contains argon gas, and an RF electrode member 322 is positioned within the reservoir. A return electrode (not shown) is attached to the patient. The fourth embodiment operates in the manner described with respect to FIGS. 5A-5D , except that the current returns to the RF generator via the return electrode on the patient's body rather than via one on the device itself. [0077] The fifth embodiment shown in FIGS. 9A and 9B is similar in structure and operation to the fourth embodiment. A conductive member 414 is positioned beneath insulated housing 412 , and openings in the housing expose electrode regions 432 of the conductive member 414 . The fifth embodiment differs from the fourth embodiment in that it is a bipolar device having a return electrode 430 formed over the insulated housing 412 . Return electrode 430 is coupled to the RF generator and is cutaway in the same regions in which housing 412 is cutaway; so as to expose the underlying conductor. [0078] Internal electrode 422 is disposed within argon gas reservoir 420 . During use, electrode regions 432 are placed into contact with body tissue to be ablated. The RF generator is switched on and begins to build the voltage of electrode 422 relative to ablation electrode regions 432 . As with the previous embodiments, conduction of ablation energy from electrode 422 to electrode regions 432 will only begin once electrode 422 reaches the voltage threshold at which the argon in reservoir 420 ignites to form a plasma. Current passes through the tissue undergoing ablation and to the return electrode 430 on the device exterior. [0079] The sixth embodiment shown in FIG. 10 is similar in structure and operation to the fifth embodiment, and thus includes a conductive member 514 , an insulated housing 512 over the conductive member 512 and having openings to expose regions 532 of the conductive member. A return electrode 530 is formed over the housing 512 , and an internal electrode 522 is positioned within a reservoir 520 containing a fixed volume of argon. The sixth embodiment differs from the fifth embodiment in that the exposed regions 532 of the conductive member 514 protrude through the housing 512 as shown. This is beneficial in that it improves contact between the exposed regions 532 and the target body tissue. [0080] A seventh embodiment is shown in FIGS. 11A through 11C . As with the sixth embodiment, this embodiment includes an insulated housing 612 (such as a heat resistant glass or ceramic) formed over a conductive member 614 , and openings in the insulated housing 612 to expose elevated electrode regions 632 of the conductive member 614 . A return electrode 630 is formed over the housing 612 . An internal electrode 622 is positioned within a reservoir 620 containing a fixed volume of argon. [0081] The seventh embodiment differs from the sixth embodiment in that there is an annular gap 633 between the insulated housing 612 and the elevated regions 632 of the conductive member 614 . Annular gap 633 is fluidly coupled to a source of suction and/or to an irrigation supply. During use, suction may be applied via gap 633 to remove ablation byproducts (e.g. tissue and other debris) and/or to improve electrode contact by drawing tissue into the annular regions between electrode regions 632 and ground electrode 630 . An irrigation gas or fluid may also be introduced via gap 633 during use so as to flush ablation byproducts from the device and to cool the ablation tip and the body tissue. Conductive or non-conductive fluid may be utilized periodically during the ablation procedure to flush the system. [0082] Annular gap 633 may also be used to deliver argon gas into contact with the electrodes 632 . When the voltage of the electrode regions 632 reaches the threshold of argon delivered through the gap 633 , the resulting argon plasma will conduct from electrode regions 632 to the ground electrode 630 , causing lateral sparking between the electrodes 632 , 630 . The resulting sparks create an “electrical file” which cuts the surrounding body tissue. [0083] An eighth embodiment of an ablation device is shown in FIGS. 12A and 12B . This device 710 is similar to the device of the fifth embodiment, FIGS. 9A and 9B , in a number of ways. In particular, device 710 includes a conductive member 714 positioned beneath insulated housing 712 , and openings in the housing which expose electrode regions 732 of the conductive member 714 . A return electrode 730 is formed over the insulated housing 712 . Internal electrode 722 is disposed within an argon gas reservoir 720 having a fixed volume. [0084] The eighth embodiment additionally includes a pair of telescoping tubular jackets 740 , 742 . Inner jacket 740 has a lower insulating surface 744 and an upper conductive surface 746 that serves as a second return electrode. Inner jacket 740 is longitudinally slidable between proximal position 740 A and distal position 740 B. [0085] Outer jacket 742 is formed of insulating material and is slidable longitudinally between position 742 A and distal position 742 B. [0086] A first annular gap 748 is formed beneath inner jacket 740 and a second annular gap 750 is formed between the inner and outer jackets 740 , 742 . These gaps may be used to deliver suction or irrigation to the ablation site to remove ablation byproducts. [0087] The eighth embodiment may be used in a variety of ways. As a first example, jackets 740 , 742 may be moved distally to expose less than all of tip electrode assembly (i.e. the region at which the conductive regions 732 are located). This allows the user to expose only enough of the conductive regions 732 as is needed to cover the area to be ablated within the body. [0088] Secondly, in the event bleeding occurs at the ablation site, return electrode surface 730 may be used as a large surface area coagulation electrode, with return electrode surface 746 serving as the return electrode, so as to coagulate the tissue and to thus stop the bleeding. Outer jacket 742 may be moved proximally or distally to increase or decrease the surface area of electrode 746 . Moving it proximally has the effect of reducing the energy density at the return electrode 746 , allowing power to be increased to carry out the coagulation without increasing thermal treatment effects at return electrode 746 . [0089] Alternatively, in the event coagulation and/or is needed, electrode 730 may be used for surface coagulation in combination with a return patch placed into contact with the patient. [0090] FIGS. 13A-13B show a ninth embodiment of an ablation device utilizing principles of the present invention. The ninth embodiment includes an insulated housing 812 having an argon gas reservoir 820 of fixed volume. A plurality of ablation electrodes 832 are embedded in the walls of the housing 812 such that they are exposed to the argon in reservoir 832 and exposed on the exterior of the device for contact with body tissue. A return electrode 830 is formed over the housing 812 , but includes openings through which the electrodes 832 extend. An annular gap 833 lies between return electrode 830 and housing 812 . As with previous embodiments, suction and/or irrigation may be provided through the gap 833 . Additionally, argon gas may be introduced through the annular gap 833 and into contact with the electrodes 832 and body tissue so as to allow argon gas ablation to be performed. [0091] An internal electrode 822 is positioned within reservoir 820 . Electrode 822 is asymmetrical in shape, having a curved surface 822 a forming an arc of a circle and a pair of straight surfaces 822 b forming radii of the circle. As a result of its shape, the curved surface of the electrode 820 is always closer to the electrodes 832 than the straight surfaces. Naturally, other shapes that achieve this effect may alternatively be utilized. [0092] Electrode 822 is rotatable about a longitudinal axis and can also be moved longitudinally as indicated by arrows in FIGS. 13A and 13B . Rotation and longitudinal movement can be carried out simultaneously or separately. This allows the user to selectively position the surface 822 a in proximity to a select group of the electrodes 832 . For example, referring to FIGS. 13A and 13B , when electrode 822 is positioned as shown, curved surface 822 a is near electrodes 832 a , whereas no part of the electrode 822 is close to the other groups of electrodes 832 b - 832 d. [0093] As discussed earlier, the voltage threshold required to cause conduction between internal electrode 822 and ablation electrodes 832 will decrease with a decrease in distance between the electrodes. Thus, there will be a lower threshold voltage between electrode 822 and the ablation electrodes (e.g. electrode 832 a ) adjacent to surface 822 a than there is between the electrode 822 and ablation electrodes that are farther away (e.g. electrodes 832 b - d. The dimensions of the electrode 822 and the voltage applied to electrode 822 are such that a plasma can only be established between the surface 822 a and the electrodes it is close to. Thus, for example, when surface 822 a is adjacent to electrodes 832 a as shown in the drawings, the voltage threshold between the electrodes 822 a and 832 a is low enough that the voltage applied to electrode 822 will cause plasma conduction to electrodes 832 a . However, the threshold between electrode 822 and the other electrodes 832 b - d will remain above the voltage applied to electrode 822 , and so there will be no conduction to those electrodes. [0094] This embodiment thus allows the user to selectively ablate regions of tissue by positioning the electrode surface 822 a close to electrodes in contact with the regions at which ablation is desired. [0095] FIG. 14A shows a tenth embodiment of an ablation device utilizing voltage threshold principles. The tenth embodiment includes a housing 912 having a sealed distal end containing argon. Ablation electrodes 932 a - c are positioned on the exterior of the housing 912 . An internal electrode 22 is disposed in the sealed distal end. Positioned between the internal electrode 922 and the electrodes 932 a - c is a conductive grid 933 . [0096] When electrode 922 is energized, there will be no conduction from electrode 922 to electrodes 932 a - c until the potential between electrode 922 and the body tissue/fluid in contact with electrodes 932 a - c reaches an initiating threshold voltage at which the argon gas will form a conductive plasma. The exact initiating threshold voltage is dependent on the argon pressure, its flowrate (if it is circulating within the device), and the distance between electrode 922 and the tissue/body fluid in contact with the ablation electrodes 932 a - c. [0097] Because the RF generator voltage output varies sinusoidally with time, there are phases along the RF generator output cycle at which the RF generator voltage will drop below the voltage threshold. However, once the plasma has been ignited, the presence of energized plasma ions in the argon will maintain conduction even after the potential between electrode 922 and the body fluid/tissue has been fallen below the initiating threshold voltage. In other words, there is a threshold sustaining voltage that is below the initiating threshold voltage, but that will sustain plasma conduction. [0098] In the embodiment of FIG. 14A , the grid 933 is spaced from the electrodes 932 a - c by a distance at which the corresponding plasma ignition threshold is a suitable ablation voltage for the application to which the ablation device is to be used. Moreover, the electrode 922 is positioned such that once the plasma is ignited, grid 933 may be deactivated and electrode 922 will continue to maintain a potential equal to or above the sustaining voltage for the plasma. Thus, during use, both grid 933 and electrode 922 are initially activated for plasma formation. Once the potential between grid 933 and body tissue/fluid reaches the threshold voltage and the plasma ignites, grid 933 will be deactivated. Because ions are present in the plasma at this point, conduction will continue at the sustaining threshold voltage provided by electrode 922 . [0099] The ability of ionized gas molecules in the argon to sustain conduction even after the potential applied to the internal electrode has fallen below the initiating threshold voltage can be undesirable. As discussed, an important aspect of voltage threshold ablation is that it allows for high voltage/low current ablation. Using the embodiments described herein, a voltage considered desirable for the application is selected as the threshold voltage. Because the ablation electrodes are prevented from conducting when the voltage delivered by the RF generator is below the threshold voltage, there is no conduction to the ablation electrode during the rise time from 0V to the voltage threshold. Thus, there is no resistive heating of the tissue during the period in which the RF generator voltage is rising towards the threshold voltage. [0100] Under ideal circumstances, conduction would discontinue during the periods in which the RF generator voltage is below the threshold. However, since ionized gas remains in the argon reservoir, conduction can continue at voltages below the threshold voltage. Referring to FIG. 4A , this results in the sloping trailing edge of the ablation voltage waveform, which approximates the trailing portion of the sinusoidal waveform produced by the RF generator ( FIG. 3 ). This low-voltage conduction to the tissue causes resistive heating of the tissue when only high voltage ablation is desired. [0101] The grid embodiment of FIG. 14A may be used to counter the effect of continued conduction so as to minimize collateral damage resulting from tissue heating. During use of the grid embodiment, the trailing edge of the ablation voltage waveform is straightened by reversing the polarity of grid electrode 933 after the RF generator has reached its peak voltage. This results in formation of a reverse field within the argon, which prevents the plasma flow of ions within the argon gas and that thus greatly reduces conduction. This steepens the slop of the trailing edge of the ablation potential waveform, causing a more rapid drop towards 0V, such that it approximates the waveform shown in FIG. 4B . [0102] FIGS. 15A and 15B show an eleventh embodiment utilizing principles of the present invention. As with the tenth embodiment, the eleventh embodiment is advantageous in that it utilizes a mechanism for steepening the trailing edge of the ablation waveform, thus minimizing conduction during periods when the voltage is below the threshold voltage. In the eleventh embodiment, this is accomplished by circulating the argon gas through the device so as to continuously flush a portion of the ionized gas molecules away from the ablation electrodes. [0103] The eleventh embodiment includes a housing 1012 having an ablation electrodes 1032 . An internal electrode 1022 is positioned within the housing 1012 and is preferably formed of conductive hypotube having insulation 1033 formed over all but the distal-most region. A fluid lumen 1035 is formed in the hypotube and provides the conduit through which argon flows into the distal region of housing 1012 . Flowing argon exits the housing through the lumen in the housing 1012 , as indicated by arrows in FIG. 15A . A pump 1031 drives the argon flow through the housing. [0104] It should be noted that different gases will have different threshold voltages when used under identical conditions. Thus, during use of the present invention the user may select a gas for the spark gap switch that will have a desired threshold voltage. A single type of gas (e.g. argon) may be circulated through the system, or a plurality of gases from sources 1033 a - c may be mixed by a mixer pump 1031 a as shown in FIG. 15C , for circulation through the system and through the spark gap switch 1035 . Mixing of gases is desirable in that it allows a gas mixture to be created that has a threshold voltage corresponding to the desired treatment voltage. In all of the systems using circulated gas, gas leaving the system may be recycled through, and/or exhausted from, the system after it makes a pass through the spark gap switch. [0105] FIGS. 16A through 16D schematically illustrate the effect of circulating the argon gas through the device of FIG. 15A . Circulation preferably is carried out at a rate of approximately 0.1 liters/minute to 0.8 liters/minute. [0106] Referring to FIG. 16A , during initial activation of the RF generator, the potential between internal electrode 1022 and ablation electrode 1032 is insufficient to create an argon plasma. Argon molecules are thus non-ionized, and the voltage measured at the load L is 0V. There is no conduction from electrode 1022 to electrode 1032 at this time. [0107] FIG. 16B shows the load voltage measured from internal electrode 1022 across the body fluid/tissue to return electrode 1030 . Once the RF generator voltage output reaches voltage threshold V T of the argon, argon molecules are ionized to create a plasma. A stream of the ionized molecules flows from electrode 1022 to electrode 1032 and current is conducted from electrode 1032 to the tissue. Because the argon is flowing, some of the ionized molecules are carried away. Nevertheless, because of the high voltage, the population of ionized molecules is increasing at this point, and more than compensates for those that flow away, causing an expanding plasma within the device. [0108] After the RF generator voltage falls below V T , ion generation stops. Ionized molecules within the argon pool flow away as the argon is circulated, and others of the ions die off. Thus, the plasma begins collapsing and conduction to the ablation electrodes decreases and eventually stops. See FIGS. 16C and 16D . The process then repeats as the RF generator voltage approaches (−V T ) during the negative phase of its sinusoidal cycle. [0109] Circulating the argon minimizes the number of ionized molecules that remain in the space between electrode 1022 and electrode 1032 . If a high population of ionized molecules remained in this region of the device, their presence would result in conduction throughout the cycle, and the voltage at the tissue/fluid load L would eventually resemble the sinusoidal output of the RF generator. This continuous conduction at low voltages would result in collateral heating of the tissue. [0110] Naturally, the speed with which ionized molecules are carried away increases with increased argon flow rate. For this reason, there will be more straightening of the trailing edge of the ablation waveform with higher argon flow rates than with lower argon flow rates. This is illustrated graphically in FIG. 17 . The upper waveform shows the RF generator output voltage. The center waveform is the voltage output measured across the load (i.e. from the external electrode 1032 across the body tissue/fluid to the return electrode 1030 ) for a device in which the argon gas is slowly circulated. The lower waveform is the voltage output measured across the load for a device in which the argon gas is rapidly circulated. It is evident from the FIG. 17 graphs that the sloped trailing edge of the ablation waveform remains when the argon is circulated at a relatively low flow rate, whereas the trailing edge falls off more steeply when a relatively high flow rate is utilized. This steep trailing edge corresponds to minimized current conduction during low voltage phases. Flow rates that achieve the maximum benefit of straightening the trailing edge of the waveform are preferable. It should be noted that flow rates that are too high can interfere with conduction by flushing too many ionized molecules away during phases of the cycle when the output is at the threshold voltage. Optimal flow rates will depend on other physical characteristics of the device, such as the spark gap distance and electrode arrangement. [0111] It should also be noted that the distance between internal electrode 1022 and external electrode 1032 also has an effect on the trailing edge of the ablation potential waveform. In the graphs of FIG. 18 , the RF generator output is shown in the upper graph. V PRFG represents the peak voltage output of the RF generator, V T1 represents the voltage threshold of a device having a large separation distance (e.g. approximately 1 mm) between electrodes 1022 and 1032 , and V T2 represents the voltage threshold of a device in which electrodes 1022 , 1032 are closely spaced—e.g. by a distance of approximately 0.1 mm. As previously explained, there is a higher voltage threshold in a device with a larger separation distance between the electrodes. This is because there is a large population of argon molecules between the electrodes 1022 , 1032 that must be stripped of electrons before plasma conduction will occur. Conversely, when the separation distance between electrodes 1022 and 1032 is small, there is a smaller population of argon molecules between them, and so less energy is needed to ionize the molecules to create plasma conduction. [0112] When the RF generator output falls below the threshold voltage, the molecules begin to deionize. When there are fewer ionized molecules to begin with, as is the case in configurations having a small electrode separation distance, the load voltage is more sensitive to the deionization of molecules, and so the trailing edge of the output waveform falls steeply during this phase of the cycle. [0113] For applications in which a low voltage threshold is desirable, the device may be configured to have a small electrode spacing (e.g. in the range of 0.001-5 mm, most preferably 0.05-0.5 mm) and non-circulating argon. As discussed, doing so can produce a load output waveform having a steep rising edge and a steep falling edge, both of which are desirable characteristics. If a higher voltage threshold is needed, circulating the argon in a device with close inter-electrode spacing will increase the voltage threshold by increasing the pressure of the argon. This will yield a highly dense population of charged ions during the phase of the cycle when the RF generator voltage is above the threshold voltage, but the high flow rate will quickly wash many ions away, causing a steep decline in the output waveform during the phases of the cycle when the RF generator voltage is below the threshold. [0114] A twelfth embodiment of a system utilizing principles of the present invention is shown schematically in FIG. 19 . The twelfth embodiment allows the threshold voltage to be adjusted by permitting the spark gap spacing (i.e. the effective spacing between the internal electrode and the ablation electrode) to be selected. It utilizes a gas-filled spark gap switch 1135 having a plurality of internal spark gap electrodes 1122 a , 1122 b , 1122 c . Each internal electrode is spaced from ablation electrode 1132 by a different distance, D 1 , D 2 , D 3 , respectively. An adjustment switch 1125 allows the user to select which of the internal electrodes 1122 a , 1122 b , 1122 c to utilize during a procedure. Since the threshold voltage of a spark gap switch will vary with the distance between the internal electrode and the contact electrode, the user will select an internal electrode, which will set the spark gap switch to have the desired threshold voltage. If a higher threshold voltage is used, electrode 1122 a will be utilized, so that the larger spark gap spacing D 1 will give a higher threshold voltage. Conversely, the user will selected electrode 1122 c , with the smaller spark gap spacing, if a lower threshold voltage is needed. [0115] It is useful to mention that while the spark gap switch has been primarily described as being positioned within the ablation device, it should be noted that spark gap switches may be positioned elsewhere within the system without departing with the scope of the present invention. For example, referring to FIG. 19 , the spark gap switch 1135 may be configured such that the ablation electrode 1132 disposed within the spark gap is the remote proximal end of a conductive wire that is electrically coupled to the actual patient contact portion of the ablation electrode positioned into contact with body tissue. A spark gap switch of this type may be located in the RF generator, in the handle of the ablation device, or in the conductors extending between the RF generator and the ablation device. [0116] FIGS. 20-26 illustrate additional embodiments of a surgical probe that utilizes voltage threshold means for controlling ablative energy delivery to tissue at a targeted site. In general, FIG. 20 depicts an exemplary probe 1200 with handle portion 1202 coupled to extension member 1204 that supports working end 1205 . The working end 1205 can have any suitable geometry and orientation relative to axis 1208 and is shown as an axially-extending end for convenience. A hand-held probe 1200 as in FIG. 20 can be used to move or paint across tissue to ablate the tissue surface, whether in an endoscopic treatment within a fluid as in arthroscopy, or in a surface tissue treatment in air. In this embodiment, the exterior sheath 1206 is an insulator material ( FIG. 21 ) and the probe is adapted to function in a mono-polar manner by cooperating with a ground pad 1208 coupled to the targeted tissue TT (see FIGS. 20 and 21 ). The system also can operate in a bi-polar manner by which is meant the working end itself carries a return electrode, as will be illustrated in FIG. 26 below. [0117] Referring to FIGS. 20 and 21 , the working end 1205 comprises a microporous ceramic body 1210 that cooperates with an interior voltage threshold mechanism or spark gap switch as described above. In one embodiment in FIG. 21 , the ceramic body 1210 has interior chamber 1215 that receives a flowable, ionizable gas that flows from a pressurized gas source 1220 and is extracted by a negative pressure source 1225 . In this embodiment, it can be seen that gas flows through interior lumen 1228 in conductive sleeve 1230 . The gas is then extracted through concentric lumen 1235 that communicates with negative pressure source 1225 as indicated by the gas flow arrows F in FIG. 21 . Any suitable spacer elements 1236 (phantom view) can support the conductive sleeve 1230 within the probe body to maintain the arrangement of components to provide the gas inflow and outflow pathways. As can be seen in FIG. 21 , the conductive sleeve 1230 is coupled by electrical lead 1238 to electrical source 1240 to allow its function and as electrode component with the distal termination 1241 of sleeve 1230 on one side of a spark gap indicated at SG. [0118] The interior surface 1242 of ceramic body 1210 carries an interior electrode 1244 A at the interior of the microporous ceramic. As can be seen in enlarged cut-away view of FIG. 22 , the ceramic has a microporous working surface 1245 wherein a micropore network 1248 extends through the thickness TH of the ceramic body surface overlying the interior electrode 1244 A. The sectional view of FIG. 21 illustrates the pore network 1248 extending from working surface 1245 to the interior electrode 1244 A. The function of the pore network 1248 is to provide a generally defined volume or dimension of a gas within a plurality of pores or pathways between interior electrode 1244 A and the targeted tissue site TT. Of particular importance, the cross-sectional dimensions of the pores is selected to insure that the pores remain free of fluid ingress in normal operating pressures of an underwater surgery (e.g., arthroscopy) or even moisture ingress in other surgeries in a normal air environment. It has been found that the mean pore cross-section of less than about 10 microns provides a suitable working surface 1245 for tissue ablation; and more preferably a mean pore cross-section of less than about 5 microns. Still more preferably, the mean pore cross-section is less than about 1 micron. In any event, the microporous ceramic allows for electrical energy coupling across and through the pore network 1248 between the interior electrode 1244 A and the targeted tissue site TT, but at the same time the microporous ceramic is impervious to liquid migration therein under pressures of a normal operating environment. This liquid-impervious property insures that electrical energy will ablatively arc through the pore network 1248 rather than coupling with water or moisture within the pore network during operation. [0119] In FIG. 21 , it also can be seen that working surface 1245 is defined as a limited surface region of the ceramic that is microporous. The working end 1205 has a ceramic glaze 1250 that covers the exterior of the ceramic body except for the active working surface 1245 . Referring now to FIG. 22 , the thickness TH of the microporous ceramic body also is important for controlling the ablative energy-tissue interaction. The thickness TH of the ceramic working surface can range from as little as about 5 microns to as much as about 1000 microns. More preferably, the thickness TH is from about 50 microns to 500 microns. [0120] The microporous ceramic body 1210 of FIGS. 20-22 can be fabricated of any suitable ceramic in which the fabrication process can produce a hard ceramic with structural integrity that has substantially uniform dimension, interconnected pores extending about a network of the body—with the mean pore dimensions described above. Many types of microporous ceramics have been developed for gas filtering industry and the fabrication processed can be the same for the ceramic body of the invention. It has been found that a ceramic of about 90%-98% alumina that is fired for an appropriate time and temperature can produce the pore network 1248 and working surface thickness TH required for the ceramic body to practice the method the invention. Ceramic micromolding techniques can be used to fabricate the net shape ceramic body as depicted in FIG. 21 . [0121] In FIGS. 21 and 22 , it can be understood how the spark gap SG (not-to-scale) between conductor sleeve 1230 and the interior electrode 1244 A can function to provide cycle-to-cycle control of voltage applied to the electrode 1244 A and thus to the targeted treatment site to ablate tissue. As can be understood in FIG. 22 , a gas flow F of a gas (e.g., argon) flows through the interior of the ceramic body to flush ionized gases therefrom to insure that voltage threshold mechanism functions optimally, as described above. [0122] FIG. 23 illustrates another embodiment of working end that included multiple conductor sleeves portions 1230 and 1230 ′ that are spaced apart by insulator 1252 and define different gap dimensions from distal surface 1241 and 1241 ′ to interior electrode 1244 A. It can be understood that the multiple conductor sleeves portions 1230 and 1230 ′, that can range from 2 to 5 or more, can be selected by controller 1255 to allow a change in the selected dimension of the spark gap indicated at SG and SG′. The dimension of the spark gap will change the voltage threshold to thereby change the parameter of ablative energy applied to the targeted tissue, which can be understood from the above detailed description. [0123] FIG. 24 illustrates a greatly enlarged cut-away view of an alternative microporous ceramic body 1210 wherein the interior electrode 1244 B also is microporous to cooperate with the microporous ceramic body 1210 in optimizing electrical energy application across and through the pore network 1248 . In this embodiment, the spark gap again is indicated at SG and defines the dimension between distal termination 1241 of conductor sleeve 1230 and the electrode 1244 B. The porous electrode 1244 B can be any thin film with ordered or random porosities fabricated therein and then bonded or adhered to ceramic body 1210 . The porous electrode also can be a porous metal that is known in the art. Alternatively, the porous electrode 1224 B can be vapor deposited on the porous surface of the ceramic body. Still another alternative that falls within the scope of the invention is a ceramic-metal composite material that can be formed to cooperate with the microporous ceramic body 1210 . [0124] FIG. 24 again illustrates that a gas flow indicated by arrows F will flush ionized gases from the interior of the ceramic body 1210 . At the same time, however, the pores 1258 in electrode 1244 B allow a gas flow indicated at F′ to propagate through pore network 1248 in the ceramic body to exit the working surface 1245 . This gas flow F′ thus can continuously flush the ionized gases from the pore network 1248 to insure that arc-like electrical energy will be applied to tissue from interior electrode 1244 B through the pore network 1248 —rather than having electrical energy coupled to tissue through ionized gases captured and still resident in the pore network from a previous cycle of energy application. It can be understood that the percentage of total gas flow F that cycles through interior chamber 1215 and the percentage of gas flow GF′ that exits through the pore network 1248 can be optimized by adjusting (i) the dimensions of pores 1258 in electrode 1244 B; (ii) the mean pore dimension in the ceramic body 1210 , the thickness of the ceramic working surface and mean pore length, (iv) inflow gas pressure; and (v) extraction pressure of the negative pressure source. A particular probe for a particular application thus will be designed, in part by modeling and experimentation, to determine the optimal pressures and geometries to deliver the desired ablative energy parameters through the working surface 1245 . This optimization process is directed to provide flushing of ionized gas from the spark gap at the interior chamber 1215 of the probe, as well as to provide flushing of the micropore network 1248 . In this embodiment, the micropore network 1248 can be considered to function as a secondary spark gap to apply energy from electrode 1224 B to the targeted tissue site TT. [0125] In another embodiment depicted in FIG. 25 , it should be appreciated that the spark gap interior chamber 1215 ′ also can be further interior of the microporous ceramic working surface 1245 . For example, FIG. 25 illustrates a microprobe working end 1260 wherein it may be impractical to circulate gas to a needle-dimension probe tip 1262 . In this case, the interior chamber 1215 ′ can be located more proximally in a larger cross-section portion of the probe. The working end of FIG. 25 is similar to that of FIG. 21 in that gas flows F are not used to flush ionized gases from the pore network 1248 . [0126] FIG. 26 illustrates another embodiment of probe 1270 that has the same components as in FIGS. 22 and 24 for causing electrical energy delivery through an open pore network 1248 in a substantially thin microporous ceramic body 1210 . In addition, the probe 1270 carries a return electrode 1275 at an exterior of the working end for providing a probe that functions in a manner generally described as a bi-polar energy delivery. In other words, the interior electrode 1244 A or 1244 B comprises a first polarity electrode (indicated at (+)) and the return electrode 1275 (indicated at (−)) about the exterior of the working end comprises a second polarity electrode. This differs from the embodiment of FIG. 21 , for example, wherein the second polarity electrode is a ground pad indicated at 1208 . The bi-polar probe 1270 that utilizes voltage threshold energy delivery through a microporous ceramic is useful for surgeries in a liquid environment, as in arthroscopy. It should be appreciated that the return electrode 1275 can be located in any location, or a plurality of locations, about the exterior of the working end and fall within the scope of the invention. [0127] The probe 1270 of FIG. 26 further illustrates another feature that provided enhanced safety for surgical probe that utilizes voltage threshold energy delivery. The probe has a secondary or safety spark gap 1277 in a more proximal location spaced apart a selected dimension SD from the interior spark gap indicated at SG. The secondary spark gap 1277 also defines a selected dimension between the first and second polarity electrodes 1230 and 1275 . As can be seen in FIG. 26 , the secondary spark gap 1277 consists of an aperture in the ceramic body 1210 or other insulator that is disposed between the opposing polarity electrodes. In the event that the primary spark gap SG in the interior chamber 1215 is not functioning optimally during use, any extraordinary current flows can jump the secondary spark gap 1277 to complete the circuit. The dimension across the secondary spark gap 1277 is selected to insure that during normal operations, the secondary spark gap 1277 maintains a passive role without energy jumping through the gap. [0128] Several embodiments of voltage threshold ablation systems, and methods of using them, have been described herein. It should be understood that these embodiments are described only by way of example and are not intended to limit the scope of the present invention. Modifications to these embodiments may be made without departing from the scope of the present invention, and features and steps described in connection with some of the embodiments may be combined with features described in others of the embodiments. Moreover, while the embodiments discuss the use of the devices and methods for tissue ablation, it should be appreciated that other electrosurgical procedures such as cutting and coagulation may be performed using the disclosed devices and methods. It is intended that the scope of the invention is to be construed by the language of the appended claims, rather than by the details of the disclosed embodiments.

The present invention relates to the field of electrosurgery, and more particularly to systems and methods for ablating, cauterizing and/or coagulating body tissue using radio frequency energy. More in particular, the systems utilize voltage threshold means for controlling the voltage applied to tissue in a cycle-to-cycle manner.

RELATED APPLICATION [0001] This application claims priority to U.S. Provisional Patent Application Ser. No.: 60/949,111, filed Jul. 11, 2007 and U.S. Provisional Patent Application Ser. No.: 60/974,634, filed Sep. 24, 2007, the disclosures of which are incorporated herein by reference. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] Hanging luggage is described with a foldable shelf, a lighted mirror and removable containers for containing various items such as toiletries, cosmetics, personal care items, accessories, jewelry and other similarly sized items. The removable inserts may be added, removed or reconfigured by the user of the luggage to customize it to suit personal taste and the specific needs of a use for the luggage. SUMMARY OF THE INVENTION [0004] The hanging luggage described herein provides for several features in combination to provide an improved article of luggage for transporting, storing and utilizing various items for personal use, such as cosmetics, personal care products, toiletries, fashion or other accessories, jewelry, medicines, small personal care appliances, and other similar items. The luggage may be used to carry and access any items that may fit into the provided containers. [0005] The luggage includes a folding hanger for hanging the luggage while packing, unpacking, or utilizing the items contained in the luggage, and which may be folded into the luggage during carrying or other transportation. The folding hanger may also incorporate a mirror to provide an aide for using cosmetic items, or other personal care items stored in the hanging luggage. The mirror may be optionally lit by light fixtures incorporated into the folding hanger or other areas of the luggage. [0006] The luggage also includes a folding shelf for conveniently setting items during their use, and which may also be folded flat inside the luggage when preparing the luggage for travel. [0007] The luggage further provides a number of containers or inserts incorporated into and attached to the luggage. The containers may be of varying sizes and shapes to accommodate storage of various items. Some of the containers or inserts may be removably attached to the luggage to allow for use separate from the luggage. The removable containers allow the user of the luggage to add, remove or reconfigure the containers in the luggage thereby customizing it to serve a specific need or the personal taste of the user. BRIEF DESCRIPTION OF THE DRAWINGS [0008] FIG. 1 is a schematic view of the hanging luggage in an open, hanging configuration. [0009] FIG. 2 is a schematic view of the hanging luggage in a partially folded configuration with several of the removable inserts disconnected from the hanging luggage panels. [0010] FIG. 3 is a partial photographic view of an embodiment of the hanging luggage in an open, hanging configuration. DETAILED DESCRIPTION [0011] Referring to FIG. 1 , the hanging luggage 100 is shown in an open configuration. The luggage 100 comprises a top panel 102 and at least one folding panel 104 . The embodiment shown in FIG. 1 includes two folding panels 104 , however other embodiments of the hanging luggage 100 may have one or more folding panels 104 . The embodiment shown in FIG. 1 has two folding panels 104 , with a first folding panel 104 foldably attached to the bottom edge of top panel 102 , and the second folding panel 104 foldably attached to the bottom edge 107 of the first folding panel 104 . The relative proportions of the folding panels to each other and to the containers and removable inserts therein may or may not be as shown in the figures. [0012] Top panel 102 and folding panels 104 may be constructed utilizing a number of methods and using a variety of materials as known in the art of making luggage. The panels may be constructed from cloth over a frame, stiff materials such as leather, plastic or synthetic materials, or hard-side materials commonly used to construct suitcases. Either the top panel 102 or the folding panels 104 , or both, may have side walls 109 extending substantially perpendicular to the panels 102 and 104 , the side walls defining an open-sided box with a depth typical of luggage or garment bags, as further described in relation to FIG. 3 . [0013] The top panel 102 and the folding panels 104 are foldably attached together along an exterior edge 106 of the panels to allow the folding panel 104 to overlay the top panel 102 in a folded configuration of the luggage. The top panel 102 folds into and is enclosed by the first folding panel 104 . The first folding panel 104 and the second folding panel 104 fold together and fasten along exterior edges 108 . [0014] The top panel 102 and folding panels 104 have interior and exterior surfaces. The exterior surfaces of the panels 102 and 104 are those facing away from a user of the luggage when the luggage is in an open configuration. The interior surfaces of the panels 102 and 104 are those that face toward the user and contain various containers as described later in the specification. [0015] In other embodiments of the luggage, top panel 102 may attach to edges 108 of folding panel 104 , and may enclose additional folding panels 104 between top panel 102 and the first folding panel 104 . [0016] The panels 102 and 104 may be attached to each other using a variety of methods for forming folding joints known in the art of making luggage. For example, the panels may be foldably attached by zippers or hinges attached to the panels, or the panels may be sewn together to form a flexible joint. Alternatively, top panel 102 and foldable panels 104 are formed from one continuous sheet of flexible material. For example, panels 102 and 104 may be formed from a single sheet of cloth or fabric. [0017] The folding panels 104 releaseably attach to each other along exterior edges 108 . The releaseable attachment along edges 108 may be one or a combination of various devices and materials for releaseable attachments, including, without limitation, zippers, Velcro, snaps, straps, latches, drawstrings or other similar means of closing luggage. [0018] One or more handles for carrying the luggage may be attached to it in various locations. A handle may be located along the exterior edge 106 , on the side of the luggage opposite the containers. A handle may be attached to the edges 108 of one or both of the panels 102 and 104 , at any point and along any side of the luggage. The handle may consist of multiple pieces that are attached to several different panels 102 or 104 , and that are disposed adjacent to one another for use as a handle only when luggage 100 is in the closed configuration. [0019] A folding hanger 110 is foldably attached to top panel 102 near edge 108 . The folding hanger 110 is adapted to hang over the bar provided in closets, or over hooks provided for hanging bags or articles of clothing. The folding hanger 110 may be formed from plastic, metal, wire, fabric, chain, or some combination thereof. The folding hanger 110 may be foldably attached to top panel 102 utilizing hinges, sewn attachment or other foldable means of connection. The hanger 110 may be folded down over top panel 102 in a folded configuration for carrying the luggage. An attachment may be provided for fastening the hook end of the hanger 110 to the top panel 102 to prevent shifting during carrying or travel, such as a strap secured by velcro or a snap. [0020] A mirror 112 is provided for use when the hanging luggage is in the open configuration. In one embodiment of the hanging luggage 100 , the mirror 112 is attached to the folding hanger 110 . The mirror 112 may also be attached to the top panel 102 independently of the hanger 110 , so long as it is foldably attached to the top panel 102 for flat storage in the folded configuration of the hanging luggage 102 . The mirror 1 12 may optionally be lit by light fixtures incorporated into the luggage. The light fixtures may be powered by batteries incorporated into the luggage, or by an accessory cord to plug the luggage into an electrical wall outlet. [0021] A shelf 114 may also be provided near edge 108 of top panel 102 adjacent to the folding hanger 110 . The shelf 114 may be used to temporarily store items otherwise stored in the compartments of the hanging luggage 100 during use when it is in the open position. Shelf 114 is formed from a rigid material capable of supporting items such as toiletries or cosmetics, including plastics, metals or flexible materials supported by a rigid frame. Shelf 114 is foldably connected to top panel 102 to allow it to fold flat against top panel 102 for storage in the folded configuration of the luggage 100 . Additional support for shelf 114 may be provided in the form of straps 115 attached to the outside edge of shelf 114 and to top panel 102 near edge 108 , or in support elements underneath shelf 114 and built into top panel 102 . [0022] Containers 116 are arrayed on both top panel 102 and folding panels 104 . Containers 116 provide storage for items of various sizes and shapes. The containers 116 may be formed from mesh, fabric, plastics, or other similar materials suitable for forming flexible containers in luggage. Containers 116 may be formed by sewing a pocket of fabric into the inside lining of panels 102 and 104 . They may also be self-contained pouches that are attached to panels 102 and 104 by sewing, gussetts, or otherwise. Containers 116 may be open on top, may close with elastic cord, drawstrings, snaps, buttons, or zip shut, or may be secured shut in other ways commonly used to secure the opening of bags, pouches, pockets, and other such containers. [0023] Certain containers 118 may be removable. Containers 118 are formed from the same types of materials and using the same methods of construction as described for containers 116 above. The removable containers 118 are releaseably attached to the top panel 102 and the folding panels 104 along the foldable attachment between the first and second folding panels 104 , and in other locations on the interior surface of the panels 102 and 104 . The removable containers 118 are releaseably attached to the panels 102 and 104 using ring binders or clips, straps, velcro, zippers, or combinations thereof. Different configurations of removable containers 118 may be formed by attaching varying sizes of removable containers 118 within the hanging luggage 100 . [0024] A user of the luggage may remove some of the removable containers 118 , may purchase and add additional removable containers of different sizes or shapes than those originally provided by with the luggage, or may rearrange the removable inserts in the luggage by unclipping the containers and reclipping them in a more suitable configuration in the luggage. By reconfiguring the removable containers 118 , the luggage 100 may be customized for a specific use or for the tastes and convenience of the user. [0025] The attachment member 122 provides the method of releasable attachment between removable containers 118 and luggage 100 . Luggage 100 may have multiple attachment members 122 located at various areas of luggage 100 , on panels 102 and 104 . In the embodiment of the luggage 100 shown in FIG. 1 , the attachment member is a ring clip device, providing releasable ring clips that may be opened or closed to remove or attach containers 118 as desired. Other embodiments of the luggage 100 may use other attachment members 122 , such as velcro strips, zippers, clips, straps or combinations thereof. [0026] Referring now to FIG. 2 , hanging luggage 100 is shown in a partially folded configuration. Shelf 114 is folded up and is flat against top panel 102 . Folding hanger 110 is folded down over shelf 114 and is flat against top panel 102 . To further fold the luggage 100 for travel, top panel 102 would be folded down into first folding panel 104 , then the folding panels 104 would be folded together and releaseably attached along edges 108 . [0027] In the folded configuration, luggage 100 may be carried by handles 120 . Handles 120 may be formed from flexible fabric straps, rigid plastic or metal, or some combination thereof. In other embodiments of the luggage 100 , removeably attached or integrated shoulder straps or integrated wheeled carriers may be provided. Such handles, straps or other means for carrying the luggage 100 may also be provided on the exterior surface of the luggage 100 at the foldable attachment between the folding panels 104 . [0028] Referring now to FIG. 3 , an embodiment of the luggage 100 is shown in the open configuration. Sidewalls 109 are shown for defining the interior of luggage 100 and extending edges 108 for attachment to the opposing edges of panels 102 and 104 , as appropriate. A view of folding hanger 110 is shown in the open position. Containers 1 16 and removable containers 118 are shown, attached to the top and folding panels, 102 and 104 respectively. FIG. 3 also includes a view of the handle 120 .

An article of luggage is described, incorporating a folding hanger, mirror and shelf, and a number of permanent and removably attached containers inside the luggage. The article of luggage may be hung in an open configuration for use of the items stored within. It may also be folded for storage or transport, in which folded configuration the hanger, mirror and shelf are folded and stored internally in the luggage. The removably attached containers may be rearranged within the luggage to provide a custom configuration.

SUMMARY OF THE INVENTION The present invention is directed to new insecticidal compositions which are useful in the kill and control of insects particularly insects of the Lepidoptera order and especially of the genus Heliothis. These compositions comprise mixtures of O,O-diethyl O-(3,5,6-trichloro-2-pyridinyl)phosphorothioate and 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane carboxylic acid:cyano(6-phenoxy-2-pyridinyl)methyl ester. It has been found that the toxic ingredients of said compositions are mutually activating. The O,O-diethyl O-(3,5,6-trichloro-2-pyridinyl)phosphorothioate employed in accordance with the teachings of the present invention is a solid material melting at ˜41°-42° C. The compound, its method of preparation and its insecticidal activity are taught in U.S. Pat. No. 3,244,586. The 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane carboxylic acid:cyano(6-phenoxy-2-pyridinyl)methyl ester employed in accordance with the teachings of the present invention is a liquid material boiling at ˜190°-200° C. under 0.1-0.2 mm Hg and has a refractive index of n D 20 of 1.5264. The compound, its method of preparation and its insecticidal activity are taught in U.S. Pat. No. 4,163,787. The new insecticidal composition of the present invention comprises about 1 part by weight of O,O-diethyl O-(3,5,6-trichloro-2-pyridinyl)phosphorothioate and from about 1/133 to about 1 part by weight of 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane, i.e. a ratio of about 133:1 to about 1:1. A preferred ratio is from about 2:1 to about 133:1 with the most preferred ratio being from about 2:1 to about 33:1. These insecticidal compositions are especially effective in killing and controlling insects, particularly Lepidoptera, especially Heliothis species, which infest crops such as corn, soybeans, tobacco and particularly cotton. The mixtures of active compounds of the present invention have been found to possess good activity against Heliothis species. Accordingly, the present invention also comprises methods for controlling such insects and/or their habitats with a pesticidally effective amount of the active compound mixture. For such uses the unmodified active materials of the present invention can be employed. However, the present invention embraces the use of an insecticidally-effective amount of the active materials in admixture with an inert material, as an adjuvant or carrier therefor, in solid or liquid form. Thus, for example, the active mixture can be dispersed on a finely divided solid and employed therein as a dust. Also, the active mixture, as liquid concentrates or solid compositions comprising the active mixture, can be dispersed in water, typically with the aid of a wetting agent, and the resulting aqueous dispersion employed as a spray. In other procedures, the active mixture can be employed as a constituent of organic liquid compositions, oil-in-water and water-in-oil emulsions, or water dispersions, with or without the addition of wetting, dispersing, or emulsifying agents. Suitable adjuvants of the foregoing type are well known to those skilled in the art. The methods of applying the solid or liquid pesticidal formulations similarly are well known to the skilled artisan. As organic solvents used as extending agents there can be employed hydrocarbons, e.g. benzene, toluene, xylene, kerosene, diesel fuel, fuel oil, and petroleum naphtha, ketones such as acetone, methyl ethyl ketone and cyclohexanone, chlorinated hydrocarbons such as carbon tetrachloride, chloroform, trichloroethylene, and perchloroethylene, esters such as ethyl acetate, amyl acetate and butyl acetate, ethers, e.g., ethylene glycol monomethyl ether and diethylene glycol monomethyl ether, alcohols, e.g., methanol, ethanol, isopropanol, amyl alcohol, ethylene glycol, propylene glycol, butyl carbitol acetate and glycerine. Mixtures of water and organic solvents, either as solutions or emulsions, can be employed. The active mixtures can also be applied as aerosols, e.g., by dispersing them in air by means of a compressed gas such as dichlorodifluoromethane or trichlorofluoromethane and other such materials. The active mixture of the present invention can also be applied with adjuvants or carriers such as talc, pyrophyllite, synthetic fine silica, attapulgus clay, kieselguhr, chalk, diatomaceous earth, lime, calcium carbonate, bentonite, fuller's earth, cottonseed hulls, wheat flour, soybean flour, pumice, tripoli, wood flour, walnut shell flour, redwood flour and lignin. As stated, it is frequently desirable to incorporate a surface active agent in the compositions of the present invention. Such surface active or wetting agents are advantageously employed in both the solid and liquid compositions. The surface active agent can be anionic, cationic or nonionic in character. Typical classes of surface active agents include alkyl sulfonate salts, alkylaryl sulfonate salts, alkylaryl polyether alcohols, fatty acid esters of polyhydric alcohols and the alkylene oxide addition products of such esters, and addition products of long chain mercaptans and alkylene oxides. Typical examples of such surface active agents include the sodium alkylbenzene sulfonates having 10 to 18 carbon atoms in the alkyl group, alkylphenol ethylene oxide condensation products, e.g., p-isooctylphenol condensed with 10 ethylene oxide units, soaps, e.g., sodium stearate and potassium oleate, sodium salt of propylnaphthalene sulfonic acid, di(2-ethylhexyl)-ester of sodium sulfosuccinic acid, sodium lauryl sulfate, sodium decane sulfonate, sodium salt of the sulfonated monoglyceride of coconut fatty acids, sorbitan sesquioleate, lauryl trimethyl ammonium chloride, octadecyl trimethyl ammonium chloride, polyethylene glycol lauryl ether, polyethylene glycol esters of fatty acids and rosin acids, e.g., Ethofat 7 and 13, sodium N-methyl-N-oleyl taurate, Turkey Red Oil, sodium dibutyl naphthalene sulfonate, sodium lignin sulfonate, polyethylene glycol stearate, sodium dodecylbenzene sulfonate tertiary dodecyl polyethylene glycol thioether (nonionic 218), long chain ethylene oxide-propylene oxide condensation products, e.g., Pluronic 61 (molecular weight 1000), polyethylene glycol ester of tall oil acids, sodium octyl phenoxyethoxyethyl sulfate, tris(polyoxyethylene)-sorbitan monostearate (Tween 60), and sodium dihexyl sulfosuccinate. The concentration of the active mixtures in liquid formulations generally is from about 0.01 to about 95 percent by weight or more. Concentrations of from about 0.1 to about 50 weight percent are often employed. In formulations to be employed as concentrates, the active materials can be present in a concentration of from about 5 to about 98 weight percent. In dusts or dry formulations, the concentration of the active ingredient can be from about 0.01 to about 95 weight percent or more; concentrations of from about 0.1 to about 50 weight percent are often conveniently employed. The active compositions can also contain other compatible additaments, for example, plant growth regulants, pesticides and the like. The present compositions can be applied by the use of power-dusters, boom and hand sprayers, spray-dusters and by other conventional means. The compositions can also be applied from airplanes as a dust or a spray. The active mixtures of this invention are usually applied at an approximate rate of from about 1/16 pound to about 5 pounds or more per acre, but lower or higher rates may be appropriate in some cases. A preferred application rate is from 1/2 pound to about 2 pounds per acre. DESCRIPTION OF THE PREFERRED EMBODIMENTS The following examples illustrate the present invention and the manner by which it can be practiced but, as such, should not be construed as limitations upon the overall scope of the same. EXAMPLE I A study was conducted to determine the effectiveness and synergistic response of various combinations of O,O-diethyl O-(3,5,6-trichloro-2-pyridinyl)phosphorothioate and 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane carboxylic acid:cyano(6-phenoxy-2-pyridinyl)methyl ester in the control of Heliothis insects. Test solutions were prepared by admixing predetermined amounts of each of the above compounds in predetermined amounts of water containing predetermined amounts of acetone and Triton X155 surfactant. Tobacco leaf discs, 3 inches in diameter were dipped into one of the above mixtures and placed in an open petri dish to dry. After the leaf discs were dry, 5 late second instar (approximately 3-day old) tobacco bud worms (Heliothis virescens) were placed in each dish and the dishes covered. All treatments were run in triplicate and on two different days. Mortality was recorded 48 hours after treatment with moribund larvae unable to crawl their own body length being counted as dead. In this test method, intoxication occurred through contact with and feeding upon treated plants. The results of this study are set forth below in Table I. TABLE I__________________________________________________________________________ Expected ActualTest Amount Amount Ratio of Control Control Percent Increase OverNo..sup.(1) Chemical.sup.(2) in PPM Chemical.sup.(3) in PPM A to B in Percent.sup.(4) in Percent Expected Control.sup.(5)__________________________________________________________________________1 -- -- -- -- -- -- 0 --2 A 12.5 -- -- -- -- 3 --3 A 25 -- -- -- -- 13 --4 A 50 -- -- -- -- 30 --5 A 100 -- -- -- -- 60 --6 -- -- B 0.75 -- -- 7 --7 -- -- B 1.5 -- -- 13 --8 -- -- B 3.1 -- -- 27 --9 -- -- B 6.2 -- -- 40 --10 -- -- B 12.5 -- -- 67 --11 A 12.5 B 0.75 16:1 9 10 212 A 12.5 B 1.5 8:1 16 23 4413 A 12.5 B 3.1 4:1 29 37 2814 A 12.5 B 6.2 2:1 42 67 6015 A 12.5 B 12.5 1:1 68 70 316 A 25 B 0.75 33:1 19 27 4217 A 25 B 1.5 16:1 24 43 7918 A 25 B 3.1 8:1 36 50 3919 A 25 B 6.2 4:1 48 63 3120 A 25 B 12.5 2:1 71 90 2721 A 50 B 0.75 66:1 35 40 1422 A 50 B 1.5 33:1 39 53 3623 A 50 B 3.1 16:1 49 70 4324 A 50 B 6.2 8:1 58 70 2125 A 50 B 12.5 4:1 77 93 2126 A 100 B 0.75 133:1 66 77 1727 A 100 B 1.5 66:1 65 73 1228 A 100 B 3.1 33:1 71 90 2729 A 100 B 6.2 16:1 76 87 1430 A 100 B 12.5 8:1 87 100 15__________________________________________________________________________ .sup.(1) Test Nos. 1-10 are control runs with Test 1 being a no chemical control (surfactant/acetone/water alone). .sup.(2) Chemical A represents O,Odiethyl O(3,5,6-trichloro-2-pyridinyl)phosphorothioate. .sup.(3) Chemical B represents 3(2,2-dichloroethenyl)-2,2-dimethylcyclopropane carboxylic acid:cyano(6phenoxy-2-pyridinyl)methyl ester. ##STR1## ##STR2## Data from Table I illustrates that better control was obtained employing the two toxicants together than would be expected from the results obtained from employing each of the two toxicants alone. These data are obtained according to the technique described in Colby, "Calculating Synergistic and Antagonistic Responses of Herbicide Combinations", Weeds, Vol. 15 (1967) pages 20-22 and Colby, "Greenhouse Evaluation of Herbicide Combinations", Proc. NEWCC, No. 19, pages 312-320.

Insecticidal compositions containing a mixture of 0,0-diethyl 0-(3,5,6-trichloro-2-pyridinyl)phosphorothioate and 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane carboxylic acid:cyano(6-phenoxy-2-pyridinyl)methyl ester are disclosed. Such compositions are useful in the kill and control of insects, particularly insects of the Lepidoptera order and especially of the genus Heliothis.

BACKGROUND OF THE INVENTION Field of the Invention This invention relates to an improved cigarette filter with a scavenging effect on gas phase free radicals in cigarette smoke. The invention uses filters that contain proanthocyanidins for scavenging the free radicals. The present invention is also directed to a method for producing an improved cigarette filter with scavenging effect on gas phase free radicals. It is well accepted that lit cigarettes produce an enormous amount of free radicals, including gas phase and solid phase free radicals. The number of free radicals in the gas phase has been estimated to be 10 15 per puff, which are primarily alkyl, alkoxyl, peroxyl and nitric oxide (NO.) free radicals. Inhaling the gas phase free radicals produced by cigarette smoke into a human body is known to produce toxicological and pathological changes that are deleterious to humans. The gas phase free radicals are widely known to be more harmful to the human body than are solid phase free radicals. In part, this is a result of the high energy levels, that is, the volatility of gas phase free radicals. Cigarette combustion, in particular, involves a complex burning process which produces free radicals that exist in the smoke. Cigarette smoke is a complex mixture of more than 4,700 chemicals, including high concentrations of highly reactive free radicals which play a major role in the toxicity of the smoke. The free radicals attack cell constituents, either directly or indirectly, and are believed to be a factor in tobacco smoke related diseases. Many parts of the body may be adversely affected by the gas phase free radicals including the lungs, mouth, pharynx, esophagus, heart and circulatory systems, and various organs. Free radicals may change the molecular structures of cell proteins and lipids and cause breaks in DNA sequences that lead to mutations, thereby increasing the risks of developing various types of cancers. Studies indicate that mainstream smoke, that is, smoke inhaled directly from a lit cigarette and sidestream smoke, which is smoke emitted from the smoldering tobacco between puffs and through the exhaled smoke emitted by a smoker, contain high concentrations of free radicals. Sidestream smoke affects both the smoker and the non-smokers around the smoker. A major health concern relates to the exposure of non-smokers, including infants and children, to tobacco smoke in the home and other locations that derives from smokers. Individuals who do not smoke but are exposed to secondary sidestream smoke may suffer the consequences of free radical damage from tobacco smoke. Most of the free radicals in burning cigarette-produced smoke gas phase are instantaneous and unstable. It is impossible to observe them directly with Electron Spin Resonance Spectroscopy (“ESR spectroscopy”) techniques. In order to observe gas phase free radicals, such as those present in cigarette smoke, a spin capture technique is employed. In this technique, gas phase free radicals are captured and then transformed into a spin adduct which can be tested via ESR spectroscopy. A spin collector (PBN) collects smoke gas phase free radicals, which are predominantly alkoxyl free radicals (RO.) and alkyl free radicals (R.). Most of the gas phase free radicals in tobacco smoke are RO. and alkyl R. free radicals. Nitrogenous substances oxidize and produce great amounts of NO free radicals (NO.) in the process of cigarette burning. A reaction of NO. with oxygen results in the production of reactive NO 2 . free radicals. A NO 2 . free radical may react with olefin, a substance produced during cigarette burning, to form alkyl free radical RO. RO. free radicals may attack cell membranes and cause lipid peroxidation. In turn, such lipid peroxidation may stimulate macrophages to release oxygen free radicals. Oxygen free radicals, on their own, may independently cause injury to cell constituents. They may poison cells and may contribute to causing lung cancer and heart disease together with the free radicals present in the smoke of a lit cigarette. Such free radicals may also attack and, thereby inactivate pulmonary ∝-1 antiprotease, which inhibits elastase and hence causes pulmonary injury. Also, free radicals from cigarette smoke are considered in the pathogenesis of smoking-induced lung diseases, such as emphysema, lung cancer and heart diseases. Components of the lung matrix itself (e.g. collagen, elastin) can be damaged and fragmented by oxidants in cigarette smoke. The damage of free radicals from cigarettes is not limited to the pulmonary tract. It was found that the urine of smokers contains 10 fold higher amounts of a typical biomarker of oxidative damage than the amounts shown in the urine of non-smokers. The noxious pro-oxidant effects of smoking may even extend beyond the epicardial arteries to coronary microcirculation and affect regulation of myocardial blood flow and cause carotid-media thickness. One filter that claims to scavenge free radicals in cigarette smoke was pursued jointly by Biophysics Institute of Academica Sinica and Beijing Cigarette Factory in 1995. It uses tea polyphenol, vitamin C, and active carbon for a compound filter. This filter scavenges approximately 14% of gas phase free radicals caused by tobacco smoke. If additional ingredients, including ematin, rutin, catechin and neo-rutin are added to the tobacco in the cigarette, approximately an additional 12% of the gas phase free radicals may be scavenged. These additional ingredients, in combination, are referred to as “kendir” and “apocynum venetum L”. Another cigarette filter that scavenges for free radicals was jointly invented by the Greece Golden Filter Company and Filter Development Company in 1999 (the “jointly developed filter”). This filter comprises active carbon and hemoglobin. It claims to scavenge about 90% gas phase free radicals found in tobacco smoke. Neither one of these two filters has gained commercial acceptance by cigarette manufacturers. There are two major reasons for the poor commercial acceptance of these filters. One is that the large dosages of additives in these filters reduce the original smoke flavor of the cigarette. This is a very significant disadvantage in the cigarette industry where cigarette taste and flavor is a key selling feature of recognized cigarette brands. Another factor is that the production of these complex filters requires a large investment in equipment modification which cigarette manufacturers are reluctant to invest. Another filter disclosed in U.S. Pat. No. 5,829,449 is directed to using L-glutathione and a source of selenium as the radical scavenger complex ingredient. Accordingly, there is a need for: i) a cigarette filter with good scavenging effect on gas phase free radicals in cigarette smoke; ii) a cigarette filter that scavenges gas phase free radicals in cigarette filters and does not significantly alter or reduce the flavor and taste of the cigarette; and iii) a cigarette filter containing free radical scavengers that are optimally exposed to cigarette smoke in order to yield a maximum scavenging effect in a short period of time. BRIEF SUMMARY OF THE INVENTION One aspect of the invention resides in an improved cigarette filter with a scavenging effect on smoking induced gas phase free radicals which is achieved through the addition of an effective amount of a filtering ingredient or a mixture of the filtering ingredient and vitamin C and/or other ingredients known in the art having antioxidant filtering properties, but excluding a certain amount of L-glutathione. The filtering ingredient is selected from a group consisting of proanthocyanidins which may include procyanidins. These ingredients include extracts of barks of pine trees, extracts of cones of cypress trees, extracts of grape seeds and any combination thereof. DETAILED DESCRIPTION OF THE INVENTION Proanthocyanidins are highly potent free radical scavengers. In particular, proanthocyanidins represent a group of plant polyphenols found in fruits with an astringent taste and in barks. Proanthocyanidins may be extracted from plant material by conventional methods using water, ethanol or acetone/water mixtures as solvents and then concentrated through the processes of solvent evaporation, freeze-drying or spray-drying. Proanthocyanidins include procyanidins and prodelphinidins. The proanthocyanidin used in the example below is Pycnogenol® pine bark extract which is produced and marketed by Horphag Research Limited. Pycnogenol® pine bark extract is derived from the bark of the French Maritime pine. It contains a range amount of approximately 70%-75% proanthocyanidins and other flavanols with free radical scavenging activity such as catechin, taxifolin and phenolic acids. The proanthocyanidins contained in this extract have a chain length of about 2 to 12 monomeric units, wherein the monomeric units consist of catechin or epicatechin. Other procyanidin-rich substances could also be used as free radical scavengers in cigarette filters. These substances include but are not limited to, extracts of the barks of pine trees, cones of cypress trees or grape seeds. Proanthocyanidins are particularly suitable for cigarette filters because they are non-volatile substances. Proanthocyanidins are biopolymers that possess a great tendency to stay adsorbed and remain inside the filter. Free radical scavenging filters of the present invention may be prepared by evenly spraying a free radical scavenger solution completely over filter filaments, and then drying the filter elements and connecting the filter elements with cut unfiltered cigarettes and/or cigarette tobacco for forming into cigarettes. Prior to drying, the filter element may be shaped in a filter bundle shaping process. Several examples of specific free radical solutions may be used. The examples and results are discussed below. EXAMPLE 1 Dissolve proanthocyanidin and vitamin C (100%) in a proportion of 1:2 into a 95% ethanol solution. Evenly spray the ethanol solution containing the dissolved proanthocyanidin and vitamin C over cigarette filaments. Dry the sprayed filaments thereafter and process the dried filaments into cigarette filters as is well known in the art. Combine same with unfiltered cigarettes. The resulting proanthocyanidin and vitamin C content in such a cigarette filter of this example is respectively equal to about 0.00015% and 0.0003% of the cut tobacco of this cigarette in weight. Testing for the effectiveness of the improved filter was performed in the following manner. Unfiltered cigarettes were used as reference cigarettes. ESR techniques were used to test the gas phase radicals respectively contained in the smoke of the cigarettes. The amount of free radicals in the filter of the present invention was compared with the amount in standard unfiltered cigarettes. Efficacy of the improved filter was conducted by using a smoking device to imitate human's smoking at a flow rate of about 400 ml/min, inhaling once for two seconds, one minute apart. The ESR testing conditions included: X band, 20 m W microwave power, 100 KHz modulation frequency and 1G modulation amplitude. See Table 1 for the test results. The free radical scavenging rate E was calculated by the following formula: E=H o ×100 /H x where H o represents the peak intensity of the reference system, and H x represents the peak intensity of scavenger containing samples. According to this formula, the gas phase free radical scavenging rate E was 24.3%. EXAMPLE 2 Using the method of Example 1, cigarettes with the improved filter having a proanthocyanidin content of about 0.00015% (based on the weight of a single cigarette of cut tobacco) were tested in accordance with the procedure explained above and calculated by the above-mentioned free radical scavenging rate formula. The gas phase free radical scavenging rate was 22.6%. For the detailed results, see Table 2. EXAMPLE 3 Using the method of Example 1, the cigarettes with the improved filter having a proanthocyanidin content of about 0.0003% (based on the weight of a single cigarette of cut tobacco) were tested in accordance with the procedure explained above and calculated by the above-mentioned free radical scavenging rate formula. Calculated by the above-mentioned free radical scavenging rate formula, the gas phase free radical scavenging rate was 27.6%. For the detailed results, see Table 3. EXAMPLE 4 Using the method of Example 1, cigarettes with an improved filter having a proanthocyanidin content of about 0.0005% (based on the weight of a single cigarette of cut tobacco) were tested in accordance with the procedure explained above and calculated by the above-mentioned free radical scavenging rate formula. Calculated by the above-mentioned free radical scavenging rate formula, the gas phase free radical scavenging rate was 29.1%. For the detailed results, see Table 4. This test indicated that when the proanthocyanidin content in the filter is 0.0005%, the gas phase radical scavenging effect is at its maximum. EXAMPLE 5 Using the method of Example 1, cigarettes with an improved filter having a proanthocyanidin content of about 0.001% (based on the weight of a single cigarette of cut tobacco) were tested in accordance with the procedure explained above and calculated by the above-mentioned free radical scavenging rate formula. Calculated by the above-mentioned free radical scavenging rate formula, the gas phase free radical scavenging rate was about 20%. For the detailed results, see Table 5. As shown by the above examples, when the proanthocyanidin content in the filter is within a range of about 0.00015% and 0.001% (based on the weight of a single cigarette of cut tobacco), a high scavenging effect on gas phase free radicals in smoke was achieved. Adding vitamin C into the filters further improved the free radical scavenging effects. The reduction of free radicals in tobacco smoke also reduces the mutagenic action of tobacco smoke and markedly increases the life-time of animals exposed to filtered smoke. In one study, mice were exposed to lethal amounts of cigarette smoke in a polyacryl glass cabin (35.6×35×20 cm) with two 1.5 cm 2 holes, one located on top of the cabin for ventilation and another located at the bottom for introducing the gas phase. Forty (40) mice were randomly divided into 4 groups. Mice in group 1 were treated with smoke from cigarettes with standard filters. Mice in groups 2 and 3 were treated with smoke from cigarettes with filters containing 0.00015% mg and 0.0005% mg proanthocyanidin, pine bark extract respectively. Mice in group 4 served as control and were not treated with cigarette smoke. Cigarette smoke was introduced into a cabin containing one group of 10 mice at a time. The time and number of cigarettes used until the lethal endpoint was reached were recorded. The deceased mice were examined for histopathological changes. All deceased mice were subject to biopsies and histopathological examination. In the control group (cigarette filters without proanthocyanidins) an obvious congestion and hemorrhage in lung tissue was observed in 80% of mice. Also, a vasodilation and congestion of small blood vessels in kidneys and slight vasodilation and congestion of central veins in livers were found. However, there were no visible abnormal changes in the heart and spleen. The presence of 0.0005% proanthocyanidin pine bark extract in cigarette filters significantly increased the survival time and reduced the acute toxicity of cigarette smoke by 70.5%. In the absence of proanthocyanidins in the cigarette filters, the mice died after inhaling the smoke of 8 cigarettes, wherein the presence of 0.0005% mg proanthocyanidin pine bark extract in the filters, mice died after exposure to the smoke of 14 cigarettes. Based on the above, the appropriate content of the above-mentioned free radical scavenger contained in a filter shall account for 0.0001%-0.001% of the cut tobacco in weight. The scavenger is more effective in this range. The proportion between the procyanidin content and the vitamin C content is equal to 0.5-1.5:1.5-2.5, and the most preferred is 1.0. In all the embodiments however, L-glutathione and a source of selenium selected from the group consisting of L-selenomethionine and L-selenocysteine are substantially or completely excluded from inclusion in the cigarette filter of the invention. TABLE 1 0.00015% proanthocyanidin and 0.0003% Vc combining filter's scavenging effect on gas phase free radical in smoke H o of control Group H x of Application Example 1 6.7 18.5 7.6 11.5 4.3 11.4 6.2 5.8 5.6 21.5 7.8 7.7 5.6 10.7 5.8 9.5 5.7 14.2 5.5 10.4 5.7 5.2 4.4 5.9 6.9 21.5 6.0 7.2 5.2 5.5 5.6 5.6 7.0 6.5 7.4 7.2 5.9 4.4 10.5 6.5 7.8 6.4 8.2 5.5 7.0 1.5 6.3 10.4 7.4 6.0 8.0 10.3 6.2 6.7 5.6 7.1 10.0 6.0 9.0 11.0 9.0 6.0 5.5 10.7 8.5 6.7 6.2 12.5 6.7 6.0 5.5 7.3 5.7 6.0 6.2 9.5 5.0 6.7 5.7 9.8 6.7 7.4 6.0 12.6 6.3 5.6 9.0 7.0 6.8 7.8 9.2 9.4 5.2 7.0 10.0 8.0 7.4 8.0 9.5 8.7 7.4 6.0 8.0 6.0 8.0 16.0 8.0 9.8 4.6 5.5 6.8 8.5 7.1 16.0 5.3 6.8 5.0 6.5 7.5 7.2 6.6 17.0 7.3 9.0 5.2 11.8 7.0 6.8 8.9 11.8 8.3 9.6 8.3 11.8 9.1 7.5 9.0 8.0 10.3 8.9 8.2 6.0 6.4 7.0 11.5 9.0 8.1 8.5 8.0 4.0 6.0 6.1 17.0 6.2 9.0 8.8 10.0 5.0 4.5 6.2 7.8 6.0 7.5 9.7 8.4 6.2 7.0 6.7 6.3 9.0 6.5 9.5 6.6 6.1 8.3 7.0 8.8 9.2 11.4 8.9 8.8 11.8 9.8 7.1 12.8 8.7 8.5 9.8 10.5 8.7 6.7 7.2 7.7 8.5 8.7 9.7 7.8 4.3 5.6 6.0 5.7 6.9 7.0 7.8 5.2 5.9 7.0 5.2 7.4 10.0 8.5 9.8 9.0 6.7 5.0 6.2 6.7 6.8 7.4 8.0 5.2 7.4 4.6 6.3 7.1 6.6 8.9 9.0 5.2 8.3 8.2 5.0 11.5 17.0 7.8 10.5 10.0 8.4 4.1 3.5 11.9 12.0 10.8 9.8 7.5 3.5 4.1 4.2 Mean value 8.96 6.73 Standard error 2.59 1.81 Scavenging effect 24.3% P <0.01 TABLE 2 0.00015% proanthocyanidin combining filter's scavenging effect on gas phase free radical in smoke H o of Control Group H x of Application Example 2 4.1 4.6 4.5 4.5 2.0 3.0 4.3 5.1 7.5 4.8 8.0 5.0 4.5 7.5 4.7 4.0 4.0 8.0 13.5 8.0 5.0 3.5 9.0 3.5 6.9 6.2 4.7 5.6 7.8 7.9 7.4 5.1 5.7 6.9 7.0 7.8 5.0 3.9 4.9 5.7 7.4 10.0 6.5 5.7 5.1 6.7 7.1 6.6 6.7 6.8 7.4 8.0 7.3 7.0 6.4 6.3 7.1 6.6 8.9 9.0 5.0 6.9 6.1 4.2 11.5 17.0 7.8 7.0 6.5 7.0 10.0 11.0 6.6 7.1 9.0 8.8 11.5 6.2 6.4 6.5 6.3 8.7 7.6 5.0 7.7 8.0 6.0 7.0 7.0 7.5 6.1 5.0 4.1 7.6 5.6 6.0 5.5 5.5 6.5 8.5 7.5 5.0 4.0 4.1 8.5 9.5 8.5 10 4.0 5.0 4.0 4.05 12 9.0 8.0 7.0 4.0 5.5 6.0 4.6 10 11.0 10.5 8.9 7.3 5.5 7.5 7.6 9.2 9.5 10.0 7.0 4.8 5.7 6.0 6.6 10.5 8.0 8.0 5.0 8.0 Mean value 7.22 5.97 Standard error 2.28 1.90 Scavenging effect 22.6% P <0.05 TABLE 3 0.003% proanthocyanidin combining filter = s scavenging effect on gas phase free radical in smoke H o of Control Group H x of Application Example 3 18.5 6.5 9.9 5.2 12.0 6.7 5.3 4.4 18.5 6.8 7.3 5.8 12.0 5.6 6.0 2.7 16.5 5.3 7.5 7.2 11.0 6.1 7.5 6.5 15.5 5.9 7.5 9.0 10.3 5.7 6.0 4.2 15.2 5.8 7.0 8.8 10.0 6.7 5.2 6.0 15.0 7.7 6.1 8.5 10.0 7.0 5.4 6.2 15.0 5.5 6.5 7.4 9.9 7.1 4.6 6.1 13.7 5.4 8.0 10.5 9.5 7.8 6.0 7.0 13.3 5.8 6.6 8.0 9.0 7.8 3.0 7.0 13.0 7.8 7.0 6.6 8.2 5.1 4.2 6.1 12.0 6.2 9.0 6.5 8.0 7.1 4.5 3.9 11.2 7.9 8.6 5.7 8.0 5.1 4.0 6.0 10.0 6.0 6.0 7.2 7.0 5.6 3.7 7.2 8.0 6.5 6.5 7.3 6.5 6.8 5.4 6.7 9.0 6.0 5.0 7.8 7.2 4.2 4.2 3.2 7.8 7.1 6.8 7.0 6.0 8.0 6.7 4.1 6.7 6.1 5.9 7.4 7.1 5.3 6.0 4.5 18.5 5.5 14.2 5.5 10.5 11.2 10.5 8.0 6.5 6.4 6.0 6.0 3.6 8.4 5.1 4.7 6.7 6.0 7.4 7.8 4.0 5.5 5.7 4.5 8.0 16.0 16.0 17.0 12.0 10.5 10.5 6.0 11.8 8.0 9.0 9.5 11.8 5.0 5.2 5.0 6.0 7.6 7.8 10.5 7.7 7.0 6.0 5.0 6.0 7.4 8.2 7.9 6.5 3.5 6.0 4.0 6.0 5.0 6.2 9.7 5.2 6.0 8.0 9.0 6.7 5.6 6.0 10.9 6.9 5.6 2.3 5.0 5.7 6.7 7.0 9.8 3.7 6.7 2.7 5.0 7.8 9.8 5.7 8.1 2.0 2.2 6.2 8.2 5.1 8.2 5.6 8.9 3.8 4.6 2.9 6.8 5.3 8.0 7.5 9.0 4.3 2.5 2.6 5.0 6.5 8.8 5.3 9.6 5.2 5.4 4.6 6.0 5.8 7.7 8.5 9.8 3.0 4.2 4.5 5.2 5.8 7.8 6.2 7.9 5.2 3.7 5.4 4.4 9.2 8.0 8.5 9.9 2.7 6.5 4.2 5.0 9.8 8.0 9.5 10.5 6.5 6.1 2.0 4.5 Mean value 8.30 6.01 Standard error 2.92 2.12 Scavenging effect 27.6% P <0.01 TABLE 4 0.0005% proanthocyanidin combining filter's scavenging effect on gas phase free radical in smoke H o of Control Group H x of Application Example 4 7.9 15.0 5.8 6.7 5.4 2.0 6.2 6.5 8.7 18.0 5.9 6.0 5.8 10.5 7.0 6.8 9.7 15.0 6.2 7.4 4.9 11.0 6.2 7.0 7.0 19.0 6.1 7.8 7.0 6.6 5.0 7.0 8.6 16.5 5.0 8.0 8.0 10.3 3.5 3.9 8.8 7.3 6.3 16.0 8.0 7.0 6.6 2.5 9.4 8.0 5.2 16.0 8.7 6.0 4.1 8.5 10.1 12.0 7.1 17.0 6.7 8.6 2.6 4.1 7.0 11.2 7.5 11.8 8.7 9.6 2.6 4.8 7.5 13.0 7.6 8.0 6.5 5.8 1.2 5.2 8.7 13.3 6.5 9.0 5.6 1.8 1.9 5.5 9.6 11.2 6.9 6.2 6.7 11.0 5.9 5.0 6.1 18.5 6.8 6.0 7.6 10.7 4.6 6.1 5.9 15.2 5.9 7.6 5.5 9.8 4.0 10.0 6.6 15.5 6.2 7.8 5.5 9.7 4.7 7.4 6.2 10.0 18.5 5.5 6.0 10.0 5.4 10.0 6.3 13.7 21.5 6.0 5.0 9.0 3.0 8.0 7.4 7.2 14.2 7.4 6.7 6.7 6.2 5.0 9.1 6.2 6.5 8.2 6.6 5.0 6.4 8.0 6.4 6.0 6.6 6.0 7.1 5.8 5.6 9.8 5.0 6.2 6.2 6.9 8.8 3.0 4.4 4.5 9.2 9.5 6.0 8.2 5.7 5.8 5.7 8.5 10.3 8.1 9.0 7.5 7.7 9.5 7.5 8.2 7.2 6.2 5.8 5.9 5.0 6.2 7.0 6.2 8.2 8.1 5.0 8.3 5.0 3.5 6.6 4.1 5.3 7.7 7.5 7.6 2.6 2.6 1.2 1.9 8.5 8.9 6.8 4.7 5.9 4.6 4.0 4.7 5.9 6.2 7.9 8.0 5.4 3.0 5.4 5.8 9.7 7.0 8.6 8.0 4.9 7.0 6.0 6.0 8.8 8.2 10.1 7.0 6.2 6.7 6.7 6.7 7.5 8.7 9.6 6.1 6.5 5.6 6.7 7.6 5.9 8.6 6.2 6.3 5.5 5.5 6.0 5.0 7.4 9.1 6.7 6.6 Mean value 8.62 6.11 Standard error 3.39 2.17 Scavenging effect 29.1% P <0.01 TABLE 5 0.001% proanthocyanidin combining filter = s scavenging effect on gas phase free radical in smoke H o of control Group H x of Application Example 5 6.6 8.5 7.8 6.6 1.2 6.5 5.8 1.2 6.6 6.0 8.0 5.6 5.8 6.0 11.1 5.9 8.6 5.4 16.0 8.6 4.0 4.8 12.0 4.0 6.9 6.1 16.0 5.9 4.9 7.2 11.8 4.9 5.8 6.1 17.0 5.3 5.2 6.2 11.0 5.2 6.4 7.8 11.8 6.4 4.5 6.6 12.5 4.5 7.1 7.8 8.0 5.1 8.0 5.7 9.0 6.0 8.2 5.7 9.0 8.2 6.2 4.7 6.7 6.2 6.3 6.0 6.2 6.3 5.9 5.0 5.2 5.9 6.7 8.5 6.0 8.1 5.2 6.0 7.0 5.2 5.7 8.0 7.6 5.2 5.2 6.0 7.0 5.3 6.9 5.3 7.8 6.9 5.1 6.3 6.5 5.1 6.2 5.8 5.5 6.2 5.1 2.7 4.0 5.1 7.8 7.1 6.0 8.8 6.0 6.0 8.0 6.0 6.8 7.2 7.4 8.8 4.0 6.9 5.0 4.0 5.8 5.9 8.2 8.6 5.6 2.9 5.4 5.6 6.7 6.5 6.0 8.1 4.1 7.0 5.5 4.1 5.7 8.1 5.0 5.2 4.7 5.8 5.0 4.7 5.6 5.0 6.2 5.0 5.0 6.0 4.3 5.2 5.9 6.5 6.2 6.7 5.2 4.3 5.0 5.2 5.9 6.0 6.0 5.4 5.6 5.7 9.5 5.1 7.2 6.5 9.2 5.7 4.3 5.0 10.7 5.1 7.5 6.7 9.5 5.6 4.9 6.6 9.5 4.4 6.5 18.5 6.0 5.9 4.9 12.5 7.5 5.0 6.7 21.5 5.3 7.2 6.1 10.7 8.2 5.2 7.3 14.2 7.3 7.5 5.8 11.5 8.0 5.6 7.6 21.5 8.2 6.5 7.7 8.7 6.0 4.3 5.8 6.5 10.3 6.7 6.1 4.8 6.4 4.9 6.4 6.4 8.1 7.3 5.6 2.0 4.9 6.0 6.6 6.0 9.0 7.6 4.9 6.0 5.8 5.6 6.3 6.0 7.4 7.8 6.5 5.6 7.1 6.1 7.3 6.7 6.7 7.8 7.1 4.0 5.6 4.9 7.8 6.0 6.0 8.5 7.1 6.0 3.5 6.0 Mean value 7.45 5.96 Standard error 2.79 2.02 Scavenging effect 20.0% P <0.05

A cigarette filter that has a scavenging effect on smoking induced gas phase free radicals. The filter ingredients are comprised of proanthocyanidins and include, but are not limited to, extracts of barks of pine tree, extracts of cones of cypress trees, extracts of grape seeds, and any combination thereof. Also, vitamin C and other known antioxidant ingredients may be added.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to U.S. Provisional Patent Application No. 61/447,509, filed Feb. 28, 2011, and is incorporated herein by reference. BACKGROUND OF THE INVENTION [0002] The present disclosure is directed to an attachment to a pet training device, such as a clicker used to train a dog. [0003] Training animals to behave as desired is an important aspect of pet ownership, and to this end many training techniques have been utilized over the years. One ubiquitous method of training a dog, for example, uses a clicking device that takes advantage of the phenomenon famously documented by Ivan Pavlov in which an animal can, over time, be conditioned to associate a pleasurable event (in Pavlov's experiment, being fed) with an auditory sound or other event, even to the extent that the animal enjoys the auditory sound itself. [0004] In this method, the dog or other pet is repetitiously given a treat, or other reward, simultaneously with activation of a hand-held clicker after behaving in a desired manner. Eventually, the pet begins to associate the clicking sound itself as a reward, after which a pet owner may simply use the clicker to indicate to the pet approval of behavior. [0005] A typical pet clicker is described in U.S. Pat. No. 7,674,153 and comprises a rigid housing surrounding an actuation member that, when actuated—usually by depression with the digit of a hand—emits a clicking sound. Usually, this sound is produced by the deflection of one end of a thin piece of metal relative to another end. Also, when the metal piece is affixed inside the cavity of a housing surrounding the metal piece, that sound may be amplified somewhat. A typical pet clicker may include an aperture at one end of the housing with which to attach the clicker to a key chain, wrist band, or other device to secure the clicker to a belt loop, a hand, etc. [0006] To be effective, the pet clicker is preferably activated as quickly as possible after the pet behaves in a desired manner. One problem that arises is that the pet clicker, when dangling from a wrist or a belt loop, is not ready for activation quickly enough to be of use, as the pet may have changed its behavior while a person grasps for the clicker and positions it in an orientation in which it can be manually actuated, after which the pet would be “rewarded” for the wrong behavior. Conceivably, a pet owner, when walking a dog, for example, could always keep the pet clicker in hand and ready to click the instant it is desired, but this is often inconvenient as the owners hands may be needed for, say, throwing a ball or other matters. [0007] What is desired, therefore, is an improved pet training apparatus that improves the speed at which a pet training device may be actuated from a position that is not grasped in a person's hand. BRIEF DESCRIPTION OF THE SEVERAL DRAWINGS [0008] FIG. 1A shows a perspective view of a first exemplary attachment to a pet training device. [0009] FIG. 1B shows a perspective view of the attachment shown in FIG. 1A , secured to both the digit of a person's hand and a pet training device in a first orientation, and also shows a phantom view of a second orientation , displaced form the first orientation, of the attachment of FIG. 1A and the attached pet training device. [0010] FIG. 2A shows a perspective view of a second exemplary attachment to a pet training device. [0011] FIG. 2B shows a perspective view of the attachment shown in FIG. 2A , secured to a pet training device. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0012] Referring to FIGS. 1A and 1B , an exemplary attachment 10 to a pet training device, such as the device 12 (in this example a dog clicker) is shown, in which an auditory sound or other activation signal is emitted upon activation after depression of an activation surface 30 on the device 12 . The attachment 10 may include a first end 14 selectively securable to the pet training device 12 . For example, because most existing dog clickers include an opening 32 for securing a key chain, wristband, etc., an attachment 10 for a pet training device that is a dog clicker 12 may have a first end 14 comprising an appropriately-sized peg-portion 16 and a flexible anchor 18 having a diameter in a relaxed state that is larger than that of the opening 32 , such that that the peg portion 16 may be inserted through the opening 32 and then used to pull the anchor 18 that so that it squeezes through the opening 32 , as well, after which the anchor 18 relaxes and secures the attachment 10 to the device 12 . It should be appreciated that other means of securing an attachment 10 to a pet training device may be appropriate, depending on the pet training device. Conceivably, for example, a pet training device may be equipped with a clevis-type mount, such that a first end 14 would only need an appropriately-sized aperture to line up with those on either side of the clevis, and a securing pin used to complete the connection. It is also desirable, though not necessary, that the first end 14 be selectively detachable from the device 12 so that it can alternately be attached to other pet training devices. For example, as can be seen in the figures, the anchor 18 may be squeezed back through the opening 32 to detach the attachment 10 from the clicker 12 . [0013] The exemplary attachment 10 may also include a second end 22 for selectively attaching the attachment 10 to a digit of a person's hand, such as a thumb. In this example, the second end 22 is a flexible ring that may expand to be squeezably secured to the desired digit. Also, as with the first end 14 , the second end may have other configurations, as appropriate, For example, the second end 22 may not be formed as a complete circle so long as it does not slip easily from the digit to which it is secured. Preferably, the second end 22 includes a tab 24 used to pull the attachment 10 from a person's digit after use. [0014] As can be readily appreciated from these figures, when the disclosed attachment 10 is used to secure a pet training device 12 to the digit of a person's hand, the training device 12 does not need to be grasped in hand, yet is always ready to be grasped, and may be activated virtually instantaneously with the very act of grasping the device 12 by depressing an activation surface 30 on the device 12 . To facilitate this feature, the attachment 10 may include a flexible neck 20 between the anchor 18 and the second end 22 that tapers in the direction of the first end 14 . The flexible neck 20 may serve two related functions. First, the taper of the neck 20 immediately adjacent the anchor 18 secures the opening 32 to the flexible neck 20 . Also, the flexibility of the neck 20 is such that the neck 20 permits the device 12 to be displaced in hand from a relaxed position as shown by the solid outline of FIG. 1B to a displaced position as shown by the phantom outline in this figure. In this case, the relaxed position refers to that to which the flexible neck region will cause the device 12 to return when displaced. In other words, the neck 20 acts to ensure that, whatever the angle or amount of deflection of the pet training device 12 , due to for example, holding a ball to be thrown, the pet training device afterward returns to its relaxed position where not only will the pet training device be ready to be grasped by simply closing the hand to which it is attached, but the activation surface 30 is also ready to be activated merely upon grasping the device 12 . [0015] Another feature of the attachment 10 is that its relative orientation with the device 12 may be reversed, and it will not lose its functionality. For example, in FIG. 1B the attachment 10 is shown in a configuration where the device 12 is secured to the digit that is used to activate the device by depressing the activation surface 30 . It is possible, however, to detach the device 12 from the attachment 10 , turn the device 12 over and reattach it so that the activation surface is facing away from the digit to which the device 12 is attached. In that case, when grasped, the activation surface may be activated using another digit, e.g. an index finger where the device 12 is attached to the thumb. This reversal may even be accomplished while the attachment is continuously secured to the thumb (or another digit) for long training periods where one digit becomes fatigued or sore after continual use, or to avoid repetitive stress injuries by a professional dog trainer, for example. [0016] In one preferred embodiment, the attachment 10 is approximately 2 inches in length and is advantageously integrally formed of the same flexible material. The inventors have discovered that Kraton G7720 G1 is a suitable material for the disclosed attachment, and preferably has a durometer of approximately 57. In this context, the term “approximately” means within 10%, although more preferably the durometer of the material used is within 5% of this number and even more preferably 2%. The inventors discovered that these disclosed ranges provide an appropriate balance between sufficient flexibility to securely extend over the digit of a person's hand, and the resiliency to both maintain a proper relative orientation of an attached pet training device 12 and to return a device 12 to that orientation from a deflected position. It should be understood that the dimensions suitable for the attachment 10 will vary based on factors such as the size of a person's fingers for which it is designed, the type and weight of pet training device to which it is intended to be attached, the size of any opening 32 on that device, etc. [0017] FIGS. 2A and 2B show another exemplary attachment 40 . The attachment 40 preferably includes a member 50 , which like the second member 22 of the attachment 10 , is used to secure the attachment 40 to the digit of a person's hand. The attachment 40 preferably includes first and second flexible attachment rings 42 and 44 , respectively, used to squeezably secure the attachment 40 to either end of a pet training device 60 having an activation surface 62 . The member 50 also includes a tab 52 used to quickly remove the attachment 40 from a digit to which it is attached. The attachment 40 is also preferably integrally formed of the same flexible material, such as Kraton G7720 G1 with a durometer of approximately 57. [0018] Preferably the attachment rings 42 and 44 are not spaced an equal distance to either side of the member 50 . This advantageously causes the aperture of the member 50 to tilt at an angle relative to the actuation surface of the pet training device 50 to which it is attached, so that a digit inserted therein is directed downwardly towards the actuation surface. The present inventors have discovered that an appropriate angle is approximately 45-degrees, and that the attachment rings 42 and 44 be spaced apart from the member 50 by respective distances equal to or exceeding a 3:1 ratio and more preferably a 4:1 ratio through opposed flexible neck regions 46 and 48 . [0019] The attachment 40 includes the functional advantages of the device 10 as previously described. More specifically, when attached to the digit of a person's hand, such as a thumb, it may be displaced to, for example throw a ball, and yet return to a relaxed position where the device 60 is ready to be activated immediately upon being grasped by a person's hand. [0020] The terms and expressions that have been employed in the forgoing specification are used therein as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding equivalence of the features shown and described or portions thereof, it being recognized that the scope of the invention is defined and limited only by the claims that follow.

An attachment selectively attachable to a pet training device that emits signal upon actuation by the hand that grasps the pet training device. The attachment includes an aperture for selectively securing the attachment to a hand and at least one connector for securing the attachment to the pet training device.

CROSS-REFERENCED RELATED APPLICATIONS [0001] This application is a continuation of International Patent Application No. PCT/CH2009/000267 filed Jul. 31, 2009, which claims priority to German Patent Application No. DE 10 2008 037 310.9 filed Aug. 11, 2008, the entire contents of both of which are incorporated herein by reference. BACKGROUND [0002] This application relates to devices for injecting, delivering, infusing, administering or dispensing a substance, and to methods of making and using such devices. More particularly, it relates to a device for self-administering a fixed dose of a substance. Such a device may be thought of and referred to as an injection pen, a fixed-dose injection pen or a fixed dose pen, and provides a convenient, efficient way of self-administering a substance stored in an ampoule or syringe inside the injection pen on a one-off basis. [0003] An example of an injection device for administering a fixedly set dose on a one-off basis, wherein the dose can be pre-set, is known from patent specification DE 10 2006 038 103 A1 owned and filed by the owner of the present application. SUMMARY [0004] An object of the present invention is to provide an injection device for administering a fixed, pre-set quantity of a substance on a one-off basis, wherein the device has a simple design and is easy to operate. [0005] In one embodiment, the present invention comprises an injection device for administering a substance, comprising a housing, a plunger rod which can be moved relative to the housing, at least one retaining element associated with the rod to hold the rod relative to the housing, and a displaceable locking sleeve which can be displaced relative to the housing from one position in which the sleeve holds the at least one retaining element in a retaining position to a second position in which the at least one retaining element is released. [0006] In one embodiment, the present invention comprises an injection device comprising a housing, a plunger rod which can be moved in the housing and on which at least one retaining element is provided that holds the plunger rod relative to the housing, and further comprising a displaceable locking unit, e.g. a cover sleeve, which can be displaced inside the housing, and which in a first position holds the at least one retaining element positively in a retaining position relative to the housing and in a second position releases the at least one retaining element. [0007] In one embodiment, the present invention comprises an injection device having a housing, by which the injection device can be held by a user. A plunger rod is provided inside the housing, which is able to push against a stopper or piston of an ampoule or syringe, likewise disposed inside the injection device, to force out a substance contained inside the ampoule or syringe and administer it by pushing against the stopper, e.g. by a needle. In some embodiments, the plunger rod has at least one retaining element which can be moved or outwardly deflected, for example a resilient arm with a radially projecting locating region. The at least one retaining element holds the plunger rod in a fixed position relative to the housing, in some embodiments on or against the housing, so that it is not able to move. A moving or sliding locking element is also provided on or in the injection device, for example a sleeve, e.g. a protective sleeve, which is able to move relative to the housing and which holds the at least one retaining element in a fixed position relative to the housing when the locking element or sleeve is in a first position. The at least one retaining element can be released when the locking element or sleeve is moved out of the first position so that the coupling between the plunger rod and the injection device or housing is released, and the plunger rod can be moved or pushed inside the injection device to initiate or effect the injection. [0008] In some preferred embodiments, the locking element or sleeve is a protective sleeve located or disposed at or in the distal region (this region may also be thought of and/or referred to as the front, forward or needle region) of the injection device and extending out from the injection device. The protective sleeve can be pushed relative to the injection device or relative to the housing of the injection device, e.g. in an axial direction into the housing of the injection device, if the injection device is placed on or against a surface such as a user's or patient's skin. In some embodiments, the protective sleeve is mounted in the housing of the injection device so that it is prevented from turning. When the housing of the injection device is pushed toward or against the skin, the protective sleeve is moved or pushed into the housing or into the injection device, in some preferred embodiments after overcoming a minimum opposing force caused by a releasable catch connection. In this case, the injection device and/or its housing moves toward the skin surface. [0009] In some preferred embodiments, at least one rib or catch or retaining step is provided on the housing, against which the at least one retaining element can be retained. The rib or retaining step may have a surface to which a longitudinal or axial axis of the injection device extends perpendicularly. In some preferred embodiments, the rib or step may be chamfered so that the at least one retaining element of the plunger rod can be released more easily when it is no longer retained or secured by the displaceable protective sleeve. The at least one retaining element of the plunger rod also has a retaining region, which complements the abutment surface of the retaining step. It can be, thus, likewise slightly chamfered. [0010] In some preferred embodiments, an injection spring element is provided, which is supported on or by the housing or an element fixedly connected or latched to the housing, e.g an end cap. The spring element pushes on the plunger rod in the distal direction (this direction may also be thought of and/or referred to as the forward, injection or delivery direction). In some embodiments, the injection spring element is tensed when the injection device is in the initial position and expends a force which is enough to move the at least one retaining element out of the retaining or locating position when the retaining element is no longer retained or locked by the lock or protective sleeve. As a result, and due to the force of the injection spring element pushing on the plunger rod, the rod is moved relative to the injection device or relative to the housing toward the stopper of the ampoule or syringe to initiate the dispensing process. [0011] In some embodiments, the protective sleeve is locked so that it is not able to rotate in the housing of the injection device or inside the injection device. In some embodiments, it may be locked by an axially extending groove and/or a web of the protective sleeve which co-operates with a co-operating, complementary web and/or an axial groove of the injection device or housing. Such an arrangement may also be thought of and/or referred to as an axial guide. [0012] In some preferred embodiments, a spring is provided which is supported against the injection device or its housing and which pushes on the displaceable protective sleeve so that the protective sleeve spring is able to apply pressure to the protective sleeve in the distal direction. When the injection device is placed on or against a surface and moved toward it, the protective sleeve can be pushed into the injection device against the force of the protective sleeve spring, causing a compression and hence tensing of the protective sleeve spring. [0013] In some embodiments, an ampoule or syringe is provided in the injection device, which is fixedly connected to the housing or fixedly retained in the injection device, for example by one or more stops and/or by the plunger rod pushing against the ampoule or stopper of the ampoule. In some preferred embodiments, the syringe has an injection needle at the distal end, which may be made safe by being covered by a removable needle guard cap. The needle is disposed on or in the injection device so that it is surrounded by the protective sleeve when the latter is pushed out and exposed when the protective sleeve is pushed back, so that when the injection device is pushed onto or against a surface, e.g. the skin, the protective sleeve can be pushed in so that the injection needle, now exposed, can be used to effect the injection. In some embodiments, the injection is effected manually by pushing the injection device onto or against a surface, obviating the need to operate a button or trigger element for the injection process. In this respect, the protective sleeve is mounted in or on the injection device so that when the injection device is pushed onto or against a surface, against or on which the protective sleeve then lies, an initial force must be overcome to enable the protective sleeve to be pushed in. This helps ensures that the injection takes place quickly once the initial force has been overcome and the protective sleeve is pushed back quickly due to the subsequent force, thus enabling a rapid piercing action by the needle. [0014] Another aspect of the present invention is that it relates, in some embodiments, to an injection device which can be assembled from few individual parts, for example only three or four individual parts, which may be molded from a plastic, e.g. a housing, protective sleeve, plunger rod and, optionally, an end cover or cap. In this respect, only a single spring is provided for the injection and, optionally, another spring for the protective sleeve. [0015] In accordance with some preferred embodiments of the present invention, an injection device can be obtained by which it is possible to set a single dose, for being administering once, after which the injection device automatically locks after the administering. Accordingly, the administered or dispensed volume is fixed on a predefined basis, e.g. it may be the entire contents of the ampoule or syringe contained in the injection device. In some preferred embodiments, dispensing takes place automatically after piercing, an advantage of which is that no other operating mechanism needs to be operated to initiate the dispensing operation after piercing. The dispensing operation takes place totally automatically after the piercing operation. In some preferred embodiments, the injection device has a safety needle guard and locks or protects the injection needle after use. In other words, in some embodiments, after n injection has taken place, the protective sleeve is automatically returned or pushed back out in the axial direction beyond the injection needle. [0016] Another aspect of the present invention is that it relates to a method of assembling or fitting an injection device comprising, in some embodiments, at least two or exactly two sub-units, wherein an ampoule or syringe to be inserted in the device is not regarded as a sub-unit. When assembling the injection device from the two sub-units, an injection spring is not tensed until the sub-units are assembled. In some preferred embodiments, the injection spring is an integral part of one of the sub-units and is in the relaxed, non-compressed or non-tensed state when the two sub-units are not assembled. This helps ensure that processes which might cause impairment or alteration due to the pressure expended by a tensed injection spring do not start to occur on assembly of the sub-units. [0017] In some preferred embodiments, one of the two units comprises the housing of the injection device and, optionally, also a protective sleeve which is inserted in the housing, is able to slide relative to it and may extend out from the distal region of the housing. The second sub-unit comprises a plunger rod, an injection spring and an injection spring support element, and the injection spring is tensed between the injection spring support element and plunger rod and can be compressed, for example. The plunger rod or plunger rod element may be moved relative to the injection spring support element and can be pushed into it guided by the injection spring support element, so that the injection spring can be tensed or compressed between the plunger rod and injection spring support element. When the injection device is being assembled, a syringe or ampoule may be inserted between the first sub-unit and the second sub-unit prior to assembly, e.g., pushed into the first sub-unit. The second sub-unit can then be coupled to, inserted in or pushed into the first sub-unit. In this respect, the plunger rod or distal end of the plunger rod is pushed against the syringe or ampoule or against a stopper which is able to slide in the syringe or ampoule. Since no fluid or no substance is able to escape from the ampoule or syringe in the initial state because a needle guard element is fitted and the plunger rod is pushed relative to the injection spring support element due to the pressure of the stopper, as the second sub-unit is inserted in the first sub-unit, the injection spring is tensed. A protective sleeve spring may also optionally be provided between the first and the second sub-unit or on the second sub-unit, which lies between the injection spring support element on the one hand and the protective sleeve on the other hand in the assembled state, so that the protective sleeve causes the protective sleeve spring to tense or compress as it is inserted in the housing. BRIEF DESCRIPTION OF THE DRAWINGS [0018] FIG. 1 is a cross-sectional view illustrating an embodiment of an injection device in accordance with the present invention in an initial state; [0019] FIG. 2 is an exploded view of the injection device illustrated in FIG. 1 prior to assembly; [0020] FIG. 3 shows the injection device illustrated in FIG. 2 in the partially assembled state; and [0021] FIGS. 4A to 4C illustrate the sequence which takes placed during an injection using the injection device of FIG. 1 . DETAILED DESCRIPTION [0022] 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 embodiments of the invention and/or components thereof may be selected from appropriate materials such as metal, metallic alloys, ceramics, plastics, etc. Unless otherwise indicated specifically or by context, positional terms (e.g., up, down, front, rear, distal, proximal, etc.) are descriptive not limiting. Same reference numbers are used to denote same parts or components. [0023] FIG. 1 illustrates an injection device with a housing 1 , which has ribs or webs 1 a on its internal face extending in the axial direction. Disposed at a proximal end of the each rib 1 a is a respective retaining element 3 a in the form of a resilient arm which locates or is urged or biased radially outward. The retaining elements 3 a are attached to a plunger rod 3 and retain it in the illustrated axial position. An injection spring 5 is provided in the rear or proximal region of the injection device, which is supported against an end cap 4 latched to or into the housing and which pushes on the plunger rod 3 and pushes the retaining elements 3 a of the plunger rod 3 in the distal (forward) direction. The retaining elements 3 a of the plunger rod 3 are retained in the locating or retained position on the edges of the webs 1 a by arms 2 a of a protective sleeve 2 , in a positively fitting arrangement or with a slight clearance, so that an injection spring 5 cannot push the plunger rod 3 in the distal direction. [0024] Disposed at the distal end of the plunger rod 3 is an ampoule or syringe 7 with a stopper 7 a which is able to slide in it, against which the plunger rod 3 is able to push. Disposed at the distal or front end of the syringe 7 is an injection needle 7 b , on which a needle guard cap 7 c is fitted, which is removed before using the injection device. The protective sleeve 2 has lugs 2 b projecting radially outward in the region of the front or distal half, which locate in a co-operating groove or recess 1 c of the housing to generate an initial resistance when the protective sleeve 2 is pushed by a user holding or urging the housing 1 against a surface. As the force applied by the user pushing on the housing 1 in the distal direction becomes stronger, these retaining elements 1 c are released from their retaining position and release the protective sleeve so that it can slide axially in the injection device 1 abruptly or in a saccadic movement into the injection device 1 , as a result of which the injection device 1 is applied in a saccadic movement to the surface causing it to be pierced by the needle 7 b. [0025] A protective sleeve spring 6 is provided in the rear or proximal part of the injection device, which is supported against the housing 1 of the injection device or, as in the depicted exemplary embodiment, against an end cap 4 fitted on or connected to the housing 1 and which pushes against the protective sleeve 2 in the distal direction. [0026] FIG. 2 is an exploded view of the injection device illustrated in FIG. 1 , in which the individual components of the injection device described above may be seen. The protective sleeve 2 has two arms 2 a pointing in the axial direction with proximal end or retaining regions 2 d and a releasing cut-out 2 c disposed between the arms 2 a axially offset from the retaining regions 2 d . The plunger rod 3 has two retaining elements 3 a and 3 a ′, which can be moved apart from one another by the retaining regions 2 d for example and/or secured to prevent them from being pressed together. [0027] FIG. 3 illustrates the partially assembled individual components with the protective sleeve 2 inserted in the housing 1 and the plunger rod 3 , injection spring 5 and end cap 4 assembled to form a unit. [0028] FIGS. 1 , 4 A, 4 B and 4 C illustrate an embodiments of an operational sequence which takes place during an injection using the injection device, starting from the state in which it is supplied, illustrated in FIG. 1 . [0029] The injection device is primed by the injection spring 5 , which is compressed or tensed between the plunger rod 3 and end cap 4 . The protective sleeve 2 is mounted or suspended so that it is not able to turn in the housing 1 and is pushed into the front, forward or distal position by the protective sleeve spring 6 . The syringe 7 is mounted in the housing 1 against stops or retaining elements 1 b , and is additionally guided in the protective sleeve 2 by arms or ribs 2 a and secured by webs 4 a of the end cap 4 . The resilient elements 3 a associated with the rod 3 project radially outward, and sit against ribs 1 a in the housing 1 and are prevented from being deflected radially inward out of the retaining position by the proximal end 2 d of the arms 2 a of the protective sleeve 2 . [0030] The end cap 4 snap fits or latches into the housing 1 . This snap-fit or latched connection is suitable to absorb the forces of the injection spring 5 and protective sleeve spring 6 . [0031] FIG. 4A illustrates the injection device in a released state after the protective sleeve 7 c has been removed from the injection needle 7 b . During piercing, the protective sleeve 2 is moved rearwardly toward or into the rear position until the resilient elements 3 a of the plunger rod 3 are released and able to deflect or move outwardly via a cut-out 2 e in the protective sleeve 2 . Due to the chamfer on the ribs 1 a in the housing 1 and on the resilient elements 3 a of the plunger rod 3 , the resilient elements 3 a of the plunger rod 3 are deflected outwardly by the force of the injection spring 5 so that the dispensing operation is automatically triggered. The injection spring 5 applies the force which is needed to deflect the resilient elements 3 a outward and thus release the plunger rod 3 , which is pushed onto the stopper 7 a of the syringe 7 by the injection spring 5 pushing it into the syringe 7 and thus automatically triggering the dispensing operation. [0032] The protective sleeve spring 6 lies against the proximal ends 2 d of the sleeve 2 and is compressed or tensed by the sleeve 2 as it is inserted. [0033] FIG. 4B illustrates the injection device after a dispensing operation. As the injection spring 5 relaxes, the plunger rod 3 is pushed forward in the distal direction. The plunger rod 3 pushes against the stopper 7 a of the syringe 7 and empties the syringe 7 completely until the stopper 7 a is at the end of the glass body of the syringe 7 . The two resilient elements 3 a and the plunger rod 3 slide across or along the ribs 1 a of the housing 1 . At the end of the dispensing operation, one of the two resilient elements 3 a snaps over the end of one or more ribs 1 a in the housing 1 and causes a noise at the end of the dispensing operation, the so-called “end click,” and locks the plunger rod 3 to prevent it from being pushed back. [0034] The other resilient element 3 a ′ on the plunger rod 3 is retained by an arm 2 a on the protective sleeve 2 acting as a locking web in the outwardly deflected state. [0035] FIG. 4C illustrates the injection device in a locked state after it has been removed from the injection site. [0036] When the injection is terminated, the injection device is removed from the injection site. As this happens, the protective sleeve 2 is pushed into the front-most or distal position by the protective sleeve spring 6 . The locking web 2 a of the protective sleeve 2 is pushed by the outwardly deflected resilient element 3 a ′ on the plunger rod 3 until the resilient element 3 a ′ snaps over the end of the locking web 2 a generating a sound or so-called “click.” In this state, the injection device is locked. The protective sleeve 2 can no longer be pushed in because it is blocked by the plunger rod 3 , which sits against the three ribs 1 a in the housing 1 . [0037] 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 illustrate 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.

An injection device for administering a substance, including a housing, a plunger rod which can be moved relative to the housing, at least one retaining element associated with the rod to hold the rod relative to the housing, and a displaceable locking sleeve which can be displaced relative to the housing from one position in which the sleeve holds the at least one retaining element in a retaining position to a second position in which the at least one retaining element is released.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates generally to medical methods, systems, and kits. More particularly, the present invention relates to methods and apparatus for the treatment of lung diseases, such as COPD, by creating and controlling atelectasis and hypoxia in segments of lung tissue. [0003] Chronic obstructive pulmonary disease (COPD) is a significant medical problem affecting sixteen million people or about 6% of the U.S. population. Specific diseases in this group include chronic bronchitis, asthmatic bronchitis, and emphysema. While a number of therapeutic interventions are used and have been proposed, none are completely effective, and COPD remains the fourth most common cause of death in the United States. Thus, improved and alternative treatments and therapies would be of significant benefit. [0004] Management of COPD is largely medical and infrequently surgical. Initially, exercise and smoking cessation are encouraged. Medications including bronchodilators and anti-inflammatories are routinely prescribed. Pulmonary rehabilitation has been shown to improve quality of life and sense of well being. Long term oxygen is generally reserved for the more severely affected patients. [0005] Emphysema is a condition of the lung characterized by the abnormal permanent enlargement of the airspaces distal to the terminal bronchiole, accompanied by the destruction of their walls. It is known that emphysema and other pulmonary diseases reduce the ability of part of the lungs to fully expel air during the exhalation phase of the breathing cycle. During breathing, the diseased portion of the lung does not fully recoil due to the diseased lung tissue being less elastic than healthy tissue. Consequently, as the airways normally held open by the elastic pull of the lungs become floppy and the diseased lung tissue exerts a diminished driving force during exhalation, the airways close prematurely resulting in air trapping and hyperinflation. [0006] In addition, hyper-expanded lung tissue occupies more of the pleural space than healthy lung tissue. In most cases, only a part of the lung is diseased while the remaining portion is relatively healthy and therefore still able to efficiently carry out oxygen exchange. By taking up more of the pleural space, the hyper-expanded lung tissue reduces the space available to accommodate the healthy, functioning lung tissue. As a result, the hyper-expanded lung tissue causes inefficient breathing by compressing the adjacent functional airways, alveolar units, and capillaries in relatively healthier lung tissue. [0007] Lung function in patients suffering from some forms of COPD can be improved by reducing the effective lung volume, typically by resecting diseased portions of the lung. Resection of diseased portions of the lungs both promotes expansion of the non-diseased regions of the lung and decreases the portion of inhaled air which goes into the lungs but is unable to transfer oxygen to the blood. Accordingly, recruitment of previously compressed functional airways, alveolar units, and capillaries in relatively healthier lung is possible resulting in more gas exchange in addition to better matching of lung and chest wall dimensions. Lung reduction is conventionally performed in open chest or thoracoscopic procedures where the lung is resected, typically using stapling devices having integral cutting blades. [0008] While effective in many cases, conventional lung volume reduction surgery (LVRS) is significantly traumatic to the patient, even when thoracoscopic procedures are employed. Such procedures often result in the unintentional removal of healthy lung tissue, and frequently leave perforations or other discontinuities in the lung which result in air leakage from the remaining lung. Even technically successful procedures can cause respiratory failure, pneumonia, and death. In addition, many older or compromised patients are not able to be candidates for these procedures. [0009] As an alternative to LVRS, endobronchial volume reduction (EVR) uses endobronchially introduced devices which plug or otherwise isolate a diseased compartment from healthier regions of the lung in order to achieve volume reduction of the diseased compartment. Isolation devices may be implanted in the main airways feeding the diseased region of the lung, and volume reduction takes place via absorption atelectasis after implantation or via collapse by actively suctioning of the target compartment prior to implantation. These implanted isolation devices can be, for example, one-way valves that allow flow in the exhalation direction only or occlusive devices that prevent flow in both directions. [0010] While a significant improvement over LVRS, EVR suffers from a significant risk of pneumothorax. Pneumothorax is a condition which results from air entering the pleural space surrounding the lung. For reasons that are not fully understood, it has been found by the inventors herein that a sudden blockage of a feeding bronchus can create conditions in the isolated lung region which can in some cases cause a pneumothorax. A spontaneous pneumothorax can result from the tearing of pleural adhesions and blebs lying under the visceral pleura of the non-treated lung areas during the rapid development of absorption atelectasis in the treated lung area. [0011] For these reasons, it would be desirable to provide alternative and improved methods and devices for performing endobronchial volume reduction and other lung therapies where the risk of inducing a pneumothorax is reduced or eliminated. [0012] 2. Description of the Background Art [0013] U.S. Pat. No. 6,679,264 describes an exemplary flow control element that limits, but does not block, fluid flow in at least one direction. The flow control element comprises a valve member supported by a ring. The valve member is preferably a duckbill-type valve having a similar construction to that of the valve member, except that the flaps are formed, secured, oriented or otherwise configured to maintain a flow opening when in their flow-controlling (as opposed to flow-allowing) orientation. The opening is sized and configured to achieve desired flow characteristics through the flow control element. [0014] U.S. Pat. No. 6,722,360 describes devices and methods for improving breathing in patients with COPD. A mouthpiece is provided, or a device is implanted in the trachea or bronchial passage, to selectively increase flow resistance to expiration while minimally increasing flow resistance to inspiration. The methods and apparatus rely on increasing proximal flow resistance in a manner which mimics “pursed lip” breathing during exhalation which has been found to benefit patients suffering from this disease by keeping the distal airways open for a longer period of time and allowing more of the inspired air volume to be evacuated during the longer exhalation time. [0015] U.S. Pat. No. 7,011,094 describes devices and methods for implanting sealing components within bronchial lumens. The sealing components may include a septum which can be penetrated with a dilation device which can provide a valve or open flow path through the septum. [0016] U.S. 2007/0005083 describes the treatment of diseased lung segments by placing a blocking element in an airway of the lung which leads to the diseased segment. BRIEF SUMMARY OF THE INVENTION [0017] In accordance with the present invention, the inventors herein have discovered that diseased regions of the lung may be treated by restricting the exchange of air through an airway or bronchus which feeds the diseased region. In contrast to the endobronchial volume reduction (EVR) protocols where air flow from the diseased region into the feeding airway or bronchus is blocked (typically by a one-way valve or a fully occlusive element), the present invention relies on reducing the rate of air exchange between the diseased region and the feeding airway or bronchus while allowing a reduced rate of air flow in both the inhalation or inspiratory direction and the exhalation or expiratory direction. [0018] Typically, the restriction will be provided by a restrictor which is implanted in the feeding airway or bronchus. The restrictor may be an orifice, a small diameter tube, a perforated membrane, a densely braided structure, perimeter channels, or other fixed-resistance element that impedes the flow of air equally in both directions. Alternatively, the resistor could provide a differential resistance in the two flow directions, for example including two or more parallel flow paths where some of the flow paths are blocked in the inhalation or exhalation direction (but at least some flow paths remain available to permit bi-directional flow at all times). Still further alternatively, the flow resistor could have a variable resistance, e.g., being an iris or other variable resistance valve element. In all cases, however, the flow resistor will permit air flow, usually being about equal, in both the inhalation and exhalation directions to provide for a controlled atelectasis, an induced hypoxia, or in some cases elements of both atelectasis and hypoxia. [0019] In a first aspect of the present invention, the reduced exchange of air between the feeding airway or bronchus and the diseased or other targeted region of the lung to be treated will induce a controlled atelectasis. “Atelectasis” is the collapse of part or all of the lung region as a result of the reduction of air flow into the region and absorption of the remaining air volume. The air which is in the targeted region will be absorbed by the pulmonary blood circulation over time. Typically, the rate of absorption is small compared to the rate at which the targeted region is filled with new air and large amounts of air come and go with a residual portion of it always remaining in the targeted lung region. By fully blocking the flow of air into the targeted lung region, as is the case with prior EVR protocols, the entrance of new air into the targeted lung region stops abruptly, and absorption of the residual air volume takes place more rapidly. Consequently, the collapse of the treated region can be uncontrolled and occur too rapidly, presenting a significant risk of pneumothorax, which is the collection of air or gas in the space surrounding the lung. By providing the controlled (but restricted) exchange of air between the treated lung region and the feeding airway or bronchus, the collapse of the treated lung region will occur more gradually and reduce the risk of pneumothorax. Gas exchange between the treated lung region and the feeding airway will decrease gradually over time until the pressure difference across the restrictor element reaches zero. At that time, atelectasis has fully developed and absorption ceases. That is, the treated region will eventually collapse as with the EVR protocols, but at a slower rate with the reduced risk of pneumothorax. Typically, the collapse of the treated lung region via atelectasis when treated by the flow restriction methods of the present invention will occur when there is little or no collateral ventilation of the treated lung region. [0020] In a second aspect of the present invention, the reduced exchange of air between the treated lung region and the feeding airway or bronchus will result in hypoxic pulmonary vasoconstriction (HPV), referred to hereinbelow as “hypoxia.” Hypoxic pulmonary vasoconstriction as a result of asphyxia has been observed since the beginning of the twentieth century, with the first convincing evidence of its existence reported by von Euler and Liljestrand in 1946 (Von Euler and Liljestrand (1946) Observations on the Pulmonary Arterial Blood Pressure in the Cat, Acta Physiol. Scand. 12: 301-320). Hypoxic pulmonary vasoconstriction shifts blood flow from the hypoxic lung regions to adjacent lung regions which are not hypoxic or are less hypoxic. Thus an induced hypoxic condition in a diseased lung segment can shift blood flow to other healthier lung regions to improve gas exchange and arterial oxygenation. [0021] According to the present invention, there is a potentially significant benefit for a patient who undergoes a simple procedure that creates localized hypoxia in the lung, even with lessened or no lung volume reduction which can occur if, for example, the treated region is collaterally ventilated. By implanting a flow restrictor in the main airway feeding a region of the lung targeted for treatment, a reduction in ventilation to the restricted region takes place. Consequently, a localized hypoxic pulmonary vasoconstriction is induced which diverts blood flow away from the induced hypoxic region to other areas in the lung which are more adequately ventilated and better perfused. As a result, ventilation and perfusion are better matched and the potential for gas exchange is increased. [0022] According to the methods of the present invention, a lung condition may be treated by implanting an air flow restrictor in an airway of a patient's lung. The restrictor reduces air flow exchange between upstream of the restrictor and downstream of the restrictor. Such air flow restriction induces at least one of controlled atelectasis and localized hypoxia in the treated region beyond the restriction. Controlled atelectasis will cause collapse of the treated region downstream of the air flow restrictor, occurring typically in treated lung regions having minimal or no collateral ventilation with adjacent lung regions. The rate of air exchange between the treated lung region and the feeding airway or bronchus will be controlled to permit collapse of the treated lung region over a preselected time period, usually in the range from 12 hours to 30 days, preferably in the range from 3 days to 15 days. Particular restrictors having dimensions and characteristics to provide for such a controlled collapse are described in more detail below. [0023] Localized hypoxia will typically occur without significant collapse of the treated lung region, wherein the hypoxia shifts blood flow away from the treated region and to other, typically more healthy, regions of the lung where improved blood oxygenation may occur. Such localized hypoxia will typically occur in treated lung regions which have significant collateral flow with adjacent lung regions, where the collateral flow will typically inhibit or prevent atelectasis and collapse. [0024] The air flow restrictors of the present invention will typically reduce the volumetric rate of the air flow exchange by an amount in the range from 10% to 99.99% of the unrestricted volumetric rate of air flow exchange, typically in the range from 99% to 99.9% of such unrestricted volumetric air flow. [0025] The restrictors useful in the methods of the present invention will comprise at least one open passage or flow path which permits restricted air flow exchange. In some instances, the restrictors may consist of a single orifice, while in other instances the restrictors may include a plurality of passages, such as a plurality of openings or perforations formed in a membrane or other blocking element. Usually, the open passage area in the flow restrictor will be in the range from 0.01% to 90% of the total cross-sectional area of the restrictor when implanted in the airway, more typically being in the range from 0.1% to 1% of said area. The total passage area will typically be in the range from 0.01 mm 2 to 5 mm 2 , more typically from 0.1 mm 2 to 1 mm 2 . [0026] In a further aspect of the present invention, a bronchial flow restrictor comprises a body having at least one open passage or flow path to permit bidirectional air flow therethrough. The body will be adapted to be expanded and anchored within the lung airway for the control of air exchange with a downstream region of the lung. The passage may consist of a single passage, e.g., in the case of an orifice plate, or the restrictor may include a plurality of passages, e.g., in the case of a perforate plate, membrane, or the like. Typically, the open passage area of the restrictor will be in the range from 0.01% to 90% of the cross-sectional area of the body when expanded. Usually, the total area of the open passages will be in the range from 0.01 mm 2 to 50 mm 2 , typically from 0.1 mm 2 to 1 mm 2 . In alternative embodiments, the passages may be formed on the outside of the body. Typically, the body will be elastic so that it may be constrained to a smaller width for introduction to the lung airway and then released to self-expand and anchor at a target location within the airway. Alternatively, the flow restrictor may be malleable (capable of non-elastic expansion) and be expandable by the application of an internal expansion force, e.g., using a deployment balloon. [0027] In a specific embodiment, the flow restrictor comprises a collapsible medical device made of a plurality of strands or ribbons that are braided, woven, or otherwise enmeshed into a cylindrical shape having a proximal end and a distal end. The strands are connected by a clamping member or otherwise to permit radial expansion and contraction as the axial length is shortened or extended. The braided structure may be very populated with the wire strands or ribbons so that a generally contiguous surface is formed, where the surface has numerous openings or apertures formed between the intersections of adjacent strands or ribbons. The openings provide an equal restriction to air flows going in and out of the target lung segments. The strands may be bare-metal wires, polymer wires or metal wires laminated with a polymer. Optionally, the braided structure may be coated with an eluting drug such as an antibiotic or one for the purpose of reducing or eliminating granulation tissue growth to facilitate elective removal of the restrictor if desired. In another embodiment, the braided structure is coated with a polymer material, but at certain locations it has one or more holes which create a restriction to air flows going in and out of the target lung segments. A variety of design options are presented by the accompanying drawings. This invention also relates to mucus transporting means to be provided with a flow restrictor. Such device would possess at its perimeters transport channels or ports for the physiological media. BRIEF DESCRIPTION OF THE DRAWINGS [0028] FIGS. 1A and 1B illustrate a first embodiment of a flow restrictor constructed in accordance with the principles of the present invention having flow apertures in a reduced diameter portion thereof. [0029] FIGS. 2A-2D illustrate a second embodiment of a flow restrictor constructed in accordance with the principles of the present invention, wherein flow apertures are located in a different location than illustrated in FIGS. 1A and 1B . [0030] FIG. 3 illustrates a third embodiment of a flow restrictor comprising a silicone body having an orifice tube therein. [0031] FIG. 4 illustrates a fourth embodiment of a flow restrictor constructed in accordance with the principles of the present invention, which comprises a continuous body structure having windows formed in one end thereof. [0032] FIGS. 5A and 5B illustrate a fifth embodiment of a flow restrictor constructed in accordance with the principles of the present invention having flow channels formed in an outer surface thereof. [0033] FIG. 6 illustrates a sixth embodiment of a flow restrictor constructed in accordance with the principles of the present invention having an internal tapered flow restrictive orifice. [0034] FIG. 7 illustrates a seventh embodiment of a flow restrictor constructed in accordance with the principles of the present invention having an internal tube which provides flow resistance. [0035] FIGS. 8A and 8B illustrate an eighth embodiment of a flow restrictor constructed in accordance with the principles of the present invention, wherein the flow restrictor has a bell shape and is constructed of a gas penetrable braid. [0036] FIG. 9 illustrates a ninth embodiment of a flow restrictor constructed in accordance with the principles of the present invention, wherein the flow restrictor comprises a cylindrical body formed of a gas penetrable braid. [0037] FIG. 10 is an anatomical diagram illustrating the lobar structure of the lungs of a patient. [0038] FIG. 11 illustrates the trans-esophageal endobronchial placement of a flow restrictor delivery catheter in an airway leading to a diseased lung region. [0039] FIG. 12 illustrates placement of a flow restrictor by the catheter placement device of FIG. 11 . [0040] FIGS. 13A and 13B illustrate the physiologic effect of placement of the flow restrictor at an airway leading to a diseased lung region with little or no collateral ventilation. [0041] FIGS. 14A and 14B illustrate the physiologic response induced by placement of a flow restrictor at an airway feeding a diseased lung region which has significant collateral ventilation. DETAILED DESCRIPTION OF THE INVENTION [0042] In the descriptions below, specific designs for bronchial flow restrictors are described. The restrictors can be placed in any bronchial airway, but generally the airways between and including the lobar bronchus and sub-sub-segmental bronchi are the desired airways to restrict. The restrictor is intended to impede air flow in both the inspiratory and expiratory direction usually about equally, and either permanently or temporarily. Flow limitation can be from 10% to 99.99% reduction of flow, usually being from 99% to 99.9% of the unrestricted flow, depending on the clinical need. [0043] The flow limitation will have at least one of two physiologic effects. In instances where the lung region distal to the restrictor is generally free from collateral ventilation, the restrictor will induce a controlled atelectasis. The distal lung region will collapse, although at a significantly slower rate of collapse than would be the case with complete occlusion of air flow into the region, and the risk of pneumothorax will be significantly reduced. In other instances where the lung region downstream from the flow restrictor is exposed to significant levels of collateral ventilation, the restricted air flow into and from the region will induce hypoxia. The resulting reduced oxygen concentrations distal to the restrictor will catalyze the von Euler reflex to shunt pulmonary perfusion to other, usually more healthy and functional, bronchopulmonary regions of the lung that have not been treated with a restrictor, and thus improve the ventilation-perfusion efficiency of the lung. [0044] FIGS. 1A and 1B illustrate a bronchial flow restrictor (BFR) 10 constructed of an elastic wire frame 12 which is laminated with an elastomeric membrane 14 . On the proximal end 16 of the BFR, the membrane 14 is incomplete or perforated, creating at least one vent hole 18 . On the distal section 20 of the BFR, apertures 22 are formed in the membrane 14 to create a path for the gas flow. The size and shape of the vent hole 18 and apertures 22 can vary in order to provide a desired flow resistance within the range defined elsewhere herein. This general design permits collapsibility of the BFR for insertion into a small catheter for delivery into the lung, allowing self-expansion of the BFR when released from the catheter. The stepped configuration of this particular design allows the BFR to be placed at or near an airway bifurcation or airway narrowing. For example, the larger proximal end may be placed in a proximal airway so that the distal smaller section 20 extends into the next generation airway which is smaller because it is distal to the proximal airway. The flow restrictions can be fabricated by the techniques described for fabrication of fully occlusive elements and one-way valves set forth in U.S. Pat. No. 6,527,761 and commonly assigned, copending application Ser. No. 11/280,592, the full disclosures of which are incorporated herein by reference. [0045] FIGS. 2A-2D describe a modified configuration 10 ′ of the previously described BFR in which distal gas flow apertures 24 are positioned to be within the lumen of the distal airway DA after the BFR has been expanded from a radially constrained diameter in the airway to an unconstrained diameter which creates a dilated pocket DP ( FIG. 2D ) in the airway. Thus, the gas flow through apertures 24 is not obstructed by the bronchial wall. [0046] FIG. 3 is a cross-sectional view of BFR 30 in which a housing 32 includes a gas flow orifice tube 34 on its distal end 36 . The housing can have a “uni-body” construction, typically being molded or cast from silicone or another biocompatible elastomer. In some instances, the housing 32 can have composite construction of wire frame with silicone membrane coating, or be formed from a variety of materials and construction methods. It can be collapsible and self expanding for a catheter based delivery. In other designs, the BFR can be malleable to allow plastic deformation and expansion by a balloon or other expandable deployment on the delivery catheter. [0047] FIG. 4 illustrates a BFR 40 in which a housing 42 comprises a plurality of windows 44 in a wall of a distal section 46 in order to permit gas flow in and out of the housing. An orifice 48 at the opposite proximal end completes the gas flow path such that the device restricts but does not obstruct gas flow. As with previously described embodiments, the housing 42 can have a uni-body construction or comprise a wire frame with silicone or other membrane covering. It can be either collapsible and self expanding or balloon expandable. [0048] FIGS. 5A and 5B illustrate BFR 50 which has gas or fluid transport channels 52 shaped or formed into an outer surface or periphery of the housing body 54 . The channels 52 will leave a space or gap between the airway wall in which the BFR is implanted and the surface of the BFR, thus providing a path for fluid flow in both directions. As mentioned previously, the housing 54 can have a uni-body or composite construction. The housing 54 can be collapsible and self expanding or balloon expandable. [0049] FIG. 6 illustrates a BFR 60 in which a housing 62 houses a funnel-shaped (or hourglass-shaped) diaphragm 64 which provides a gas flow orifice 66 in the center of the diaphragm. Distal and proximal apertures 68 and 70 , respectively, allow air flow into and out of the housing 62 , and the tapered orifice 66 defined by the diaphragm 64 restricts the flow. The diameter of the orifice 66 can be selected to provide a desired flow resistance. The housing 62 can have a uni-body construction or be a wire braided structure encapsulated with silicone or other elastomere. The diaphragm can be a flexible silicone material or other elastomere in order to facilitate compressibility of the BFR 60 for insertion into the lung via a delivery catheter lumen. [0050] FIG. 7 illustrates BFR 70 in which a gas flow tube 72 is axially aligned in a housing 74 . Construction of the housing 74 can be similar to any of the concepts previously described. The gas flow tube 72 can be constructed of any tubular material, preferably being a flexible polymer. Flexibility is advantageous since a flexible tube will facilitate insertion into the lung. The housing 74 can have any of the constructions described previously. [0051] FIGS. 8A and B and 9 A and B illustrate non-covered, tightly packed wire braid flow restrictors 80 and 90 . The tight backing of the wire braid can eliminate the need for a membrane cover to achieve occlusion while providing a perforate or foraminous surface 82 and 92 , respectively, to permit a controlled flow of air therethrough. [0052] Referring now to FIG. 10 , the respiratory system of a patient starts at the mouth and extends through the vocal cords and into the trachea where it then joins the main stem bronchi B which leads into the right lung RL and the left lung LL. The bronchi going into the right lung divide into the three lobar bronchi which lead into the upper lobe RUL, the middle lobe RML and the lower lobe RLL. The lobes of the right lung include a total of ten segments (three in the RUL, two in the RML, and five in the RLL) which are discrete units of the lung separated from each other by a fibrous septum generally referred to as a lung wall. The left lung LL includes only an upper lobe LUL and a lower lobe LLL, where the individual lobes include four to five segments each [0053] Each lung segment, also referred to as a bronchopulmonary segment, is an anatomically distinct unit or compartment of the lung which is fed air by a tertiary bronchus and which oxygenates blood through a tertiary artery. Normally, the lung segment and its surrounding fibrous septum are intact units which can be surgically removed or separated from the remainder of the lung without interrupting the function of the surrounding lung segments. In some patients, however, the fibrous septum separating the lobes or segments may be perforate or broken, thus allowing air flow between the segments, referred to as “collateral ventilation.” [0054] Use of a delivery catheter 100 for placement of a BFR in accordance with the principles of the present invention is shown generally in FIGS. 11 and 12 . The catheter 100 is advanced through the mouth, down through the trachea T, and through the main bronchus into the left lung LL. A distal end 102 of catheter 100 is advanced into the left lung LL, and further advanced to an airway which feed a diseased lung region DR. The catheter 100 may be introduced through the main bronchus B and into the left lung LL without the use of a bronchoscope or other primary introducing catheter, as illustrated in FIG. 11 . Alternatively, the catheter 100 may be introduced through a conventional bronchoscope (not shown) which is positioned in the main bronchus above the branch between the right and left lungs. Alternatively, the catheter 100 may be introduced into the lung through a scope, such as a visualizing endotracheal tube (not shown) which is capable of advancing into the branching airways of the lung is advantageous in that it facilitates positioning of the delivery catheter 100 at the desired airway leading to a target lung segment. Construction and use of a visualizing endotracheal tube is taught, for example, in U.S. Pat. No. 5,285,778, the full disclosure of which is incorporated herein by reference. It would be possible, of course, to utilize both the bronchoscope B and the endotracheal tube ET in combination for positioning the delivery catheter 100 in the desired lung segment airway. [0055] After the distal end 102 of the delivery catheter 100 has been positioned in the main airway or bronchus feeding the diseased region DR, the catheter can optionally be immobilized, for example by inflating a balloon or cuff 104 . After immobilizing the distal end of the catheter, a pusher or other element 106 can be advanced in order to eject the bronchial flow restrictor BFR in the bronchus, where it optionally self-expands to anchor in place. Although not illustrated, it would also be possible to use an inflatable balloon or other deployment device on the catheter 100 in order to position a plastically deformable restrictor at a desired location. [0056] Referring now to FIGS. 13A and 13B , after the bronchial flow restrictor BFR has been placed in the airway leading to a diseased region DR, illustrated as a first lung segment LS 1 , air flow into and out of the segment as the patient inhales and exhales will be restricted by placement of the BFR, as generally described above. As shown in FIGS. 13A and 13B , the first lung segment LS 1 is surrounded by a fibrous septum FS which is generally intact so that little or no collateral ventilation with adjacent lung segments LS 2 and LS 3 will occur. Thus, as shown in FIG. 13B , the reduced air flow into and out of the treated lung segment LS 1 will induce atelectasis and cause the treated segment to deflate. Deflation of the treated segment LS 1 , in turn, allows the adjacent, healthier lung segments LS 2 and LS 3 to expand and provide improved patient blood oxygenation. Moreover, the slower rate of atelectasis reduces the risk to the patient of pneumothorax, as discussed above. [0057] Referring now to FIGS. 14A and 14B , in other instances, the diseased lung region DR may have a perforated or otherwise damaged region of the fibrous septum DFS which permits collateral ventilation between the diseased region (LS 1 ) and an adjacent lung region LS 2 . In those instances, air entering via the collateral channels is already low in oxygen and placement of the bronchial flow restrictor BFR will significantly reduce the amount of oxygenated air entering the diseased region LS 1 /DR via the feeding bronchus. As shown in FIG. 14B , over time, the reduced and non-oxygenated air exchange with the diseased region DR will induce hypoxia in the region (shown with the cross-hatching) which will catalyze the von Euler reflex to shunt pulmonary perfusion to other healthier regions of the lung, such as adjacent healthy segments LS 2 and LS 3 . [0058] It will be appreciated, however, that the induced lung collapse and induced hypoxia may occur to differing degrees in even the same treated region. In particular, the shift between lung collapse and hypoxia may depend, at least in part, on the degree to which collateral ventilation exists between the diseased region and adjacent healthier lung regions. Thus, although it may be desirable to perform a diagnostic on the patient to determine whether or not a particular diseased region is subject to collateral ventilation (as taught, for example, in commonly owned, copending application Ser. No. 11/296,951 (Attorney Docket No. 017534-002820US), filed on Dec. 7, 2005, the full disclosure of which is incorporated herein by reference), it would not be necessary. Treatment of diseased lung regions using the bronchial flow restrictors of the present invention may be advantageous regardless of the collateral ventilation status of a particular region. [0059] While the above is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. Therefore, the above description should not be taken as limiting the scope of the invention which is defined by the appended claims.

Lung conditions are treated by implanting a flow restrictor in a passageway upstream from a diseased lung segment. The restrictor will create an orifice at the implantation site which inhibits air exchange with the segment to induce controlled atelectasis and/or hypoxia. Controlled atelectasis can induce collapse of the diseased segment with a reduced risk of pneumothorax. Hypoxia can promote gas exchange with non-isolated, healthy regions of the lung even in the absence of lung collapse.

FIELD OF THE INVENTION This invention relates to methods of playing games and methods of amusement; in particular, this invention relates to methods of playing wagering games, especially wagering games in the context of a casino or other commercial venue; most particularly this intention relates to methods of playing card games at tables in a casino or other commercial venue and virtual card games in self contained games in the casino environment. STATE OF THE ART The card game known as Blackjack or Twenty-One is a common card game played for recreation in every conceivable venue, including homes, dormitory rooms, lunch rooms and, of course, in casinos and other organized venues for the promotion of wagering throughout the world. In Twenty-One the outcome is determined by either the player or the dealer having the highest hand value that does not total more than twenty one as defined by the numerical amounts of the cards in the hand value. The hand value is defined by the numerical value of the cards dealt with two exceptions: a) the face cards are all defined to have a value of ten, and b) the ace may have a value of either one or eleven at the player's option. The best hand is called the blackjack, and consists of a two card hand totaling twenty one, which is a hand comprising an ace and a ten. As the game is typically played, insurance, doubling down, and splitting a pair are the only side bets normally allowed, when “side bet” is defined as a bet that requires an additional wager, and is based on an occurrence that may or may not affect the ultimate outcome of the game. The two traditional side bets mentioned illustrate the concept. When the dealer shows an ace a player may place a second bet to ‘insure’ that the dealer doesn't have a ten as his down card. If the dealer has some other card than a ten, the player loses the wager for the insurance, play continues for that hand, and the player may still win the hand. Similarly, the player may double down by placing a second bet after the first two cards have been dealt that the next card dealt to him will give him a better hand than the dealer—that is, his three card hand will beat the hand the dealer eventually will wind up with. Splitting a pair is not quit a side bet as herein defined, since the player splits a pair of cards, for example a 9-9, and then player plays both of the two hands to the conclusion of the game, each hand containing a 9 from his original hand. He may usually split the next hand if he gets a third 9. Of course the rules for these side bets may vary from casino to casino. The need for casinos to attract more customers, particularly the casual player who may not fully understand the table games, has caused a recent upsurge in interest in developing new easy to understand and play side-bets for established table games such as Twenty-One. The need has resulted in several innovations in table games found in casinos. Some have filled the need admirably, but the average life time for a variant side bet game is short enough that there remains a continuing need for candidate games. SUMMARY OF THE INVENTION A card game that can be a side bet or an adjunct to the casino card game of twenty-one is played by placing a wager that the face up card of a dealer will be a value of ten; dealing to at least one player the first two cards of a twenty-one game from at least one randomly shuffled deck of cards containing at least one standard playing card deck of fifty two cards; dealing to a dealer two cards, the first of said cards being dealt one face up, and the second of said cards, a hole card, being dealt face down; determining if the dealers face up card is a card with a value of ten: which is a ten card, a jack card, a queen card or a king card; then depending on the value of the face up card following one of two courses of action, if there is no ten, jack, queen or king showing, collecting the money bet the ten wager, then continuing to deal the twenty-one game until its resolution; if the dealer has a ten card showing, paying the wager at a first predetermined amount if his hole card is an Ace, paying the wager at a second predetermined amount if his hole card is a ten, paying the wager at a third predetermined amount if he has anything other than an ace or a ten; then continuing to deal the twenty-one game until its resolution This invention provides a method for playing a modified form of blackjack or twenty-one played with at least one standard deck of at least fifty two cards consists of wagering whether the dealer has a winning hand based on the observation that the dealer has dealt himself a ten as an up card. In particular this invention provides a card game comprising the method of: Placing a wager that the face up card of a dealer will be a value of ten; Dealing to at least one player the first two cards of a twenty-one game from at least one randomly shuffled deck of cards containing at least one standard playing card deck of fifty two cards; Dealing to a dealer two cards, the first of said cards being dealt one face up, and the second of said cards, a hole card, being dealt face down; Determining if the dealers face up card is a card with a value of ten: a ten crd, a jack card, a queen card, or a king card; If the dealers face up card is not a ten, jack, queen or king, collecting the money bet the ten wager, then continuing to deal the twenty-one game until its resolution; If the dealer has a ten card showing, paying the wager at a first predetermined amount if his hole card is an Ace, paying the wager at a second predetermined amount if his hole card is a ten, and paying the wager at a third predetermined amount if he has anything other than an ace or a ten value card; then continuing to deal the twenty-one game until its resolution. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Blackjack or twenty one is defined herein as a game wherein a first participant, hereinafter the ‘dealer’, who plays for the house, deals two cards apiece to a second participant, hereinafter the ‘player’, and himself. The player is therefore really playing against the house. The point of the game is for the player to match or beat the dealer's cards without going over twenty one points, called going ‘bust.’ Points are determined by the number of the card: that is a 2 is worth two points, a 3, three points and so forth, up to a 10 being worth ten points. The face cards, that is the Jacks, Queens, and Kings, are all worth ten points and an ace is worth either one point (which is used in what is termed a ‘hard’ hand) or eleven points (which is used in a ‘soft’ hand). The best hand is twenty one points, which can be achieved by any number of cards but the two card hand of an ace, counted here as an eleven, and any card worth ten points, which hand is called a Blackjack, is considered the best. Herein, a deck of cards will considered to be a deck containing a minimum of fifty two cards including an ace (A), 2, 3, 4, 5, 6, 7, 8, 9, 10, Jack (J), Queen (Q), and King (K) in the four suits of clubs, spades, hearts and diamonds. J, Q, and K are defined as the face cards; and face cards and ten cards have a value of ten in the game of twenty one. A two card hand will herein be denoted as, for example, 2-7 for a hand containing a two, of any suit, and a seven, of any suit. Other cards may be added to the deck, such as jokers or the like, so the total number of cards may well be higher than fifty two. Moreover, from one to seven or more extra decks may be added to the original first deck. However, the “deck” as defined herein will always contain at least the fifty two cards of the standard deck, and those fifty two cards will always be randomly shuffled before being dealt to the player. As used herein, a “card” can be a physical elongate paper or plastic item with a numerical value printed thereon, or it can be a virtual card, which is defined herein is any representation of a playing card that may look identical to the numerical side of a physical card or may be abbreviated, having, for example, only a number and a suit identified thereon. Virtual cards are used in conjunction with a computer, or similar digital processing means, which will display the virtual card on a video display monitor or other active display device. As used herein, the term “video monitor” includes CRT video monitors and all equivalents of CRT video monitors such as LED screens and plasma screen displays of any sort that displays graphical images of digital information. If virtual cards are used then the “dealer” will usually be a virtual dealer. The virtual dealer is a computer, specifically the processor of the computer. The processor calculates the values of the hands as they are played and displays the hands to the player on a display device. In general, the player will activate the processor by dropping a coin into a slot and pressing a button. However, strictly computer driven games, that include no possibility of money changing hands are also contemplated by the invention—for example, games played at home and the like strictly for amusement or for practice for actual play in a casino. If one uses a computer style of game, the dealer's role remains unchanged from what it would be if the dealer was a live person standing or sitting at the gaming table. Therefore, as used herein, the term “dealer” will includes both live dealer and the virtual dealer created by the processor. The dealer does not normally participate beyond dealing in most twenty one games, but the person playing the dealer may be rotated in and out, and the dealer may play hands against himself—thereby lowering the likelihood of a player winning any given hand. There may be between one to as many as seven players in the normal casino version of the blackjack or twenty one game, although, in theory, the number of players could be much greater. This invention is a method of playing the game of twenty-one between either a live dealer or a virtual dealer. The dealer may be dealing either real cards or virtual cards. The dealer, live or virtual, will deal to at least one live twenty-one player. The player will place a first wager on whether the twenty-one player or the dealer will win the twenty-one game. This is the standard bet in Twenty-one. The player may then place a second bet if the dealer shows a ten that the dealer will win the hand. That is, if the player knows the dealer has deal himself a 10, he may place a wager that the dealer will win the hand, or, the player may place the bet at the same time he makes the wager on the twenty one hand. The dealer deals to the player the first two cards of a twenty-one game from at least one randomly shuffled deck of cards containing at least one standard playing card deck of fifty two cards. The dealer also deals himself two cards, one face up, and one face down. The face down card is the “hole” card. It will be appreciated that if the dealer is a virtual dealer, the deck of cards is formed by shuffling 52 numbers, each representing a card using any of several standard algorithms. Images of the randomly shuffled cards are then presented on the video monitor. Once the first two cards are dealt, if the dealer has a ten card showing, he will resolve the first wager, if he does not, he will collect the money wagered for the ten wager, then he will continue to deal the twenty-one game until its resolution. It will be realized that this game can be played without any monetary wager or bet being made. All that needs be done is that the player have some means of indicator means to indicate whether he wants to play this form of cards, and an indication or indicator proving that he has won or he lost the hand. If the dealer has a ten card showing, he will pay 6 to one if his hole card is an Ace, 3 to one if his hole card is a ten, and 1 to 1 if he has anything other than an ace or a ten. The wager described is on the first two cards dealt only, that is to say, if the dealer draws a ten for any other card he may deal to himself, there is no money to be paid to the player. A preferred mode of playing this game includes an optional bonus bet as part of the payout for the side bet, where if the dealer has a ten card, and his face down or hole card is also a ten card (the ten cards here being the card between a nine and a jack ONLY) the player receives an enhanced bonus, usually about 40 to one. This invention has been described in detail with reference to specific embodiments of the invention and examples thereof. Alterations, modifications, and other changes to those embodiments and examples will invariably suggest themselves to those of ordinary skill in the art relating to this invention. Therefore, it is intended that the scope of this invention should be determined solely by reference to the appended claims, which appended claims encompass all such alterations, modifications, and changes.

A side bet for Blackjack also known as twenty-one is disclosed. The player places a side wager that the dealer's up card will be a ten-value card. If the dealer's up card is a ten-value card, then the player is paid 1 to 1. Potential additional side payoffs include whether the dealer's hole card is a ten-value card, in which case the player wins 3 to 1 or whether the dealer's hole card is an ace, in which case the player is paid 6 to 1. Other potential side payoffs are also disclosed.

CROSS REFERENCE TO RELATED APPLICATION This application is a continuation of U.S. application Ser. No. 10/647,950 filed on Aug. 26, 2003 now U.S. Pat. No. 7,294,104 which is a continuation of U.S. application Ser. No. 09/779,021 filed on Feb. 7, 2001 now U.S. Pat. No. 6,610,009 which is a continuation of U.S. application Ser. No. 09/235,593 filed on Jan. 22, 1999 now U.S. Pat. No. 6,200,263 which claims priority to U.S. Provisional Application Ser. No. 60/072,406 filed on Jan. 23, 1998, the contents of which are hereby incorporated by reference in their entirety. BACKGROUND 1. Technical Field The subject disclosure relates to minimally invasive surgical procedures and apparatus, and more particularly to apparatus for holding surgical instrumentation during surgery associated with the thoracic cavity. 2. Background of Related Art It is well established that the performance of various types of surgical procedures using less invasive techniques and instrumentation has provided numerous physical benefits to the patient while reducing the overall cost of such procedures. One area, for example, which has experienced a great increase in the performance of less invasive procedures is in the area of heart surgery. In particular, coronary artery bypass graft (CABG) procedures have been performed using less invasive techniques with much success. Access to the patient's thoracic cavity for such procedures in the past was typically achieved by a large longitudinal incision in the chest. This procedure, referred to as a median sternotomy, requires a saw or other cutting instrument to cut the sternum and allow two opposing halves of the rib cages to be spread apart. U.S. Pat. No. 5,025,779 to Bugge discloses a retractor which is designed to grip opposite sternum halves and spread the thoracic cavity apart. The large opening which is created by this technique enables the surgeon to directly visualize the surgical site and perform procedures on the affected organs. However, such procedures that involve large incisions and substantial displacement of the rib cage are often traumatic to the patient with significant attendant risks. The recovery period may be extended and is often painful. Furthermore, patients for whom coronary surgery is indicated may need to forego such surgery due to the risks involved with gaining access to the heart. U.S. Pat. No. 5,503,617 to Jako discloses a retractor configured to be held by the surgeon for use in vascular or cardiac surgery to retract and hold ribs apart to allow access to the heart or a lung through an operating window. The retractor includes a rigid frame and a translation frame slidably connected to the rigid frame. Lower and upper blades are rotatably mounted to the rigid frame and the translation frame respectively. Such a “window” approach requires instrumentation that can be inserted into and manipulated within the limited space available in and around the surgical site. Therefore, a continuing need exists for more versatile and varied surgical instrumentation which facilitates performing surgical procedures in limited access cavities of a patient during less invasive surgical procedures. A need also exists for instrument holding apparatus to retain surgical instruments in place during surgical procedures and free the surgeons hands. SUMMARY The present disclosure addresses the above-noted needs while providing various embodiments of an apparatus for holding surgical instruments that have many unique features and advantages over the prior instrumentation. The presently disclosed apparatus for holding surgical instruments provides greater versatility during surgical procedures which are less invasive than traditional procedures. For example, in one embodiment, the present disclosure provides an apparatus for holding a surgical instrument relative to a base, which includes a mounting portion configured and dimensioned to engage a portion of a base, a jaw assembly including first and second jaw members which define a retaining area therebetween configured and dimensioned to retain the shaft of a surgical instrument therein and thereby fix the length of the instrument shaft relative to the base and an operative site, and an instrument position adjustment mechanism which includes an adjustment member rotatably disposed in relative to the mounting portion to facilitate selective position adjustment of the jaw assembly with respect to the mounting portion. The instrument position adjustment mechanism may include a lock member such that when positioned in a locked position, the adjustment member is prevented from moving relative to the mounting portion and when the lock member is positioned in an unlocked position, the adjustment member is permitted to move relative to the mounting portion. The jaw assembly preferably includes a jaw approximation control member which controls movement of one of the first and second jaw members relative to the other of the first and second jaw members. BRIEF DESCRIPTION OF THE DRAWINGS Various preferred embodiments are described herein with reference to the drawings, wherein: FIG. 1 is a perspective view of a surgical retraction system incorporating a variety of retractors, a heart manipulator and a heart stabilizer, all positioned on a base; FIG. 2 is a perspective view of the instrument holder of the present disclosure showing an instrument shaft retained in the horizontal position and the jaws in the open position; FIG. 3 is a side view of the instrument holder in the position of FIG. 2 ; FIG. 4 is a perspective view of a first section of a base mounting assembly of the present disclosure; FIG. 5 is a perspective view of a second section of the base mounting assembly; FIG. 6 illustrates the ball for enabling maneuverability of the jaw assembly; FIG. 7 illustrates a side view of the shaft which is connected at one end to the ball and at the opposite end to the jaw assembly; FIG. 8 is a side view of the locking screw which retains the ball in a fixed position; FIG. 9 illustrates the handle which attaches to the locking screw for rotating the screw; FIG. 10 is a side view showing the handle attached to the locking screw to form a ball locking assembly; FIG. 11 is a perspective view illustrating the instrument holder with the jaws in the closed position and maneuvered to hold the instrument shaft at an angle; FIG. 12 is a side view illustrating the instrument holder maneuvered to position the instrument shaft perpendicular to the base of the retraction system; FIGS. 13A and 13B are perspective and side views, respectively, of the stationary jaw for holding the instrument shaft; FIG. 14 is a perspective view of the movable jaw; FIG. 15 is a perspective view of an alternative embodiment of an instrument holder constructed in accordance with the present disclosure; and FIG. 16 is a side view of the instrument holder embodiment of FIG. 15 . DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS The instrument mounting holder of the present disclosure is designed to mount various accessory instruments to the ring base disclosed in U.S. patent application Ser. No. 08/718,283, filed Sep. 20, 1996, the entire contents of which are incorporated herein by reference. FIG. 1 is a drawing from the '283 patent application and shows a base 50 , retractors 60 , 70 and 80 , a heart stabilizer 90 and a heart manipulator 100 . A detailed description of these instruments, how they are mounted to the base 50 , and their surgical function is disclosed in the '283 application. The present disclosure is directed to an instrument holding apparatus, which is removably positionable on base 50 , and can mount a variety of instruments such as an illumination instrument, a grasper, a retractor, a heart stabilizer or any other instrument that would be useful in performing the surgical procedure. Only the shaft of the accessory instrument is shown in the drawings and is represented generically by reference letter “S”. Referring to FIGS. 1-5 , instrument holder 1 includes a mounting portion, such as a base mounting assembly 10 composed of a first section 12 and a second section 14 , an instrument position adjustment mechanism 30 , and a jaw assembly 51 for supporting the instrument shaft S. As best shown in FIG. 4 , first section 12 includes a neck 19 having a socket 15 formed therein for receiving a ball 32 , described below. A lip 18 is formed to hook around a front edge 45 , FIG. 1 , of base 50 . An extension 16 extends through a groove 22 formed in second section 14 , shown in FIG. 5 . A lip 20 of second section 14 is configured to mount to an outer edge 46 of base 50 . A biasing spring, not shown, is attached at one end to first section 12 and at the opposite end to second section 14 to help retain the sections 12 and 14 together while allowing first section 12 and second section 14 to be pulled slightly away from each other, against the force of the spring, to facilitate mounting to and release from base 50 . Referring to FIGS. 6-12 , position adjustment mechanism 30 includes a ball 32 , FIG. 6 , a ball shaft 34 , FIG. 7 , a lock member such as locking screw 36 , FIGS. 8 and 10 , and a locking screw handle 38 , FIGS. 9 and 10 . Ball 32 is attached to end 35 of ball shaft 34 . Alternatively, ball 32 and shaft 34 could be integral. End 37 of ball shaft 34 is attached to jaw assembly 51 . Ball 32 is maneuverable by rotational and pivotal movement through a multitude of positions within neck 19 in order to maneuver the jaws to position the shaft S (and associated instrument) in a variety of orientations. Such maneuverability is shown for example by comparing FIGS. 3 , 11 and 12 . Once the jaw assembly 51 is maneuvered to the desired position, handle 38 , which is attached to locking screw 36 via arm 39 extending through aperture 41 , is rotated to advance locking screw 36 so that abutment end 33 tightly presses against ball 32 . This locks ball 32 in position and prevents movement thereof. Referring to FIGS. 13A , 13 B and 14 , jaw assembly 51 includes a movable jaw 64 having an internally threaded opening 71 to receive mounting screw 58 of a stationary jaw 52 . Arm 66 of movable jaw 64 is mounted within a groove 56 formed on stationary jaw 52 . Ball shaft 34 is adhesively mounted within a recess (not shown) of stationary jaw 52 , although other means of connection are also contemplated. A jaw approximation control member, such as locking knob 72 , as best shown in FIGS. 3 and 10 , is attached to a mounting screw 58 such that rotation of locking knob 72 rotates threaded mounting screw 58 to advance movable jaw 64 towards a stationary jaw 52 . Spring 59 biases movable jaw 64 to the open position, away from stationary jaw 52 . Approximation of jaws 52 and 64 grasps and retains instrument shaft S therebetween. Referring back to FIG. 2 , in conjunction with FIGS. 13A , 13 B and 14 , a pair of friction enhancing members such as rubber pads 54 and 69 are mounted within grooves 61 and 68 formed on stationary jaw 52 and movable jaw 64 , respectively, to facilitate atraumatic grasping of instrument shaft S. In use, instrument shaft S is placed between movable jaw 64 and stationary jaw 52 with the jaws in the open position as shown in FIG. 2 . Knob 72 is rotated to close the jaws 64 , 52 to clamp and securely hold instrument shaft S. Jaw assembly 51 is manually movable to position the instrument shaft S at the desired angle relative to base 50 as ball 32 pivots within socket 15 of neck 19 . Once pivoted to a desired position, for example, the position shown in FIG. 11 or FIG. 12 (other positions are clearly contemplated), locking screw handle 38 is rotated to advance locking screw 36 against ball 32 to lock ball 32 in place. This prevents further movement of the jaw assembly 51 . Referring to FIGS. 15 and 16 , an alternative embodiment of the presently disclosed apparatus for holding instruments is designated as instrument holder 100 . Instrument holder 100 is similar to instrument holder 1 . Therefore, the following description will only focus on those aspects of instrument holder 100 which differ from instrument holder 1 . In contrast to base mounting assembly 10 of instrument holder 1 , instrument holder 100 includes a mounting portion, such as a base mounting assembly 110 which is in the form of a clip having first and second lips 118 , 120 which extend from a bottom surface of mounting assembly 110 . Mounting assembly 110 is preferably fabricated from flexible material and includes a cantilevered extended portion 111 which deflects upon the application of a generally vertically directed force. Thus, in order to mount instrument holder 110 to base 50 , lip 118 is fitted over the inner rim of base 50 and instrument holder 100 is moved into closer approximation with base 50 so that lip 120 cams outwardly and flexes extended portion 111 upwardly until lip 120 passes over the outer edge of base 50 and snaps back to its normal configuration as shown in FIG. 16 . Once positioned on base 50 , instrument holder 100 functions in the same way as instrument holder 1 described above to retain surgical instruments therein. Another difference between instrument holder 100 and instrument holder 1 is the configuration of the locking knob. In particular, screw handle 38 of instrument holder 1 is in the form of a rotatable lever whereas screw handle 138 of instrument holder is in the form of a wing having extended portions 138 a and 138 b extending radially outwardly from the center along a plane. It will be understood that various modifications may be made to the embodiments of the apparatus for holding surgical instruments shown and described herein. Therefore, the above description should not be construed as limiting, but merely as examples of preferred embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the present disclosure.

An apparatus for holding a surgical instrument relative to a base is provided having a mounting portion configured and dimensioned to engage a portion of a base, a jaw assembly including first and second jaw members which define a retaining area therebetween configured and dimensioned to retain the shaft of a surgical instrument therein and thereby fix the length of the instrument shaft relative to the base and an operative site, and an instrument position adjustment mechanism which includes an adjustment member rotatably disposed in relative to the mounting portion to facilitate selective position adjustment of the jaw assembly with respect to the mounting portion.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. application Ser. No. 11/478,107 Filed Jun. 29, 2006, which is a continuation of Ser. No. 09/754,723 filed on Jan. 4, 2001, which is a continuation of Ser. No. 08/842,121 filed on Apr. 23, 1997, which is a continuation of 08/295,913 filed on Oct. 13, 1994, that issued as U.S. Pat. No. 5,631,224 on Oct. 28, 1998 and reissued as reissue patent RE 37,302 on Jul. 31, 2001, which is a national application under 35 U.S.C. 371 of PCT/DK93/00099 filed on Mar. 18, 1993, which claims priority to Danish application 363/92 filed Mar. 19, 1992, the contents of which are fully incorporated herein by reference. FIELD OF THE INVENTION [0002] The present invention relates to the use of GLP-1(7-37), GLP-1(7-36)amide, or certain related compounds for the preparation of a medicament for use in the treatment of diabetes in a regimen which additionally comprises treatment with an oral hypoglycaemic agent. The invention also relates to a method of treating diabetes by using said medicament. BACKGROUND OF THE INVENTION [0003] Diabetes is characterized by an impaired glucose metabolism manifesting itself among other things by an elevated blood glucose level in the diabetic patients. Underlying defects lead to a classification of diabetes into two major groups: type 1 diabetes, or insulin demanding diabetes mellitus (IDDM), which arises when patients lack β-cells producing insulin in their pancreatic glands, and type 2 diabetes, or non-insulin dependent diabetes mellitus (NIDDM), which occurs in patients with an impaired β-cell function besides a range of other abnormalities. [0004] Type 1 diabetic patients are currently treated with insulin, while the majority of type 2 diabetic patients are treated either with agents that stimulate β-cell function or with agents that enhance the tissue sensitivity of the patients towards insulin. [0005] Among the agents applied for stimulation of the β-cell function, those acting on the ATP-dependent potassium channel of β-cells are most widely used in current therapy. The so-called sulfonylureas such as tolbutamide, glibenclamide, glipizide, and gliclazide are used extensively and other agents such as AG-EE 623 ZW also acting at this molecular site are under development (AG-EE 623 ZW is a company code for (S)-(+)-2-ethoxy-4-[2-[[3-methyl-1-[2-(1-piperidinyl)phenyl]butyl]-amino]-2-oxoethyl]benzoic acid, a compound described in European patent publication No. 147,850 (to Dr. Karl Thomae GmbH)). Among the agents applied to enhance tissue sensitivity towards insulin metformin is a representative example. [0006] Even though sulfonylureas are widely used in the treatment of NIDDM this therapy is, in most instances, not satisfactory: In a large number of NIDDM patients sulfonylureas do not suffice to normalize blood sugar levels and the patients are, therefore, at high risk for acquiring diabetic complications. Also, many patients gradually lose the ability to respond to treatment with sulfonylureas and are thus gradually forced into insulin treatment. This shift of patients from oral hypoglycaemic agents to insulin therapy is usually ascribed to exhaustion of the β-cells in NIDDM patients. [0007] Over the years, numerous attempts have therefore been made to provide novel agents which stimulate β-cell function in order to offer the NIDDM patients an improved treatment. Recently, a series of peptides derived from glucagon-like peptide-1 have been considered as insulinotropic agents for therapeutic use. [0008] Glucagon-like peptide-1, also referred to as GLP-1, is a peptide sequence found in the C-terminal portion of mammalian proglucagon. Prior to 1985, no definite biological activity of GLP-1 had been reported. However, in 1985 it was demonstrated that the amide of a fragment of GLP-1, namely GLP-1(1-36)amide, stimulates insulin release from isolated precultured rat pancreatic islets in the presence of glucose in a dose-dependent manner (Schmidt, W. E. et al. Diabetologia 28 (1985) 704-7). This finding suggests that GLP-1(1-36)amide and related peptides might be useful in the treatment of type 2 diabetes. Due to its substantially closer sequence homology to glucagon and glucose dependent insulinotropic peptide, also referred to as GIP, Schmidt et al. suggested that an even stronger glucagon- and/or GIP-like biological activity could be expected with GLP-1(7-36) than with the intact peptide. In recent years, particular interest has focused on the GLP-1 fragments GLP-1(7-37) and GLP-1(7-36)amide and analogues and functional derivatives thereof. The designation GLP-1(1-36) indicates that the peptide fragment in question comprises the amino acid residues from (and including) number 1 to (and including) number 36 when counted from the N-terminal end of the parent peptide, GLP-1. Similarly, the designation GLP-1(7-37) designates that the fragment in question comprises the amino acid residues from (and including) number 7 to (and including) number 37 when counted from the N-terminal end of the parent peptide, GLP-1. The amino acid sequence of GLP-1(7-36)amide and of GLP-1(7-37) is given in formula I: (I) His-Ala-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Val-Ser- Ser-Tyr-Leu-Glu-Gly-Gln-Ala-Ala-Lys-Glu-Phe- Ile-Ala-Trp-Leu-Val-Lys-Gly-Arg-X which shows GLP-1(7-36)amide when X is NH 2 and GLP-1(7-37) when X is Gly-OH. [0009] That GLP-1(7-36)amide is indeed an insulinotropic agent in man has been demonstrated by Kreymann, B. et al. who infused this peptide into healthy volunteers and observed a significant rise in plasma insulin ( Lancet 2 (1987) 1300-304). [0010] The insulinotropic action of GLP-1(7-37) in diabetic as well as in nondiabetic subjects has been demonstrated by Nathan, D. M. et al. Diabetes Care 15 (1992) 270-76. [0011] International Patent Application No. WO 87/06941 (to The General Hospital Corporation) relates to a peptide fragment which comprises GLP-1(7-37) and functional derivatives thereof and to its use as an insulinotropic agent. [0012] International Patent Application No. 90/11296 (to The General Hospital Corporation) relates to a peptide fragment which comprises GLP-1(7-36) and functional derivatives thereof and has an insulinotropic activity which exceeds the insulinotropic activity of GLP-1(1-36) or GLP-1 (1-37) and to its use as an insulinotropic agent. [0013] International Patent Application No. 91/11457 (to Buckley et al.) relates to effective analogs of the active GLP-1 peptides 7-34, 7-35, 7-36, and 7-37. [0014] The effect of GLP-1(7-37) in combination with glibenclamide on insulin secretion from rat pancreatic islets was studied in vitro by Parker, J. C. et al. ( Diabetes 40 (suppl. 1) (1991) 237 A). Only an additive effect of the two agents was observed. [0015] However, to the best of the knowledge of the present inventors the surprising synergistic effect in vivo achieved by the combined use of an oral hypoglycaemic agent and a fragment of GLP-1 or an analogue or a functional derivative thereof has not previously been disclosed. SUMMARY OF THE INVENTION [0016] The present invention relates to the surprising finding that when GLP-1 related peptides are administered in combination with oral hypoglycaemic agents in general and with sulfonylureas in particular for treatment of type 2 diabetes, a synergistic effect is observed. This surprising observation has been made even in type 2 diabetic patients who fail to respond when sulfonylureas are administered alone. [0017] Thus, in its broadest aspect the present invention relates to the use of GLP-1(7-37), GLP-1(7-36)amide, or a pharmaceutically acceptable peptide containing a fragment of the GLP-1(7-37) sequence, or an analogue or a functional derivative of such a peptide for the preparation of a medicament for use in the treatment of type 2 diabetes in a regimen which additionally comprises treatment with an oral hypoglycaemic agent and to a method of treating type 2 diabetes which method comprises administering an effective amount of GLP-1(7-37), GLP-1(7-36)amide, or a pharmaceutically acceptable peptide containing a fragment of the GLP-1(7-37) sequence, or an analogue or a functional derivative of such a peptide to a patient in a regimen which additionally comprises treatment with an oral hypoglycaemic agent. [0018] In a first preferred embodiment, the present invention relates to the use of GLP-1(7-36)amide for the preparation of a medicament for use in the treatment of type 2 diabetes in a regimen which additionally comprises treatment with an oral hypoglycaemic agent. [0019] In a further preferred embodiment, the present invention relates to the use of GLP-1(7-37) for the preparation of a medicament for use in the treatment of type 2 diabetes in a regimen which additionally comprises treatment with an oral hypoglycaemic agent. [0020] In a further preferred embodiment, the present invention relates to the use of an analogue of GLP-1(7-37) for the preparation of a medicament for use in the treatment of type 2 diabetes in a regimen which additionally comprises treatment with an oral hypoglycaemic agent. [0021] In a further preferred embodiment, the present invention relates to the use of a functional derivative of GLP-1(7-37) for the preparation of a medicament for use in the treatment of type 2 diabetes in a regimen which additionally comprises treatment with an oral hypoglycaemic agent. [0022] In a further preferred embodiment, the present invention relates to the use of GLP-1(7-37) or a fragment thereof or an analogue or a functional derivative of any of these including GLP-1(7-36)amide for the preparation of a medicament for use in the treatment of type 2 diabetes in a regimen which additionally comprises treatment with tolbutamide. [0023] In a further preferred embodiment, the present invention relates to the use of GLP-1(7-37) or a fragment thereof or an analogue or a functional derivative of any of these including GLP-1(7-36)amide for the preparation of a medicament for use in the treatment of type 2 diabetes in a regimen which additionally comprises treatment with glibenclamide. [0024] In a further preferred embodiment, the present invention relates to the use of GLP-1(7-37) or a fragment thereof or an analogue or a functional derivative of any of these including GLP-1(7-36)amide for the preparation of a medicament for use in the treatment of type 2 diabetes in a regimen which additionally comprises treatment with glipizide. [0025] In a further preferred embodiment, the present invention relates to the use of GLP-1(7-37) or a fragment thereof or an analogue or a functional derivative of any of these including GLP-1(7-36)amide for the preparation of a medicament for use in the treatment of type 2 diabetes in a regimen which additionally comprises treatment with gliclazide. [0026] In a further preferred embodiment, the present invention relates to the use of GLP-1(7-37) or a fragment thereof or an analogue or a functional derivative of any of these including GLP-1(7-36)amide for the preparation of a medicament for use in the treatment of type 2 diabetes in a regimen which additionally comprises treatment with a biguanide. [0027] In a further preferred embodiment, the present invention relates to the use of GLP-1(7-37) or a fragment thereof or an analogue or a functional derivative of any of these including GLP-1(7-36)amide for the preparation of a medicament for use in the treatment of type 2 diabetes in a regimen which additionally comprises treatment with metformin. [0028] In a further preferred embodiment, the present invention relates to the use of GLP-1(7-37) or a fragment thereof or an analogue or a functional derivative of any of these including GLP-1(7-36)amide for the preparation of a medicament for use in the treatment of type 2 diabetes in a regimen which additionally comprises treatment with (S)-(+)-2-ethoxy-4-[2-[[3-methyl-1-[2-(1-piperidinyl)phenyl]butyl]amino]-2-oxoethyl]benzoic acid. [0029] In this specification, analogues of GLP-1(7-37) or of GLP-1(7-36)amide, respectively, means peptides which differ from GLP-1(7-37) or from GLP-1(7-36)amide, respectively, in that at least one of the amino acid residues of GLP-1(7-37) or of GLP-1(7-36)amide, respectively, independently has been exchanged by another amino acid residue, preferably one which can be coded for by the genetic code. The definition also comprises the case when amino acid residues are added at or deleted from the N-terminal and/or the C-terminal end of the peptide. Preferably, the total number of such additions, deletions and exchanges does not exceed five, more preferred it does not exceed three. DETAILED DESCRIPTION OF THE INVENTION [0030] As mentioned above, patients treated with sulfonylureas gradually fail to respond to sulfonylurea treatment. It is generally accepted among those skilled in the art that this failure is due to exhaustion of β-cells which, accordingly, are unable to excrete insulin in response to glucose stimulation. Also, it is generally accepted that the efficacy of sulfonylureas is limited by the capacity of β-cells to produce and excrete insulin. Accordingly, one would not expect any additional therapeutic advantage by treating NIDDM patients with sulfonylureas and other agents stimulating β-cell function as well. [0031] Our finding that NIDDM patients may advantageously be treated with GLP-1 related peptides in combination with sulfonylureas or other oral hypoglycaemic agents is therefore, indeed, surprising. In fact, we have found that concomitant treatment with oral hypoglycaemic agents and GLP-1 related peptides results in a synergistic response by the NIDDM patients: treatment with oral hypoglycaemic agents and GLP-1 related peptides gives rise to a metabolic response greater than the sum of the responses of either agents when applied alone. Even in cases of sulfonylurea failures, the oral agents have been found to significantly enhance efficacy of GLP-1 related peptides. [0032] Combined treatment with GLP-1 related peptides and oral hypoglycaemic agents is thus novel, therapeutically useful, and surprising. Unforeseen, therapeutic advantages can be gained by treating the NIDDM patients with both types of drugs. [0033] Among the GLP-1 related peptides that can thus be used in the treatment of type 2 diabetes GLP-1(7-37) and GLP-1(7-36)amide are particularly advantageous, as they are identical to the naturally occurring hormones. Shorter peptides comprising part of the GLP-1(7-37) sequence or analogues of such shorter peptides or analogues of GLP-1(7-37) itself or functional derivatives of any of these can also be used to advantage, since pharmacodynamic and pharmacokinetic properties can be changed according to patients' demand by modifying the GLP-1 related fragment. [0034] The GLP-1 related peptides can be administered by methods currently available according to the invention for administration of peptides. Nasal application is particularly advantageous from a patient complience point of view. Details in this respect can be found in our copending Danish patent application No. DK 0364/92 relating to nasal administration of medicaments comprising GLP-1 related peptides which was filed simultaneously with the present application. The contents of said application is hereby incorporated in its entirety by reference. Administration by injection or infusion will be preferred in instances where a specific protracted plasma profile of the active peptide is required, and oral administration is preferred in instances where extent and kinetics of absorption is not a critical issue. [0035] The oral hypoglycaemic agent used according to the invention can be any oral agent exhibiting a glucose lowering effect. Among these agents, those acting on the ATP-dependent potassium channel of the β-cells are preferred such as glibenclamide, glipizide, gliclazide and AG-EE 623 ZW. The peptides according to the invention may also advantageously be applied in combination with other oral agents such as metformin and related compounds or glucosidase inhibitors as, for example, acarbose. [0036] The features disclosed in the present description, examples and claims may, both separately and in any combination thereof, be material for realizing this invention in diverse forms thereof. The invention is further illustrated by the following examples which are not to be construed as limiting, but merely as an illustration of some preferred features of the invention. EXAMPLE 1 [0000] Synergistic Effect of GLP-1(7-36)Amide and Glibenclamide in NIDDM Patients. [0000] Assays [0037] Blood samples were collected in plastic tubes containing EDTA (0.048 ml, 0.34 M) and Trasylol® (1000 IU Kallikrein inhibitor, obtained from Bayer, West Germany) and immediately placed on ice. The samples were centrifuged at 4° C and the plasma was stored at −20° C. Blood glucose was measured by a glucose oxidase method according to A. S. Hugget and D. A. Nixon, Lancet 2 (1957) 368-370. Plasma C-peptide concentrations were determined by radioimmunoassay (RIA) using a commercially available kit (Novo Research Institute, Denmark). Plasma glucagon concentrations were measured by RIA using antibody 30K as described by G. R. Faloona and R. H. Unger in B. M. Jaffe and Behrman, eds. Methods of Hormone Radioimmunoassay , Academic Press, New York (1974) 317-330. [0038] For further experimental details (e.g. on calculation of isoglycaemic meal-related insulin response, IMIR), reference is made to M. Gutniak, C. Ørskov, J. J. Holst, B. Ahren and S. efendic, The New England Journal of Medicine 326 (29) (1992) 1316-1322, where a different experiment performed under similar conditions is described. [0000] Methods [0039] On four different days the effect of either injecting glibenclamide, 1 mg i.v., or infusing GLP-1(7-36)amide at a rate of 0.75 pmol per kilogram of body weight per minute or a combination thereof was studied in the same group of 6 insulin treated obese NIDDM patients (Body Mass Index: 30.1±2.4 kg/m 2 ) and compared to administration of saline as control. Ordinary administration of insulin was stopped 24 hours before the administration of the test compounds or of the saline started and all subjects were fasted overnight. A Biostator (Miles, Diagnostic Division, Elkhart, Ind.) was used for insulin administration in this period in order to normalize blood glucose levels before the administration of the test compounds was initiated and also to keep a normal postprandial blood glucose pattern 180 minutes following the ingestion of a standard test meal comprising boiled potatoes, boiled beef, cooked carrots, a glass of milk containing 0.5% butterfat, and a slice of bread baked from a mixture of wheat and rye flours. In this meal, 28, 26, and 46% of the energy comes from protein, fat and carbohydrates, respectively. Administration of the test compounds was performed (glibenclamide, saline) or initiated (GLP-1(7-36)amide, respectively, 30 minutes after normoglycaemia was achieved. The infusion of (GLP-1(7-36)amide was continued for 210 minutes. After 30 minutes (time zero), the subjects were given the test meal which was consumed within 15 minutes. Blood samples were obtained at −30, 0, 15, 30, 90, 120, 150 and 180 minutes. [0000] Results [0040] After the ingestion of the meal, meal-related C-peptide response, glucagon response and isoglycaemic meal-related insulin requirement (IMIR) was measured. The results are summerized in Table 1. TABLE 1 C-peptide Glucagon response response (pg/ml/210 (pg/ml/210 min) min) IMIR (U) Control (saline) 7.4 ± 3.6  269345 ± 6299 17.4 ± 2.8  GLP-1(7-36)amide 25 ± 9.8  10451 ± 5126 6.3 ± 2.0 glibenclamide 105 ± 53.9 *) 8.3 ± 1.0 GLP-1(7-36)amide + 184 ± 55.1  2526 ± 4873 2.7 ± 0.7 glibenclamide *) glibenclamide had no significant influence on glucagon release. [0041] As indicated in the table, both GLP-1(7-36)amide and glibenclamide significantly increased meal-related C-peptide response (p<0.02) and when administered in combination exerted a clear synergistic effect. GLP-1(7-36)amide suppressed the glucagon response (p<0.01) while glibenclamide had no significant effect. However, in combination with GLP-1(7-36)amide the glucagon response was almost abolished. Finally, both glibenclamide and GLP-1(7-36)amide lowered IMIR and in combination IMIR was as low as 2.7±0.7. [0042] In summary, this experiment demonstrates a strong synergistic effect of a combination of GLP-1(7-36)amide and glibenclamide. EXAMPLE 2 [0000] Synergistic Effect of GLP-1(7-36)Amide and Glibenclamide in NIDDM Patients with Secondary Failure to Sulfonylurea Treatment. [0000] Methods. [0043] Eight patients with NIDDM and secondary failure to sulfonylurea treatment participated in the study (age 57.6±2.7 years, body mass index 28.7±1.5 kg/m 2 , diabetes duration 7.6±1.2 years, HbA 1C 5.8±0.5). The diabetic patients fulfilled the criteria for NIDDM and IDDM according to the USA National Diabetes Data Group. None of the patients had impaired renal function, automatic neuropathy, or proliferative retinopathy, and all had normal liver function. They were instructed to eat a standard diet for diabetic patients at least 2 weeks before and during the study. The patients treated with sulfonylureas stopped their medication one week before the experiments. Those who were treated with insulin were instructed to stop the injections of NPH insulin 24 hours before the studies. Blood glucose concentrations were controlled with subcutaneous injections of regular insulin. [0044] All the subjects were studied after an overnight fast. At 07.30 h on the morning of each study, three cannulas were inserted. One cannula was placed in an antecubital vein and was used to sample blood intermittently for hormone assays. It was flushed with saline after each sampling. A second cannula inserted retro-gradely in a dorsal hand vein was used for continuous monitoring of blood glucose concentrations. The venous blood was arterialized by heating the forearm and hand in a thermoregulated sleeve (Kanthal Medical Heating AB, Stockholm, Sweden) at 45° C. The third cannula was inserted in the contralateral antecubital vein and was used for all infusions. From approximately 08.00 hours, the patients were connected to a Biostator in order to normalize their blood glucose concentrations. The algorithm of the Biostator was adjusted in order to normalize basal blood glucose levels. The target for blood glucose concentrations was 4-5 mmol/L. When the target was reached, the Biostator algorithm was changed to monitoring and the feedback insulin infusion was stopped. The experiments were started 30 minutes after normoglycemia was achieved, approximately 90 minutes after connection to the Biostator. An infusion of saline or 0.75 pmol/kg/min of GLP-1(7-36)amide (Peninsula Laboratories, St. Helens, Merseyside, England) then was started and continued for 210 minutes. In glibenclamide experiments an i.v. injection of 1 mg glibenclamide (Hoechst AG, Germany) was given at the same time point. These four studies were performed in a random order with 2-4 weeks elapsed between the experiments. At time 0 the subjects were given a standard lunch, as described in Example 1 which they ate within 15 minutes while sitting in bed. Blood samples were taken at FV, −60, −30, −15, 0, 15, 30, 90, 120, 150, and 180 minutes. Blood glucose was measured continuously. [0000] Results. [0045] In the basal state, the effect on blood glucose and C-peptide levels was monitored 45 minutes after administration of GLP-1(7-36)amide, glibenclamide or a combination thereof had started. The results are summarized in Table 2. TABLE 2 Blood glucose C-peptide mmol/l pmol/l Control (saline) 6.0 ± 0.3  0.53 ± 0.06 GLP-1(7-36)amide 5.1 ± 0.4 0.63 ± 0.1 glibenclamide 6.0 ± 0.3  0.56 ± 0.007 GLP-1(7-36)amide + 4.5 ± 0.1 0.72 ± 0.1 glibenclamide [0046] These results clearly demonstrates the synergistic effect of the two compounds as glibenclamide had no significant effect on its own while the effect of the combination of GLP-1(7-36)amide and glibenclamide, clearly, exceeded that of GLP-1(7-36)amide alone. [0047] After the ingestion of the meal, the insulinogenic indices (integrated insulin/integrated glucose response) were calculated, again highlighting the synergistic effect of the two compounds, a shown in Table 3. TABLE 3 Insulinogenic index Control (saline)  1.6 ± 0.6 GLP-1(7-36)amide 21.0 ± 7.2, glibenclamide 10.6 ± 2.8, GLP-1(7-36)amide + glibenclamide 37.5 ± 9  [0048]

The invention employs GLP-1 (7-37), GLP-1(7-36)amide, and certain related compounds in combination with an oral hypoglycaemic agent for treating diabetes mellitus.

BACKGROUND OF THE INVENTION [0001] 1. The Field of the Invention [0002] The present invention relates to diffusion devices, kits and methods for delivering supplemental air to a patient. [0003] 2. The Relevant Technology [0004] Maintaining a sufficient oxygen supply is critical to sustaining human life. While most people can easily obtain sufficient oxygen through normal breathing of ambient air, there are circumstances where ordinary breathing cannot provide adequate oxygen. Patients are often given supplemental air enriched with oxygen. The need for supplement air can be caused by many different conditions, including lung disease, trauma, hazards such as smoke inhalation, and premature birth. Supplemental air can also be used to deliver a medicament to a patient. [0005] Supplemental air is typically administered by delivering oxygenated air from a tank to the mouth and/or nose of the person. There are two principle ways supplemental air is administered to a person. One technique uses an oxygen mask that covers the person's nose and mouth. The oxygen mask typically allows the person to breathe surrounding air while delivering supplemental air to the space between the mask and the patient's face. The supplemental air mixes with the air being inhaled to ensure adequate oxygenation of the patient. Oxygen masks are commonly made of a translucent plastic. They typically have a connector on the outside that allows a hose to be attached and an outlet on the inside of the mask for delivering the supplemental air. They may have an elastic cord that wraps around the back of the head to secure the mask to the patient. [0006] While oxygen masks are very effective at delivering supplemental air to a patient, they can be uncomfortable, awkward, unsightly, and pose health risks for some patients. Some patient's can feel claustrophobic or anxious when hoses and/or devices are attached to their face or head. Infants and young children tend to pull them off as they are typically averse to objects covering their faces. Adults might use them while in a hospital, bedridden or otherwise out of sight of others, but may be averse to wearing them in public, particularly in social settings where they may draw negative attention and cause embarrassment. Masks muffle speech and inhibit normal conversation. From a safety standpoint, masks that cover the patient's face can make it difficult for caretakers to discover foreign objects or debris, such as food, vomit or mucous, that might be accidentally inhaled by the patient or that might obstruct the diffusion of supplement air [0007] To avoid some of the problems associated with masks, patients can be given supplemental air through a nasal device, i.e., tubes inserted into the nostrils and taped to the patient's face. Rather than covering the entire mouth and nose, the nasal device delivers supplemental air to only the nose. Nasal air delivery devices permit viewing of the mouth and allow the patient to talk more easily. However, such devices require nasal breathing by the patient to obtain supplemental air. Nasal delivery devices also suffer from negative social stigma, as they are both unsightly and emit audible bursts of air. Infants and young children tend to rip the tubes out of their noses, thereby destroying their effectiveness. [0008] One attempt to avoid the disadvantages of masks and nasal devices utilizes a food grade funnel jerry-rigged with a universal connector stuffed into the smaller end, often with the aid of tape to hold it in place, to which is attached a hose that supplies oxygen enriched supplemental air. This improvised funnel device is laid on the chest of an infant and supplemental air is blown out the enlarged funnel opening toward the face of the infant. [0009] Because the improvised funnel device does not cover the infant's face, infants do not notice it and tend to leave it in place, at least while sleeping on their backs. However, even small movements can cause the improvised funnel device to fall off the infant's chest, creating a dangerous situation for infants who require supplemental air to live. Consequently, the improvised funnel device generally cannot be used while the infant is awake or otherwise prone to move. It requires careful attention and/or frequent monitoring by a health care provider. Unless taped to a patient's body (e.g., by winding surgical tape around the funnel and patient's chest), the device cannot be used by a patient in a sitting, standing or other upright position, but only while supine on the patient's back. Tape may not always stick well to a patient's shirt, or it may stick too well and leave adhesive residue. [0010] Another problem with the improvised funnel device is that the universal connector is merely provisionally attached and can easily become detached or leak. Leakage can cause waste and/or result in insufficient supplemental air reaching the patient. Detachment can result in total cessation of supplemental air to the patient, which can result in harm or death. [0011] In view of the foregoing, there is a tremendous need, long felt in the art, to provide improved devices and methods for delivering supplemental oxygen to a patient. BRIEF SUMMARY OF THE INVENTION [0012] The present invention relates to supplemental air diffusion devices that overcome some or all of the aforementioned problems. The supplemental air diffusion devices include an inlet stem to which a supplemental air hose can be attached, a frustroconicoidal diffusion body integrally attached to the inlet stem, and attachment means on the diffusion body for attaching accessory patient attachment devices to the diffusion body. The invention provides for ready and secure attachment of the diffusion device to a patient while in many different positions, reliable diffusion of supplemental air to the patient without the risk of leaking or detachment of the inlet stem, and easy removal of the device from the patient. The diffusion device can be attached so as to not block or cover any part of the patient's face (e.g., on the chest below the neck). [0013] The inlet stem of the diffusion device advantageously includes coupling means for releasably locking a female coupler of an air supply hose thereto. In one embodiment, the coupling means comprise a plurality of ribs and/or recesses formed on an outer surface of the inlet stem. In use, the ribs and/or recesses on the inlet stem form a male connector which interlocks with one or more corresponding ribs and/or recesses associated with an inner surface of a female connector on an end of the air supply hose. The inlet stem can be tapered to permit progressively tighter fit between the inlet stem and the female air supply hose connector as the female connector is inserted over the inlet stem. The inlet stem may include a stop, such as an annular ridge, that limits the distance the inlet stem can be inserted into the female connector. [0014] The inlet stem is advantageously formed integrally with the frustroconicoidal diffusion body to prevent the inlet stem from becoming detached during use. The diffusion device may include stiffening means for preventing bending or collapse of the inlet stem relative to the diffusion body while inserting the inlet stem into the female connector of the air supply hose. An example of stiffening means are one or more raised stiffening ribs molded into the surface of, and bridging the interface between, the diffusion body and inlet stem. The stiffening means can also prevent bending or detachment of the inlet stem from the diffusion body while attached to and/or being removed from the female connector of the air supply hose. [0015] The diffusion body is generally frustroconicoidal and has a smaller inlet opening at one end into which supplemental air is introduced from the inlet stem and an intermediate body portion that expands to an enlarged diffusion opening through which the supplemental air can be diffused toward a patient's face. The increase in size of the frustroconicoidal diffusion body from the smaller inlet opening to the enlarged diffusion opening causes a decrease in velocity of the supplement air stream as it diffuses to fill the volume of the diffusion body. An enlarged column of supplement air exits the diffusion opening and moves toward the vicinity of the patient's mouth and nose at a controlled velocity. [0016] The attachment means provide for attachment of one or more accessory patient attachment devices to the diffusion device. Examples of means for attaching an accessory patient attachment device to the diffusion device include one or more slits, holes, snaps, Velcro®, adhesive, permanent weld, or combinations thereof formed on the air diffusion body and/or on a flange extending laterally from the air diffusion body. [0017] The accessory patient attachment devices are configured and provide means for removably attaching the diffusion device to a patient. Examples of accessory patient attachment devices and means for removably attaching the diffusion device to a patient's include one or more snaps, buttons, clips, clamps, Velcro®, or combinations thereof. The one or more accessory patient attachment devices may be integrally or removably connected to the diffusion device. One example of an accessory patient attachment device comprises a spring-loaded clamp that clips onto a patient's clothing and a flexible strap that can be attached to the diffusion device (e.g., by being looped through a recess in the air diffusion body or a recess in a flange extending laterally from a side of the diffusion body). The flexible strap includes a snap, Velcro® or other interlocking feature for securing the strap to the diffusion device. The accessory patient attachment device may also include an elongate strap that can wrap around and provide direct attachment of the diffusion device to the patient's body. [0018] According to one particularly useful embodiment, the attachment means provides for attachment of multiple spaced-apart accessory patient attachment devices to the air diffusion body. This allows the diffusion device to be attached to a patient's body or clothing at spaced-apart points or regions of connection (e.g., 2), which greatly increases positional stability of the device compared to a single point of attachment. Providing multiple points or regions of connection greatly reduces the degree of freedom of movement of the diffusion device compared to a single point of connection, which may allow a diffusion device to flop back and forth in response to patient movements. Reducing the degree of freedom of movement increases comfort to the patient and more reliably directs the supplement air flow toward the person's mouth and nose. [0019] The diffusion device may be advantageously formed from a transparent polymer, which provides greatly improved ability to see if emesis or other foreign debris might have fallen into the diffusion body and/or inlet stem, which could potentially block the flow of supplemental air and compromise the ability of the patient to receive supplemental air. [0020] In an alternative embodiment, the diffusion device may have a pre-attached air supply hose. The supply hose may be removably or integrally attached to the inlet stem of the diffusion device. In one embodiment, the outer wall of the inlet is stepped to provide a smaller outer diameter at the tip and a larger diameter up the wall to increase tightness of fit between the inlet stem and air supply hose. An end of the air supply hose can be attached over and glued or otherwise integrally connect onto the outer wall of the inlet stem. An elongate main portion extends from the inlet end for attachment to an air supply. [0021] The invention also includes a method for delivering supplemental air to a person. The method includes providing a supplemental air diffusion device as described herein, attaching one end of an air supply hose to the inlet stem and another end of the air supply hose to a supplement air supply, and attaching the diffusion device to the clothing or body of a person with the diffusion opening directing supplemental air toward the mouth and nose of the person. In the case where initially separate accessory patient attachment devices are used, they are first attached to the diffusion device and then used to removably attach the device to the patient's clothing or body. [0022] Because the supplemental air diffusion device is securely attached below the person's face, the person can move about and assume different positions without compromising the ability to obtain supplemental air. The ability of the inventive diffusion device to remain in place near a patient's face is particularly beneficial in the case of infants who require supplemental air to stay alive. Compared to conventional masks and nasal tubes, a person can talk and socialize with minimal intrusiveness and does not appear like an obvious invalid, which can greatly improve confidence in social settings. [0023] The invention further includes kits for use in delivering supplemental air to a patient. An exemplary kit includes a supplemental air diffusion device as discussed herein, an air supply hose having a connector at one end for coupling the air supply hose to the inlet stem of the diffusion device, and one or more accessory patient attachment devices as described herein, or which are generally known in the art for use in attaching badges or other devices to a person's clothing, for use in removably and securely attaching the diffusion device to a person's clothing or body. [0024] The inventive devices, kits and methods advantageously allow persons to non-intrusively receive supplemental oxygen without having to wearing a mask over their face or having tubes stuffed into their nose. Such devices, kits and methods can provide supplemental air whether the person is standing or sitting, conscious or unconscious. The inventive devices, kits and methods are particularly advantageous for use with infants and small children because the diffusion device is less likely to be removed by the infant or child as they are not connected to the head or face of the infant or child. The diffusion devices are far more aesthetically pleasing compared to masks or tubes. The devices of the invention also provide improved safety for patients since health care provides can more easily examine the airway of a patient using the device and/or can observe objects that may be blocking the optimal flow of air through the diffusion device. This is particularly true in the case where the device is made from a transparent material. BRIEF DESCRIPTION OF THE DRAWINGS [0025] To further clarify the above and other advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which: [0026] FIG. 1 illustrates a perspective view of a supplemental air diffusion device according to one embodiment of the invention; [0027] FIG. 2 illustrates a bottom perspective view of the air diffusion device of FIG. 1 ; [0028] FIG. 3 illustrates a top view of the supplemental air diffusion device of FIG. 1 ; [0029] FIG. 4 illustrates a side elevational view of the air diffusion device of FIG. 1 ; [0030] FIG. 5A is a cross-sectional view of the air diffusion device of FIG. 1 ; [0031] FIG. 5B is a cross-sectional view of an alternative embodiment of a supplemental air diffusion device according to the invention; [0032] FIG. 5C is a cross-sectional view of another alternative supplemental air diffusion device according to the invention; [0033] FIG. 5D is a cross-sectional view of another alternative supplemental air diffusion device according to the invention having an air guiding extension; [0034] FIGS. 6A and 6B illustrate exemplary accessory patient attachment devices that may be used to attach a supplemental air diffusion device to a patient's clothing; [0035] FIG. 7 illustrates a kit that includes a supplemental air diffusion device, accessory patient attachment devices, and an air supply hose tubing configured for coupling the supplement air diffusion device to a supplemental air supply; [0036] FIG. 8A illustrates a diffusion device attached to an infant's clothing providing supplemental air to the infant; and [0037] FIG. 8B illustrates a diffusion device attached around an infant's body providing supplemental air to an infant. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0038] The present invention is directed to devices for delivering supplemental air to a patient, methods for using the device, and kits including the device. The supplemental air diffusion device is shaped and configured for attachment to the body or clothing of a patient and to direct supplemental air toward the mouth and nose of a person without being connected over the head or face of the patient. [0039] For purposes of this invention, the term “frustroconicoidal” is strictly not limited to shapes that are precisely defined by the term “frustroconical”. Rather, “frustroconicoidal” includes, but is not limited to, conical-like shapes that have a circular or semicircular cross-section, a v-shaped cross-section, a parabolic cross-section, a stepped cross-section, among others. [0040] FIGS. 1 and 2 show perspective views of a supplemental air delivery device 10 according to one embodiment of the invention. Supplemental air delivery device 10 includes a frustroconicoidal air diffusion body 12 having an air diffusion end 14 and an air inlet end 16 . Air diffusion end 14 defines an enlarged diffusion opening 18 , and air inlet end 16 defines a smaller inlet opening 20 . Air diffusion body 12 defines an outer wall that generally increases in size, and bounds an inner passageway, extending between inlet opening 20 and diffusion opening 18 . [0041] Integrally attached to diffusion body 12 is an inlet stem 22 proximal to inlet end 16 , which includes a stem opening 23 in fluid communication with inlet opening 20 . Inlet stem may be tapered on both the inner and outer walls. [0042] Diffusion opening 18 can be any size and shape so long as it is sufficiently large to direct a desired amount of supplemental air toward a patient's face (i.e., mouth and nose). Body 12 increases in size from inlet end 16 toward diffusion end 14 . FIG. 3 is a top view of diffusion device 10 , illustrating exemplary diameters of the diffusion opening 18 , inlet opening 20 , and stem opening 23 according to one embodiment of the invention. As shown in FIG. 3 , diameter 24 of diffusion opening 18 is substantially larger than diameter 26 of inlet opening 22 , which is larger than diameter 27 of stem opening 23 . The expansion of body 12 between inlet opening 20 and diffusion opening 18 , and to some extent the increasing inner diameter of inlet stem 22 , allow the diffusion device to reduce the flow speed of air traveling out of device 10 compared to air flowing into device 10 . [0043] The desired diameter of diffusion opening 18 can depend on the volume of air being delivered to the patient and the age of the patient. For example, diffusion openings with smaller diameters are typically used with infants and small children, while larger diameter diffusion openings can be used with older patients. In one embodiment, the diameter 24 of the diffusion opening 18 is greater than 5 cm, more preferably greater than 7.5 cm, and most preferably greater than 10 cm. [0044] The diffusion device 10 also includes one or more flanges (e.g., flanges 28 a and 28 b ) extending from air diffusion body 12 . Flanges 28 a and 28 b include slits or openings 30 a and 30 b (collectively slits or openings 30 ). The slits 30 provide means for attaching accessory patient attachment devices to diffusion device 10 . Flanges 28 can have any shape or thickness and slits or openings 30 can have any size or shape so long as the openings 30 can be formed in flanges 28 . [0045] In a preferred embodiment, device 10 includes at least two flanges for use connecting diffusion device 10 to a patient via accessory patient attachment devices. Providing more than one attachment point for connecting device 10 to the body or clothing of the patient is advantageous as it prevents device 10 from swiveling from side to side when a person wearing the device leans from side to side. In one embodiment, the flanges are proximate to the center of gravity of the device. In another embodiment, the flanges 28 are positioned near the proximal end 14 of the device 10 . [0046] Turning now to FIG. 4 , the air diffusion body is shown having a bell-shaped outer wall portion 36 and inlet stem 22 is shown to include coupling means integrally formed therein. In one embodiment, coupling means 32 include a plurality of ribs 34 a - 34 d. The stem 22 can be tapered and/or the ribs 34 can have an increasing diameter such that the ribs 34 form a tighter fit from the distal toward the proximal rib (i.e., an increasingly tighter fit from rib 34 a to 34 d ) as a connector of an air supply hose is inserted over the inlet stem 22 . Ribs 34 can be configured to couple with a female connector 56 of an air supply hose 56 ( FIG. 7 ). In a preferred embodiment, the coupling means 32 are integrally formed into the inlet stem 22 of diffusion device 10 to prevent leaking or inadvertent decoupling during use, as can occur if the coupling means are a separate device attached to inlet stem 22 . [0047] FIG. 4 also shows stiffening means, attached to the air diffusion body 12 and air inlet stem 22 , for preventing bending or collapse of the inlet stem 22 relative to the diffusion body 12 while inserting the inlet stem 22 into a female connector of an air supply hose. As illustrated, the stiffening means may comprise one or more raised stiffening ribs (e.g., stiffening ribs 38 a - 38 c ) molded into the surface of, and bridging the interface between, the diffusion body 12 and inlet stem 22 . [0048] Diffusion device 10 is not limited to a device having a conical shape diffusion body. Frustroconicoidal air diffusion body 12 can have any shape with an enlarged opening at the proximal end that tapers to a smaller inlet opening for introducing air. FIGS. 5A-5D provide example alternative embodiments of the invention. FIG. 5A illustrates a device 38 with a conical or substantially v-shaped cross-section. The cross-section of device 38 in FIG. 5A has a generally linear taper. FIG. 5B alternatively shows a device 40 having a substantially parabolic cross-section. FIG. 5C shows a device 42 having a stepped cross-section. FIG. 5D shows a device that also includes an air guiding wall extension built into the air diffusion body in order to help direct air flow toward the patient's mouth and nose. [0049] The invention also extends to frustroconicoidal devices that have shapes other than those illustrated in FIGS. 5A-5D . For example, the diffusion device is not limited to symmetrical cross sections. The diffusion device can have a regular or irregularly shaped horizontal cross-section. In one embodiment, the horizontal cross-section is a circle. Alternatively the horizontal cross-section can be a semicircle. [0050] The diffusion device of the invention may be used in conjunction with one or more accessory patient attachment devices, which are used for attaching the diffusion device to the body or clothing of a patient. FIGS. 6 a and 6 b illustrate exemplary accessory patient attachment devices 44 and 44 ′ for attaching diffusion device 10 to a patient. Accessory patient attachment devices 44 and 44 ′ include a strap 46 , a male snap 48 , female snap 50 , and a clamp 52 . Strap 46 can be secured to flanges 28 by inserting strap 46 into slit or opening 30 . Snaps 48 and 50 can then be connected to secure strap 46 to device 10 . Clamp 52 or 52 ′ is then available for attachment to clothing on a patient. Strap 46 , snaps 48 and 50 , and clamps 52 and 52 ′ can be made of any material including plastic, metal or ceramic. [0051] Alternative configurations of accessory patient attachment devices 44 can be used. Patient attachment device 44 can be any length. Patient attachment device 44 can have two clamps or two snaps instead of one of each type of fastener. In one embodiment, a clamp can be used that is spring loaded to provide a desired clamping force. Alternatively the clamp can be made of memory plastic where the memory of the plastic provides the clamping force. Any means for attaching the accessory patient attachment device to the diffusion device and patient, including those disclosed herein and others known to those of ordinary skill in the art. Other examples of suitable connectors include buttons, Velcro® (i.e., hook and look systems), adhesives, and polymeric welds. The patient attachment device my include a strap that wraps around the patient's body rather than attaching directly to clothing. [0052] The present invention also includes kits for delivering supplemental air to a patient using the air diffusion device of the invention. As illustrated in FIG. 7 , the kit may include an air diffusion device 10 , one or more patient connectors 44 a, 44 b, and an air supply hose 56 . Air supply hose 56 is shown having a female connector 58 that is configured to engage coupling means 32 on inlet stem 22 of device 10 . Patient connectors 44 a and 44 b are configured to attach to device 10 through slits or openings 30 . According to other embodiments of kits according to the invention, either the air supply hose 56 or connectors 44 are merely optional. [0053] Device 10 can be made of any material that is compatible with the air supply being used and suitable for use on a person. Examples of suitable materials for making device 10 include polymers and metals. Biocompatible polymers are preferred. An example of a suitable material for manufacturing the diffusion device 10 includes a highly clarified polypropylene random copolymer. According to one embodiment, the diffusion device is advantageously made from a transparent material. Manufacturing device 10 from a transparent material may be advantageous in the case where it is desirable for a health care provider to view the inside of the device (e.g., to check for sputum, emesis or other foreign materials that might block air flow through the diffusion device 22 . In one embodiment, the polymer is FDA food grade and does not contain latex. [0054] In a preferred embodiment, diffusion device 10 is manufactured as a single integrated piece including the frustroconicoidal air diffusion body and the inlet stem. A single integrated piece can be achieved by manufacturing the diffusion device using injection molding. Forming the diffusion device as an integral, one-piece unit is advantageous because it eliminates the need to seal the joint between a separately formed coupling device and the inlet stem. Furthermore, an integrally formed coupler eliminates the risk that the coupler will leak or separate from the device during use. [0055] FIG. 8A shows the use of a supplemental air diffusion device 10 , accessory patient attachment devices 44 , and air supply hose 56 to provide supplemental air to an infant. Accessory patient attachment devices 44 are connected to respective openings in the flanges extending form an outer surface of device 10 . Accessory patient attachment devices 44 are also connected to the clothing of the infant. Device 10 is thereby connected to the infant at a point below the head of the infant, with the diffusion opening 18 positioned so as to direct supplemental air toward the face of the infant. Preferably the diffusion device is attached to the patient with the diffusion opening near the patient's chin such that air is efficiently delivered to the patient's mouth and nose, but not so close to the face so as to bother the infant and trigger a response that would compromise the efficacy of the device. [0056] Air supply hose 56 is connected to the inlet stem of supplemental air device 10 . The end of air supply hose opposite device 10 can be connected to any known air supply. In one embodiment, the air supply hose is connected to an air tank with an enriched supply of oxygen. The air tank can include a regulator to release oxygenated air at a desired flow rate and/or at prescribed intervals. The air supply system can also include a nebulizer or other device for introducing a medicament into the air being delivered to the patient. [0057] During use, air supplied by hose 56 enters diffusion device 10 through inlet stem 22 at a relatively high flow rate. The air is diffused as it passes through the frustroconicoidal-shaped body. Because the diffusion opening 18 is much larger than the inlet into stem 22 , the flow of air leaving device 10 through opening 18 is much slower than the flow in hose 56 . Diffusion opening 18 is sized, shaped, and positioned to deliver the diffused air toward the mouth and nose of the patient. The fasteners on patient connector 44 ensure that the position is maintained during use. [0058] FIG. 8B illustrates an accessory patient attachment device that includes an elongate strap that can wrap around and provide direct attachment of the diffusion device to the patient's body. [0059] The diffusion device of the invention allows a health care provider to effectively deliver supplemental air to a patient. Although the diffusion device does not provide a seal around the mouth of the patient, the amount of air can be adjusted to account for supplemental air lost to the surrounding air. The amount of supplemental air delivered to the patient is calculated based on the predicted amount of air lost to the surrounding air. The flow rate can be determined by the health care practitioner. [0060] The present invention advantageously allows a health care provider to deliver a consistent amount of supplemental air to a patient. Because the supplemental air diffusion device connects to the body or clothing of a patient instead of the head, the patient is much less likely to remove the device without permission from the health care provider. The air delivery device of the invention can be safer for a patient to use since the patient is more likely to maintain a supplemental air supply over a longer period of time. In many cases the benefits of maintaining a substantial flow of supplemental air outweigh the disadvantage of not sealing the air diffusion device around the patient's mouth and nose. [0061] The air diffusion device can be positioned in places other than the chest where the patient's position requires a different placement. For example, in some situations, the patient's head may be turned to the side of the body for a lengthy period of time. In this case, the supplemental air diffusion device can be positioned near the shoulder area of the patient to better deliver supplemental air to the patient. [0062] The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

A supplemental air diffusion device is shaped and configured to be attached to the body or clothing of a patient below the head and deliver supplemental air toward the mouth and nose of the patient. The supplemental air diffusion device includes a frustroconicoidal air diffusion body that has a smaller inlet opening at an inlet end and an enlarged diffusion opening at a diffusion end. An air inlet stem is integrally attached to the air diffusion body and includes a plurality of ribs and/or recesses for releasably locking a female connector of an air supply hose over the inlet stem. A pair of spaced-apart slits are provided through a flange extending laterally from an outer surface of the air diffusion device. Initially separate accessory patient attachment clamps are looped through the slits and provide for releasable attachment of the air diffusion device to a patient's clothing. A kit may include an air diffusion device, one or more accessory patient attachment clamps, and an air supply hose for establishing fluid communication between the air diffusion device and an air supply.

FIELD OF THE INVENTION The invention relates to a garment comprising an absorbent section and a waist belt attached directly or indirectly thereto, said waist belt having two belt portions extending on either side of said absorbent section for securing to each other around a wearer of the garment, as defined in the preamble of claim 1. BACKGROUND OF THE INVENTION Absorbent garments of the above mentioned type are well known in the art. The type of garment in question has a belt attached integrally with the absorbent garment portion and requires that, after fastening the belt around the waist with the attached end at the back of the wearer, the end not attached to the belt section should be passed through the wearer's legs and attached by some means of releasable attachment to the belt at the front. The means of releasable attachment could be a hook and loop (also called touch and close) type fastening means, for instance such as sold under the name “VELCRO”. Published application WO-A-91/08725 discloses an example of such a garment in one embodiment. One of the problems recognised with such garments is the problems of handling the belt portions which project from either side of the absorbent portion of the integrated garment in such a way so as to be able to quickly and accurately take hold of the belt portions and fasten them together. However the belt material still needs to be cheap since it is integrated with a garment which together with the belt form a disposable unit. Where the problem of incontinence is involved, it will be appreciated that persons suffering from this problem are often old and have physical handicaps of various types. As a consequence, they have more difficulty fastening the belt by themselves and often require the assistance of personnel for fitting the garments. Thus there is a need to find for a solution which allows easy and correct fitting of the absorbent garment, particularly in the case of handicapped persons. SUMMARY OF THE INVENTION The aforementioned problems of handling are solved by the features of the belt according to claim 1. The resultant belt of the garment is one which is not prone to excessive wrinkling which could be painful for the wearer and not too stiff which causes problems of cutting and abrasion itself. Additionally, a garment is achieved with a belt which can be made cheaply and is particularly suitable for adult incontinence applications. Preferred features of the belt are defined in the dependent claims. The flexure resistance of a material sample is measured by its peak bending stiffness, thus as defined in claim 1 and as disclosed in the sample testing method of U.S. Pat. No. 5,009,653, said testing equipment, procedure and calculations hereby being incorporated by reference, the peak bending stiffness is determined by a test modelled after the ASTM D 4032-82 CIRCULAR BEND PROCEDURE, the procedure being considerably modified and performed as indicated in U.S. Pat. No. 5,009,653. The CIRCULAR BEND PROCEDURE is a simultaneous multi-directional deformation of a material in which one face of a specimen becomes concave and the other face becomes convex. The CIRCULAR BEND PROCEDURE gives a force value related to flexure-resistance, simultaneously averaging stiffness in all directions. The tests were carried out on the belt of the present application using the apparatus from U.S. Pat. No. 5,009,653 necessary for the CIRCULAR BEND PROCEDURE which is a modified Circular Bend Stiffness Tester, having the following parts: A smooth-polished steel plate platform which is 102.0×102.0×6.35 millimetres having an 18.75 millimetre diameter orifice. The lap edge of the orifice should be at a 45 degree angle to a depth of 4.75 millimetres. A plunger having an overall length of 72.2 millimetres, a diameter of 6.25 millimetres, a ball nose having a radius of 2.97 millimetres and a needle-point extending 0.88 millimetre therefrom having a 0.33 millimetre base diameter and a point having a radius of less than 0.5 millimetre, the plunger being mounted concentrically with the orifice and having equal clearance on all sides. It should be noted that the needle point is merely to prevent lateral movement of the test specimen during testing. Therefore, if the needle-point significantly adversely affects the test specimen (for example by puncturing an inflatable structure), than the needle-point should not be used. The bottom of the plunger should be set well above the top of the orifice plate. From this position, the downward stroke of the ball nose is to the exact bottom of the plate orifice. A force-measurement gauge and more specifically an Instron inverted compression load cell. The load cell has a load range of from 0.0 to 2000.0 grams. An actuator, and more specifically the Instron Model No. 1122, having an inverted compression load cell. The Instron 1122 is made by the Instron Engineering Corporation, Canton, Mass. It should be noted that, whilst the term “absorbent garment” has been used particularly in conjunction with incontinence, and particularly adult incontinence, the invention is not limited to this particular use or any particular size or type of absorbent garment implied thereby and it is clear for the skilled man that such belts could be used with baby's or children's nappies (diapers) for example, merely by adapting the dimensions appropriately. BRIEF DESCRIPTION OF THE DRAWINGS The invention will now be explained in more detail with reference to certain non-limiting embodiments and with reference to the accompanying drawings, in which FIG. 1 depicts a garment including a belt according to the invention, and FIG. 2 shows various attachment means used in accordance with fastening the belt of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 shows a garment generally denoted 1 which consists of an absorbent portion 2 and a belt portion generally denoted 3 . The belt could be either one continuous belt 3 attached to the absorbent portion 2 at one end 4 thereof or could be two separate belt portions 7 and 8 each attached to a respective side of the end 4 (or 5 ). The manner of attachment per se is of no importance for the present application. If it is desirable to impart elasticity to a belt made of two separate belt portions, it is conceivable that the end 4 of the absorbent portion 2 be elasticized. The general appearance of the garment in the figures is known per se and thus no detailed explanation of all elements will be entered into. At one end of one part 7 of the belt 3 there is provided a flexible strip 6 of hook elements, of the hook and loop type of fastening means, which can either be secured to the belt part 8 (on the side not shown) or to a loop strip arranged on the belt part 8 . Additional advantages, as explained below, will be obtained by particular dimensions and orientation of this strip. Whilst the belt is preferably substantially rectangular in shape comprising two laterally spaced longitudinal edges 9 and 10 , between which the strip 6 will be attached, other shapes are conceivable. However, with a rectangular belt, the width of the belt should lie between 70 mm and 160 mm in adult incontinence applications. Using such a belt, it is now possible to achieve good handling characteristics of the belt parts 7 and 8 even with the use of non-woven materials by selecting the range of stiffness according to the ASTM D 4032 modified test to lie between 25 g and 90 g. Below 25 g, the problem of wrinkling arises and this, as previously explained, is undesirable. Thus a free zone part of the belt (e.g. in the middle of one belt part 7 ) stiffness will lie in the stated range. In particular according to the invention, the preferred range of stiffness lies between 30 g and 55 g and the best handling is obtained between 35 g and 50 g. Thus, in particular with the range of belts used for adult incontinence applications, the inventors have succeeded in achieving the optimum handling characteristics whilst still preventing wrinkling or stiff regions which cause discomfort. A non-woven material is preferably used for either one or both sides of the belt, said non-woven material being of a type to which the hook elements of the strip 6 can releasable attach. By use of a non-woven material for the releasable attachment surface of the belt it is possible to achieve particularly favourable peel strength and shear strength combinations, which give a peel strength down to 0.1-2.0 Ncm −1 , preferably as low as 0.2-0.8 Ncm −1 , and a shear strength greater than 1 Ncm −2 , though preferably greater than 15 Ncm −2 and normally greater than 20 Ncm −2 . The use of non-woven material is of course advantageous since it will be cheaper than woven material and thus more suitable to disposable garments. Such values are also valid for the attachment of strips 12 and 13 on end 5 of the garment which are attached to the non-shown side of the belt after fastening of the belt and passing through the wearer's legs. The optimal handling characteristics which have now been achieved can of course thus be maintained even when using an inner side material for the belt part which is of absorbent material, preferably of non-woven sort, without increasing the cost to greater than prior art solutions using non-lined belts. Since comfort of the wearer is a particularly important consideration in this field and in particular to fitting of the belt, it has been shown advantageous to adopt a particular placement of the hook element strips for fastening the belt together. Thus in order to reduce, to a great extent the possibility of the hook element strips contacting the wearer's waist due to incorrect fitting of the belt, or for the case where the waist of the user increases dimension, the hook element strip or strips are made of such a length and width and are positioned with such an orientation so as to avoid this. As can be seen from FIG. 2, showing three possible strip embodiments 15 , 16 and 17 , the distance between the outer edges of the strip(s) is spaced at a distance from each edge 9 , 10 of the belt. In this way, when the belt is fitted, if slightly angled or not correctly overlapped, the hook elements will not project beyond the edge of the belt and thus will not contact the wearer's body. As can be seen, the strips are generally elongate, or in the case of a series of strips 16 as in FIG. 2 ( b ), the series of strips is elongate. Preferably a ratio of greater than 2:1 elongation is used and even more preferably an elongation ration of over 3:1. Thus to achieve the aforementioned advantages it is preferable to lay the strips with their larger dimension across the belt width, as depicted, and to give the strips a dimension such that the larger dimension has a length of between 25% and 75% of the width (z) of the main area of the belt. By width of the belt, is hereby meant the width of the belt at the zone where the strip(s) 15 , 16 and 17 will attach. Thus in the embodiment of FIG. 2 ( c ), although the strip 17 extends entirely across the reduced portion of the belt, the strip still lies within the stated range. In particular it has been found particularly advantageous to use a strip with a length which is less than 60% or even more preferable less than 50%. Due to the shear strength which can be achieved by the use of non-woven materials as the belt attachment surface, it is also easy to acquire adequate shear strength with only minimal attachment area. Additionally, with the choice of belt stiffness as claimed it is further also possible to avoid wrinkling occurring from attachment strips even when using smaller strip dimensions. Whilst particular embodiments of the invention have been described above, it is to be understood that these are in no way limiting for the scope of the invention which is defined by the claims appended hereto. Additionally, it will be understood by the skilled man that, whilst not preferred, the belt stiffness range can be used for non-integral belt applications also, for example where an absorbent chassis is fitted to the belt, by releasably attachable means.

The invention concerns a garment ( 1 ) comprising an absorbent section ( 2 ) and a waist belt ( 3 ) attached directly or indirectly thereto. The waist belt has two belt portions ( 7, 8 ) extending on either side of said absorbent section for securing to each other around a wearer of the garment. The particular handling characteristics of the belt parts of the waist belt ( 3 ) are significantly improved by manufacturing a belt stiffness of between 25 g and 90 g as measured by the modified version of test ASTM D 4032-82

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention provides a device attached to the shaft of a golf club that reduces the effect of the user's dominant hand on his/her golf swing and at the same time helps to define the correct swing path and impact timing. 2. Description of the Prior Art It is well known that one of the most important elements and a key to a successful golf swing is the golfer's grip. The art of positioning the fingers, hands and pressure applied to the grip has been described numerous times. In addition, there have been many devices invented for the purpose of teaching and achieving an improved golf grip or swing. The placement of hand and fingers on grip of club is rather easily accomplished by careful observation and following instructions. But the feeling of gripping a club and the amount and placement of pressure is very difficult to describe to an individual since each interprets and feels differently. As simple as gripping a club is, it is the most recognized and believed to be the leading cause of an inconsistent golf swing. For an efficient swing, the importance of placement of fingers and hands is fundamental. But knowing the fundamental alone does not cure problems in inconsistency; most problems may be cured by understanding how the sub-dominant and dominant hand work together. It is known that the sub-dominant hand leads and controls the path of the golf swing. However, many golfers tend to utilize the dominant side over the sub-dominant side, consciously or unconsciously, more than necessary. This can be caused by an increase of the grip pressure, usage of wrist, turning of the hand or even the body movement. Nervousness, anxiousness, desire, lack of concentration, . . . etc. can also cause this type of problem. The actual golf swing takes a very short time from start to finish and problems can occur anytime during the swing. What is required to overcome these mistakes is to provide a device that is simple to use and allows the user to practice conveniently as possible and not to interfere in anyway with the practice swing and to be able to compare one's own swing to the correct swing and be able to repeat the corrected swing consistently for trust and self confidence. One of the most common and leading cause of mistake in golf is the grip. In many cases, the positioning of the hand and its pressure applied to the grip will determine the swing path and the angle of the club head, especially at the point of impact with the golf ball. A golf swing uses every part of the body sequentially and/or simultaneously in continuous motion. Therefore, when the mistake occurs during the motion, it most likely creates another mistake that leads to others. The grip connects the user's body and the club and it is one of the most important elements of the resultant golf swing. The grip has to be securely connected and at the same time, be sensitive to the club feel. The following illustrates how the grip and pressure effects the golf swing. A. Positioning of Fingers and Hands: Strong grip, which promotes the dominant hand to be active and most likely closes club face at impact. Weak grip, which promotes an open club face at impact. B. Place of and Amount of Pressure Applied: Excess pressure, resulting in active hands. Dominant hand takes authority of movement. Arm and hand dominated swing, over the top, under cutting. Premature turning of upper body. Decrease swing speed. Balance control. Reverse Pivot. SUMMARY OF THE INVENTION The most common problems in having a successful golf swing is caused by an active dominant hand. An effective golf swing requires that parts of the body be utilized differently than normally used for everyday life especially the dominant side of the body. The dominant hand has to be relaxed and the sub-dominant hand lead the swing. The logic and theory are told and explained to the date but in reality even seasoned players occasionally make mistakes by letting the dominant hand be more active than necessary, a natural instinct of a typical golfer. To overcome this instinct and the golf swing accordingly, the present invention provides a device attached to the golf club grip that is simple in design and simple to use. It is portable and can be used to compare the feeling of swing and correct an improper swing. The device of the present invention provides the following advantages: Able to go back and forth with device for quicker comparison and for better and faster learning. Able to hit ball with device. Better concentration for swing. Better feel of impact zone, clearly and easy to understand body and hand position. Better control of club head. Better balance throughout the swing. Better understanding of the timing of releasing the dominant side for power. Better understanding of the role and task for the positions of the dominant hand. Better understanding of where and what amount of pressure to apply on the grip. Better chance to achieve, smooth and natural swing that fundamentally fits to an individual. Exercise the proper use of power. Exercise the feel of power transition, from leading (sub-dominant hand) to dominant hand. Increase club head speed that leads to distance and spin to control the ball flight. Learn role and task of sub-dominant hand. Learn and understand the task of dominant hand. Teaches proper movement (sequence of motion) fit to an individual's physical capabilities for the golf swing, leading to consistency and playing successful golf Understanding of position, angle of club head, and its affect. The present invention will benefit all players, from beginners to advanced players. A. For Beginners: Ease of achieving smooth swing, which fit individual's physical capabilities. Correct premature take-back and downswing by active dominant hand. Learn how to use hands properly. Utilizing sub-dominant and dominant hand the correct way. Better feel of swing. Better balancing, smooth, and consistent swing. B. For Advanced Player: Better understanding of relationship between club head and hand. Ease of working on shot making. Ease of correcting one's problem by themselves. Improvement of direction, distance and timing, and for consistent and better golf Trusting own swing for confidence. The device has a mounting member enabling the device to be secured to the golf club grip. A positioning member is threadly engaged with a threaded post which is substantially perpendicular to the top surface of the mounting, the height of the positioner being adjustable to accommodate the hand size of a golfer. DESCRIPTION OF THE DRAWINGS For a better understanding of the present invention as well as other objects and further features thereof, reference is made to the following description which is to be read in conjunction with the accompanying drawing therein: FIG. 1 is a perspective view of the device of the present invention; FIGS. 2A-2D are plan and sectional views of a first embodiment of the device shown in FIG. 1 ; FIGS. 3A-3D are plan and cross-sectional views of a second embodiment of the device shown in FIG. 1 ; FIGS. 4A-4D illustrates the steps for attaching the device of the present invention to a golf club grip; FIG. 5 illustrates the most common grip used by golfers, wherein the pinky of the golfers dominant hand over wraps and is positioned between the index and middle finger of the golfers sub-dominant hand; FIG. 6 illustrates the device of the present invention attached to the grip of a golf club where the thumb and index finger of a golfer's dominant hand is positioned in the V formed thereby the remaining fingers being extended; FIG. 7 illustrates the device of the present invention attached to the grip of a golf club wherein the thumb and index finger of a golfer's dominant hand is positioned in the V formed thereby, the index finger being hooked, the remaining fingers being extended; FIG. 8 illustrates the device of the present invention used with the over wrap grip shown in FIG. 5 ; and FIGS. 9A-9C illustrate a third embodiment of the present invention. DESCRIPTION OF THE INVENTION FIG. 1 is a perspective view of the device 10 of the present invention. Device 10 comprises a mount 12 with a post member 14 secured to the top surface of mount 12 , post member 14 having a threaded top portion 16 . An adjustable grip positioner 18 is movable via threaded portion 16 to a position where a user's hand can be comfortably positioned between lip 20 of the positioner 18 and the top surface 22 of mount 12 as will be set forth hereinafter. A stopper 24 prevents the separation of positioner 18 from mount 12 . Locking member 26 secures mount 12 in position on the golf club as will be described hereinafter. Device 10 is designed to teach a player (left or right handed) the proper use of the sub-dominant and dominant hands, the relationship between hands, and the hand relationship between club-head and hands. These teachings enable a user to overcome many problems in his/her golf swing, help master the consistent swing that makes golf enjoyable and help users to concentrate on shot making instead of being worried about making contact with the golf ball. A golf swing using the fundamental, or conventional, grip is conducted with both arms relaxed, extended and holding club lightly, the shoulder being turned to take back the golf club and letting the sub-dominant side (left for right handed and right for left handed) lead the swing. The palm of the dominant hand is facing the target; at this position, the angle of the palm of the hand is the same angle as the leading edge of the club head. At the addressing stage, the club head is square to the direction of the target or perpendicular to its swing path. For the correct swing, as soon as the club head leaves the address position to the back swing, the golf club head starts to turn, or rotate, to the same angle as the swing path or plane and stays at the same angle. The club head has to point to a certain direction during the swing such as the direction of the angle of the golf club leading edge, the same angle as of the swing plane and the same as the opened hand palm. This open hand method is helpful to the learning process, since the player learns to concentrate only on the position or angle of the hand to know the position of the club head, instead of trying to adjust the club head by hand. The device of the present invention does not control or maneuver the club or club head by hand but enables the club to act as the extension of the hand and thus enabling the club head react to or follow the hand. Device 10 improves a golf swing by using a method of practicing the golf swing with an opened hand as shown in FIG. 6 , or partially opened as shown in FIG. 7 with a hooked index finger and the rest of the fingers extended as shown. This method prevents the dominant hand from controlling the golf club by making the sub-dominant hand work harder and take the leading role in the swing. Device 10 is designed ergonomically to fit in the hand of a conventional golf grip, as shown in FIG. 8 , with minimum interference with the swing (the device is for practice purposes only, not for a regulated golf game). By attaching the device 10 to the golf club grip in the manner shown in FIGS. 4A-4D , device 10 is ready for use (note that lock 26 may be unnecessary in cases where mount 12 fits securely on the golf club grip). Positioner 18 is adjusted by being moved up or down to a position individualized to a particular player such that the club will stay attached when a player's hands are opened but the “V” formed between the index finger and thumb of dominant hand is closed. Device 10 is compact in size and can fit most clubs and the user need not carry any extra equipment to practice on his/her own. Device 10 , in addition to be used for practice, can be used to address and hit the golf ball on and off golf courses. FIGS. 3A-3D illustrate a second embodiment of the present invention. In particular, device 100 comprises mount 102 , lock 104 , adjustable grip positioner 106 having an interior threaded portion 108 , stopper 110 , threaded screw 109 having portions 112 and 114 and short internally threaded post 116 protruding from the outer surface of positioner 102 . In use, positioner 106 is rotated such that it moves along the threaded screw 109 to the proper user position. Device 100 is portable and mount 102 and lock 104 can be positioned and remain on the club grip during practice. Mount 102 , because of short post 116 , can remain secured to the golf club (preferably on the golf grip 103 as shown in FIG. 5 ) grip and stored in a conventional golf bag with minimum interference. When required for practice, post 109 is screwed on mount 102 via threaded portion 114 , post 109 already having been adjusted to the proper position within positioner 106 and practice conducted in the same manner as with device 10 , discussed hereinabove. Lock 104 (identical to lock 26 shown in FIGS. 1 and 2 ) has curved portions 117 and 119 forming channels along their length. Cylindrically shaped mount 102 has lower foot shaped members 121 and 123 along its length. FIGS. 4A-4D illustrate the sequence used in attaching and securing mount 12 to the grip of a golf club (the description that follows is the same for securing mount 102 ). In particular, device 10 is first positioned over the shaft 132 of golf club 130 ( FIG. 4A ) and then moved in direction of arrows 136 towards golf club grip 138 ( FIG. 4B ). Device 10 is then moved to an appropriate position on grip 138 ( FIG. 4C ) and, if necessary, lock 26 is moved in a manner ( FIG. 4D ) such that the channels formed by curved portions 27 and 29 therein engage foot shaped members 31 and 33 , respectively, on mount 22 as shown in FIG. 1 . Referring not to FIGS. 9A-9C , a third embodiment of the present invention is illustrated. In essence, device 200 is similar to the version shown in FIGS. 3A-3D with the addition of a quick release post 202 in order to expedite the attachment/release of post to/from adjustable grip positioner 206 . Post 202 is L-shaped and comprises legs 208 and 210 , leg 208 sliding into a channel 212 formed in member 214 . The bottom surface of leg 208 has an opening 216 formed therein. The top surface of positioner 218 has a vertically movable protrusion, or dimple, 220 formed thereon. The post 202 is secured to the mounting plate by a user inserting leg 208 into channel 212 (direction of arrow 213 ) in a manner such that protrusion 220 clicks into opening 216 . A user can remove device post 202 by pulling the post in direction indicated by arrow 220 . In this case, protrusion 218 retracts enabling the post to be removed. While the invention has been described with reference to its preferred 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 invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from its essential teachings.

A training device for use with a golf club. A mounting member enables the device to be mounted on the grip of a golf club. A positioning member is threadly engaged with a threaded post which is substantially perpendicular to the top surface of the mounting, the height of the positioner being adjustable to accommodate the hand size of the golfer.

FIELD OF THE INVENTION [0001] The instant invention relates to a dry chemical system for extinguishing a difficult fuel or flammable liquid fire in an industrial scale storage tank having a roof creating a space above the liquid, typically a fixed roof on top of the tank. BACKGROUND OF THE INVENTION [0002] Industrial fuel and/or flammable liquid storage tanks frequently have a roof creating a space above the liquid, usually a fixed conically- or geodesically-shaped roof welded to the top of the tank. Such tanks may have a double roof, including an internal floating roof, called a floater, designed to float on top of the fuel/liquid with seals for sealing against the inside tank wall. The fixed cone or geodesic top roof is typically attached by welding. A roof system comprised of either a single fixed top portion or of two portions, a fixed top and a floater, creates and defines a space or cavity between either the surface of the fuel/liquid and/or the floater below and the top roof above. [0003] Vents are typically provided to vent to the atmosphere vapors that collect in the space or cavity between the fuel/liquid (or floater) and a top fixed roof. The usual vents are “eyebrow vents”, comprising spaced rectangular openings around a top portion of the vertical tank wall, and/or roof vents, comprising spaced openings around the periphery of the top roof Each vent typically has a covering of some type. [0004] In the event of a fire in the fuel or flammable liquid tank having a fixed top roof, it is industry standard procedure, regulated by the NFPA, to extinguish the fire (or at least to attempt to do so) by a foam attack, the attack comprising laying a foam blanket on the fuel/liquid surface, typically by discharging foam into the space or cavity between and a fixed top roof and the liquid surface and/or a floater. It should be understood that the fire may, at least initially, occur only at the vents, where the fuel/liquid vapors meet atmospheric air. The vapor mixture in the cavity, at least initially, may be too rich to burn. NFPA has guidelines for the rate of foam application and the duration of a foam attack, adjusted for different type fuels or flammable liquids, different foams and different tanks, in order to achieve extinguishment. [0005] Recent discoveries by the instant inventor while extinguishing a blended fuel tank fire in Guatemala, revealed that foam alone may not extinguish a difficult fuel or flammable liquid fire in a storage tank having a fixed top roof, even when foam is placed in the cavity in accordance with NFPA recommended procedures, rates and durations. This appears disturbingly true of the new blended fuels having a high-octane content. It is a disconcerting discovery. Foam alone may not extinguish the fire at all, and quite likely will not do so per current NFPA regulations or guidelines. [0006] The instant invention teaches, therefore, an improved system designed to cost effectively extinguish a “difficult fire” in a tank with a fixed roof, or a roof that creates a space between the roof and the liquid. The improved system is designed in particular to cost effectively extinguish a fire of a difficult to extinguish fuel or flammable liquid having a high-octane content. The invention teaches a staged and timed discharge of dry chemical into the space between the burning fuel/liquid and the roof. The timing of the staging of the discharge of the dry chemical is selected to follow a pertinent period of foam application. Dry chemical is a limited and rationed resource. Discharging the dry chemical too soon might be ineffective and, thus, waste the resource. [0007] The discharging of the dry chemical can be effected by one of several means or techniques, using portable and/or fixed systems. (A “fixed system” is equipment put in place prior to a fire, fixed prior to an emergency, in anticipation of emergencies. In contrast, portable systems are brought to the locale of the emergency upon notice.) Vents provided to vent vapors that collect under a roof can be advantageously used as an entry means to discharge the dry chemical into the space above the fuel/liquid and below the roof Both portable and fixed systems could utilize such existing vents. Alternately special vents for fixed foam systems can be utilized for a fixed dry chemical system. [0008] It is the inventor's experience and observation that dry chemicals, timely inserted into the space between burning fuel/liquid and the roof, after substantial foam attack, chase any remaining persistent, pernicious fire or vagrant flames in the cavity and serve to completely extinguish the fire. Foam alone is an inferior more costly means, if not a totally inadequate means, to completely extinguish residual flames in such a tank. Foam is expensive. The extra time required to secure extinguishment, even if it can be achieved, with a continued application of foam alone as compared to the instant invention, is unnecessarily costly. [0009] The instant staged dry chemical methodology and apparatus for extinguishing a “fixed roof” (so to speak) tank fire may be implemented in various forms, including using portable apparatus and/or fixed systems. Fixed systems and/or special portable apparatus could be less risky for firefighters, and as such would be preferred over a portable embodiment requiring firefighters to climb the tank, walk over the roof and insert dry chemical through an existing or created vent or opportune opening with a hand held nozzle. [0010] The term “difficult to extinguish fuel or flammable liquid” or “difficult fuel or flammable liquid fires” is used herein to refer to fluid fuels or flammable liquids that are, at least, in substantial part, low-surface tension fuels/liquids and/or high-vapor pressure fuels/liquids and/or octane-boosted fuels/liquids and/or oxygenated fuels/liquids. The implied comparison in these instances would be recognized by one of skill in the art to be with the historic straight chain fuels or flammable liquids of the mid-20th century. [0011] It should be understood that although a tank may be designed with, and originally exist with, a particular roof system, the initiation of a fire or hazard may have altered or destroyed part or all of the original roof system. Thus, the characterization of a storage tank may have to be reassessed. Original floating roofs, or floating roof portions, may have tilted or partially sunk or totally sunk. Seals may have been destroyed, in whole or in part. Fixed roofs may have been blown awry, or may have been partially dislodged or tilted, or at least their connections, such as a welded connection with a tank wall, may have been partially or totally destroyed. The instant invention relates to a tank that, at the time of the fire, still has at least a significant roof portion creating a substantially enclosed space above the fuel/liquid and below the roof That is, the invention relates to situations where a difficult fuel or flammable liquid is on fire and there is at least a significant roof portion above the fuel/liquid surface, defining a substantially enclosed space or cavity therebetween. Although welds may be blown off from an original fixed roof portion, and hatches and vents may be blown apart, the invention applies if there remains a significant space or cavity between a burning fuel/liquid and a roof portion. Note again: the fuel/liquid may be burning only where it secures sufficient oxygen, such as at least initially where fuel vapors meet the atmosphere at vents or other open portions. SUMMARY OF THE INVENTION [0012] The instant invention discloses a system for extinguishing a fire of a difficult to extinguish fuel or flammable liquid in a storage tank having at least a roof portion that creates a substantially enclosed space above a significant portion of the liquid and below the roof, usually a tank fitted with a fixed top roof that remains substantially in place. The invention includes creating a foam blanket on the fuel/liquid surface, such as by discharging foam into a cavity above the fuel/liquid. (A foam blanket should be understood to include foam and/or film.) Preferably, after covering at least 90% of the liquid surface with a foam blanket and/or after establishing a foam blanket for a significant period of time under the circumstances, such that at least a minimal blanket of foam is created under the circumstances, most preferably after at least two-thirds of a NFPA recommended application rate/duration procedure guideline for the foam attack, then discharging dry chemical into a cavity above the foam blanket and below a roof portion. Preferably the dry chemical would be discharged during the last ten minutes of a NFPA recommended application rate/duration procedure guideline for a foam attack. Dry chemical would typically be discharged for a period of five to fifteen seconds. Existing vapor vents offer fortuitous openings for discharging the dry chemical into the cavity between the fuel/liquid and the roof using portable or fixed dry chemical systems. Preferably a dry chemical fixed system could be already in place, having conduits and a nozzle ready to be connected to dry chemical sources, such as wheeled units or a dry chemical skid, and having a discharge orifice or nozzle in the cavity. [0013] Fixed apparatus for extinguishing a difficult fuel or flammable liquid fire in a storage tank having a cavity between the fuel/liquid surface and a roof portion could include at least one dry chemical supply pipe or line rising along a portion of a tank wall and having at least one end opening created in a tank vent, such as through a roof or eyebrow vent, or through a fixed foam system opening into the tank. The supply pipe could be placed in fluid communication with a wheeled unit, a skid, or the like, having a source of dry powder. The supply pipe is preferably permanently affixed, but could be portable. BRIEF DESCRIPTION OF THE DRAWINGS [0014] A better understanding of the present invention can be obtained when the following detailed description of the preferred embodiments are considered in conjunction with the following drawings, in which: [0015] FIG. 1 illustrates a tank with a fixed top roof and a floater, creating a space or cavity in between. It should be understood that if a floater were not there, the space or cavity would be between the liquid surface and the fixed top. [0016] FIG. 2 illustrates a top view of a fixed top roof on a tank. The roof illustrates vents and portions of a dry chemical supply system. [0017] FIG. 3 illustrates a dry chemical riser pipe for a tank with a fixed roof [0018] FIG. 4 illustrates an embodiment of a dry chemical discharge head for insertion inside a tank shell, preferably for insertion inside a vent. [0019] FIG. 5 illustrates a tank with a fixed roof, the tank having a fixed foam system and a fixed dry chemical system. [0020] FIGS. 6 and 7 illustrate details of the fixed foam and dry chemical system of FIG. 5 . [0021] The drawings are primarily illustrative. It would be understood that structure may have been simplified and details omitted in order to convey certain aspects of the invention. Scale may be sacrificed to clarity. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0022] FIG. 1 illustrates tank T having what is referred to as a composite roof system, the system comprised of a floating roof portion or floater FR and a fixed roof portion FXR. Space or cavity C is created between the floating roof portion FR and fixed roof portion FXR. Floating roof portion FR is understood to be floating on top of fuel/liquid F in tank T. It should be understood and appreciated that were there no floater, or were no floater to substantially remain at the time of a fire, the space or cavity C would be created above the fuel/liquid surface and below the fixed top roof portion. [0023] In a worst-case scenario, fuel/liquid F is a blended fuel. Blended fuels can have a high-octane content that leads to difficult extinguishment situations. Fuel/liquid F is at least a difficult fuel/liquid to extinguish [0024] Tank T in FIG. 1 also illustrates portions of a fixed or portable system for application of dry chemical, comprising a ring-shaped pipe extension PE having pipe extension legs with “T”ed ends PEN. FIG. 4 is a more detailed figure illustrating a pipe extension PE having “T”ed ends PEN. The “T”ed ends are structured to insert into eyebrow vents EV of tank T and to discharge therein a dry chemical, discharged inside of the tank shell into cavity C. [0025] In a typical embodiment fixed roof portion FXR is a cone roof fixed to the top of the tank wall Geodesic-shaped fixed top roofs are also known. Floating roof portion FR floats up and down with the surface of the fuel/liquid left in the tank T and has seals to seal against the inner tank wall. [0026] FIG. 2 illustrates a top view of a cone roof FXR having a series of roof vents RV and roof vent covers CRV. FIG. 2 also illustrates portions of a fixed or portable system for application of dry chemical, including top extension TE extending up and onto cone roof FXR. In the embodiment of FIG. 2 pipe or line extension PE circles cone roof FXR proximate vents RV. A portion of pipe or line extension PE extends to vents RV such that the extension is capable of discharging dry chemical through the vent into cavity C in the tank. [0027] FIG. 3 illustrates a portion of a dry chemical (fixed or portable) system including a riser pipe or supply pipe P. Preferably a tank comes equipped with a fixed riser pipe for application of dry chemical. However, a non-fixed portable dry chemical riser pipe P, or line, could be utilized. In a simple case, the pipe extension and pipe end might be no more than the end part of a straight riser pipe P. An end of such a straight dry chemical riser pipe could be inserted or wedged during a fire into an eyebrow vent. [0028] In a situation where no fixed application system for dry chemical exists, offering preinstalled elements such as riser pipes, or pipe extensions, pipe ends and/or nozzles, the methodology can be carried out by firefighters using portable nozzles attached to supply lines. In such cases, however, a firefighter would have to approach (or to create) appropriate vents or openings on the tank or on the roof, proximate a cavity, in order to insert a dry chemical nozzle through the vent or opening. [0029] The methodology for extinguishing a difficult fire in a tank with a fixed roof portion includes an initial foam attack wherein a foam blanket is created. (Again, foam includes film.) Preferably foam is inserted into a cavity between a floating bottom roof portion and/or the fuel/liquid surface and a top roof portion to establish and create a foam blanket. Foam should be inserted or placed in the cavity until the fuel/liquid surface is substantially covered and the fire is substantially abated. Substantial abatement of the fire can be determined to have occurred in most cases when a foam blanket has been laid upon the surface of the fuel/liquid and/or floating roof in accordance with present NFPA guidelines for the foam, fuel/liquid and tank. The period of time this takes varies depending upon the type of foam used, the capacity for discharging foam, the size and complexity of the tank and the nature of the fuel/liquid it contains. Forty-five minutes represents a typical regulatorily approved time period for launching and sustaining a foam attack in a cavity between a floating roof and a top roof In a preferred embodiment, sometime during the last ten minutes of any such foam attack, dry chemical would be inserted through one or more vents, or other available tank openings, into the cavity. If safer or more remotely activatable means are not available, the dry chemical attack can be implemented by a firefighter carrying a hand held nozzle, attached to a line and source of dry chemical, up to a suitable opening into the cavity. A ten second application of dry chemical offers a reasonable expectation for extinguishing the remnants of the fire, the vagrant remaining flames associated with the difficult fire, especially those associated with the new blended fuels. It is the experience of the instant inventor that dry chemical timely inserted into such cavities in the above situation appears to “chase” the remaining fire within the cavity and to extinguish it. Without such dry chemical treatment, for difficult fuels maintenance of a foam blanket may have to be extended for two or three times the present regulatorily set time periods, incurring considerable unanticipated expense. Indeed, there is no guarantee or experience conclusively showing that foam alone can extinguish a fire of a difficult flammable liquid in a tank under a fixed roof [0030] Dry chemical is a relatively scarce commodity at a fire. The usage of dry chemical is carefully marshaled. Limitations on the supply of dry chemical make discharging dry chemical, even for a period of minutes, essentially unfeasible or impossible. Hence, dry chemical, if it is to be utilized, must be utilized judiciously. As a resource, compared to water and/or foam, in almost all circumstances its availability for use must be considered to be quite limited. Thus, a dry chemical attack is not preferred to be commenced until at least after two-thirds of the time period for a standard recommended NFPA foam attack as per NFPA guidelines. For example, if the foam attack should last over 55 to 60 minutes, the dry chemical attack preferably should not be begun until sometime in approximately the last 20 minutes, preferably not until sometime in the last 10 minutes. If there is no NFPA recommended application rate/duration procedure guideline for a particular foam or tank or fire in a given circumstance, the firefighter should extrapolate a reasonable guideline for the situation based on existing NFPA recommendations in the closest related circumstances, and take that as the NFPA guideline for this case. [0031] FIG. 5 illustrates a tank T having a fixed roof FXR and a preferred embodiment for a fixed system for use in applying foam and dry chemical. The preferred fixed system for use in applying foam and dry chemical includes a foam expansion chamber FC-HC and related conduits and valving attached to a tank, the apparatus modified to provide dry chemical capabilities. Chamber FC-HC is shown attached at an upper level of a wall portion of tank T and communicating with the inside of the tank through opening O. Foam chamber FC-HC is shown in this embodiment having its own opening O or port into the inside of tank T and cavity C. Fixed pipe P communicates dry chemical between a typically mobile or portable dry chemical supply system, which could comprise, for instance, dry chemical wheeled units DCWV or a typical dry chemical skid DCS brought to the emergency. Dry chemical wheeled units would typically feed into a dry chemical collection manifold CM and then through a line to fixed pipe P. Fixed pipe P channels the dry chemical through foam expansion chamber FC-HC and through opening O to a discharge orifice or nozzle inside the tank. [0032] FIGS. 6 and 7 offer a side view and a plan view of foam expansion chamber FC-HC with dry chemical capabilities, as well as related conduits and valving. The foam expansion chamber provides a chamber for expansion and loss of velocity of the foam concentrate, prior to being discharged through opening O in sidewall of tank T. The foam system is fed fire extinguishing fluid comprising liquid water and foam concentrate through fluid pipe FP. The water and foam concentrate liquid passes through orifice plate OP having a small hole or orifice, creating a pressure differential there through. Orifice plate OP has a handle H and resembles a paddle. Pressure differential created over the orifice plate in line FP serves to draw in air through air vent AV shown as a mushroom vent with a screen. In the instant embodiment a check valve V is presented in the line as a vapor seal. Sufficient pressure from the water, foam concentrate and air will break the vapor seal sending the fluid into foam chamber FC. In foam chamber FC the foam will further expand and lose velocity prior to being discharged through opening O into the inside of tank T. Foam chamber FC is shown with an inspection cover or hatch CV, particularly important for inspection of the vapor seals. [0033] In regard to the associated fixed system for the application of dry chemical, a chemical is fed from a source through pipe P, through its own check valve, vapor seal V, and then extending through opening O to a dry chemical discharge tip. The vapor seals or check valves may be of different designs and locations. FIGS. 6 and 7 also illustrate a high flow discharge tip HFT and a low flow discharge tip LFT. The discharge tip provides for discharging dry chemical preferably in three directions, to the left, to the right and adjustably toward the center. The tip might discharge in just one direction, preferably then adjustably toward the center. The discharge tip is preferably adjustable upon installation for anticipated preferred flow rates and directions, given the tank size. For instance, the discharge tip might be adjusted to discharge approximately 70 pounds per second total, 30 pounds per second to the left, 30 pounds per second to the right and 10 pounds per second toward a central area. [0034] The foregoing description of preferred embodiments of the invention is presented for purposes of illustration and description, and is not intended to be exhaustive or to limit the invention to the precise form or embodiment disclosed. The description was selected to best explain the principles of the invention and their practical application to enable others skilled in the art to best utilize the invention in various embodiments. Various modifications as are best suited to the particular use are contemplated. It is intended that the scope of the invention is not to be limited by the specification, but to be defined by the claims set forth below. Since the foregoing disclosure and description of the invention are illustrative and explanatory thereof various changes in the size, shape, and materials, as well as in the details of the illustrated device may be made without departing from the spirit of the invention. The invention is claimed using terminology that depends upon a historic presumption that recitation of a single element covers one or more, and recitation of two elements covers two or more, and the lie. Also, the drawings and illustration herein have not necessarily been produced to scale.

A system and apparatus for extinguishing a fire of a difficult to extinguish fuel or flammable liquid in a storage tank fitted with at least a significant top roof portion, the system including timely discharge of dry powder into a significantly enclosed space or cavity defined between the fuel/liquid surface, or between any floater remaining thereon, and the fixed top roof portion, and apparatus to facilitate the system.

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 61/279,522, filed Oct. 21, 2009. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT This invention was made with government support under Grant Numbers CA19358 and CA114053 awarded by the National Institute of Health. The government has certain rights in the invention. BACKGROUND OF THE INVENTION Therapeutic and Diagnostic NP Platforms and Nanovectors. Nanoscience is being developed in conjunction with advanced medical science for further precision in diagnosis and treatment. Multidisciplinary biomedical scientific teams including biologists, physicians, mathematicians, engineers and clinicians are working to gather information about the physical properties of intracellular structures upon which biology's molecular machines are built. A new emphasis is being given to moving medical science from laboratory to the bedside and the community. This platform development program brings together an outstanding laboratory that is pioneering biomedical applications of PAA nanovectors (Kopelman), together with an innovative porphyrin chemistry and a world-class PDT group at RPCI that is highly experienced in the high volume screening and in vitro/in vivo evaluation of novel compounds, and in developing new therapies from the test tube to FDA approval for clinical use. Although nanoplatforms and nanovectors (i.e. a nanoplatform that delivers a therapeutic or imaging agent) for biomedical applications are still evolving, they show enormous promise for cancer diagnosis and therapy. The approach has been the subject of several recent reviews2 Therapeutic examples include NP containing PDT agents, folate receptor-targeted, boron containing dendrimers for neutron capture and NP-directed thermal therapy. Recently, we have evaluated the therapeutic and imaging potential of encapsulated, post-loaded and covalently linked photosensitizer-NPs. In PAA NP the post-loading efficiency showed enhanced in vitro/in vivo therapeutic and imaging potential. PAA NP have core matrixes that can readily incorporate molecular or small NP payloads, and can be prepared in 10-150 nm sizes, with good control of size distributions. The surfaces of NPs can be readily functionalized, to permit attachment of targeting ligands, and both are stable to singlet oxygen (1O2) produced during PDT. PAA-NP have the advantages of (1) A relatively large knowledge base on cancer imaging, PDT, chemical sensing, stability and biodegradation. (2) No known in-vivo toxicity. (3) Long plasma circulation time without surface modification (see Preliminary Data), but with biodegradation and bioelimination rates controllable via the type and amount of selective cross-linking (introduced during polymerization inside reverse micelles). (4) Scale-up to 400 g material has been demonstrated, as well as storage stability over extended periods. Limitations include relative difficulty in incorporating hydrophobic compounds (although we have accomplished this), leaching of small hydrophilic components unless they are “anchored”, and unknown limitation on bulk tumor permeability because of hydrogel swelling. PDT and Cancer Therapy. The major challenge of cancer therapy is preferential destruction of malignant cells with sparing of the normal tissue. Critical for successful eradication of malignant disease are early detection and selective ablation of the malignancy. PDT is a clinically effective and still evolving locally selective therapy for cancers. The utility of PDT has been demonstrated with various photosensitizers for multiple types of disease. It is FDA approved for early and late stage lung cancer, obstructive esophageal cancer, high-grade dysplasia associated with Barrett's esophagus, age-related macular degeneration and actinic keratoses. PDT employs tumor localizing PSs that produce reactive 1O 2 upon absorption of light which is responsible for the destruction of the tumor. Subsequent oxidation-reduction reactions also can produce superoxide anions, hydrogen peroxide and hydroxyl radicals which contribute to tumor ablation4. Photosensitizers have been designed which localize relatively specifically to certain subcellular structures such as mitochondria, which are highly sensitive targets5. On the tumor tissue level, direct photodynamic tumor cell kill, destruction of the tumor supporting vasculature and possibly activation of the innate and adaptive anti-tumor immune system interact to destroy the malignant tissue6. The preferential killing of the targeted cells (e.g. tumor), rather than adjacent normal tissues, is essential for PDT, and the preferential target damage achieved in clinical applications is a major driving force behind the use of the modality. The success of PDT relies on development of tumor-avid molecules that are preferentially retained in malignant cells but cleared from normal tissues. Clinical PDT initially was developed at Roswell Park Cancer Institute (RPCI), and we have one of the world's largest basic and clinical research programs. The RPCI group developed Photofrin®, the first generation FDA approved hematoporphyrin-based compound. Subsequently, our group has investigated structure activity relationships for tumor selectivity and photosensitizing efficacy, and used the information to design new PSs with high selectivity and desirable pharmacokinetics. Although the mechanism of porphyrin retention by tumors in not well understood, the balance between lipophilicity and hydrophilicity is recognized as an important factor7 In our efforts to develop effective photosensitizers with the required photophysical characteristics, we used chlorophyll-a and bacteriochlorophyll-a as the substrates. Extensive QSAR studies on a series of the alkyl ether derivatives of pyropheophorbide-a (660 nm) led to selection of the best candidate, HPPH (hexyl ether derivative) 8,9, now in promising Phase II clinical trials. Our PS development now extends to purpurinimide (700 nm) and bacteriopurpurinimde (780-800 nm) series with high 102 producing capability10-13 Long wavelength absorption is important for treating large deep-seated tumors, because longer wavelength light increases penetration and minimizes the number of optical fibers needed for light delivery within the tumor Advantages of Longer Wavelength Photosensitizers (700-800 nm) for Phototherapy Over HPPH: The penetration of light through tissue increases as its wavelength increases between 630 and 800 nm. Once light has penetrated tissue more than 2-3 mm it becomes fully diffuse (i.e. non-directional). In diffusion theory, the probability that a photon will penetrate a given distance into tissue is governed by the probability per unit path. The intrinsic absorption of most tissues is dominated by hemoglobin and deoxyhemoglobin, with the strong peaks of the absorption bands at wavelengths shorter than 630 nm. The tails of these bands extend beyond 630 nm and grow weaker with increasing wavelength. Thus the probability of a photon being absorbed by endogenous chromophores decreases with increasing wavelength from 630-800 nm and the scattering also decreases with wavelength14 resulting in the very large increase in light penetration at ˜600 to 800 nm. PDT and Nanoparticle Platforms Photosensitizers have several very desirable properties as therapeutic agents deliverable by NP: (1) Only a very small fraction of administered targeted drug makes it to tumor sites and the remainder can cause systemic toxicity. However, PDT provides dual selectivity in that the PS is inactive in the absence of light and is innocuous without photoactivation. Thus the PS contained by the NP can be locally activated at the site of disease. (2) PDT effects are due to production of 1O2, which can readily diffuse from the pores of the NP (see Preliminary Data). Thus, in contrast to chemotherapeutic agents, release of encapsulated drug from the NP, is not necessary. Instead, stable NP with long plasma residence times can be used, which increases the amount of drug delivered to the tumors. (3) PDT is effective regardless of the intracellular location of the PS. While mitochondria are a principal target of 1O2, PS incorporated in lysosomes are also active the photodynamic process causes rupture of the lysosomes with release of proteolytic enzymes and redistribution of the PS within the cytoplasm. NP platforms also provide significant advantages for PDT: (1) High levels of imaging agents can be combined with the PS in the NP permitting a “see and treat” approach, with fluorescence imageguided placement of optical fibers to direct the photoactivating light to large or subsurface tumors, or to early non clinically evident disease. (2) It is possible to add targeting moieties, such as cRGD or F3 peptide to the NP so as to increase the selective delivery of the PS. (3) The NP can carry large numbers of PS, and their surface can be modified to provide the desired hydrophilicity for optimal plasma pharmacokinetics. Thus, they can deliver high levels of PS to tumors, reducing the amount of light necessary for tumor cure. Molecular Targeting. F3/Nucleolin Targeting F3 peptide is a 31-amino acid synthetic peptide derived from a fragment of the nuclear protein, high mobility group protein 2 (HMGN2)15. HMGN2 is a highly conserved nucleosomal protein thought to be involved in unfolding higher-order chromatin structure and facilitating the transcriptional activation of mammalian genes 62 when injected i.v., F3 peptide internalizes and accumulates in the nuclei of HL-60 cells and human MDA-MB-35 breast cancer cells. Tissue and cellular localization of F3 peptide indicated that it homes selectively to tumor blood vessels and tumor cells and has the remarkable property of being able to carry a payload into the cytoplasm and nucleus of the target cells. Furthermore, NPs with surface attached F3 behave similarly, attaching selectively to nucleolin expressing cells, and then channeled towards the cell nucleus. Recent literature shows that the F3 peptide binds to cell surface-expressed nucleolin on the target cells. Although primarily known as a nuclear and cytoplasmic protein a cell surface form of nucleolin also exists. Nucleolin is expressed on the surface of MDA-MB-35 cells1 and shuttles between the cytoplasm and the nucleus and between the cell surface and the nucleus. Nucleolin is also overexpressed in 9L glioma cells. Therefore, the mechanism of F3 targeting is recognition by nucleolin at the surface of actively growing cells (tumor cells and neovascular endothelial cells), which then binds and internalizes it, and transports it into the nucleus. While nucleolin can carry F3-targeted molecules from the cell surface into the nucleus, F3-labelled PAA nanoparticles containing Photofrin accumulated in the cytoplasm, which is useful because mitochondria are the primary target of PDT-produced 1O2. F3 targeting has been used recently to deliver nano-sized particles composed of lipids or quantum dots to tumor vasculature. Integrin Targeting. Integrins are a major group of cell membrane receptors with both adhesive and signaling functions. They influence behavior of neoplastic cells by their interaction with the surrounding extracellular matrix, participating in tumor development16. Integrin αVβ3 in tumor cells binds to matrix metalloprotease-2 in a proteolytically active form and facilitates cell-mediated collagen degradation and invasion. It over-expresses in U87 and 9L glioma tumors. An increase in its expression is correlated with increased malignancy in melanomas. αvβ3 plays a critical role in angiogenesis and is up-regulated in vascular cells within human tumors. Significant overexpression of αvβ3 is reported in colon, lung, pancreas, brain and breast carcinomas, which was significantly higher in metastatic tumors. Our objective is to prepare a known integrin αvβ3-targeting ligand. While some recent work suggests that dimeric RGD peptides provide additional affinity and tumor binding, our recent in vitro data with HPPH-RGD conjugates (in one of which the binding site was blocked) shows the validity of our approach using monomeric RGD peptides. Imaging Optical Imaging and Tumor Detection. Multiple, complementary techniques for tumor detection, including magnetic resonance, scintigraphic and optical imaging are under active development. Each approach has particular strengths and advantages. Optical imaging includes measurement of absorption of endogenous molecules (e.g. hemoglobin) or administered dyes, detection of bioluminescence in preclinical models, and detection of fluorescence from endogenous fluorophores or from targeted exogenous molecules. Fluorescence, the mission of absorbed light at a longer wavelength, can be highly sensitive: a typical cyanine dye with a lifetime of 0.6 nsec can emit up to 1032 photons/second/mole. A sensitive optical detector can image <103 photons/second. Thus even with low excitation power, low levels of fluorescent molecular beacons can be detected. A challenge is to deliver the dyes selectively and in high enough concentration to detect small tumors. Use of ICG alone to image hypervascular or “leaky” angiogenic vessels around tumors has been disappointing, due to its limited intrinsic tumor selectivity. Multiple approaches have been employed to improve optical probelocalization, including administering it in a quenched form that is activated within tumors, or coupling it to antibodies or small molecules such as receptor ligands. Recent studies have focused on developing dye conjugates of small bioactive molecules, to improve rapid diffusion to target tissue and use combinatorial and high throughput strategies to identify, optimize, and enhance in vivo stability of the new probes. Some peptide analogs of ICG derivatives have moderate tumor specificity and are entering pre-clinical studies. However, none of these compounds are designed for both tumor detection and therapy. It is important to develop targeting strategies that cope with the heterogeneity of tumors in vivo, where there are inconsistent and varying expressions of targetable sites. Photosensitizers are not Optimal for Tumor Detection Photosensitizers (PS) generally fluoresce and their fluorescence properties in vivo has been exploited for the detection of early-stage cancers in the lung, bladder and other sites 17 For treatment of early disease or for deep seated tumors the fluorescence can be used to guide the activating light. However, PS are not optimal fluorophores for tumor detection for several reasons: (i) They have low fluorescence quantum yields (especially the long wavelength photosensitizers related to bacteriochlorins). Efficient PS tend to have lower fluorescence efficiency (quantum yield) than compounds designed to be fluorophores, such as cyanine dyes because the excited singlet state energy emitted as fluorescence is instead transferred to the triplet state and then to molecular oxygen. (ii) They have small Stokes shifts. Porphyrin-based PS have a relatively small difference between the long wavelength absorption band and the fluorescence wavelength (Stokes shift), which makes it technically difficult to separate the fluorescence from the excitation wavelength. (iii) Most PS have relatively short fluorescent wavelengths, <800 nm, which are not optimal for detection deep in tissues. Advantages and Limitations of Bifunctional Photosensitizes Fluorophore Conjugates. In a separate study we have developed certain bifunctional conjugates that use tumor-avid PS to target the NIR fluorophores to the tumor18. The function of the fluorophore is to visualize the tumor location and treatment site. The presence of the PS allows subsequent tumor ablation. The optical imaging allows the clinician performing PDT to continuously acquire and display patient data in real-time. This “see and treat” approach may determine where to treat superficial carcinomas and how to reach deep-seated tumors in sites such as the breast, lung and brain with optical fibers delivering the photo-activating light. A similar approach was also used for developing potential PDT/MRI conjugates in which HPPH was conjugated with Gd(III)DTPA Due to a significant difference between imaging and therapeutic doses, the use of a single molecule that includes both modalities is problematic. However, with PAA NPs we were able to solve this problem. PS-Directed PET Imaging. Positron emission tomography (PET) is a technique that permits non-invasive use of radioisotope labeled molecular imaging probes to image and assay biochemical processes at the level of cellular function in living subjects20. PET predominately has been used as a metabolic marker, without specific targeting to malignancies. Recently, there has been growing use of radiolabeled peptide ligands to target malignancies. Currently, PET is important in clinical care and is a critical component in biomedical research, supporting a wide range of applications, including studies of gene expression, perfusion, metabolism and substrate utilization, neurotransmitters, neural activation and plasticity, receptors and antibodies, stem cell trafficking, tumor hypoxia, apoptosis and angiogenesis21. Available isotope labels include 11C (t1/2=20.4 min), 18F (t1/2=110 min), 4Cu (t1/2=12.8 h) and 124I (t1/2=4.2 days). For targeting, a long circulation time may be desirable, as it can increase delivery of the agent into tumors. HPPH and the iodobenzyl pheophorbide-a have plasma half lives ˜25 h. The long radiological half life of 124I is well matched to the pheophorbides; it permits sequential imaging with time for clearance from normal tissue. Labeling techniques with radioiodine are well defined with good yield and radiochemical purity22. Despite the complex decay scheme of 124I which results in only 25% abundance of positron (compared with 100% positron emission of 18F), in vivo quantitative imaging with 124I labeled antibodies has been successfully carried out under realistic conditions using a PET/CT scanner A variety of biomolecules have been labeled with 124I. We have devised a coupling reaction which rapidly and efficiently links 124I to a tumor-avid PS23-25, and used the conjugate to target and image murine breast tumor and its metastasis to lung (See Experimental Section). Acquisition of clinical PET images can be slow, but combination PET-CT scanners allow real time guidance of therapeutic interventions. Also, new developments in tracking may permit real time interventions guided by PET data sets. NPs can Optimize Tumor Detection and Treatment of Brain Tumors: A photosensitizer (PS) with increased selectivity and longer wavelength could be a more suitable candidate for brain and deeply seated tumors (especially breast, brain and lung). The evolution of light sources and delivery systems is also critical to the progression of photodynamic therapy (PDT) in the medical field. Two different techniques: interstitial and intracavitary light delivery have been used for treatment of brain tumors. Powers et al26 using interstitial PDT on patients with recurrent brain tumors showed that the majority of patients had tumor recurrence within two months of treatment. However, it was later observed that treatment failures appeared to occur outside the region of the effective light treatment. Chang et al reported an effective radius of tumor cell kill in 22 glioma patients of 8 mm compared with the 1.5 cm depth of necrosis noted by Pierria with the intracavitary illumination method. It is believed that tumor resection is important so that the numbers of tumor cells remaining to treat are minimized. With stereotactic implantation of fibers for interstitial PDT there is no cavity to accommodate swelling and a considerable volume of necrotic tumor which causes cerebral edema. However, cerebral edema can be readily controlled with steroid therapy. Compared to chemotherapy and radiotherapy, patients with brain tumors treated with PDT have definitely shown long-term survival, whereas glioma patients treated with adjuvant chemotherapy or radiotherapy do not show additional benefits as reported by Kostron et al27 and Kaye et al.28 On the basis of our preliminary data, the αvβ3 targeted NPs may improve tumor-selectivity and PDT outcome. Importance of Multifunctional NPs in Brain-Tumor Imaging and PDT: The prognosis for patients with malignant brain tumors is linked to the completeness of tumor removal. However, the borders of tumors are often indistinguishable from surrounding brain tissue so tumor excision is highly dependent upon the neurosurgeon's judgment. To identify tumors, neurosurgeons use diagnosticimaging methods such as Computed Tomography (CT) or Magnetic Resonance Imaging (MRI), which enhance the contrast between tumor and surrounding brain tissue. However, there are frequently discrepancies between intraoperative observations of tumor margins and preoperative diagnostic imaging studies. Unlike CT and MRI, intraoperative ultrasound can provide real-time information to locate the tumor and define its volume. However, once resection commences is also limited by signal artifacts caused by blood and surgical trauma limit tumor identification at the resection margin. Intraoperative MRI allows the neurosurgeon to obtain images during surgery, which can improve the completeness of the tumor resection, however microscopic disease is still not detected. In an ideal situation, the surgeon would perform the brain tumor resection with continuous guidance from high-contrast fluorescence from the tumor observed directly in the resection cavity. BRIEF SUMMARY OF THE INVENTION The present invention relates to polyacrylic acid (PAA) nanoparticles containing a photosensitizer and an imaging enhancing agent. The photosensitizer is preferably a tetrapyrollic photosensitizer having the structural formula: or a pharmaceutically acceptable derivative thereof, wherein: R 1 and R 2 are each independently substituted or unsubstituted alkyl, substituted or unsubstituted alkenyl, —C(O)R a or —COOR a or —CH(CH 3 )(OR a ) or —CH(CH 3 )(O(CH 2 ) n XR a ) where R a is hydrogen, substituted or unsubstituted alkyl, substituted or unsubstituted alkenyl, substituted or unsubstituted alkynyl, or substituted or unsubstituted cycloalkyl; _where R 2 may be —CH═CH 2 , —CH(OR 20 )CH 3 , —C(O)Me, —C(═NR 21 )CH 3 or —CH(NHR 21 )CH 3 where X is an aryl or heteroaryl group; n is an integer of 0 to 6; where R 20 is methyl, butyl, heptyl, docecyl or 3,5-bis(trifluoromethyl)-benzyl; and R 21 is 3,5,-bis(trifluoromethyl)benzyl; R 1a and R 2a are each independently hydrogen or substituted or unsubstituted alkyl, or together form a covalent bond; R 3 and R 4 are each independently hydrogen or substituted or unsubstituted alkyl; R 3a and R 4a are each independently hydrogen or substituted or unsubstituted alkyl, or together form a covalent bond; R 5 is hydrogen or substituted or unsubstituted alkyl; R 6 and R 6a are each independently hydrogen or substituted or unsubstituted alkyl, or together form ═O; R 7 is a covalent bond, alkylene, azaalkyl, or azaaraalkyl or ═NR 20 where R 20 is 3,5-bis(tri-fluoromethyl)benzyl or —CH 2 X—R 1 or —YR 1 where Y is an aryl or heteroaryl group; R 8 and R 8a are each independently hydrogen or substituted or unsubstituted alkyl or together form ═O; R 9 and R 10 are each independently hydrogen, or substituted or unsubstituted alkyl and R 9 may be —CH 2 CH 2 COOR 2 where R 2 is an alkyl group that may optionally substituted with one or more fluorine atoms; each of R 1 -R 10 , when substituted, is substituted with one or more substituents each independently selected from Q, where Q is alkyl, haloalkyl, halo, pseudohalo, or —COOR b where R b is hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, aryl, heteroaryl, araalkyl, or OR c where R c is hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, or aryl or CONR d R e where R d and R e are each independently hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, or aryl, or NR f R g where R f and R g are each independently hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, or aryl, or ═NR h where R h is hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, or aryl, or is an amino acid residue; each Q is independently unsubstituted or is substituted with one or more substituents each independently selected from Q 1 , where Q 1 is alkyl, haloalkyl, halo, pseudohalo, or —COOR b where R b is hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, aryl, heteroaryl, araalkyl, or OR c where R c is hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, or aryl or CONR d R e where R d and R e are each independently hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, or aryl, or NR f R g where R f and R g are each independently hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, or aryl, or ═NR h where R h is hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, or aryl, or is an amino acid residue. The photosensitizer may be conjugated with an image enhancing agent prior to incorporation into the nanoparticle, after incorporation into the nanoparticle or the photosensitizer and/or image enhancing agent may chemically bound to the nano particle and/or one or more of the photosensitizer and image enhancing agent may be physically bound to the nanoparticle. Imaging enhancing agents may be for essentially any imaging process, e.g. Examples of such imaging enhancing agents are discussed in the background of the invention previously discussed and in the list of references incorporated by reference herein as background art. It is to be understood that other agents may be incorporated into the nanoparticle such as tumor targeting moieties and tumor inhibiting or tumor toxic moieties. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS As used herein “Figure” and “Fig.” are used interchangeably. FIG. 1A shows the structural formula of HPPH-CD (cyanine dye) conjugate 1 used as a photosensitizer and imaging agent. FIG. 1B : Is a graph showing In vivo photosensitizing efficacy of HPPH-CD conjugate 1 in C3H mice bearing RIF tumors (10 mice/group) at variable drug doses. The tumors were exposed to light (135 J/cm2/75 mW/cm2) at 24 h post-injection. FIG. 1C shows a scanned image showing localization of the conjugate 1 in a live mouse 24 h after injection (drug dose 0.3 μmole/kg). The light treatment parameters are not optimized (in progress) [Without PAA NP] FIG. 2 . Shows whole body images of BALB/c mice bearing Colon26 tumors with PAA NPs formulations (HPPH and cyanine dye (CD) were post-loaded in 2 to 1 ratio). The CD concentration was kept constant (0.3 μmol/kg) at the images were obtained at variable time points. A=24 h, B=48 h and C=72 h post injection (λex: 785 nm; λEm: 830 nm). L=Low and H=High. FIG. 3 . Is a graph showing In vivo PDT efficacy of HPPH and CD post loaded in a ratio of 2:1 and 4:1 in PAA and ORMOSIL NPs. Note: HPPH dose: 0.47 μmol/kg in PAA NPs and 0.78 μmol/kg in ORMOSIL NPs. FIG. 4 . Slow release of HPPH and CD from PAA NPs (post loaded in 2:1 ratio) after several washes with 1% HSA. FIG. 5A is a diagram showing structure of PAA nanoparticles (PAA NP's) FIG. 5B . Shows comparative in vivo imaging at variable time points of BALB/c mice bearing Colon26 tumors with HPPH-CD conjugate 1 and CD-conjugated with PAA NPs/post;-loaded with HPPH. The NPs were more tumor specific. (Mouse 1) FIG. 6 . shows a series of scans wherein in Panel 1 shows: (4T1 tumors): Primary (PT) and metastasized tumors (MT) dissected. Panel 2 (4T1 tumors): PET imaging of the dissected primary and metastasized tumors. Panel 3 (BALB/C mouse bearing 4T1 tumor): Whole body PET imaging. The tumor metastasis in lung was clearly observed. Panel 4: The position of the lung is shown by the transmission scan using 57Co source in mice with no lung metastasis. Panel 5: (BALB/C mouse bearing Colo-26 (non-metastatic tumor): Whole body imaging by PET. A high accumulation of the 124I-photosensitizer in tumor is clearly observed without any significant accumulation in lungs (injected dose: 100 μCi). T=Tumor, PT=Primary tumor; MT=Metastatic tumor. FIG. 7 . In vivo biodistribution of 18F-FDG (100 μCi, half-life 2 h) at 110 min and 124I-PS 2 (100 μCi, half-life 4.2 d) at 48 h in BALB/c mice bearing Colon 26 tumor (3 mice/group). Tumor-uptake was similar for both agents. However, the higher uptake of FDG over 124I-PS 2 in normal organs is clearly evident. FIG. 8A . shows in vivo PET imaging (72 h post injection) and biodistribution (24 h, 48 h and 72 h postinjection) of 124I-labeled photosensitizer 2 without PAA nanoparticles in BALB/c mice bearing Colon26 tumors (see the text). [Biodistribution of PET imaging agent 2: No PAA, with PAA]. FIG. 8B shows in vivo PET imaging (72 h post injection) and biodistribution (24 h, 48 h and 72 h postinjection) of 124I-labeled photosensitizer 2 with PAA nanoparticles in BALB/c mice bearing Colon26 tumors (see the text). FIG. 8C shows Biodistribution of PET imaging agent 2: No PAA and with PAA FIG. 9 . Fluorescence intensity of cells targeted by F3-targeted (A series), F3-Cys targeted (B series) and nontargeted NPs (F series) in nucleolin rich MDA-MB-435 cell lines. FIG. 10 . Fluorescence (left) & Live/dead cell assay (right) of HPPH conjugated PAA NPs + or − F3-Cys peptide incubated for 15 min with MDA-MB-435 cells. FIG. 11 . Confocal images showing the target-specificity of F3-Cys peptide in 9L Glioma tumor cells. Left: F3-Cys PEG Rhodamine-PAA NPs (9L cells). Right: PEG Rhodamine-PAA NPs (9L Cells) FIG. 12 . In vivo biodistribution of 14 C-labeled HPPH, and 14 C-labeled HPPH post-loaded into PAA NPs in BALB/c mice bearing Colon26 tumors. 13 C-labeled PS (3.8 μCi/0.2 mL) were administered to 12 mice/group. At 24, 48, 72 h after. injection, three mice/time-point were sacrificed. The organs of interest were removed and the radioactivity was measured The raw data were converted to counts/gram of tissue. FIG. 13A . In vivo biodistribution of iodinated photosensitizer 531ME at 24, 48 and 72 h post injection. FIG. 13B In vivo biodistribution of iodinated photosensitizer of PAA NPs at 24, 48 and 72 h post injection. 531-ME Post-Loaded into 30 nm PAA Nanoparticles. FIG. 13C In vivo biodistribution of iodinated photosensitizer of PAA NPs at 24, 48 and 72 h post injection. 531-ME post pre-treatment with 150 nm PAA Nanoparticles. FIG. 14 shows the structural formula of HPPH. FIG. 15 is a diagram of Multifunctional PAA Nanoparticles. FIG. 16 shows flow diagrams for preparation of preparation of postloaded nanoparticles. DETAILED DESCRIPTION OF THE INVENTION Application of HPPH, a tumor-avid photosensitizer for developing bifunctional agents for fluorescence imaging/PDT and its limitations: We have previously shown that certain tumor-avid PS(s) (e.g., HPPH) conjugated with NIR absorbing fluorophore(s) (non-tumor specific cyanine dyes) can be used as bifunctional agents for tumor-imaging by fuorescence and phototherapy (PDT). Here, HPPH was used as a vehicle to deliver the imaging agent to tumor. The limitation of this approach was that the conjugate exhibited significantly different dose requirements for the two modalities. The imaging dose was approximately 10-fold lower than the phototherapeutic dose ( FIGS. 1B and 1C ), which could be due to a part of the 1O2 (a key cytotoxic agent responsible for the destruction of the tumors) produced on exciting the PS being quenched by the fluorophore leading to its photo-destruction. Exposing the tumor at 780 nm (excitation wavelength for the cyanine dye) produced in vivo emission at 860 nm and, as expected, no significant photobleaching of the fluorophore (CD) or the PS(HPPH) was observed. Advantages of PAA NPs for Developing Fluorescence-Imaging/PDT Agents: For investigating the utility of PAA NPs three different approaches were used. First HPPH and the cyanine dye (fluorophore) were post-loaded in variable ratios (HPPH to CD: 1:1; 2:1; 3:1 and 4:1 molar concentrations). In brief, HPPH was postloaded to PAA NPs first. Free HPPH was removed by spin filtration and then cyanine dye was postloaded. It was spin-filtered again, washed several times with 1% bovine calf serum and the concentration was measured. The 2:1 formulations produce the best tumor imaging and long-term tumor cure in BALB/c mice bearing Colon26 tumors. This formulation contained in a single dose the therapeutic dose of HPPH (0.47 μmol/kg) and the imaging dose of Cyanine dye (0.27 mol/kg), which were similar to the components used alone for tumor imaging and therapy, but with much more tumor selectivity (skin to tumor ratio of HPPH was 4:1 instead of 2:1 without NPs). Under similar treatment parameters the Ormosil NPs showed a significantly reduced response (imaging and PDT, not shown). The stability of the drugs in PAA NP was established by repeated washing with aqueous bovine calf serum through Amicon centrifugal filter units with a 100 KDa or larger cut off membrane and drug in the filtrate was measured spectrophotometrically. The comparative in vivo PDT efficacy of the ORMOSIL and PAA formulations, their tumor imaging potential and stability (in vitro release kinetics) is shown in FIGS. 2-4 , which clearly illustrate the advantages of PAA NPs in reducing the therapeutic dose by almost 8-fold without diminishing the tumor-imaging potential and also avoiding the Tween-80 formulation required for the HPPH-CD conjugate 1. In the 2 nd approach the HPPH CD conjugate 1 was post-loaded to PAA NPs, which certainly enhanced the tumor imaging, but the therapeutic dose was still 10-fold higher (similar to the HPPH CD conjugate, FIG. 5B ). In the 3rd approach the cyanine dye was conjugated peripherally to the PAA NPs first and then HPPH was post loaded. Again, compared to HPPH-CD conjugate 1, the PAA formulation showed enhanced tumor-specificity (imaging) ( FIG. 5B ). PET Imaging and PDT: PAA NPs Decreased the Liver Uptake of the 124I-Photosensitizes (Pet Imaging Agent) and Enhanced the Tumor-Specificity Our initial investigation with an 124I-labeled PS 2 indicates its in vivo PDT efficacy and capability of detecting tumors104-106 (RIF, Colon26, U87, GL261, pancreatic tumor xenograft)) and tumor metastases (BALB/c mice bearing orthotopic 4T1 (breast) tumors) ( FIG. 6 ). Interestingly, compared to 18F FDG PS 2 showed enhanced contrast in most of the tumors including those where 18F FDG-PET provides limited imaging potential (e.g., brain, lung and pancreatic tumors). See FIG. 7 for comparative biodistribution. This is the first report showing the utility of porphyrin-based compounds as a “BIFUNCTIONAL AGENT” for imaging breast tumor and tumor metastasis. Similar to most NPs, PAA NP accumulate in liver and spleen. Their clearance rate from most organs is significantly faster than Ormosil NP and they do not show long-term organ toxicity. Even tumor-avid porphyrinbased PS exhibit high uptake in liver and spleen, but are non-toxic until exposed to light. The PS clear from the system quickly (days) without organ toxicity. However, radioactive PS such as the 124I-labeled analog 2 (superior to 18F-FDG in PET-imaging of lung, brain, breast and pancreas tumors) with a T1/2 of 4.2 days could cause radiation damage to normal organs. Based on the observation of high uptake of PAA NPs in liver and spleen (below) we postulated that saturating the organs with the non-toxic PAA NPs before injecting the PET agent might reduce uptake and radiation damage by 124I-imaging agent. For proof-of principle blank PAA NPs were first injected (i.v.) into mice bearing Colon26 tumors followed 24 h later by i.v. 124I-analog (100−50 μCi). The mice were imaged at 24, 48 and 72 h post injection and biodistribution studies were performed at each time point summarized in FIGS. 8A-8C (only 72 h images shown). The presence of PAA NPs made a remarkable difference in tumor contrast with brain, lung and pancreatic tumors). See FIG. 7 for comparative biodistribution. PAA NPs can be Targeted to Nucleolin with F3-Cys: F3-targeted NPs were prepared using two kinds of F3 peptides: F3 peptide conjugated to NP via one of the 8 lysines available in its sequence and F3-Cys peptide conjugated to NP via cysteine. Cysteine capped NPs served as non-targeted control. Three 25 mg batches of each type of NP contained: 2.6, 5.1 and 7.7 mg F3, (A3-A5) respectively; 2.7, 5.3 and 8 mg F3-Cys (B3-B5) respectively, and 0.29, 0.58 and 0.87 mg Cys (C3-C5) respectively. The fluorescence intensity from PAA NP incubated in vitro with nucleolin positive MDA-MB-435 cells is shown in FIG. 9 . The F3-Cys conjugated NPs show considerably higher binding efficiency than non-targeted NPs, while F3 conjugated NPs do not. Conjugation via a cysteine link preserves the specificity of F3 peptide for nucleolin. In addition excess cysteine on the NPs helps to minimize the non-specific binding. Additional experiments (not shown) suggested that the amount of F3-Cys peptide (5.3 mg/25 mg NP) used for B4 NPs was optimal. Optical Properties of Post-Loaded PAA NPs. The absorption spectrum of PAA NPs post-loaded with both HPPH and cyanine dye (even at 0.5 mg/ml), clearly shows characteristic signatures for both the PS and dye, without aggregation-induced broadening, while the fluorescence spectrum shows strong signals from both components. HPPH Conjugated PAA NPs with F3-Cys Peptide at the Outer Surface Show Targeted Specificity: F3-mediated specificity is retained in the presence of conjugated HPPH. F3 targeted NPs did targeted NPs did not, indicating that F3-mediated specificity is retained in the presence of conjugated HPPH. F3 targeted NPs did not accumulate in the nucleus. On activation of cells with light at 660 nm only F3-targeted NP caused cell kill ( FIG. 11 ). Cell internalization of F3-targeted NPs was confirmed by fluorescence confocal microscopy. HPPH Conjugated PAA NPs with F3-Cyspeptide at the Outer Surface Show Targeted Specificity: The specificity of targeted NPs was tested by fluorescent imaging ( FIG. 10 ). F3 targeted HPPH conjugated PAA NP specifically bound to MDA-MB-435 cells (expressing nucleolin) while non-targeted NPs did not, indicating that F3-mediated specificity is retained in the presence of conjugated HPPH. F3 targeted NPs did not accumulate in the nucleus. On activation of cells with light at 660 nm only F3-targeted NP caused cell kill ( FIG. 11 ). Cell internalization of F3-targeted NPs was confirmed by fluorescence confocal microscopy. F3-Cys Shows Target-Specificity in 9L Glioma Cells: Similar to F3-cys, a pegylated form of F3-Cys PEG on PAA NPs also showed remarkable target-specificity in 9L rat glioma cells which also expresses nucleolin, FIG. 11 . (Note: HPPH is replaced with a Rhodamine moiety). Biodistribution Studies: PAA NP Enhances Tumor Uptake of HPPH: The biodistbiodistribution of 14C-HPPH and 14C-HPPH post-loaded PAA NP was performed in BALB/c mice bearing Colon26 tumors at 24, 48 and 72 h post injection (3 mice/time point) and the results are summarized in FIG. 12 . As can be seen presence of PAA NPs made a significant increase in tumor uptake with reduced uptake in other organs. Size of PAA NPs Made Remarkable Difference in Tumor-Enhancement: The biodistribution of 124I-photosensitizer was investigated using variable sizes of nanoparticles either injecting the NPs first and then administrating the labeled photosensitizer or postloading the labeled photosensitizer to PAA NPs and then perform in vivo biodistribution in mice at 24, 48 and 72 h. The results summarized in FIGS. 13A-13C clearly indicate that the size of PAA NPs makes a significant impact in tumor enhancement. Experiments related to in vivo PDT efficacy of these formulations are currently in progress. This invention shows the utility of porphyrin-based compounds in a “BIFUNCTIONAL AGENT” for imaging breast tumor and tumor metastasis. Similar to most NPs, PAA NP accumulate in liver and spleen. Their clearance rate from most organs is significantly faster than Ormosil NP and they do not show long-term organ toxicity. Even tumor-avid porphyrin based PS exhibit high uptake in liver and spleen, but are non-toxic until exposed to light. The PS clear from the system quickly (days) without organ toxicity. However, radioactive PS such as the 124I-labeled analog 2 (superior to 18F-FDG in PET-imaging of lung, brain, breast and pancreas tumors) with a T1/2 of 4.2 days could cause radiation damage to normal organs. Based on the observation of high uptake of PAA NPs in liver and spleen (below) we postulated that saturating the organs with the non-toxic PAA NPs before injecting the PET agent might reduce uptake and radiation damage by 124I-imaging agent. For proof-of principle blank PAA NPs were first injected (i.v.) into mice bearing Colon26 tumors followed 24 h later by i.v. 124I-analog (100-150 μCi). The mice were imaged at 24, 48 and 72 h post injection and biodistribution studies were performed at each time point summarized in FIGS. 8A-8C (only 72 h images shown). The presence of PAA NPs makes a remarkable difference in tumor contrast with significantly reduced uptake in spleen and liver and improved tumor-uptake/contrast at 24, 48 and 72 h post injection (3 mice/group Similar studies (tumor-imaging and PDT efficacy) in which the labeled PS is post-loaded to variable sizes. Similar studies (tumor-imaging and PDT efficacy) in which the labeled PS is post-loaded to variable sizes PAA NPs are currently in progress.

A composition comprising PAA nanoparticles containing a post loaded tetrapyrollic photosensitizer and an imaging agent and methods for making and using same.

CROSS-REFERENCES TO RELATED APPLICATION, IF ANY None. BACKGROUND OF THE INVENTION The invention relates to fire extinguishers using an explosive charge to disperse a fire quenching solution. The prior art discloses a number of devices in which an explosive cartridge or the like is placed within an extinguishing medium. Pierce U.S. Pat. No. 764,763 illustrates an early approach towards such a device where a waterproof cartridge shield intrudes into a holder containing an extinguishing agent. Owing to the construction of the Pierce device, the cartridge shield consumes a considerable portion of the holder's volumetric capacity, reducing its fire quenching ability. Furthermore, the shape and placement of the cartridge shield permit the brunt of the explosive thrust to take the path of least resistance and expel through the fuse inlet aperture. Thus, the substantially non-compressible aqueous solution around the shield will not be dispersed either as widely or in such a uniform pattern as may be desired to achieve optimum results. The patent to J. H. Walrath, U.S. Pat. No. 750,416, displays the same disadvantages pointed out in the Pierce design, but uses a dry extinguishing powder rather than the aqueous extinguishing solution used in the present invention. There is, in other words, considerable room for improvement. SUMMARY OF THE INVENTION The construction and operation of the present invention is directed towards an apparatus which, upon detonation, will produce a cloud of atomized fluid droplets. The aim is not only to disperse a given quantity of fire extinguishing fluid, but also to transform the fluid into a vapor form which will squelch a fire more effectively than the direct application of large fluid droplets. In contrast to known prior art, the present invention uses a spherical, encased, explosive charge suspended centrally within a larger spherical shell confining a fluid extinguishing agent which surrounds the spherical charge. The centrally located explosive charge is held in place by radial, outwardly extending spider arms attached to the inner wall of the enclosing spherical shell. Several arrangements for detonating the inner spherical charge are disclosed. One utilizes a thin, water proof conduit, extending from the spherical charge through the fluid and then through the spherical shell, the conduit housing a fuse for igniting the charge. In an alternative construction, a pressure sensitive piston in communication with the encased fluid cooperates with a firing pin and a percussion cap to provide a pressure-derived means for activating the charge upon the shell's jarring contact with another object. Depending on the particular application of the disclosed invention, the various detonation means may be used alone or in combination. Upon explosion, the spherical charge exerts pressure outwardly and equally upon the surrounding fluid, resulting in a generally spherical distribution of finely divided fog droplets. Dramatic instantaneous cooling of the affected area results, lowering the temperature of fire supporting oxygen and combustible material. Also, a portion of the oxygen within the area is physically displaced by the fog droplets. The explosive creation of the vapor cloud augments the fire snuffing process, the concussive shock wave having a shattering effect upon conflagrations as is well known to oil and gas well firefighters. In summary, the cooling, oxygen displacement, and detonation wave effects created by the present invention all cooperate to extinguish the subject fire in a most effective manner. Thus, it is an object of the present invention to extinguish fires through the concussive creation of a generally spherical fog-like atmosphere of finely divided fluid. It is another object to provide a concussive-type fire extinguisher capable of being deposited on fires from aircraft or other airborne means. It is yet another object to provide direct ignition as well as shock actuated means for detonating the concussive-type fire extinguishers of the present design. These and other objects and advantages of the present invention will be disclosed in the drawings and detailed description to follow. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an elevational view partially cut-away to show the case of the inner spherical charge and its support arms radially extending to the outer spherical shell, the safety closure plug being shown in closed safety position; FIG. 2 is a cross-sectional view, taken to an enlarged scale, of the inner spherical charge disclosed in FIG. 1, the safety closure plug being shown in its withdrawn or operative, position; FIG. 3 is an elevational view partially cut-away and showing an alternative embodiment of the detonation means, including an ignition fuse, a waterproof conduit, and a detonation cap; and, FIG. 4 is a cross-sectional view, taken to an enlarged scale, of the inner spherical charge disclosed in FIG. 3, showing the intrusion of the conduit into the spherical charge and the conduit's connection to the internal detonation cap. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Turning now to FIG. 1, the invention 11 generally comprises a frangible, outer shell 12 containing an inner spherical charge 13 surrounded by an aqueous solution 14. The outer shell 12 is made from a material, such as a pliable plastic, which is breakable when subjected to considerable impact forces, yet durable enough to withstand normal handling stresses. A plurality of support legs 16 extends radially outwardly from the central spherical charge 13 to the inner surface of the outer shell 12. The spherical charge 13 is thus centrally suspended within outer shell 12 and enclosed by a substantially equal measure of solution 14 on all sides. The internal construction of the spherical charge 13 is most clearly revealed in FIG. 2. A charge encasement 17 contains an explosive charge 18 and protects it from contact with the aqueous solution 14. A shock-actuated detonator 19 penetrates the encasement 17 but a waterproof seal is nevertheless maintained. The detonator 19 includes a piston 21, hollow cylinder 22, and percussion cap 23. In its safety position, a closure member 24 fits snugly within a conjugate aperture 26, or bore, defined by the adjacent protruding end of the cylinder 22. As shown in FIG. 1, the closure member 24 and flange-like lip 27 effectively seal aperture 26 and thereby isolate piston 21 from reacting to any pressure increases within the outer shell 12 filled with aqueous solution 14. During transport and normal handling of the invention 11, detonation of spherical charge 13 is thus precluded. A transverse shear pin 30 through the piston 21 prevents any translational movement of the piston and provides an additional safety measure against premature detonation. The fire extinguisher of the invention 11 is particularly effective when dropped upon a spot fire or on a fire line from an elevated position, such as from an airplane or helicopter. Since the spherical outer shell 12 has no "preferred" attitude, no particular care must be exercised in orienting the device before it is dropped. Just before the device 11 is dropped, however, closure member 24 must be removed, to ensure that detonation will occur upon contact of the outer shell 13 with the ground or any object, such as a burning tree. Interconnected pull ring 28, connecting cord 29, or rod, and closure member 24 are manually withdrawn from spherical charge 13. FIG. 2 shows closure member 24 and connecting cord 29 in a withdrawn position, exposing the outer head 25 of the piston 21 to the aqueous solution 14. The device is thus armed and can be dropped in the desired direction, towards the fire to be extinguished. Piston 21 is slidably positioned within the cylinder 22 yet the seal between the two is sufficiently tight to prevent the aqueous solution 14 from entering into air chamber 31 as the device descends. Upon encountering the ground or an object below, the outer shell 12 is subjected to very large impact forces which displace the generally non-compressible aqueous solution 14. The air contained within the air chamber 31 is compressible, however, and offers the path of least resistance for pressure impressed upon the large head end 25 of the piston 21. The piston 21 is thereby urged with great speed and force inwardly towards air chamber 31 and percussion cap 21, the shear pin 30 being severed by the sudden force as the piston 21 slides inwardly. A firing pin 32, positioned upon the inward extremity of the piston 21, is translated into abrupt contact with percussion cap 23, thus igniting the explosive charge 18. Owing to the spherical shape of the charge encasement 17, the outwardly expanding forces generated by the explosion are exerted uniformly throughout a spherical field. The uniformity of explosive force, coupled with the spherical shape of the confined aqueous solution, produces a generally spherical distribution of finely divided droplets of aqueous solution 14. The pattern that the fog of droplets actually assumes can be distorted by surrounding objects, but these objects are thereby assured of receiving an adequate blast of cooling droplets. The aqueous body 14 can include, in solution, fire retardant chemicals such as halides or borates to bolster the fire quenching capabilities of the device. A number of factors act jointly to extinguish a fire subjected to the explosive blast. First, the droplets efficiently cool both the combustible materials and surrounding air below the ignition point. Second, fire retardant chemicals, contained within the droplets and mixed with the aqueous solution 14, serve to inhibit further burning. Third, oxygen necessary for support of combustion is displaced by the outwardly expanding cloud of moisture vapor and fine droplets. Lastly, the concussive forces from the blast act suddenly to snuff the fire. While none of these extinguishing effects individually is particularly new, the cumulative manner in which the device produces the desired result does represent a new and significant advance in the art. Having explained one preferred form of the invention 11, a variant embodiment will now be discussed, the alternative arrangement for detonating the explosive charge 18 being illustrated in FIGS. 3 and 4. Fuse ignition of the charge 18 may be desirable if the device is placed in an area where it is to detonate automatically should flames erupt in close proximity. For instance, remote or rarely visited storage areas and mine shafts would be ideal applications for an automatic fuse ignition version of the device. Thus, while the shock-actuated detonator heretofore described is particularly useful for aerial bombing, a fuse ignition type of detonator affords unique advantages in attacking fires whose presence is unknown. A heat-resistant tube or conduit 33 extends between an interior portion of the charge encasement 17 and the frangible outer shell 12. A registering aperture in the outer shell 12 permits a plurality of fuse threads 34, impregnated with an appropriate burning chemical, to enter the outer extremity of conduit 33. A fast-burning chemical 36 within the conduit 33 extends from the relatively slow burning fuse threads 34 to a heat-activated detonator cap 37. In operation, the fuse threads 34 are ignited by a contiguous fire, spreading ignition to chemical 36, thence to detonator cap 37, which activates. Explosive charge 18 then detonates, the operation then being identical to that previously explained. Owing to the slender transverse dimension of the conduit 33, little force of the explosion will be lost to the outside. Thus, the efficient, generally spherical distribution of the finely particularized droplets will be maintained by this alternative detonation means. The shock-activated detonator system of FIGS. 1 and 2 and the fuse ignition system of FIGS. 3 and 4 can often be used in combination to advantage in aerial attacks on fires. Should detonator 19 fail to ignite explosive charge 18 upon impact, the fuse ignition system will provide a backup, ensuring ignition and explosive disruption of the fire shortly thereafter.

A waterproofed explosive charge is suspended within a frangible, spherical shell containing an aqueous solution. The assembly is dropped from an airplane or helicopter towards a fire below. Either a shock-actuated percussion cap or a fuse-ignited detonation cap activates the explosive charge at the appropriate moment and the resultant explosion creates a vapor-like fog. A portion of the combustion-supporting oxygen is displaced by the fog droplets. The minute water droplets also absorb heat energy, thereby lowering surrounding air and fuel temperatures. These effects, coupled with the concussive shock wave, act to snuff the fire.

FIELD OF THE INVENTION [0001] The invention concerns the prevention of the adverse effects of antibiotics, secondary to their action on the gastrointestinal flora and the selection of resistant bacteria strains. BACKGROUND [0002] The liver may excrete a great many parenterally administered antibiotics into the bile in active, unmodified active form or as active metabolites. These antibiotics may be reabsorbed in the ileum and thereby return to the liver via the portal vein to be eventually excreted. This circulation is said to be enterohepatic. [0003] When excreted in the digestive tract in unmodified active form or as active metabolites, these antibiotics may exert selective pressure on the bacteria populations forming the normal micro-flora of the intestine and colon. Such microbial selection has two main consequences: the occurrence of acute diarrhoea induced by the antibiotics and the selection and dissemination of resistant bacteria strains. [0004] The onset of acute diarrhoea caused by antibiotics is commonly observed with parenteral broad-spectrum antibiotics. The frequency and severity are determined by various factors including the duration of the treatment, the activity spectrum of the antibiotic used and the dose (Aires, Kohler et al., 1999). Acute diarrhoea induced by antibiotics is thereby observed in about 5-10% of all patients receiving antibiotic therapy with amoxicillin, 10-25% with an amoxicillin-clavulanic acid association and 2-5% with 3 rd generation cephalosporins, fluoroquinolones, azithromycin, clarithromycin, erythromycin and tetracyclines (Gilbert, 1994; Bartlett, 1996, Hogenauer, Hammer et al., 1998; Wistrom, Norrby et al., 2001). [0005] Although the majority of the cases of acute diarrhoea caused by antibiotics are benign, they may be accompanied by severe colitis in 10-20% of all cases. In most cases, this colitis is secondary to the selection of Clostridium difficile, a spore-forming, Gram-positive anaerobic bacteria resistant to most antibiotics (Gerding, 1989; Anand, Bashey et al., 1994). The pathogenicity of this bacteria is related to the production of both toxins A and B. These toxins induce an intense inflammatory reaction with the recruitment of neutrophils in the lamina propria and in the most severe forms, pseudo-membranous colitis, so named because of the appearance of the colorectal mucosa (Kelly, Pothoulakis et al., 1994). The mortality with pseudo-membranous colitis is high, especially in young children and the elderly. These colitises were responsible for over 7200 deaths in the United-States in 2010 (Sherry, Murphy et al., 2012). Other pathogens may be responsible for acute diarrhoea of varying severity induced by antibiotics, such as Klebsiella oxytoca, Clostridium perfringens type A, Straphylococcus aureus and Candida albicans (Sparks, Carman et al., 2001; Gorkiewicz, 2009). [0006] The selection pressure that antibiotics exert on the intestinal micro-flora also contributes to the spread of resistant bacteria in the environment. The majority of the infections caused by these microorganisms in hospitals, also known as nosocomial infections, are particularly common and severe in intensive care and surgical units. In particular, they involve catheter infections, urinary tract infections, lung diseases and post-operative infections. They are mainly caused by Gram-negative enterobacteria, coagulase-positive or negative staphylococci, enterococci and Candida albicans (Richards, Edwards et al., 2000). [0007] Nosocomial infections are an important cause of death and a major health issue. The emergence of resistant bacteria, secondary to the widespread use of antibiotic treatment, complicates the treatment of these nosocomial infections and represents a considerable cost to society. In Europe, nosocomial infections are directly responsible for approximately 25,000 deaths each year and an additional cost in healthcare and productivity losses estimated at over 1.5 billion euros per year (ECDC/EMEA Joint Working Group, 2009). In the United States, about 1.7 million nosocomial infections are directly or indirectly responsible for almost 99,000 deaths each year (Klevens, Edwards et al., 2007). [0008] Antibiotics, in particular tetracylines, are extensively used in veterinary medicine in the treatment of livestock and pets. In addition, the use of these antibiotics is allowed in the United States to favour the growth and weight gain in livestock. Of course, this intensive use participates in the dissemination of resistant bacteria in the environment (Institute of Medicine, 1988; Committee on Drug Use in Food Animals, 1999, Georgetown University Center for Food and Nutrition Policy, 1999). [0009] Beta-Lactams [0010] Beta-lactams inhibit the transpeptidases and transglycosylases involved in the formation of peptidoglycane, an essential component of the cell wall of Gram-positive and Gram-negative bacteria (Walsh, 2000). They have a beta-lactam ring, as well as variable lateral chains (for example, 1 st , 2 nd , 3 rd and 4 th generation cephalosporins) that modify their pharmacokinetic properties and the efficacy of their antimicrobial spectrum (Turner, 2005). This class includes the penicillins, cephalosporins, carbapenems and monobactams). [0011] Beta-lactam antibiotics are the most commonly prescribed antimicrobials. They are extensively used clinically for different types of infection (for example, ear, respiratory and gastrointestinal infections). Several routes of administration may be used but the parenteral route is preferred for severe sepsis, usually treated in hospitals. They are frequently associated with other classes of antibiotics for serious infections, such as the association of amoxicillin/clavulanic acid with a macrolide in cases of atypical pneumonia. [0012] The intensive use of beta-lactam antibiotics has favoured the emergence of bacteria resistance. The main mechanism is the acquisition of beta-lactamases, enzymes able to hydrolyse their beta-lactam core. To date, there are several hundred or even thousands of different beta-lactamases that can be grouped into families according to the sequence homology (substrate and inhibitors). These enzymes are generally classified according to their preferential substrate (penicillinase, cephalosporinase, imipenemase, etc.). In addition, beta-lactamases have evolved to become resistant to inhibitors or broaden their action spectrum on the latest beta-lactams (Turner, 2005; Drawz and Bonomo, 2010). These inhibitors (clavulanic acid, sulbactam, etc.) are generally administered simultaneously with beta-lactams and irreversibly bond with bacterial beta-lactamases. [0013] Ambler's classification illustrates the huge diversity of these beta-lactamase enzymes. They are grouped in four families (A, B, C and D) according to their nucleotide sequence (Ambler, 1980). Groups A, C and D have a catalytic serine while group B includes the zinc-dependent metallo-beta-lactamases. [0014] Class A beta-lactamases include several sub-families, including TEM type enzymes (Bush and Jacoby, 1997), ancestral enzymes for resistance to penicillin and aminopenicillin (for example, ampicillin, amoxicillin, becampicillin). TEM-36 is an IR-TEM, that is, a clavulanic acid-resistant beta-lactamase (Zhou, Bordon et al., 1994; Henquell, Chanal et al., 1995; Chaibi, Sirot et al., 1999); TEM-36 or IRT-7 identifier on the Lahey Clinic site (http://www.lahey.org/Studies/temtable.asp). Clavulanic acid is clinically used in association with amoxicillin to broaden the antibiotic spectrum to germs that have acquired a classic beta-lactamase (TEM-1). Under the pressure of selection, the TEM have gradually become resistant to the inhibitor by mutating several amino acids that are currently well characterised (Chaibi, Sirot et al., 1999). [0015] Among the class A beta-lactamases, we also find cefotaximases, enzymes that evolved from TEM to broaden their spectrum to 3 rd generation cephalosporins (Salverda, De Visser et al., 2010). For example, the enzyme CTX-M16 (Genbank identifier of the protein: AAK32961) preferentially hydrolyses cefotaxime when compared with different penicillins (Bonnet, Dutour et al., 2010). [0016] The PC1 enzyme (UniProtKB/Swiss-Prot identifier of the protein: P00807) encoded by the gene blaZ is a class-A beta-lactamase catalytic serum (Ambler, 1975; Knott-Hunziker, Waley et al., 1979; Kemal and Knowles, 1981; Hertzberg and Moult, 1987). This enzyme produced by coagulase-positive Staphylococcus aureus and methi-R Bacillus subtilis hydrolyses the beta-lactam ring of methicillin (Novick, 1963). [0017] Aminoglycosides [0018] Aminoglycosides, also referred to aminosides, are amino sugars linked by a glycoside bridge to a central aminocyclitol core. The structure of this central core is used to distinguish three groups: streptomycins (streptomycin), desoxystreptamins (Kanamycin, Amikacin, Gentamicin) and fortimicins (Dactamicin). [0019] The theoretical antibiotic spectrum of aminoglycosides is very wide and includes aerobic Gram-negative bacteria (bacilli, cocci and coccobacilli), positive or negative coagulase staphylococci and Gram-positive bacilli. In addition, streptomycin is active on Mycobacterium tuberculosis and amikacin on atypical mycobacteria ( Mycobacterium avium intracellulare, etc.), as well as Nocardia asteroids. The aminoglycosides have a synergic activity with beta-lactams and vancomycin. [0020] The aminoglycosides are usually administered parenterally, since little or none is absorbed in the digestive tract. They are mainly eliminated in unchanged form, mainly in the urine by glomerular filtration (85 to 90% of the dose administered is eliminated within 24 hours), and to a lesser extent in the bile without entero-hepatic circulation (about 0.5 to 2% of the dose administered according to the antibiotic) (Leroy, Humbert et al., 1978). This gastric excretion of aminoglycosides results in the selection of resistant bacteria, exposing to a slightly increased risk of pseudomembranous colitis by Clostridium difficile (Arnand, Bashey et al., 1994). [0021] The bactericidal effect of aminoglycosides is fast on many pathogens. Aminoglycosides fix on the 30S ribosomal prokaryote sub-unit and alter the accuracy of the bacterial translation (Poehlsgaard and Douthwaite, 2005). Most of the aminoglycosides bond with 16S ribosomal RNA, the RNA component of the 303 ribosomal sub-unit, at the decoding site (site A). [0022] Bacteria may develop resistance to aminoglycosides by three main mechanisms that may coexist in the same cell (Ramirez and Tolmasky, 2010). A first chromosomic mechanism leads to a reduction of the affinity of the aminoglycoside for its ribosomal target, 16S ribosomal RNA, through its methylation (Doi and Arakawa, 2007). A second mechanism is based on cell permeability failure by modification of the membrane permeability (Hancock, 1981) or an aminoglycoside efflux outside of the cell by an active mechanism (Aires, Kohler et al., 1999). Finally, the enzyme inactivation is the most frequently observed mechanism. Genes encoding these enzymes are carried by plasmids and/or transposons. The resistance is thereby transferable and is often epidemic in hospitals. These enzymes catalyse the irreversible bonding of aminoglycoside with different chemical groups and are grouped in three classes (Shaw, Rather et al., 1993; Ramirez and Tolmasky, 2010). The phosphotransferases (APH) which catalyse a transfer reaction of a phosphate radical of ATP or GTP, the nucleotideyltransferases (ANT) enable the transfer of an adenyl radical and use ATP as a substrate and the acetyltransferases (AAC) transfer an acetyl radical using acetyl-CoA as substrate. Each enzyme class has different sub-classes according to the substituent of the aminoglycoside. The same enzyme can inactivate several aminoglycosides with identical molecular sites. [0023] AAC(6′)-lb-cr (Genbank identifier of the protein: ABC17627.1) is an enzyme from the N-acetyltransferase family naturally produced by enterobacteria. It catalyses the acetylation of an —NH 2 group in position 6′, giving this enzyme a resistance profile identical to other enzymes in the sub-class AAC(6′) (Robicsek, Strahilevitz et al., 2006). Like other enzymes in the family AAC(6′), AAC(6′)-lb-cr is active on a wide range of aminoglycosides including amikacin and the C1a and C2 enantiomers of gentamicin, but has a very low activity on the C1 enantiomer of gentamicin (Robicsek, Strahilevitz et al., 2006). AAC(6′)lb-cr, is probably due to the evolution of the enzyme AAC(6′)-lb by mutation of Trp102Arg and Asp179Tyr residues. This results in the acquisition of enzyme activity on ciprofloxacin, a fluoroquinolone, an activity that is considerably lower for norfloxacin and pefloxacin. [0024] Fluoroquinolones [0025] Fluoroquinolones (for example, norfloxacin, ofloxacin, ciprofloxacin and pefloxacin) form a large class of synthetic bactericidal antibiotics derived from quinolones by chemical modifications, in particular the addition of a fluorine atom. [0026] The fluoroquinolones are broad spectrum antibiotics which differ from one antibiotic to another. The spectrum of fluoroquinologes includes Gram-negative bacilli ( Salmonella spp., Escherichia spp., Shigella spp., Proteus spp., Enterobacter spp., Helicobacter pylori ), Gram-positive cocci (positive and negative coagulase staphylococcus, streptococcus, enterococcus ), Gram-negative cocci ( gonococcus, meningococcus ) and Gram-positive bacilli. [0027] The tissue distribution of fluoroquinolones is excellent even in the cerebrospinal fluid, the prostrate, bones and bile. Fluoroquinolones are thereby widely used in case of tissue infection (meningitis, pneumonia, bone and joint infection, infection of the upper urinary tract or prostate infection, etc). However, the serum level of fluoroquinolones is often low and may even be lower than the MIC (Minimum Inhibitory Concentration) of certain germs, favouring the emergence of bacterial resistance. [0028] The excretion of fluoroquinolones depends on the product used. It is mainly hepatic for pefloxacin, while it is mainly renal for oflaxacin and other fluoroquinolones. Their biliary and digestive elimination accounts for the risk of pseudomembranous colitis by Clostridium difficile, in particular by the strain Bl/NAP1/027, which is especially virulent (Vardakas, Konstantelias et al., 2012; Deshpande, Pasupuleti et al., 2013; Slimings and Riley, 2013). [0029] Fluoroquinolones target DNA gyrase and bacterial topoisomerase II and IV. They form an irreversible complex between these enzymes and bacterial DNA, which prevents DNA replication and causes the death of the bacteria. [0030] Four quinolone resistance mechanisms have been characterised (Robicsek, Jacoby et al., 2006): (i) an increased activity of efflux pumps, provoking a reduction in the intracellular concentration of the antibiotic (Morita, Kodama et al., 1998), (ii) the production of proteins that bind to DNA gyrase or topoisomerase IV, protecting them as well as the fixation of fluoroquinolones (Robicsek, Jacoby et al., 2006), (iii) a modification of the DNA gyrase or topoisomerase IV responsible for high level resistance by reduction of the affinity of the fluoroquinolones for their targets (Robicsek, Jacoby et al., 2006), (iv) finally, the production of an aminoglycoside N-acetyltransferase, AAC(6′)lb-cr (Genbank identifier of the protein: ABC17627.1) capable of catabolising the modification of ciprofloxacin and, to a lesser degree, norfloxacin and pefloxacin (Robicsek, Strahilevitz et al., 2006). [0031] These mechanisms of resistance, whose frequency is quickly increasing, have been identified in many bacteria species, including coagulase-positive Staphylococcus aureus, beta-haemolytic streptococci and enterococci (Robicsek, Jacoby et al., 2006). [0032] Macrolides [0033] Macrolides are a homogenous family of natural and semi-synthetic antibiotics with a relatively limited number of representatives (for example, erythromycin, spiramycin, josamycin, clarithromycin, roxithromycin, azithromycin and telithromycin). [0034] The activity spectrum of macrolides is relatively broad and includes aerobic Gram-positive cocci ( streptococcus, pneumococcus, enterococcus and straphylococcus ) and anaerobic Gram-negative cocci, Gram-negative cocci, certain Gram-negative bacilli such as Helicobacter pylori, and different bacteria with a strict intracellular replication such as Legionella pneumophilia, Mycoplasma pneumoniae and Mycoplasma urealyticum, Clamydiae pneumoniae and Clamydiae trachomatis. However, enterobacteria are intrinsically resistant to macrolides since their outer cell membrane prevents the passage of hydrophobic molecules such as macrolides. [0035] Macrolides are widely distributed in the body, with the exception of cerebrospinal fluid, the brain and urine. Elimination is mainly biliary, after metabolism by the cytochrome P450. The administration of macrolides is associated with an increased risk of pseudomembranous colitis secondary to the selection of Clostridium difficile (Gilbert, 1994; Bartlett, 1996; Hogenauer, Hammer et al., 1998; Wistrom, Norrby et al., 2001). [0036] Macrolides are inhibitors, which bond reversibly with the 50S sub-unit of prokaryotic ribosomes, at site P. They thereby prevent the transfer and dissociation of the peptidyl-tRNA complex (transfer RNA) from site P to site A, and thereby inhibit the peptide chain elongation (Tenson, Lovmar et al., 2003). [0037] Three resistance mechanisms to macrolides are known (Roberts, Sutcliffe et al., 1999; Roberts, 2008): (i) a change in the target by methylation or mutation of the bacterial 23S ribosomal RNA, forming 50S ribosomal RNA. This resistance mechanism, which is most often encountered, is macrolides, lincosamides and streptogramines B (Weisblum, 1995), (ii) production by cell pumps leaking the antibiotic outside of the cell, resulting in a decrease in the intracellular concentration, (iii) inactivation by enzymes (esterase erythromycin a phosphotransferase erythromycin) modifying the macrolides so that their affinity for the ribosome is greatly reduced. This type of resistance is also transmitted by mobile genetic elements. [0038] Erythromycin esterase enzymes inactivate macrolides by hydrolysis of the macrolactone core. Most of these enzymes belong to two sub-classes: ereA (Ounissi and Courvalin, 1985) and ereB (Arthur, Autissier et al., 1986). Enzyme ereB (UniProtKB/Swiss-Prot identifier: P05789.1) with a very broad spectrum (erythromycin, clarithromycin, roxithromycin and azithromycin), although telithromycin is resistant to hydrolysis (Morar, Pengelly et al., 2012). [0039] Tetracyclines [0040] Cyclines or tetracyclines are a family of bactericidal antibiotics derived from tetracycline (for example chlorotetracycline, doxycycline, minocycline). These molecules have the characteristic of having four fused rings, hence the name. [0041] The activity spectrum of tetracylines extends to many aerobic and anaerobic Gram-positive and Gram-negative bacteria. Tetracyclines are also active on unconventional pathogens such as Mycoplasma spp., Chlamydia spp., Rickettsia trepoinemes and some protozoa ( Babesia divergens, Babesia microti, Theileria parva ). The mycobacteria and Enterobacteriaceae Proteus and Pseudomonas are naturally resistant. [0042] Most of the tetracyclines are eliminated by glomerular filtration in active form except for chlorotetracycline. Tetracyclines are also eliminated in the bile with enterohepatic cycle. The use of tetracyclines is also associated with an increased risk of pseudomembranous colitis secondary to the selection of Clostridium difficile (Gilbert, 1994; Bartlett, 1996; Hogenauer, Hammer et al., 1998; Wistrom, Norry et al., 2001). [0043] Antibiotics from the cycline family inhibit the fixation of aminoacyl-tRNA of site A of the ribosomal 305 sub-unit and thereby inhibit the translation (Chopra and Roberts, 2001). At least three mechanisms of resistance have been identified: (i) the expression of efflux proteins, inducing a reduction in the intracellular concentration of tetracyclines, (ii) an enzyme modification of the molecular target, preventing the bonding of tetracyclines, (iii) inactivation by TetX (GenBank identifier of the protein: AAA27471.1), an NADPH-dependent oxyreductase tetracycline (Speer, Bedzyk et al., 1991). This enzyme induces bacterial resistance with respect to all tetracyclines. [0044] Lincosamides [0045] Lincosamides (lincomycin and its semi-synthetic derivative clindamycin) are bacteriostatic antibiotics that, although the chemical structure differs from that of the macrolides, have a similar mode of action and are grouped with the spectogramines B in a single family called MLS (macrolides, lincosamides and streptogramines). [0046] The action spectrum of lincosamides covers the majority of Gram-positive bacteria (for example, Bacillus cereus, Corynebacterium diphtheria, Enterococcus faecium, MSSA and MRSA, B Staphylococcus, non-groupable Staphylococcus, Streptococcus pneumonia, Streptococcus pyogenes ) with a few exceptions such as Streptococcus faecalis, as well as a great many anaerobic bacteria with the noteworthy exception of Clostridium difficile (for example, actinomyces, bacteroides, fusobacterium, Propionibacterium acnes ). Most of the Gram-negative bacteria are resistant except for a few rare exceptions (for example, Bordetella pertussis, Campylobacter, Chlamydia, Helicobacter and Legionella ). [0047] Lincosamides are mainly eliminated by the kidney and to a lesser extent in the bile with the enterohepatic cycle. Their elimination from the gastrointestinal tract and their antibacterial activity account for the high frequency of pseudomembranous colitis by Clostridium difficile selection. [0048] Like the macrolides, the lincosamides inhibit bacterial translation by reversibly bonding with the 50S ribosome sub-unit, at sites A and P (Tu, Blaha et al., 2005). Three resistance mechanisms acquired with lincosamides are known (Roberts, Sutcliffe et al., 1999): (i) a change in the target by methylation or mutation of the bacterial 23S ribosomal RNA, comprising the 50S ribosomal RNA. This resistance mechanism, the one most frequently encountered, is common to macrolides, lincosamides and B streptogramines (Weisblum, 1995), (ii) expression by the bacteria of pumps that efflux the antibiotic outside of the cell, provoking a reduction in its intracellular concentration, (iii) enzyme inactivation of lincosamides reducing their affinity for their molecular target. [0049] Enzymes able to inactivate lincosamides belong to the family of lincomycin nucleotidyltransferases Inu(A) or lin (A) in staphylococci, Inu(B) or lin(B) in Enterococcus faecium, and linB-like in anaerobics (Leclercq, Brisson-Noel et al., 1987; Bozdogan, Berrezouga et al., 1999). For example, the enzyme Inu(B) (UniProtKB/TrEMBLication of the protein: Q9WVY4) catalyses the transfer of an adenyl residue on the hydroxyl group in position 3 of the lincomycin and clindamycin (Bozdogan, Berrezouga et al., 1999). [0050] Counter the Side Effects of These Antibiotics [0051] The prior art is familiar with inhibitors of antibiotics that aim at reducing the adverse reactions previously reported in the intestine. These inhibitors are essentially targeted against beta-lactams and primarily consist of beta-lactamases administered orally for their dissemination in the intestinal tract. [0052] Patent EP0671942 relates to a medical application, a medical procedure and a pharmaceutical preparation. This invention can target the action of beta-lactams administered parenterally and reduce the adverse reactions due to the inactivation of a portion of the antibiotic in the digestive tract, by administering an enzyme such as beta-lactamase orally, either separately of simultaneously with the antibiotic. This leads to the breakdown of the antibiotic. [0053] The EP2086570 application uses, with a similar method, a class A beta-lactamase, more specifically the P1A enzyme, to reduce the intestinal side effects associated with antibiotic therapy combining a beta-lactam and a beta-lactamase inhibitor. [0054] The efficacy of P1A beta-lactamase was evaluated pre-clinically and clinically. This enzyme hydrolyses the aminopenicillins (for example, amoxicillin) and the ureidopenicillins (for example, piperacillin), but is sensitive to beta-lactam inhibitors. Oral administration in the dog, simultaneously with a parenteral administration of ampicillin reduced, in a dose-dependent manner, the amount of ampicillin detected in the jejunal lumen in these animals. In addition, the presence of P1A beta-lactamase was not detected in the circulation and the serum concentrations of ampicillin were not significantly modified (Harmoinen, Vaali et al., 2003; Harmoinen, Mentula et al., 2004). The oral administration of this enzyme in the mouse receiving a parenteral administration of piperacillin very significantly reduced the number of resistant microorganisms to this antibiotic in the faeces (VRE- Enterococcus faecium, Klebsiella pneumoniae and Candida glabrata ) (Stiefel, Pultz et al., 2003; Mentula, Harmoinen et al., 2004). [0055] Finally, a clinical trial demonstrated that the oral administration of P1A beta-lactamase reduced the number of isolates of Enterobacteriaceae resistant to ampicillin in healthy volunteers after the intravenous administration of ampicillin, as well as the number of Enteriobacteriaceae isolates resistant to other class of antibiotics, in particular resistant to the tetracyclines (Tarkkanen, Heinonen et al., 2009). [0056] Recombinant beta-lactamase enzymes belonging to other classes of beta-lactamases have also been developed. Patent EP2038411 describes a metallo-beta-lactamase mutant and its synthesis to reduce the intestinal side effects in patients receiving carbapenemes. [0057] The prior art also includes dosage forms to target the delivery of these enzymes in the intestine. Patent FR2843303 describes multi-particle dosage forms for oral administration for delivery limited to the colon of enzymes able to inhibit macrolides such as erythromycin esterase. Disadvantage of the Solutions in the Prior Art [0058] The solutions in the prior art use enzymes only targeting one type of antibiotic, beta-lactamases breaking down beta-lactams or erythromycin esterase inhibiting macrolides. [0059] Different antibiotics are generally used on hospital patients and are even combined in the same patient. The inhibition of a single class of antibiotics only has a modest or minimum effect on the emergence of resistant bacterial strains. [0060] By way of example, severe infections with Gram-negative bacilli are frequently treated with an association of 3 rd generation cephalosporin and an aminoglycoside, whereas atypical pneumonia is readily treated with an association of amoxicillin-clavulanic acid and a macrolide or tetracycline. [0061] Since the antibiotic inhibitors described in the prior art are directed against a single class of antibiotics, they are not effective in preventing the emergence of resistant bacteria strains in an environment where different classes of antibiotics are simultaneously used, in particular in hospitals. Solution Provided by the Invention [0062] The present invention proposes, in its most widely accepted sense, to overcome the drawbacks of the prior art by providing a hybrid protein molecule comprising at least two proteins capable of inhibiting the activity of at least one antibiotic, each protein having different biochemical properties, said proteins being related. In one embodiment, said proteins capable of inhibiting the activity of at least one antibiotic are linked together covalently. [0063] The hybrid protein molecule, according to the invention, inhibits the activity of at least one antibiotic to reduce the intestinal side effects of antibiotics, such as acute diarrhoea caused by antibiotics and nosocomial infections secondary to the administration of parenteral antibiotics. [0064] It is understood that the present invention has a broader spectrum of action compared with the solutions in the prior art. [0065] Preferably, the hybrid protein molecule in the present invention is administered orally. The hybrid protein molecule according to the invention may comprise proteins capable of inhibiting many classes of antibiotics and, in particular, the associations most commonly used in clinical practice. Thus, the administration of the single hybrid protein molecule can target several antibiotics, thereby reducing the number of products prescribed. [0066] Hybrid protein molecule refers to a hybrid protein formed by the artificial combination of two or more polypeptide chains. [0067] Inhibition of the antibiotic activity refers to all processes leading to a reduction or suppression of the biological activity of the antibiotic considered. This includes, without limitation, the bonding of the antibiotic on another molecule in a specific manner (for example, with a monoclonal antibody or a fragment of a monoclonal antibody) or a non-specific manner (for example, by adsorption), a modification of the antibiotic by enzymatic or non-enzymatic addition of a chemical group or hydrolysis of the antibiotic by an antibiotic or non-antibiotic mechanism. [0068] Advantageously, at least one of the proteins is an enzyme able to inhibit the activity of at least one antibiotic. [0069] In another embodiment, each protein is an enzyme able to preferentially inhibit the activity of at least one antibiotic. [0070] Advantageously, each protein preferentially inhibits the activity of different antibiotics. [0071] In another embodiment of the present invention, the hybrid protein molecule comprises at least two proteins able to inhibit the activity of at least one antibiotic, each enzyme having different biochemical properties, said enzymes being bound together covalently. [0072] It is understood that each enzyme preferentially breaks down two different antibiotics. [0073] The present invention unexpectedly demonstrates that the hybrid protein molecules as defined above combine the respective functional activities of the proteins forming them, resulting in the expansion of their action spectrum and the potentiation of their efficacy in a hospital environment subject to high selection pressure. [0074] Several types of proteins that inactivate one or more antibiotics may be used to form the hybrid protein molecule, including fragments of monoclonal antibodies (for example, monovalent or bivalent ScFv), hydrolase enzymes or enzymes catalysing other types of modifications. [0075] Advantageously, the hybrid protein molecule according to the invention consists of one or several proteins able to inhibit the activity of an antibiotic, preferably an antibiotic selected from among a beta-lactam, an aminoglycoside, a fluoroquinolone, a macrolide, a tetracycline and/or a lincosamide. Preferably, each protein in the hybrid protein molecule inhibits the activity of different antibiotics. In one embodiment, the hybrid protein molecule comprises two proteins capable of inhibiting the activity of antibiotics belonging to the same class. [0076] Advantageously, the sequence of at least one of the component proteins in the hybrid protein has a protein sequence homology of at least 40% with SEQ lD1 to SEQ lD7. This sequence homology is determined using CLUSTALW2 or CLUSTALOMEGA software with standard calculation parameters (Thompson, Higgins et al., 1994; Larkin, Blackshields et al., 2007). Preferably, this sequence homology is at last 50%, and even more preferably at least 60% with SEQ lD1 to SEQ lD7. [0077] The component proteins or enzymes of the hybrid protein molecule may comprise zero, one or several glycosylations. [0078] In one embodiment, the proteins or enzymes are combined into a single monocatenary protein. [0079] In a preferred embodiment, the hybrid protein molecule comprises two enzymes inhibiting the activity of at least one antibiotic, one of the said enzymes is a beta-lactamase and one of the said enzymes is an enzyme chosen from among the beta-lactamases, the enzymes inhibiting an aminoglycoside, the enzymes inhibiting a fluoroquinolone, the enzymes inhibiting a macrolide, the enzymes inhibiting a tetracycline or the enzymes inhibiting a lincosamide, said enzymes being bonded together. [0080] It is understood that the hybrid protein molecule may comprise: two beta-lactamase enzymes bound together; or an enzyme selected from among the beta-lactamases and an enzyme inhibiting an aminoglycoside, interconnected, said enzyme inhibiting an aminoglycoside being a phosphotransferase, a nucleotidyltransferase or an acetyltransferase; or an enzyme selected from the beta-lactamases and an enzyme inhibiting a fluoroquinolone, interconnected, said enzyme inhibiting a fluoroquinolone being an aminoglycoside N-acetyltransferase; or an enzyme selected from among the beta-lactamases and an enzyme inhibiting a macrolide, interconnected, said enzyme inhibiting a macrolide being an erythromycin esterase or an erythromycin phosphotransferase; or an enzyme selected from among the beta-lactamases and an enzyme inhibiting a tetracycline, interconnected, said enzyme inhibiting a tetracycline being a NADPH-dependent oxydoreductase tetracycline; or an enzyme selected from among the beta-lactamases and an enzyme inhibiting a lincosamide, interconnected, said enzyme inhibiting a lincosamide being a nucleotidyltransferase lincomycine. [0087] The inventors have unexpectedly and surprisingly found that the efficacy of the hybrid protein molecule against its target antibiotics is equal to the enzymes comprising it taken alone. [0088] These hybrid proteins may also be obtained artificially as a single protein chain resulting from the translation of a single reading frame obtained either by direct fusion of the respective reading frames of the protein components, or by means of a nucleotide sequence encoding an adapter consisting of one or several amino acids. This adapter, known to be inert and without specific biological action, may be flexible, semi-rigid or rigid (Chen, Zaro et al., 2013). [0089] According to another embodiment, the proteins or enzymes are linked together covalently or by cross-linking. [0090] These hybrid proteins may also be obtained artificially by cross-linking using chemical agents (Chen, Nielsen et al., 2013), enzymatic catalysis (Paguirigan and Beebe, 2007), exposure to ultraviolet light (Fancy and Kodadek, 1999), or any other method resulting in the formation of a covalent bond. Alternatively, such hybrid proteins may be obtained by assembly of one or several protein sub-units non-covalently by means of high-affinity ligands, such as for example the complex (strept)avidin/biotine (Schultz, Lin et al., 2000; Lin, Pagel et al., 2006; Pagel, Lin et al., 2006). [0091] According to another embodiment, the present invention provides a pharmaceutical composition for human or veterinary use comprising the hybrid protein molecule according to the invention for use in the prevention of changes in the intestinal flora. [0092] Advantageously, the invention provides a pharmaceutical composition for use in the prevention of nosocomial infections. [0093] Advantageously, the invention provides a pharmaceutical composition for use in the prevention of diarrhoea associated with the administration of antibiotics. [0094] According to a preferred embodiment, the pharmaceutical composition comprising the hybrid protein molecule according to the invention is a dosage form for oral administration. [0095] It is understood that the invention provides a pharmaceutical composition comprising a hybrid protein molecule for the prevention of changes in the normal intestinal flora in order to prevent the spread of resistant bacteria in the environment, reduce the risk and/or severity of the nosocomial infections caused by multi-resistant microorganisms, and to reduce the frequency and severity of diarrhoea caused by antibiotics. [0096] Advantageously, the pharmaceutical composition is for administration in humans, including paediatrics. It is understood that the pharmaceutical composition according to the present invention may be administered, preferably orally, before, at the same time or after the administration of one or several antibiotics. [0097] In another embodiment, the pharmaceutical composition is for veterinary use in the prevention of the spread of bacterial resistance to antibiotics by pets and in farm animals receiving antibiotics. [0098] The pharmaceutical composition according to the invention also includes any pharmaceutically acceptable substance such as adjuvants, excipients, stabilisers, salts, additives, binders, lubricants, coating agents, colorants, flavours, or any other conventionally used agent known to the person skilled in the art. [0099] The pharmaceutical composition according to the invention may be in solid or liquid form, not limited in the form of a gel, syrup, capsule, tablet, suspension or emulsion. [0100] According to one variant, the pharmaceutical composition comprises at least one gastro-protective agent. [0101] Gastro-protective agent refers to an agent resistant to gastric juices for a delayed release of the hybrid protein molecule in the intestine, preferably in the duodenum and jejunum. The gastro-protective agent may also be a coating agent such as but not limited to the despolymethacrylates (for example, Eudragit®), cellulose-based polymers (cellulose ethers, for example Duodcell®, cellulose esters), polyvinyl acetate copolymers (for example Opandry®) or any other agent for coating or encapsulation or process known to the person skilled in the art. [0102] According to another aspect, the invention includes a method for the production of the hybrid protein molecule in a living non-human recombinant organism. [0103] A living recombinant organism refers to any cell capable of being genetically engineered to produce the hybrid protein molecule. [0104] Without limitation, the term cell capable of being genetically modified refers to any prokaryotic cell (for example Escherichia coli ), yeast (for example Saccharomyces cerevisiae, Pichia pastoris, Kluyveromyces lactis, Yarrowia lipolytica ), insect cells infected or not infected with a baculovirus, mammalian cells (for example CHO, CHO-K1, HEK293, HEK293T). DESCRIPTION [0105] The present invention will be better understood in the light of the description of the following non-limiting examples. DESCRIPTION OF THE FIGURES [0106] FIG. 1 presents a protein sequence alignment of different beta-lactamases belonging to the family of IR-TEM (Amber Class A). The alignment was performed with CLUSTALW2 software on the https://www.ebi.ac.uk/Tools/msa/clustalw2 site using the default settings. FIG. 1 shows, by the alignment of several sequences, that the IR-TEM enzymes show >90% protein identity. These enzymes are relatively well preserved and share between 80 and 99% protein sequence identity and are also well characterised (Bonnet, 2004). [0107] FIG. 2 presents a protein sequence alignment of different beta-lactamases belonging to the family of CTX-M cefotaximases (Amber Class A). The alignment was performed on the https://www.ebi.ac.uk/Tools/msa/clustalw2 site using the default settings on the software. [0108] FIG. 3 provides an illustration of the PCR technique used to generate the hybrid proteins. Two proteins are first amplified separately with a common sequence (at the 3′ and 5′ ends respectively) constituting a linker. The two fragments are then hybridised to the level of the complementary DNA sequence (that of the linker) and the whole is re-amplified using external primers. [0109] FIG. 4 describes all of the constructs used to express the TEM-36 (SEQ lD1), CTXM-16 (SEQ lD2), TEM36-GGGGGG-CTXM16 (SEQ lD8), CTXM16-GGGGGG-TEM36 (SEQ lD9) and TEM36-G(EAAAK)2-CTXM16 (SEQ lD 10) proteins in Pichia pastoris. Cloning into the vector pJexpress915 was performed in Xhol/Notl using, when necessary, moderate digestion to preserve the internal Notl sites at the coding DNA sequence of CTXM16. [0110] FIG. 5 presents the DNA fragments cloned into Xhol/Notl coding for the TEM-36 (SEQ lD1), CTXM-16 (SEQ lD2), TEM36-GGGGGG-CTXM16 (SEQ lD8), CTXM16-GGGGGG-TEM36 (SEQ lD9) and TEM36-G(EAAAK)2-CTXM16 (SEQ lD 10) proteins and that were obtained by PCR using the pJexpress915-SEQ-F and pJexpress915-SEQ-R primers and the following programme (95° C. 30 sec-25 cycles [95° C. 30 sec-53° C. 45 sec-72° C. 1 min]-72° C. 5 min-4° C.). [0111] FIG. 6 presents the hybrid proteins and their constituent enzymes TEM-36 (SEQ lD1) and CTMX-16 (SEQ lD 2) on a 12% SDS-PAGE gel as obtained by expression and purification in Pichia pastoris and after having undergone de-glycosylation treatment by EndoHf. [0112] FIG. 7 describes all of the constructs used to express the TEM-36 (SEQ lD1), CTXM-16 (SEQ lD2) proteins and the hybrid proteins TEM36-GGGGG-CTXM16, CTXM-16-GGGGG-TEM36 in Escherichia coli. The cloning into the pET-26b(+) vector was carried out by Ndel/Hindlll. [0113] FIG. 8 presents DNA fragments cloned into Ndel/Hindlll in the pET-26(+) encoding TEM-36 (SEQ lD1), CTXM-16 (SEQ lD2), TEM36-GGGGG-CTXM16, CTXM16-GGGGG-TEM36 and which were obtained by PCR using the T7-F and T7-R primers and the following programme (95° C. 30 sec-25 cycles [95° C. 30 sec-55° C. 45 sec-72° C. 1 min]-72° C. 5 min-4° C.). [0114] FIG. 9 presents hybrid proteins (TEM36-G 5 -CTXM16 and CTXM16-G 5 -TEM36) and their constituent enzymes TEM-36 (SEQ lD1) and CTXM-16 (SEQ lD 2) on a 12% SDS-PAGE gel as obtained by expression in E. coli and purification from the periplasmic fraction. [0115] FIG. 10 presents the DNA fragments encoding the AAC-6′-lb-cr (SEQ lD4), CTXM-16 (SEQ lD2) and AAC-H6-CTXM16 obtained in the construction of the fusion AAC-H6-CTXM16 (SEQ lD 18). [0116] FIG. 11 presents the hybrid protein AAC-H6-CTXM16 and its constituent enzymes AAC-6′-lb-cr (SEQ lD4) and CTXM-16 (SEQ lD 2) on a 12% SDS-PAGE gel as obtained after expression and purification in E. coli for AAC-6′-lb-cr and the hybrid protein and P. pastoris for CTXM-16. [0117] FIG. 12 presents DNA fragments encoding for EreB (SEQ lD5), TEM36 (SEQ lD1) and EreB-H6-TEM36, which were obtained in the construction of the fusion EreB-H6-CTXM16 (SEQ lD 20). DESCRIPTION OF THE LISTING OF SEQUENCES [0118] Table 1 below summarises the listing of sequences and maps each SEQ-lD (ID No. in the table), the type of sequence, its name, its origin, its expression organism and its size. [0000] TABLE 1 Identification of sequences 1 to 22 of the sequence listing Identifier ID Common (GeneBank/Swiss- Expression Type No. name Prot/UnitProtKB) Original host microorganism Length Description Protein 1 TEM36 Not available Escherichia coli E. coli. / 263 aa β-lactamase P. pastoris (aminopenicillinase) Protein 2 CTXM6 AAK32961 Escherichia coli E. coli. / 263 aa β-lactamase P. pastoris (cefotaximase) Protein 3 PC1 P00807 Staphylococcus E. coli. / 257 aa β-lactamase aureus P. pastoris (methicilli) Protein 4 AAC-6′-lb-cr ABC17627.1 Escherichia coli E. coli. / 199 aa fluroquinolone acetylating P. pastoris aminoglycoside acetyltransferase Protein 5 Ereb P05789.1 Escherichia coli E. coli. / 419 aa Erythromycine esterase P. pastoris Protein 6 TetX AAA27471.1 Bacteroides E. coli. / 388 aa Tetracycline oxydo-reductase fragilis P. pastoris NADPH-dependent Protein 7 LnuB (or Q9WVY4 Enterococcus E. coli. / 267 aa Lincomycine linB) faecium P. pastoris nucleotidylttransferase Protein 8 TEM36-G 6 - Not available Artificial Pichia 532 aa Fusion TEM36 and CTXM16 CTXM16 pastoris with flexible 6 Glycine liner Protein 9 CTXM16- Not available Artificial Pichia 532 aa Fusion CTXM16 and TEM36 G 6 -TEM36 pastoris with flexible 6 Glycine linker Protein 10 TEM36- Not available Artificial Pichia 537 aa Fusion TEM36 and G(EAAAK) 2 - pastoris CTXM16 with rigid linker CTXM16 G(EAAAK) 2 Nucleotide 11 TEM36 Not available Escherichia coli E. coli. / 4158 bp Total sequence of vector P. pastoris pJexpress915 with TEM36 insert cloned in Xhol/Notl Nucleotide 12 CTXM16 AAK32961 Escherichia coli E. coli. / 900 bp Sequence of the insert P. pastoris CTXM16 cloned in Xhol/Notl Nucleotide 13 TEM36-G 6 - Not available Artificial Pichia 1680 bp Sequence of the insert CTXM16 pastoris TEM36-G 6 -CTXM16 cloned in Xhol/Notl Nucleotide 14 CTXM16- Not available Artificial Pichia 1634 bp Sequence of the insert G 6 -TEM36 pastoris CTXM16-G 6 -CTXM16 cloned in Xhol/Notl Nucleotide 15 TEM36- Not available Artificial Pichia 1648 bp Sequence of the insert G(EAAAK) 2 - pastoris TEM36-G(EAAAK)2- CTXM16 CTXM16 cloned in Xhol/Notl Nucleotide 16 CTXM16 AAK32961 Escherichia coli E. coli 870 Insert Ndel/Hindlll coding for CTX-M16 in the vector pET26b+ Nucleotide 17 AAC-6′-lb-cr ABC17627.1 Escherichia coli E. coli 627 Insert Ndel/Hindlll coding for AAV in the vector pJ404 Nucleotide 18 AAC-H6- Not available Artificial E. coli 1416 Fusion AAC-6′-lb-cr with CTXM16 CTX-M16 with a Tag polyhistidine type linker Nucleotide 19 EreB P05789.1 Escherichia coli E. coli 1287 Insert Ndel/Hindlll coding for AAC in the vector pET26b+ Nucleotide 20 EreB-H6- Not available Artificial E. coli 2076 Fusion EreB with TEM36 TEM36 with a Tag polyhistidine type linker Protein 21 AAC-H6- Not available Artificial E. coli 468 Fusion AAC-6′-lb-cr with CTXM16 CTX-M16 with a Tag polyhistidine type linker Protein 22 EreB-H6- Not available Artificial E. coli 688 Fusion EreB with TEM36 TEM36 with a Tag polyhistidine type linker EXAMPLE 1 Hybrid Protein Molecule Consisting of the Fusion of TEM-36 and CTX-M16 by a Flexible Linker [0119] The first embodiment of the present invention describes the fusion of IR-TEM (SEQ lD1); (Chaibi, Sirot et al., 1999)) with a cefotaximase (SEQ lD2; (Bonnet, Dutour et al., 2001)) via a flexible polyglycine linker (6 glycine residues in this example) and giving rise to a hybrid protein (SEQ lD8) able to hydrolyse even amoxicillin in the presence of clavulanic acid as well as ceftriaxone. [0120] The nucleotide sequences encoding the proteins TEM-36 (SEQ lD1) and CTX-M16 (SEQ lD2) were commercially obtained by gene synthesis in an expression vector for Pichia pastoris (https://www.dna20.com/services/gene-synthesis?gclid=CPnQIp3c9r0CFaoewwodnREAlg). The nucleotide sequence of TEM-36 inserted into the expression vector corresponds to SEQ lD 11 and the nucleotide sequence of CTX-M16 inserted in the expression vector corresponds to SEQ lD 12. These sequences were then amplified by PCR (95° C. 30 sec-25 cycles [95° C. 30 sec-TM° C. 45 sec-72° C. 1 min]-72° C. 5 min-4° C.) using a high fidelity DNA polymerase (Pfu, Promega) and partially complementary primers and the protein linker constituent (GGGGGG in this example) as indicated in Table 2. TEM-36 was amplified using the pair of TEM36-F and TEM36-6G-R primers with a TM of 57° C. CTXM16 was amplified using the pair of 6G-CTXM16-F and CTXM16-R primers with a TM of 57° C. The constituent sequences of the linker GGGGGG are indicated in bold type and underlined in Table 2. [0000] TABLE 2 List of primers used to construct the hybrid sequence and protein TEM-36/CTX-M16 to a rigid linker. ID SEQ Primer name No. Sepuence5′-3′ Host TEM36-F 23 GAGGGTGTCTCTCTCGAG Pichia pastoris TEM36-6G-R 24 TCCACCTCCACCTCCTCC CCAATGTTTGATTAGGGA Pichia pastoris 6G-CTXM16-F 25 GGAGGTGGAGGTGGA CAGACGTCAGCCGTGCAGCAAAAG Pichia pastoris CTXM16-R 26 GCTAGGCGGCCGCTTTTACAAACCTTCAGC Pichia pastoris [0121] The two PCR fragments thereby obtained were hybridised at a TM of 55° C. and supplemented during 5 cycles of PCR without primers (95° C. 30 sec-55° C. 45 sec-72° C. 2 min15) using a high fidelity DNA polymerase (Pfu, Promega). The complete sequence encoding the hybrid protein was re-amplified after the addition of the external primers (TEM36-F+CTXM16-R). This embodiment of fusions by PCR is schematically presented in FIG. 3 . [0122] The TEM36-GGGGGG-CTXM16 fusion thereby produced was cloned with restriction enzymes Xhol and Notl in the pJexpress915 vector (expression Pichia pastoris ) ( FIG. 4 ). The sequence of the hybrid construction was verified in both directions and corresponds to the fusion described. FIG. 5 summarises the PCR fragments obtained with the primers pJexpress915-SEQ-F and pJexpress915-SEQ-R. [0123] The vectors pJexpress915 expressing TEM-36, CTX-M16 and the fusion TEM36-GGGGGG-CTXM16 were amplified in Escherichia coli DH10B by maintaining a Zeocine (Invitrogen) selection pressure of 25 μg/ml on salt-depleted LB medium (Yeast extract 5 g/l; Tryptone 10 g/l; NaCl 5 g/l pH=7.5). To transform Pichia pastoris, 2 μg of linearized vector with the Swa l enzyme were electroporated into 60 μl of competent cells by a shock at 1500 V. The transformed cells are taken up in 1 ml of cold Sorbitol 1 M and put into culture for 2 hours at 30° C. prior to spreading (for 200 μl) on YPD-agar medium (Yeast extract 10 g/l; Peptone 20 g/l; Dextrose 20 g/l; agar 15 g/l-Phosphate 10 mM pH=6.8) containing 100 to 400 μg/ml of Zeocin and nitrocefin (20 μg/ml). [0124] Expression in Pichia pastoris from the vector pJexpress915 leads to a secretion of proteins of interest, which are found in the culture medium. On YPD-agar plates containing nitrocefin, the secreted beta-lactamases induce a red hydrolysis halo (λ=486 nm) around the colonies that is representative of the level of expression. After 48 hours of incubation, the transformants with the best expression for each construct was inoculated in Sterlin tube containing 5 ml of YPD and 100 μg/ml of Zeocin and grown for 48 hours at 30° C. and stirred at 200 rpm. [0125] The pre-cultures are then inoculated in 400 ml (200 ml per baffled Erlenmeyer flask) of fresh YPD medium without antibiotic selection pressure with an initial optical density of 0.2 at 600 nm. The culture is left for 48 hours at 30° C. under stirring at 100 rpm. After centrifugation at 10,000×g for 15 minutes at 4° C., the culture medium (supernatant) is stored at 4° C. in the presence of benzamidine (1 mM final). The proteins of the culture medium are then concentrated 10 times by tangential filtration through a 10 kDa membrane (Vivaflow 10 module, Sartorius) to a volume of 40 ml, then to 10 ml by ultrafiltration on 10 kDa membrane (Centricon, Millipore). The 10 ml are injected on a size exclusion chromatography column (Superdex G75 for the TEM-36 and CTX-M16 proteins, Superdex G200 for melting; 26*60 columns GE Healthcare), and eluted in 10 mM of sodium phosphate buffer pH=7.0 by 1 ml fraction and with a flow rate of 1 ml/min. [0126] The fractions with the highest activity on nitrocefin (VWR) and the best purity (SDS-PAGE) is combined and concentrated to about 0.1-0.5 mg/ml. The protein content of the samples is measured by BCA (Pierce), absorbance at 280 nm and verification on SDS-PAGE gel. FIG. 6 provides the results. [0127] For CTX-M16 and the fusion, which have N-glycosylation sites, the glycosylation is verified by cleavage of the sugars with EndoHf enzyme (New EnglandBiolabs) according to the manufacturer's recommendations (overnight at 37° C. in non-denaturant conditions). The proteins produced and purified are confirmed by tryptic digestion and MALDI-TOF mass spectrometry analysis. [0128] As indicated in FIG. 6 , the TEM-36 protein is not glycosylated and its size is compatible with the expected size of 28 kDa, as opposed to the CTX-M16 proteins and the different fusions. The apparent molecular weight of the latter on SDS-PAGE gel is higher (45 kDa versus 28 kDa and >66 kDa versus 56 kDa for CTX-M16 and the fusions respectively. Cutting with EndoHf provides proteins with the expected molecular weight (28 kDa and 56 kDa for CTX-M16 and the respective fusions), thereby confirming that these proteins are glycosylated. [0129] The purified proteins were tested on different beta-lactams (amoxicillin (Apollo Scientific), Augmentin® (GlaxoSmithKline) and Ceftriaxone (Rocéphine®, Roche)). The assays are carried out at pH-STAT (Titrino 2.5, Metrohm) in a reaction volume of 25 ml at 37° C. and pH=7.0. The substrates are prepared at 4 g/l in a 0.3 mM Tris buffer, 150 mM NaCl. The enzyme hydrolysis of the beta-lactam nuclei releases an acid and induces a drop in the pH. The principle of the assay is to compensate for the acidification by the addition of 0.1 N sodium hydroxide so as to remain at pH=7.0. In these conditions, one unit corresponds to 1 μmole of sodium hydroxide added per minute, that is, one μmole of beta-lactam hydrolysed per minute. Table 3 below lists the specific activities measured for each protein on the three substrates (mean of 6 replicates). [0000] TABLE 3 Specific activities of hybrid protein TEM- 36/CTX-M16 with a flexible linker and their constituent enzymes produced and purified in Pichia pastoris Specific activity (U/mg) Substrate Proteins Amoxicillin Augmentin ® Ceftriaxone TEM-36 816 ± 90 97 ± 74 0 CTX-M16 31 ± 2 0 306 ± 44 TEM36-GGGGGG- 695 ± 98 42 ± 33 114 ± 44 CTXM16 [0130] These results show that the fusion between TEM-36 and CTX-M16 generates a hybrid protein with an activity both on an aminopenicillin even in the presence of a beta-lactamase inhibitor and a third generation cephalosporin. Since both activities are described as antagonist in the literature (Ripoll, Baquero et al., 2011), there is no known natural enzyme with such high catalytic constants on these two substrates. EXAMPLE 2 Hybrid Protein Molecule Consisting of the Fusion of CTX-M16 and TEM-36 by a Flexible Linker [0131] A second embodiment of the present invention describes the fusion of a cefotaximase (SEQ lD2; (Bonnet, Dutour et al., 2001)) with an lR-TEM (SEQ lD1; (Chaibi, Sirot et al., 1999)) via a flexible linker polyglycine (6 glycine residues in this example) and giving rise to a hybrid protein (SEQ lD9) able to hydrolyse amoxicillin even in the presence of clavulanic acid as well as ceftriaxone. [0132] This embodiment is identical that described in Example 1 with the exception of the PCR primers used to amplify sequences CTXM16 and TEM-36. [0133] CTXM-16 was amplified using a pair of primers CTX16-F and CTXM16-6G-R with a TM of 58° C. TEM-36 was amplified using the pair of primers 6G-TEM36-F and TEM36-R with a TM of 58° C. The constituent sequences of the linker GGGGGG are indicated in bold type and underlined in Table 4. [0000] TABLE 4 List of primers used to construct and sequence the hybrid protein CTX-M16/TEM-36 with a flexible linker. ID SEQ Primer name No. Sepuence5′-3′ Host CTXM16-F 27 GAGGGTGTCTCTCTCGAG Pichia pastoris CTXM16-6G-R 28 TCCTCCTCCTCCTCC TCCCAAACCTTCAGCTATGATCCG Pichia pastoris TEM36-6G-F 29 GGAGGAGGAGGAGGAGGA CACCCTGAGACACTTGTCAAG Pichia pastoris TEM36-R 30 TTGAGCGGCCGCCCCTCA Pichia pastoris [0134] The two PCR fragments thereby obtained were hybridised at a TM of 55° C. and supplemented during 5 cycles of PCR without primers (95° C. 30 sec-55° C. 45 sec-72° C. 2 min15) using a high-fidelity DNA polymerase (Pfu, Promega). The complete sequence encoding the hybrid protein was re-amplified after the addition of the external primers (CTXM16-F+TEM-36-R). [0135] The conditions used for the expression and purification of the hybrid protein CTXM16-GGGGGG-TEM36 were strictly identical to those described in Example 1. The hybrid protein thereby obtained is also glycosylated as shown in FIG. 6 and combines a persistent penicilinase activity in the presence of clavulanic acid with a cefotaximase activity. [0136] As in the case of Example 1, no natural protein presents the specific activities described in Table 5 on both substrates amoxicillin/clavulanic acid and ceftriaxone. [0000] TABLE 5 Specific activities of hybrid protein CTX- M16/TEM-36 with a rigid linker and their constituent enzymes produced and purified in Pichia pastoris Specific activity (U/mg) Substrate Proteins Amoxicillin Augmentin ® Ceftriaxone TEM-36 816 ± 90 97 ± 74 0 CTX-M16 31 ± 2 0 306 ± 44 TEM36-GGGGGG- 890 ± 83 42 ± 14 123 ± 35 CTXM16 EXAMPLE 3 Hybrid Protein Molecule Consisting of the Fusion of TEM-36 and CTX-M16 by a Rigid Linker [0137] The third embodiment of the present invention describes the fusion of an IR-TEM (SEQ lD1; (Chaibi, Sirot et al., 1999)) with a cefotaximase (SEQ lD2; (Bonnet, Dutour et al., 2001)) via a rigid protein linker (motif G(EAAAK) 2 in this example) and giving rise to a hybrid protein (SEQ lD10) able to hydrolyse amoxicillin even in the presence of clavulanic acid as well as ceftriaxone. [0138] This embodiment is identical that described in Example 1 with the exception of the PCR primers used to amplify the sequences CTXM16 and TEM-36. TEM-36 was amplified using the pair of primers TEM36-F and TEM36-G(EAAAK) 2 with a TM of 58° C. CTXM16 was amplified using the pair of primers CTXM16-G(EAAAK) 2 -F and CTXM16-R with a TM of 58° C. The constituent sequences of the linker G(EAAAK) 2 are indicated in bold type and underlined in Table 6. [0000] TABLE 6 List of primers used to construct and sequence the hybrid protein CTX-M16 and TEM-36 with a rigid linker. ID SEQ Primer name No. Sepuence5′-3′ Host TEM36-F 23 GAGGGTGTCTCTCTCGAG Pichia pastoris CTXM16-R 26 GCTAGGCGGCCGCTTTTACAAACCTTCAGC Pichia pastoris TEM36- 31 TGCTGCCTCTTTAGCGGC CGCCTCTCCCCAATGTTTGATTAGGGA Pichia G(EAAAK) 2 -R pastoris CTXM16- 32 GCCGCTAAAGAGGCAGCA GCAAAACAGACGTCAGCCGTG Pichia G(EAAAK) 2 -F pastoris [0139] The two PCR fragments thereby obtained were hybridised at a TM of 55° C. and supplemented during 5 cycles of PCR without primers (95° C. 30 sec-55° C. 45 sec-72° C. 2 min15) using a high-fidelity DNA polymerase (Pfu, Promega). The complete sequence encoding for the hybrid protein was re-amplified after the addition of external primers (TEM36-F+CTXM16-R). [0140] The conditions used for the expression and purification of the hybrid protein TEM36-G(EAAAK) 2 -TEM36 were strictly identical those described in Example 1. The hybrid protein thereby obtained is also glycosylated ( FIG. 6 ) and combines a persistent penicillinase activity in the presence of clavulanic acid with a cefotaximase activity. [0000] TABLE 7 Specific activities of hybrid protein CTX- M16/TEM-36 with a flexible linker and their constituent enzymes produced and purified in Pichia pastoris Specific activity (U/mg) Substrate Proteins Amoxicillin Augmentin ® Ceftriaxone TEM-36 816 ± 90 97 ± 74 0 CTX-M16 31 ± 2 0 306 ± 44 TEM36-GGGGGG-  890 ± 176 34 ± 6  141 ± 55 CTXM16 [0141] As in Examples 1 and 2, no natural protein presents the specific activities described in Table 7 on both substrates amoxicillin/clavulanic acid and ceftriaxone. EXAMPLE 4 Non-Glycosylated Hybrid Protein Molecules Consisting of the Fusion of TEM-36 and CTX-M16 (and Vice-Versa) by a Flexible Linker [0142] The coding sequences for TEM-36 (SEQ lD1) and CTXM16 (SEQ lD2) were commercially obtained by gene synthesis (https://www.dna20.com/services/gene-synthesis?gclid=CPnQlp3c9r0CFaoewwodnREAlg) in a periplasmic expression vector for E. coli. The nucleotide sequences were obtained in phase with the reading frame encoding a periplasmic targeting peptide (MSIQHFRVALIPFFAAFCLPVFA) with an Ndel restriction site at the initiating methionine and a Hindlll restriction site after the stop codon. Gene fragments Ndel/Hindlll were then sub-cloned in the pET-26b(+) vector (Invitrogen). [0143] As shown in FIG. 3 , we created two hybrid protein molecules by overlap PCR. The nucleotide sequence of TEM-36 and CTX-M16 were amplified by PCR (95° C. 30 sec-25 cycles [95° C. 30 sec-TM° C. 45 sec-72° C. 1 min]-72° C. 5 min-4° C.) using a high-fidelity DNA polymerase (Pfu, Promega) and partially complementary primers constituting the linker protein (GGGGGG in this example). TEM-36 was amplified with a TM of 55° C. using either the primer pair T7-F and TEM36-G6-R-co or the primer pair TEM36-G6-F-co and T7-R. CTXM16 was amplified with a TM of 55° C. using the primer pair CTXM16-G6-F-co and T7-R or the primer pair CTXM16-G6-R-co and T7-F. The constituent sequences of the linker GGGGGG are indicated in bold type and underlined in Table 8. [0000] TABLE 8 List of primers used to construct and sequence the hybrid protein TEM-36/CTX-M16 with a flexible linker. ID SEQ Primer name No. Sepuence5′-3′ Host T7-F 33 TAATACGACTCACTATAGGGGAAT E. coli TEM36_36G_R_co 34 TCCTCCTCCTCCTCCTCC CCAATGTTTAATCAGGCT E. coli CTXM16-G6_F_co 35 GGAGGAGGAGGAGGA CAGACGTCAGCCGTGCAGCAAAAG E. coli CTXM16-G6_R_co 36 TCCTCCTCCTCCTCCTCC CAAACCTTCAGCTATGATCCG E. coli TEM36-6G-F 37 GGAGGAGGAGGAGGAGGA CACCCTGAGACACTTGTCAAG E. coli T7-R 38 CTAGTTATTGCTCAGCGGTGG E. coli [0144] The two PCR fragments thereby obtained (TEM36-G6+G6-CTXM16 and CTXM16-G6+G6-TEM36) were hybridised at a TM of 55° C. and supplemented during 5 cycles of PCR without primers (95° C. 30 sec-53° C. 45 sec-72° C. 2 min15) using a high-fidelity DNA polymerase (Pfu, Promega). The complete sequence encoding for the hybrid protein was re-amplified after the addition of external primers (T7-F+T7-R) operating at a TM of 55° C. [0145] The fusions TEM36-GGGGGG-CTXM16 and CTX-M16-GGGGGG-TEM36 thereby produced were cloned with the Ndel and Hindlll restriction enzymes in a pET26b+ vector (expression in E. coli ) ( FIG. 7 ). [0146] The sequences of the hybrid constructs were verified in directions and revealed that the linker of the 2 hybrid protein molecules actually consist of only 5 glycines. A more favourable nucleic rearrangement probably occurred at the time of the PCR hybridations. FIG. 8 sums up the PCR fragments obtained with the primers T7-F and T7-R. [0147] The pET-26b(+) expression vectors expressing TEM-36 (SEQ lD1), CTX-M16 (SEQ lD2) and the fusions TEM36-G 5 -CTXM16 and CTXM16-G 5 -TEM36 were amplified in Escherichia coli DH10B by maintaining a Kanamycin (Euromedex) selection pressure at 50 μg/ml on LB medium (Yeast extract 5 g/l; Tryptone 10 g/l; NaCl 10 g/l pH=7). The expression strain BL21(DE3) pLysS was transformed with the expression vectors by heat shock. The transformed cells were spread on LB-agar medium (Yeast extract 5 g/l; Tryptone 10 g/l; NaCl 10 g/l; Agar 15 g/l pH=7) containing 50 μg/ml of Kanamycin. [0148] The expression in E. coli from the pET-26b(+) vector leads to an addressing of the proteins of interest in the periplasmic compartment of bacteria where they are functional. The fusions created as described in Example were evaluated in 2 complementary ways: (i) by biochemically characterising the partially purified proteins and (ii) by comparing the minimum inhibitory concentrations (MIC) of different b-lactams (amoxicillin, Augmentin and Rocéphine) on the expression strains. [0149] Purification of Hybrid Protein Molecules and Their Component in E. Coli: [0150] The transformed bacteria are grown in 100 ml of LB+50 μg/ml of Kanamycin at 37° C. and with stirring at 200 rpm until saturation. The pre-cultures are then inoculated at 1/40 th in 1 L of LB medium+50 μg/ml Kanamycin. When the OD600 nm reached a value of 0.6 (about 2 hours), the protein production is induced by the addition of 0.5 mM final IPTG and continues for 16 hours at 20° C. with stirring at 200 rpm. The cells are centrifuged at 5,000×g for 15 minutes at 4° C. and the sediment immediately taken up in an osmolysis buffer to break the outer membrane and recover the periplasma. The cells are taken up with 1 ml of buffer (Phosphate 100 mM, Sucrose 500 mM, EDTA 1 mM pH=7.0) for 120 Units of OD600 nm and incubated for several minutes with vortex homogenisation (protocol adapted from (Schlegel, Rujas et al. 2013)). After centrifugation at 12,000×g for 20 minutes at 4° C., the supernatant containing the periplasmic proteins is concentrated on Amicon Ultra (15 ml, 10 kDa, Millipore) until the volume does not exceed 10 ml. The totality of the proteins is injected on an exclusion chromatography column (Superdex G75, GE Healthcare) and the proteins are eluted in phosphate buffer (Phosphate 10 mM, NaCl 100 mM pH=7.0) per 1 ml fraction and with a flow of 1 ml/min. The fractions with the highest activity on nitrocefin (VWR) and the best purity (SDS-PAGE) are combined and concentrated to about 0.1-0.5 mg/ml. The protein content of the samples is measured by absorbance at 280 nm and verification on SDS-PAGE gel. FIG. 9 presents the partially purified proteins as obtained before biochemical characterisation. [0151] The enzyme activities of the purified proteins were measured on different beta-lactams (amoxicillin (Apollo Scientific), Augmentin® (GlaxoSmithKline) and Ceftriaxone (Rochéphine®, Roche)) as described in the above examples and the results are compiled in Table 9 below. [0000] TABLE 9 Specific activities of hybrid protein molecules TEM36-G 5 -CTXM16 and CTXM16-G 5 -TEM36 (flexible linker) and their constituent enzymes produced and purified in Escherichia coli BL21(DE3) pLysS. Specific activity (U/mg) Substrate Proteins Amoxicillin Augmentin ® Ceftriaxone TEM-36 3593 ± 87  385 ± 31  1 ± 1 CTX-M16 21 ± 1 0 158 ± 14 TEM36-GGGGGG- 633 ± 99 24 ± 5 138 ± 32 CTXM16 CTXM16-GGGGG- 566 ± 32 17 ± 5  103 ± 3142 TEM36 [0152] As in Examples 1 to 3, no natural protein presents the specific activities described in Table 9 on both substrates amoxicillin and ceftriaxone. [0153] Resistance of Strains of E. Coli Expressing the Hybrid Protein Molecules to Various Beta-Lactams: [0154] The transformed bacteria (expressing TEM36, CTXM16 or the fusions TEM36-G5-CTXM16 and CTXM16-G5-TEM36) or the empty strain (BL21(DE3)pLysS) are put in culture in 5 ml of LB+50 μg/ml of Kanamycin when necessary at 37° C. and stirring at 200 rpm until saturation. The pre-cultures are then inoculated at 1/40 th in 5 ml of LB+50 μg/ml Kanamycin medium and when the OD600 reaches a value of 0.6 (about 2 hours), the production of protein is induced by the addition of final IPTG 1 mM and continues for 1.5 hours at 37° C. with stirring at 200 rpm. [0155] The cells are normalised at 108 cfu/ml and diluted in cascade to 10 7 , 10 6 , 10 5 , 10 4 cfu/ml and 5 μl of each suspension are deposited on an LB-Agar plate containing increasing concentrations of antibiotics (Amoxicillin 0, 2, 4, 8, 16, 32, 64, 128, 256, 512, 1024 μg/ml; Augmentin 0, 1, 2, 4, 8, 16, 32, 64, 128, 256, 512 μg/ml and Rocéphine 0, 0.5, 1, 2, 4, 8, 16, 32, 64, 128, 256, 512 μg/ml). [0156] The dishes were incubated at 37° C. overnight and the results were recorded the following day. The MICs correspond to the lowest concentration of antibiotic at which the highest inoculum doesn't grow. [0157] The data is provided in Table 10 below. [0000] TABLE 10 MICs of beta-lactam antibiotics for strains of E. coli expressing the hybrid protein molecules TEM36-G 5 -CTXM16 and CTXM16-G 5 -TEM36 (flexible linker) and their constituent enzymes. Antibiotics MIC (μg/ml) Strain Amoxicillin Augmentin Rocephine BL21(DE3)pLysS <0.5 <0.5 <0.5 BL21(DE3)pLysS + TEM36 >1024 512 <0.5 BL21(DE3)pLysS + CTXM16 >1024 4 512 BL21(DE3)pLysS + TEM36-G 5 - >1024 128 64 CTXM16 BL21(DE3)pLysS + CTXM16- >1024 128 128 G 5 -TEM36 [0158] The E. coli cells expressing the hybrid protein molecules as described in Example 4 present a multidrug resistance phenotype to aminopenicillins (with or without inhibitors such as clavulanic acid) and 3 rd generation cephalosporins such as ceftriaxone. No natural bacteria strain has so far been described in the literature with such a phenotype. EXAMPLE 5 Hybrid Protein Molecule Consisting of the Fusion of CTX-M16 and AAC-6′-lb-cr by a Poly-Histidine Linker [0159] The nucleotide sequences encoding the CTX-M16 (SEQ lD2) and AAC-6′-lb-cr proteins (hereafter called AAC) (SEQ lD4) were commercially obtained by gene synthesis in an expression vector for E. coli, respectively pJexpress411 (KanR) and pJ404(AmpR). The nucleic sequence of CTX-M16 inserted in the vector pJexpress411 corresponds to SEQ lD16 and the nucleic sequence of AAC inserted in the vector pJ404 corresponds to SEQ lD12. These sequences were then amplified by PCR (95° C. 30 sec-25 cycles [95° C. 30 sec-TM° C. 45 sec-72° C. 1 min]-72° C. 5 min-4° C.) using a high-fidelity DNA polymerase (Pfu, Promega) and partially complementary primers constituent of the protein linker (HHHHHH in this example) as indicated in Table 11. CTX-M16 was amplified using the primer pair 6H-CTX-F and T7R with a TM of 62° C. ACC was amplified using the primer pair AAC-F_coli and AAC-6H-R with a TM of 50° C. The constituent sequences of the linker HHHHHH are indicated in bold type underlined in Table 11. [0000] TABLE 11 List of primers used to construct and sequence the hybrid protein AAC-H6-CTXM16 with a polyhistidine linker. ID SEQ Primer name No. Sepuence5′-3′ Host AAC-F_coli 39 GAAGGAGATATACATATGAGCAACGCT E. coli AAC-6H-R 40 GTGGTGATGATGGTGGTGCGC E. coli H6-CTX-F 41 CACCATCATCACCACCAGACGTCAGCCGTGCAGCAAAAG E. coli T7-R 38 CTAGTTATTGCTCAGCGGTGG E. coli [0160] The two PCR fragments thereby obtained were hybridised at a TM of 62° C. and supplemented during 5 cycles of PCR without primers (95° C. 30 sec-62° C. 45 sec-72° C. 2 min15) using a high-fidelity DNA polymerase (Pfu, Promega). The complete sequence encoding for the hybrid protein was re-amplified after addition of the external primers (AAC-F_coli+T7R). This embodiment of fusions by PCR is schematically presented in FIG. 3 . The inserts encoding for AAC, CTXM16 and the fusion AAC-6H-CTXM16 were loaded on 1% agarose gel to illustrate their respective size ( FIG. 10 ). [0161] The fusion AAC-6H-CTXM16 thereby produced was cloned with Ndel and HinDlll restriction enzymes in the pET26b+ vector ( E. coli expression) according to the principle illustrated in FIG. 7 . [0162] The sequence of the hybrid construction was verified in both directions and corresponds to the fusion described. [0163] The pJ404-AAC expression vectors expressing AAC and pET-AAC-6H-CTXM16 expressing the fusion AAC-H6-CTXM16 were transformed in Escherichia coli BL21(DE3)pLysS by maintaining an 100 μg/ml Ampicillin (Euromedex) and 50 μg/ml Kanamycin (Euromedex) selection pressure on LB medium (Yeast extract 5 g/l; Tryptone 10 g/l; NaCl 10 g/l pH=7.5. The expression of AAC as well as the AAC-6H-CTX fusion in E. coli from vector pJ404 results in inclusion bodies for the proteins of interest. [0164] For each protein, 1 L of LB is seeded at 1/40 th from a saturated pre-culture and then grown at 37° C. with stirring at 200 rpm until an OD (600 nm) of about 0.4-0.6. The cultures are induced for 4 hours at 37° C. and 200 rpm by the addition of 0.5 mM final IPTG. At the end of production, the cells are centrifuged and the sediment is taken up at 40 ml/L of culture in lysis buffer (10 mM Tris-HCl, 150 mM NaCl, 1 mM EDTA, 0.1% Triton X100 pH=8.0 and 0.25 mg/ml lysozyme) and then frozen at −80° C. The cells are thawed out and lysed for 45 minutes at ambient temperature in the presence of MgSO 4 (20 mM) and DNAse (10 μg/ml). The lysate is centrifuged (30 min at 12,000×g at 4° C.) and the sediment containing the inclusion bodies of the proteins of interest (AAC and AAC-6H-CTXM16) is taken up in buffer A (10 mM Phosphate, 150 mM NaCl, 10 mM Imidazole, 8 M Urea pH=8.0). The proteins are purified by Nickel affinity chromatography and eluted with a gradient of buffer B (10 mM Phosphate, 150 mM NaCl, 500 mM Imidazole, 8 M Urea pH=8.0). [0165] The fractions containing the proteins of interest are mixed, incubated for 1 hour at 4° C. in the presence of 1 mM DTT, then re-natured by 3 successive dialyses in 10 mM Phosphate buffer, 150 mM NaCl pH=8. The proteins are clarified by centrifugation then concentrated to a volume not exceeding 10 ml by ultrafiltration through a 10 kDa membrane (Centricon, Millipore). The proteins are injected onto a size exclusion chromatography column (Superdex G200; columns 26*60 GE Healthcare) and eluted in 10 mM Phosphate buffer, 150 mM NaCl pH=8.0 by 1 ml fraction with a flow of 1 ml/min. [0166] The fractions with the highest activity on Nitrocefin (VWR) and the best purity (SDS-PAGE) are combined and concentrated to about 0.5 mg/ml. The protein content of the samples is measured by BCA (Pierce), absorbance at 280 nm and verification on SDS-PAGE gel. FIG. 11 presents the results of the purified proteins obtained. [0167] The purified proteins were tested on different antibiotics: Ceftriaxone (RocéphineED, Roche) for the beta-lactams and kanamycin for the Aminoglycosides. The assays on ceftriaxone were carried out at pH-STAT (Titrino 2.5, Metrohm) in a reaction volume of 25 ml at 37° C. and pH=7.0. The substrates are prepared at 4 g/l in a 0.3 mM Tris buffer, 150 mM NaCl. The enzyme hydrolysis of the beta-lactam nuclei releases an acid and results in a drop in the pH. The principle of the assay is to compensate this acidification by the addition of 0.1 N sodium hydroxide so as to remain at pH=7.0. In these conditions, one unit corresponds to 1 μmol of sodium hydroxide added per minute, that is one μmol of beta-lactam hydrolyzed per minute. [0168] The activity of acety-transferase is measured by an indirect colorimetric assay with acetyl-CoA (Sigma-Aldrich) as acetyl group donor, Kanamycin as acceptor and Elleman reagent (DTNB, Sigma-Aldrich) to titrate the CoEnzymeA reduced (—SH) molecules released during the enzyme reaction [Ref]. The reaction takes place on a microtitration plate with increasing quantities of purified enzymes, in a final volume of 200 μl and with concentrations of 500 μM Kanamycin, 500 μM AcetylCoA and 250 μM DTNB. In these experimental conditions, the ion TNB 2 absorbs at 412 nm with an ε(λ=412 nm) apparent 19 000 M −1 .well −1 (well of a 96 well plate filled with 200 μl) and 1 unit corresponds to one nanomole of TNB 2 released per minute at 37° C. [0169] Table 12 below sums up the specific activities measured for each protein on the three substrates (mean of 6 experiments, that is, n=6). [0000] TABLE 12 Specific activities of hybrid protein AAC-H6- CTX-M16 and their constituent enzymes Specific activity (U/mg) Substrate Proteins Kanamycin Cetriaxone AAC 10.2 ± 3.2 0 CTX-M16 0 336 ± 5  AAC-6H-CTXM16 14.2 ± 2.4 270 ± 36 [0170] These results show that the fusion between AAC-6′-lb-cr and CTX-M16 generates a hybrid protein able to hydrolyze a third generation cephalosporin and inactivate an aminoglycoside by acetylation. There is no known natural enzyme capable of inactivating an antibiotic in these two classes. EXAMPLE 6 Non-Glycosylated Hybrid Protein Molecules Consisting of the Fusion of EreB and TEM36 by a Tag Polyhistidine Type Linker [0171] The sequences encoding for TEM-36 (SEQ lD1) and EreB (SEQ lD5) were commercially obtained by gene synthesis in an expression vector for E. coli. The gene fragments Ndel/Hindlll were then sub-cloned in the pET-26b(+) vector (Invitrogen). [0172] According to the principle described in FIG. 3 , we produced a hybrid protein molecule EreB-H6-TEM36 by overlap PCR. The nucleotide sequence of TEM-36 and EreB were amplified by PCR (95° C. 30 sec-25 cycles [95° C. 30 sec-TM° C. 45 sec-72° C. 1 min]-72° C. 5 min-4° C.) using a high-fidelity DNA polymerase (Pfu, Promega) and partially complementary primers constitutive of the protein linker (histidine tag 6 in this example). TEM-36 was amplified with a TM of 65° C. using primer pair EreB6HTEM36_coli_F and T7_R. EreB was amplified with a TM of 65° C. using the primer pair EreB_coli_F and EreB6HTEM36_R. The constituent sequences of the HHHHHH linker are indicated in bold type and underlined in Table 13. [0000] TABLE 13 List of primers used to construct and sequence the hybrid protein EreB-H6-TEM-36. ID SEQ Primer name No. Sepuence5′-3′ Host EreB_coli_F 39 GATATACATATGCGTTTTGAAGAGTGG E. coli EreB6HTEM36_R 40 GTGATGGTGATGGTGGTG CTCATAAAC E. coli EreB6HTEM36_coli_F 41 CACCACCATCACCATCAC CACCCGGAAACCCTGGTGAAAGTT E. coli T7-R 38 CTAGTTATTGCTCAGCGGTGG E. coli [0173] The PCR fragments thereby obtained were hybridized at a TM of 55° C. and supplemented during 5 cycles of PCR without primers (95° C. 30 sec-55° C. 45 sec-72° C. 2 min15) using a high-fidelity DNA polymerase (Pfu, Promega). The complete sequence encoding for the hybrid protein was re-amplified after the addition of external primers (EreB_coli_F+T7-R) operating at a TM of 55° C. [0174] The EreB-H6-TEM36 fusion thereby produced was cloned with the Ndel and Hindlll enzyme restrictions in the pET26b+ vector (expression in E. coli ) ( FIG. 7 ). [0175] The sequence of hybrid construction was verified in both directions. FIG. 12 sums up the PCR fragments obtained with the T7-F and T7-R primers on the pET-TEM36, EreB and EreB-H6-TEM36 series. [0176] The pET-26b(+) expression vectors expressing TEM-36 (SEQ lD1), EreB (SEQ lD2) and the fusion EreB-H6-TEM36 were amplified in Escherichia coli DH10B while maintaining a 50 μg/ml Kanamycin (Euromedex) selection pressure on LB medium (Yeast extract 5 g/l; Tryptone 10 g/l, NaCl 10 g/l pH=7). The expression strain BL21(DE3) pLysS was transformed with the expression vectors by heat shock. The transformed cells were spread on LB-agar medium (Yeast extract 5 g/l; Tryptone 10 g/l; NaCl 10 g/l; agar 15 g/l pH=7) containing 50 μg/ml of Kanamycin. [0177] The functionality of the proteins of interest (TEM36, EreB and the fusion EreB-H6-TEM36) in E. coli was evaluated by measuring the resistance of the expression strains to different b-lactam (amoxicillin and augmentin) and macrolide (erythromycin) type antibiotics. [0178] The transformed bacteria (expressing TEM36, EreB or EreB-H6-TEM36) or the empty strain (BL21(DE3)pLysS) are put in culture in 5 ml of LB+50 μg/ml of Kanamycin when necessary at 37° C. with stirring at 200 rpm until saturation. The pre-cultures are then inoculated at 1/40 th in 5 ml of LB+50 μg/ml Kanamycin medium and when the OD600 nm reaches a value of 0.6 (about 2 hours), the production of protein is induced by the addition of 1 mM final IPTG and continued for 1.5 hours at 37° C. with stirring at 200 rpm. [0179] The cells are normalized to 108 cfu/ml and diluted in cascade to 10 7 , 10 6 , 10 5 , 10 4 cfu/ml and 5 μl of each suspension are deposited on an LB-agar dish containing increasing concentrations of antibiotics (Amoxicillin 0, 2, 4, 8, 16, 32, 64, 128, 256, 512, 1024, 2048 μg/ml; Augmentin 0, 2, 4, 8, 16, 32, 64, 128, 256, 512, 1024 μg/ml and Erythromycin 0, 2, 4, 8, 16, 32, 64, 128, 256, 512, 1024 μg/ml). [0180] The dishes are incubated at 37° C. over night and the results are recorded the next day. The MICs correspond to the lowest concentration of antibiotic at which the highest inoculum no longer grows. [0181] The data are provided in Table 14 below. [0000] TABLE 14 MICs of beta-lactam and macrolide antibiotics for strains of E. coli expressing the hybrid protein molecule EreB-H6-TEM36 and their constituent enzymes. Antibiotics MIC (μg/ml) Strain Amoxicillin Augmentin Erythromycin BL21(DE3)pLysS <2 <2 256 BL21(DE3)pLysS + >2048 512 256 TEM36 BL21(DE3)pLysS + EreB <2 <2 >1024 BL21(DE3)pLysS + EreB- 32 8 >1024 H6-TEM36 [0182] The E. coli cells expressing the hybrid protein molecule as described in Example 6 presents a multidrug resistance phenotype to aminopenicillins (with or without inhibitors such as clavulanic acid) and macrolides such as erythromycin. No natural bacteria strain has so far been described in the literature with such a phenotype resulting from the expression of a single protein.

The invention relates to a hybrid proteinaceous molecule comprising at least two proteins capable of inhibiting the activity of at least one antibiotic, the proteins each having different biochemical properties and being bonded to one another. The hybrid proteinaceous molecule inhibits the activity of a least one antibiotic in order to reduce the intestinal side effects of antibiotics, such as severe diarrhoea caused by the antibiotics, and nosocomial infections secondary to parenteral antibiotic therapy.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT This invention was made with Government support under Grant No.R44NS35413 awarded by the National Institute of Neurological Disorders and Stroke and Grant No. R44MH54949 awarded by the National Institute of Mental Health. The Government has certain rights in the invention. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates, generally, to wireless data acquisition systems for data communications and, more particularly, to wireless data acquisition systems which employ small size, low power and low cost components and which may be adapted for different applications by software programming. 2. Description of the Related Art All data acquisition systems generally operate in a similar fashion. They receive an external input from some type of sensing device, condition and/or convert the input to a format suitable for transmission, as necessary, and transmit it to another piece of equipment usually a monitor or controller, which may be a computer, and more specifically, a personal computer. The external input is generally an analog signal, although digital signals, frequently on-off switching, pulse-width modulation, or serial data protocols, are also involved. The inputs, though, come in many forms with many different characteristics, be they pneumatic, hydraulic or electronic, to list a few. Modern applications, control schemes and devices usually necessitate the use of electronic inputs in one form or another. For example, electronic analog inputs may have ranges of 4-20 mA, +/-5 volts, +/-15 volts, or microvolts to millivolts. In the case of a wired system the analog input can be transmitted directly over interconnecting wiring with the major concern being that the interconnecting wires be suitably shielded to prevent interference by nearby electromagnetic sources. Signal conditioning becomes critically important for wireless systems, though. This is especially so when considering power consumption, size and cost factors. Because electronic inputs can have different characteristics (e.g.: high frequency or low frequency) and ranges (e.g.: microvolts to many volts), data acquisition systems are either application specific, i.e. designed to accept and condition a particular type of signal, i.e.: current, with a range of 4-20 mA for instance, or include separate discrete signal conditioning devices which consume a large amount of power and add considerable size. Radio frequency (RF) wireless data acquisition systems can convert the input to a conditioned electronic signal which is used to modulate a carrier frequency which is then transmitted as a radio frequency signal to equipment in another location. The conditioned signal is encoded with data corresponding to the status of the input. The radio frequency signal is received, demodulated and decoded and the data is read, displayed, stored, and/or acted upon, i.e. monitored, analyzed, by equipment at the receiving point. In the United States the Federal Communications Commission (FCC) regulations govern RF transmissions, and similar agencies regulate RF transmissions in other countries, specifically as to the frequency band that can be utilized to transmit the signal and the strength of the signal. Other data transmission means, such as infrared, optical, or any means which does not require a mechanical connection is understood to offer similar advantages as RF transmission. Wireless data acquisition systems are well known in the art. In the biomedical area, U.S. Pat. No. 5,704,351 to Mortara discloses a multiple channel biomedical digital telemetry transmitter. Mortara teaches an 8 channel biomedical transmitter specifically directed to electrocardiogram (EKG) signal transmission in the 902 to 928 MHz band. The Mortara device includes input circuitry and an analog-to-digital converter which receives the input signal from an EKG electrode and converts it to a digital signal which is inputted to a microprocessor. The microprocessor then converts the digital signal to a serial digital output signal which is used to frequency modulate the radio frequency carrier signal for telemetry transmission. The carrier frequency is adjustable within the 902 to 928 MHz band by two manual frequency setting switches. The use of these manual switches is the only adjustment available on the Mortara device and only to manually set the frequency within the 902 to 928 MHz band. The input circuitry and analog-to-digital converter are not adjustable nor adaptable to accept different input signal characteristics. In addition, the Mortara device cannot be adjusted, by programming or otherwise, to operate in any other frequency band. Finally, the Mortara device is just a transmitter and, therefore, is not able to receive RF or other signals to control its operation. Similarly, U.S. Pat. No. 5,755,230 by Schmidt et al, discloses a device for monitoring a physiological signal, in this case EEG, and transmitting it by RF signal to a receiver. Like Mortara, the Schmidt device also cannot be modified or adjusted to receive inputs from different physiological sensors. U.S. Pat. No. 5,579,775 to Dempsey, discloses a Dynamic Control of a Patient Monitoring System. Like Mortara and Schmidt, Dempsey '775 teaches a patient monitoring system with a telemetry subsystem which monitors and transmits an RF signal representing signals it receives from one or more physiological monitoring instruments. Unlike Mortara and Schmidt, Dempsey '775 teaches a receiving subsystem which can receive RF signals, in a backchannel arrangement to control the operation of the system. Dempsey '775, though, does not disclose or teach a system with the capabilities to adjust or modify input means, by software programming or otherwise, in response to different physiological signals. The device relies on separate monitoring sections in order to accommodate different physiological signals, i.e., EEG, ECG, SpO 2 etc. U.S. Pat. No. 5,417,222, also to Dempsey, discloses a portable processor interfaceable with a telemetry monitor at its I/O port. The Dempsey '222 device includes a telemetry monitor comprising a physiological monitor which receives selected physiological signals indicating a specific physiological condition of a patient. The physiological monitor is a specific type of monitor, i.e. one that reads signals of a specific physiological function, EKG for example. In the event that a different physiological function is to be monitored, i.e. EEG, a different physiological monitor must be employed. The device taught in this patent is designed to operate with basic physiological monitors already utilized in patient diagnostic services. Actually, the Dempsey '222 patent really only teaches the interface of a programmable processor, an example of which is given as Hewlett Packard 100LX palmtop processor (Hewlett Packard being listed as assignee of the patent) with a physiological monitor. Like the device in Dempsey '775, the device is not able to adapt or change the physiological monitor, by software or otherwise, to accept different physiological signals. Fluke Corporation markets a wireless data acquisition system entitled "Wireless Logger". The system is an integration of Fluke's Hydra Data Logger, a portable instrument monitor/analyzer, which accepts wired external inputs, with a RF modem. The Hydra Data Logger includes a universal input module which accepts and conditions the external inputs. The resulting signals are transmitted by the modem to another modem wired to a personal computer. The separate modem and universal input module are relatively large and consume up to 10 watts of power. In addition, the operation of the system is not software programmable. RF Neulink markets a similar system utilizing the VHF (136-280 MHz) and UHF (403-512 MHz) bands. Accordingly, a need exists for a programmable wireless data acquisition system having a signal processing module which is capable of accepting multiple external inputs having different characteristics and ranges, and is able, through software programming, to convert and condition these external inputs, generate a radio frequency signal encoded with data corresponding to the external inputs, be frequency agile and adaptable, and transmit said radio frequency signal to a base station. In addition, a need exists for such a programmable wireless data acquisition system employing small size, low power consumptive and low cost components. Finally, a need exists for such a system which can accurately and dependably transmit data. BRIEF SUMMARY OF THE INVENTION The present invention provides a method and apparatus to satisfy the aforementioned need. Accordingly, an object of the present invention is to provide a programmable wireless data acquisition system which is capable of accepting multiple external inputs having different characteristics and ranges. Another object of the present invention is to provide a programmable wireless data acquisition system which is small, has low power consumption and contains low cost components. Still another object of the present invention is to provide a programmable wireless data acquisition system which can adapt to any changes in the character, type or range of external inputs while the system is operating without affecting or discontinuing its operation. Still another object of the present invention is to provide a programmable wireless data acquisition system which can be reconfigured easily by minor component changes. Accordingly, the present invention relates to a programmable wireless data acquisition system comprising a signal processing module containing a module microcontroller having a memory. The signal processing module operation includes inputting, conditioning and processing at least one external input having a certain range, character and type, and transmitting by wireless means a signal encoded with data corresponding to said external input. The module microcontroller adapts the signal processing module in response to variation in the range, character and type of the external input such that the adaptation occurs during signal processing module operation. In another aspect, the present invention relates to a programmable wireless data acquisition system, comprising a signal processing module having certain components populated therein and having a module microcontroller having a memory. The signal processing module operation includes inputting, conditioning and processing at least one external input and transmitting by wireless means a signal encoded with data corresponding to the external input. The signal processing module being adaptable to varying characteristics and ranges of different of the external inputs by reconfiguring the component population of the signal processing module. In yet another aspect, the present invention relates to a programmable wireless data acquisition system, comprising a signal processing module comprising a module microcontroller having a memory. The signal processing module operation includes inputting, conditioning and processing at least one external input and transmitting by wireless means a signal encoded with data corresponding to the external input. The at least one external input comprising at least one physiological signal wherein the physiological signal is from the group of physiological signals consisting of EEG, EKG, EOG, SpO 2 , PO 2 , PCO 2 EMG, blood pressure, heart rate, pulse, body temperature, air flow and respiration. The module microcontroller adapts the signal processing module in response to variation in the range, character and type of the physiological signal such that the adaptation occurs during signal processing module operation. In still yet another aspect, the present invention relates to a programmable wireless data acquisition system, comprising a signal processing module containing a module microcontroller having a memory, a module transmitter and a module receiver. The signal processing module operation includes inputting, conditioning and processing at least one external input having a certain range, character and type, and transmitting a radio frequency signal encoded with data corresponding to the external input. The module microcontroller through the module receiver receives a radio frequency signal with instructions for adapting the signal processing module in response to variation in the range, character and type of the external input such that the adaptation occurs during signal processing module operation. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS Further features of the present invention will become apparent to those skilled in the art to which the present invention relates from reading the following specification with reference to the accompanying drawings in which: FIG. 1 is a block diagram of the present invention. FIG. 2 is a block diagram of the signal processing module of the present invention. FIG. 3 is a block diagram of the base station of the present invention. FIG. 4 is a block diagram showing the data acquisition function of the present invention in the signal processing module. FIG. 5 is a block diagram of the programming of the firmware in the signal processing module. FIG. 6 is a block diagram of the programming of the interrupt service routine in the firmware of the signal processing module. DETAILED DESCRIPTION OF THE INVENTION Referring now to the drawings and, in particular to FIG. 1, there is shown a block diagram of the present invention. An external input 12 from sensor 14 is inputted to signal processing module 16. Although, one sensor 14 and one external input 12 are shown, the signal processing module 16 is capable of accepting multiple external inputs 12 from multiple sensors 14. The signal processing module 16 generates a signal 18 encoded with data corresponding to the external input 12. The signal processing module 16 transmits the signal 18 by wireless means. to base station 40 In FIG. 1, the wireless means is shown as radio frequency (RF). In this case, the signal processing module generates a radio frequency signal 18 by frequency modulating a frequency carrier and transmits the radio frequency signal through module antenna 20. The base station 40 receives the radio frequency signal 18 through base antenna 42, demodulates the radio frequency signal 18, and decodes the data. It is understood that other wireless means can be utilized with the present invention, such as infrared and optical, for example. Although one module antenna 20 and one base antenna 42 is shown in this embodiment, it is understood that two or more diversity antennas can be used and are included in the present invention. An external programming means 60, shown in FIG. 1 as a personal computer, contains software which is used to program the signal processing module 16 and the base station 40 through data interface cable 62. The data interface cable 62 is connected to the base station 40 and signal processing module 16 by respective connectors 64. The same data interface cable 62 or two different interface cables 62 can be used, one for the base station 40 and one for the signal processing module 16. The signal processing module 16 and the base station 40 can be programmed by connecting a data interface cable 62 between it and an external programming means 60 or by radio frequency (or other type) of signals transmitted between a base station 40 to the signal processing module 16 or to another base station 40. RF signals, therefore, can be both transmitted and received by both signal processing module 16 and base station 40. In this event the signal processing module 16 also includes a module receiver 29 while the base station 40 also includes a base transmitter 84, in effect making both the signal processing module 16 and the base station 40 into transceivers. In addition, the data interface cable 62 also can be used to convey data from the base station 40 to the external programming means 60. If a personal computer is the external programming means 60, it can monitor, analyze and display the data in addition to its programming functions. The base receiver 80 and module receiver 29 can be any appropriate receivers, such as direct or single conversion types., The base receiver 80 preferably is a double conversion superheterodyne receiver while the module receiver 29 preferably is a single conversion receiver. Advantageously, the receiver employed will have automatic frequency control to facilitate accurate and consistent tuning of the radio frequency signal 18 received thereby. Referring now to FIG. 2, there is shown a block diagram of the signal processing module 16 with the sensor 14 and the module antenna 20. The signal processing module 16 comprises input means 22, analog-to-digital (A/D) means 24, a module microcontroller 26 with a nonvolatile memory, advantageously, an EEPROM 261, a module transmitter 28, a module receiver 29 and a module power supply 30. Although the module antenna 20 is shown externally located from the signal processing module 16, it can also be incorporated therein. The module antenna 20 may be a printed spiral antenna printed on a circuit board or on the case of the signal processing module 16 or other type of antenna. A module power supply 30 provides electrical power to the signal processing module 16 which includes the input means 22, A/D means 24, module microcontroller 26 module transmitter 28 and module receiver 29. The input means 22 is adjustable either under control of the module microcontroller 26 or by means of individually populatable components based upon the specific external input 12 characteristics and range enabling the input means 22 to accept that specific external input 12. For example, if the input is a 4-20 mA analog signal, the input means 22 is programmed by the module microcontroller 26 and/or populated with the components needed to accept that range and characteristic of signals. If the input characteristics change the programming and/or components change accordingly but the same platform circuit board design is utilized. In other words, the same platform design is utilized notwithstanding the character, range, or quantity (number of external inputs 12) [up to a predetermined limit] of the input. For example, bioelectric signals such as EEG, EMG, EKG, and EOG have typical amplitudes of a few microvolts up to a few tens of millivolts. For a given application, a specific frequency band of interest might be from 0.1 Hz to 100 Hz, whereas another application may require measurement of signals from 20 Hz to 10 KHz. Alternatively, measurement of vital signs such as body temperature and respiration rate may deal with signals in a range of +5 volts, with a frequency content from DC (0 Hz) to 20 Hz. For other applications such as industrial process monitoring, the information of interest may be contained in the signal as a current, such as a 4 to 20 mA current loop sensor, or it may take the form of resistance, impedance, capacitance, inductance, conductivity, or some other parameter, The present invention provides a single device for measuring such widely disparate signal types and presents distinct economic advantages, especially to small enterprises such as a medical clinic located in a rural area, which would be empowered by this invention to conduct tests which would otherwise have required patient travel to a large medical center, with all the attendant cost thereof. This is possible due to the selectively adaptable input means 22 and A/D means 24, the frequency agile module transmitter 28 and base transmitter 84, and the programmability of the module microcontroller 26 and EEPROM 261. One universal platform design then can be utilized for all applications. In addition, the signal processing module can comprise multiple copies of the input means 22 and the A/D means 24. Cost savings can be achieved by multiplexing at several different points in the input means 22 and the A/D means 24 allowing hardware to be shared among external inputs 12. After receipt by the input means 22, the external input 12 is inputted to the A/D means 24. The A/D means 24 converts the input to a digital signal 32 and conditions it. The A/D means 24 utilizes at least one programmable A/D converter. This programmable A/D converter may be an AD7714 as manufactured by Analog Devices or similar. Depending upon the application, the input means 22 may also include at least one low noise differential preamp. This preamp may be an INA126 as manufactured by Burr-Brown or similar. The module microcontroller 26 can be programmed to control the input means 22 and the A/D means 24 to provide specific number of external inputs 12, sampling rate, filtering and gain. These parameters are initially configured by programming the module microcontroller 26 to control the input means 22 and the A/D means 24 via input communications line 35 and A/D communications line 36 based upon the input characteristics and the particular application. If the application changes, the A/D converter is reconfigured by reprogramming the module microcontroller 26. In this manner, the input means 22 and the A/D means 24 can be configured to accept analog inputs of 4-20 mA, +/-5 volts, +/-15 volts or a range from +/-microvolts to millivolts. They also can be configured to accept digital inputs, for detection of contact closure, for example. The module microcontroller 26 controls the operation of the signal processing module 16. In the present invention, the module microcontroller 26 includes a a serial EEPROM 261 but any nonvolatile memory (or volatile memory if the signal processing module remains powered) can be used. The EEPROM 261 can also be a separate component external to the module microcontroller 26. Advantageously, the module microcontroller 26 may be PIC16C74A PIC16C74B or a PIC16C77 both manufactured by MicroChip, or an Amtel AT90S8515 or similar. The module microcontroller 26 is programmed by the external programming means 60 through the connector 64 or through radio frequency signal from the base station 40. The same module microcontroller 26, therefore, can be utilized for all applications and inputs by programming it for those applications and inputs. If the application or inputs change, the module microcontroller 26 is modified by merely reprogramming. The digital signal 32 is inputted to the module microcontroller 26. The module microcontroller 26 formats the digital signal 32 into a digital data stream 34 encoded with the data from the digital signal 32. The digital data stream 34 is composed of data bytes corresponding to the encoded data and additional data bytes to provide error correction and housekeeping functions. Advantageously, the digital data stream 34 is organized in data packets with the appropriate error correction data bytes coordinated on a per data packet basis. These packets can incorporate data from a single input channel or from several input channels in a single packet, or for some applications may advantageously include several temporally differing measurements of one or a plurality of input channels in a single packet. The digital data stream 34 is used to modulate the carrier frequency generated by the transmitter 28. The module transmitter 28 is under module microcontroller 26 control. The module transmitter 28 employs frequency synthesis to generate the carrier frequency. In the preferred embodiment, this frequency synthesis is accomplished by a voltage controlled crystal reference oscillator and a voltage controlled oscillator in a phase lock loop circuit. The digital data stream 34 is used to frequency modulate the carrier frequency resulting in the radio frequency signal 18 which is then transmitted through the module antenna 20. The generation of the carrier frequency is controlled by the module microcontroller 26 through programming in the EEPROM 261, making the module transmitter 28 frequency agile over a broad frequency spectrum. In the United States and Canada a preferred operating band for the carrier frequency is 902 to 928 MHz. The EEPROM 261 can be programmed such that the module microcontroller 26 can instruct the module transmitter 28 to generate a carrier frequency in increments between 902 to 928 MHz. as small as about 5 to 10 KHz. In the US and other countries of the world, the carrier frequency may be in the 2400 to 2483.5 MHz. band, 5.725 to 5.875 GHz. band, or the 24.0 to 24.25 GHz. band, or other authorized band. This allows the system to be usable in non-North American applications and provides additional flexibility. The voltage controlled crystal oscillator (not shown) in the module transmitter 28, not only provides the reference frequency for the module transmitter 28 but, advantageously also, provides the clock function 38 for the module microcontroller 26 and the A/D means 24 assuring that all components of the signal processing module 16 are synchronized. An alternate design can use a plurality of reference frequency sources where this arrangement can provide certain advantages such as size or power consumption in the implementation. The module receiver 29 in the signal processing module 16 receives RF signals from the base station 40. The signals from the base station 40 can be used to operate and control the signal processing module 16 by programming and reprogramming the module microprocessor 26 and EEPROM 261 therein. The base station 40 has a base antenna 42 through which RF signals 18 are received. Base microcontroller 86 controls the operation of the base station 40 including base receiver 80, base transmitter 82, and base power supply 88. Base receiver 80 receives the RF signal 18 from base antenna 42. The base receiver 80 demodulates the RF signal 18 and the base microcontroller 86 removes any error correction and performs other housekeeping tasks. The data is then downloaded through connector 64 to the external programming means 60 or other personal computer (PC) or data storage/viewing device for viewing in real time, storage, or analysis. Referring now to FIG. 4, there is shown a block diagram of the input means 22 and A/D means 24 of the signal processing module 16, which provides for the data acquisition function of the present invention. The signal processing module 16 is variably configurable through software programming initiated by the external programming means 60 to the EEPROM 261 of the microcontroller 26. The variable configurability enables the signal processing module 16 to receive external inputs 12 having different characteristics and ranges and to provide variable sampling rate, filtering and gain of the external inputs 12 based upon such characteristics and range and/or the specific application. For example, if the present invention is utilized in a biomedical environment, EEG diagnosis and monitoring for instance, the sampling rate will need to be much higher than it would be for an industrial setting measuring thermocouple readings. The ability to reconfigure the system for varying signal characteristics arises at three separate levels in the present invention. For maximum flexibility, such reconfiguration can be carried out during a series of measurements by means of the wireless link, which is understood in this context to be bidirectional. Depending on the characteristics of the received signal 18, the base station 40 can command the signal processing module 16 to reconfigure the input means 22 and/or A/D means 24 to accept an external input 12 of larger amplitude, or a different frequency range, where signal characteristics change significantly during the course of a series of measurements. Alternatively, for cost, size, and power advantages, this adjustment could be carried out prior to a series of measurements, with the configuration information stored in memory in the signal processing module 16, where this memory is advantageously implemented in a nonvolatile form such as EEPROM 261, allowing the configuration information to be retained, for instance, across power outages and obviating the need for module receiver 29 and base transmitter 84, saving cost. A third alternative, which provides advantages in certain technical parameters, is to arrange the implementation of the signal processing module 16 such that minor changes in component values or parameters can reconfigure the same basic hardware to accept widely divergent external input 12 types. This reconfiguration could take place at the factory, providing cost and inventory advantages to the manufacturer, or it could be performed by the end user, providing similar cost advantages to the user in allowing one piece of equipment to perform multiple tasks. A number of configurable components are shown in FIG. 4. Any given component of this arrangement, though, may be omitted, and, in some cases, the order of the components may be changed to gain certain advantages such as physical size, power consumption, or cost, without changing the basic spirit of the invention. Components in this FIG. 4 may be combined, either by having a single component carry out the function of two or more of the components shown or by combining functions within a single package such as an integrated circuit or hybrid module. Certain components may also operate with a fixed configuration, limiting the flexibility of certain parameters while retaining the advantages of configurability in other components. The external input 12 inputs to the input protection network 221, which protects the signal processing module 16 against damage caused by faults or unanticipated conditions encountered at the external inputs 12. Depending on the rigors expected to be encountered in any given application and the tolerance to size and weight, the input protection network 221 may be omitted, may consist of a simple resistor network, or may include more elaborate protection such as diodes, zener diodes, transorbs, gas discharge tubes, and other components commonly known to those of ordinary skill in the art. Typically, the input protection network 221 is not configurable but its configurability in the present invention provides advantages in certain applications. Configuration options can include adjustable limits on input voltage and/or current as well as rates of change of those parameters, and other electrical parameters as well. These configuration changes can be achieved by changes to component values on a common platform for smallest size, or can be changed under processor control by means of various switches such as relays. A signal within normally expected ranges passes essentially unchanged to the measurement type means 222. The measurement type means 222 allows selection of the external input 12 configuration. The measurement type means 222 may be used to configure the input circuitry to accept external inputs 12 which are single-ended voltage (a voltage with respect to a common reference shared between several signals), differential voltage (voltage between two defined conductors), differential current (current flowing through a conductor), single-ended current (current flowing to a common reference), frequency, capacitance, inductance, resistance, impedance, conductivity, or any other electrical parameter. The measurement type means 222 converts the external input 12 to a common parameter such as voltage or current, which can be interpreted by the succeeding blocks regardless of the original type of external signal 12 measured. One input channel can be built with several different measurement type means, which can be selectively enabled by means of an analog switch, such as that found in the AD7714 chip in the present invention. It is understood that the AD7714 chip can provide many of the functions of the A/D means 24 and the input means 22 thus reducing the overall size of the signal processing module 16. In the preferred embodiment, the output of the measurement type means 222 is a varying voltage carrrying the information which was present in the original signal, or in certain cases, a series of voltage measurements, which are then conveyed to the prefilter 223. The prefilter 223 allows rejection of external inputs 12 of large signals which are outside the frequency band of interest, so that such signals do not saturate the low-noise preamplifier 224. The prefilter 223 can be advantageously arranged to be a relatively simple filter to provide cost, size, and power advantages, because it need only reject out of band signals to the extent necessary to protect the low-noise preamplifier 224. A typical application might use a simple "R-C" filter to reject offset voltages in an AC-coupled application, or to reject extremely high frequencies which fall well beyond the frequency band of interest, or a combination of the two. Configurability of this section can be limited to simply enabling or bypassing the prefilter 223, or may be more elaborate in allowing selection of cutoff frequencies. In the preferred embodiment this prefilter consists of a simple RC filter which can be bypassed under firmware control, to minimize noise injection; however, an alternate embodiment could incorporate electrically adjustable components such as electronic potentiometers or varactors to provide even more flexibility at the expense of size and noise injection. The prefiltered signal is then pased to the low-noise preamplifier 224. The low-noise preamplifier 224 is advantageous in certain applications to allow application of gain to the external input 12 early in the signal chain, before significant noise is introduced by the inherent characteristics of certain components, such as thermal noise. Configurability of the gain applied at this step provides an advantage in allowing the present invention to accept larger external inputs 12 using a low gain (unity gain or lower), or alternatively to accurately measure very small external inputs 12 with minimal noise by using higher gain. This gain can be selectively chosen to be either a fixed value or unity gain under processor control by means of the signal selector built into the AD7714 used in the preferred embodiment, or can be designed to allow a selection of one of several gains by means of analog switches combined with a plurality of gain setting resistors. Gain applied at this stage has the net effect of dividing any downstream noise by the gain factor applied here. This more robust signal output by the preamplifier 224 is then passed to the AC coupling filter 225. The AC coupling filter 225 is a highpass filter used to allow the system to reject the DC offset or steady state value of an external input 12 wherein the offset is not of interest, allowing additional gain to be applied to the changes in the external input 12. For instance, bioelectric signals such as EEG, EMG, or ECG are normally of interest only for the changes in those signals, and the absolute offset level is not of interest for diagnostic purposes. The cutoff frequency may be configured to allow adjustment of various parameters such as settling time, or may be adjusted to zero to effectively bypass the AC coupling filter 225. In the preferred embodiment, the filter may be bypassed by use of the signal selector switch in the AD7714; however, the use of adjustable components such as electronic potentiometers or varactors would allow more flexibility in choosing the cutoff frequency, at the expense of size and power consumption. The resulting signal, now stripped of any interfering DC offset if so configured, is then passed to the antialias filter 226. The antialias filter 226 is a lowpass filter required to guard against false signals caused by aliasing between external input 12 content and sampling rate of downstream sampling functions such as multiplexing or analog-to-digital conversion. The Nyquist sampling theorem shows that any frequency content in the sampled signal which is higher than one-half the sampling rate of the sampling function will cause aliasing, which results in false signals. In practice the antialias filter 226 is more commonly set to a smaller fraction of the sampling rate, usually between 1/4 and 1/10 the sampling rate. Regardless of the rate or ratio used, the cutoff frequency of the antialias filter 226 must change when the sampling rate changes significantly, to retain the most advantageous ratio of the sampling rate to the filter passband. The programmable cutoff frequency of the antialias filter 226 is thus required to allow for variable sampling rates. In the preferred embodiment, the high sampling rate of the delta sigma modulator in the AD7714 permits the use of a simple fixed RC type filter, with the anitalias filtering begin provided as an inherent digital filter in the AD7714; however, an alternate embodiment might use a switched capacitor filter such as the MAX7409 or other filter with a programmable cutoff frequency. The resulting filtered signal is then conveyed to the programmable gain amplifier 241 in the A/D means 24. The programmable gain amplifier 241 adjusts the external input 12 amplitude to match the amplitude accepted by the A/D converter 242. In the preferred embodiment this programmable gain amplifier is included in the AD7714 integrated circuit, but this function could also be provided with a dedicated programmable gain amplifier, or alternatively through the use of analog switches or adjustable components such as potentiometers or DACs. If too much gain is applied, the programmable gain amplifier 241 itself or downstream components will saturate, introducing severe distortion and usually rendering the external input 12 unmeasureable. If, on the other hand, insufficient gain is applied here, the quantization noise of the analog-to-digital conversion process comes to dominate the external input 12, causing a severe degradation in the signal-to-noise ratio. For instance, a typical 16-bit A/D converter 242 can distinguish between 2 16 or 65536 distinct levels. With an A/D converter 242 input range of ±3 volts, each level reperesents 92 μV. If insufficient gain is applied to the external input 12 such that the total signal swing is only 200 μV, the A/D converter 242 will convert at most three distinct levels, rendering fine features of the external input 12 totally illegible. The module microcontroller 26 therefore adjusts the gain applied in the programmable gain amplifier 241 such that the expected external input 12 as processed and filtered by the preceding elements as described above, is amplified to cover as much of the A/D converter 242 input range as practical, or some other gain which optimizes signal features of interest. Additionally, in some applications it is advantageous to have the module microcontroller 26 adjust this gain dynamically depending upon the actual measured external input 12. For instance, the module microcontroller 26 might increase the programmable gain amplifier 241 gain when a measured external input 12 is very small, and then decrease the gain to avoid saturation when the external input 12 amplitude increases. This automatic gain control provides an increase in the total dynamic range achievable by the system without requiring expensive, large, and power-hungry components such as very high resolution A/D converters 242. The signal resulting from application of the specified gain is then passed to the A/D converter 242. At least two parameters of a typical A/D converter 242 can be readily adjusted to achieve various goals as the situation dictates. First, the sampling rate may be adjusted to balance the conflicting goals of high fidelity measurements and low digital data rate. Where a signal has no high frequency content of interest, the sampling rate may be adjusted to a very low rate to minimize the demands on downstream processes such as digital filtering or telemetering of the data. On the other hand, sampling an external signal 12 with significant high-frequency content of interest demands a higher sampling rate. In the preferred embodiment, the sampling rate is programmable via the AD7714; in other implementations the sampling rate can be made adjustable by means of an externally applied sampling clock to an A/D converter. The adjustable sampling rate allows the controller to adapt the A/D converter 242 to best meet the system demands of the moment. In a similar fashion, selection of the resolution provided by the A/D converter 242 must balance faithful reproduction of the external input 12 against total digital data rate. Depending on the particular A/D converter 242 used, there may also be a tradeoff of the maximum achievable sampling rate against the selected resolution, wherein selection of a higher resolution lowers the maximum attainable sampling rate. Again the module microcontroller 26 can adjust this parameter to best meet the system requirements, selecting higher resolution when smaller changes in the measured signal amplitude must be reported, and lower resolution when the lack of such a requirement allows advantages in the form of either a higher sampling rate or a lower digital data rate. In the preferred embodiment, the AD7714 can be programmed to either 16 bit or 24 bit resolution, and the firmware running in the microcontroller can selectively transmit 8, 12, 16, or 24 bits of the acquired data. The digital filter 243, the module microcontroller 26, or other downstream process can also reject certain portions of the digital data stream to provide an effective decrease in resolution where this decrease is advantageous, especially when the data must later cross a bandwidth-limited link such as a RF, IR or optical link. The A/D converter 242 passes the signal, now in the form of a succession of digital values, to the digital filter 243 for further processing. The digital filter 243 extracts external input 12 parameters of interest while rejecting other signals, commonly referred to as noise. Implementation of the digital filter 243 could alternatively be in the form of analog filters applied anywhere in the signal chain prior to the A/D converter 242, but implementation as a digital filter 243 provides advantages as to programmability, calibration, drift, and accuracy. The digital filter 243 could be implemented in many forms, depending upon the demands of the particular application. In the preferred embodiment, the digital filter is inherent in the analog to digital conversion process inside the AD7714, but it is understood that the digital filter 243 could be implemented as firmware inside the module microcontroller 26 itself, or as a digital signal processor, or as a specialized integrated circuit, or by some other means. Regardless of implementation, the programmability of the digital filter 243 allows the system to readily adapt to changing measurement requirements, whether those changes are brought about by changes in the environment, changes in the external input 12 itself, or changes in the focus of the overall system. The resulting output from the digital filter 243 is a stream of digital values, ready for further processing such as assembly into the desired format for transmission by the firmware. Referring now to FIG. 5 there is shown a block diagram of the firmware of the present invention. The signal processing module 16 firmware defines several modes of operation 100. There are several "test" modes which are used during factory calibration of the device. In addition, there are several operation modes which have mode-specific configuration. For example, the signal processing module 16 can be programmed to operate in a first operational mode in which it transmits calibration data (used to properly zero the analog inputs) for the first three seconds of operation (or for some other predetermined time), and then switches to a second operational mode which transmits analog signal information as collected from the A/D converters 242. The configuration for each mode of operation is programmed in the non-volatile memory EEPROM 261. Once power is first applied to the signal processing module 16, the module microcontroller 26 performs the basic device initialization, including proper configuration of the I/O ports and internal variables 102. Next, the module microcontroller 26 reads the initial device configuration 104 from the EEPROM 261. This configuration controls the input means 22 of the signal processing module 16, including the number of external inputs (also herein referred to as channels), the resolution of the A/D converter 242, and the sampling rate of each individual input channel. This configuration also controls the operation of the module transmitter 28 in the signal processing module 16, including the carrier frequency, modulation type, output power control, and the length in bytes of each transmitted RF message packet. This configuration also describes the initial mode of operation for the signal processing module 16. Once the initial configuration has been read, the module microcontroller 26 enters the first mode of operation described in the configuration. It reads the mode-specific configuration 106, which includes the state of the module transmitter 28 and the analog inputs as used in the mode. This configuration can reside in EEPROM 261 or in module microcontroller 26 memory. The module microcontroller 26 then initializes all the peripheral devices according to this mode configuration 108. In the special case that this is the "shutdown" mode, the module microcontroller 26 will perform a software power-down 110. Once the mode has been initialized, the module microcontroller 26 begins execution of the interrupt service routine (ISR) 112, which is responsible for transmitting the data in the form of messages along the modulated RF carrier. Operation of the interrupt service routine is asynchronous and distinct from the mainline code, and is described later. The module microcontroller 26 begins execution of the mode-specific "opcodes" 114, which are a sequence of instructions contained either in EEPROM 261 or in the module microcontroller 26 memory. These opcodes are performed for each operational mode. The module microcontroller 26 reads the first operational code from the EEPROM 261 and interprets the opcode, performing an appropriate action: If the opcode instructs the module microcontroller 26 to change modes 116, the module microcontroller 26 terminates the ISR 118 and returns to the mode initialization, and begins execution of a new operational mode; If the opcode instructs the module microcontroller 26 to begin a loop construct 120, the module microcontroller 26 begins the loop by initializing a loop counter variable 122; If the opcode instructs the module microcontroller 26 to end a loop construct, the module microcontroller 26 increments the loop counter variable and determines if the loop is complete 124. If not, the module microcontroller 26 resets the index of current opcode to the beginning of the loop, otherwise it sets the index of the next opcode to after the loop; If the opcode instructs the module microcontroller 26 to initialize a single A/D converter 242, the module microcontroller 26 will perform the specified calibration 126; If the opcode instructs the module microcontroller 26 to the read a single A/D converter 242, the module microcontroller 26 will take the reading and insert the data into the current message to be transmitted over the RF carrier 128; If the opcode instructs the module microcontroller 26 to insert a special byte of data into the RF message, the module microcontroller 26 will insert this data into the message 130. This special message byte may include an identifier to uniquely identify the signal processing module 16, an error check field such as a cyclic redundancy check, or some data representing the internal state of the signal processing module 16 such as the RF frequency, measured temperature, etc. After each opcode has been read and interpreted, the module microcontroller 26 determines if the RF message has been completely filled and is ready to be transmitted over the RF carrier 132. If it has, the module microcontroller 26 marks a flag variable for the interrupt service routine to begin transmitting the RF message 134. Next, the module microcontroller 26 performs any housekeeping tasks, such as updating the RF tuning parameters based on changes in temperature, updating timers, etc. 136 Finally, the module microcontroller 26 returns to execute the next opcode in the sequence 114. Referring now to FIG. 6 there is shown a block diagram of the software programming function of the ISR 150. The ISR is responsible for transmitting the individual message bytes over the RF carrier. The ISR is executed by a hardware interrupt which occurs immediately before every byte to be transmitted over the RF carrier. The ISR detects whether an RF mesage is completely filled 152. If the ISR detects (based on the flag variable) that an RF message is not yet completely filled by the main code, the ISR transmits a "filler" byte, or a byte with an even number of "1" and "0" bits 154. This acts to maintain an even (50%) modulation duty cycle on the carrier frequency. Once the ISR detects that the main code has filled an RF message to be transmitted, it transmits the RF sync bytes 156. These are two unique bytes transmitted at the beginning of every RF message which are easily identified by the base station 40 as the start of a message. Once the RF sync bytes have been transmitted, the ISR transmits each message byte of the RF message, in sequence 158. Once the RF message has been completely transmitted 160, the ISR resumes transmitting filler bytes until the next RF message is filled by the main code. Because of the phase locked loop based frequency synthesizer used in the present invention, the module transmitter 28 and base transmitter 84 are frequency agile over the frequency range. Since the module receiver 29 and the base receiver 80 employ automatic frequency control, the present invention consumes relatively low power as the module transmitter 28 and base transmitter 84 can be intermittently powered down without loosing reception due to drift or sacrificing data transmission accuracy. The utilization of programmable firmware allows inexpensive and flexible operation for the inputting, conditioning and processing of any type, character and range of the external inputs. This also allows the module microcontroller 26, in response to the variation of the external inputs 12 or, in response to instructions received by RF signal through the module receiver 29, to adapt the signal processing module 16 based upon the variations allowing the signal processing means 16 to input, condition, process and transmit said external input notwithstanding said variation. The present invention performs this adaptation without the need to modify or alter hardware or select or use different hardware already present in the device. In other words all adaptation can be accomplished by software programming totally. A particular embodiment of the invention has been described, but those skilled in the art will recognize that many modifications are possible that will achieve the same goals by substantially the same system, device or method, and where those systems, devices or methods still fall within the true spirit and scope of the invention disclosed. Therefore the invention should be considered to be limited in scope only in accordance with the following claims.

A programmable wireless data acquisition system, comprising a transmitting device and a receiving device. The transmitting device is capable of receiving multiple external inputs and generating and transmitting a radio frequency signal encoded with data corresponding to the inputs. The transmitting device is variably configurable to enable it to accept inputs having different characteristics and ranges and to enable it to provide variable sampling rate, gain and filtering of the inputs. The transmitting device having a microprocessor such that the microprocessor controls the operation thereof. The receiving device is capable of receiving the radio frequency signal, demodulating it and decoding the data. The receiving device has a microprocessor such that the microprocessor controls the operation thereof. External programming device programs the transmitting device and the receiving device by wired connection or through radio frequency signal.

BACKGROUND OF THE DISCLOSURE Field of the Disclosure The disclosure relates to vest assemblies and more particularly pertains to a new vest assembly for securely holding and providing easy access to tools, allowing adjustment of the vest for a better fit, and providing ventilation to dissipate heat accumulated within the vest. SUMMARY OF THE DISCLOSURE An embodiment of the disclosure meets the needs presented above by generally comprising a flexible panel having a first end, a second end, and a pair of lateral sides extending between the first end and the second end. An aperture is positioned in the panel between the first end and the second end and between the lateral sides of the panel. The aperture defines a dorsal portion of the panel extending from the aperture to the first end of the panel when the panel is draped over shoulders of a person while a neck of the person extends through the aperture. A pocket is coupled to the panel and has an open top end, a closed bottom end, and a perimeter wall extending between the open top end and the closed bottom end. The closed bottom end and the perimeter wall define an interior space configured for holding a plurality of tools. A top edge of the perimeter wall defines an opening into the interior space. A flap is coupled to the pocket and is positionable between an opened position and a closed position wherein the flap closes the opening when the flap is in the closed position and the flap exposes the opening when the flap is in the opened position. An interior fastener couples the flap to the pocket when the flap is in the closed position. An exterior fastener couples the flap to the panel when the flap is in the opened position. There has thus been outlined, rather broadly, the more important features of the disclosure in order that the detailed description thereof that follows may be better understood, and in order that the present contribution to the art may be better appreciated. There are additional features of the disclosure that will be described hereinafter and which will form the subject matter of the claims appended hereto. The objects of the disclosure, along with the various features of novelty which characterize the disclosure, are pointed out with particularity in the claims annexed to and forming a part of this disclosure. BRIEF DESCRIPTION OF THE DRAWINGS The disclosure will be better understood and objects other that those set forth above will become apparent when consideration is given to the following detailed description thereof. Such description makes reference to the annexed drawings wherein: FIG. 1 is a top front side perspective view of a tool kit vest assembly according to an embodiment of the disclosure in use. FIG. 2 is a front view of an embodiment of the disclosure. FIG. 3 is a back, view of an embodiment of the disclosure. FIG. 4 is a side view of an embodiment of the disclosure. FIG. 5 is a cross-sectional view of an embodiment of the disclosure taken along line 5 - 5 of FIG. 2 , FIG. 6 is a front view of a pocket of an embodiment of the disclosure in use and in the opened position. DESCRIPTION OF THE PREFERRED EMBODIMENT With reference now to the drawings, and in particular to FIGS. 1 through 6 thereof, a new vest assembly embodying the principles and concepts of an embodiment of the disclosure and generally designated by the reference numeral 10 will be described. As best illustrated in FIGS. 1 through 6 , the tool kit vest assembly 10 generally comprises a flexible panel 12 having a first end 14 , a second end 16 , and a pair of lateral sides 18 , 20 extending between the first end 14 and the second end 16 . The panel 12 is preferably made from canvas or other lightweight material. An aperture 22 is positioned in the panel 12 between the first end 14 and the second end 16 and between the lateral sides 18 , 20 of the panel 12 . The aperture 22 defines a dorsal portion 24 of the panel 12 extending from the aperture 22 to the first end 14 of the panel 12 when the panel 12 is draped over shoulders 26 of a person while a neck. 28 of the person extends through the aperture 22 . The aperture 22 further defines a ventral portion 30 of the panel 12 extending from a forward edge 32 of the aperture 22 to the second end 16 of the panel 12 when the panel 12 is draped over the shoulders 26 of the person while the neck 28 of the person is positioned in the aperture 22 . The forward edge 32 of the aperture 22 12 is preferably U-shaped. A pair of holes 34 , 36 is positioned in the panel 12 between the first end 14 and the second end 16 . Each of the holes 34 , 36 is positioned in an associated one of the lateral sides 18 , 20 proximate the aperture 22 wherein the holes 34 , 36 are configured for receiving a person's arms 38 therethrough when the panel 12 is draped over the shoulders 26 of the person and the neck 28 of the person is positioned in the aperture 22 . An outer edge 40 of each of the holes 34 , 36 is concavely curved into the ventral and dorsal portions 30 , 24 of the panel 12 . A plurality of interwoven strands 42 is coupled to the first end 14 of the panel 12 wherein the strands 42 define a semi-permeable barrier 44 in the panel 12 configured to prevent heat from accumulating in the panel 12 . The strands 42 extend between the lateral sides 18 , 20 of the panel 12 . The strands 42 are offset from the aperture 22 , a bottom edge 46 of the panel 12 , and the lateral sides 18 , 20 of the panel 12 . The strands 42 are offset from the aperture 22 and the bottom edge 46 of the panel 12 a greater distance than the strands 42 are offset from the lateral sides 18 , 20 . The dorsal portion 24 of the panel 12 surrounding the strands 42 is of increased strength as compared to the ventral portion 30 of the panel 12 so as to provide increased stiffness for areas of high stress. Similarly, the panel 12 is of increased strength surrounding the aperture 22 and above the shoulders 26 of the person when the panel is draped over the shoulders 26 of the person. A slit 48 extends between the second end 16 of the panel 12 and the aperture 22 . The slit 48 extends transversely between the aperture 22 and the second end 16 of the panel 12 and defines a first side 50 and a second side 52 of the second end 16 . A slide fastener 54 is coupled to opposite edges 56 , 58 of the slit 48 . The slide fastener 54 comprises a pair of complementary toothed tracks 60 , 62 and a graspable portion 64 . The graspable portion 64 is coupled to the toothed tracks 60 , 62 wherein the graspable portion 64 interlocks the toothed tracks 60 , 62 when pulled upwardly toward the aperture 22 and separates the toothed tracks 60 , 62 when pulled downwardly away from the aperture 22 . A plurality of pockets 66 is coupled to the panel 12 . Each of the pockets 66 has an open top end 68 , a closed bottom end 70 , a perimeter wall 72 , and a front side 102 positioned opposite a back side 104 . The perimeter wall 72 extends between the open top end 68 and the closed bottom end 70 . The closed bottom end 70 and the perimeter wall 72 define an interior space 74 configured for holding a plurality of items 76 . A top edge 78 of the perimeter wall 72 defines an opening 80 into the interior space 74 . The plurality of pockets 66 further comprises a first pocket array 82 and a second pocket array 84 . The first pocket array 82 is coupled to the first side 50 of the second end 16 of the panel 12 . The pockets 66 of the first pocket array 82 comprise a first pocket 86 , a second pocket 88 , a third pocket 90 , a fourth pocket 92 , and a fifth pocket 94 . The first pocket 86 is positioned proximate the aperture 22 . The third pocket 90 is positioned distally relative to the aperture 22 . The second pocket 88 is positioned between the first pocket 86 and the third pocket 90 . The fourth and fifth pockets 92 , 94 are coupled to the third pocket 90 . The fourth and fifth pockets 92 , 94 are spaced and horizontally aligned. The fifth pocket 94 is positioned nearer the slide fastener 54 than the fourth pocket 92 . The fourth pocket 92 may hold a handheld transceiver device. A medial section 96 of the fifth pocket 94 defines a notch 98 extending into the closed bottom end 70 of the fifth pocket 94 . The notch 98 is positioned between opposite ends 100 of the fifty pocket 94 . The notch 98 extends between the front side and back side 102 , 104 of the fifth pocket 94 . The notch 98 has a pair of opposed ends 106 and a medial portion 108 coupling the opposed ends 106 wherein the fifth pocket 94 has a size and shape configured to receive a tape measuring tool 110 . The second pocket array 84 is coupled to the second side 52 of the second end 16 of the panel 12 . The pockets 66 of the second pocket array 84 comprise a top pocket 112 , a middle pocket 114 , a bottom pocket 116 , and a supplemental pocket 118 . The top pocket 112 is positioned proximate the aperture 22 . The bottom pocket 116 is positioned distally relative to the aperture 22 . The middle pocket 114 is positioned between the top pocket 112 and the bottom pocket 116 . A strap 120 extends across the opening 80 of the supplemental pocket 118 . The strap 120 extends from the front side 102 to the back side 104 of the supplemental pocket 118 wherein the strap 120 is configured to secure an electronic device 126 , such as a cell phone, within the interior space 74 of the supplemental pocket 118 . The first pocket 86 , the second pocket 88 , the third pocket 90 , the top pocket 112 , the middle pocket 114 , and the bottom pocket 116 define main pockets 128 . The interior space 74 of the main pockets 128 is configured to hold a plurality of tools 130 . The main pockets 128 of the first pocket array 82 are spaced and vertically aligned. The main pockets 128 of the second pocket array 84 are spaced and vertically aligned. A plurality of spaced vertical partitions 132 is coupled to the top pocket 112 , the middle pocket 114 , the first pocket 86 , and the second pocket 88 . The partitions 132 extend through the interior space 74 and define a plurality of compartments 134 within the pockets 66 wherein the compartments 134 are configured for organizing and separating tools 130 placed within the pockets 66 . A length of the pockets 66 extends from each of the open top ends 68 to an associated one of the closed bottom ends 70 . The third pocket 90 and the bottom pocket 116 are equal in length wherein each has a length between approximately 10 centimeters and 30 centimeters. The second pocket 88 has a longer length than the middle pocket 114 wherein the second pocket 88 has a length between approximately 10 centimeters and 20 centimeters and the middle pocket 114 has a length between approximately 8 centimeters and 18 centimeters. The first rocket 86 has a longer length than the top pocket 112 wherein the first pocket 86 has a length between approximately 5 centimeters and 15 centimeters and the top pocket 112 has a length between approximately 3 centimeters and 12 centimeters. A flap 136 is coupled to the main pockets 128 and the fourth and fifth pockets 92 , 94 . The flap 136 is positionable between an opened position 138 and a closed position 140 wherein the flap 136 closes the opening 80 when the flap 136 is in the closed position 140 and the flap 136 exposes the opening 80 when the flap 136 is in the opened position 138 . A pair of interior fasteners 142 is provided. A first one 144 of the interior fasteners 142 couples each of the flaps 136 to the pockets 66 when the flaps 136 are in the closed position 140 . The interior fasteners 142 enable the flaps 136 to remain in the closed position 140 when desired. A second one 146 of the interior fasteners 142 couples a first end 148 of the strap 120 to the supplemental pocket 118 . The interior fasteners 142 are complementary portions 150 , 152 of hook and loop fastener. One of the complementary portions 150 , 152 of hook and loop fastener of the first one 144 of the interior fasteners 142 is a square-shaped strip coupled to an inside face 154 of the flaps 136 . One of the complementary portions 150 , 152 of hook and loop fastener of each of the first and second one 144 , 146 of the interior fasteners 142 is an elongated strip positioned vertically on the front side 102 of the pockets 66 . One of the complementary portions 150 , 152 of hook and loop fastener of the second one 146 of the interior fasteners 142 is coupled to an inner face 158 of the first end 148 of the strap 120 . The complementary portions 150 , 152 of hook and loop fastener of the interior fasteners 142 are vertically aligned. A pair of exterior fasteners 160 is provided. A first one 162 of the exterior fasteners 160 couples the flaps 136 of the main pockets 128 to the panel 12 when the flaps 136 are in the opened position 138 . A second one 164 of the exterior fasteners 160 couples the flap 136 of the fifth pocket 94 to the third pocket 90 when the flap 136 is in the opened position 138 . The exterior fasteners 160 permit the flaps 136 to remain in the opened position 138 when desired. The exterior fastener 160 may be complementary portions 166 , 168 of hook and loop fastener. The complementary portions 166 , 168 of hook and loop fastener of the exterior fastener 160 are vertically aligned. Each of the complementary portions 166 , 168 of hook and loop fastener of the exterior fastener 160 is a square-shaped strip. One of the complementary portions 166 , 168 of hook and loop fastener of each of the first and second one 162 , 164 of the exterior fasteners 160 is coupled to an exterior face 170 of the flap 136 . One of the complementary portions 166 , 168 of hook and loop fastener of the first one 162 of the exterior fasteners 160 is coupled to the panel 12 proximate an upper edge 172 of the flap 136 . One of the complementary portions 166 , 1 . 68 of hook and loop fastener of the second one 164 of the exterior fasteners 160 is coupled to the front side 102 of the third pocket 90 . Each of the exterior fasteners 160 has a length equal to its width wherein the length and width are each between approximately 0.5 centimeters and 3 centimeters. Each of the elongated strips of the interior fasteners 142 has a width between approximately 0.5 centimeters and 2 centimeters and a length between approximately 2 centimeters and 8 centimeters. A loop 183 is coupled to the second side 52 of the second end 66 . The loop 183 is positioned below the bottom pocket 116 nearer to the slit 48 than the lateral side 20 . The loop 183 is arcuate and has a first end 184 spaced from a second end 136 . The loop 183 extends outwardly from the panel 12 wherein the loop 183 is configured for holding a hammer therein. A pair of first fasteners 188 couples the first end 184 of the loop 183 to the panel 12 . A pair of second fasteners 190 couples the second end 186 of the loop 183 to the panel 12 . The pairs of first and second fasteners 188 , 190 are preferably rivets, though other conventional fasteners may be used instead. The loop 183 is preferably comprised of leather, though other suitable materials fall within the scope of the invention. The loop 183 has a thickness between approximately 0.05 centimeters and 2.0 centimeters, a height between approximately 1.5 centimeters and 4.5 centimeters, and a length between approximately 5.0 centimeters and 10.0 centimeters. A pair of glove holders 192 is coupled to the panel 12 . Each of the glove holders 192 is positioned on an associated one of the first side 50 and the second side 52 of the second end 16 proximate the aperture 22 . Each of the glove holders 192 comprises a loop having a first end 194 spaced from a second end 196 . The glove holders 192 extend outwardly from the panel 12 wherein each of the glove holders 192 is configured for holding one of a pair of gloves therein. The glove holders 192 are preferably stitched to the area of the panel 12 having increased strength and are preferably constructed from the same material as that of the panel 12 . An inner fastener 198 is coupled to the panel 12 and to an inner surface of each of the first and second ends 194 , 196 of the glove holders 192 such that the inner fastener 198 couples the glove holders 192 to the panel 12 . The inner fastener 198 may be complementary portions of a hook and loop fastener. The inner fastener 198 preferably has the same dimensions as each of the exterior fasteners 160 . A pair of side straps 174 is coupled to the panel 12 . Each of the side straps 174 is positioned on an associated one of the lateral sides 18 , 20 of the panel 12 . The side straps 174 extend from the first end 14 to the second end 16 of the panel 12 . A side fastener 176 is coupled to each of the side straps 174 . The side fastener 176 comprises first and second complementary portions 178 , 180 wherein the first and second complementary portions 178 , 180 are selectively engaged to permit adjustability of the panel 12 via adjustment of the side straps 174 . Each the side fasteners 176 preferably comprises a buckle 182 . In use, as stated above and shown in the Figures, the panel 12 is secured around the neck 28 of a person, such that the panel 12 is draped over the torso and shoulders 26 of the person, while the neck 28 of the person extends through the aperture 22 . The graspable portion 64 of the slide fastener 54 is pulled upwardly toward the aperture 22 so as to interlock the toothed tracks 60 , 62 . The side straps 174 are adjusted to adjust the panel 12 . Items 76 , such as tools 130 and electronic devices 126 , are placed in the pockets 66 . The flaps 136 are moved to the closed position 140 to secure the items 76 within the interior space 74 of the pockets 66 . The flaps 136 are moved to the opened position 138 to retrieve the items 76 when desired. To remove the panel 12 , the graspable portion 64 of the slide fastener 54 is pulled downwardly away from the aperture 22 so as to separate the toothed tracks 60 , 62 . With respect to the above description then, it is to be realized that the optimum dimensional relationships for the parts of an embodiment enabled by The disclosure, to include variations in size, materials, shape, form, function and manner of operation, assembly and use, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by an embodiment of the disclosure. Therefore, the foregoing is considered as illustrative only of the principles of the disclosure. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the disclosure to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the disclosure.

A tool kit vest assembly securely holds and provides easy access to tools, allows for adjustment of the vest, and provides ventilation to dissipate heat. The assembly includes a flexible panel having a first end and a second end. An aperture is positioned in the panel between the first end and the second end and between a pair of lateral sides of the panel. A dorsal portion of the panel extends from the aperture to the first end of the panel. A pocket is coupled to the panel. A flap is coupled to the pocket and is positionable between an opened position and a closed position. An interior fastener couples the flap to the pocket when the flap is in the closed position. An exterior fastener couples the flap to the panel when the flap is in the opened position.

RELATED APPLICATIONS This application claims benefit from U.S. Provisional Application for Patent Application No. 62/298,038 filed Feb. 22, 2016, which is hereby incorporated by reference in its entirety. BACKGROUND The field of the present device and method relates to spring-loaded animal traps, and more particularly, to catch release mechanism for a spring-loaded animal trap, such as a mouse trap, animal trap, or the like. With standard mouse traps, also known as snap traps or spring-loaded arm bar mouse traps, the catch serves two primary purposes, to restrain the holding arm bar when the trap is set and to hold the bait. In order for the trap to activate, the rodent must apply sufficient force on the catch through the eating or manipulation of the attached bait to cause the catch to release the holding arm bar. It is too often the case that the mouse can gently eat the bait without activating the trap. Thus, when later checked, the trap may still be set, yet the catch cleaned of the bait. What is needed is a trap that senses more than just direct pressure on the catch and accounts for other movements or applications of force applied on other portions of the trap. SUMMARY The present improved animal trap and unique catch release mechanism or snap trap actuator eliminates substantial eating or removal of the bait without the trap activating and provides a dual means to activate the trap. This is accomplished by the present catch release mechanism having a sliding member which slides within a hole through the platform of the trap under the influence of gravity and a prop which holds at least a portion of the trap platform above a support surface. When the prop is destabilized by an external force (e.g., applied by a rodent on any part of the trap), the prop's support of the platform is disturbed, permitting the platform to fall toward the support surface. The platform falls relative to the sliding member; and the sliding member is forced toward the catch by contact with the support surface, thus pushing the catch so that the catch releases the holding arm bar to activate the trap. In a first embodiment, an animal trap is provided and generally comprises a platform having a top surface with a first section, a second section, and a middle section located between the first section and the second section; a catch attached to the top surface, the catch being to move relative to the top surface; a pivoting kill bar hammer rotationally attached to the middle section of the platform and being biased towards the second section; a holding arm bar with a proximal end and a distal end, the holding arm bar attached through a pivot to the first section of the platform by the proximal end, when in a set configuration the distal end of the arm bar releasably coupled to the catch to hold the kill bar hammer toward the first section; and a catch release mechanism comprising a sliding member and a prop, the prop supporting the platform in a tilted orientation above the support surface; where, when the prop is destabilized, the platform drops downwards to push the sliding member upwards by contact with the support surface and into the catch causing the catch to move and release the distal end of the holding arm bar to permit the pivoting kill bar hammer to return towards the second end. Optionally, the platform may further comprise a bottom surface opposite the top surface, the prop is pivotally connected to the bottom surface. The prop may be attached to or separable from the platform or other part of the trap. The prop may have a tapered end. The platform may have a through hole into which the sliding member is inserted, a portion of the sliding member is positioned beneath the catch when in the set configuration. As an option, the sliding member comprises a rod and the portion of the sliding member is an enlarged head. The sliding member may further comprise an enlarged base, the enlarged head is positioned above the top surface and the enlarged base is positioned below the top surface to trap the sliding member within the through hole. The rod of the sliding member may slide freely within the through hole. In the set configuration, the prop holds a second portion of the platform a distance above the support surface with the enlarged base held slightly above the support surface and the enlarges head resting on the top surface. The prop may be destabilized by movement of the platform or any part of the trap. Optionally, the bait can be applied to the catch release mechanism and/or the second section of the platform. In another embodiment, an animal trap is provided and generally comprises a platform comprising a top surface that supports a pivoting kill bar hammer, a catch, and a holding arm bar, in a set configuration, the pivoting kill bar hammer repositioned from an initial position against a bias and held in a set position by the holding arm bar releasably coupled to the catch; and a catch release mechanism comprising a sliding member and a prop, the prop supporting the platform in a tilted orientation above the support surface; where, when the prop is destabilized, the platform drops downwards to push the sliding member upwards by contact with the support surface and into the catch causing the catch to move and release the distal end of the holding arm bar to permit the pivoting kill bar hammer to return towards the initial position. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS FIG. 1 is a perspective view of the embodiment of the present animal trap with the catch release mechanism; FIG. 2 is a partial cross-sectional perspective view of the embodiment of FIG. 1 more clearly illustrating the catch release mechanism; FIG. 3A is a magnified partial cross-sectional perspective view of FIG. 2 , showing the animal trap in the set configuration; FIG. 3B is a magnified partial cross-sectional perspective view of FIG. 2 , showing the animal trap in the activated state or configuration; FIG. 4A is a side view of the animal trap of FIG. 1 , showing the animal trap in the set configuration; and FIG. 4B is a side view of the animal trap of FIG. 1 , showing the animal trap in the set activated state or configuration. LISTING OF REFERENCE NUMERALS OF FIRST-PREFERRED EMBODIMENT animal trap 20 platform 22 catch 24 pivoting kill bar hammer 26 holding arm bar 28 catch release mechanism 30 top surface 32 bottom surface 34 first section 36 second section 38 middle section 40 catch staple 42 catch hook 43 bait holder 44 catch bottom surface 45 catch distal end 46 rod 48 rod staple 50 , 52 bar staple 54 bar proximal end 56 bar distal end 58 hammer spring 60 , 62 sliding member 64 prop 66 tapered end 68 through hole 70 sliding rod 72 enlarged head 74 enlarged base 76 support surface arrow A 1 , A 2 , A 3 , A 4 , A 5 , A 6 , A 7 , A 8 , A 9 DESCRIPTION OF THE PREFERRED EMBODIMENTS The detailed descriptions set forth below in connection with the appended drawings are intended as a description of embodiments, and is not intended to represent the only forms in which the present securement system may be constructed and/or utilized. The descriptions set forth the structure and the sequence of steps for constructing and operating the securement system in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent structures and steps may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the invention. Referring first to FIGS. 1 and 2 , an animal trap ( 20 ) is disclosed, generally having a wood platform ( 22 ) (although other materials may be used, such as metal, plastic, linoleum, acrylic glass, or a platform with a veneer to match the support surface, etc.) with a top surface ( 32 ) having a first section ( 36 ), a second section ( 38 ), and a middle section ( 40 ) between the first section ( 36 ) and the second section ( 38 ). The sections ( 34 , 36 , 38 ) are not precisely delineated, but instead, represent three general areas of the top surface ( 32 ) upon which various parts of the trap ( 20 ) may be positioned. A bar staple ( 54 ) is located within the first section ( 36 ), with the holding arm bar ( 28 ) attached to the bar staple ( 54 ) by a loop on the end to create a pivoting attachment. Of course, because the bar staple ( 54 ) is U-shaped with the end of the holding arm bar ( 28 ) looped about it, the holding arm bar ( 28 ) is permitting to pivot and move about the bar staple ( 54 ) in multiple directions. The pivoting kill bar hammer ( 26 ) is generally made from a single wire bent into a rectangular shape, with one side of the rectangle held, much like an axle, by a first rod staple ( 50 ) and a second rod staple ( 52 ) pinned to the middle section ( 40 ) of the top surface ( 32 ). One or more springs ( 60 , 62 ) (such as a torsion spring) biases the rotation of the pivoting kill bar hammer ( 26 ) towards the second section ( 38 ) of the top surface ( 32 ) with enough force and impulse to capture a rodent between the pivoting kill bar hammer ( 26 ) and the second section ( 38 ). A catch staple ( 42 ) pivotally holds the catch ( 24 ) to the top surface ( 32 ) within or near the middle section ( 40 ). The catch ( 24 ) includes a bait holder ( 44 ) and a catch hook ( 43 ) configured to engage the distal end ( 58 ) of the holding arm bar ( 28 ) when the animal trap ( 20 ) is in the set configuration, as shown in FIG. 1 . As with standard spring-loaded traps, in the set configuration, the pivoting kill bar hammer ( 26 ) is rotated from the second section ( 38 ) and towards the first section ( 36 ) against the biasing force of the springs ( 60 , 62 ). As the pivoting kill bar hammer ( 26 ) is manually held towards the first section ( 36 ), the holding arm bar ( 28 ) is rotated over the pivoting kill bar hammer ( 26 ) such that the proximal end ( 58 ) of the holding arm bar ( 28 ) touches the pivoting kill bar hammer ( 26 ) to arrest its movement. Then, the distal end ( 58 ) of the holding arm bar ( 28 ) is positioned beneath the catch hook ( 43 ) so that the distal end ( 58 ) pushes up on the catch hook ( 43 ) to provide a temporary engagement. If activated, the spring force acting on the pivoting kill bar hammer ( 26 ) will cause the distal end ( 58 ) to disengage from the catch hook ( 43 ) swing back, and release the pivoting kill bar hammer ( 26 ) so that it strikes the second section ( 38 ) of the top surface ( 32 ). The catch release mechanism ( 30 ) is illustrated more clearly in the partial cross-section of FIG. 2 . The illustrated embodiment of the catch release mechanism ( 30 ) comprises a sliding member ( 64 ) positioned in a through hole ( 70 ) formed through the platform ( 22 ), from the top surface ( 32 ) to the bottom surface ( 34 ). The sliding member ( 64 ) is permitted to axially slide within the through hole ( 70 ), preferably freely sliding or with little resistance. The through hole ( 70 ) may be lined with a tubular liner made of plastic, metal, or other material that permits the sliding member ( 64 ) to slide without undue friction or binding. When the platform ( 22 ) is lifted above the support surface (S), under the influence of gravity, the sliding member ( 64 ) slides downward towards the earth. An enlarged head ( 74 ) is connected to a top end of the sliding member ( 64 ) and is positioned above the top surface ( 32 ) and beneath the catch ( 24 ). An enlarged base ( 76 ) is connected to a bottom end of the sliding member ( 64 ) and is positioned beneath the bottom surface ( 34 ) of the platform. The enlarged head ( 74 ) and the enlarged base ( 76 ) limit the travel of the sliding member ( 64 ) so that the sliding member ( 64 ) remains in the through hole ( 70 ). Further the enlarged head ( 74 ) is sized so that it pushes upon the catch ( 24 ) (preferably on the catch distal end ( 46 ) or any other portion) when the sliding member ( 64 ) slides upwards towards the top surface ( 32 ). The enlarged head ( 74 ) and the enlarged base ( 76 ) may be made of various materials, such as metal, plastic, and such. The enlarged base ( 76 ) may further include a rubber foot to enhance grip on the support surface (S). The sliding member ( 64 ) may be a rod, tube, strip, square stock, or any other configuration that permits sliding within the through hole ( 70 ). Still referring to FIG. 2 , the catch release mechanism ( 30 ) further comprises a prop ( 66 ) or other support that provides an unstable support to hold at least a portion of the platform ( 22 ) above a support surface (S). In the present example embodiment, the prop ( 66 ) is a small wood board with a tapered end ( 68 ). However, the prop may be made of a length of wire, a rod, a rectangular sick, toothpick-like structure, nail-like structure, or any other configuration that provides temporary support of the platform ( 22 ) that is easily destabilized by an external force applied to any or most any portion of the animal trap ( 20 ). In the illustrated example, the prop ( 66 ) is stood between the bottom surface ( 34 ) of the platform ( 22 ) and the support surface (S), held in place through frictional engagement with both surfaces. In an alternate embodiment (not shown), a wire hinged to a staple on the bottom surface ( 34 ) provides a prop which acts as an unstable support. Thus, the prop ( 66 ) may be permanently attached to the trap ( 20 ) or temporarily engaged. Referring to FIG. 3A , a magnified view of FIG. 2 is provided to more clearly illustrate the operation and components of the present catch release mechanism ( 30 ). This figure, as well as and FIG. 4A , illustrates the animal trap ( 20 ) in the set or armed configuration, with the prop ( 66 ) supporting the second section ( 38 ) a distance above the support surface (S) and the first section resting on the support surface (S), forming a lean-to like arrangement. In the illustrated embodiment, the height of the prop ( 66 ) is sufficient to permit the sliding member ( 64 ) to slide downward within the through hole ( 70 ), so that the enlarged head ( 74 ) rests on the top surface ( 32 ) and the enlarged base ( 76 ) is held slightly above the support surface (S). Although, in another embodiment (not illustrated), the enlarged base ( 76 ) rests upon the support surface (S), holding the enlarged head ( 74 ) slightly above the top surface ( 32 ). Arrows (A 1 , A 2 ) illustrate that the prop ( 66 ) is permitted to collapse or fall in any direction if the platform ( 22 ) were to be shifted or jarred relative to the support surface (S). The frictional engagement between the prop ( 66 ) and the support surface (S) and the platform ( 22 ) is easily overcome by movement, vibration, shifting, or other forms of contact between an animal and the trap ( 20 ). Arrow (A 3 ) illustrates the up and down axial movement of the sliding member ( 64 ) within the through hole ( 70 ). FIGS. 3B and 4B illustrate the animal trap ( 20 ) in the triggered or activated configuration, after an animal has applied a force to the platform ( 22 ), the catch ( 24 ), the enlarged head ( 74 ), the prop ( 66 ), or any other portion of the animal trap ( 20 ). As discussed above, a sufficient external force applied by the animal will cause the prop to break contact and slide relative to one or both of the support surface (S) and the bottom surface ( 34 ). Arrow (A 8 ) illustrates the prop ( 66 ) falling down and permitting the platform ( 22 ) to drop toward the support surface (S) under the influence of gravity. As the platform ( 22 ) drops down, the enlarged base ( 76 ) of the sliding member ( 64 ) contacts the support surface (S), which pushes upwards on the sliding member ( 64 ) pushing the sliding member ( 64 ) upward and toward the catch ( 24 ). Because the enlarged head ( 74 ) is positioned beneath the catch ( 24 ), upward movement of the sliding member ( 64 ) (indicated by arrow (A 7 )) causes the enlarged head ( 74 ) to rotate or otherwise move the catch ( 24 ) about the staple ( 42 ), as indicated by arrow (A 6 ), to disengage the catch hook ( 43 ) from the distal end ( 58 ) of the holding arm bar ( 28 ), to release the holding arm bar ( 28 ) and permit its rotation (as indicated by arrow (A 4 )) under the spring force of the pivoting kill bar hammer ( 26 ) rotating back toward the second section ( 38 ) (as indicated by arrow (A 9 )), thus trapping the animal. With the present animal trap ( 20 ), the catch may be released in two ways, first, by the traditional manner where the animal torques the catch itself or by simply shifting the platform ( 22 ) to knock over the prop ( 66 ). The bait (peanut butter, etc.) may be placed on the catch ( 24 ), on the enlarged head ( 74 ), on the top surface ( 32 ), or any portion of the animal trap ( 20 ) which would position the animal between the platform ( 22 ) and the pivoting kill bar hammer ( 26 ) when the trap ( 20 ) is activated. Although the sliding member ( 64 ) is shown with an enlarged head ( 74 ) and enlarged base ( 76 ) these are illustrative of just one embodiment, and are not required. An alternate sliding member may include a wire inserted through the through hole ( 70 ), with the ends of the wire bent at a ninety degree angle to prevent retraction. The present animal trap ( 20 ) provides a substantially increased level of sensitivity and easily activates upon the slightest nudge, even while the animal is merely investigating the bait. Thus, consumption of the bait is not required to activate the trap. While particular forms of the present securement system have been illustrated and described, it will also be apparent to those skilled in the art that various modifications can be made without departing from the spirit and scope of the design. Accordingly, it is not intended that the invention be limited except by the claims.

The present improved animal trap and unique catch release mechanism eliminates substantial eating or removal of the bait without the trap activating and provides a dual means to activate the trap. This is accomplished by the present catch release mechanism having a sliding member which slides within a hole through the platform of the trap under the influence of gravity and a prop which holds at least a portion of the trap platform above a support surface. When the prop is destabilized by an external force, the prop's support of the platform is disturbed, permitting the platform to fall toward the support surface. The platform falls relative to the sliding member; and the sliding member is forced toward the catch by contact with the support surface, thus pushing the catch so that the catch releases the holding arm bar to activate the trap.

This application is a U.S. national stage application under 35 U.S.C. §371 of International Application No. PCT/EP2011/059677, filed Jun. 10, 2011, claiming priority to United Kingdom Patent Application No. 1010766.2, filed Jun. 25, 2010, and to U.S. Provisional Application No. 61/358,856, filed Jun. 25, 2010, each of which is incorporated by reference in its entirety into this application. The present invention relates to a delivery system for a self-expanding implant to line a bodily lumen, which includes a sheath to hold the implant in a radially compressed configuration prior to and until deployment in the lumen, when the sheath is withdrawn along the axis of the lumen. Self-expanding implants such as stents and stent grafts are often delivered to a stenting site within a bodily lumen with the use of a catheter delivery system that is advanced percutaneously and transluminally. Although most stents and stent grafts are for the cardiovascular system, self-expanding implants can also be delivered transluminally to body lumens that carry bodily fluids other than blood. A stent without a coating is often called a “bare” stent. Stent grafts that carry a covering of a material such as expanded polytetrafluoroethane (ePTFE) are often called “covered” stents or “stent grafts”. A self-expanding stent need not be made of metal but usually is, and that metal is usually a nickel titanium shape memory alloy commonly known as “NITINOL”. Given that a self-expanding stent will expand when freed of the constraint of the catheter delivery system, it follows that the catheter delivery system confining the stent will be subject to radially outward pressure from the confined stent, at least at body temperature 37° C. With NITINOL, the outward radial pressure dwindles to zero as the temperature of the stent is reduced to temperatures around 0° C. and below, with the austenitic crystal lattice changing, as the temperature reduces, to a martensitic crystal lattice. Thus, at low temperatures, with the self-expanding stent in the martensitic state, the hoop stress on the sheath surrounding the stent in the delivery system will be relatively low, even to the extent of being close to zero. However, as the temperature rises towards body temperature, the radially outward pressure on the confining sheath will increase. Given that the confining sheath has to be flexible if the distal end of the catheter delivery system is to advance along a tortuous bodily lumen, it is invariably made of a synthetic polymeric material rather than metal. Such materials are subject to deformation and the deformation of polymers is a time-dependent phenomenon. Suppose that the self-expanding stent confined within its sheath is stored for a period of weeks or months, at room temperature or above. There is the possibility, perhaps likelihood, that the sheath will stretch and the stent will expand radially to some extent, during the extended period of storage. Even more significant, in coated stents such as those made of Nitinol with an ePTFE covering, relaxation of the compacted ePTFE layer on the stent also contributes to radial distortion of the sheath. As the quest continues for ways to deliver implants to ever-smaller diameter locations within the body, through ever-more tortuous delivery paths, the pressure on designers of implants and delivery systems to reduce to ever-smaller values the passing diameter of the distal end of the catheter system where the implant is located, continues to increase. This pressure pushes designers to think of sheath designs of ever-smaller wall thickness. The smaller the wall thickness of the sheath, the greater the difficulty of resisting the radially outward pressure imposed on the sheath by the stored implant. One promising route to reduce yet further the wall thickness of the confining sheath is, perhaps paradoxically, to provide that the sheath has a double layer, namely, as a cylindrical sheath that doubles back on itself. It starts proximally of the implant, extends distally over the full length of the implant and then is turned back radially outwardly on itself, to continue back along the length of the implant, extending proximally, to a position proximal of the proximal end of the implant. That turned back end of the sheath, proximal of the implant, can be pulled proximally, when the time comes to release the stent. That proximal pull will draw proximally, progressively, the point along the length of the sheath where the sheath material doubles back on itself. That location where the sheath material doubles back on itself progresses proximally along the length of the implant, releasing as it goes the stent portion radially inside it, so that, when it finally reaches the proximal end of the implant, the implant is fully released into the bodily lumen. The present invention represents a way to minimise the wall thickness of sheath material surrounding a self-expanding implant, so that the passing diameter of the distal end of a catheter-type implant delivery system can be reduced yet further. According to the present invention there is provided in such a delivery system a confining element, preferably in the form of a sleeve, to surround the sheath during a storage period between placement of the implant within the sheath and said withdrawal of the sheath, the confining element serving to reduce the hoop stress in the sheath during said storage period and being removable from the sheath prior to advancement of the sheath into the said bodily lumen. It will appreciated by skilled readers that, when the confining element acts to reduce the hoop stress in the sheath during the storage period this, in turn, can reduce the amount of time-dependent creep deformation of the sheath in contact with the stent during the storage period, that would otherwise tend to increase the diameter of the sheath, under pressure from the implant within it. In some cases such an increase could result in increasing the passing diameter of the distal end of the delivery system to a value higher than is needed for delivery of the implant, and higher than the minimum that can be achieved with the specific delivery system prior to any period of extended storage. In others, the increase could lead to fouling of the sheath during movement relative to other components of the delivery system. It may be convenient to make the confining element as a sleeve of a heat-shrinkable material and shrink it around the sheath during manufacture of the delivery system. Such a shrinking step will bring the confining structure into embracing contact with the distal end of the delivery system. Thus, the microstructure of the heat shrunk material can be more resistant to creep stretching under hoop stress from the confined implant than the same material prior to being subjected to the heat shrinking step. The proposal to put the sheath inside a sleeve is of no value unless the sleeve can easily be removed when the time comes to use the delivery system for delivering the implant. At that point, the sleeve must be removed prior to advancing the distal end of the delivery system into the body of the patient. One convenient way to strip off the sleeve is to include with the sleeve an elongate pull element that will, when it pulled in the proper direction, part the sleeve progressively, from one end of the sleeve towards the other, to release the hoop stress in the sleeve and release the sheath from the surrounding sleeve. One need only think of the way in which the clear plastic film around a packet of cigarettes is released from the cigarette packet to understand how any such elongate pull element might work. To assist the operation of the pull element in the environment of an operating theatre, the inventor contemplates providing the free end of any such pull element with a finger ring to receive a finger and serve as a pull ring to pull the pull element to part the sleeve. The inventor envisages making the sleeve of a PET material (polyethylene terephthalate) (polyethylenephthalate). The above mentioned self-expanding implant release system that relies on a sheath that doubles back on itself will work optimally only when the sheath material can slide on itself, so that the outer of the two coaxial layers of the sheath can easily slide proximally over the abluminal surface of the inner layer of the sheath. Suppose that such a doubled back sheath is confined inside a surrounding sleeve that imposes uniform pressure on all parts of the surface of the outer layer of the doubled back sheath. It is not inconceivable that there will be some tendency for the two facing layers of the sheath somehow to “stick” to each other, at least locally. Self-evidently, it is important that the confining sleeve shall not induce such adherence between the two facing layers of the sheath confined within it. Preferred embodiments of the present invention offer improved prospects to defeat any such tendency for adherence between the two layers of a roll back sheath. Specifically, a preferred system according to the present invention will include means to establish spaced pressure relief zones interposed between the sheath and the sleeve for preferentially carrying the forces acting between the sheath and the sleeve, whereby zones of the sheath that lie between adjacent pressure relief zones are relieved of the full magnitude of said forces. In other words, by confining to particular pressure zones the radially inward squeezing action of the sleeve on the sheath, the intervening parts of the surface area of the sheath will be spared the radially inward pressure and so the outer of the two facing layers of the sheath will not be pressed with full force against the abluminal surface of the inner of the two sheath layers. Indeed, with careful design of the sleeve system, it ought to be possible to arrange for there to be a physical gap between the abluminal surface of the inner sheath layer and the luminal surface of the outer sheath layer, in locations between two adjacent pressure zones. Skilled readers will appreciate that confinement of the full squeezing force of the sleeve on the sheath to specific spaced zones interspersed with pressure relief zones offers the possibility to neutralise any tendency for the two sheath layers to stick to each other in the pressure zones. This is particularly the case if the pressure zones are confined to lines of contact on the abluminal surface of the outer layer of the sheath that run parallel to the axis of the sheath and implant. This is because any such line of contact, where sticking is likely to occur preferentially, runs along the length of the implant and therefore should present a minimal sticking problem when the sheath is progressively peeled backwards along the length of the implant from its distal end to its proximal end. Specifically, suppose there are six lines of contact between the sleeve and the sheath, evenly distributed at 60° intervals around the circumference of the sheath. After the sleeve has been removed, and the sheath is pulled proximally to release the implant, we can take it that any sticking is likely to be found at one or more of those six points of contact distributed evenly around the circumference. However, when most of the circumference of the sleeve is peeling back from any sticking, such adherence as is to be found at the six points of contact is broken by shearing and so ought to provide hardly any impediment to the smooth and progressive rolling back of the sheath membrane to release the implant. One way to provide a plurality of such lines of contact parallel with the axis of the sheath and implant is to provide between the sheath and the sleeve a plurality of elongate members, evenly distributed around the circumference of the sheath and sleeve and all parallel to the axis of the sheath and implant. It may be useful to provide such elongate members as tubes. It may be optimal to select the tube diameter and the number of tubes such that they are in close proximity, or even in contact with each other, in the annular gap between the sheath and the sleeve. In one preferred embodiment, for example, there are six such tubular elongate members, thus with their long axis at spaced intervals of 60° around the circumference of the axis of the implant. Another possibility is four tubes at 90° intervals parallel but spaced apart from each other. Skilled readers will appreciate that there is no absolute need to have adjacent elongate members in continuous contact with each other, side-by-side, over the full length of the implant. When there are enough points of contact distributed along the length of the elongate members, at spaced intervals, there is no need for any such side-by-side contact between the spaced contact points. If spacers are used, there need be no contact at all between the adjacent elongate members. In the illustrated embodiment described below, it is shown how wall portions of elongate tubular members can be selectively removed to provide spaced points of side-by-side contact but a continuous line of contact of each elongate tubular member with the sheath confined radially within it. It will likely be convenient and effective to provide the above-mentioned elongate members as components made of metal. It is envisaged that the extra cost to a delivery system for an implant caused by the provision of the elongate members and sleeve will be minimal in relation to the performance advantages obtainable, particularly in relation to the storage periods and temperatures that are liable to be encountered in practical day-to-day use of such implant delivery systems. BRIEF DESCRIPTION OF THE DRAWINGS For a better understanding of the present invention, and to show more clearly how the same may be carried into effect, reference will now be made, by way of example, to the accompanying Drawings, in which: FIG. 1 is a section taken transverse to the long axis of the distal end of a delivery system for a self-expanding implant; FIG. 2 is a section taken in a plane normal to the long axis of the distal end of a delivery system for a self-expanding implant; and FIG. 3 is an isometric view through an assembly of elongate members applicable to the embodiment shown in section in FIG. 1 together with an example of an isolated elongate member for use in such an assembly. DETAILED DESCRIPTION Best Mode There now follows a description of one exemplary embodiment for putting the present invention into effect. FIG. 1 shows a first embodiment of the present invention, being a delivery system for a self-expanding implant to line a bodily lumen. The inner components of the delivery system are essentially conventional, but will be described here to aid the reader in understanding the interaction between the various components of the system. Defining an axis of the delivery system is inner catheter 11 , which runs from a distal end of the delivery system (on the left hand side of the Figure) to a proximal end of the delivery system (not shown in the Figure but some distance beyond the right hand of the Figure). Inner catheter 11 defines a lumen through which guide wire 21 runs. Guide wire 21 is provided to be inserted percutaneously and guided through the body passages which the stent delivery system is to navigate before the delivery system itself is introduced, in order to more easily guide the proximal end of the stent delivery system to its intended location in the body. Coaxial with the inner catheter, and located around it in a compressed configuration is implant 31 , in the present instance being a self-expanding NITINOL stent. The stent is held in a radially compressed configuration onto the inner catheter by means of inner sheath layer 41 , which radially surrounds the stent and applies inwardly radial pressure thereto to maintain the stent in its compressed configuration. In the system depicted, inner sheath 41 extends distally and then folds back on itself at a distal turning point to return proximally as outer sheath 42 . This configuration is conventionally known as a roll-back design, as will be explained later in terms of stent deployment. Outer sheath 42 extends proximally until a region A, where its radius reduces to that of pull portion 51 , where it attaches. Pull portion 51 extends proximally to the proximal end of the delivery system to convey an actuating tensile force from the operator to outer sheath 42 . In contrast, push element 61 is provided to restrain the stent 31 from proximal axial movement relative to inner catheter 11 . Accordingly, push element 61 is provided fixed in relation to inner catheter 11 , in some embodiments by means of the inward pressure of inner sheath 41 . Atraumatic tip 91 is provided distal of stent 31 to shield the distal end of inner sheath 41 and outer sheath 42 from the body passages through which the stent delivery system travels, and vice versa. What has been described so far is for the most part conventional. However, the embodiment shown in FIG. 1 also provides a confining structure 80 , including rod members 81 a , 81 b , 81 c , 81 d , 81 e and 81 f , of which only 81 a and 81 d are shown. The rod members lie essentially parallel to inner catheter 11 at substantially equal circumferential spacings therearound and are confined themselves by sleeve 82 . The radial configuration is shown in FIG. 2 , in which the structures inward of outer sheath 42 have been simplified for clarity. Confining element 82 , here being a confining sleeve, provides inward radial pressure on the rods, which themselves provide inward radial pressure on outer sheath 42 at each of the six points of contact of the rods to the outer sheath around the circumference thereof. On the other hand, between the points of contact no pressure is applied. This can be seen more easily in FIG. 2 , including the phenomenon of close compression of the layers 41 , 42 at the contact points of the rods 81 , while voids 71 exist between layers 41 , 42 at regions between the points of rod circumferential contact. By applying this radial compression to outer sheath 42 , the tendency of stent 31 to distort, by virtue of its natural tendency to expand and thus apply radial pressure, inner and outer sheaths 41 and 42 is inhibited. Prior to use in surgery, the stent delivery system is provided in the form shown in FIG. 1 in which it may be stored for an extended period. The user, just prior to surgery, removes the confining structure 80 , by, for example, splitting sleeve 82 and discarding the rods 81 . The stent will then be available for use in its design-intended configuration, having dimensions and geometry undistorted over time by the aging process. Next, the guide wire is inserted into the body percutaneously and navigated beyond the stent site. The delivery system is then directed along the guide wire to reach a particular body lumen, for example a cardiac artery. In the configuration of stent shown in the present embodiment, the pull element 51 is then retracted by application of tensile force from the proximal end of the system. The outer sheath 42 thus slides proximally over inner sheath 41 such that the folded portion distal of inner sheath 41 and outer sheath 42 progressively rolls back to expose the stent. Meanwhile, push element 61 , being coupled to inner catheter 11 , which is held static at the stenting site by compression forces from the proximal end of the system, restrains the stent from proximal movement to ensure accurate deployment at the intended stenting site. As the pull element is retracted, radial pressure is released on the stent and stent 31 assumes its expanded configuration, such that the inner radial void of the stent becomes larger than atraumatic tip 91 , and the stent engages with the walls of the bodily lumen. The stent delivery system may then be swiftly and easily retracted the way it arrived, leaving the stent secured in place. Of course, many other configurations of stent delivery system than roll-back systems may be used in conjunction with confining structure 80 . Indeed, confining structure 80 provides an effective means of containing any self-expanding implant delivery structure which is otherwise liable to expand over time and therefore potentially exceed its design tolerances. For example, confinement structure 80 can be used with stent delivery systems having pull-back, rather than roll-back, sheaths. The construction of elements within confining structure 80 may be, as has been mentioned, conventional. On the other hand, the innovative confining structure 80 may itself be realised in a number of different forms. Considering the arrangement of FIGS. 1 and 2 , confining structure 80 is provided as longitudinal rods spaced equidistantly about the circumference of the outer sheath 42 , but other configurations to those shown in FIG. 1 are entirely possible. For example, the rods may instead be formed as hollow cylinders and/or their arrangement and spacing around the circumference of the outer sheath may be varied. For example, four rods or eight rods may be contemplated, and their diameter varied in comparison to the diameter of the outer sheath. In some embodiments, a split-wire 83 , shown schematically in FIG. 2 , may be provided, running the length of the sleeve, to enable the user to easily and swiftly split the sleeve before use, without the use of a separate tool. Such a split-wire may run distally (portion 83 a ) within the sleeve between two of the rods and may then loop at the distal end before returning (portion 83 b ) to the proximal end on the outside of the sleeve, terminating in a pull-ring 84 . Pulling on the pull-ring will then cause the wire to split the outer sleeve longitudinally, distal to proximal. Thin steel wire is suitable as a split-wire, in some embodiments. In one embodiment, the rods do not touch but approach each other closely. This permits a high degree of contact with the outer sheath and confinement thereof while preventing variations in confining force or inability to sufficiently compress due to the rods touching one to another. In another embodiment, the rods are configured to touch one another at a desired level of confining pressure or confining diameter, to prevent the inner components of the stent delivery system becoming crushed by overpressure. In the above embodiment, the conventional stent structure lying within the confining structure, namely that lying within the radius of the outer sheath, typically has a diameter of around 2.4 mm. In such a configuration, stent diameters themselves of around 2.1 mm are conceivable, in their compressed state. Of course, in their expanded state such stents typically achieve outer diameters of around 7 mm, depending on application. For such applications, rods of the confining structure having a diameter around 2 mm may be appropriate. As to the other components, the atraumatic tip 91 is typically formed from polyurethane, the inner catheter is typically a polyimide tube, while the inner and outer sheaths are typically formed from 80 μm-thick PET which are respectively cold drawn (for the inner sheath) and heat shrunk (for the outer sheath) to a reduced thickness during manufacture. The thickness may be reduced from an original thickness of 80 μm down to a reduced thickness of 40 μm, in one exemplary embodiment. Further details of the construction of typical roll-back stent delivery systems to which the present invention may be applied may be found in published patent applications, such as WO 2006/020028 A1. The rods are envisaged to be made from steel or polyamide, but other materials, including both metals and polymers, are well within the choice of the skilled designer to select. However, both steel and polyamide are considered to be especially able to give the required resistance to distortion preferred in embodiments of the present invention. Indeed, if the rods are sufficiently resistant to deformation, it may not be required to provide a sleeve running the entire length of the confining structure, but to merely provide a number of compressing ligatures spaced along the length of the rods, in the manner of the hoops used to compress a traditional barrel of beer, wine or ale. Therefore, another embodiment is possible wherein the outer sleeve is replaced by a series of rings which may be slid along the rods to release them. Alternatively, a clamshell clamping arrangement may be provided around the rods, which arrangement may be released by a catch prior to use of the delivery system. Another embodiment is contemplated having a configuration of confining structure as shown in FIG. 3 . FIG. 3 does not show the inner stent delivery components or the outer sleeve, but shows how a bundle of six tubes may be arranged to perform the same function as the rods 81 , even though portions of the tubes have been cut out circumferentially, except for certain circumferentially intact portions spaced along the length. These uncut portions, having a complete circumference, transfer the compressive force of the sleeve through the tubes to the confined inner components of the stent delivery system. On the other hand, where the circumference is not complete, sufficient of the circumference remains to provide a line of pressure along the stent delivery components to achieve the effects of the invention. In this embodiment, the characteristics of the material from which the tubes are formed will determine how closely the full-circumference portions need to be spaced and how much of the circumference may be removed in the intervening cut-out portions. However, it is envisaged that the advantages of the present invention may be obtained even when the cut-out portions retain only around 130° of circumference each. As to the construction of an embodiment of the complete confined delivery system, starting from a complete conventional stent delivery system, the rods are located in their predetermined positions around the conventional delivery system and heat-shrink tubing applied to the outside. This heat-shrink tubing is typically PET tubing, which will shrink radially within around five seconds when a temperature of 200° C. is applied. During manufacture of stent delivery systems, it is generally considered highly undesirable to apply heat to a region proximate to a compressed-shape memory stent, in case the memory of the expanded configuration is distorted or destroyed, leading to potential catastrophic deployment failure. However, in the described embodiment, heat-shrinking of the outer sleeve is entirely possible, since the intervening rods and air gaps provide sufficient insulation to prevent effective heat transfer to the stent during the period when the heat-shrink tube is heated to cause it to shrink and radially confine the rods. The present invention is not limited to the presently-disclosed embodiments, but rather solely by the scope of the appended claims. The skilled reader will easily contemplate how embodiments of the confining structure may be incorporated into other constructions of implant delivery systems where dimensional creep due to aging is undesirable. Such embodiments may not be herein explicitly described, but with nevertheless be clearly within the ambit of the skilled reader without undue experimentation and without the exercise of inventive skill.

The present disclosure provides a delivery system for a self-expanding implant ( 31 ) which includes a sheath ( 41, 42 ) which surrounds and constrains the implant prior to delivery and a confining element ( 80 ) which surrounds the sheath during storage. The confining element preferably includes elongate members ( 81 ) running axially along the sheath, which compress the sheath and the stent to reduce hoop stress in the system without promoting undesired adhesion between layers of the sheath.

[0001] The invention pertains to machines for brewing and dispensing espresso drinks. In particular, the invention is an apparatus and associated method for controlling, automating, and duplicating the brewing conditions for multiple doses of espresso. [0002] Machines for preparing espresso drinks in a commercial retail environment are well known. In general, these espresso machines include a heating source for generating steam and hot water in a reservoir, a basket for holding ground espresso, and a dispensing spout. There are several increasingly sophisticated means of controlling the flow of the steam and hot water through the espresso, out the spout, and into the cup. Perhaps the simplest means is a manually-controlled valve which is opened to permit a pressurized flow of hot water through the grounds and out the spout into a cup below. More modern machines, such as the Hydra TM espresso machine manufactured by Synesso Incorporated of Seattle Washington, incorporate computer control of the valve. The operator of such machines either presses a button or operates a toggle switch, sensed by the computer to control the valve. Some espresso machines fully automate the brewing sequence, such that a single operation of the button provides a precise dose of water through the grounds, with attendant precise control of the water temperature and driving pressure. Commercial machines may include several dispensing heads. [0003] A commercial establishment for preparing and selling espresso drinks faces several inter-related problems, each of which is influenced by the particular espresso machine that the establishment has chosen to adopt. The first problem is one of simplicity of use. Because it is often a primary source of business revenue, the espresso machine must be capable of dispensing drinks at a high rate. The procedures for setting up the machine for each dose must be as short and simple as possible. Many existing espresso machines are automated for this reason. An attendant advantage to this automation is that that brewing sequence for each successive dose of espresso is highly consistent. [0004] Automation presents a competing problem, however. The operating mechanism in existing automated espresso machines is largely limited to an on/off switch or button. The competing problem to simplifying the operation for employees also serves to limit the ability of them to vary the espresso making process to account for changes in the coffee. The taste of the final espresso product can vary significantly with the type of coffee, the grind, and the age of the coffee, for example. Current machines have very limited capability for the experienced user to adjust the brew on the fly to account for these changes. [0005] The inventors have recognized these problems in the prior art, and have arrived at a novel and ingenious solution. An improved espresso machine is described here which incorporates a control scheme for detecting the operating input from the user during the brewing process. The espresso machine senses the operating inputs from the user and saves those inputs to a computer memory as an adjusted set of brewing parameters. The adjusted brewing parameters may then be employed during subsequent use of the machine. Thus, an experienced user can vary the brewing process on the fly, and without the need for time-consuming programming or process set-up. The invention simultaneously provides for a better coffee brew and increased product throughput. [0006] In accordance with the principles of the present invention, an improved espresso brewing apparatus is described which combines an espresso dosing unit, pump, and a group control head disposed adjacent the dosing unit with a controller and computer temporary brew memory. An actuation of the group control head handle actuates at least one of the controller, the pump and a control valve in the dosing unit to provide a controlled dose of hot water through a filter. The controller also saves parameters related to two or more signal inputs from the group control head into the temporary brew memory. The controller is also operable to retrieve the parameters for use during a programmed brew sequence used in a subsequent operation of the espresso machine. [0007] Also in accordance with the principles of the present invention, an improved method for providing a controlled dose of hot water the improved espresso machine is described. The method comprises the steps of sensing a momentary actuation of the group control head handle to an angular brew position. Steps of opening a control valve to begin the dose and initiating a saving of subsequent actuating step into the temporary brew memory responsively follow. The method also comprises a step of sensing a subsequent actuation of the handle which starts a pump and saves the parameter to the temporary memory. The method also comprises a step of sensing a third actuation of the handle which stops the pump to end the dose and saves this parameter to the temporary memory. The saved parameters become a set of brew parameters in the memory. If the first momentary actuation is not followed by any further actuations, then the parameters stored in the temporary memory become identical to the set of parameters already used by the programmed brew sequence. [0008] As used herein for purposes of the present disclosure, the term “processor” or “controller” is used generally to describe various apparatus relating to the operation of the inventive apparatus, system, or method. A processor can be implemented in numerous ways (e.g. such as with dedicated hardware) to perform various functions discussed herein. A processor is also one example of a controller which employs one or more microprocessors that may be programmed using software (e.g. microcode) to perform various functions discussed herein. A controller may be implemented with or without employing a processor, and may also be implemented as a combination of dedicated hardware to perform some functions and a processor (e.g., one or more programmed microprocessors and associated circuitry) to perform other functions. Examples of controller components that may be employed in various embodiments of the present disclosure include, but are not limited to, conventional microprocessors, application specific integrated circuits (ASICs), and field-programmable gate arrays (FPGAs). [0009] It is understood that the term “memory” refers to computer storage memory of types generally known in the art. Memory may be volatile or non-volatile computer memory such as RAM, PROM, EPROM, and EEPROM, floppy disks, compact disks, optical disks, magnetic tape, etc. In some implementations the computer memory media may be encoded with one or more programs that, when executed on the one or more processors and controllers, perform at least some of the functions discussed herein. Various storage media may be fixed within a processor or controller or may be transportable, such that the one or more programs stored thereon can be loaded into a processor or controller so as to implement various aspects of the present invention. The terms “program” or “computer program” are used herein in a generic sense to refer to any type of computer code (e.g. software or microcode) that can be employed to program one or more processors or controllers. [0010] In various implementations, there terms “outputs”, “inputs”, “signals”, and the like may be understood to be electrical or optical energy impulses which represent a particular detection or processing result. IN THE DRAWINGS [0011] FIG. 1 illustrates an embodiment of an espresso machine according to the present invention. [0012] FIG. 2 illustrates the plumbing system of the FIG. 1 espresso machine. [0013] FIG. 3 illustrates an exploded diagram of one embodiment of the inventive group control head. [0014] FIGS. 4( a ), 4( b ) and 4( c ) illustrate the operation of the FIG. 3 group control head. [0015] FIG. 5 is a system block diagram of one embodiment of the electrical sensing and control circuit. [0016] FIG. 6( a ) and FIG. 6( b ) illustrate two embodiments of a visual display for the espresso machine of the present invention. [0017] FIG. 7 illustrates a brewing sequence for the espresso machine. [0018] FIG. 8 illustrates an embodiment of an inventive method for operating the espresso machine of the present invention. [0019] FIG. 9 illustrates a flow chart method for saving and retrieving a set of brew parameters in the espresso machine. [0020] FIG. 10 is a state machine diagram for a simplified method of saving a set of brew parameters to the espresso machine. [0021] FIGS. 11( a ), 11( b ), 11( c ), and 11( d ) illustrate a set of state machine diagrams for a various operating modes of the espresso machine. [0022] FIG. 12 illustrates a visual display for saving a set of brew parameters from one dosing unit to other dosing units in the espresso machine. [0023] FIG. 13 illustrates a more detailed view of an external programming controller for the espresso machine. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0024] Espresso Machine Including Improved Non-contact Group Control Head [0025] Now turning to the illustrations, FIG. 1 shows an espresso machine_of the present invention. Espresso machine 100 includes an espresso dosing unit 102 having at least one group control head 110 which controls the operation of the machine to provide an espresso dose. Espresso machine 100 includes an internal source of water and steam pressure. Each dose of espresso is dispensed from a brew tank 150 at the outlet of the water source. Brew tank 150 is sized to contain hot water under pressure with enough volume, for example about 1.9 liters, for one or more doses of espresso. Typically, brew tank 150 includes a heating element to maintain the water temperature at an optimal temperature for brewing. [0026] At the outlet of brew tank 150 is a filter 160 for holding ground coffee. Filter 160 is sized to hold enough tamped-in grounds for one dose of espresso. Filter 160 is of course removable so that coffee grounds can be replaced after each use. At the outlet of filter 160 is an outlet spout 170 for guiding the dispensed dose of espresso into a cup, not shown, held or placed below the spout. For the purposes of this description, an espresso dosing unit 102 is generally understood to include at minimum the brew tank 150 , filter 160 and outlet spout 170 . [0027] Many commercial espresso machines include a visual display 180 disposed on the group control head 110 , or on the machine 100 adjacent the dosing unit or group control head. Visual display 180 can display basic shot parameters such as time to completion, dose size, and the like. Because of the need for quick and efficient dosing of espresso shots in commercial settings, it is important that the information provided on visual display 180 is kept as simple, clear and as uncluttered with unneeded data as possible. [0028] It may be noted that the type of grounds placed in the filter 160 may vary. The harvested source and variety of coffee, the texture of the grind, and the age of the coffee grounds affect the taste of the final product in several ways. The coffee variation may affect the tamp of the grounds in the filter 160 and the resulting pressure differential between the brew tank and the spout. The coffee variation also affects the interaction between the grounds and the hot water flowing through them. Each of these factors changes the taste of the dosed espresso. An experienced user desiring to optimize taste needs the ability to vary properties of the brew to account for these variations. [0029] The espresso machine of FIG. 1 also illustrates additional dosing units which include additional group control heads such as second group control head 110 ′ and third group control head 110 ″. The additional dosing units allow for increased throughput of espresso drinks. Each of the additional dosing units may also include dedicated visual displays such as shown in FIG. 1 at second visual display 180 ′ and third visual display 180 ″. The number of dosing units is not important to the invention. [0030] Any of the optional dosing units may be pre-programmed using an optional external programming controller 190 . Default brew parameters such dispensing temperature, dose size, and applied pressure profile may be entered via programming controller 190 . With reference to FIG. 13 , programming controller 190 includes a programmer display 192 , which may display text related to a current state of the selected dosing unit or may display text related to a programmed brewing sequence parameter. User selection of the text to be viewed on the controller 190 may be selected via one or more programmer selection buttons 194 disposed next to the corresponding text line, or may be selected via a set of up-and-down programmer scrolling arrows 196 . Adjustment of parameters may be entered via the scrolling arrows 196 . Other user interfaces such as keyboards, touch pad screens, and the like may be used as well for these functions. [0031] It should be noted that efficient use of controller 190 may entail a more advanced operating skill, and may distract from the ongoing dosing unit operation. Thus, use of programming controller 190 may be generally more desirable during business idle time or downtime. [0032] Now referring to FIG. 2 , a plumbing arrangement 200 that may be incorporated within the FIG. 1 espresso machine is shown. A single steam tank 202 is generally located within the main housing of the espresso machine, heated to provide a constant temperature and pressure steam source that is commonly used for foaming milk and the like. An external water source 210 , such as from building plumbing, and associated valve arrangement provides fill water for the steam tank 202 . The water source 210 is also used by a pump 204 as a source of water to brew tank 250 and optional brew tanks 250 ′ and 250 ″. Pump 204 may also operate under computer control to control or vary the pressure in brew tank 250 and consequently the pressure profile across the coffee grounds in the filter 260 as the shot is flowing. An optional bypass control valve 208 and associated plumbing from the pump 204 discharge, i.e. between brew tank 250 and pump, back to the pump 204 suction is also shown. Computer control may operate the optional bypass control valve 208 during the pump operation to establish a time-pressure profile across the filter by diverting the high pressure pump water away from the operating brew group. [0033] As can be seen in FIG. 2 , flow of pressurized water from pump 204 to brew tank 250 may pass through the steam tank 202 . This feature permits feed water to be pre-heated before entering the brew tank 250 , which makes temperature control at the brew group more precise. [0034] Brew tank 250 holds pressurized hot water that is ready for dispensing through the filter 260 . Brew tank 250 typically includes a heating element for continued precise temperature control, as well as a temperature sensor and an optional pressure sensor. Brew tank 250 or the dedicated plumbing leading to it may also include a flowmeter. [0035] Control valve 206 starts and stops the pressurized hot water flow from brew tank 250 through filter 260 through the outlet spout 170 . In a preferred embodiment, control valve 206 is operated under control of an automated controller, which in turn operates responsive to an actuation signal input from the group control head. Control valve 206 under such control thus provides a controlled volume output of the shot. [0036] If control valve 206 is opened without the pump 204 operating, a reduced flow through the brew tank still occurs. This state is useful at the beginning of a brew to pre-infuse dry coffee grounds with hot water before pumped flow begins. This state may also be useful at the end of the brew to avoid excessive “blonding” of the flow as the grounds are expended. The time between the stopping of the pump and final closing of the control valve establishes a low pressure finish. The value of the low pressure finish may be a percentage of the pumped flow volume to the total flow volume of the brew shot. [0037] FIG. 3 illustrates an exploded diagram of a preferred embodiment of a group control head 300 assembly according to the present invention. The assembly is mounted to the espresso machine 100 via a base 302 . Base 302 may be generally cylindrically shaped with a center axis disposed in the vertical plane. Base 302 may optionally be part of brew tank 250 , and may include a shroud surrounding the lower vertical portion. [0038] A top plate 324 is disposed on base 302 . Top plate 324 comprises a pivot pin 325 centered on the center axis. Pivot pin 325 is arranged to provide a rotational axis for an actuator 340 . In addition, a centering post 350 is disposed at a radial idle position on the top plate 324 , the post arranged orthogonally from the vertical center axis. Preferably, centering post 350 is disposed near an edge of top plate 324 . Centering post 350 is preferably constructed of a ferrous material that is magnetically attractive to a magnet. [0039] Actuator 340 is disposed on top plate 325 at pivot pin 325 . Actuator 340 includes a mounting arm, at the end of which a magnet 342 is disposed. The arrangement of actuator 340 on top plate 325 is such that magnet 342 rests adjacent to but not touching center post 350 . Actuator 340 is also free to rotate about pivot pin 325 but is held in an idle position 400 , FIG. 4 , by the magnetic force between magnet and post. This biasing force opposes any rotational force which rotates the actuator 340 , and causes the actuator to return to the radial idle position when the rotational force is removed. This holding feature thus serves as an automatic centering feature. [0040] Affixed to top plate 324 is at least one proximity sensor 375 which is operable to sense a position of the magnet 342 with respect to the sensor. Proximity sensor 375 is disposed at a fixed angle away from the radial idle position. When an actuating force rotates the actuator magnet 342 away from the idle position, magnet 342 is positioned near sensor 375 . An optional second proximity sensor 376 may be disposed at a second fixed angle from the radial idle position. The second fixed angle may be the opposite angle from the radial idle position. Similarly, when an actuating force rotates the actuator magnet 342 in the opposite direction away from the idle position, magnet 342 is positioned near and is detected by sensor 376 . [0041] Proximity sensors 375 , 376 are preferably arranged on a proximity sensor board 374 which is held in fixed position above top plate 324 and actuator magnet 342 . Magnet 342 is thus free to rotate under the proximity sensor board. In addition, a preferred arrangement is of a single magnet 342 which serves as both an automatic centering magnet and a positioning source to be detected. The arrangement is simpler and requires fewer parts. Of course, the particular arrangement of magnet to sensor(s) may be modified within the scope of the invention. [0042] A preferred type of proximity sensor 375 , 376 is a linear type Hall Effect sensor. Such a sensor is commonly understood to provide an analogue output which corresponds to the relative position of a magnet. One advantage of a Hall Effect sensor is that it is non-contact and so has no parts to wear out. The Hall Effect sensor requires minimal periodic adjustment or calibration, and optionally could be used with a comparator to provide a more precise positioning over a large number of cycles. [0043] Importantly, the Hall Effect sensor provides an analogue output that contains more than a simple binary actuation signal or pattern of binary signals. The sensor can provide a signal input to a device controller which is representative of the magnitude of the magnet movement, the velocity of relative movement, and the duration of a held magnet rotation. Thus, the Hall Effect sensor provides the user with a more precise and useful control of the group head. [0044] The user interface portion of the FIG. 3 group control head is a rotational handle 314 , which is fixed by screws or other means to actuator 340 . The handle 314 may comprise a protective shell which fits over the top plate 324 , actuator 340 and the arrangement of sensors 375 , 376 . A paddle 316 is preferably disposed on handle 314 extending away from the protective shell and in such a manner as to provide easy rotational actuation of the group control head. [0045] In operation, the user experiences a resistive force not unlike a spring force when she rotates the paddle. When the paddle is released, the entire group head control assembly returns to the idle position due to the attraction of magnet and post. [0046] FIGS. 4( a ), 4( b ) and 4( c ) illustrate the operation of the FIG. 3 group control head 300 , wherein magnet 342 may be positioned over an arc in proximity to, but not in contact with, at least one proximity sensor. At rest, the group control head is automatically centered and held in the idle position 400 as shown in FIG. 4( a ) . The magnetic attraction between magnet 342 and post 350 provides the holding force. The output of proximity sensor 375 and/or optional sensor 376 indicates that the magnet 342 is in the idle position 400 . [0047] FIG. 4( b ) shows the group control head 300 in a brew position 410 . Here, the user has rotated paddle 316 in the clockwise, or left, direction such that proximity sensor 375 senses the proximity of magnet 342 . The user also experiences a counterclockwise resistive force not unlike a spring force when she rotates the paddle 316 , due to the ongoing attraction between displaced magnet 342 and post 350 . The attraction repositions the actuator 342 to the idle position 400 when the paddle 316 is released. The effect of the paddle rotation of FIG. 4( b ) is to send an input signal corresponding to the sensed magnet position to a controller. The controller in turn may begin a programmed sequence of outputs to the espresso machine to dispense a shot of coffee. [0048] FIG. 4( c ) illustrates an optional control position 420 of the group control head 300 corresponding to a counterclockwise, or right, rotation of paddle 316 . Second proximity sensor 376 senses the proximity of magnet 342 . The user also experiences a clockwise counter-force not unlike a spring force when she rotates the paddle 316 , due to the ongoing attraction between displaced magnet 342 and post 350 . The attraction repositions the actuator 342 to the idle position 400 when the paddle 316 is released. The effect of the paddle rotation of FIG. 4( c ) is to send a second input signal corresponding to the sensed magnet position to a controller. The controller in turn may perform an auxiliary action, such as ending an ongoing shot. [0049] The user of course experiences the above described group control head 300 as having one actuator which has a clockwise, or left, paddle position and a counter-clockwise, or right, paddle position. As will be further described, actuations of short duration and longer duration may provide different responses in the machine control. A short duration actuation may be referred to as a “bump”, while longer duration actuations may be referred to as a “hold” or a “long hold.” A bump may be, for example, a paddle rotation and release lasting less than 250 milliseconds. An example hold may be from greater than 250 milliseconds up to greater than about 2.5 seconds. [0050] FIG. 5 illustrates a system block diagram of one embodiment of the electrical sensing and control circuit for an espresso machine electrical system 500 . The electrical system 500 can be arranged on a single central printed circuit board or may be distributed among several sub-units. For example, FIG. 5 shows one hardware controller 510 , but system 500 could equivalently include a separate controller 510 disposed on each group control head in the apparatus. Either the single visual display 520 as shown or a display 520 dedicated to each separate group control head may be used to convey status information. A power supply 540 provides electrical power to the system 500 . [0051] The heart of system 500 is controller 510 , which can be any of a known CPU or other computer processing unit such as an application specific integrated circuit (ASIC), field programmable gate array (FPGA), or reduced instruction set computing (RISC) type. Controller 510 operates to control the espresso brewing process in response to various inputs. Controller 510 may also operate in accordance with a computer program stored in a computer memory 530 . Controller 510 and the computer program then provide a repeatable and coordinated sequence of outputs that generate a controlled dose of espresso. Controller 510 may also be arranged in a programming mode to accept programming instructions from external programming controller 190 and to store those instructions in memory 530 for later use. Similarly, controller 510 may provide a program control data set point or parameter from a user interface to memory 530 . Controller 510 may also provide output to a visual display 520 that is located near the respective group control head such that important operating status information can be seen at a glance. [0052] Also shown in FIG. 5 is that memory 530 is preferably apportioned into several parts. A first part is the computer temporary brew memory 532 , which as will be described saves parameters related to the current brewing process. The temporary brew memory essentially contains a set of brewing parameters established at the last brew. For example, if the user shortens a pre-infusion period by actuating the group control head handle, that new pre-infusion duration is captured in the temporary brew memory. Each dosing unit has its own temporary brew memory. [0053] Another part of memory 530 comprises a computer storage memory 534 for storing previously saved complete sets of brewing parameters. The portions may be arranged in pages, with a left portion and a right portion for each page. In one embodiment, each dosing unit is provided with from one to three pages. More preferably, computer storage memory 534 comprises at least two storage locations, without any paging arrangement. Shown in FIG. 5 is an exemplary embodiment of storage memory 534 having six storage locations 541 through 546 . Each portion or storage location is sized to contain one set of brewing parameters. Each dosing unit has its own computer storage memory 534 . [0054] Outputs from each group head are provided as inputs to controller 510 . Examples of inputs are a group head water flow meter 502 and a brew tank temperature sensor 504 . Controller 510 may use these inputs to start or stop the brew program or to otherwise control various heating and pumping components. Controller 510 preferably operates under the further control of an internal clock or timer to shift between various phases of the brew process. [0055] Controller 510 also accepts signal inputs from each respective group control head 300 via proximity sensor outputs 375 , 376 . The accepted signal inputs control the program sequence that provides the espresso dose. An example is a received input from non-contact proximity sensor 375 that corresponds to a single actuation of the group control head handle. Controller 510 then issues a coordinated program sequence of output instructions to provide the dose. The outputs can be one or more of a pump control output 522 , a control valve control output 524 , and a bypass valve output 526 . [0056] A second input control example is a received signal input from the second non-contact proximity sensor 376 that corresponds to a different single actuation of the group control head handle. Controller 510 responsively issues an output to one or more of a pump control output 522 , a control valve control output 524 , and a bypass valve output 526 to, for example, immediately end the controlled dose. [0057] FIG. 6( a ) and FIG. 6( b ) illustrate two embodiments of the information provided on the optional visual display 180 for the espresso machine of the present invention. The displayed information provides the user with the current status of the machine and group control head guidance instructions with simple indications. [0058] FIG. 6( a ) shows an operational display 600 provided during normal operation or during a programmed brewing sequence. The most prominent feature of this display is a shot timer 602 . Shot timer 602 will typically display the total duration of the shot, e.g. 32 seconds, during idle times between brews. During the brew sequence, shot timer 602 preferably displays the elapsed time from the start of the shot, although similar indications of shot progression such as count-down time or time from the start of a particular sequence phase are included within the scope of this invention. [0059] Mode icon 604 shows the espresso machine mode of operation, which may include a manual mode, a manual program or a volumetric program mode. Here shown on icon 604 is the volumetric program mode icon VP. An espresso machine operating in volumetric program mode is typically controlled on a flow basis as sensed by the flow meter. An espresso machine operating in manual program mode MP is typically controlled by the sequence timer with some control by the user. Manual mode M is typically a mode of operation under full control by the user. [0060] Phase icon 606 indicates a relative duration of each phase of the brewing sequence. The phases will be described in more detail with reference to FIG. 7 . The embodiment shown uses simple bar graphs to display the relative length of each of three phases. [0061] Memory storage location icon 608 shows the memory portion of computer storage memory 534 that is currently selected for use. Here, icon 608 is a dot which points to a first memory storage location. Additional storage location icons, if available, may be arrayed below icon 608 or along the right border of display 600 . If the storage memory location is ready to receive data, a save icon 610 is shown. [0062] FIG. 6( b ) shows a save mode display 620 that is shown during the transfer of brew parameters between the temporary memory and/or storage memory locations. When in save mode, and when the storage memory location is ready to receive data, one display embodiment incorporates a save left icon 622 and a storage memory cycling icon 624 guides the user to save the current data via a left bump and to select the storage memory for saving by cycling through the locations with one or more right bumps of the group control head respectively. In this case, the “M” mode icon 604 indicates that the saving is being performed from a manual mode of operation. [0063] FIG. 7 illustrates a brewing sequence 700 for the espresso machine. From an idle state, the sequence is started at start step 702 by the user operating the group control head paddle or by pushing a button. The controller 510 initiates the programmed sequence at step 716 using the currently-selected set of brew parameters and also begins to save brewing data into the temporary memory 532 . [0064] The brewing phases then begin at a pre-infusion brew phase 717 . During this phase, controller 510 opens the dosing unit control valve 524 , 206 to pre-infuse the dry coffee grounds with unpressurized water from the brew tank 250 . This phase typically begins in response to the same first input signal received from the user at the start step 702 . [0065] At the end of the pre-infusion phase, an optional pressure ramp up phase 720 begins. The transition from pre-infusion to pressure ramp up may be in response to a programmed sequence time or to a user input from the group control head paddle. Pressure ramp up phase 720 starts the pump 204 and optionally opens the bypass control valve 208 to gradually pressurize the brew tank 250 to drive water through the grounds. [0066] In response to a programmed sequence time or to a user input from the group control head paddle, a full pressure brew phase 720 begins. During this phase, the bypass control valve is closed and the pump is running to provide maximum shot flow through the grounds. [0067] Depending on the particular grounds in use, an undesirable “blonding” of the flow may occur as the grounds are used up during the full pressure brew phase 720 . To avoid the effects of blonding, the sequence may then transition to an optional pressure ramp down phase 724 . Like ramp up phase 720 , the pump is running and the bypass control valve is opened to gradually reduce pressure on the grounds. The beginning of this phase may occur in response to a programmed sequence time or to a user input from the group control head paddle. [0068] A stop shot phase 726 ends the brewing sequence. This phase typically functions to ensure that the precise shot volume is dispensed. Here, the pump is not running but the control valve is still open. The transition into the stop shot phase 726 may be in response to a programmed sequence time or to a user input from the group control head paddle. Similarly, the stop shot phase is ended by closing control valve 524 , 206 when the full dose has been dispensed as sensed by elapsed time, flow meter volume, or by user input. The machine then re-enters an idle mode at end step 727 . [0069] Shown next to each phase of the sequence is an exemplary operational display 600 on visual display 180 . Shown is the total time of the sequence at the beginning and end as well as the elapsed time during the sequence. Also shown is the Manual Programming MP operating mode and the stored parameter set that is in use. Optionally, display 180 may show a volume dispensed instead of an elapsed time during the brewing phases. [0070] The above described sequence is driven by a set of parameters or settings which control each phase. For example, the set of parameters may include a pre-infusion time, a low pressure ramp up time, a full pump dispense time, a ramp down time, and a total dose water volume dispensed. Generally, a set can be defined with four parameters. End step 726 , for example, can be defined with the low pressure finish percent, which may be a percent of overall shot time or overall shot volume. [0071] Method and Apparatus for Optimizing a Set of Brew Parameters [0072] FIG. 8 illustrates a flow chart for an inventive method of operating the espresso machine of the present invention, and in particular a method 800 for optimizing and storing the conditions for a controlled dose of hot water dispensed from the machine. The method then saves the optimized set of brew parameters for a subsequent use of the espresso machine. Method 800 begins at start step 802 . The method then proceeds to a step 804 of providing the espresso machine apparatus as previously described, including the dosing unit, the group control head 110 , 300 , the pump 204 , the temporary brew memory, and the controller. Providing step 804 may also include the steps of activating the apparatus, initiating the program stored in memory, preheating and pre-pressurizing the system, and/or preparing and installing the grounds filter. After completion of providing step 804 , the espresso machine is ready to dispense espresso, and begins to monitor at the group control head proximity sensor 375 , 376 inputs. [0073] Step 806 is for monitoring and sensing a momentary actuation or bump of the group control head handle to a particular angular brew position. Step 806 pauses at monitoring sub-step 807 until controller 510 senses an actuation. When an actuation is sensed, another sub-step, mode decision step 808 determines the type of actuation and continues the method accordingly. For example, a sensed bump actuation may send the method into the brew mode 812 , and a long duration actuation may send the method into a programming or saving mode of operation 912 . The saving mode of operation, and its return to the monitoring step 806 will be described in more detail. [0074] An actuation direction decision step 810 immediately follows step 808 . The direction of actuation, clockwise/left (CW) or counter-clockwise/right (CCW), may cause the method 800 to respond differently depending on whether a shot is brewing at the time of actuation or not, i.e. in an idle state. If no shot is brewing at actuation, as sensed by the controller at shot brewing decision steps 814 and 820 , the direction may determine which of two sets of parameters is used for the subsequent shot, i.e. the set stored in the current computer temporary brew memory or a different set stored in the computer storage memory respective to the CW left or CCW right bump. In a preferred embodiment, a sensed CCW right bump with no shot brewing causes the controller to retrieve the set of brew parameters stored at the next sequential memory storage location 541 - 546 for that group head at cycling step 821 . That set is placed into the temporary brew memory at step 824 . If the CCW right bump is repeated, the brew parameters at the next sequential memory storage location 541 - 546 is retrieved into temporary memory at 821 , and so on. Thus, the operator experiences a cycling of stored recipes on that group head. [0075] If a CW left bump is sensed while in the idle state, method 800 proceeds to begin the programmed sequence at step 816 according to the selected set of parameters stored from step 824 in the temporary computer brew memory. The programmed brew sequence then begins as described in FIG. 7 with the pre-infusion step 717 of opening the control valve to begin the controlled dose of hot water. Step 816 also initiates a saving into the computer temporary memory of subsequent actuation steps. Then the method 800 returns to the sensing/monitoring step 806 to await the next sensed actuation of the group control head paddle. [0076] If no further actuations occur, the programmed sequence of FIG. 7 automatically completes itself and delivers a controlled dose in accordance with the selected set of parameters. The set of parameters saved to the temporary brew memory would in this case be identical to the selected set. [0077] If the selected set of parameters is set to a null manual MAN setting or the mode of operation is in the Manual mode, the method 800 may continue in a completely manual sequence. The sequence still follows the FIG. 7 sequence, but the transition between each phase occurs at an actuation sensing and never at an elapsed time. In an example manual mode operation, the first momentary action of the group control head handle begins the pre-infusion step whereby the control valve is opened and the parameter saving is initiated. The controller would respond to subsequent CW momentary actuations of the handle by repeatedly proceeding along the cycle of step 808 , step 810 , step 814 , a proceed to next shot phase 818 , and a return to step 806 . Thus, the full pressure phase, and/or the optional pressure ramp up or ramp down phase is controlled by the repeated sensed CW actuations at next shot phase 818 . These phases involve starting and running the pump to provide the controlled dose of hot water through the dosing unit. At each phase transition, a parameter related to the duration of each phase is saved into the computer temporary memory at saving step 824 . [0078] In one embodiment of the completely manual mode, the third actuation of the proceed to next shot phase 818 stops the pump to end the controlled dose of hot water. Optionally, a fourth actuation of the next shot phase 818 closes the control valve at the proper shot dose volume corresponding to end sequence step 726 . The duration of each of these phases is saved into the temporary memory at saving step 824 . The overall saving of these steps thus creates a complete set of brew parameters in memory. The saved set of brew parameters may be used in subsequent programmed brew sequences. [0079] As can be seen in FIG. 8 , a CCW bump of the group control head handle sensed at step 810 while the shot is brewing as sensed at step 820 always causes the method to immediately proceed to stop shot step 822 . This step 822 stops the pump and closes the control valve to end any further flow through the dosing unit. A user may also perform this actuation if, for example, when the desired brew volume has already been reached but the flow is continuing under the ongoing programmed sequence. [0080] FIG. 8 also illustrates how the method 800 may be used to dynamically adjust, while operating in the automatic programmed brew sequence mode, a set of parameters that have already been saved in memory. In this situation, the espresso machine is prepared to dispense the next dose using a previously saved set of parameters. When the momentary actuation is repeated and sensed at step 806 , the control valve is re-opened and the controller newly initiates the saving of parameters into the temporary memory. The new programmed brew sequence begins again. If no further actuations are sensed during the brew, then the programmed brew sequence automatically controls the control valve and pump to replicate the previous controlled dose of hot water. [0081] But if the user desires to adjust, i.e. shorten, one or more of the sequence phases, then she merely again bumps the paddle CW to truncate that phase and immediately start the next phase at step 818 . This action may, for example be a repeat of the third momentary actuation step, which stops the pump and therefore stops the replication. The phase duration as defined by the actuation is saved into the temporary memory as part of a new, i.e. second, set of brew parameters. In one embodiment the saving at step 824 further comprises the step of overwriting the previous set of brew parameters with the second set of parameters in the temporary memory. This second set can then be used for subsequent brews. In a preferred embodiment, adjustment of every brew phase is enabled for Manual mode of operation, and a limited adjustment of only the low pressure finish phase, step 724 of FIG. 7 , is enabled during Manual Program mode of operation. [0082] A summary of the FIG. 8 operation is illustrated in state table 801 . There shown is the response in the espresso machine corresponding to each particular operation of the group head control handle during the normal, or brew mode of operation. [0083] The espresso machine apparatus that is previously described may be modified to use the method 800 for storing and adjusting the dosing conditions. In addition, the machine may optionally comprise visual display 180 , which displays the phase of the sequence as the sequence proceeds. After the sequence is complete, the visual display 180 may display an indication that the phases have been saved as a new set of parameters. Example [0084] The barista prepares the espresso dosing unit and refreshes the grounds in the filter. She decides to manually brew a shot. The barista bumps the group control head paddle to the left to begin pre-infusion and watches for the first drips to pass the filter basket. Once the basket is saturated, she bumps the paddle left again to add pump pressure. The shot speed begins to increase and the color of the flow begins to lighten toward the end of the shot. She bumps the paddle left again to return to line pressure, then bumps it right to end the shot. [0085] Example parameters saved into temporary memory for this manual shot are 6.2 seconds pre-infusion and 60 milliliters water volume with a 97% low pressure finish. This set of parameters is now available to save for future replication. [0086] Of course, if the sequence is not progressing satisfactorily, a bump of the paddle to the right while the shot is in progress immediately ends the shot. [0087] Method and Apparatus for Saving an Optimized Set of Brew Parameters [0088] FIG. 9 continues the FIG. 8 method flow, further describing a method 900 for storing brewing parameters in an espresso machine. The method starts when the first sensed actuation of the group control head handle at step 806 enters the machine into a program and save mode of operation 912 . This path is shown by the indicator AP. An example first actuation is a long hold, e.g. greater than 250 milliseconds, to enter this mode. [0089] Responsive to entering the program and save mode of operation 912 , the current set of brew or shot parameters is obtained from the computer temporary brew memory at step 902 . The visual display 180 corresponding to the dosing unit may begin to flash the save icon 610 at this time to indicate the saving/programming mode of operation. One object of this invention is that this current set of shot parameters can then be assigned to as many computer storage memory locations on as many different group control heads in the system as desired. In addition, the visual display 180 may also begin to indicate the current set of brew parameters. Of course, if the operator desires to store a set of brew parameters that is not currently in the computer temporary brew memory, she may transfer the desired set of parameters from a computer storage location to the temporary brew memory prior to the obtaining step above. Preferably, this is done by selecting the computer storage location with the desired parameters with one or more right bumps from idle, step 821 , and then running that shot with a left bump, step 816 shown in FIG. 8 . [0090] Also responsive to entering the program and save mode of operation 912 at the first sensed actuation, the controller selects a default or initial computer storage memory location at initial storage memory step 903 . This default computer storage location may be pre- selected to appear each time the save mode is entered, or may simply be the last storage memory location used. If the espresso machine has multiple dosing units, the controller may select a default memory location at each group control head. Preferably, the visual display(s) 180 displays the active computer storage memory location at this step. The group control head of the first sensed actuation may optionally display brew parameters from the set in the temporary brew memory or the computer storage memory at the obtaining step. [0091] Method for Storing Brewing Parameters, Single Dosing Unit [0092] After entering the save mode of operation 912 , the method proceeds to the step of saving the set of parameters from the last shot brewed, i.e. the parameters in the computer temporary brew memory, into a computer storage memory location. In one simple embodiment, the operator merely bumps the group control head handle to the left, sensed as a second actuation by the controller. The method flow shows the bump sensed as a left actuation at direction step 906 and as a bump at duration step 910 . The left bump causes the controller to save the set of brew parameters into the default or initial storage memory from step 903 . [0093] The operator may wish to save the set of brew parameters into a different computer storage memory location than the default location. The operator selects a different location by scrolling through the available locations with one or more right bumps of the group control head handle. The controller senses the input at direction step 906 and duration step 911 to scroll to the next available storage memory at step 914 . Step 914 preferably includes the display of the computer storage memory location on visual display 180 , as exemplified in FIG. 6( b ) . A subsequent left bump, steps 906 , 910 saves the set of parameters to the selected location at step 908 . It is preferable that the bumps for scrolling and saving are in opposite directions of the handle, but the particular directions described above may be swapped within the scope of the invention. [0094] The operator exits the save mode of operation at step 940 and returns to the brew mode of operation. The controller may exit the save mode in several ways, e.g. by a time-out or immediately upon the saving step. Preferably, an affirmative actuation triggers the exit, such as a group head control handle “right hold” actuation, as shown by the path of direction step 906 and as a hold at duration step 911 . [0095] An additional function may be provided while in the save mode of operation. The controller may cycle to another of a group mode at cycle mode step 909 , e.g. Manual Mode or Manual Program Mode or Volumetric Program Mode, responsive to a sensed left hold from the group control head handle via direction step 906 and duration step 910 . When a set of parameters is subsequently saved, the set will correspond to that particular group mode. [0096] A summary of the FIG. 9 operation is illustrated in state table 901 . There shown is the response in the espresso machine corresponding to each particular operation of the group head control handle during the program and save mode of operation. [0097] Transferring a Set of Brew Parameters between Espresso Dosing Units [0098] If the espresso machine is a multi-head device having a plurality of previously described espresso dosing units, the machine may be arranged to transfer a desired set of brewing parameters from one of the dosing units to another. In this embodiment, a controller 510 is in communication with all of the group control heads, temporary memories, and storage memories. A visual display is optionally associated with each dosing unit. [0099] The system is arranged such that when a program and save mode of operation is entered at any of the dosing units, for example by the method flow chart of FIG. 9 , controller 510 activates all of the dosing units for saving. [0100] FIG. 12 illustrates one embodiment of the group display 1200 . After entering the save mode 900 and obtaining the desired set of brew parameters with one of the group control heads, all of the visual displays 180 , 180 ′, 180 ″ will display a save screen 620 , 620 ′, 620 ″ and a flashing save icon 610 . Any of the other group control heads can be scrolled as described above to select that dosing unit's desired storage location for saving. Then each group control head can separately save the desired set of brew parameters to the selected memory and exit the save mode as described above. Exiting from the save mode alternatively may be accomplished all at once by exiting the save mode, step 940 , at the source group control head. [0101] After either of the above described transferring steps, a programmed brew sequence may be initiated at any of the dosing units according to the transferred set of brew parameters. When a subsequent group control handle bump for another of the dosing units is sensed at its step 806 , then a new programmed brew sequence is initiated according to the transferred set of parameters. The espresso machine then automatically conducts the programmed sequence at step 812 to dispense the new dose of espresso. Thus the conditions for the desired dose are replicated across the dosing units. [0102] FIG. 10 illustrates example visual display graphics and state machine diagram 1000 that accompany the program and save mode of operation. Prior to entering the save mode, the espresso machine is in the brew mode of operation 1001 , and typically runs a shot to automatically save the last shot into the computer temporary brew memory at step 1002 . The operator then performs a right hold, e.g. for 2.5 seconds, at enter save mode step 1004 , whereupon the visual display 180 begins to flash the save icon. The operator then optionally bumps right one or more times at step 1006 to change the desired computer storage memory location for saving. When the desired location is selected, the operator bumps left at save step 1008 to save the shot parameters to the location. The operator then exits the save mode at step 1010 with a right hold, e.g. for 2.5 seconds. [0103] After the save mode of operation ends at exit step 940 , the espresso machine is then ready to enter the brew mode again with the newly saved and selected set of brew parameters. If a different set of brew parameters is desired, the operator simply bumps right one or more times to cycle through the recipes, and stops when the desired recipe is reached. When a subsequent group control handle bump is sensed at step 806 , then the new programmed brew sequence is initiated according to this new second set of parameters. The espresso machine then automatically conducts the programmed sequence at step 812 to dispense the new dose of espresso. [0104] FIGS. 11( a ) through 11( d ) illustrate an additional series of state machine diagrams for the operation of the espresso machine. FIG. 11( a ) illustrates program mode adjustment state machine 1102 . When the controller senses a left hold, e.g. 2.5 seconds, on a group control head handle, the controller enters the cycle program mode. Subsequent left holds cause the controller to cycle its program mode through the available programs, here shown the modes Manual 1104 , Manual Program 1106 , Volumetric Program 1108 , and cycle back to Manual 1110 . Further detail about operating in these modes is shown in FIG. 11( b )-( d ) . [0105] FIG. 11( b ) illustrates one exemplary operation of the Manual Mode 1120 , a mode that allows the operator complete control of the shot parameters. Starting from an idle state at steps 802 , 804 , the operator bumps left to start the shot by pre-infusion at start step 1122 . The controller begins the pre-infusion operation, and awaits subsequent bumps left before advancing the shot to the next phases of pressure ramp-up step 1124 , full pressure brew step 1126 , and pressure ramp-down step 1128 respectively. The shot is stopped at step 1129 at a sensed bump right. The brew parameters are retained within the computer temporary brew memory. Visual display 180 may display the current phase and parameters during the shot. [0106] FIG. 11( c ) illustrates one exemplary operation of the Manual Program Mode 1130 , a mode that allows the operator limited control of the shot parameters. Starting from an idle state at steps 802 , 804 , the operator bumps left to start the shot by pre-infusion at start step 1132 . The controller automatically advances the shot to the next phases of pressure ramp-up step 1134 , full pressure brew step 1136 , and pressure ramp-down step 1138 . The shot is stopped at step 1139 at a sensed bump right. The operator may adjust the “blonding” of the shot at step 1136 with a left bump to truncate the shot pressure, and then may end the shot at the desired volume (if necessary) with a right bump at stop step 1139 . Visual display 180 may display the current phase and parameters during the shot. [0107] FIG. 11( d ) illustrates one exemplary operation of the Volumetric Program Mode 1140 , a mode that allows the operator control of the start of the shot only. Starting from an idle state at steps 802 , 804 , the operator bumps left to start the shot by pre-infusion at start step 1142 . The controller then automatically advances the shot to each next phase at pressure ramp-up step 1144 , full pressure brew step 1146 , and pressure ramp-down step 1148 according to the program brew parameters in use. The shot is automatically stopped at step 1149 upon reaching the pre-programmed volume as sensed by the flowmeter. In this program mode, the operator may truncate the shot at any time with a bump right. The visual display 180 may display the current phase and parameters during the shot. [0108] The functionality of the various program modes corresponds to the method flow steps as shown in FIG. 8 . For example, a sensed CCW actuation at step 810 with a shot brewing at step 820 which immediately ends the shot at step 822 . This corresponds to the right bumps at FIG. 11 steps 1129 and 1139 . [0109] When the paddle is released, the save mode of operation then exits at exit step 940 . The espresso machine is then ready to enter the brew mode again with the newly saved and selected set of brew parameters. When a subsequent group control handle bump is sensed at step 806 , then a new programmed brew sequence is initiated according to this new second set of parameters. The espresso machine then automatically conducts the programmed sequence starting at step 812 to dispense the new dose of espresso. [0110] Retrieving a Stored Set of Parameters for Use [0111] FIG. 8 at state machine table 801 also illustrates a method for obtaining from storage memory a set of parameters for use, where the set of parameters has been previously stored in one of the page portions instead of the temporary brew memory. This functionality is enabled simply by cycling through the memory storage locations by means of scrolling with the group control head handle. In the FIG. 9 embodiment, the group control head handle is bumped right one or more times to cycle through the storage locations, up to six. When cycled, visual display 180 preferably highlights the particular location. A subsequent bump to the opposite left side then starts the shot using that selected recipe. The shot parameters are also transferred to the temporary brew memory during the shot, for subsequent saving and use. Example [0112] Some example settings for a page in computer storage memory appear in Table 1 below: [0000] Brew Group 2 (Volumetric Mode) Program 1 Pre-infuse 4.0 Ramp Up 1.8 % of Shot Brewed 91% Total Water Volume 350 [0113] A note from the morning barista says that they made a great shot earlier in the day and saved it in Brew Group 2 Program 1. We are currently using Program 2 on the second group, so the first step is to cycle to the Program 1 by bumping the group head control handle five times until Program 1 is highlighted on visual display 180 ′. Then we prepare a filter puck and bump left. The programmed sequence will run through 4 seconds of pre-infusion, ramp up for 1.8 seconds, and then run the pump until 91% of the total flow meter count of 350, corresponding to about 60 ml of water, has been dispensed. The pump will then shut off and the shot will finish at line pressure. [0114] An espresso machine apparatus as described in FIGS. 1 through 6 comprises each of the elements that are necessary to perform the methods described above. An optional external programming controller 190 , described in FIG. 13 may be used in concert with the group control heads, controller, memories, and programmed sequences for additional flexibility in programming. [0115] FIG. 13 shows an embodiment of the optional external programming controller 190 that may be used with the inventive espresso machine. Controller 190 is preferably handheld and communicatively connected to the controller 510 by wired or wireless means. Controller 190 includes three main features. Programmer display 192 displays information related to the stored programs. Programmer selection buttons 194 are arranged next to the display to enable the user to select particular items in display 192 . Programmer scrolling arrows 196 enable the user to adjust values of the displayed items. [0116] If no useful set of brewing parameters yet exists in computer storage memory, or if it is desired to enter the values without brewing, one or more of the parameter set values may be more easily entered via the controller 190 . For example, the user wishes to adjust the volume of the shot on number 2 brew group, i.e. dosing unit. She scrolls with the scrolling arrows 196 until Brew Group 2 is displayed. The desired set of brew parameters resides in the memory storage location 1 , so she presses the button 194 that is adjacent that label. Then she presses the scrolling arrows to adjust the volume to the desired amount. Another press of the button 194 deselects the line and updates the set of brew parameters at that memory location. As previously described, this new set of brew parameters can be saved to any of the other memory locations in any of the other brew groups, and can be used with the group control head controls during the next brew. The entry of data using programmer 190 may also be conducted in concert with selection and saving of that data via the group control head operations as described above. [0117] Modifications to the device, method, and displays as described above are encompassed within the scope of the invention. For example, various configurations of the plumbing and electrical systems which fulfill the objectives of the described invention fall within the scope of the claims. Also, the particular appearance and arrangement of the apparatus may differ. [0000] Table of Elements Number Name  100 Espresso machine  102 Espresso dosing unit  110 Group control head  110′ Second group control head  110″ Third group control head  150 Brew tank  160 Filter  170 Outlet spout  180 Visual display  180′ Second visual display  180″ Third visual display  190 External programming controller  192 Programmer display  194 Programmer selection buttons  196 Programmer scrolling arrows  200 Espresso machine  202 Steam tank  204 Pump  206 Control valve  208 Bypass control valve  210 Water source  250 Brew tank  250′ Second brew tank  250″ Third brew tank  260 Filter  300 Group control head  302 Base  314 Handle  316 paddle  324 Top plate  325 Pivot pin  340 Actuator  342 Magnet  350 Centering post  374 Proximity sensor board  375 First proximity sensor  376 Second proximity sensor  400 Idle position  410 Brew position  420 Control position  500 Espresso machine electrical system  502 Group head flow meter  504 Brew tank temperature sensor  510 Controller  520 Visual display  522 Pump control output  524 Control valve control output  526 Bypass valve output  530 Computer memory  532 Computer temporary brew memory  534 Computer storage memory Computer storage memory page Page left portion Page right portion  540 Power supply  541-546 Computer storage memory storage locations  600 Operational display of programmed sequence  602 Shot timer display  604 Mode icon  606 Brew sequence phase display  608 Memory storage location icon  610 Save icon  620 Save mode display of brew parameter set transfer  620′ Second save mode display (not used)  620″ Third save mode display (not used)  622 Save left icon  624 Storage memory cycling icon  700 Espresso machine brewing sequence  702 Brewing start step  716 Brewing initiation step  717 Pre-infusion brew phase  720 Pressure ramp up phase  722 Full pressure brew phase  724 Pressure ramp down phase  726 Stop shot phase  727 End step  800 Method for providing hot water dose  802 Method start step  804 Providing an espresso machine step  806 sensing step  807 Monitoring step  808 mode decision step  810 actuation direction decision step  812 brew mode  814 shot brewing decision step  816 begin programmed sequence step  818 Proceed to next phase in sequence step  820 shot brewing decision step  821 Cycle recipe step  822 stop shot step  824 save into temporary memory step  900 Method for storing brewing parameters in an espresso machine  901 Saving method state table  902 Obtain brew parameters step  903 initial computer storage memory location step  906 Sense actuator direction step  908 Save to selected storage memory step  909 Group mode cycling step  910 Duration step  911 Duration step  912 Enter program and save mode of operation  914 scroll to the next available storage memory at step  940 Exit from program and save mode of operation 1000 Visual display state machine diagram, save mode 1001 Initial brew mode of operation 1002 Save last shot into computer temporary brew memory step 1004 enter save mode step 1006 change computer storage memory location step 1008 save to active computer storage memory step 1010 Exit save mode step 1102 Program mode adjustment state machine 1104 Manual mode 1106 Manual program mode 1108 Volumetric program mode 1110 Manual mode cycle 1120 Manual (M) mode of operation 1122 M start and pre-infusion step 1124 M pressure ramp-up step 1126 M full pressure brew step 1128 M pressure ramp-down step 1129 M stop step 1130 Manual Program (MP) mode of operation 1132 MP start and pre-infusion step 1134 MP pressure ramp-up step 1136 MP full pressure brew step 1138 MP pressure ramp-down step 1139 MP stop step 1140 Volumetric Program (VP) mode of operation 1142 VP start and pre-infusion step 1144 VP pressure ramp-up step 1146 VP full pressure brew step 1148 VP pressure ramp-down step 1149 VP stop step 1200 Groups display

An espresso machine that includes a group control head for controlling the brewing and dispensing of espresso drinks. The group control head is in communication with a controller and memory. The combination is arranged to selectively record into the memory the brewing parameters during the dosing of espresso. A subsequent operation of the group control head then enables the controller to recall the recorded parameters such that the previous brewing conditions are replicated. Associated methods for recording the parameters under control of the group control head are also described.

BACKGROUND OF THE INVENTION 1. Field of Invention This invention relates to catheter devices using guide wires for guiding the catheter to the desired location within a body. More particularly, this invention relates to such catheter devices which include motor driven drive unit for driving a torque cable. Specifically, the invention herein relates to structures which control such a guide wire from migrating along its longitudinal axis while the torque cable is being operated by a motor drive unit. 2. Previous Art: As described in U.S. Pat. Nos. 5,250,059; 5,084,010 and 4,479,952 which are specifically incorporated herein by reference, there exists a plethora of different catheter designs. In many catheter designs, specifically where directional atherectomy catheters are used, it is desirable to use a guide wire to guide the catheter to the desired position within a body. In order to guide the catheter to the desired position within the body, the catheter is used in conjunction with a motor drive unit, a torque cable and a guide wire. Typically, the torque cable consists of a cable having a hollow interior wherein one end of the cable is connected to the motor drive unit and the other end of the unit is connected to a work element. Work elements can include cutting devices, ablation elements or even telemetry. The guide wire is located in the central interior opening of the torque cable. The guide wire is made from material such as spring steel or Nitinol. The guide wire typically has a diameter of between 0.009" and 0.0018". Typically, the guide wire is manipulated to the desired location by rotating and hand feeding the guide wire through the cutter torque cable via a conduit inside the motor drive unit. Unfortunately, when the cutter torque cable is spun by the motor drive unit, the spinning action of the cutter torque cable against the guide wire causes a sympathetic spinning action of the guide wire, which is located in and protrudes from the central lumen in the cutter torque cable. The cutter torque cable can also be translated along the longitudinal axis of cable with or without the rotation of the cutter. This translational movement of the cutter torque cable also causes sympathetic translation of the guide wire which is located in and protrudes from the central lumen of the cutter torque cable. Such migration of the guide wire can cause trauma to the biological conduit near the treatment site. While controlling the axial migration of the guide wire, the guide wire needs to rotate freely as the sympathetic action between the cutter torque cable and guide wire may varyingly dictate. If the guide wire is kept from rotating at the proximal end, the spinning action of the cutter torque cable against the guide wire may cause the distal end of the guide wire to wind up and fail. What is needed is a device for controlling the migration of the guide wire while allowing the guide wire to spin during rotation and longitudinal motion of the cutter torque cable. The device for controlling the guide wire migration should fit within the conventional motor drive system and should not add greatly to the expense of the operation. SUMMARY OF THE INVENTION It is a general object of this invention to provide a guide wire migration controller which prevents substantial migration of the guide wire during catheter cutting operation. It is another object of this invention to provide a device for controlling migration of the guide wire during operation of the catheter cutting which adapts easily with the conventional motor drive unit. It is another object of this invention to provide a guide wire migration controller which prevents substantial migration of the guide wire without interfering with rotation of the torque cable. In accordance with the above objects and those that will become apparent below, a guide wire migration controller is provided in accordance with this invention which comprises: a controller including: a housing connectable to the motor drive; a guide wire gripper for gripping the guide wire along its longitudinal axis and being insertable within the housing; and a locking member for locking the guide wire gripper within the housing, whereby, the gripper is locked within the housing preventing guide wire migration along the longitudinal axis. In a preferred embodiment, the motor drive unit has a distal side having a track member with a track axis approximately 90° to the longitudinal axis of the guide wire and the housing has a rail member for connection to the motor drive unit track member. The rail member is slidably connectable to the track member and slidable along the track axis. In a preferred embodiment, the gripper comprises a solid body having a keyhole opening. The gripper is made from a polymeric material which creates a friction grip with the guide wire. As will be appreciated, the guide wire is able to rotate within the housing with the gripper attached therein; however, it is limited from movement along the longitudinal axis by the space between the gripper and the housing. In another preferred embodiment, each of the gripper housing and locking member define a solid body having a central keyhole opening, which is normally outwardly extending, but upon appropriate force may have its opposed open ends brought together. In another preferred embodiment, the locking member has a raised annulus which slidably and rotatably fits within an inner race in the housing for releasable and locking connection therewith. In this preferred embodiment, the gripper and the locking member rotate freely with the rotational movement of the guide wire. It is an advantage of the guide wire migration controller in accordance with this invention to provide a device which can be readily adapted to conventional motor drive units, catheters and guide wires. BRIEF DESCRIPTION OF THE DRAWING For a further understanding of the objects and advantages of the present invention, reference should be had to the following detailed description, taken in conjunction with the accompanying drawing, in which like parts are given like reference numerals and wherein: FIG. 1 illustrates, in perspective view, the guide wire migration controller in accordance with this invention in connection with a typical catheter. FIG. 2 illustrates the guide wire migration controller in accordance with this invention in conjunction with a motor driven catheter assembly. FIG. 3 is an exploded view of the guide wire migration controller of FIG. 2 connectable to a motor drive unit. FIG. 4 is a cross-sectional view of the guide wire migration controller of FIG. 2 taken along line 4--4 and looking in the direction of the arrows. FIG. 5 is a cross-sectional view of the guide wire migration controller of FIG. 4 taken along line 5--5 and looking in the direction of the arrows. FIG. 6 is a perspective view of the guide wire migration controller in accordance with this invention in use. DETAILED DESCRIPTION OF THE INVENTION The invention will now be described with respect to FIG. 1 which illustrates the guide wire migration controller generally denoted by the reference numeral 10 in use with a catheter 100. As is conventional, the guide wire 14 is fed though a lumen in the torque cable to the desired position. Once at the desired position, the torque cable is rotated. Using the guide wire migration controller 10, the guide wire 14 remains substantially in place despite the activation of the motor drive unit 12 and consequently the torque cable. With particular reference to FIG. 2 there is seen the guide wire migration controller (controller) 10 in accordance with this invention in conjunction with a motor driven catheter assembly. The guide wire migration controller 10 illustrated in FIG. 1 is connected to a motor drive unit 12. A guide wire 14 allows a catheter 100 (FIG. 1) to follow and be guided thereby. The torque cable is rotated by motor drive unit 12 by operating a switch 16. The switch 16 typically toggles the operation of the motor drive unit 12 in an on/off condition. With respect to FIG. 3, there is shown an exploded enlarged view of the guide wire migration controller 10. The guide wire migration controller 10 includes a housing 20, a gripper 22 insertable within the housing and a locking member 24 for locking the gripper into the housing 20. The housing 20 includes a body 30. The body 30 defines a split ring having a longitudinal opening 32. The opening allows the body to be squeezed so that opening ends 34 and 36 may be moved toward each other. As will be appreciated, it is preferred that the body be made of a plastic material so that when the ends are released the body is normally urged to the open position wherein the longitudinal opening 32 is again seen. It will be appreciated that the preferred embodiment utilizes the opening for removable connection with the motor drive unit 12. The housing 20 includes a set of projecting ears 40. The ears 40 project and extend from the body 30. The motor drive unit 12 has a distal end which is adjacent the operating end of the guide wire 14, and a proximal end 42 which is opposite the distal end. The proximal end of 42 of the motor drive 12 has a track axis 44. A track member 46 is provided within the proximal end 42 along the track axis 44. The ears 40 define rail members 50. The rail members 50 are sized and shaped for compatible connection with the track member 46. The ends 34 and 36 and the housing 20 are squeezed together forcing normally outwardly urging ends 34 and 36 together so that the rail members 50 may be connected to the track member 46 for slidable engagement. The slidable movement is in the direction of the track axis 44. The guide wire migration controller includes the gripper 22 as set forth above. The gripper 22 has a body 60 having an opening 62. The opening 62 comprises a slice removed from the gripper 22. The slice can be from several thousandths of an inch to one hundredth of an inch. As with the housing body 30, the gripper body 60 has ends 64 and 66 which are normally in the open position, with the ends 64 and 66 urged apart. The slice terminates at a radius end 68. The radius end 68 is sized and shaped for compatible gripping of the guide wire 14. The gripper 22 is made from a polymeric material suitable for gripping a thin metal wire. Such polymers include polyurethanes, RTV silicone, silicone rubbers and elastomeric materials in general. Also, it is preferred that the gripper 22 be made of a plastic material which will keep the ends 64 and 66 in a normally openly urged position. Thus, the opening 62 will be easily identifiable under normal circumstances. It will be appreciated that when the gripper is inserted within the housing 20, the ends 64 and 66 are moved together providing additional gripping force on the guide wire in the opening 62. The guide wire migration controller 10 additionally includes a locking member 24 for locking the gripper 22 within the housing 20. The locking member 24 has a body 70 also having a keyhole opening 72. The keyhole opening 72 has a center opening 74 and opposed ends 76 and 78. As described earlier with reference to the body 30 and body 60 of the housing and gripper respectively, the opposed ends 76 and 78 are normally urged apart for similar reasons. The guide wire 14 fits within center opening 74 and operates similarly to that discussed above with reference to the gripper 22. The body 70 includes an annulus 80 in the preferred embodiment. In the preferred embodiment, the housing body 30 includes an inner race 82. The inner race 82 and the annulus 80 are sized and shaped for compatible rotatable matable connection. As will be appreciated once the guide wire 14 is gripped by the gripper 22 and locked within the housing 20, it should be provided with a means for rotating. The combination of the annulus 80 and inner race 92 allows for such rotation. Thus, the guide wire 14 may rotate freely while the gripper 22 grips the guide wire 14 and rotates together with the locking member 24 through the combination of the inner race 82 and annulus 80. As illustrated with reference to FIG. 4 the guide wire migration controller 10 is connected to the motor drive unit 12. The rail members 50 fit snug within the track member 46. The gripper 22 is held in place by the locking member 24. The guide wire 14 is securely held by the gripper 22. As the guide wire is sympathetically rotated by the motor drive 12, the guide wire rotates with the gripper 22 attached. The locking member 24 rotates with the gripper with the annulus 20 rotating within the race 82. It will be appreciated with respect to FIG. 3 that the longitudinal opening 32 in the housing 20, the keyhole opening 72 in the locking member 24, and the guide wire gripper opening 62 align to receive the guide wire and to permit removal of the guide wire. With respect to FIG. 5 there is shown a side elevational cross-sectional view of the guide wire migration controller 10. As illustrated in FIGS. 5 and 6, the guide wire migration controller is able to slide within the track member 46 from one position to another along the track axis 44. With respect to FIGS. 3, 5 and 6, there is shown the guide wire migration controller in use. As seen, with particular reference to FIG. 6, the guide wire 14 is hand fed through the motor drive unit 12 into the catheter. During the hand feeding process, the housing 20 is moved away from the entrance of the catheter where the guide wire 14 is fed. This is accomplished by moving the catheter along its track 46 to a second position, generally shown in phantom in FIG. 6. The rail member has a detent cutout 51 on one of its sides which is compatible with a protuberance 53 on the track member 46. A second protuberance 55 also extends into track member 46 as illustrated clearly in FIG. 5. In the first position, the detent cutout 51 is secured at position 1 by protuberance 53. In the second position where the housing 20 is moved away from the entrance of the catheter, the detent cutout 51 is moved to a second position wherein the detent cutout 51 is secured at the second position by protuberance 55. In order relocate and secure the guide wire 14 to the migration controller 10, the openings in each of the locking member 24, the gripper 22 and the housing 20 are aligned for compatible connection with the guide wire 14. In order to facilitate this, the locking member 24 is provided with a locating member 90. As will be appreciated, since the gripper 22 is normally outwardly extending and diverging from its ends 64 and 66, it does not rotate freely within the housing 20 or locking member 24. Thus, the opening 62 and opening 74 of each of the gripper 22 and the locking member 24 are aligned and generally stay in alignment. The locating member 90 is used to align the openings 62 and 74 of the gripper 22 and locking member 24, respectively, with the opening 32 of the housing 20. In the second position, the slots are aligned prior to moving to the first position for capturing the guide wire. Thus, the physician has little or no trouble in moving the guide wire migration controller 10 from the first to second position or from the second to first positions. In an alternate embodiment as shown in phantom in FIG. 3, the locating member comprises a ridge 92 used for the same purpose as locating member 90. While the foregoing detailed description has described details of the guide wire migration controller in accordance with this invention, it is to be understood that the above description is illustrative only and not limiting of the disclosed invention. Particularly, the types of opening and materials used may be varied within the scope and spirit of this invention. Additionally, various types of motor drive units, as well as guide wires, may be utilized, again within the scope and spirit of this invention. It will be appreciated that this invention is to be limited only by the claims as set forth below.

Disclosed herein is a guide wire migration controller device. The device includes a housing, a gripper insertable in the housing and a locking member for keeping the gripper within the housing. The gripper grips a guide wire operated by a motor drive unit. The gripper limits the migrational movement of the guide wire by gripping the guide wire and limiting the movement to the amount of tolerance between the gripper and the housing and locking member. The gripper rotates freely within the housing depending upon the rotational movement of the catheter torque cable wire. In a preferred embodiment the migrational movement of the guide wire along its longitudinal axis is translated into slidable movement of the controller relative to the motor drive unit.

BACKGROUND OF THE INVENTION The present invention relates to exercise devices and more particularly, an exercise device for simulating skating and strengthening muscles used therein. The invention also relates to a method for exercising muscles used in skating. With the increasing popularity of skating, particularly in-line roller skating, there has become an increased demand for exercise apparatus and methods which would allow the user to more closely simulate skating action and exercise and strengthen muscles used in skating. There is also a need for a device which provides a cardiovascular or aerobic exercise while allowing a person to train for skating. There are a number of prior art devices which attempt with varying degrees of success to simulate a skating motion while allowing the user to exert force and exercise and strengthen muscles. For example, U.S. Pat. No. 4,340,214 to Schutzer discloses a training apparatus for skaters. The Schutzer apparatus is similar to the slideboard which is well known among serious skaters. The Schutzer device provides a lateral, inclined track which allows side-to-side motion and stretching of feet and legs. An upright at the center of the device helps to maintain the user's body in the correct position. U.S. Pat. No. 4,781,372 to McCormick and U.S. Patent No. 4,811,941 to Elo, both disclose skating exercise devices which utilize a foot stirrup that moves along a linear track and is resisted by a weight stack. The track and stirrup are arranged to allow the user to be generally in a squatting position which attempts to simulate the skater's position. The track in each device is pivotable about a point in front of the user. The McCormick device appears to allow adjustment for pushing at different angles. The track of the Elo device also pivots in an attempt to simulate skating motion. U.S. Pat. No. 4,915,373 to Walker discloses a further exercising machine for ice skating. The Walker device includes a bicycle-type saddle in the center, on which the user is seated in a crouching position. Foot stirrups ride in two triangular tracks on either side of the saddle, intended to approximate skating motion. A portion of each track is designated as a power section and is provided with means for creating drag on the stirrup as it passes therethrough, in order to require greater exertion of force by the user over that portion. A further device, known as The Skating Machine™ by Sport Specific Inc. includes articulated arms with foot stirrups that pivot at two points in front of the user. Resistance is provided by adjustable fluid cylinders. None of the devices discussed above closely simulates a natural and dynamic skating motion. Thus, in spite of the many different devices in the prior art, there is a need for an exercise apparatus which will allow close simulation of a natural and dynamic skating motion at both relatively high and low speeds while allowing strengthening or aerobic exercise. This need has not yet to date been met by the art. SUMMARY OF THE INVENTION It is therefore an object of the present invention to provide an apparatus and method for skate training exercise which closely simulates the natural and dynamic motion of a skater. This and other objects are achieved according to the present invention by an apparatus for skate training exercise, comprising a frame with at least one arm having a first end pivotably mounted on the frame and a second end capable of movement between a first position and a second position along an arc defined by the arm. Mounted on the second end of the arm are means for securing the foot of a user, wherein said means is configured and dimensioned such that the user is positioned with the pivot point disposed behind the user. The apparatus also includes means for resisting movement of the arm from the first position to the second position and may further include means for returning the arm from the second position to the first position. In a preferred embodiment, the apparatus has first and second arms, wherein the arms are disposed adjacent to each other with their respective pivot points disposed along a common line. The common line is at least approximately perpendicular to both arms when the arms are parallel to a line defining a direction of simulated forward travel. Each arm preferably pivots through a total angle of about 120° . Preferably about 60° of the total angle of travel is toward the other arm and beyond a line passing through its respective pivot and parallel to the forward travel line. The apparatus according to the invention may further comprise flexible element means for linking the arms with said resisting and returning means. Resistance means such as electro-magnetic resistance or fly wheel resistance mechanisms may be employed. The flexible element means may include chains, cables or other suitable elements. In the method for skate training exercise according to the invention, the following steps are included: Guiding a user's first foot along an arcuate path having a center point disposed behind the user. Preferably, the arcuate path has a radius at least about the length of the user's leg. Resisting force applied by the user along the arcuate path in a direction away from the user's body. Stopping movement along the arcuate path at a predetermined position. A further step may involve assisting the user in returning his/her foot to the first position along the arcuate path. The steps may be repeated alternately between the user's first foot and second foot. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a plane view of a first embodiment of the skate training apparatus according to the present invention; FIG. 2 is a side view of the apparatus shown in FIG. 1; FIG. 2A is a partial, enlarged side view of the sprocket assembly shown in FIGS. 1 and 2; FIG. 3 is a perspective view of a person using an apparatus of FIG. 1 to simulate skating; FIG. 4 is a side view of an embodiment of a foot stirrup according to the invention; FIG. 4A is a schematic cross-sectional view through line 4A--4A of FIG. 4; FIG. 5 is a cross-sectional view through line 5--5 of FIG. 4; FIG. 6 is a partial side view of a fly wheel-fan resistance mechanism according to an alternative embodiment of the invention; FIG. 7 is a schematic plan view of a further alternative embodiment of the invention; FIGS. 8 and 9 are perspective and plan views, respectively, of an alternative embodiment of the invention; and FIGS. 10 and 11 are schematic plan and front views, respectively, of a further alternative embodiment of the invention employing weight stack resistance. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS FIGS. 1, 2 and 3 illustrate a basic arrangement for the skate training exercise apparatus 10 according to the present invention. Skating arms 12 are pivotably mounted on frame 14 at pivots 16. Frame 14 includes internal frame members 18, 20, 22, 24 and 26 to provide structural stiffness and support pulleys or sprockets as described below. Flexible elements 28, such as cables or chains are secured at 30 to skating arms 12. By way of example, in the embodiment described herein, flexible element 28 is a bicycle-type chain cooperating with sprockets 32. Other arrangements, for example using cables and pulleys also may be used and are discussed below. The components of the present invention are constructed of commercially available materials, the selection of which is within the ability of the ordinary skilled worker. Chains 28 are wound around sprockets 32 mounted on frame 14. The chain and sprockets associated with one of the skating arms are disposed above the other chain and sprockets to prevent interference therebetween. Chains 28 come together at resistance sprocket assembly 36 which includes side-by-side ratcheted sprockets 36A and 36B mounted one above the other on a single shaft 38 (FIG. 2A). Both cables then continue in a parallel arrangement to connect with return springs 40. Return springs 40 traverse around dual pulley 42 and are secured at 44 to frame member 18. Skating arms 12 are provided, at the end opposite pivots 16, with foot stirrups 52 having straps 54 to secure the user's foot therein. Once the user has strapped his feet into the stirrups, he or she pushes out and to the side, simulating a skating stroke. Skating arms 12 pivot about pivot points 16 causing chain 28 to travel therewith and around sprockets 32. As chain 28 extends with the arm, it causes resistance sprocket assembly 36 to rotate. Sprockets 36A and 36B are ratcheted on shaft 38 such that rotation of either in the forward direction (counterclockwise in FIG. 1) causes rotation of sprocket 36C, also in the forward direction. The ratchet allows each sprocket 36A or B to reverse direction as its associated skating arm returns to center, without reversing sprocket 36C. An appropriate resistance means cooperates with sprocket 36C to provide the desired resistance for the user. In the embodiment shown in FIGS. 1 and 2, resistance is provided by an electro-magnetic resistance mechanism 46, which is known in the art. A resistance chain 48 traverses around sprocket 36C which is mounted concentrically with sprockets 36A and 36B. Chain 48 runs around the associated sprocket of resistance mechanism 46, the operation of which is understood by persons skilled in the art. Stops 60 can be provided on frame 14 to control the outward angle of travel of skating arm 12. The stop position may be adjustable, such as by a screw as shown. Once the skating arm has reached limit of travel and the user releases force applied thereto, spring 40, which was extended by the outward travel of skating arm 12, causes the return of skating arm by acting through chain 28. Inside stops 61, mounted on arms 12, control the degree of inward travel of arms 12 by abutting against frame member 26 (the left hand stop is omitted from the drawings for clarity). Preferably, the total angle of travel of a skating arm is at least about 60°, with about five to fifteen degrees being to the inside of the skating arms. More preferably, the total angle of travel is about 120°, with approximately 60° to the inside. As shown in FIG. 1, stops 60 and 61 are adjusted to allow about 80° total travel, 60° to the outside and 20° to the inside. The extent of travel is indicated by arms 12a, shown in phantom lines. Ideally the extent of travel is adjusted such that during regular skating motion the stops are not contacted. Instead, the outward motion of an arm is stopped by a combination of increasing resistance from the resistance means and the user's weight shift at the end of a stroke. The superior dynamic skating motion achievable with the present invention is due, at least in part, to the arrangement of skating arms 12 and location of pivots 16 with respect to the user. By placing the user's feet at the end of the relatively long skating arms with pivot points located behind the user, the natural skating motion is closely simulated while at the same time providing a mechanism which is relatively simple and easy to adapt for resistance. Preferably, the length of skating arms 12 from pivot 22 to stirrup pivot 56 is about the same or slightly greater than the length of the average user's leg, approximately 34-36 inches. If desired, the skating arms can be provided with an adjustable length. Other dimensions of the apparatus which have provided satisfactory results are the distance between pivot points 16 along member 26 being about fifteen inches and the distance along arms 12 from pivot 16 to connection 30 being about twenty-four inches. The realism of the skating motion is further enhanced by the positioning of the pivot points to allow the user's feet to "crossover" on the inward movement. As explained above, at least approximately five to fifteen degrees of the angular travel of the skating arms is to the inside; that is, towards the opposite foot from a position where the arm is perpendicular to frame member 26. Preferably, as shown in FIGS. 8 and 9, the arms may travel freely an equal amount to both sides. At the point where the arm is perpendicular to member 26, it is also parallel to an imaginary line representing the direction of simulated skating. The angular travel is to both sides of the line representing the direction of skating. Referring to FIGS. 2 and 8, it can be seen that skating arms 12 are constructed as a truss, with upper and lower members to provide sufficient strength and rigidity. Pivots 16 comprise shafts 62 to which the upper and lower members of skating arm 12 are secured, such as by welding. Shaft 62 is carried in upper and lower bearings 64, 66 respectively. Bearings 64 and 66 are preferably pillow block bearings which provide low friction and high strength in order to continue to pivot freely without binding under the loads exerted in supporting the cantilevered skating arms. Stationery grip 70 is provided to allow the user to steady himself when getting on and off the apparatus and also to provide security for new users. Moving support 72 provides support for more experienced users during skating motion and allows the user to support the upper body without detracting from the natural skating motion. Support 72 comprises shaft 74 with curved handle 76 at the upper end. At the opposite end, shaft 74 is secured to frame 14 by a ball joint 78 to allow free side-to-side motion. As shown in FIGS. 1 and 2, stirrups 52 are secured directly to arms 12. However, preferably, stirrups 52 are permitted to rotate with respect to arms 12. Rotation may be through a limited angle or 360°. A useful means for limiting and controlling the rotation of the stirrups is illustrated in FIGS. 4 and 5. As shown therein, stirrup 52 is mounted on shaft 80 and also has pin 82 extending downward therefrom. Shaft 80 is received in bearing 84, mounted on arm 12. Bearing 84 is preferably a roller bearing to reduce friction to the greatest extent possible. A person of ordinary skill in the art can select a suitable bearing. Pin 82 is received in slot 86 of control arm 88. Control arm 88 is pivotably mounted on skating arm 12 at pivot 90. The motion of control arm 88 is restrained by extension spring 92, which is secured between the control arm and skating arm 12. In a further alternative, stirrup 52 is canted at an angle θ of between about 5°-15°, as shown in FIG. 4A. The angle is such that the high side of the stirrup is to the outside. Preferably angle θ is about 10°. With the arrangement described above, as the user's foot moves outward during the skating motion, the stirrup pivots to maintain the foot essentially parallel to the imaginary direction of travel, just as it would during actual skating. As the stirrup pivots around shaft 80, pin 82 rotates outward with respect to arm 12, but is restrained by control arm 88 and spring 92. The user's feet thus follow the natural skating motion while not pivoting freely so as to feel uncontrolled. Persons of ordinary skill in the art will appreciate that resistance means other than electromagnetic as described above may be readily adapted to the present invention. For example, shown in FIG. 6 is a fly wheel-fan resistance mechanism for use in an alternative embodiment of the present invention. Fly wheel-fan mechanisms are known to one of ordinary skill in the art. Ratchet sprockets 36A and 36B are arranged on shaft 38, as previously described. However, instead of resistance sprocket 36C at the top, shaft 38 is supported by an additional bearing 94. Shaft 38 extends downward, below frame member 26, into a space 96 defined by frame 14. Fly wheel-fan 100 is mounted on shaft 38 in the space provided. The back-and-forth motion of the arms, acting through chains 28 and ratcheted sprockets 36A and 36B, causes shaft 38 to rotate the fly wheel-fan and create resistance to the user's motion. A plain fly wheel or friction resistance with or without a fly wheel also may be used. A further alternative embodiment of the present invention is illustrated schematically in FIG. 7. In this embodiment, skating arms 12A and B are provided with laterally extending power arms 110A and B, respectively, mounted one above the other to avoid interfering with each other. Cables 28 are secured to the ends of power arms 110 and are guided around pulleys 32 to drums 112. Cables 28 are wrapped around the drums so that the outward motion of arms 12 causes the cable to unwrap and rotate the drums. Drums 112 are ratchet mounted on shafts in the same manner that ratchet sprockets 36A and 36B are mounted on shaft 38. The drums drive the shaft, which in turn drives resistance means such as fly wheel-fans 100. Separate fly wheel-fans 100 are shown for each drum in the embodiment of FIG. 7; however, the drums may cooperate through a common shaft to utilize a single fly wheel-fan. Other resistance means as described herein are also contemplated. Drums 112 are provided with torsion springs to rewrap the cable during the return swing of arms 12. Additional, optional springs, such as extension springs 116, can be provided for greater resistance and faster return. A further alternative embodiment is illustrated in FIGS. 8 and 9. This embodiment is shown without foot stirrups or grips, which may be provided as previously described. Skating arms 12 are again mounted on shafts 62, carried by pillow block bearings 64 and 66. However, the shafts extend below the lower bearing with a separate fly wheel-fan resistance mechanism 100 mounted on each. In order to provide resistance in only the outward stoke direction, each flywheel-fan is mounted on shaft 62 with internal ratchet 101. The use of individual fly wheels, directly mounted on shafts 62 eliminates the need for a cable and pulley system. As also shown in FIGS. 8 and 9, frame 14 can be configured to occupy the entire area which will be required for operation of the device. Although not necessarily required for stability, this larger foot print increases safety because it prevents other equipment or objects from being placed too close to the skating device when it is not in use. FIG. 9 also clearly illustrates the capability of the skating arms to move freely in both directions as desired (in phantom lines at 12c). With advanced and well conditioned skaters positive stops and positive return means are not required. The skater's natural outward push against the resistance will create a natural stop, against which the next stroke is made. Return of the skating arms occurs automatically with the next successive stroke. The crossover of the trailing skating arm as previously described will occur naturally to correspond to the degree of crossover the user applies in actual skating. One or more weight stacks also may be used for resistance. Weight stacks are particularly useful for strength training machines. FIGS. 10 and 11 schematically illustrate a strength training device according to the present invention. Cable cam 120 is secured to arm 12, both of which rotate around pivot 16. Pivot 16 is again disposed behind the user during use of the invention. Cable 28 is secured to the cam at one end and traverses around pulleys 32 to weight stack 122. Both cam 120 and weight stack 122 are conventional and well understood by persons skilled in the design of exercise machines. The user selects the amount of weight desired and places his or her foot in stirrup 52. Resistance footpad 124 is provided for the user to push against. Preferably, in order to allow exercise of both legs, a second skating arm, cam and weight stack can be arranged in mirror image configuration adjacent to the first. In this case resistance foot pad 124 is replaced by the stirrup of the opposite skating arm. Suitable locking means to secure one skating arm while the other is extended can be provided by a person of ordinary skill in the art.

Apparatus and method for skate training exercise comprising arms of relatively long length pivotably mounted on a frame. The user's foot is secured in a stirrup on the arm opposite the pivot point. A resistance means is provided to provide resistance as the user pushes his foot away from the body along an arcuate path defined by the arm in simulated skating stroke. A return means is provided to assist the user in returning his foot along the arcuate path after predetermined angle is traversed. Various resistant means include electro-magnetic, fly wheel-fan and weight stack.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a device for analyzing the function of a heart, having a measurement unit for generating a measurement signal related to an electrical or mechanical heart variable, and an evaluation unit for evaluating the measurement signal. 2. Description Of the Prior Art In the monitoring, diagnosis and treatment of a heart's function, accurate determination of the heart's current condition, with minimal risk of erroneous interpretations, is important. Automatic monitoring of the heart is a valuable asset in the treatment of heart disease so that a therapeutic measure can be instituted without delay when necessary. The electrocardiogram (ECG) is one heart variable which is an indicator of a heart's function. Sensing the ECG in order to obtain a measurement signal which can be evaluated in establishing the condition of the heart is known in the art. One way to graphically elucidate the electrocardiogram by plotting the voltage in a recorded electrocardiogram against the time derivative of the voltage is described in an article entitled "Phase Plane Plot of Electrograms as a Marker of Ventricular Electrical Instability During Acute Ischemia: Initial Experimental Results and Potential Clinical Applications", published in the journal PACE, Vol. 15, part II, November 1992, pp. 2188-2193. This procedure produces a curve corresponding to the ECG signal. The article shows that there is a relationship between changes in parts of the curve during acute ischemia and the development of ventricular fibrillation. The authors of the article state that a presentation of an electrocardiogram in graphical form can be an excellent complement to traditional, real-time presentation. U.S. Pat. No. 4,417,306 describes an apparatus which monitors and stores heart signals. The apparatus senses the ECG, and the ECG signal must have a predesignated slope, amplitude, duration and course to be accepted as a heart beat. The QRS complex is the main segment sensed, i.e., the electrical signals which occur in the heart when there is a ventricular beat (ventricular systole). U.S. Pat. No. 4,453,551 describes an apparatus designed to detect ventricular fibrillation (VF). The apparatus senses the ECG signal from the heart, digitizes it and amplifies it to a predetermined amplitude. The amplified signal can then be analyzed in different ways to ascertain whether or not VF is present. For example, the statistical distribution of gradients or the frequency of the maximum negative gradient can be analyzed. European Application 0 220 916 describes an apparatus designed to detect the presence of ventricular tachycardia (VT) and VF and to supply treatment to terminate these conditions. The apparatus senses the heart's ECG at a plurality of points on the heart and determines the sequence in which the signals are detected at the different measurement points. In VT and VF, the sequence deviates from the normal pattern in different ways. SUMMARY OF THE INVENTION It is an object of the present invention to provide a device which analyzes the function of the heart in a reliable, efficient but still simple manner. Another object is to provide a device which can be used for diagnosing heart defects, monitoring heart functions and adapting therapy to make treatment as safe and effective as possible. The above objects are achieved in accordance with the principles of the present invention a device having a measurement and evaluation unit wherein the evaluation unit includes means for generating at least one parameter signal on the basis of the measurement signal, and the evaluation unit analyzes related values for the measurement signal and the parameter signal by determining whether they satisfy a predesignated number of conditions. Instead of analyzing only one measurement signal, the device first generates a parameter signal from the measurement signal, and related signal values of the measurement signal and parameter signal are analyzed. A normally working heart (as in a healthy heart) is hemodynamically stable, and a virtually identical sequence of related values is generated from one heart cycle to another, so different conditions are satisfied in the same sequence cycle after cycle. Pathological changes and other abnormal conditions in a heart affect the satisfying of different conditions in a distinct way and can therefore be easily identified. The conditions can consist of any kind of mathematical relationship. Certain relationships for different, known changes in a specific individual can also be used. Preferably, the related variables correspond to coordinates forming a curve in a coordinate system, with the measurement signal and parameter signal as coordinate axes, and preferably the predetermined number of conditions corresponds to a predetermined number of areas in the coordinate system, whereby the evaluation unit determines the sequence in which the curve traverses the predetermined number of areas. Having the related values correspond to coordinates in a coordinate system results in a clarified analysis. The generated curve becomes virtually identical, from one heart cycle to another, as long as the heart functions in a constant manner. An application filed simultaneously herewith having U.S. Ser. No. 08/051,250 entitled "Device for Analyzing the Functioning of a Heart" (Noren et al.,), filed Apr. 23, 1993 describes a device which analyzes heart-related signals by utilizing a two- or multidimensional representation of the signals. In another embodiment of the device in accordance with the invention the means for generating at least one parameter signal from the measurement signal is a differentiator which obtains the first derivative of the measurement signal. With the derivative of the measurement signal as a parameter, related values are obtained which, for a normal heart, form a substantially closed curve with a small loop inside a larger loop in the coordinate system. This curve changes when e.g. a VT or a VF is present. Definition of different areas the curve can pass in various heart conditions and the determining of the areas the curve passes and in which sequence the areas are passed make it possible to identify different arrhythmias and anomalies. The curve changes even when certain other specific cardiac events occur, such as retrograde conduction and extrasystoles. Spontaneous and stimulated heart beats give rise to different curves, and the device can be used for detecting both spontaneous heart beats and stimulated heart beats. As an alternative or a complement to differentiation, the means for generating a parameter signal from the measurement signal may be or include an integrator which integrates the measurement signal. By the use of an integrated signal, with integration occurring over a plurality of heart cycles, the system is more stable, and the curve does not wander outside the predetermined decision areas. If the integration interval is shorter than a heart cycle, a parameter signal is produced which with the measurement signal, forms a curve in the same way as the measurement signal and the measurement signal's derivative. Integration produces simultaneous filtration of noise. An enhancement of the device is achieved in an embodiment of the invention wherein the evaluation unit has a plurality of comparators, each of which is supplied with at least one of the measurement signal or the parameter signal and an input signal. Each comparator represents a line in the coordinate system, which lines delineate the predetermined number of areas. Each corresponding comparator generates an output signal when the curve being analyzed is on one side of a specific line, associated with that comparator. The evaluation unit in this embodiment also includes a sequence analyzer for determining the sequence in which the comparators generate output signals. Each comparator thus represents a line in the coordinate system, and the comparator's output signal is zero or one ("low" or "high"), depending on which side of the line the curve is located. With a plurality of lines, the coordinate system is subdivided into a plurality of areas which can be made larger or smaller. On the basis of the comparators' output signals, the course of the curve can be followed throughout each heart cycle and compared with various predetermined courses in order to determine the condition of the heart. The lines can be parallel to one another, perpendicular to one another, arise from a common point, arise from a plurality of points, etc. In order to be able to shift the curve in relation to the coordinate system and additionally to form a plurality of different lines, preferably the evaluation unit further includes a reference signal generator which generates a reference signal serving as the input signal for at least one comparator. An additional enhancement is obtained in a further embodiment of the invention including a first timer for measuring the time in which the related values satisfy at least one specific condition. In this embodiment, therefore, information is obtained in addition to that provided by condition satisfaction itself or, when a curve is described, the course of the curve in relation to the measurement signal parameter signal (MS-PS) diagram, thereby increasing the possibility of attaining reliable identification of various conditions in the heart. Alternately, or as an additional complementary feature, the device may include a second timer to measure the time elapsing from a time at which the relevant values satisfy a first specific condition until they satisfy a second specific condition. In a further embodiment, the device includes a pulse generator for generating and emitting stimulation pulses to the heart according to the state of the heart as analyzed by the device. The device can thereby supply a therapeutic measure when necessary, such as a specified pacing, antitachycardia or defibrillation sequence. DESCRIPTION OF THE DRAWINGS FIG. 1 shows, in block diagram form, an embodiment of the device according to the invention. FIG. 2 shows a spontaneous heart signal and a stimulated heart signal. FIG. 3 is a schematic illustration, for explaining the operation of the invention. FIG. 4 shows a block diagram of a comparator unit in the device. FIGS. 5 and 6 illustrates state sequences arising in the device of the invention for two different heart sequences. DESCRIPTION OF THE PREFERRED EMBODIMENTS An embodiment of the invention in the form of a pacemaker 1 is shown in FIG. 1 is connected to a heart 7. A tip electrode 3 and a ring electrode 4 are placed in the right ventricle of the heart 2 and are connected, via a first electrode conductor 5 and a second electrode conductor 6 to a pulse generator 7 in the pacemaker 1. The pulse generator is also connected to pacemaker can 20 which functions as an indifferent electrode, i.e., the pulse generator 7 can either emit stimulation pulses between the tip electrode 3 and the ring electrode 4 or between the tip electrode 3 and the pacemaker can 20. A detector 8 is connected in parallel with the first electrode conductor 5 and the second electrode conductor 6. The detector 8 senses the heart's electrical activity, i.e., the ECG, and sends a measurement signal to a signal shaper 9. The signal shaper 9 first filters the signal in a bandpass filter 10. The bandpass filter 10 primarily eliminates high frequency noise which could otherwise overwhelm subsequent signal components. After filtration, the filtered signal is sent to each of an amplifier 11, a differentiator 12 and an integrator 13 which integrates the signal for a plurality of heart cycles. In this manner, three parameter signals are formed from the single measurement signal. The signal shaper 9 contains a reference generator 14 which generates a reference signal. The reference generator 14 is connected to pacemaker electronic circuitry 15 which includes e.g., a battery and microprocessor for controlling the pacemaker. The four signals, at least two of which constitute coordinates forming a curve in a coordinate system, are sent to a comparator unit 16. The comparator unit 16 comprises a plurality of comparators representing different lines in the coordinate system. Each comparator generates an output signal when the curve is on a specific side of the line the comparator represents. So a plurality of output lines X1, X2, . . . , Xn runs from the comparator unit 16 to a sequence analyzer 17 which identifies those comparators which emitted an output signal and the sequence in which this occurs. A plurality of sequence signal lines Y1, . . . , Ym runs from the sequence analyzer 17 to pacemaker electronic circuitry 15, in which the microprocessor decides whether any action should be taken on the basis of the signal from the sequence analyzer 17. A physician can, with the aid of a programming unit 19 communicate with pacemaker electronic circuitry 15 via a telemetry unit 18, in order e.g., to change the lines the comparators in the comparator unit 16 represent or in order to retrieve stored information on detected sequences and the treatment given. FIG. 2 shows an example of two different signals which can be detected in the pacemaker 1. A spontaneous heart signal 25 is shown at the top. Here, the spontaneous heart signal 25 only shows the QRST complex in the heart signal 25, i.e., the signals generated by ventricular depolarization in systole and repolarization in diastole. A stimulation pulse 26, resulting in a stimulated heart signal 27, is shown at the bottom. Again, only the ventricular signal is shown. As a direct comparison shows, the stimulated heart signal 27 lacks the positive R wave found in the spontaneous heart signal 25, while the negative part of the stimulated heart signal 27 is simultaneously more pronounced than the S wave in the spontaneous heart signal 25. The repolarization wave in the stimulated heart signal 27 is larger than the T wave in the spontaneous heart signal 25. In FIG. 3, the proportional value is plotted against the derivative for each point in time. The spontaneous heart signal 25 then generates the curve 30 and the stimulated heart signal 27 generates the curve 31. The signal lines represented by the comparators have also been entered into the coordinate system. The comparators will be described in greater detail in conjunction with FIG. 4. As can be seen, the morphological difference between the spontaneous heart signal 25 and the stimulated heart signal 27 is depicted with greater clarity in the PD-coordinate system than in the real time diagrams in FIG. 2. As noted above, the comparator unit 16 contains a plurality of comparators. FIG. 4 shows one way of constructing the comparator unit 16 With four comparators 32, 33, 34, and 35, four different limit conditions are created which respectively correspond to lines 45, 46, 47, and 48 in the PD diagram in FIG. 3. Input signals to the comparator unit 16 consist of the proportional signal in signal line 36, the integrated signal in signal line 37, the reference signal in signal line 38 and the derivative signal in signal line 39. In the first comparator 32, the proportional signal is supplied to the negative input via a first resistor 40a. The integrated signal is also supplied via a potentiometer 41a, to the negative input. The derivative signal, via a second resistor 40b, and the reference signal, via a second potentiometer 41b are supplied to the positive input. The output signal from the first comparator 32 has been designated X1, and the following conditions must be satisfied for the first comparator 32 to emit an output signal: D+(C.sub.b ·V.sub.ref)-P-(C.sub.a ·I)>0, wherein the proportional signal is generally designated P, the derivative signal is generally designated D, the integrated signal is generally designated I, the reference signal is generally designated V ref , the resistors 40a, 40b, etc. all have the same value set at one, and the potentiometers' value in relation to the resistors is designated C a for the first potentiometer 41a, C b for the second potentiometer 41b, etc. Thus, the first line can be written: D=P+C.sub.a I-C.sub.b V.sub.ref, which produces the line 45 in the PD diagram in FIG. 3. The first comparator 32 generates an output signal when the curve 30 is above the line 45. In the corresponding manner, the proportional signal is connected, via a resistor 40c and a first inverter 43a, to the negative input in the second comparator 33. The integrated signal is also connected, via a third potentiometer 41c and the first inverter 43a, to the negative input. The derivative signal, via a fourth resistor 40d, and the reference signal, via a fourth potentiometer 41d are supplied to the positive input. The output signal from the second comparator 33 has been designated X2, and the condition D+C.sub.d V.sub.ref -(-P-C.sub.c I)>0 must be satisfied for an output signal to be received from the second comparator 33, i.e., the line D=-P-C c I-C d V ref . This is line 46 in the PD diagram. For the comparator 34, the proportional signal is analogously connected to the negative input, via a fifth resistor 40e and a second inverter 43b, and the integrated signal, via a fifth potentiometer 41e and the second inverter 43b. The derivative signal via a sixth resistor 40f, and the reference signal, via a sixth potentiometer 41f are supplied to the positive input. Output X3 from the third comparator 34 produces an output signal when the curve is above line 47 in the PD diagram. The fourth comparator 35 has its negative input connected to virtual ground 42, and to the positive input are connected the derivative signal, via a seventh resistor 40g and the reference signal, via a seventh potentiometer 41g. The output X4 produces an output signal when the curve is above line 48 in the PD diagram. As shown by the curves in the PD diagram in FIG. 3, the spontaneous curve 30 encloses both a first point 49 at the intersection of lines 45 and 46 and a second point 50 at the intersection of lines 45, 47 and 48, whereas the stimulated signal 31 only encloses the second point 50. A determination by the sequence analyzer 17 of whether the generated curve encloses both the first point 49 and the second point 50 is sufficient to distinguish spontaneous heart signals from stimulated heart signals and to determine whether the signal is spontaneous or stimulated. More generally, the areas formed between the lines 45, 46, 47 and 48 can be said to represent different states of the device, since the combination of output signals from the comparators 32, 33, 34 and 35 are unique to each area. If, for example, starting from the origin in the PD diagram conditions for emission of a signal by the first comparator 32, the third comparator 34 and the fourth comparator 35, respectively corresponding to lines 45, 47, and 48, are satisfied, this results in a signal state of 1011 for signal outputs X1, X2, X3, X4. If each state described by a curve is recorded, a number of different heart conditions can be identified. The function of the sequence analyzer 17 can thereby be described with state sequence graphs, as shown in FIGS. 5 and 6. FIG. 5 shows eight states, corresponding in principle to the states which can occur in the above-described embodiment. The intersection of lines 46 and 48 (not shown) results in an additional area and state which is not shown in the FIG. The spontaneous curve shown in FIG. 3 will commence in state 1011 in the sequence graph, then cross line 46 to state 1111 and then, after crossing line 45, to state 1101, etc., traversing the entire sequence back to state 1011. FIG. 6 shows the sequence between states covered by the stimulated signal 31. It also begins in state 1011 but subsequently crosses line 45 and goes directly to state 1011, thereafter following the same sequence as the spontaneous signal 30. On the basis of the possible sequences a signal is able to follow, the sequence analyzer 17 can be devised to identify specific state change sequences, thereafter emitting a signal to pacemaker electronic circuitry 15 in the pacemaker 1. The lines 45 through 48 can be shifted in different ways with the potentiometers 41a through 41g so as to adapt conditions to different patients. Each sequence, or series of changes in state, corresponds to a specific morphology for the input signal, and since morphology changes in different ways in the presence of different heart conditions, such as tachyarrhythmias and extrasystoles, fast and reliable identification of the heart's current condition is achieved. If necessary, therefore, suitable therapy can be instituted immediately. Especially with patients suffering from different types of tachyarrhythmia, a pacemaker with an analyzer according to the invention can easily identify the different types and institute the therapeutic measure most appropriate to the condition in question. To increase reliability in the identification of different heart conditions, the sequence analyzer 17 can be equipped with a timer which measures the time a generated curve is in a specific state. Since every condition is unique, the sensing of each condition transition is not always necessary; only a few transitions need to be noted as arising in a specific way (e.g., a transition from a specific state or taking a specific amount of time to pass between two specific states), in order for a valid identification of the current heat condition to be made. Although modifications and changes may be suggested by those skilled in the art, it is the intention of the inventors to embody within the patent warranted hereon all changes and modifications as reasonably and properly come within the scope of their contribution to the art.

A device for analyzing the function of a heart has an electrical measurement unit for generating a measurement signal related to an electrical or mechanical heart variable, and an evaluation unit for evaluating the measurement signal. The device further includes circuitry for generating at least one parameter signal from the measurement signal. The evaluation unit analyzes related values in the measurement signal and the parameter signal, these related values corresponding to coordinates which form a curve in a coordinate system, the measurement signal and the parameter signal serving as coordinate axes, by sensing the sequence in which the curve passes a predesignated number of areas in the coordinate system. The device is capable of detecting spontaneous and stimulated heartbeats, tachyarrhythmias, retrograde conduction, ectopic beats, etc.

RELATED APPLICATIONS [0001] The present application is a continuation of U.S. patent application Ser. No. 11/002,604, filed Dec. 2, 2004, now U.S. Pat. No. 7,155,766, which is expressly incorporated herein by reference. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to a bolster for an air mattress. [0004] 2. Description of Background Art [0005] A number of types of air mattresses are known, including low air loss beds, lateral rotation beds and fluidized bead beds. See, e.g. U.S. Pat. Nos. 6,694,555, 6,536,056, and 6,353,950, expressly incorporated herein by reference in their entirety. One type of known design has a series of transversely oriented bladders disposed side-by-side to form a mattress. Each bladder has a port for inflation and rapid deflation, and typically has a series of punctures on the top to provide a low flow of air out of the bladder toward the person lying on the bed. A blower control is typically provided to inflate the mattress and heat the air, and a number of other functions may be provided as well. The blower control may have a number of zones, for example head, back, buttock, and leg. Each of these zones may have independent pressure control. In addition, the blower control may be integrated with the bed frame control, to adjust for inclination, sitting posture, etc. The blower control may also provide an auxiliary output, for example to provide lateral rotation. [0006] Pneumatic bolsters are also known. See, e.g., U.S. Pat. No. 6,668,399, expressly incorporated herein by reference in its entirety. See also, U.S. Pat. Nos. 5,421,044; 5,956,787; 6,085,372; 6,065,166; 6,154,900; 6,782,574; 6,739,001, each of which is expressly incorporated herein by reference in its entirety. SUMMARY OF THE INVENTION [0007] The present invention provides a pneumatic bolster for an air mattress support, wherein the mattress comprises a plurality of adjacent bladder segments disposed transversely across the bed, the bolster having a tension web portion having a set of perforating apertures through which the transverse bladder segments are inserted, and a pneumatically inflated longitudinal bolster portion, at a lateral edge of the tension web, sitting on the upper surface of the mattress, adapted to impede rolling or sliding of an occupant of the bed. Typically, the bolster is bilaterally symmetric, and thus protects both lateral edges of the mattress, but need not be so. In a symmetric form, the two tension webs are interconnected at their bottom edges which lay under the mattress. [0008] The bolster is compatible with various mattress designs, although the size and spacing of apertures typically must correspond to the mattress bladders. Because the purpose of the tension web is to position the bolster, other suitable positioning means may be employed. For example, instead of a sheet having a series of oval apertures, this portion may be configured as a set of straps between the bolster and lower restraining portion. Likewise, instead of apertures, the bolster may be positioned by a sheet having a series of pockets for enveloping the termini of the mattress bladders. [0009] The lower edge of the tension web (or other positioning structures) is subjected to a transverse force, toward the centerline of the mattress. In a bilaterally symmetric embodiment, this force is conveniently provided by the interconnection of positioning structures with a tensile sheet, thus pulling each other. [0010] The longitudinal bolster portions may be attached to straps at the edge of the mattress bladders, or the bed frame, by a set of straps spaced longitudinally at the lateral edge of the bolster cushion. Thus, the bolster is subjected to tensile forces from both sides; on a lateral side by tensile forces provided through straps or other connection system to the mattress straps or the bed frame; and medially by the tensile sheet or its functional equivalent. Typically, the bolster substitutes for the normally provided bed rails, and serves similar functions. [0011] The tension web (or positioning structures) are subject to tensile forces exerted at different heights, i.e., above the mattress laterally, and below the mattress medially, so it will typically be inclined upward and outward, forming an open-top trapezoid. The apertures are oval or elliptical, to accommodate an oval or cylindrical mattress bladder segment. To place the bolster on a mattress, the bolster may be situated on the mattress while it is deflated and flexible, with the ends of the mattress bladders inserted through the apertures. [0012] The bolster is typically inflated to a higher pressure than the bladders of the mattress, since it is intended, over a smaller surface area, to resist shifting of the occupant of the bed. It is, however, not inflated to such a high pressure that there would be injury risk if the occupant hit or bump into it. In fact, a particular advantage of the bolster over a bedrail is that it would tend to reduce in-bed injuries associated with bedrails, both from hitting into them and getting body parts caught when they are raised and lowered. [0013] The bolster may be provided with ingress/egress regions which have a lower nominal height above the mattress. For example, this may be achieved by constricting the bolster bladder by forming a set of longitudinal seals between opposing sides of the bladder. These ingress/egress regions may extend over about the middle fifth of the bolster. Thus, an ambulatory occupant of the bed can sit up and extend his or her feet over the constricted portion, and then exit the bed, or enter the bed in corresponding manner, without deflating the bolster. [0014] The preferred design also includes a vent valve, which allows a rapid deflation of the bolster, for example to allow repositioning of an immobile person out of the bed without sitting up or climbing over the bolster, or to provide unimpeded access in case of emergency. [0015] Since the bolster is inflated to a generally higher pressure than the rest of the mattress, through a common blower, the valve may include a checkvalve function, to prevent backflow when, for example, an external pressure is applied to the bolster. The valve is typically designed to allow at least 50% reduction in superambient pressure of the bolster within about 3 seconds, to allow near immediate access in case of emergency. For example, if the bolster is inflated to 2 psia, it would drop to no more than 1 psia within 3 seconds. Of course, other deflation parameters may be employed. [0016] The bolster may be provided with a separately valved zone on a blower system, thus eliminating the need for the separate manually actuable valve. In addition, the dump function of the valve may be electronically controlled by the blower control, to allow a single actuation of a “CPR” function to deflate the entire bed structure in case of emergency. [0017] These and other objects, features, and advantages of the present invention will become evident to those skilled in the art in light of the following brief description of the drawings and detailed description. BRIEF DESCRIPTION OF THE DRAWINGS [0018] FIG. 1 shows a top perspective view of a bolster assembly in accordance with the present invention; [0019] FIG. 2 shows a top perspective view of the bolster assembly of FIG. 1 installed on an air mattress; [0020] FIG. 3 shows an end view of the bolster and mattress of FIG. 2 with a person lying on the mattress; and [0021] FIG. 4 shows an exploded view of the components of the bladder portion of the assembly. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0022] The mattress 10 comprises a plurality and inflatable tubular bladder elements 15 (or “cushions” or “air bags”). The individual cushion elements 15 may be arranged into a plurality of body support regions: e.g., the head region, the back region, the buttock region, and the leg/foot region. The mattress 10 is typically used for the reduction or relief of skin interface pressures for patient at risk of developing pressure ulcers or patients who already have pressure ulcers. [0023] All air bladders, e.g., of both the mattress 10 and the bolster 1 , in the preferred embodiment, comprise a polyurethane coated, impermeable, heavy duty fabric. The air bladder elements 15 of the mattress 10 preferably have a defined set of perforations, to permit a steady flow, relatively low flow of air through the fabric. [0024] A control unit (or “controller”) includes the components for inflating and controlling the mattress, and, in the case of a hospital bed, for interfacing with patient caregiver. As will be evident to those of ordinary skill in the art, such components (not shown) include a blower, a microprocessor or the equivalent, a heater, various valves and pressure sensors, manifolds, and connections, in such manner as may be desired. A separate valve and pressure sensor are provided for the bolster system. The controller has a housing adapted with adjustable hooks for mounting on the footboard or siderail of frame. The control unit connects to each one of cushions via a plurality of fluid lines (not shown) contained within a trunk line to supply the cushions with air as an inflating medium. A separate fluid line is provided for supplying the bolster with air. The fluid lines connect to their respective cushions using any suitable means such as a quick connect valve that includes a male member having a flange and a female member having a cavity about its inner surface for receiving the flange. [0025] The controller comprises an operator input and display, processor unit, power supply, heater, temperature sensor and temperature control, blower and blower control, pressure sensors, and an air controller valve bank. The controller connects to any suitable power source such as a 120 VAC power line, preferably via a “hospital grade” outlet. The controller generates control signals for the air control valve bank to allow blower to inflate each of cushions and the bolster to appropriate pressures. The air control valve bank comprises, for example, 5 air control valves corresponding to the four zones of the mattress and the bolster. It may also comprise 4 controlled zones plus an uncontrolled output, for use in conjunction with a separate bolster valve system. While known blower controllers do not typically include a port for a bolster, they may include ports for bladders intended to position a patient along the sagittal, coronal, and or transverse planes. If available, one of these may be substituted, or an additional port provided specially for this purpose. [0026] An integrated blower controller can be provided which not only controls the inflation of the air bolster 1 , but also includes sensors and alarms to make sure a caregiver does not leave the bed in an unsafe state, i.e., bolsters uninflated and bed occupied. Other monitors and enunciators may also be provided, for example, to sense a disoriented patient trying to climb over the bolster, which would generally cause a pressure fluctuation. [0027] Likewise, in a rapid inflate bolster configuration, the bolster may be relatively uninflated normally, and sense when the occupant is touching it or trying to roll or shift over it. In such cases, the bolster 1 could rapidly inflate, thus impeding the undesired activity, while leaving the occupant in a less confined environment otherwise. The sensor could be, for example, a pressure sensor or touch sensor on the bolster 1 bladder, or an optical interruption sensor along the length of the bolster 1 . [0028] A “CPR” button on the controller provides the user with the option of automatically and completely deflating each of mattress cushions 15 and bolster 1 , and a deflate button for deflating the bolster 1 only. Alternately, the bolster 1 deflate function may be separate from the controller, by means of a valve which blocks flow of air from the controller and vents air in the bolster 1 . It is also possible to control the left and right bolster bladders 1 a , 1 b separately, if desired. If the user presses CPR button, processor unit deactivates the blower and controls the air control valves in air control valve bank such to open the fluid lines to the atmosphere. [0029] The side bolsters 1 a , 1 b according to the present invention are typically used to assist in the prevention of patients falling out of bed. The preferred embodiment of the present invention also has a mid-section entrance (ingress)/egress region 3 having a lower height that allows ingress-egress without deflating either of the side bolsters 1 a , 1 b . However, one or both of the bolsters 1 can also be deflated when performing nursing procedures or when the patient wishes to exit or enter the bed. The air bolsters 1 can be deflated for shipping and mattress storage. [0030] As shown in FIG. 4 , the bolster 1 is provided as a heat-sealed polyurethane-coated fabric pneumatic structure. The bolster bladders 1 a , 1 b are formed be sealing together a top half 12 and bottom half 13 , to form a closed space there-between. At approximately the middle third or middle fifth of the bladder 1 , the potential space may be constricted by additionally forming seals between the two sheets 12 , 13 , thus limiting their separation when inflated. [0031] The bolster 1 as it is designed is manufactured by radio frequency (RF) welding sheets of urethane coated nylon fabric that have been previously die cut to the proper configuration. The material could also be nylon/vinyl, straight vinyl, or straight urethane among many other materials that are known in the art for creation of inflatables. The mattress 10 that it is used with is manufactured out of similar materials for its air cells, along with a number of other fabrics for the remainder (urethane/nylon top cover with a polyester filled quilted backing, and a 1680 denier nylon “tub” that contains the cells) [0032] Advantageously, the top 12 and bottom 13 sheets have extensions 2 a , 2 b spaced along their length to form straps 2 , which are provided with snaps or other attachment devices, which may include statistical hook and loop fasteners (e.g., Velcro®), magnets, hooks, or the like. These straps 2 are designed to encircle the straps 11 of the mattress, to hold the bolster 1 in place at its lateral edges. [0033] The upper sheet 12 is shaped to provide the bolster bladder 1 a or 1 b and straps 2 a . The lower sheet 13 also forms the bolster bladder 1 a or 1 b , and straps 2 b , and additionally provides the tension web 4 , and inflation nipple 8 . The tension web 4 , which in this design is contiguous with the lower sheet or base 7 , but need not be, has a series of oval apertures 14 spaced and sized to accommodate the mattress bladders 15 . Opposite the bolster bladder 1 a or 1 b , a tensile extension is provided, which may be sealed or snapped to the tension web 4 of the opposite bolster 1 b or 1 a , to complete the base 7 . Alternately, the bolster 1 may be provided on a single side of the mattress 10 , and thus may be attached to the bed frame along its midline (not shown). [0034] As shown in FIG. 1 , the interconnected tension webs 4 form a trapezoidal concave-upward structure, having a series of apertures 14 , above which the bolster bladders 1 a , 1 b sit. FIG. 1 also shows the vent valve 5 and pneumatic conduit (air hose 6 ) to the bolster bladders 1 a , 1 b . The vent valve 5 permits a user to manually deflate the bolster bladders 1 a , 1 b and dump the air to the environment, without deactivating the blower. Thus, the bolster 1 assembly can be provided separately and independently from a blower, and may be retrofit onto existing beds. If the bolster bladders 1 a , 1 b are to be operated separately, the vent valve 5 would include a pair of controls for operating separate valve bodies. [0035] FIG. 2 shows the bolster 1 assembly in place on an inflated air mattress 10 . In this case, the air mattress 10 has bladders 15 which are taller than wide, due to a central seal in each segment. The tension web 4 provides a strap-like portion 4 a which extends between each pair of adjacent segments 15 . The straps 2 at the lateral edge of the bolster bladder 1 a , 1 b are wrapped around the straps 11 of the mattress bladders 15 , which in turn are attached to the bed frame (not shown), and thus held in position laterally. As can be seen, the central constricted portion 16 at the entrance/egress portion 3 of the bolster 1 has a lower height than the unconstricted remaining portions, facilitating ingress and egress of a mobile occupant. [0036] FIG. 3 shows an occupant lying on the air mattress 10 , with the bolsters 1 positioned to impede rolling and/or shifting. Since the bladder 1 structures are pneumatic, and inflated to a relatively low pressure, there is a low risk of injury if an occupant were to thrash or bump into the bolster 1 , and the risk of entrapment or pinching of arms and legs in a falling bed rail is eliminated. [0037] The bolster according to the present invention may also be used in a modified form for other types of mattresses and bolsters. For example, the pneumatic cushion may be replaced with a foam cushion, using the same attachment and positioning system, e.g., straps 2 and tension web 4 , as described above. This attachment method gives strong lateral strength to the bolsters from moving on the bed without reducing an air mattress surface's pressure relief characteristics. Thus, the lateral tensile support for the bolster cushions is below the mattress, not above it, preventing a “hammocking” effect that reduces the advantages of an air mattress. That is, if the medial tensile member were provided above the mattress surface, it would produce relatively high forces against the skin of the occupant corresponding to the lateral force asserted against the bolster. This tends to reduce the advantageous independent and resilient effect of the individual mattress bladders. [0038] Likewise, the air bolster system may be used on other types of mattresses, for example the tension web elements could periodically perforate through a foam mattress, allowing the bolsters to be laterally supported by a tension which is applied below the mattress cushion. (In order to allow installation, the strap-like portions would be separable, and for example, snap, hook or hook-and-loop fasten together.) Likewise, a foam mattress may be provided with snaps, hooks or hook-and-loop fasteners on its upper surface, displaced from the lateral edge, to allow positioning of the bolster with respect to the mattress. The lateral edge of the bolster could be attached directly to a bedframe, instead of the mattress, or to the lateral edge of the mattress. In order to reduce or balance the tensile forces on the surface of a mattress, while maintaining a sealed surface, the attachment points for the bolster may be reinforced from below with a tensile member, such as a strap or cable, internal to the mattress. Beneath the mattress, further attachment points may be provided to further transmit the forces, for example through straps to the rigid bed frame. Alternately, the tensile forces may be passed internal to the mattress, beneath the padding. [0039] Although the present invention has been described in terms of the foregoing embodiment, such description has been for exemplary purposes only and, there will be apparent to those of ordinary skill in the art, many alternatives, equivalents, and variations of varying degrees that will fall within the scope of the present invention. That scope, accordingly, is not to be limited in any respect by the foregoing description, rather, it is defined only by the claims which follow.

A bolster for resisting rolling of a person off of a mattress, comprising a lateral cushion adapted to be disposed proximate and parallel to an edge of the mattress, and a tensile portion having a means for attachment to said lateral cushion, providing a distributed tensile force to resist a laterally outward displacement of the lateral cushion, the tensile force being transmitted beneath the mattress having a force vector downward and inward. Both the lateral cushion and the mattress may be inflatable, and preferably a pair of lateral cushions, interconnected by a tensile sheet below the mattress, are provided.

This is a continuation of co-pending application Ser. No. 07/467,902, filed on Jan. 22, 1990, now U.S. Pat. No. 5,062,637. BACKGROUND OF THE INVENTION The present invention relates to games of the board type, and more particularly to a game using jigsaw puzzles. Various forms of board games have been devised over the years. Also, numerous form of jigsaw puzzles have been created. Board games are games which usually are played by two or more people. On the other hand, a jigsaw puzzle is not a game as such, but is a puzzle with pieces which are put together by a single person, although others can help in placing the pieces. Both board games and jigsaw puzzles present challenges to those who play such games, and those who put together such puzzles. They vary from the very simple to the incredibly complex. Board games and jigsaw puzzles both can provide minutes and hours of fun, enjoyment and intrigue, but their attributes and capabilities have not been combined into a useful and fun jigsaw puzzle and board game. Accordingly, it is a principal object of the present invention to provide a new jigsaw puzzle game. Another object of this invention is to provide a jigsaw board game which may comprise from only a few playing pieces to as many as a large number of playing pieces. A further object is to provide a new game employing modified jigsaw puzzles. BRIEF DESCRIPTION OF THE DRAWINGS These and other objects and features of the present invention will become better understood through a consideration of the following description taken in conjunction with the drawings in which FIG. 1 is a top plan view of a jigsaw puzzle game according to the present invention, FIG. 2 is a view similar to FIG. 1 but with several of the game pieces removed, FIG. 3 is a view of the underside of the removed game pieces, FIG. 4 is a cross-sectional view taken along a line 4--4 of FIG. 1, and FIG. 5 is a view of a second jigsaw puzzle game and removed pieces similar to that of FIGS. 1-4 and for use with the latter in playing the present game. In accordance with a preferred embodiment of the present invention, a game board in the form of a jigsaw puzzle with borders surrounding the playing area is provided, along with removable pieces which are formed like in a conventional jigsaw puzzle. The bottom side of each of these pieces has an identification as does the area of the game board base where each piece fits. One or more of the removable pieces has, on its bottom, a particular indicia, for example the word "Scramble." Two or more of the game boards are provided respectively for two or more players, and the game proceeds according to the instructions and rules which are detailed subsequently. DETAILED DESCRIPTION Turning now to the drawings, a pair of jigsaw puzzle game boards 10 and 11 are shown in respective FIGS. 1 and 5. FIGS. 2 through 4 provide further details of the game board 10 of FIG. 1. The two game boards can be similar but preferably are not identical. Turning now to the construction of the game board 10 shown in FIGS. 1 through 4, the same includes a base or backing 12 (note the cross-sectional view in FIG. 4), and a frame or border 14 secured thereto in a conventional manner as by an adhesive (not shown), thereby forming a tray-type construction for holding the game pieces (which are in the form of jigsaw puzzles pieces) on and within the tray. The edge 14 thus not only forms a decorative border but also prevents the game pieces from sliding off of the composite game board. The game board further comprises a plurality of individual game pieces 16, 17, 18, etc. which are separated along mating edges such as 16a, 16b and 16c of FIG. 1. Suitable surface indicia, and exemplified generally by flowers 20, which may take any of many forms such as maps, cartoon characters, pictures and the like are provided on the upper or top surface of the game pieces 16, 17, etc. The thus-far described game board is like a typical jigsaw puzzle. The game board has additional new constructional features and interrelationships which will now be described. Each of the game pieces 16, 17, etc. has a specific identification provided on the bottom thereof which (1) identifies its game board, and (2) identifies its specific position on the game board, thereby making it easy to locate and place each game piece on the game board. FIG. 3 illustrates three of the game pieces 16, 17 and 18 which have been removed from the game board as shown in FIG. 2. The underside of the game pieces 16, 17 and 18 in FIG. 3 include the identifications "A1" "A2" and "A4," the letter A" standing for game board A and the number standing for number and position of the piece on that board. The upper surface 24 of the base 12 of the game board 10 as seen in FIG. 2 has like identifications thereon corresponding to the removed pieces. Thus, as seen in FIG. 2, the identifications seen on the base 12 are "A1," "A2," and "A4." In addition, the base 12 has lines (e.g., 24a, 24b, 24c, etc.) drawn or printed thereon the same as the outline of the respective game pieces. These lines, and the identifications (A1, A2, etc.) facilitate finding the location of and positioning of the game pieces. The identifications on the pieces and on the base 12 of the game board are provided, contrary to the normal jigsaw puzzle, to facilitate locating the game piece on the board. The respective game pieces A1, A2 and A4 of FIG. 3 fit in the locations A1, A2 and A4 so identified in FIG. 2. The remaining pieces and base location have like identifications (A3, and A5-A12, not seen, for the remaining pieces of the twelve piece game. In addition, one or more, and preferably three, of the game pieces on the underside has an additional indicia, such as in the present case the term "Scramble" for reasons to be discussed subsequently. This indicia is not placed on the base 12. While the physical construction of the game board is like that of a conventional jigsaw puzzle, particular identifications and/or indicia are provided on the bottom of each and every game piece, and similar identifications are provided on the underlying base 12 of each game piece and, further, several of the game pieces have the particular added indicia, such as the word "Scramble" as noted. The game board 11 shown in FIG. 5 is like that of FIG. 1, but preferably has different artwork 25 on the surface of the game pieces to distinguish the two game boards and, additionally has a different identification (e.g., "B") to indicate that it is a different game board. In this regard, the game pieces, identified as 26, 27, 28, 29, etc. use the letter "B" in the identification of the game pieces and areas of the base 12 to indicate that this is Game B. Additional game boards can be provided, depending on the number of players, with each player having one game board. The game boards and game pieces as described are used and interrelated in the playing of the present game in the manner set forth below. Each player of the game must have one complete puzzle like that shown in FIG. 1 or FIG. 5. Preferably, each puzzle has the same number of pieces. Any number of players from two on can compete. Play begins with each player emptying all of the game pieces from his puzzle, picture side up, in the center of the playing table. The pieces are then scrambled (mixed) and any one or more players can scramble and mix the pieces. Each player picks one piece, preferably with eyes closed, from the pile to select the order of play. The players then show the bottom side of the puzzle piece selected, and the lowest number is entitled to be the first player, and so on. The pieces selected are returned to the pile. The first player so selected then closes his eyes and picks ten pieces from the pile. Only the first player makes this selection thus far. Once the ten pieces are selected and placed bottom side up, the identifications on the bottom of the pieces are checked, and any pieces not matching that player's puzzle (the first player in this case) are returned to the pile and scrambled. That is, with the puzzle A of FIG. 1 and the puzzle B of FIG. 5, if the first player has the "A" puzzle of FIG. 1 and selects some "B" pieces, the "B" pieces are returned to the pile; only the "A" pieces are kept by this first player who has the A puzzle. The remaining pieces selected by the first player (the "A" game pieces in this case) are placed on the board in the usual manner of filling in a jigsaw puzzle. In the event there is a game piece labelled "Scramble" like the "A2" piece in FIG. 3, this piece also is placed in the game board; however, this piece has a particular significance. When the "Scramble" piece has been selected from the pile and placed in the game board (and the remaining pieces picked on that turn for that game board are placed in the game board), then the game board is moved or passed to the player to the left (and, likewise, the other players' boards are moved to the player to the left). If, per chance, this first player picks more than one "Scramble" piece, then the game boards will be moved the number of positions to the left corresponding to the number of "Scramble" pieces picked in that turn. For example, if the first player picked and played two "scramble" pieces, then the puzzle (Puzzle A in this case) would move to the second player to the left, with the other players' puzzles likewise moving two positions. In the case of only two players with Puzzles A and B of FIGS. 1 and 5, the first player would receive his puzzle back (it would move to the second player who had Puzzle B, and then move back to the first player). Once the first player has completed putting pieces in his puzzle, and his and the other puzzles have moved the one or more player positions as indicated by the number of "Scramble" pieces, then the second player, with his eyes closed, selects ten pieces from the pile on the table. Play continues now by this player as previously described. A score sheet, as will be described subsequently, may be kept to determine what players have contributed more or less to the completion of a game. However, the first player to complete a puzzle, any puzzle he happens to be working on regardless of whether or not it is the one he started off with, is the winner of the game. There are several additional rules which increase interest in the present game. When a player picks his ten pieces from the pile on the table, he must do so and not peek while selecting the pieces. If the player peeks while picking pieces, the selected pieces are returned to the pile, and that player looses his turn. The pieces in the pile may be mixed or "Scrambled" by any player at any time, even while pieces are being picked, to facilitate randomness of the pieces picked. Although the number of "Scramble" pieces will vary with the number of pieces within a given puzzle, typically two to three such pieces are provided. While the twelve-piece puzzle game boards shown in FIGS. 1 and 5 are quite suitable for a child's game, typically game boards with more pieces, such as thirty to fifty pieces, generally are preferred. The following chart provides an example of a game with four players and four respectively different puzzles. The typical game time is approximately forty-five minutes, and players may range in age from about 5 years to 100 years old. ______________________________________Game No. 1______________________________________Player 1 - Puzzle A Player 2 - Puzzle BPick 10, Scramble Pick 10, ScrambleKeep Pieces Winner Keep Pieces Winner______________________________________4 0 5 12 1 1 06 0 4 24 1 4 02 0 3 06 0 6 03 0 6 029 2 29 3______________________________________Player 3 - Puzzle C Player 4 - Puzzle DPick 10, Scramble Pick 10, ScrambleKeep Pieces Winner Keep Pieces Winner______________________________________5 1 3 17 0 4 03 0 6 14 0 7 06 2 4 02 0 2 04 1 2 131 4 28 3______________________________________ In the example given, each puzzle can have thirty pieces, three of which have the "Scramble" indicia on the bottom. The game boards are identified as "Puzzle A," "Puzzle, B," "Puzzle C" and "Puzzle D," with the bottom of the game pieces and top surface of the boards bearing the matching letters and numbers as indicated in the Figures and as explained previously. Once the order of play has been decided, the first player picks ten pieces with his eyes closed from the pile of 120 pieces. The pieces picked for another's puzzle are returned to the pile and scrambled for the next player. In the chart which follows, it can be seen (Column 1) that Player 1 picked ten pieces, only four of which were for his puzzle (with the remaining six being returned). The first player received zero Scramble pieces (Column 2) on the first turn. Player 2 picked ten pieces, five of which were for his puzzle, and one of which was a Scramble piece (Columns 1 and 2). The play continues with players 3 and 4. On the second turn for Player No. 1, only two of the picked ten pieces were for his puzzle, but one was a " Scramble" piece as shown in Columns 1 and 2 under Player A--Puzzle A. The game is continued as illustrated. While the chart is in the form of score sheets, they are not necessary as part of the game, but they are helpful for keeping track of how well a player may, through his "extra sensory perception" or other ability, be able to pick high numbers of pieces of his particular puzzle. The game is exciting and provides untiring fun, and is a game of individual ingenuity. It will be apparent that the game boards can be manufactured in the form of jigsaw puzzles, but with the added letter and number identifications on the game pieces and on the base 12 of the game board, and along with the "Scramble" indicia. On the other hand, standard puzzles can be modified by the addition of these fications and indicia to create and play the present game. Standard jigsaw puzzles thus can be provided with the letter/number identifications and indicia in the form of self-adhesive labels to be applied to the bottom of the game pieces and to the top surface of the base of the game board, and the outlines 24a, 24b, etc. of the game pieces can be added (e.g., in ink) on the base 12. While embodiments of the present invention have been shown and described, various modifications may be made without departing from the scope of the present invention, and all such modifications and equivalents are intended to be covered.

There is disclosed herein a game using jigsaw puzzle like game boards but wherein each game piece in the form of a jigsaw puzzle piece and the underlying board both have matching letter and number identifications facilitating locating where the game piece is to be placed. Certain game pieces have a unique indicia, such as the word "Scramble" which, after being placed on a board, results in the game boards of all players being shifted one player position. The game boards are like jigsaw puzzles with borders to retain the game pieces on the board. Each player has a board, and all game pieces are piled on the playing table. The first player selects a number of game pieces, such as ten, and places those matching his board on his board, and those not matching are returned to the pile. The first player to complete a puzzle is the winner.

BACKGROUND OF THE INVENTION This invention relates generally to agricultural chemicals. More particularly, the present invention relates to a closed agricultural chemical mixing system whereby highly toxic, concentrated pesticides, herbicides and the like may be properly prepared and loaded for subsequent spraying upon a desired field or crop. In recent years it has become increasingly apparent that the variety of pesticides, herbicides and the like used in farming operations can be exceedingly harmful to both the environment and the personnel working at a job site. For example, the loading areas associated with aeronautical agricultural spraying operations tend to be repeatedly subjected to the vapors and residue associated with the various agri-chemicals which must be continuously loaded into the airplanes. In the past it has been the practice to simply pour the desired chemical concentrate manually into a tub or container, whereupon water may be haphazardly mixed until the desired chemical solution is achieved. "Systems" of the latter type, although characteristic of the prior art, are now in general disfavor because of the resultant deleterious environmental impact. Closed agricultural mixing or batching systems employ a partial vacuum delivered to a holding tank of some form, which vacuum is then utilized to draw or suck the toxic contents of a container of herbicide or pesticide, etc. into the holding tank for subsequent mixing or diluting. After mixing in holding tanks the substance may then be forced into awaiting airplanes for spraying in the normal manner. The most representative prior art patent known to applicant in U.S. Pat. No. 3,976,087, issued to J. Bolton for a closed mixing system. Other patents of possible relevance are U.S. Pat. No. 3,797,744 which includes a plurality of chemical holding tanks and U.S. Pat. No. 3,640,319. In a busy aeronautical agricultural spraying operation empty airplanes may continuously be approaching the service area for refilling. Where the airplanes must wait for the attendant to first mix the various holding tanks with the desired chemical and then unload the chemical, such sequential operation will result in an appreciable waste of time. It has been found most advantageous to provide a closed mixing system which is capable of loading one airplane while simultaneously mixing chemicals in anticipation of the arrival of the next airplane. Therefore it is an object of this invention to provide a "closed system" agri-chemical mixing and transferring apparatus capable of simultaneously loading an airplane while mixing chemicals to prepare for another airplane. A related object is to provide a closed mixing system of the character described which is environmentally sound and minimizes pollution. A similar object of this invention is to provide a closed mixing system which minimizes the risk of exposure of the ground operator to the concentrated chemical preparations with which he must work. Still another object of this invention is to provide a closed agri-chemical mixing system of the character described which is capable of self-cleaning its various constituent parts through a self-contained rinsing subsystem. A still further object of this invention is to provide a closed system agri-chemical mixing system which may be completly self-contained and self-operable without the need for an external vacuum generation system. Yet another object of this invention is to provide a closed agri-chemical mixing system which presents minimal danger to the ground personnel at aero-spraying facilities. These and other objects and advantages of this invention, along with features of novelty appurtenant thereto, will appear or become apparent in the course of the following description. BRIEF DESCRIPTION OF THE DRAWINGS In the following drawings, which form a part of the specification and which are to be construed in conjunction therewith, and in which like reference numerals have been employed throughout to indicate like parts in the various views: FIG. 1 is a perspective view of a preferred form of the invention, with parts thereof broken away or shown in section for clarity; FIG. 2 is a sectional view of one of the large holding tanks shown in FIG. 1, with parts thereof broken away or shown in section for clarity; FIG. 3 is a sectional view of the small holding tank preferably employed by the instant invention, with parts broken away for clarity; FIG. 4 is a rear plan view of the invention, with parts thereof broken away or shown in section for clarity; FIG. 5 is a sectional view of the powder box preferably utilized by the present invention, with parts thereof broken away or shown in section for clarity; FIG. 6 is a sectional view with parts thereof broken away for clarity showing a conventional probe adapted to be utilized with the present invention secured to a conventional agri-chemical concentrate container; FIG. 7 is a diagrammatic view of the mixing subsystem showing the material flow path utilized by the present invention; FIG. 8 is a diagrammatic view showing the preferred vacuum flow path employed by the invention; and FIG. 9 is a diagrammatic view showing the preferred rinse operation flow path employed by the invention. DETAILED DESCRIPTION OF THE INVENTION With initial reference to FIGS. 1 and 4, the closed mixing apparatus 10 comprises a generally cubicle chassis 12 defined by a plurality of walls 14, 16 and a rigid frame superstructure 18 of preferably metallic construction. The entire carriage 12 may include a set of optional support wheels 20 so that the apparatus may be conveniently moved by the operator to an accessible position for operation. However, stationary placement of the apparatus 10 is preferred. It is preferred that the supporting surface 22 be of asphalt, concrete or the like so that tipping or tilting of the mechanism can be avoided. The invention 10 preferably comprises a plurality of chemical concentrate holding tanks including two large tanks 22 and 24 and a smaller tank 26, all rigidly secured to chassis 12. A powder box 30 is also secured to chassis 12, and, as will be described in more detail later, serves process dry chemical concentrate. The function of the apparatus 10 is to draw concentrated agri-chemicals from conventional containers 34 into the holding tanks 22, 24, and 26 for appropriate dilution with water and subsequent delivery into agricultural spray planes 36, 38 or similar agricultural spraying apparatus. The container 34 are tapped by generally L-shaped probes 40 of tubular construction which are then linked to the appropriate fittings illustrated on chassis wall 16 through conventional hoses 42. In operation five probes, each having two lines, may be simultaneously connected to apparatus 10. A vacuum subsystem 39 (FIG. 8) is actuated to initiate operation of the invention 10. A partial vacuum is first introduced into one of the tanks 22, 24 or 26 for subsequent concentrate filling of same. In order to initiate either the material flow, vacuum or rinse operations of the invention, one or more of the various valves, illustrated in FIGS. 7 thru 9 in diagrammatic form and in FIG. 1 in pictorial form must appropriately be opened. In FIG. 1 each of the valve handles are illustrated in an "off" position. To turn an individual valve "on" the handle portion, visible in FIG. 1, is manually grasped and rotated counter-clockwise approximately 90 degrees. Referring now to FIGS. 1, 4, 6 and 7, a mixing subsystem 25 is illustrated. The first stage during a mixing or batching operation is for a conventional probe 40 to be coupled to the desired chemical concentrate tank 34 through lid 34A thereof such that the probe tip portion is disposed within the concentrated liquid chemical 35. As illustrated, probe 40 is fitted with a five-gallon extension tube 41A comprising its lower tip. The probe line 42 must be extended from the probe handle 43 (FIG. 6) to chassis 12 for connections to an appropriate probe inlet coupling 51 thru 57. Each inlet coupling comprises conventional "quick connect-disconnect" fittings mechanically secured to chassis surface 16. (Probe rinse line 120 may also be coupled to appropriate fittings, as will be discussed later.) Probe inlet coupling 51 is coupled to large tank 22 via pipe 61A (FIG. 7), probe valve 61, manifold 61E and pipe 61B. Probe inlet coupling 52 is similarly connected to large tank 22 via lines 62A, probe inlet valve 62 and manifold 61E. Probe valve 61 and 62 are manually operated via adjustment of handles 61C and 62C respectively, which are offset from panel 14 (FIG. 1). Probe inlet coupling 55 (FIG. 1) leads to large tank 24 via probe valve 65 (FIG. 7), manifold 65E and line 65B. Probe inlet coupling 56 also leads to large tank 24, through line 66A, probe valve 66, manifold 65E and pipe 66B. The handle portions 65C and 66C of valves 65 and 66 respectively project outwardly from surface 14 (FIG. 1). The small tank probe inlet 53 communicates with small tank 26 via pipes 63A, 63B and small probe valve 63. Valve 63 is controlled by handle 63C from the front of the apparatus. Before the concentrated contents 35 of container 34 will be drawn into the desired holding tank, a partial vacuum must be introduced in the tank to be filled by operating vacuum subsystem 39. Vacuum is generated by a pair of conventional vacuum pumps 70 and 72 (FIGS. 8, 4) which are electrically driven and controlled by a conventional electrical switch 74 mounted on chassis panel 14. Pumps 70 and 72 are secured within chassis 12 to the cubicle frame portion 18 thereof (FIG. 4). Partial vacuum is transferred through a first vacuum manifold 75 and a moisture filter 76 to a second vacuum manifold 78 which communicates with three vacuum intake valves 80, 81 and 82 which are respectively coupled to tanks 22, 24 and 26 (FIG. 8). When the vacuum pumps are actuated their waste output may be vented to the atmosphere via an exhaust pipe 84 which leads to an enviornmentally protective exhaust filter 86 and from thence to an atmospheric vent pipe 88. Vacuum intake valves 80 and 82 are controlled through handles 80C, 81C, and 82C mechanically located in the top portion of chassis surface 14 (FIG. 1). As will be discussed later in conjunction with FIG. 2, tanks 22 and 24 are provided with internal float valves 83 and 85 to prevent the intake of liquid into vacuum lines when the holding tanks are full of concentrate. With the vacuum pumps 70, 72 appropriately energized by actuation of conventional switch 74, a partial vacuum may be introduced in the desired tank 22, 24, or 26 by opening one of valves 80, 81 or 82 respectively. With a partial vacuum applied to the appropriate holding tank or tanks, it will be apparent that subsequent opening of probe inlet valves 61, 62, 65, 66 or 63 will draw chemical concentrate into the desired tank from the container 34, providing that an appropriate hose (hose 42) has been appropriately terminated in the correct probe inlet coupling 51 thru 57. For example, if small tank 26 is to be filled with chemical concentrate 35, hose 42 must be connected to coupling 53 (as illustrated in FIG. 1) so that when valve 63 is opened (by manipulation of valve handle 63C), concentrate will be drawn directly into small tank 26. As will be described in more detail later in conjunction with FIGS. 2 and 3, each of the holding container tanks preferably includes a site level or gauge which visibly indicates tank level. After an appropriate amount of chemical concentrate is drawn into the desired holding tank 22, 24 or 26, the previously discussed probe inlet valves are closed and the vacuum pump switch 74 is turned to an "off" position. Prior to loading the aircraft (or other external sprayer device) with the contents of the holding tank 22, 24 or 26, the remaining partial vacuum must first be dissipated. Accordingly, vacuum vent valves 90, 91, and 92 are respectively coupled between tanks 22, 24, and 26 to exhaust vent manifold 87 via pipes 90A, 91A and 92A (FIG. 8). Venting to the atmosphere thus occurs via filter 86 and vent pipe 88. Vent valves 90 thru 92 may be manually manipulated by grasping handle portions 90C, 91C, or 92C respectively (FIG. 1). Next, a loading hose 94 is connected between the spray tanks of the aircraft 36 or 38 and the aircraft load coupling 95 (FIG. 7) at the rear of the apparatus. An appropriate material dump valve 96 thru 99 must then be actuated to allow the contents of tanks 22, 24, 26 (or powder box 30) to enter dump manifold 100. Dump valves 96 thru 99 are actuated via manipulation of corresponding handle portions 96C thru 99C associated with front panel 16 (FIG. 1). Aircraft fill valve 102 is actuated via handle 102C to interconnect hose 94 with transfer manifold 103 via pipe 95B. Transfer pump 104, interconnected between transfer manifold 103 and dump manifold 100, is actuated by switch 106 (FIG. 1) and electrically powered in a conventional fashion. When the transfer pump is actuated the aircraft may thus be filled with an appropriate amount of chemical concentrate. Once chemical concentrate is delivered to the aircraft, transfer pump 104 may be turned off and the dump valve in use (96 thru 99) will be closed. Thereafter fresh water valve 110, which delivers water supplied from an external source through pipe 111 into manifold 100, may be opened by manipulation of handle 110C. Fresh water may then be pumped via pump 104 through load valve 102, conduit 95B, and loading hose 94 into the aircraft tank to dilute the concentrate already delivered thereto. Mixing amounts and ratios may be controlled with the use of the aircraft tank gauges, for example. A powder box subassembly 30 (FIG. 5) is preferably included for mixing dry chemical concentrate. A valve 112 (FIG. 7) actuated through handle 112C (FIG. 1) is interconnected between transfer manifold 103 and a powder box 30 through a conduit 114. It will be apparent that water may therefore be forced into the powder box through the transfer pump when valves 110, 112 are opened. When a sufficient level of water has been introduced into powder box 30, valve 110 may be closed and powder box dump valve 99 may be opened so that water and chemical powder will be continuously recirculated (through valve 112, conduit 114, powder box 30, dump valve 99, manifold 100, pump 104 and transfer manifold 103). In this manner dry chemical concentrate may be thoroughly mixed with water prior to subsequent delivery to aircraft 36 in the manner already discussed (through valve 102, line 94, etc.). Apparatus 10 is provided with a rinsing subsystem so that after a loading operation involving a particular tank has been completed, rinsing of either the external concentrate container, the appropriate holding tank, the probe, the powder box, or internal system pipes may take place. Probe rinse line 120 (FIG. 6) is connected between probe quick connector 123 and one of the probe rinse couplings 49, 54 or 57 (FIGS. 1, 9). Probe rinse coupling 57 leads through a conduit 130 and through a probe rinse valve 132 into a fresh water rinse manifold 134, which receives water from an external low volume source through a line 136. Probe rinse valve 132 is actuated via handle 132C (FIG. 1). Similarly, probe rinse couplings 49 and 54 are coupled to manifold 134 via probe rinse valves 129 and 131 respectively, which valves are respectively operated via handles 129C and 131C (FIG. 1). Thus each probe inlet coupling may be operably associated with a corresponding probe rinse coupling. After rinse water has accumulated within the concentrate container it may be drawn into the appropriate holding tank and then loaded into the airplane (or other sprayer device) through the procedures already discussed. Where the concentrate container is not empty, the probe and its intake line 42 may be rinsed by coupling rinse line 120 instead to fitting 121 (with valve 43B closed) and thereafter following the above set forth procedure. With reference now to FIG. 2, large container tank 22 (similar to container tank 24) comprises a preferably metallic cylindrical casing 180 adapted to securely contain the chemical concentrate 182 drawn there within. At the bottom of the container a material dump pipe 96B is provided, terminating in dump valve 96 (FIG. 7) already discussed. At the top of container 180 rinse pipe 140A delivers pressurized water (during the rinsing cycle discussed in conjunction with FIG. 9) to a propeller mechanism 186 which sprays water interiorly of the container to thoroughly rinse the sides and substantially the entire internal surface area thereof. At the side of container 180 a conventional sight gauge 190 is provided for visually monitoring tank levels. Gauge 190 comprises a pair of pipe fittings 191 and 192 between which a substantially translucent tube 194 is suspended. The level of fluid within tube 194 is visible to the operator of the apparatus 10, so that the amount of fluid to be transferred to the awaiting airplane can be readily determined. A conventional float valve assembly 83 is provided to prevent the inadvertent introduction of chemical concentrate into vacuum line 80A. It should be understood that large tank 24 is identical with tank 22. Referring now to FIG. 3, small tank 26 comprises an elongated, cylindrical container 200 of preferably metallic construction, and is somewhat smaller in diameter than the large tanks 22 or 24. A lower material dump pipe 98A extends to material dump valve 98. At the top of the container a vacuum pipe 92B (also illustrated in FIG. 8) is provided, and a propeller rinse apparatus 206 driven by pressurized water provided through pipe 142A is included to thoroughly rinse the interior of the container. Pipe 63B provides material input responsive to the partial vacuum already discussed. Again, a slight tube 210 is provided of conventional construction for monitoring tank level. As illustrated in FIG. 5, the powder box 30 comprises a cylindrical, preferably metallic enclosure 220 which includes a hinge top portion 222 which may be opened manually in order to deposit powdered chemical concentrate within the apparatus. Material dump pipe 99B is secured through conventional pipe fitting techniques to the bottom of the casing 220. Rinsing pipe fitting 143B drives a propeller system for spraying the entire internal surface area of the container 224 during the rinsing cycle. Pipe fitting 114 injects water at the top of the container 220. Importantly, severe agitation of the contents 226 within container 220 may be provided by the propeller agitation system 228 located within the device. Agitation system 228 includes a top-mounted motor 230 which drives a lower internally located propeller 232 through a rotating shaft 234. When the powder box agitation switch 238 (FIG. 1) is activated, motor 230 will thereby mix the contents of the powder box apparatus. It will be apparent from the foregoing that, due primarily to the multi-valve and multi-manifold fluid transfer arrangements already discussed, the various tanks 22, 24, 26, and 30 may be employed substantially independently of each other. From the foregoing, it will be seen that this invention is one well adapted to obtain all the ends and objects herein set forth, together with other advantages which are obvious and which are inherent to the structure. It will be understood that certain features and subcombinations are of utility and may be employed without reference to other features and subcombinations. This is contemplated by and is within the scope of the claims. As many possible embodiments may be made of the invention without departing from the scope thereof, it is to be understood that all matter herein set forth or shown in the accompanying drawings is to be interpreted as illustrative and not in a limiting sense.

A closed agri-chemical mixing and transferring system ideally adapted for mixing agri-chemical concentrate for subsequent use in agricultural spraying operations. The system comprises a plurality of independently operable subsystems for generating vacuum, intaking raw concentrate, and subsequently loading a sprayer device. The self-contained vacuum subsystem comprises a pump for generating partial vacuum, and means for selectively introducing partial vacuum to preselected ones of a plurality of chemical holding tanks. The mixing subsystem comprises a plurality of couplings adapted to be connected to external probes which may be attached to external chemical concentrate containers. Probe inlet switching valves in fluid flow communication with holding tanks direct partial vacuum to draw chemical concentrate through the probes into the holding tanks. The loading subsystem comprises a transfer manifold adapted to be connected to a source of water and a plurality of dump valves for selectively transferring the concentrated contents of a loaded holding tank to the transfer manifold. Transfer pump means are employed to transfer liquids within the transfer manifold through appropriate valves to an external sprayer machine thereby loading same. A powder box subsystem is preferably included to accommodate dry chemical concentrate.

This is a division of application Ser. No. 07/256,650 filed Oct. 11, 1988, now U.S. Pat. No. 4,969,474, issued Nov. 13, 1990. BACKGROUND OF THE INVENTION The present invention pertains generally to the treatment of urinary incontinence and more particularly to an incontinent bladder control method and apparatus incorporating a prosthesis for selectively restricting urine flow in a urethra. Both males and females have an external sphincter formed about the urethra which, when functioning normally, constricts the urethra and prevents flow of urine from the bladder except when the bladder is voided during normal urination. Urinary incontinence may result from several causes. For example, in females stretching or lengthening of the pelvic attachments to the bladder and urethra (termed cystocele or urethrocele) may occur, such as following a normal vaginal parturition, thereby allowing the bladder to descend from a normal position (FIG. 1) into a lower position (FIG. 2) thus functionally shortening the urethra. This form of incontinence may be surgically corrected by re-securing the bladder and urethra into a normal or near-normal position in the pelvis (FIG. 3), thereby regaining normal or additional urethral length. In this type of incontinence, the essential elements of the sphincter are intact. A more difficult form of urinary incontinence relates to iatrogenic injury to the urethral sphincter. Such injury is common in the male following certain types of prostate surgery (e.g., for prostate malignancy and sometimes for benign prostatic hypertrophy) and produces incontinence as result of damage to or loss of the external urethral sphincter. This form of incontinence is treated by repair or augmentation of the sphincter, or by substitution of its function by implantation of a prosthetic sphincter. It is not treatable by repositioning surgery, as in the case of female urethrocele/cystocele, because that surgery requires an intact sphincter. There are numerous prior art prosthetic sphincters for selectively closing and opening the urethra to prevent incontinence. These devices typically incorporate an inflatable cuff which surrounds the urethra or encloses it on two sides, and which is inflated to restrict urine flow in the urethra. Examples of such prosthetic sphincters are seen in U.S. Pat. No. 4,571,749 to Fischell, U.S. Pat. No. 4,222,377 to Burton and in other prior patents referenced in the accompanying information disclosure statement. Implementing this approach can encounter surgical difficulties and using it involves problems of control, both with potentially serious complications. Surgery in the female requires a difficult dissection behind the bladder neck and urethra, risking perforation of the adjacent vaginal wall. In males, dissection in this area encounters the prostate and rectum, risking rectal injury/fistula. After implantation, control and maintenance of pressure in the cuff has been found to be difficult. Inadequate pressure (inflation) applied by such prior art devices may fail to occlude the urethra and thus permit continued incontinence. When sufficient pressure is applied, incontinence can be initially prevented but then may recur as result of partial tissue loss or necrosis of the urethra due to excessive localized pressure applied to the urethra by the prosthetic sphincter. Another drawback associated with the prior art prosthetic sphincters, which are activated by transfer of an incompressible fluid, relates to the complex control systems used for inflating and deflating the sphincter. Examples of such prior art systems are seen in U.S. Pat. No. 4,571,749 to Fischell and in U.S. Pat. No. 3,744,063, which includes a fluidic control system for inflating and deflating an artificial sphincter that includes four check valves. Other examples are disclosed in the accompanying information disclosure statement. Accordingly, a need remains for a better way to treat urinary incontinence, particularly in males and in cases of iatrogenic injury to the external sphincter. SUMMARY OF INVENTION It is an object of the present invention to provide a method and apparatus for treatment of incontinent bladder function which overcomes the above enumerated disadvantages which are inherent in prior art devices and methods. A further object of the invention is to provide a prosthesis which is simply constructed and which may be easily used by a patient to selectively restrict or permit urine flow in the urethra. Another object is to provide such a urinary incontinence treatment method and apparatus capable of restricting urine flow without compressing the urethra to the extent that tissue loss or necrosis occurs. Yet another object of the invention as aforesaid is to enable treatment of incontinence in both males and females in the same way and with similar effectiveness. The apparatus of the invention comprises a reservoir containing fluid and an inflatable compression means positionable between the bone of a human pelvis and the urinary bladder and in fluid communication with the reservoir. A releasable one-way valve means is included between the reservoir and compression means for controlling and maintaining inflation of the compression means. The compression means is designed to fit between the posterior symphysis of the patient's pubis and anterior side of the patient's urethra. So positioned, inflation of the compression means compresses the urethra along one side and over an extended area to occlude the urethral lumen. Means for directing inflation of the compression means can be provided to direct expansion of the compression means preferentially in an inferior-posterior direction, i.e., parallel to the posterior symphysis pubis, to impinge upon the anterior aspect of the urethra. The method of the instant invention comprises the steps of (a) elevating the patient's bladder, (b) elongating the urethra and (c) compressing a lengthwise extent of the urethra. This is preferably done by surgically implanting the inflatable compression means at the neck of the elevated bladder between the pubis and ventral side of the urethra and releasably inflating the compression means. Inflation of the compression means can be directionally channelled for urging the same against the urethra substantially along its length. Placement and operational effectiveness of the compression means are aided by elevating the bladder. This functionally lengthens the urethra and reduces lumen size so that it can be occluded more easily by inflating the compression means. Inflation of the compression means on only one side of the urethra and over an extended area of its length minimizes risk of necrosis of urethral tissue. Additionally, because compression of the urethra is on one side and against lower abdominal contents, control will be at least partially responsive to intraabdominal pressure variations, e.g., due to bladder filling, coughing, so as to help maintain continence. Further objects, features and advantages obtained by the instant invention will become more fully apparent when the following detailed description of a preferred embodiment is read in view of the accompanying drawing. BRIEF DESCRIPTION OF DRAWINGS FIG. 1 is a simplified diagram showing a lateral sectional view of a normal bladder and pubis of a human female in standing position. FIG. 2 is a view similar to FIG. 1 showing a cystocele and urethrocele condition. FIG. 3 illustrates a conventional surgical correction of the condition shown in FIG. 2. FIG. 4 is a view similar to FIG. 1 showing a simplified diagram illustrating implementation of the present invention to correct urinary incontinence in either male or female. FIG. 5 is a more detailed lateral view of the device shown implanted in FIG. 4. FIG. 5A is a frontal elevation view taken along line 5A--5A in FIG. 5. FIG. 5B is a longitudinal section view taken along line 5B--5B in FIG. 5. FIG. 5C is a cross-sectional view taken along line 5C--5C in FIG. 5B. FIG. 6 is a sectional view taken along lines 6--6 in FIG. 5A showing interior details and operation of the first embodiment with the reservoir being inflated and compression balloon deflated in solid-lines and the reservoir deflated and compression balloon inflated in dashed lines. FIG. 7 is a view similar to FIG. 6 of a second embodiment of the invention, showing operation of the releasable check valve to equilibrate the reservoir and compression balloon to permit voiding. FIG. 8 is a more detailed female anatomic diagram similar to the view of FIG. 4 showing a device constructed in accordance with the invention in deflated condition to permit voiding. FIG. 9 is a view like FIG. 8 showing the compression balloon in a filled condition for occluding the urethra. FIG. 10 is a male anatomic diagram similar to the view of FIG. 8, showing the compression balloon deflated in solid lines and inflated in dashed lines. DETAILED DESCRIPTION Turning now to the drawings, and more particularly to FIG. 1, indicated generally at 10 is a simplified diagram of a portion of normal anatomy of a female in standing position. Included in this lateral view is a bladder 11, bladder neck 12 and a urethra 14. Also included is the pubis bone 16. The distal end 13 of the urethra is a relatively fixed position by virtue of attachments 17 to the inferior pubic arch and anterior-superior vaginal tissues. A sphincter surrounding the urethra normally maintains the lumen or central opening through urethra 14 in a closed condition thereby preventing urine from traversing the urethra. Relaxing the sphincter opens the lumen to permit voiding of urine from bladder 11. Turning now to FIG. 2, indicated generally at 18 is a view similar to FIG. 1 illustrating an anatomic defect which may occur in females and which is referred to as cystocele and/or urethrocele, producing "stress" incontinence. Structures corresponding to those previously illustrated and described in FIG. 1 bear the same numbers in FIG. 2. The cystocele/urethrocele condition is defined as a downward migration of bladder 11, bladder neck 12 and urethra 14 from the normal position shown in FIG. 1 to the position shown in FIG. 2. Such migration is typically a result of a structurally inadequate muscular floor of the anterior pelvis. It is thought to be a normal aging process accelerated by pregnancy and vaginal delivery of the fetus. Stretching or lengthening of the pelvic attachments to the bladder and urethra permits bladder 11 and urethra 14 to descend into the lower position shown in FIG. 2. When in the lowered position of FIG. 2 with its distal end 13 attached as indicated at 17, urethra 14 is effectively shortened and thus the lumen assumes a larger effective diameter. With the lumen diameter so enlarged, the sphincter itself may be distended, lack sufficient range and/or strength to fully occlude the lumen, thereby resulting in urinary stress incontinence. Urinary incontinence of the cystocele/urethrocele type illustrated in FIG. 2 can typically be successfully corrected by various conventional surgical procedures. FIG. 3 illustrates the anatomy after successful surgical correction of the cystocele/urethrocele condition of FIG. 2. The procedure consists of elevating the bladder and fixing it by sutures 15 to the posterior surface of the superior pubic arch. This functionally lengthens the posterior surface of the urethra 14 by bringing bladder neck 12 and urethra back into a more superior and anterior position from the location shown in FIG. 2 while the attachments 17 retain the distal end 13 in place below pubis 16. A more difficult form of urinary incontinence relates to iatrogenic injury which is common in the male following surgery for prostate malignancy, and, in some instances, surgery for benign prostatic hypertrophy. This form of incontinence is secondary to damage to or loss of the muscle and/or nerve elements of the external sphincter mechanism. Prosthetic surgery has been necessary to correct this type of defect since normal muscle and/or nerve supply is irreparably lost; thus, a substitute sphincter must be utilized. As discussed above, the prior art methods using artificial sphincters have various drawbacks that my invention avoids as next described. Turning now to FIG. 4, indicated generally at 20 is a prosthetic device constructed in accordance with the invention implanted in a female. Anatomy corresponding to that previously identified in FIGS. 1-3 is identified with the same numbers in FIG. 4. Generally speaking, device 20 includes a compressible reservoir balloon 22, an inflatable balloon 24, which functions as an inflatable compression means, and a tube 26 providing fluid communication between balloons 22, 24. A lateral attachment tab 28 fixed to the superior pubis 16 secures tube 26 and thus balloons 22, 24 in position as shown. A quantity of a suitable liquid is contained within tube 26 and balloons 22, 24. As more fully explained, a transfer of liquid into balloon 24 is used to selectively compress urethra 14 in an anterior-posterior direction in an area just above the location of the natural sphincter. The compression platform against which the urethra is compressed is ultimately the sacrum and coccyx with intervening rectum and pelvic viscera providing a buffer (see FIGS. 8-10). The total volume of fluid in the device 20 is controlled by adding fluid to or subtracting fluid from the device by inserting a noncoring needle through a self-sealing diaphragm 23 in the anterior wall of reservoir 22. An important part of the surgical procedure of implanting device 20 includes fixing the anterior-superior bladder to the posterior rectus fascia above the level of the superior pubic rami. This is accomplished by sewing a 1 cm. by 2-3 cm. felt matrix or mesh patch 30 to the anterior bladder wall. The patch in turn is then sewn to the posterior aspect of the rectus fascia (not shown) via suture 32. Additional detail concerning the implantation of device 20 and the anchoring of the bladder via suture 32 is provided hereinafter. Attention is now directed to FIGS. 5, 5A, 5B, 5C, 6 and 7 for more detailed consideration of the structure of device 20. Device 20, except for attachment tab 28 and a pair of staples 34, 36 which are used to anchor the lateral attachment tabs 29 of attachment 28 as shown in FIG. 4, is constructed of or encased by conventional plastic implantable material. Reservoir balloon 22 is shaped to contain a relatively large volume of fluid while maintaining a relatively small anterior-posterior width as viewed in FIG. 4. The relatively wide lateral dimension of balloon 22, as viewed in FIG. 5A, overlies the broad expanse of anterior pubic bone 16 when implanted. Compression balloon 24 similarly has a somewhat flattened shape with an oval cross section best seen in FIGS. 5B and 5C. This shape helps locate and maintain the compression balloon in position between the concavity of the pubic symphysis and the anterior urethra. In the first embodiment shown in FIG. 6, balloon 24 includes a restraining means or skirt-like cup 38 fixedly attached to tubing 26 as shown in FIG. 5B. As fluid moves from balloon 22 to balloon 24 via tube 26, in a manner which is hereinafter more fully described, cup 38 restricts expansion of balloon 24 to a direction substantially downwardly along an axis 40 in FIG. 5B. The dashed line outline 24' in FIG. 5B illustrates the configuration of the lower portion of balloon 24 when the same is further inflated from the solid-line view of FIG. 5B. The dashed line configuration is obtained because of the restraining action of cup 38 on the expansion of upper portion of balloon 24. FIGS. 6 and 7 are more detailed sectional views of device 20 and an alternate embodiment 44 respectively, constructed in accordance with the invention. Both embodiments of the invention as disclosed in FIG. 6 and FIG. 7 incorporate the same structure in balloon 22 up to and including the attachment of the same to tube 26. Thus, in the views of FIGS. 6 and 7 all structure to the left of the break-line in tube 26 is substantially identical in each embodiment and thus contain the same reference numerals in the various figures. Referring to FIG. 6, a check valve 46 is incorporated into balloon 22 at the entrance to tube 26. In the example shown valve 46 includes a resilient cylindrical valve body 48 having an axial bore 50. One end of bore 50 communicates with balloon 22 along a substantially planar side 52 of valve body 48 while the other end of bore 50 communicates with tube 26 along an opposite convex or dome-shaped side 54 of the valve body. A resilient circular membrane 56 is attached about the circumference of side 54 to the inside of the wall of balloon 22 and, in the view of FIG. 6, is flushly sealed against side 54. Membrane 56 has pair of openings 57, 59 spaced radially apart from the center of the membrane and from axial bore 50. In the closed position shown in FIG. 6, a greater pressure on the right side of membrane 56 seals the membrane against dome 54 to block openings 57, 59 and prevent fluid flow from tube 26 to bore 50. The embodiment of FIG. 7 illustrates check valve 46 in its open condition. Compression of valve body 48 via a patient's thumb 72 and forefinger 74 deforms the valve body 48 and lifts membrane 56. This action opens holes 57, 59, allowing fluid to flow via bore 50 into reservoir 22. Additional details concerning the opening of check valve 46 are provided hereinafter in connection with the description of operation of the various embodiments of the invention. At its juncture with tube 26, balloon 22 forms a resilient connecting member 58. Member 58, as seen in FIGS. 6 and 7, includes thickened walls which resiliently maintains member 58 in a domed shape spaced axially from the valve body as shown in the drawing. The structure of valve 46 is believed to be known and, by itself, is not my invention. When balloon 22 is compressed, as indicated by dashed lines 22', fluid is discharged through bore 50 and openings 57, 59 and tube 26 into the compression balloon, distending the compression balloon as indicated by dashed lines 24', 66'. When valve 46 is squeezed between the patient's fingers, sufficient fluid in the distended compression balloon flows back to the reservoir balloon to equilibrate the pressures in both balloons. The compression balloon thus contracts. In the embodiment of FIG. 6, the inflatable balloon 24 has an entrance connected to tube 26 and has a wall of uniform thickness. Cup 38 is also shown fixedly connected to tube 26 with an upper portion including the entrance to balloon 24 retained inside cup 38. Cup 38 is made of an implantable material which is stiffer or thicker than the wall of balloon 24 and, as later described in more detail, does not deform when balloon 24 is inflated. Cup 38 functions to direct balloon expansion upon inflation so that greatest expansion occurs along the central axis 64 of tube 26, as indicated by dashed lines 24'. In the embodiment of FIG. 7, an inflatable balloon 66 is fixedly attached to tube 26. The embodiment of FIG. 7 does not include a discrete retaining member, like cup 38 in FIG. 5B and FIG. 6, but functions in essentially the same manner. Unlike the wall of balloon 24 in FIG. 5B, the wall of balloon 66 varies axially in thickness. As can be seen, the thickest portion of the balloon occurs adjacent its attachment to tube 26. The wall tapers uniformly about the circumference of the balloon, down to minimum thickness at a latitude midway between the end of the balloon attached to tube 26 and the outermost balloon end. Thereafter, balloon 66 is formed of a substantially uniform thickness wall. With balloon 66 so formed, the outermost end of the balloon tends to expand more rapidly in response to balloon inflation than the remainder of the balloon. This causes maximum expansion of balloon 66 along the axis 70 of tube 26, as indicated by a dashed line 66' in FIG. 7. Turning now to FIG. 8, device 20 is shown after being implanted in a female patient indicated generally at 76. Structure previously identified herein is identified with the same number in FIG. 8. Additional anatomical structure includes the coccyx 78, such comprising the lowermost portion of the spine. Also illustrated are the rectum 80 and vagina 82. In the view of FIG. 8, balloon 24 is shown in a substantially deflated or contracted condition. In FIG. 9, balloon 24 is illustrated in an inflated condition such that urethra 14 is compressed in an anterior-posterior direction between balloon 24 and the tissue posterior to urethra 14, thereby occluding the urethral lumen as illustrated. A portion of the patient's forefinger 84 is shown in dashed lines compressing the reservoir balloon 22 against the pubis 16. This action forces fluid from reservoir balloon 22 through tube 26 to inflatable balloon 24. The balloon 24 expands axially, preferentially compressing a lengthwise portion of the urethra. In FIG. 10, device 20 is illustrated implanted in a male patient indicated generally at 86. Included in male patient 86 is a coccyx 88, a rectum 90 and a prostate gland 92, shown in dashed lines, encircling urethra 94. The urethra depends from bladder 96, there being a bladder neck 98 formed between the bladder and urethra 94. Device 20 is mounted via attachment tab 28 to pubis bone 100. Surgical access for the implantation of the proposed incontinence device is via a standard lower vertical mid-line abdominal or horizontal (Pfannenstiel's) incision, with separation of the rectus muscles to gain access to the retropubic (anterior pelvic) space and to the superior pubic rami. Each of devices 20, 44 are attached to the anterior-superior aspect of the anterior pubic rami on either side of the symphysis pubis by staples 34, 36 driven into pubis 16 (pubis 100 in FIG. 10) through lateral attachment tabs 29. Reservoir balloon 22 is implanted in a subcutaneous pocket overlying the anterior pubic rami and symphysis in an area accessible to the patient for manual actuation (compression of the reservoir balloon). The underlying bone serves as a platform against which the reservoir is compressed. Inflatable balloon 24 (or 66 in FIG. 7) is connected to reservoir balloon 22 over the superior aspect of the symphysis pubis via tubing 26. Attachment tab 28 is integrated with tube 26 and serves as the only point of fixation of the device to bone or adjacent structures. Balloon 24 is implanted behind the pubic symphysis and above the pubic arch within the retropubic space of the pelvis. Balloon 24 is positioned so that the bladder neck and urethra are compressed by it before the urethra passes through the pelvic diaphragm (not shown) under the pubic arch. After separation of the rectus muscles via the earlier described standard surgical approaches, only blunt dissection may be necessary to gain access within the retropubic space for implanting the balloon 24 in a fixed relationship with the adjacent superior urethra and bladder neck. No dissection posteriorly or laterally of the urethra and bladder neck is necessary. This greatly simplifies the surgical procedure and avoids the possibility of rectal or vaginal injury. Venous structures in this area, particularly in the mid-line retropubic space, are numerous and large. Little or no dissection of these veins is required. Ligation, if necessary, or compression of these veins by the device 20, should not produce venous stasis since ample collateral veins are present laterally. Balloons 24, 66 are narrow in the anterior-posterior dimension and wider in the lateral dimension, and oval in cross section to conform to the concavity of the posterior pubic symphysis. This shape stabilizes the compression device between the anterior bladder, bladder neck, and superior urethra posteriorly, and the concave posterior aspect of the pubic symphysis, anteriorly. The bladder as well as the pelvic contents hold the inflatable balloon in position behind the pubic symphysis at or near the midline. No additional fixation of device 20 to the posterior pubic bone or pelvic structure is necessary, as the shape of the device allows for stable positioning in this location within the concavity of the pelvis (between the diverging arms of the inferior pubic rami, anteriorly). An integral and important part of the surgical procedure includes a means to affix the anterior-superior bladder to the posterior rectus fascia above the level of the superior pubic rami. Tube 26 is routed through the mid-line fascia through the incision between the rectus muscle bodies at or near their insertion on the superior aspect of the anterior pubic rami. The fascial incision is closed in standard fashion with interrupted sutures. The most inferior sutures bracket the interconnecting tubing as it exits the pelvis, thus securing fascial tissue around it and preventing herniation. Before fascial closure, a felt matrix or mesh patch 30 (in FIG. 4) of a biologically inert material, such as Dacron®, is sewn to the anterior bladder wall over a distance of 2-3 cms. transversely. This, in turn, is sewn via suture 32, to the posterior aspect of the rectus fascia prior to the fascial closure, well above the rectus insertions and device 20. Tissue incorporation into the felt occurs both from the bladder aspect and the fascial aspect, effecting a secure union. This fixes the bladder to anterior structures (abdominal wall) thus stabilizing the bladder and urethra and preventing inferior migration of the bladder with expansion of balloon 24 as might otherwise occur. This concept is an extension of existing surgical principles with regard to stress urinary incontinence correction in the female. In conjunction with this portion of the surgery, electrodes can be incorporated within the bladder wall, or affixed to it, to record the status of bladder filling via a strain gauge or similar instrument. This sensor, in turn, is linked to a warning device, for the patient who has deficient sensory enervation, or to nursing staff for the incompetent or incapacitated patient, to signal the need for voiding. The potential benefit of such a bladder warning system is great for institutionalized patients who are incapable of normal control (patients with Alzheimer's Disease, etc.). This requires an attentive nursing staff but would be a vast improvement over the incontinence that is often encountered in nursing home and convalescent center environments. Because of the bladder fixation to be employed in this surgery, and the attendant temporary bladder dysfunction that is frequently seen with similar surgical procedures (e.g., for correction of stress incontinence in the female), it is likely that a temporary form of urinary drainage will be necessary in conjunction with the above described surgery and placement of a device constructed in accordance with the invention. A bladder catheter is placed in the mid-line through the fascial closure at a level higher than the placement of device 20 (again incorporated between fascial interrupted sutures). A Foley catheter or similar retention device is utilized for this purpose and is positioned adjacent the fixation felt 30 to aid in bringing the bladder into close opposition to the anterior abdominal wall via traction on the catheter during the post-operative period. This catheter is removed when voiding function is re-established and the patient is accomplished in the operation in the device and its voiding valve. At that time, the wound should be well-healed and the bladder well-fixed and stabilized anteriorly. Reservoir balloon volume is carefully monitored at the time of surgery to ensure that adequate bladder emptying is possible when inflatable balloon 24 (in devise 20) is deflated, or at equal pressure with the reservoir. A portion of the reservoir balloon that is accessible from the anterior-superior aspect of this prosthesis component is designed with a self-sealing diaphragm 23 to allow perforation by a non-coring needle introduced through adjacent skin to add or subtract fluid volume. With reference to FIGS. 8 and 9, after the device is implanted and the patient wishes to close the urethra to prevent bladder voiding, forefinger or fingers 84 is used to compress balloon 22 against pubis 16. When such compression occurs, as shown in FIGS. 6 and 7, fluid in balloon 22 is forced through bore 50. The increased pressure distends membrane 56 away from side 54 of valve body 48 thereby allowing fluid flow from bore 50 through holes 57, 59, and into tube 26 thereby inflating compression balloon 24, 66 and ultimately compressing the urethra between the balloon and the tissue posterior to the urethra. When the patient removes his or her finger(s), back pressure of the fluid in the compression balloon seals membrane 56 against the bore 50, blocking back flow of fluid. When the patient desires to void his or her bladder, the patient can compress valve body 48 between his or her thumb 72 and forefinger 74 as shown in FIG. 7. Such compression lifts membrane 56 away from side 54 of the valve body thereby permitting flow from compression balloon 24 through tube 26 and holes 57, 59 in membrane 56. The fluid passes through bore 50 and back into reservoir balloon 22, thus allowing the device to resume the configuration shown in FIG. 8. With the balloon no longer inflated, the urethra opens, permitting voiding. After voiding, the patient again compresses the reservoir balloon with his or her forefinger to inflate balloon 24 thereby occluding the urethra lumen, as illustrated in FIG. 9, to prevent incontinence. Since the inflatable balloon in each embodiment expands primarily along the longitudinal axis of tube 26, increasing expansion is directed in an inferior direction perpendicular to the pelvic diaphragm (not shown). Compression of the superior urethra results from expansion of the inflatable balloon over a broad surface area. The risk of tissue necrosis is minimal since the urethra is compressed only in the inferior-posterior direction and only with sufficient fluid transfer to effect continence. The compression is directed only upon the anterior wall of the urethra, ultimately compressing the urethra against the sacrum and coccyx posteriorly, with intervening rectum and pelvic contents providing a buffer. With balloon 24 inflated, the urethra, already elongated and stabilized, is compressed and further lengthened as it is urged posteriorly by the expanding balloon. As the urethra is lengthened, the diameter of the lumen therein decreases, thus requiring less force to occlude the same. The area of compression of the urethra exceeds the anatomic size of the external sphincter in males. The locus of compression is immediately above the urogenital diaphragm (above the external sphincter) in the male. Since the inflatable balloon 24 is secured only by attachment tab 28, it is somewhat mobile. This mobility permits the balloon to be forced into a more inferior position with sudden increased abdominal pressure (such as with coughing, sneezing, etc.) or as directed by the patient (via voluntary Val Salva maneuver) to effect increased urethral compression. This voluntary patient maneuver can be utilized in the competent patient having intact bladder sensation in circumstances such as sudden bladder contraction. It can be seen that the invention provides a bladder incontinent control method and apparatus which is easily operated and controlled by the patient. The patient controls both the degree of urethral compression, via incremental transfer of fluid from the patient-accessible reservoir balloon, and voiding function. The latter is effected by the patient or nursing personnel by a single manipulation which effects rapid urethral decompression. Another advantage of this invention is the ease of surgical access via standard anterior lower abdominal approaches, avoiding lateral and posterior dissection around the urethra and bladder neck. The concept utilizes urethral compression over a broad area at the highest level feasible, i.e., at the bladder neck and superior urethra. This allows the use of the proposed device in patients who have failed inflatable cuff applications or other surgical treatments at a lower level. Having illustrated and described the principles of my invention in two alternative embodiments, in both males and females, it should be appreciated that additions and modifications may be made without departing from such principles. I claim all variations and modifications within the spirit and scope of the following claims.

A method and apparatus for controlling urinary incontinence in a patient includes positioning a reservoir containing fluid subcutaneously over the patient's anterior pubis; an inflatable compression balloon between the patient's posterior pubic symphysis and urethra; and a conduit extending over the pubis for fluid communication between said reservoir and said compression balloon. The compression balloon is inflated in response to fluid flow from said reservoir, when manually compresed by the patient. A manually releasable, one-way valve positioned in the conduit between said reservoir and said compression device retains fluid in the compression balloon under pressure and is externally actuable by the patient for equilibrating pressure in the reservoir and compression balloons to permit voiding. The bladder of the patient is elevated and connected anteriorly to the patient's abdominal wall by a felt matrix or mesh patch affixed to the bladder to effectively lengthen and stabilize the urethra. The compression balloon is arranged and positioned to compress in an inferior-posterior direction solely against an extended area the anterior side of urethra for occluding the urethra.

RELATED APPLICATION [0001] This application claims the benefit of co-pending U.S. provisional application No. 61/765,385 filed Feb. 15, 2013, which is incorporated herein by reference. FIELD OF THE INVENTION [0002] This invention is directed to a system and method for closing a wound. BACKGROUND OF THE INVENTION [0003] Traumatic injuries typically occur away from medical facilities. Thus, the victim must be transported from the site where the injury occurred, such as a battlefield or a roadside, to the medical facility for treatment. During this ‘short term’ period, for example, transportation from the site to the facility, it may be best to keep the wound closed, as much as possible, and even covered, if possible, to prevent, for example, ingress of contaminants, or to facilitate treatment. [0004] Two such devices have been proposed, they are discussed below. [0005] U.S. Pat. No. 3,971,384 discloses a suture less closure device. The device has a tie strip with an anchor affixed at one end of the strip and a slide lockably engaged on the strip. The anchor is affixed to the skin on one side of the incision and the slide is affixed to the skin on the other side on the other side of the incision. The incision is closed by pulling the strip through the slide and locking the strip in the slide. [0006] U.S. Design Patent No. D652,145 discloses a wound closure device. The device has two wound closure clips and a strip therebetween. [0007] While these devices may be used in the situations discussed above, improvements are needed. Those improvements include, but are not limited to, ease of operation, compactness, reduced weight, fewer pieces, rapid deployment, and versatility, to mention a few. [0008] Accordingly, the invention, discussed below, addresses and improves upon, at least, the issues mentioned above. SUMMARY OF THE INVENTION [0009] A system for wound closure has at least two closure elements. One closure element is detachably tethered to another closure element. Each closure element includes: a base member with an integral strap hingably connected to the base member, and a lock member slidably disposed on the strap and being lockable on the strap. Alternatively, the base member defines a plane and the strap being affixed to the base member at an angle to the plane. The system may further include a wound covering disposed between the straps and the wound. The wound covering may be a laminate having at least two layers; a first layer is a moisture impervious layer adapted to contain body heat, and a second hydrophilic layer is adapted to retain moisture. DESCRIPTION OF THE DRAWINGS [0010] For the purpose of illustrating the invention, there is shown in the drawings a form that is presently preferred; it being understood, however, that this invention is not limited to the precise arrangements and instrumentalities shown. [0011] FIG. 1 is an illustration of one embodiment of the system for closure of a wound. [0012] FIG. 2 , taken generally along section lines 2 - 2 of FIG. 1 , is an embodiment of the base member. [0013] FIG. 2A is an enlarged view of a portion of the embodiment shown in FIG. 2 . [0014] FIG. 3 , taken generally along section lines 2 - 2 of FIG. 1 , is another embodiment of the base member. [0015] FIG. 4 is an illustration of the inventive system with the strap folded and releasably affixed to the base member and the lock mechanism of the lock member in an open position. [0016] FIGS. 5A and 5B illustrate one embodiment of the lock mechanism in an open position and a closed position, respectively. [0017] FIG. 6 is an illustration of the inventive system in operation along with an optional wound covering. DESCRIPTION OF THE INVENTION [0018] Referring to the drawings, where like elements have like numerals, there is shown in FIG. 1 an embodiment of the system for closure of a wound 10 , for example, short term closure. Generally, system 10 comprises a closure element 12 . In one embodiment, several closures elements 12 may be joined together via a tether 14 . But, closure elements 12 may be independent, i.e., not tethered. Several, as used herein, may mean at least two, but may include up to 12 , or any whole number between 2 and 12 . [0019] The tether 14 may be breakable or cuttable, so that the number of closures 12 may be tailored to a suitable number for closure of the wound. Tether 14 may be positioned on an upper portion of the closure elements 12 , so that the tether 14 does not touch the skin. [0020] The system 10 may be made of one or more injection moldable thermoplastic materials, alone or in combination. Such thermoplastic materials include, but are not limited to, polyolefins (for example, polyethylene and polypropylene), polyesters (for example, polyethylene terephthalate), polyamides (for example, nylon), or the like. [0021] Closure element 12 generally includes a base member 16 , a strap 18 , and a lock member 20 . The base member 16 may be integral with the strap 18 . The lock member 20 may be slidably and/or removably engaged with strap 18 . [0022] Referring to FIGS. 1-4 , the base member 16 will be discussed in greater detail hereinafter. Base member 16 generally includes a strap fastener 22 and a bottom plate 24 . Base member 16 optionally includes at least one pair of staple holes 26 through the bottom plate 24 . Any number of pairs of staple holes may be used, for example, 1-4 pairs of staple holes including any whole number between 1 and 4. The staple holes 26 may be used so that the base member may be stapled to the skin surrounding the wound. The base member may also optionally include at least one pair of staple guides (e.g., teeth) 28 , for example, upstanding from the lateral edges of the bottom plate 24 . Additionally, the staple guides 28 allow the base member 16 to be more flexible therebetween. Any number of pairs of staple guides may be used, for example, 1-6 pairs of staple guides including any whole number between 1 and 6. [0023] As shown in FIG. 4 , strap fastener 22 may be used to releasably secure strap 18 , so that the strap 18 may be held away for the wound. Strap fastener 22 may be any mechanism that can releasably hold strap 18 . The strap fastener 22 may be generally located on the base member 16 at an end of the bottom plate 24 distal the strap 18 . In one embodiment, shown in FIGS. 1 , 2 , and 4 , strap fastener 22 may comprise a pair of lateral clips 30 , each clip 30 spaced from the other so as to releasably secure strap 18 therebetween. The strap fastener 22 may optionally include strap engagement member 31 . Strap engagement member 31 working with clips 30 may more securely hold the folded strap 18 in strap fastener 22 . In another embodiment (not shown), strap fastener may be a post with mushroom head upstanding from bottom plate 24 for releasable engagement with one or more holes (not shown) through the strap 18 . [0024] Referring to FIG. 2A , base member 16 may include an adhesive 32 for releasably securing base member 16 to the skin adjacent the wound. In one embodiment, the adhesive 32 may be affixed to a bottom surface of the bottom plate 24 . Adhesive 32 may be any adhesive suitable for releasably adhering the base member 16 to the skin adjacent the wound. The adhesive 32 may be a hydrocolloid dressing (for example, commercially available under such tradenames as Duoderm, Granuflex, Ultec, and 3M Tegaderm Hydrocolloid) and/or pressure sensitive adhesive. In one embodiment, the adhesive 32 covers all or a portion of the bottom surface of bottom plate 24 . In one embodiment, the adhesive 32 may be protected, prior to use, by a release layer 34 . In another embodiment, adhesive 32 may include a mesh (not shown) throughout the adhesive 32 and may extend beyond the peripheral edge of the adhesive 32 . [0025] The base member 16 may be integral with strap 18 . Integral, as used herein, may refer to the base member 16 and the strap 18 being molded as a single unit. The joint between the base member 16 and strap 18 should be flexible (i.e., capable of bending to allow fastening of the free end of the strap 18 to the base member 16 as shown in FIG. 4 ). The strap 18 may be hingably connected with the base member 16 . In one embodiment, see FIG. 2 , a hinge 36 joins the base member 16 with strap 18 . Hinge 36 , as shown in FIG. 2 , may be formed by a thinning of material between the base member 16 and strap 18 (e.g., a living hinge). In another embodiment, see FIG. 3 , the strap 18 is joined to the base member 16 at an angle 38 . Angle 38 may be any angle greater than 0° and less than 90°. The angle 38 may be in the range of 10°-45°, or 15°-35°. In one embodiment, the angle 38 may be about 30°. [0026] Strap 18 , see FIGS. 1 , 4 , 5 A, and 5 B, is a elongated member extending away from the base member 16 . The strap 18 is flexible. The strap may have a plurality of teeth 40 along a surface of strap 18 (for example, the upper surface). These teeth 40 , in one aspect of the invention, may work with strap engagement member 31 of the strap fastener 22 (discussed above); and in another aspect of the invention, these teeth 40 may engage with strap engagement member 54 to hold the strap 18 fast in locking mechanism 42 (discussed below). The strap 18 may be any length. In one embodiment, the length may range from 12 inches to 36 inches. Strap 18 may be severable. For example, the strap may be severed (for example, with a knife or scissors) along its length so that the strap length may be tailored to a suitable length for closure of the wound. In one embodiment (not shown), the strap 18 may include one or more notches at regular intervals (for example, 1 or 2 inches) along the length of the strap 18 to facilitate severability. The notch may run across the width of the strap 18 (i.e., generally perpendicular to the longitudinal axis of the strap 18 ) and may be an area of the strap that may be generally thinner in depth than other areas of the strap, so that the notch acts as a guide for a knife to facilitate strap cutting in the dark as may be necessary under battle field conditions. [0027] Lock member 20 , see FIGS. 5A and 5B , may be slidably releasable on strap 18 . Lock member 18 may be slid along strap 18 to facilitate closure and access to the wound. Lock member generally includes a locking mechanism 42 for releasably engaging strap 18 . In one embodiment, the lock member 20 may include a bottom plate 44 with the locking mechanism 42 joined to an upper surface of the bottom plate 44 . [0028] Lock member 20 optionally includes at least one pair of staple holes 26 through the bottom plate 44 . Any number of pairs of staple holes may be used, for example, 1-4 pairs of staple holes including any whole number between 1 and 4. The staple holes 26 may be used so that the base member may be stapled to the skin surrounding the wound. The base member may also optionally include at least one pair of staple guides (e.g., teeth) 28 , for example, upstanding from the lateral edges of the bottom plate 44 . Additionally, the staple guides 28 allow the lock member 20 to be more flexible therebetween. Any number of pairs of staple guides may be used, for example, 1-6 pairs of staple guides including any whole number between 1 and 6. [0029] The locking mechanism 42 , in one embodiment, may include a foldable lid 46 mounted via a hinge 48 to wall 50 . The lid 46 is movable from an open position, FIG. 5 A, to a closed position, FIG. 5B . The lid 46 may include a clasp 52 which is releasably engagable with wall 50 . Optionally, the lid 46 may include strap engagement member 54 for holding the strap in a non-slidable manner when the lid 46 is in the closed position. Optionally, the locking mechanism 42 may include a mechanism (not shown) so that when lid 46 is in the closed position, the strap 18 may be pulled therethrough, thereby closing the wound by drawing the base member 16 and lock member 20 together. This mechanism may only allow the strap to be pulled through in one direction and hold fast in the opposite direction. [0030] Lock member 20 may include an adhesive for releasably securing lock member 20 to the skin adjacent the wound. In one embodiment, the adhesive may be affixed to a bottom surface of the bottom plate 44 . The adhesive may be any adhesive suitable for releasably adhering the lock member 20 to the skin adjacent the wound. The adhesive may be a hydrocolloid dressing (for example, commercially available under such tradenames as Duoderm, Granuflex, Ultec, and 3M Tegaderm Hydrocolloid) and/or pressure sensitive adhesive. In one embodiment, the adhesive covers all or a portion of the bottom surface of bottom plate 44 . In one embodiment, the adhesive may be protected, prior to use, by a release layer. In another embodiment, adhesive may include a mesh (not shown) throughout the adhesive and may extend beyond the peripheral edge of the adhesive. The adhesive may be positioned on the lock member 20 in the same fashion as the adhesive 32 is employed with the base member 16 , and shown in FIG. 2A . [0031] In operation, referring to FIG. 6 , system 10 is removed from a sterile packaging (not shown). The system 10 is spread, as necessary, so that the base member 16 is on one side of the wound, the lock member 20 is on another side of the wound, and the strap 18 traverses the wound. With the locking mechanism 42 in the open position ( FIG. 5A ), the base member 16 and lock member 20 are affixed to the skin adjacent the wound, via the adhesive. Staples (not shown) may be used to further secure the base member 16 and lock member 20 to the skin adjacent the wound. Strap 18 is inserted into the open locking mechanism 42 . The base member 16 and lock member 20 may be drawn together, whereby the wound may be closed (closure may only be sufficient to prevent internal organs from spilling from the wound during transportation, full closure of the wound may not be necessary or possible). Thereafter, the lock mechanism 42 may be closed ( FIG. 5B ), so that the strap 18 is fixed in place. Excess strap 18 (e.g., strap 18 extending beyond lock member 20 ) may be trimmed, as desired. If necessary to gain access to the wound after closure with system 10 , the locking mechanism 42 may be released ( FIG. 5A ) for access and then reclosed ( FIG. 5B ). [0032] Optionally, wound covering 60 may be included with system 10 . Wound covering 60 adds, among other things, further protection to the wound. Wound covering 60 may also, without limitation, prevent ingress of contaminants into the wound, prevent spillage of internal organs from the wound, assist in retaining body heat, assist in retaining moisture that may escape from the wound, and provide a vehicle through which medicines and/or fluids may be administered to, or through, the wound. Wound covering 60 may be any size. For example, the wound covering 60 may have dimension of 12 inches by 12 inches by 3 mm. [0033] Wound covering 60 , in one embodiment, may be a laminate. The laminate may have at least two layers. A top layer 62 may be for preventing escape of heat and moisture through the wound and preventing ingress of contaminants to the wound. Top layer 60 , in one embodiment, may be an aluminized plastic sheet. The aluminized surface faces toward or away from the wound. A middle layer 64 may be for administering fluids and/or medicines to the wound. Middle layer 64 may be a hydrophilic foam and/or an opened cell foam. Middle layer 64 may be affixed to top layer 62 . Additionally, wound covering 60 may include a third layer. Bottom layer 66 may be a perforated plastic film, so that fluids and/or medicines fed into the middle layer 64 may be distributed into the wound. Top layer 62 may be joined to bottom layer 66 via a weld seam 68 . Weld seam may be made by any suitable technique (for example, thermal weld, ultrasonic weld, adhesive, radio-frequency weld, and the like). Wound covering 60 may further include a fluid ingress port 70 . Port 70 may be coupled with, for example, a saline bag (not shown). Port 70 is in fluid communication with middle layer 64 and extends beyond the weld line 68 . Fluids and/or medicines may be administered from the saline bag through the port 70 to middle layer 64 , and then into the wound from the middle layer 64 and through the bottom layer 66 . Port 70 may be a luer lock-type device. Wound covering 60 may be supplied with system 10 folded and packaged in a sterile packaging or can be opened and worn on the inside of a battlefield helmet. [0034] In operation, the wound covering 60 is spread over the wound, and then system 10 may be deployed as described above. [0035] The system 10 may be compressed into a relatively small sterile package and is light-weight. Thus, it may be easily carried into a battlefield situation. [0036] While, originally intended for short term closure, the system 10 may also have benefit in other surgical-type procedures, including, for example, any hospital/medical environment, such as an operating theater, emergency room, trauma center, or the like. [0037] The present invention may be embodied in other forms without departing from the spirit and the essential attributes thereof, and, accordingly, reference should be made to the appended claims, rather than to the foregoing specification, as indicating the scope of the invention.

A system for wound closure has at least two closure elements. One closure element is detachably tethered to another closure element. Each closure element includes: a base member with an integral strap hingably connected to the base member, and a lock member slidably disposed on the strap and being lockable on the strap. Alternatively, the base member defines a plane and the strap being affixed to the base member at an angle to the plane. The system may further include a wound covering disposed between the straps and the wound. The wound covering may be a laminate having at least two layers; a first layer is a moisture impervious layer adapted to contain body heat, and a second hydrophilic layer is adapted to retain moisture.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] The present application claims the priority of the PCT application PCT/US2006/027518 filed on Jul. 14, 2006, which, in turn, claimed the priority of the filing of the U.S. provisional patent application 60/699,445 filed on Jul. 15, 2005, of which the present application also claims the priority. BACKGROUND [0002] K. A. Kelly et al., in their U.S. Pat. Nos. 5,738,637, issued Apr. 14, 1998, 6,234,984, issued May 22, 2001, 6,325,771, issued Dec. 4, 2001, and 6,645,163, issued Nov. 11, 2003, as well as their U.S. patent application Ser. Nos. 9/818,102, filed Mar. 27, 2001, and 10/705,487, filed Nov. 11, 2003, have provided a remarkable manual device for effectuating CPR on a patient suffering cardiac arrest. The disclosures of these patents and applications are incorporated here by reference. The CPR device of Kelly et al. permits the quick, correct, facile and reliable, manual application of CPR to a person suffering cardiac arrest. [0003] Prior concepts of CPR have focussed on two separate lines of thought. The first of these has instructed individuals to place their hands on the chest of the person in extremis and push down in a repeated cycle. This unassisted CPR suffers from several limitations. Foremost amongst these is the fact that very few individuals, even those supposedly trained in such CPR, can accomplish the task correctly to provide a significant improvement in the patient's chances of surviving the emergency. Further, this type of CPR has only succeeded in placing a force acting downward on the chest of the victim. While this may produce some desired blood flow, it entirely ignores the significant potential of increasing circulation by constricting the person's chest. Not surprisingly, this type of CPR has not proven particularly successful in saving lives of individuals suffering cardiac arrest. [0004] The second type of CPR procedure does the opposite from the first: It circumvents the individual's chest with some sort of sleeve that then undergoes constriction to squeeze the chest and increase the desired blood flow as discussed above. A pneumatic sleeve with an air pressure device often powers this type of apparatus. However, this type of CPR typically fails to a provide downward force into the chest to achieve that assist to the circulation discussed with regards to manual CPR discussed above. Further, this type of apparatus typically requires a substantial financial investment and also necessitates significant training to assure its proper attachment to a patient and subsequent operation, even when “automated.” Notwithstanding the foregoing, significantly improved examples of this type appear in U.S. Pat. No. 4,770,164 issued on Sep. 13, 1988, to R. Lach et al. as well as in the Kelly et al. patents and applications listed above. In fact, the latter show an automated apparatus accomplishing both types of CPR forces, downward and circumferential, discussed above. [0005] Substantial interest has focussed on the ready use of defibrillation on persons suffering from cardiac arrest. While this process has a significant place in the treatment of such persons, it does not aid in bringing oxygen to the heart so that it can function upon defibrillation. [0006] The manual CPR apparatus shown in the Kelly et al. patents and applications facilely accomplish both types of circulation assistance. It allows the downward force placed on it to pass directly into the chest of the patient to effectuate the radial force that directly depresses the chest. However, it also tightens a belt placed around the patient's chest to constrict it and the patient's chest to achieve further and important circulation around the heart muscle. [0007] Significantly, the Kelly et al. device requires a minimal financial investment and virtually no training. This allows its placement in many and varied locations, such as the trunks of police squad cars and at gymnasiums and its use by individuals, such as the police themselves and others like coaches and other institutional personnel. In its simplest form, this CPR apparatus utilizes a belt placed around the victim and attached to a mechanism. When the operator pushes down on the handles forming part of this mechanism, some of the downward force passes straight through to the patient in the form of a radial force directed inward from his or her sternum into the chest. Significantly, the device converts part of the applied downward force into a tangential component that effects a circumferential tightening of the belt around the chest to squeeze it and further promote blood circulation around the heart. [0008] While the Kelly et al. device described in its simplest form above has proven effective for persons with cardiac arrest, the patent and applications listed above disclose many additional features that may enhance its effectiveness in particular situations. Thus, the device may include a backboard to which the belt attaches or through slots in which the belt passes. The backboard may also have a raised portion for the patient's head, and the raised portion may house breathing apparatus and gas (such as oxygen) for the patient. [0009] As other sophistications, the Kelly et al. device may include a force sensor to indicate the pressure applied to the victim's chest. An indicator of this force may then allow the operator to achieve more effective and safe treatment. [0010] As a further safety feature, the apparatus may include a device for limiting the amount of circumferential tightening applied to the patient's chest. In particular, this feature may allow a choice between several different forces applied around the chest. [0011] To assure full chest expansion between down strokes, Kelly et al.'s device may incorporate a component on its chest-contacting surface for adhering the device to the chest. Upon the release of pressure, this adherence will assist to expand the chest by pulling up on the patient's torso. This adhering device may take the form of suction cups or even some form of adhesive. [0012] Kelly et al. also suggest a signal generator forming part of their device. This component has the purpose of producing a periodic signal. This signal simply informs the operator when to push down on the apparatus and helps achieve a rhythmic application of force at the interval that portends the greatest positive effect on the patient. [0013] The apparatus may also include two or more electrodes, spaced apart from each other, that contact the patient's chest at different locations for the purposes discussed below. Two electrodes may attach to the base of the device which sits on the chest. Alternately, one may attach to the base while a second connects to the belt. Or, the two may attach at different locations along the longitudinal axis of the device's belt. Or, with more, the electrodes may attach to the belt and at several locations around the belt. [0014] The electrodes may serve to obtain an electrocardiogram of the patient. Alternately or additionally, the electrode may defibrillate the heart when necessary. [0015] As seen from the above, the Kelly et al. device has provided vastly improve CPR to individuals in dire need of such treatment. Naturally, the work continues to improve this mechanism even further. SUMMARY [0016] An improved apparatus for increasing the flow of blood in a patient will typically include a base contoured to seat near a central region of a patient's chest, an actuator, and a substantially inelastic belt means configured to wrap around the patient's chest substantially in a plane. A force converter then mounts on the base and couples to the actuator. This converter has belt connectors that couple to opposite extremities of the belt means with the belt means substantially in the plane described above. The converter serves to convert into belt tightening resultants applied to the belt connectors and directed substantially tangentially to the chest a force applied to the actuator at two separated points along a line making a nonzero angle to the plane of the belt means and directed toward the chest. [0017] The Kelly et al. device carried two handles for the operator to apply a force to by pushing down on at separated locations for the CPR. The handles were separated by a line that actually lay in the plane defined by the belt. Stated in other words, the separation between the handles lies across the patient's chest, or, more accurately, perpendicular to the patient's longitudinal axis. This then requires the operator to straddle the patient or to try to configure his or her own body in an unnatural configuration to achieve the downward force on the two handles. The new device described above obviates this problem from the Kelly et al. device by moving the separation of the handles away from the plane of the belt that circumnavigates the patient's chest. This allows the operator to assume a more natural position along the side of the patient. [0018] More particularly, the line separating the two handles may lie substantially perpendicular to the plane of the belt means. Stated alternately, the line separating the two handles, or the force points, lies substantially parallel to the longitudinal axis of the patient's torso. In either instance, the operator may facilely grab the handles to perform the life-saving function. [0019] Rather than focussing upon the plane of the belt means that circumvents the patient, a description of an improved CPR device may focus on the points of attachment of the opposite extremities of the belt means to the belt connectors of the force converter. These two points generally define a first line. The converter then converts into belt tightening resultants applied to the belt connectors directed substantially tangentially to the chest a force applied to the actuator at two separated points along a second line making a nonzero angle to the first line and directed toward the chest. As suggested above, the preferred location of the second line along which the operator applies his or her force lies substantially perpendicular to the first line defined by the points of attachment of the opposite extremities of the belt means to the belt connectors of the converter. Or, the first line along which the operator applies the force lies substantially parallel to the longitudinal axis of the torso of said patient. [0020] A method of CPR treating a patient, as indicated above, commences with seating a base of a blood flow increasing apparatus on a patient's chest near a central region of that chest. It then includes wrapping a belt means with first and second opposite extremities around the patient's chest, with the belt means itself substantially forming a plane. Any of the extremities of the belt means not already fastened to the apparatus are, accordingly, fastened to it, with the belt means substantially forming a plane. At this point, a force is applied at two separated points along a line making a nonzero angle with the plane defined above and directed toward the chest to an actuator coupled to a converter. The converter is, of course, coupled to the base and the belt means. Lastly, the force is converted into belt tightening resultants directed substantially tangentially to the chest. [0021] Preferably, the line along which the force is applied lies substantially perpendicular to the plane defined by the belt means. Or, this line lies substantially parallel to the longitudinal axis of the patient's torso. [0022] Alternately, the first and second extremities of the belt means are separated from each other substantially along a first line when fastened to the apparatus. A force is then applied toward the chest at two separated points along a second line making a nonzero angle relative to the first line and directed to an actuator coupled to a converter which in turn couples to the base and the belt means. Lastly, the force is converted into belt tightening resultants directed substantially tangentially to the chest. As above, the first line may lie substantially perpendicular to the second line, or alternately, substantially parallel to the longitudinal axis of the patient's torso. BRIEF DESCRIPTION OF THE FIGURES [0023] FIG. 1 shows an operator employing an improved device to administer CPR force from the side of a patient and along a line parallel to the patient's torso. [0024] FIG. 2 gives an end view along the line 2 - 2 of the CPR device of FIG. 1 but without the operator. [0025] FIG. 3 provides a similar view of the CPR device of FIGS. 1 and 2 but with a downward force exerted on the device's handles. [0026] FIG. 4 shows an isometric view of the CPR apparatus of FIGS. 1 to 3 . [0027] FIG. 5 displays the components of the CPR device of FIGS. 1 to 4 in exploded view. [0028] FIG. 6 gives an isometric view of the CPR apparatus of FIGS. 1 to 4 and very similar to that of FIG. 4 in particular but in a depressed, or compressive, state. [0029] FIG. 7 illustrates a CPR device the same as that in FIGS. 1 to 6 with a view very similar to that in FIG. 3 but including the use of a backboard. [0030] FIG. 8 shows, in an isometric view, a CPR device allowing the application of any of a number of preselected CPR forces somewhat similar to that seen in FIGS. 13 to 17 of the incorporated Kelly et al. patents and applications but permitting the location of the force at any two points around a circle relative the patient's torso. [0031] FIG. 9 gives an end elevational view along the line 9 - 9 of the CPR device shown in FIG. 8 with the compressive configuration in phantom. [0032] FIG. 10 provides an isometric view of a CPR apparatus utilizing a converting unit similar to that of FIGS. 1 to 7 but allowing the application of force at any two points around a circle over the patient's torso. [0033] FIG. 11 portrays a side elevational view along the line 11 - 11 of the CPR device of FIG. 10 . [0034] FIG. 12 gives an end elevational view along the line 12 - 12 of the CPR device of FIG. 10 and showing the compressive state in phantom. [0035] FIG. 13 has an enlarged view along the line 13 - 13 of the belt attaching mechanism of the CPR apparatus of FIG. 10 . [0036] FIG. 14 provides an isometric view of an alternate CPR apparatus allowing the application of force along a line parallel to the patient's torso and in which the belt ends raise upward upon the application of a compressive force. [0037] FIG. 15 has the same view of the same CPR apparatus of FIG. 14 but with the belt and one side removed to illustrate the working of that device's mechanism. [0038] FIG. 16 gives a cross-sectional view along the line 16 - 16 of the CPR device of FIG. 14 . [0039] FIG. 17 portrays a CPR device virtually identical to that of FIGS. 14 to 16 except that it uses a suction cup to contact the patient's chest to assist in chest expansion between force applications. DETAILED DESCRIPTION [0040] FIGS. 1 to 7 show the CPR device generally at 30 attached by the belt 31 to the patient 32 undergoing CPR treatment. As seen particularly in FIGS. 1 to 3 and 7 , the belt 31 generally defines a plane as it circumvents the patient 32 . The handles 33 and 34 of the CPR device 30 lie (and are separated from each other) along the line 35 . The line 35 , in turn, generally forms a perpendicular angle with the plane of the belt 31 . It also lies generally parallel to the longitudinal axis 36 of the patient 32 . [0041] This orientation of the handles 33 and 34 allows the operator 40 to kneel or otherwise position himself or herself along the side of the patient 32 and facilely place his or her hands 41 and 42 on the handles 33 and 34 , respectively, to effectuate CPR. The operator 40 need not straddle the patient 32 or assume some other inconvenient or less effective position. [0042] To administer CPR, the operator 40 places the belt 31 around the patient's back and the apparatus 30 on the patients' chest. He or she then attaches the belt ends 45 and 46 to the device 30 . Specifically, the ends 45 and 46 wrap around the rods 47 and 48 and attach there using such standard couplings such as hooks and loops, any of the connections shown in Kelly et al.'s patents and applications, or the quick release clamp discussed below with regards specifically to FIG. 13 . This produces the configuration shown in particular in FIGS. 1 , 2 , and 4 . [0043] The operator then pushes downward on the handles 33 and 34 . This accomplishes two tasks. First, the device 30 transmits a downward force directly onto the sternum of the patient 32 to directly compress the chest. This provides the first component of the CPR. [0044] Second, pushing down on the handles 33 and 34 forces their interconnecting bar 53 to descend, with its bearings 55 and 56 , along the openings 57 and 58 in the sides 59 and 60 , respectively, of the U-bar 61 , permanently affixed to the base 62 . The bar 53 , in turn, surrounded by the bearings 65 and 66 , passes through the openings 67 and 68 in the triangular side plates 69 and 70 , respectively, as clearly seen in FIG. 5 . Thus, pushing down on the handles 33 and 34 causes the bar 53 to force the side plates 69 and 70 to travel downwards as well. [0045] The plates 69 and 70 moving up and down forces the levers 75 to 78 to rotate around their respective pivot points 81 to 84 , respectively. To see this, the bolt 85 journals the pivot points 81 and 83 of the side plates 75 and 77 , respectively, to the opening 89 in the base 62 while similarly the bolt 86 rotatingly connects the pivot points 82 and 84 to the base 62 . In turn, the bolt 91 passes through the slot 93 in the side plate and journals to the upper arm 95 of the lever 75 . With the bar 53 in its raised position, the bolt 85 sits towards the interior of the side plate 69 as particularly seen in FIGS. 2 and 4 . Pushing down on the handles 33 and 34 forces the plate 69 to move in the same direction which, concomitantly, forces the bolt 91 to move downward and, at the same time, towards the outside of the slot 93 . This forces the lever 75 to rotate in the counterclockwise direction in FIGS. 4 and 5 , the upper arm 95 of the lever 75 to move downward, and the lower lever arm 97 to travel upward all around the pivot point 81 to the position seen in FIGS. 3 , 6 , and 7 . [0046] Exactly the same takes place with regards to the lever 76 which has its upper arm 102 slidingly affixed to the side plate 70 by the bolt 104 which passes through the slot 106 and moves along it. An exactly analogous analysis shows that pushing down on the handles 33 and 34 causes the lever 76 to rotate in the counterclockwise direction, in FIGS. 4 and 5 , its upper arm 102 to descend, and its lower arm 108 to elevate. Thus, in summary, pushing down on the handles 33 and 34 forces the lower arms 97 and 108 of the levers 75 and 76 , respectively, to raise. However, the bar 48 , to which the end 45 of the belt 31 attaches, is itself connected to the lower lever arms 97 and 108 . Thus, pushing down on the handles 33 and 34 raises the belt end 45 and tightens the belt 31 . [0047] Exactly the same thing happens to the other belt end 46 . Pushing down on the handles 33 and 34 causes it to also raise and tighten the belt 31 . As a consequence, a downward force on the handles 33 and 34 both depresses the chest of the patient and tightens the belt around it, as seen in FIGS. 3 and 7 . [0048] The latter FIG. 7 shows the use of the CPR device 30 on a patient 32 placed on the backboard 121 . As seen there, the belt 31 passes through the two openings 123 and 124 . To facilitate the use of the CPR apparatus 30 , the backboard may permit the semipermanent attachment of the belt 31 for quicker use when needed. The backboard 121 may contain any or all of the features shown for such an item in the patents and applications of Kelly et al. [0049] Additionally, as seen in FIGS. 4 and 5 , the lockpin 127 fits into the opening 128 of the side plate 69 , and with the handles 33 and 34 in their raised position, the openings 129 , 130 , and 131 of the levers 75 and 77 , and the U-bar 59 , respectively. This keeps the device 30 in the elevated configuration shown in FIG. 4 to permit the taut attachment of the belt 31 immediately prior to use and prevent possibly deleterious movement when not in use. [0050] As seen in the above figures, the levers 75 to 78 have the unique shape of T-bases with the upper arms bent 90 degrees to the horizontal (as seen there). This allows the upper arms to move to their descended positions seen in FIGS. 3 , 6 , and 7 without interfering the raising of the ends 47 and 48 holding the belt ends 45 and 46 to tighten the belt 31 . In the tightened position seen in these figures, the bars 45 and 46 actually nestle in the 90 degree bends of the upper lever arms. [0051] FIGS. 8 and 9 show a CPR device generally at 150 built upon the unit shown in FIGS. 13 to 17 of the Kelly et al. patents and applications. Without repeating the analysis contained there, the device has the two over-center levers 151 and 152 that pivot about the point 153 . The belt ends attach to the bars 157 and 158 connected to the respective lever arms 159 and 160 of the levers 151 and 152 . As seen from the perspective of FIG. 9 , the belt end from the right in the figure will attach to the bar 157 and the belt end from the left attaches to the bar 158 . In turn, the lever arm 159 separates the bar 157 (and the right belt end) from the pivot point 153 and the lever arm 160 does the same action for the left-belt-end bar 158 . [0052] As the levers 151 and 152 pivot about the point 153 , the bars 157 and 158 move upward and towards each other. This causes the ends of the belt attached to these bars to similarly move upwards and toward each other and tighten the belt about the torso of the CPR patient. [0053] The stop pin 163 serves to limit the amount of rotation of the levers 151 and 152 about the pivot point 153 . In particular, placing the pin 163 in the opening 164 permits the least amount of such rotation while placing it in the openings 165 and 166 allows ever increasing rotation and thus tightening of the belt about the patient's chest. Removing the pin 163 eliminates the barrier to rotation altogether should that prove necessary. [0054] To operate the CPR device 150 , the attendant pushes down on the wheel 171 . The exact location where the operator places his or her hands does not matter to any particular degree. However, for balance, locating the pressure points on generally opposite sides of the wheel 171 would appear somewhat desirable. In particular, the wheel 171 permits placing the hands at two locations separated by a line lying generally parallel to the bars 157 and 158 . However, these bars 157 and 158 , with the belt surrounding the patient's chest and attached to them, lie generally parallel to the patient's longitudinal axis and also perpendicular to the plane defined by the belt circumnavigating the patient. The two posts 173 and 174 rigidly attach the wheel 171 to the side plate 175 , and the posts 177 and 178 connect it to the plate 179 . Thus, the operator's pushing down on the wheel causes the side plates 175 and 179 to descend. It also causes a downward pressure on the patient's chest. [0055] As the side plates 175 and 179 descend, they similarly cause the rod 181 , coupled to the upper lever arms 159 by the caps 183 which also pass through the slots 185 , to move downward. At the same time, the rod 188 , coupled to the plates 175 and 179 by the caps 190 which pass through the slots 192 , also goes down and takes with it the upper lever arms 160 . Thus, pushing down on the wheel 171 at any points around its circumference causes the levers 151 and 152 to pivot about the point 153 which has the effect of pulling up on the belt ends by the 157 and 158 to tighten it circumferentially about the patient's chest. This action is in addition to the direct downward force exerted on the patient's chest discussed above. [0056] FIGS. 10 to 12 show the CPR apparatus generally at 201 that operates in virtually the same manner as the device 30 in FIGS. 1 to 7 and includes a substantial number of important additional features. Initially, the manual operation of the apparatus 201 involves the attendant pushing down on the wheel 202 . The wheel 202 , in turn rigidly connects to the side plates 203 and 204 though the struts 205 to 208 and causes then to descend at the same time. As with the device 30 in FIG. 1 , the downward motion of the side plates 203 and 204 first places a depressive force on the patient's chest 212 . It also causes the levers 215 and 216 to rotate about their pivot point 217 and the levers 219 and 220 to rotate about their pivot point 221 to raise the belt ends 225 and 226 and circumferentially constrict the chest 212 in exactly the same fashion as the device 30 in FIGS. 1 to 7 . The only difference in the two devices 30 and 201 in their mechanical operation is that the operator places his or her hands at most any generally opposed points on the wheel 202 in FIGS. 10 to 12 whereas the operator must grab the opposed handles 33 and 34 in FIGS. 1 to 7 . This gives the device 201 an additional degree of flexibility not provided by the device 30 . [0057] However, the CPR device 201 of FIGS. 10 to 12 has numerous other features that enable it to perform its life-saving function in many different advantageous ways. Thus, as seen in FIGS. 10 and 12 , the base 231 of the CPR device 201 includes the combined electrocardiogram (“EKG”) and defibrillation (“defib”) and possibly pressure sensitive pad 232 . Similarly, the belt 233 incorporates the EKG-defib pads 234 to 236 . The pads 232 and 234 to 236 have the usual functions indicated by the terms EKG and defibrillation. These pads couple to the wire 237 which may serve as an antenna or a quick connect and disconnect device through the plug 238 . The wire may embed within the belt 233 . The plug may allow for connection to an external computer or other device for monitoring the patient. It may also allow connection to a telephone or other device for transmission of its signals to other stations, and it may also indicate its own location. [0058] Additionally, the CPR equipment 201 includes the electronic pack indicated generally at 243 that provides a variety of functions to aid in the task of saving a patient's life. First it may have the EKG display 244 which connects, in turn, to the pads 232 and 234 to 236 . This provides a skilled operator with an indication of the patient's condition and progress. Next to the EKG display 244 , the pack 243 may include the visual indicator 245 which tells the operator when to push down and complete a stroke. Most conveniently, the indicator 245 may take the form of a light that shines when it wishes for a CPR stroke. [0059] The pack 243 also incorporates the display gauge 251 that indicates the pressure exerted by the operator's downward stroke. This informs the operator if he or she is providing adequate force to achieve effective CPR. The gauge receives its input from a pressure pad that may have a colocation with or form part of the EKG-defib pad 232 . [0060] The speaker 252 may provide an audible signal to indicate that a compression should occur. It could also provide verbal directions to facilitate the attachment and use of the CPR device 201 itself. Sitting next to the speaker 252 , the on-off switch 253 controls the overall operation of the pack 243 . As seen best in FIG. 11 , the pack 243 also includes the computer 261 that controls the pack's other functions. It may also incorporate security features such as passwords or biometric measurements to identify the attendant and limit access to the operation of the pack 243 . The computer 261 may also record and store information concerning the actuation of the equipment and the signals generated by it. In particular, the computer 261 can monitor the overall operation of the device and determine the most advantageous times to compress, ventilate or defibrillate the patient based in part on signals received from the pads 232 and 234 to 236 . It can then operate the components that achieve these functions. The battery 262 then provides the power for the other components discussed above. [0061] Additionally or separately, the pack 243 nay include the fluid piston or electrical motor 267 that can assist in the operation of the device 201 or operate it itself. It can receive its fluid or electrical power though the coupling 268 that connects to the electrical or fluid cable 269 , as appropriate. The cable 269 then passes to the control assembly 270 which includes the gauge 273 which indicates the amount of pressure or electricity remaining in the tank or battery 274 . The rotary switch 275 may turn the motor on and off and allow the selection of the frequency of the application of the CPR cycles. The selector switch 276 then permits a determination of the force to be applied to the patient. This may also work with feedback along the multichannel cable 269 to maintain the pressure at the preselected value. [0062] Alternately, the tank 274 may simply hold oxygen that will travel along the cable 269 to the device 201 for delivery to the patient. The controller 270 in this instance includes the on-off and magnitude rotary switch 275 , the pressure controller 276 , and the gauge 273 . [0063] FIGS. 10 and 12 also show the detachable guide 281 that can releasably attach to the belt ends 225 and 226 of the belt 234 . The guide 281 and each of the ends 225 and 226 may include a mechanism such as hooks and loops to attach them together. The guide 281 provides some stiffness to allow the belt ends 225 and 226 to be forced under the patient and fed into the device 201 . It also provides some additional length for tightening the belt 233 around the patient's chest 212 should that prove necessary. [0064] FIGS. 10 to 13 also show the clip generally at 285 for holding the belt 233 onto the bar 286 . The Kelly et al. patents and applications suggest hooks and loops for this purpose. This type of connecting device may well perform with complete satisfaction for the anticipated uses of a CPR mechanism. However, the hooks and loops attachment may not prove acceptable under all conditions. Thus, it loses its effectiveness when wet or dirty. Moreover, it can wear out after extensive use. [0065] The clip 285 avoids these limitations. It includes the curved metal latch 289 which can rotate about its journaled connection 290 to the levers 216 and 220 . Inserting the belt into the clip first involves lifting the latch 289 by turning it in the counterclockwise direction in FIG. 13 and feeding the belt end 226 (possibly with the guide 281 attached) between it and the bar 286 . Locking the belt 233 in place then proceeds by pressing the latch extension 291 in the clockwise direction in that figure. This forces the latch knob 292 to press against the belt 233 and hold it against the bar 286 . Any force that would tend to pull the belt 233 out of the device actually causes the latch knob 292 to push the belt 233 harder against the bar 286 and, by squeezing the belt more tightly, keep it in place for the CPR. Releasing the belt 233 from the latch 285 merely involves lifting the latch end 291 with the fingers and moving it in the counterclockwise direction. This opens the space between the knob 292 and the bar 286 and permits the facile removal of the belt end 226 . [0066] FIGS. 14 to 16 show the CPR device generally at 301 built on the principles shown in FIG. 6 of the Kelly et al. patents and applications. The base 302 sits upon the patient's chest, and the belt 303 circumnavigates the patient's thorax in the usual fashion. The belt end 307 passes under the rod 308 affixed to the side 309 by the tabs 310 . Similarly, the other belt end 311 passes under a rod held by tabs (all not seen in the figure) to the side 312 . The belt ends 307 and 311 pass onto the stage 315 (in FIGS. 15 and 16 ) where the cap 316 holds them securely in place with the belt snug around the patient's chest. [0067] The stage 315 and the cap 316 attach to the two rack gears 321 and 322 which have the teeth 323 on both sides. The rack gears 321 and 322 and thus the stage 315 and the cap 316 remain free to move vertically relative to the base 302 and the sides 311 and 312 . Furthermore, The platform 315 attaches to the post 325 which can also move vertically in the housing 326 , which is also attached to the base 302 . The insertion of the post 325 into the housing 326 guides the vertical motion of the stage 315 . As the stage 315 moves upward, it also pulls the belt ends 307 and 311 in the same direction. This pulls the belt ends 307 and 311 through the rods (one of which appears in FIG. 14 and bears the number 308 ) and tightens the belt 303 around the patient's chest for CPR. [0068] However, the vertical motion of the stage 315 and thus the tightening of the belt 303 fall ultimately under the control of the handles 331 and 332 . The left handle (in the figures) 331 attaches to the two arms 335 and 336 which, in turn, connect to the two gear segments 337 and 338 , respectively. [0069] Pushing down on the handle 331 will cause the arms 335 and 336 and the gear segments 337 and 338 to rotate in the counterclockwise direction (in the figures) around the rod 341 attached to the sides 309 and 312 by the bolts 343 and 344 , respectively. As the handle 331 and thus the gear segments 337 and 338 rotate in the counterclockwise direction, the teeth on the segments 337 engage the teeth 323 on the left side of the rack gears 321 and 322 causing them to move upwards. This takes the stage 315 and the belt ends 307 and 311 in the same direction which serves to tighten the belt 303 around the patient's chest for CPR. [0070] Similarly, the handle 352 connects to the two arms 353 and 354 . Pushing down on the handle 352 causes it to rotate in the clockwise direction and move its two gear segments (only the one of which labeled 357 appears in the figures) in the same direction. These, in turn, engage the right side of the rack gears 321 and 322 causing them to move upwards. This helps lift the state 315 and tighten the belt 303 around the patient's chest. [0071] Thus, pushing down on the handles 331 and 352 accomplishes two tasks. First, it applies a downward force directly from the base 302 onto the patient's chest to depress it. Second, it tightens the belt 303 around the patient's chest to compress it. Both of these actions contribute to the desired CPR. [0072] The spring 361 sits around the bar 341 and biases the handle 331 in the clockwise direction. If the operator releases the handle 331 after a CPR cycle, the spring 361 will move it back to the upright position seen in the figures. There it will wait for the next cycle. [0073] FIG. 17 shows a CPR device generally at 401 identical to the unit 301 of FIGS. 14 to 16 . However, it also includes the large suction cup 402 that sits on the patient's chest. Upon the completion of a CPR stroke (as discussed in reference to FIGS. 14 to 16 ), the operator can pull upwards on the handles 303 and 304 . This will cause the suction cup 402 upward and pull the patient's chest in the same direction. This chest expansion assists in the blood flow around the heart and also facilitates the patient's obtaining air for breathing. Instead of the suction cup, the device 410 may have an adhesive on the bottom of its base to accomplish the same objectives.

Manual CPR apparatus allowing the application of force at two points separated by a line making a nonperpendicular angle relative to the longitudinal axis of the patient. The line separating the two force points may also lie out of the plane formed by the device's belt which circumnavigates the patient's torso. These geometrical configurations allow the facile application of the CPR force to the device by one or more operators located along the side of the patient. The device may have the capability to limit the achieved circular chest compression to one of a plurality of magnitudes. The device may also provide signals to indicate the appropriate times for applying pressure and may incorporate electrocardiogram and defibrillation components. The device may contact the patient's chest with a suction cup or other adhering component to assist in the patient's chest expanding in the interval between compressive strokes.

This is a continuation of copending application Ser. No. 08/799,240 filed Feb. 14, 1997. BACKGROUND OF THE INVENTION 1. Field of the Invention This disclosure relates to the non-invasive application of ultrasonic energy to enhance and/or accelerate the process of wound healing, and more particular, to the healing of wounds including ulcers, such as venous ulcers. 2. Description of the Related Art Venous ulcers on human legs have proven difficult to treat, for example, because of the lack of vascularization in and around the wound. The term "wound" for the purposes of "wound healing", as used throughout the present disclosure, includes ulcers such as venous ulcers as well as burns, ulcerated wounds due to, for example, diabetes, surgical incisions or other surgical cuttings including stitched surgical cuttings, skin grafts, hair transplants, re-vascularization, bed sores, tissue dehiscence, and ligament and tendon repair and reconstruction. In general, as used throughout the present disclosure, the term "wound healing" encompasses addressing damage to, repair of, or restoration of soft tissue. U.S. Pat. No. 4,530,360 to Duarte (hereafter "Duarte"), describes a basic therapeutic technique and apparatus for applying ultrasonic pulses from an ultrasonic applicator placed on the skin at a location adjacent a bone injury. Duarte gives a range of radio frequency (RF) signals for creating the ultrasound, ultrasonic power density levels, a range of duration of each ultrasonic pulse, and a range of ultrasonic pulse frequencies. The length of daily treatment is also described in Duarte. The Duarte patent is incorporated herein by reference. U.S. Pat. Nos. 5,003,965 and 5,186,162, both to Talish and Lifshey (hereafter "Talish '965" and "Talish '162", respectively) describe an ultrasonic delivery system in which the RF generator and transducer are both part of a modular applicator unit which is placed at the skin location. The signals controlling the duration of ultrasonic pulses and the pulse repetition frequency are generated apart from the applicator unit. Talish '965 and Talish '162 also describe fixture apparatus for attaching the applicator unit so that the operative surface is adjacent to the skin location. In one application described in Talish '965 and Talish '162, the skin is surrounded by a cast. 5,211,160 to Talish and Lifshey (hereafter "Talish '160") also describes a fixture apparatus which is mounted on uncovered body parts; i.e. without a cast or other medical wrapping. Talish '160 also describes various improvements to the applicator unit. Each of Talish '965, Talish '162, and Talish '160 is incorporated herein by reference. U.S. patent application Ser. No. 08/388,971 entitled Locator Method and Apparatus and 5,626,554 to Ryaby, Talish and McCabe (hereafter "Ryaby '554"), 5,556,372 to Talish, Ryaby, Scowen and Urgovitch (hereafter "Talish '372"), and 5,520,612 to Winder, Talish and Ryaby (hereafter "Winder '612"), entitled Gel Containment Structure, Apparatus for Ultrasonic Bone Treatment, and Acoustic System for Bone-fracture Therapy, respectively, provides ultrasonic apparatus and methods which are applicable to wound healing. U.S. patent application Ser. No. 08/388,971 and Ryaby '554, Talish '372, and Winder '612 are incorporated herein by reference. In general, an ultrasound carrier frequency between 20 kHz and 10 MHz coupled with a relatively low-frequency modulating signal, such as 5 Hz to 10 kHz, and a spatial peak temporal average acoustic intensity, such as an intensity less than about 100 milliwatts/cm 2 , should aid in and should be effective in wound healing. Heretofore, such techniques have not been applied to heal wounds by internal application of ultrasound, such as using reflection of ultrasonic waves by reflection from internal tissue such as bone. SUMMARY It is herein recognized that both longitudinally propagating ultrasound and shear waves generated by a transducer mechanism and/or by such longitudinally propagating ultrasound provide effective healing of wounds. A portable therapeutic device and method of use thereof for healing a wound includes a transducer having an operative surface, with the transducer, disposed substantially adjacent to the wound to emit ultrasound to propagate in the direction of the wound for the healing thereof. Reflections of the ultrasound by bone tissue and by skin layers propagate toward the wound as longitudinal waves for the healing thereof, and shear waves are generated by the longitudinal waves and/or the reflected longitudinal waves for the healing of the wound. The transducer may include an axis and a focusing element for focusing the propagation of the ultrasound at a predetermined angle with respect to the axis, with the focused ultrasound propagating toward the wound for the healing thereof. Alternative configurations of the operative surface of the transducer include an annularly shaped operative surface for emitting the ultrasound therefrom, with the wound encircled by the operative surface for receiving the ultrasound and/or reflected ultrasound. A housing may be provided for positioning the transducer substantially adjacent to a portion of the skin substantially adjacent to the wound, and for causing the portion of the skin to form a cavity, with the operative surface of the transducer disposed in the cavity to emit the ultrasound to an internal surface of the wound for the healing thereof. Reflective media may be internally disposed within the body having the wound for reflecting the ultrasound from the transducer to propagate toward the wound for the healing thereof. Fixture structures, extending about a portion of the body having the wound, may also be provided for positioning the transducer substantially adjacent to the skin substantially adjacent to the wound. The fixture structure may include an adjustable strap. In other embodiments, the transducer may be a rod-shaped operative surface having an axis for emitting the ultrasound radially toward the wound for the healing thereof. Using the disclosed therapeutic devices, wounds are safely and simply treated, with such wounds as venous ulcers responsive to therapeutic ultrasound to be healed effectively. Such therapeutic devices and methods of use provide for wound treatment by modest adaption of existing devices for delivering ultrasound in therapeutic settings. In one embodiment, a device is provided for delivering an ultra-high-frequency carrier signal for low power excitation of an acoustic transducer which is acoustically coupled to a limb or other part of a living body. The transducer is positioned adjacent an external skin location in the vicinity of the external border of the wound on the skin to provide a surgical, non-invasive transcutaneous delivery of at least part of its acoustic energy directed from the external skin location toward a portion of a bone located within the body in the vicinity of the boundary of the wound internal to the body. The boundary of the wound internal to the body is also referred to herein as the internal or interior surface of the wound. Once the acoustic energy enters the body, it passes into internal body tissue and/or fluids. The acoustic energy, in the form of ultrasonic pulses, is reflected off the surface of underlying bone or other ultrasound reflective material, and the reflected ultrasound travels toward at least part of the internal surface or underside of the wound. Healing of the wound at the internal surface by the generation of epithelial cells is enhanced via the acoustic stimulation. Preferably, a low frequency signal which is present as a modulation of the carrier frequency is transmitted from the ultrasonic transducer, through interposed soft tissue, and onto the surface of the bone. The carrier wave incident on the bone surface, or other reflection surfaces in the body, is reflected toward the internal surface of the wound. When the carrier wave impinges the internal surface of the wound, at least a portion of the carrier wave is converted into therapeutically beneficial shear waves of acoustic energy, flooding a region of the internal surface of the wound. The shear waves increase vascularization at the internal surface of the wound, thus enhancing growth of epithelial cells. The epithelial cell growth represents healing of the wound. The technique thus promotes healing of the wound from the internal surface of the wound. The number, position, and size of ultrasonic applicators used at the external skin location are chosen based on the size and position of the wound, and the relative position and proximity of the bone from which the ultrasonic waves are reflected. One or more ultrasonic therapy treatments per day, each having a duration of approximately 20 minutes, is suitable. BRIEF DESCRIPTION OF THE DRAWINGS The features of the disclosed therapeutic ultrasound apparatus and method will become more readily apparent and may be better understood by referring to the following detailed description of an illustrative embodiment of the present invention, taken in conjunction with the accompanying drawings, where: FIG. 1 is a cut-away perspective view showing a device and method of use thereof for wound healing; FIG. 2 is a side view of an embodiment of an ultrasound transducer; FIG. 3 is a side cross-sectional view of the device using a focusing attachment; FIG. 3A is a cut-away perspective view of an alternative embodiment of the transducer configured to have an annular shape and a woven fabric covering; FIG. 4 is a frontal view of a typical wound disposed on a torso; FIG. 5 is a cut-away perspective view of the wound healing device disposed near the wound in the torso; FIG. 6 is a cut-away perspective view of the wound healing device applied to a wound in conjunction with a gel bladder; FIG. 7 is a cut-away perspective view of the wound healing device causing an indentation of the torso to orient the transducer for healing the wound; FIG. 8 is a cut-away perspective view of the wound healing device operating in conjunction with an internally disposed reflecting medium; FIG. 9 is a cut-away perspective view of an alternative configuration of the wound healing device having an annular configuration and a woven fabric covering and operating in conjunction with an internally disposed reflecting medium; FIG. 10 is a cut-away perspective view of an alternative configuration of the wound healing device having a rod-like configuration; FIG. 11 is a cut-away perspective view of an alternative configuration of the wound healing device having an annular configuration without a woven fabric covering; and FIG. 12 is a perspective view of an alternative configuration of the wound healing device attachable to a thigh for healing a wound thereupon. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now in specific detail to the drawings, with like reference numerals identifying similar or identical elements, as shown in FIG. 1, the present disclosure describes an apparatus 10 and method of use thereof for wound healing, which includes an ultrasonic generator 12 and one or more ultrasonic applicators 14, which include ultrasonic transducers 16 known in the art, for applying ultrasonic waves 18, 20 to a wound 22, such as an ulcer. More than one applicator 14 or transducer 16 may be used to stimulate larger wounds, as needed. The spatial peak temporal average acoustic intensity of the applicators 14 is between about 5 mW/cm 2 and about 100 mW/cm 2 . The carrier frequency and intensity of the ultrasonic treatment is selected by taking into account such factors as: (1) the amount of soft tissue interposed between the external skin location, where the ultrasonic applicator 14 is positioned, (2) the position and cross-section of the bone site 24 from which the ultrasonic waves 18 are reflected, (3) the amount of soft tissue interposed between the bone 26 and the internal surface 28 of the wound 20, and (4) the size, topography and medical characteristics of the internal surface 28 of the wound 20, and, consequently, shear waves or surface acoustic waves (SAW) and longitudinal waves to be generated at the site. The carrier wave is modulated with an audio signal approximately between 5 Hz and 10 Khz. Low level ultrasound delivers a primary wave called the longitudinal wave 30, which is emitted by the transducer 16 of the applicator 14 as shown in FIG. 1. There are also shear waves or SAW 32 generated by the ultrasound from the transducer 16 which radiate outward along the skin surface. The primary longitudinal wave 30 is partially incident on a bone 26 in the body, and so is partially reflected at a reflection site 24 to generate a reflected portion 34, with the reflected portion 34 directed toward the internal surface 28 of the wound 22. The primary longitudinal wave 30 may also be reflected by other surfaces. For example, as shown in FIG. 1, the internal layer 36 of skin on the opposite side of a limb to the transducer 16 may provide a reflective surface to thus generate additional reflected longitudinal waves 38 directed from the opposite internal skin layer 36 to the wound 22. When the reflected longitudinal waves 34, 38 impinge on the internal surface 28 of the wound 22, such reflected longitudinal waves 34, 38 are at least partially converted to shear waves or SAW 32 in and around the internal surface 28 of the wound 22, which enhance wound healing at the internal surface 28 by stimulating cell production by the mesenchymal line, thus promoting vascularization and epithelialization. As shown in the illustrative embodiment in FIG. 1, the ultrasonic applicator 14, including the transducer 16 configured as a modular unit, is placed adjacent an external skin location 40 in the vicinity of the external border of the wound 22. A gel bladder 42, or alternatively a loose conducting gel or other ultrasound conducting media, is positioned between the transducer 16 and the external skin location 40. As shown in FIG. 1, the ultrasound which is transmitted into the soft tissue medium in the form of longitudinal waves 30 diverges as it moves toward the bone 26 or other surfaces such as the skin layer 36 providing reflection. The reflected ultrasound, in the form of longitudinal waves 34, 38, continues to diverge as it approaches the internal surface 28 of the wound 22, so that the ultrasonic treatment delivered to the general site of the wound 22 covers a relatively large region of the internal surface 28 of the wound 22. Alternatively, as shown in FIG. 2, the transducer 16 may have an attachment, typically positioned between the operative surface 46 of the transducer 16 and the gel bladder 42, which acts as a focusing element to focus the ultrasound emitted from the operative surface 46 into the soft tissue. In another embodiment, the transducer 16 may be configured to have the focusing element integrally formed with the transducer 16. FIG. 3 shows a side view of the transducer housing of FIG. 2 showing the transducer 16 including the focusing element, illustratively embodied as the attachment 44. Thus, the ultrasound emitted from the transducer 16 in the form of a primary longitudinal wave 30 may be directed at an angle 48 with respect to an axis 50 associated with the transducer and thence toward the bone 26 or other reflective surfaces when the ultrasound enters the soft tissue. The reflected waves 34, 38 also remain relatively focused. The reflected longitudinal waves 34, 38 may generate respective sets of shear waves or SAW for providing a combined therapeutic treatment to the wound 22. As shown in FIG. 3, the reflected longitudinal wave 34 created by reflection of the primary longitudinal wave 30 off the bone 26 is incident on a portion of the internal surface 28 of the wound 22, thus creating a first set of shear waves 52. The reflected longitudinal wave 38 created by the reflection of the primary longitudinal wave 30 off the opposite side layer 36 of tissue is incident on a separate portion of the wound 22, thus creating a second set of shear waves 54. In addition to this technique, the angle 48 of the ultrasonic emission may be swept and/or modified, either physically or electronically, so that different regions of the internal wound surface 28 may be treated. In either technique, two or more transducers may be used, as determined by the size, length, etc. of the wound 22. Generally, multiple transducers may be provided at a number of external skin locations around the wound 22 in order to increase the effectiveness of the ultrasonic therapy reflected to the internal surface 28 of the wound 22. In the illustrative embodiments of FIGS. 1-3, the ultrasonic head module of the ultrasonic applicator 14 includes the transducer 16 of an ultrasonic treatment apparatus. For clarity, the fixture structure which holds the head module adjacent the external skin location 40 is omitted. Also omitted are the electronics and other features which ultimately provide the excitation signals for the transducer 16. These are described in further detail in the above-referenced patents and patent applications, which have been incorporated by reference. Alternatively, or in conjunction, the at least one ultrasonic applicator 14 may be moved, or may be configured to be movable, to a different external skin location adjacent the wound 22 in order to provide treatment to various portions of the wound 22. Varying the position of the at least one ultrasonic applicator, including moving the transducer 16 circularly or linearly along the skin, also provides treatment of varying intensity at portions of the wound 22. The transducer 16 itself may also be configured to vibrate with respect to a given external skin location, so that the longitudinal waves 30 generated therefrom and transmitted through the soft tissue are more uniform, thus providing more uniform treatment, including more uniform shear waves, at the internal wound surface 28 where the reflected longitudinal waves 34, 38 impinge. The transducer 16 may be made to vibrate with respect to a housing (not shown in FIGS. 1-3 for clarity) which holds the transducer 16 adjacent an external skin location to accomplish such uniformity of longitudinal waves 30. The focusing of ultrasonic waves described with respect to FIGS. 2-3 above is illustratively shown with a substantially planar operative surface 46 and a substantially conical attachment 44. In alternative embodiments, the focusing of ultrasonic waves may be provided by configuring the transducer 16 with non-planar surfaces such as non-planar operative surfaces or non-planar segments to generate and emit ultrasound with different propagation characteristics in order to allow differing patterns and intensities of ultrasonic waves to be transmitted toward the internal surface 28 of the wound 22. This provides a variety of therapeutic ultrasonic stimulation and treatment at the internal surface 28. For example, the transducer segments may be pie shaped, annular rings, or other configurations, which may be activated separately or in unison. Alternatively, or in conjunction, the transducer 16 may be provided with a modal converter or transducer lens, which may also change the pattern of the ultrasound emitted from the transducer 16. The carrier frequency and/or the modulating frequency may also be varied or swept through a range of frequencies in order to provide a variety of treatments to the internal wound surface 28. The frequencies may be varied either in a continuous manner, or discrete changes may be made in the applied frequency. Varying the carrier and/or modulating frequency is especially useful in applying ultrasonic treatment to promote a variety of stages of cell regeneration in approximately the same region during the same therapy session. In an alternative embodiment, FIG. 3A illustrates treatment of a wound 22 such as a venous ulcer as in FIGS. 1-3, but utilizing an annular-shaped transducer 56 having a curved operative surface 58 (shown in a cut-away perspective view in FIG. 3A) composed of a composite piezoelectric material attached by a connector 60 to an ultrasonic generator (not shown in FIG. 3A), in which the composite piezoelectric material disposed in a woven fabric 62 or a semi-permeable member provides ultrasonic conductivity between the transducer 56 and the skin of the patient. The woven fabric 60 may have either a hard or a pliable construction, and may be composed of material conductive of ultrasound. Alternatively, the woven fabric 60 may be porous for retaining and releasing ultrasound conductive gel. The transducer 56 is cut or constructed to surround the external surface of the wound 22. When the appropriate RF signals are applied, the composite piezoelectric material of the transducer 56 emits ultrasonic waves having the therapeutic parameters previously described. Primary longitudinal waves 64, 66 are emitted from the composite piezoelectric material into the body, as shown in FIG. 3A, and reflected from the surface of the bone 26 or from other reflective interfaces, to generate reflected longitudinal waves 68, 70, respectively, which are directed onto the internal surface 28 of the wound 22, thus creating therapeutic shear waves 72, 74, respectively. It is understood that the composite piezoelectric material may completely surround the wound 22; thus, the primary longitudinal waves 64, 66 are emitted from around the entire wound, reflected from the reflecting material, and incident on the internal surface 28 of the wound 22, thereby flooding the internal surface 28 of the wound 22 with the induced shear waves 72, 74. While the embodiments of the present invention described above refer to the reflection of a primary longitudinal wave from a bone to an internal surface of a wound, the present invention also encompasses delivery of ultrasound to the internal surface of the wound where there is no bone or other reflecting surface in the vicinity of the wound, as described below in further detail with reference to FIGS. 4-11. FIG. 4 illustrates the front of a male torso 76 having a wound 78 on the stomach. The views illustrated in FIGS. 5-11 are cross-sectional views of FIG. 4 taken across lines 5--5. As shown in FIG. 5, a transducer 80 is positioned in a transducer housing 82 disposed upon the external skin of the torso 76 adjacent to the external border of the wound 78, and a longitudinal wave 84 emitted from the transducer 80 penetrates far into the body before it is reflected off a surface internal to the torso 76 such as the spine or any internal organs such as the lungs, stomach, or intestines, which may contain gases such as air, with reflected longitudinal waves then directed onto the internal surface 86 of the wound 78. This is especially true when the person is overweight, or when the cross-section of available reflecting surfaces is small and/or uneven. The longitudinal wave 84 may provide some therapeutic healing of the wound 78, but the intensity of the reflected wave incident on the internal surface 86 of the wound 78 may be too attenuated to provide the necessary therapeutic treatment. FIG. 6 shows an alternative method and embodiment of treating such wounds of the torso 76, in which a gel bladder 88 is interposed between the external surface of the wound 78 and the operative surface of the transducer 80. The longitudinal wave 84 emitted from the transducer 80 travels directly through the gel bladder 88 and into the wound 78, thus creating a shear wave 90 when the longitudinal wave 84 is incident on the internal surface of the wound 78. The gel bladder 88 is to be sterile, especially if the wound 78 is open, and may be impregnated with medication, such as an antibacterial ointment, which flows into the wound 78 and/or its surface during the ultrasonic treatment. FIG. 7 illustrates another method and device for treating the wound 78 of a torso 76, in which the transducer 80 is pressed against the external surface of the lower torso, such as approximately adjacent the stomach, to be positioned near the wound 78. By pressing the transducer housing 82 against the external region of the stomach, a local indentation 92 is created. The transducer housing 82 may be turned as it is pressed inward, so that the operative surface 94 of the transducer 80 is directed in the general direction toward the internal surface 96 of the wound 78 within the indentation 92. As shown, the longitudinal wave 98 emitted is incident directly on at least a portion of the internal surface 96 of the wound 78, thus inducing therapeutic shear waves 100. If a specially configured transducer, or alternatively a transducer attachment 102, is used, such as shown in FIG. 3, for focusing the ultrasound in a specific direction, the longitudinal wave 98 may be emitted off of a center axis 104 of the transducer 80, for example, in a direction toward the internal surface 96 of the wound 78, without the need for turning the transducer housing 82 as it is pressed against the skin. FIG. 8 illustrates another method and device for treating a wound 78, in which a reflecting medium 106 is inserted into the body in the proximity of the internal surface 96 of the wound 78. The properties of the reflecting medium 106 provide for the reflection of the longitudinal wave 108 toward the internal surface 96 of the wound 96, as if a bone were present, such as described above with reference to FIGS. 1-3A. The reflecting medium 106 may be composed of a variety of materials, and may be fixed in the body or inserted temporarily. For example, the reflecting medium 106 may be a metallic plate, a gas filled pouch, or other quasi-permanent inserts. The reflecting medium 106 may be also be, for example, a contrast agent composed of, for example, bubbles in a gelatin, which is injected intravenously prior to the treatment. In one embodiment, the contrast agent may be absorbable by the body in a relatively short period, thus the contrast agent acts as a temporarily inserted reflecting medium. An inserted reflecting medium 106, as described with respect to FIG. 8 above, performs particularly well in conjunction with a piezoelectric ultrasonic material or device. As shown in FIG. 9, the piezoelectric ultrasonic device 110 may be embodied as the device 56 described above with respect to FIG. 3A. The piezoelectric ultrasonic device 110 may be configured to surround the exterior boundary of the wound 78. As shown in FIG. 9, illustrative examples of the longitudinal waves 112, 114 generated from the piezoelectric ultrasonic device 110 surrounding the wound 78 are reflected off of an internally disposed medium 116 and onto the internal surface 96 of the wound 78, thereby generating therapeutic shear waves (not shown in FIG. 9) at the internal surface 96 of the wound 78. It is understood that the piezoelectric ultrasonic device 110 completely surrounds the wound 78; thus, longitudinal waves not limited to the illustrative examples of longitudinal waves 112, 114 are emitted around the entire wound 78, reflected from the reflecting material 116, and incident on the internal surface 96 of the wound 78, to flood the internal surface 96 of the wound 78 with induced shear waves. In an alternative embodiment shown in FIG. 10, an ultrasonic transmitting rod 118 is provided which emits at least one longitudinal wave 120 radially from the axis of the ultrasonic transmitting rod 118. The rod 118 may be composed of, for example, a composite piezoelectric material, and the rod 118 is secured to the patient by a harness apparatus 122, 124 such that the rod 118 is pressed against the skin adjacent the wound 10, and a portion of the longitudinal wave 120 is incident on the internal surface 96 of the wound 78, thus inducing therapeutic shear waves (not shown in FIG. 10). In another alternative embodiment shown in FIG. 11, an ultrasonic transmitting ring 126 is provided which emits longitudinal waves 128, 130 radially from the surface of the ring 126. The ring may be composed of, for example, a composite piezoelectric material, and may be configured in a manner similar to the piezoelectric ultrasonic devices 56 and 110 in FIGS. 3A and 9, respectively, without the woven fabric to act as an ultrasonic conductor. Accordingly, ultrasonic conductive gel may be used with the ring 126 of FIG. 11. With the ring pressed against the skin surrounding the wound 78, a portion of the longitudinal waves 128, 130 emitted from the ring 126 is incident on the internal surface 96 of the wound 78, thus inducing therapeutic shear waves 132, 134. It is understood that the ring 126 may be configured to completely surrounds the wound 78; thus, longitudinal waves including the illustrative longitudinal waves 128, 130 are emitted from around the entire wound 78 and incident on the internal surface 96 of the wound 78, to flood the internal surface 96 of the wound 78 with induced shear waves 132, 134. In an alternative configuration shown in FIG. 12, the wound healing device 136 includes a transducer 138 positioned in a housing 140 which is secured by an adjustable securing structure 142 to a thigh for healing a wound 78 thereupon, with the transducer 138 emitting longitudinal ultrasonic waves 144 which generate shear waves (not shown in FIG. 12) upon contact with the internal surface of the wound 78. In an illustrative embodiment, the adjustable securing structure 142 shown in FIG. 12 includes an adjustable strap 146 having a first portion 148 engaging a second portion 150 using hook and link fasteners. Alternatively, a belt with a buckle and notches may be used, or a sterile adhesive strip for adhering to the thigh. As noted above, the term "wound" as used herein, has a broad meaning, generally encompassing addressing damage to, repair of, or restoration of soft tissue. The present invention may be used, for example, to prevent surgical adhesions, by stimulating the proper repair of surgical incisions. It may also prevent or arrest wound dehiscence, by promoting vascularization at the surfaces adjacent surgical incisions. It may also be used in cosmetic surgery, for example, by enhancing the healing of hair transplants, or by directly stimulating regeneration of cells. Accordingly, modifications such as those suggested above, but not limited thereto, are to be considered within the scope of the invention.

A portable therapeutic device and method of use generate longitudinally propagating ultrasound and shear waves generated by such longitudinally propagating ultrasound to provide effective healing of wounds. A transducer having an operative surface is disposed substantially adjacent to the wound to emit ultrasound to propagate in the direction of the wound to promote healing. Reflections of the ultrasound by bone tissue, by skin layers, or by internally disposed reflective media propagate toward the wound as longitudinal waves, with shear waves generated by the longitudinal waves for the healing of the wound. A focusing element is used for focusing the propagation of the ultrasound at a predetermined angle toward the wound. The operative surface of the transducer may be annularly shaped to encircle the wound to convey the ultrasound and/or reflected ultrasound thereto. A housing may be provided for positioning the transducer near a portion of the skin near the wound, and for indenting the skin to form a cavity, with the transducer disposed in the cavity to emit the ultrasound toward an internal surface of the wound. Fixture structures, such as adjustable straps, may extend about a portion of the body to position the transducer near the wound.

CROSS-REFERENCE TO RELATED APPLICATION [0001] None. ABSTRACT [0002] A modified dental implant fixture designed with a multiple of three or more thread or groove patterns such that the threads or grooves transition from smaller to larger moving in the apical direction along the long axis of the dental implant body. Such a modified implant maintains adequate wall thickness for a deep conical connection. BACKGROUND OF THE INVENTION [0003] The present disclosure relates generally to dental implants, and more specifically to a dental implant having a deep female conical connection which can result in limited wall thickness. By combining an innovative thread or combination of thread and groove patterns that transition from smaller coronal to larger and deeper apical threads, which are helpful in providing greater primary stability, a dental implant that maintains adequate wall thickness, when a deep conical connection is utilized, is achieved. [0004] Dental implants are used in place of missing natural teeth to provide a base of support for single or multiple teeth prosthetics. These implants generally include two components, the implant itself and the prosthetic mounting component referred to as an abutment upon which the final prosthesis is installed. The implant has apical and coronal ends, whereby the coronal end accepts the base of the prosthetic abutment using connection mechanisms of different designs. One such mechanism is a deep female conical receptor with an internal alignment or anti-rotational component such as a hex, double hex, spline or other single/multi-sided arrangement used for prosthetic alignment and anti-rotation stability. Deep female conical connections have been shown to prevent micro movement between the implant body and the abutment when loaded but can have the disadvantage of limited wall thickness especially if the implant is of a tapered design. [0005] In practice, the implant body is surgically inserted in the patients jaw and becomes integrated with the bone. More specifically, the implant body is screwed or pressed into holes drilled in the respective bone. The surface of the implant body is characterized by macroscopic and microscopic features that aid in the process of osseointegration. Once the implant is fully integrated with the jaw bone, the abutment is ready to be mounted. For two-stage implant designs, the abutment passes through the soft tissue that covers the coronal end of the implant after healing and acts as the mounting feature for the prosthetic device to be used to restore oral function. Implants of the single-stage design extend at least partially through the soft tissue at the time of surgical insertion. The coronal end of the implant body acts as part of a built-in abutment design with the margin of the coronal collar usually being employed as the margin of attachment for the prosthesis used to restore oral function. [0006] Both single and two stage implants are characterized by a central bore hole at their coronal ends that is generally threaded to accept a central screw to hold the abutment securely to the implant body. The exception would be some implants where the abutment is friction fit into the central bore hole and no screw is required. In any event, the implant, abutment, and screw are typically fabricated from titanium or a titanium alloy. Some implants are zirconia based, alumina based or sapphire based ceramics, and, in regions of high esthetic demands, the abutments are zirconia based. In some instances, ceramics and metals are combined to make a single component, though this is usually limited to the abutment component of the implant system. There is also promising research on the use of titanium zirconia alloys as well. [0007] One of the original implant designs was the so-called Branemark type implant characterized by an external hex. The hex was originally used to insert the implant and later utilized as an external anti-rotational and alignment element. This design usually displays a bone loss pattern described as a cupping of the bone at the coronal end of the implant once loaded with occlusal forces. This cupping pattern usually stabilizes after about one year of function with vertical bone loss of approximately 2 mm. By that time, loss of bone critical to the predictable support of overlying soft tissue is lost. As implant designs evolved internal connections utilizing an internal hex became much more common. For example, Astra Tech Inc. (“Astra”) was one of the first companies to introduce a deep conical design and use a double hex as their internal orientation element. [0008] In addition to having a more stable implant connection (deep female conical connection), Astra has also addressed the coronal bone loss by introducing micro threads at the coronal aspect of the implant body. This further modification is designed to distribute and transfer forces to the surrounding bone. However, clinicians are increasingly demanding dental implants with macro designs that achieve higher insertion torque values that generally translate to high initial implant stability. Prior Astra implants with a coronal flair had a single lead micro thread of 0.185 mm combined with a single lead apical thread of about 0.6 mm. To increase primary stability the micro threads were increased to 0.22 mm and made triple lead so as to be timed, together with having the same pitch, as the apical threads. This dramatically increased the required insertion torque and primary stability. Accordingly, in order to have more aggressive/deeper apical threads with wider spacing in combination with coronal micro threads of a similar dimension and still allow for adequate wall thickness for the deep female conical connection, an additional transitional thread pattern(s) of intermediate thread size(s) between the coronal micro threads and the larger apical threads is disclosed herein. However, the same thread pattern with inherent advantages can be utilized with any implant and is not limited to one with a deep conical connection. [0009] Another advantage to a larger apical thread, in addition to increasing primary stability, is to increase surface area particularly on larger diameter implants when wall thickness is less of an issue. While apical threads in the size range of 0.6 to 0.66 may be ideal for implants in the 3.0 to 4.5 mm diameter, larger diameter implants have adequate distance between the central bore hole and the outer wall to allow for deeper apical threads. The resulting increase in surface area is particularly beneficial for large diameter, shorter implants which, depending on the clinical circumstances, would allow surgeons to avoid the maxillary sinus in the upper posterior region of the mouth. [0010] More recent Astra implants have moved away from using an untimed micro thread of approximately 0.185 mm paired to a single lead apical thread of 0.6 mm, and now use a triple lead micro threads of about 0.22 mm timed to a single apical thread of approximately 0.66 mm. Meanwhile, U.S. Pat. No. 7,677,891 to Niznick (incorporated herein by reference) proposes quadruple lead (i.e. 4×) coronal threads spaced 0.3 mm apart and timed to double lead (i.e. 2×) apical threads spaced 0.6 mm apart with the 4× coronal threads being spaced considerably greater than 0.22 mm. Referring to FIG. 1 , the implant 10 , includes a tapered body 12 with two externally-threaded regions 14 and 16 . Proximal, externally-threaded region 14 includes V-shaped ×4 lead threads all of which have the same pitch. Distal portion 16 includes V-shaped ×2 lead threads. This type of implant design has a couple of disadvantages. First, in soft bone, the apical threads are limited to approximately 0.6 mm because coronal micro threads cannot be any larger than 0.3 mm and maintain crestal bone. Perhaps more critical, is the fact that a 2× apical thread increases the insertion speed. Specifically, if a sloped topped (e.g. U.S. Pat. No. 6,655,961) or asymmetric (e.g. copending application U.S. Ser. No. 12/494,510) coronal configuration is utilized, controlling the speed of the implant advancement into the host bone is essential. Accordingly, and as disclosed herein, the most apical thread should be a single thread (i.e. ×1). [0011] There is considerable prejudice among dentists and manufactures as to the benefits of tapered or straight walled implant designs. Some, like Astra, even combine a tapered coronal aspect with a parallel walled apical portion of the implant. Most now agree that some type of tapered apical cutting end, even on the parallel walled design, is desirable. This is demonstrated on Astra's recently introduced TX (tapered apex) design. Referring to FIG. 2 in particular, the implant 20 , includes a straight walled body 22 with two externally-threaded regions 24 (proximal) and 26 (distal). The tapered apex 28 has been added to make initial installation, into holes drilled in the respective bone, easier. [0012] However, both straight, tapered or a combination of tapered and straight bodied dental implants have their place in the field of implant dentistry depending on bone type and clinical application. For example, in the upper arch the bone is softer and the apical ends of adjacent teeth are closer together than in the lower arch. Therefore, a tapered design (that with a smaller apical end) fits between the roots of adjacent teeth more suitably while the tapered design compresses the softer maxillary bone upon insertion thus increasing implant primary stability at the time of placement. In the lower arch the bone is denser and root proximity is less of an issue so implants with parallel walls are considered more suitable by many clinicians. [0013] A tapered implant with a truly more concave profile has not been utilized in the dental implant field. While Astra does transition from a straight apical end to a 6 degree flared coronal design, the transition is abrupt. What is proposed herein is a 2 and then a 5 degree concave flare (or any like progressive) transition be utilized. Besides allowing adequate wall thickness, another advantage, when combined with the proposed herein combination of thread sizes, is to increase implant primary stability as measured by resonance frequency analysis while possibly lowering the amount of torque required to seat the implant. [0014] Accordingly, it is a general object of this dosclosure to provide a series of thread or a combination of groove and thread patterns that transition in spacing, size, pitch and depth such that adequate wall thickness for a deep internal female conical connection is maintained while allowing for an apical macro tread design that will result in greater primary stability for the dental implant while still keeping the rate of insertion within the limits that allow for either a sloped or asymmetric coronal configuration. [0015] It is a another object of this disclosure to enable implants with a tapered implant body to maintain adequate wall thickness when utilizing a deep female internal conical connection and still allow for a macro tread design that will result in greater primary stability while still keeping the rate of insertion within the limits that allow for either a sloped or asymmetric coronal configuration to be aligned with the surrounding bony topography. [0016] It is a further object of this disclosure to enable implants with a concave tapered implant body profile to maintain adequate wall thickness when utilizing a deep female internal conical connection and still allow for a macro thread design that will result in greater primary stability while still keeping the rate of insertion within the limits that allow of either a sloped or asymmetric coronal configuration to be aligned with the surrounding bony topography. [0017] It is a more specific object of this disclosure to enable a large diameter, shorter length implants with deeper apical threads with increased surface area while maintaining adequate wall thickness for a deep conical connection and coronal micro threads. [0018] These and other objects, features and advantages of this disclosure will be clearly understood through a consideration of the following detailed description. SUMMARY OF THE INVENTION [0019] According to an embodiment of the present invention, there is provided a dental implant for implanting within a human jawbone having an implant body with an outer surface, a longitudinal axis, a coronal end and an apical end. The coronal end includes a deep female conical receptor that creates a wall thickness between the outer surface of the implant body and the receptor. At least three differently sized threaded regions are positioned on the outer surface of the implant body with each region transitioning from smaller to larger in the apical direction along the axis. [0020] There is also provided a dental implant for implanting within the human jawbone having a longitudinal implant body with an outer surface, an apical end and a coronal end. A series of three or more thread patterns that start near the coronal end are in series with each one becoming progressively larger, deeper and/or wider in size when moving in the apical direction along the implant body. BRIEF DESCRIPTION OF THE DRAWINGS [0021] FIG. 1 is a side elevational view of a prior art implant. [0022] FIG. 2 is a side elevated view of a prior art implant having a tapered apex. [0023] FIG. 3 is a cross-sectional side elevated view of a prior art implant without thread timing or a tapered apex. [0024] FIG. 4 is a cross-sectional side elevational view a prior art implant with thread timing and a tapered apex. [0025] FIG. 5 is a cross-sectional side elevational view of an implant according to the principles of an embodiment of the present invention. [0026] FIG. 6 is a cross-sectional side elevational view of an alternate embodiment of an implant. [0027] FIG. 7 is a cross-sectional side elevational view of an alternate embodiment of an implant. [0028] FIG. 8 is a cross-sectional side elevational view of an alternate embodiment of an implant. [0029] FIG. 9 is a cross-sectional side elevational view of an alternate embodiment of an implant. [0030] FIG. 10 is a cross-sectional side elevational view of an implant. [0031] FIG. 11 is a side elevated view of an implant according to the principles of an embodiment of the present invention. [0032] FIG. 12 is a side elevated view of an alternate embodiment of an implant. [0033] FIG. 13 a is a side elevated view of an alternate embodiment of an implant. [0034] FIG. 13 b is a cross-sectional side elevational view of the implant of FIG. 13 a. [0035] FIG. 13 c is a top plan view of the implant of FIG. 13 a. [0036] FIG. 13 d is a perspective view of the implant of FIG. 13 a. [0037] FIG. 13 e is a detailed view of the variable thread form detail of FIG. 13 a. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0038] An embodiment of the subject invention will now be described with the aid of numerous drawings and included measurement designations. Unless otherwise indicated, such measurements are used for explanatory purposes only and they are not deemed to be limiting of the disclosed embodiments herein. The purpose of describing these measurements is to illustrate that the concept of using three or more thread or groove patterns while maintaining adequate wall thickness for a deep conical connection can be utilized for a wide variety of implant sizes and designs. [0039] In any event, turning now to the Figures, and in particular FIG. 3 , a prior art dental implant 30 is illustrated. This implant 30 is 11 mm long and has a step-wise diameter taper from 4.5 mm at its coronal end to 3 mm at its apical end. Two 60° thread patterns, at 1× to 1× are used on this implant 30 . The coronal threads 32 are 0.185 mm apart with grooves 0.1 mm deep, while the apical threads 34 are 0.6 mm apart with grooves 0.325 mm deep. The deep female conical connection 36 is the space within the implant 30 denoted by the dotted lines. This design provides for an upper wall thickness 38 of 0.303 mm and a lower wall thickness 40 of 0.440 mm. [0040] The prior art implant 50 of FIG. 4 is the next generation Astra design of FIG. 3 and is again 11 mm long, but instead of having a step-wise diameter taper from 4.5 mm to 3 mm ( FIG. 3 ), it utilizes a tapered apex (similar to FIG. 2 ) going down to 2 mm. While such a tapered apex makes installation of the implant easier, the thread pattern needed to be adjusted in an attempt to increase wall thickness for the deep conical connection. Specifically, two 80° thread patterns, at 1× to 3×, are used on this implant 50 . With 80°, the resulting reduced thread depth will increase the wall thickness. The coronal threads 52 are 0.22 mm apart with grooves 0.082 mm deep, while the apical threads 54 are 0.66 mm apart with grooves 0.246 mm deep. The deep conical connection 56 has an upper wall thickness 58 of 0.321 mm and a lower wall thickness of 0.519 mm. The change to 0.22 mm 3× coronal thread timing dramatically increases implant primary stability while the change to 80 degree threads increases all thickness for both the coronal threads 52 and the apical threads 54 . [0041] It has become apparent that an implant having a deep female conical connection is preferred to prevent micro movement between the implant and the abutment. In order to have both deeper apical threads that increase primary stability and coronal micro threads or grooves that better distribute force to the surrounding bone, an embodiment of the present invention adds at least one intermediate or middle thread to the pattern. This additional thread provides the necessary wall thickness to prevent implant breakage during function. [0042] There have been studies claiming that certain thread timing patterns are more ideal than others. Specifically, that a 2× to 4× combination allows for the micro threads to follow partially in the path of the major apical thread with only a new middle thread being cut. However, Astra's 1× to 3× thread does much the same thing where the transition to 3× from 1× merely adds one smaller thread above and one below the major thread which itself transitions to a micro thread following the prior path of the major thread. While the 2× to 4× pattern avoids cross cutting the major apical threads, the 1× to 3× Astra pattern does essentially the same thing. Accordingly, in one of the solutions disclosed herein, a 1× to 2× to 3× thread pattern, there would be cross cutting for the 2× apical threads but not for the most coronal 3× micro thread. However, as long as the same thread pitch is maintained in a tapered implant design or one with a slightly concave coronal profile cross cutting is inconsequential as the bone is being compressed and expanded outward. [0043] Cross cutting may be avoided for either a straight walled or tapered body implant using a 1× to 2× to 4× combination. However, bone gap jumping of up to 0.5 mm is clinically proven upon the immediate implant placement and therefore the only possible benefit might be for the ease of implant insertion as bone healing will fill in any cross threaded area in the bone. Taken to the extreme, and taking a 1× to 3× to 5× combination as an example, only the 5× portion would start to cross cut the 3× threads and only for the most coronal 20-25% or less. Furthermore, with a 1× to 2× to 4×, or a 1× to 3× to 6× no cross cutting would take place. For those knowledgeable in multiple lead thread timing this is well understood. [0044] The utilization of a middle thread to the pattern will now be described. An example thereof is first shown in FIG. 5 . In particular, this implant 70 is 11 mm long and has a step-wise diameter taper from 4.5 mm at its crown to 2 mm at its apex and is shown with 5° of coronal taper 72 and 2° of mid wall taper 74 . Three thread patterns, 80° at 1× to 80° at 2× to 80° at 4×, are used on this implant 70 . The coronal threads 76 are 0.22 mm apart with grooves 0.082 mm deep, the middle threads 78 are 0.44 mm apart with grooves 0.164 mm deep and the apical threads 80 are 0.88 mm apart with grooves 0.476 mm deep. The deep conical connection 82 has a mid wall thickness 84 of 0.372 mm and a lower wall thickness 86 of 0.607 mm, both of which exceed the parameters for prior art FIGS. 3 and 4 . [0045] While the straight walled apical diameter 88 has increased to 3.868 mm due to the increased thread depth in that region, the implant will go into the same diameter bone site as the prior art implant of FIG. 4 . Further, since the apical wall thickness has been increased to 0.607 mm, the parallel walled region could become slightly tapered with a minimal apical wall thickness equal to or greater than 0.519 mm shown in FIG. 4 . It should be noted that the implant of FIG. 4 does not allow the parallel walled section to become tapered because the apical threads were changed from 60° to 80° from the prior art of FIG. 3 in order to increase wall thickness for additional strength. [0046] It will be appreciated that merely adding an intermediate or middle or transitional thread to any implant will not create the acceptable wall thickness. For example, implant 90 of FIG. 6 differs from FIG. 5 by using 6° of coronal and 3° of mid wall taper and again all three thread patterns are at 80° and the apical thread 92 depth is 0.328 mm. This allows a mid wall thickness 94 of only 0.304 mm and a lower wall thickness 96 of 0.518 mm. The lower wall thickness is acceptable but the middle wall thickness is less than prior art FIG. 4 and the parallel wall section could not become slightly tapered as for the implant shown in FIG. 5 as it is already 0.001 mm below minimum dimension per FIG. 4 . Accordingly, the implant described in FIG. 5 is preferable to the implant of FIG. 6 . [0047] Three or more thread patterns can also be used on larger implants. For example, 11 mm long with step-wise diameter taper from 5 mm to 2.5 mm implants are shown in FIGS. 7 and 8 . Referring first to FIG. 7 , the implant 100 has a thread pattern of 60° at 1× to 80° at 3× to 80° at 5×. The coronal threads 102 are 0.2 mm apart with grooves 0.074 mm deep, the middle threads 104 are 0.33 mm apart with grooves 0.123 mm deep and the apical threads 106 are 1 mm apart with grooves 0.541 mm deep. The deep conical connection 108 has a mid wall thickness 110 of 0.595 mm and a lower wall thickness 112 of 0.553 mm. [0048] The implant 120 of FIG. 8 has all three thread patterns at 80° with a 1× to 3× to 6× pitch. The coronal threads 122 are 0.2 mm apart with grooves 0.074 mm deep, the middle threads 124 are 0.4 mm apart with grooves 0.149 mm deep and the apical threads 126 are 1.2 mm apart with grooves 0.447 mm deep. The deep conical connection 128 has a mid wall thickness 130 of 0.569 mm and a lower all thickness 132 of 0.647 mm. [0049] Referring now to FIG. 9 , this implant 140 is 11 mm long and has a step-wise diameter taper from 4.5 mm at its crown to 2 mm at its apex. Three thread patterns, 80° at 1× to 80° at 2× to 80° at 3×, are used on this implant 140 . The coronal threads 142 are 0.22 mm apart with grooves 0.082 mm deep, the middle threads 144 are 0.44 mm apart with grooves 0.164 mm deep; and the apical threads 146 are 0.66 mm apart with grooves 0.246 mm deep. The deep conical connection 148 has a mid wall thickness 150 of 0.372 mm and a lower wall thickness 152 of 0.689 mm. [0050] The slightly more tapered implant 160 of FIG. 10 has the same thread pattern and measurements of FIG. 9 . However, as discussed with regard to FIG. 6 , and due to the implant 160 dimensions, acceptable wall thickness is not created. While the deep conical connection 162 has a lower wall thickness 164 of 0.599 mm, the mid wall thickness 166 is merely 0.304 mm. Accordingly, the implant described in FIG. 9 is preferable to the implant of FIG. 10 . [0051] FIG. 11 shows a dental implant 170 with multiple thread patterns in profile. In this case, the deep apical threads 172 are followed by middle threads 174 and then coronal threads 176 up to the unthreaded portion 178 and top surface 180 . [0052] FIG. 12 shows a dental implant 190 with an addition set of threads. In particular, the deep apical threads 192 are followed by middle threads 194 and coronal threads 196 leading to parallel groove threads 198 before reaching the unthreaded portion 200 and the top surface 202 . It will be appreciated that two or more parallel groove patterns may be employed. [0053] One of the more advantageous uses for the present invention is to allow for wider diameter dental implants; the same can be said of shorter and wider diameter implants. For example, FIG. 13 a shows an implant 210 that is 6.50 mm long and has a diameter taper from 5.50 mm at its crown to 4.75 mm at its apex. Three thread patterns, a 1× to 2× to 3× all at 60°, are used on this implant 210 . The coronal threads 212 are 0.25 mm apart with grooves 0.14 mm deep and the middle threads 214 are 0.375 mm apart with grooves 0.20 mm deep. As for the apical threads 216 , they are shown with the apical minor diameters progressively being lowered, which results in the most apical thread having a more aggressive cutting profile (see FIG. 13 e ). Conversely, allowing the minor diameter to migrate coronally will result in a most apical buttress thread. The deep conical connection 218 of this shorter implant 210 is shown in FIG. 13 b - d. The combination multiple thread pattern of this design maintains the necessary wall thickness 220 between the deep conical connection 218 and the grooves of the thread patterns. [0054] Alternatively, 60° 1×, 2×, 4× threads could be used with the coronal threads 212 being 0.22 mm apart and 0.12 mm deep and the middle threads 214 being 0.44 mm and 0.24 mm while the apical threads would be spaced 0.88 mm apart and be variable or of consistent depth. [0055] The present disclosure addresses the issue of limited wall thickness associated with a deep conical connection. However, there are other advantages inherent in the design that could equally be applied to the implant with a different abutment connection Accordingly, while particular embodiments of the invention have been shown and described, it will be apparent to those skilled in the art that changes and modifications may be made therein without departing from the invention if its broader aspects, and, therefore, the aim in the appended claims is to cover all such changes and modifications as fall within the true spirit and scope of the present invention.

A modified dental implant fixture designed with a multiple of three or more thread or groove patterns which provide adequate wall thickness for a deep female conical connection such that the threads or grooves transition from smaller to larger moving in the apical direction along the long axis of the dental implant.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation-in-part application based on U.S. Ser. No. 11/500,317 filed on Aug. 8, 2006 entitled “Intracoronary Injection of a Mixture of Autologous Bone Marrow Derived Mononuclear Cells and Autologous Bone Marrow Derived Mesenchymal Stem Cells for Utilization and Rescue of Infarcted Myocardium. BACKGROUND OF THE INVENTION Technical Field [0002] There are several methods to deliver cells to the heart, among them: intracoronary (by the use of a catheter), intracardiac (directly into the heart during the intraoperative procedure of coronary artery bypass grafting, CABG or by transendocardial delivery), and intravenously (direct injection into a main blood vessel in the arm, leg, etc). [0003] Myocardial dysfunction resulting from atherosclerosis related myocardial infarction (MI) is a widespread and important cause of morbidity in the USA and mortality amongst adults. Due to scar- and ischemia-related post infarction events, clinical manifestations are enormous and heterogeneous. The damaged left ventricle undergoes progressive ‘remodeling’ and chamber dilation, with myocyte slippage and fibroblast proliferation. These events reflect an apparent lack of effective intrinsic mechanisms for myocardial repair and regeneration. Unless, deep (and still unknown) modifications are introduced in the area proximate to the damage to force proliferation of resident myocytes (Beltrami, 2001), all restorative therapies for MI must consider the use of an exogenous source of cardiomyocyte progenitors. [0004] A main issue in the decision to be taken has been the source and nature of cells to utilize. According to preclinical studies, the choice has ranged from resident differentiated but quiescent cardiomyocytes to stem cells or cardiomyocyte progenitors (Warejcka, 1996; Wang, 2000; Siminiak, 2003). Since, a cardiac monopotential stem cell has not yet been identified, the clinical options are narrowed to the use of a multipotential stem cell exhibiting a potential to differentiate into the cardiomyocyte lineage. From this point of view, marrow-located stem cells display the required biological properties for a cell therapy approach to treat patients with myocardial infarction (Wulf, 2001; Wagers, 2002; Herzog, 2003). Using animal models, it has been reported a near-normalization of ventricular function after treatment of acute infarcted myocardium with locally-injected bone marrow-derived precursor cells (Jackson, 2001; Orlic, 2001, for a recent review, see Husnain, 2005). However, it was not clear whether the beneficial effect produced by the graft was elicited by hematopoietic stem cells, precursors for cardiomyocytes and/or endothelial cells, stem cell plasticity or just contamination with other marrow cells (Wagers, 2002). On the other hand, the transplantation of unfractionated sheep bone marrow into chronically infarcted myocardium did not result in any beneficial effect (Bel, 2003). [0005] In addition, several studies have utilized mesenchymal stem cells (MSC) as a cell archetype for regenerative purposes after myocardial infarction. In vitro studies have shown that MSC have the potential to differentiate into spontaneous beating myotube-like structures, which express natriuretic peptides, myosin, desmin, and actinin and exhibit sinus node-like and ventricular cell-like action potentials (Makino, 1999; Bittira, 2002). In vivo studies have shown that when MSC are implanted into myocardium they undergo a milieu-dependent (microenvironment) cardiomyogenic differentiation and develop into myofibers containing striated sarcomeric myosin heavy chain and cell to cell junctions (Wang, 2000; Barbash, 2003). The xenogeneic or syngeneic transplantation of MSC have shown that infused cells were signaled and recruited to the normal and/or injured heart (Allers, 2004; Bittira, 2002), where they undergo differentiation and participate in the pathophysiology of post-infarct remodeling, angiogenesis and maturation of the scar (Bittira, 2003; Pittenger, 2005; Minguell, 2006). Furthermore, recent pig studies have shown that MSC infusion improves left ventricular function following myocardial infarction with no detectable immune or other toxicity (Min, 2002; Shake, 2002). [0006] Thus, the results of experimental studies showing that the implant of bone marrow-derived progenitor cells improves heart function after myocardial infarction have prompted several groups to test this notion in people. In the last 3 years, various clinical studies have assessed the effect of transplantation of autologous bone marrow in myocardial regeneration after acute myocardial infarction. In all these studies, the source of “repairing” cells has been the bone marrow mononuclear cell fraction (BM-MNC), which contains B, T and NK lymphocytes, early myeloid cells, endothelial progenitors and a very low number of hematopoietic and/or mesenchymal stem cells. In these studies, bone marrow was aspirated (40-250 ml) from patients, the BM-MNC prepared and the resulting cells (10.sup.6 to 10.sup.7) implanted into the infarcted ischemic myocardium, by using either a direct or a catheter-mediated injection. Results showed that the autologous implantation procedure is safe, feasible and seems to be effective under clinical conditions (Assmus, 2002; Perin, 2003; Sekiya, 2002; Stamm, 2003; Strauer, 2002; Tse, 2003). In all cases, the observed therapeutic effect was attributed to bone marrow progenitors-associated neovascularization (angiogenesis, Rafii, 2003), thus improving perfusion of infarcted myocardium. [0007] Based on preclinical and clinical studies, the rationale of the present clinical study is the following: every clinical attempt for myocardial regeneration might consider the implant of autologous progenitor cells, with the potential to differentiate and mature into cardiomyocytes, thus contributing to the recovery of local contractility. However, a comprehensive therapy should also consider the revascularization of the ischemic tissue by the implant of endothelial progenitor cells. BRIEF SUMMARY OF INVENTION [0008] Consequently, we propose that the combined infusion of autologous purified and expanded marrow-derived mesenchymal stem cells (a source of cardiomyocyte progenitor) and autologous bone marrow mononuclear cells (a primary source of endothelial progenitors) represents an effective and enduring myocardial replacement therapy. The above presupposes that the pair of implanted autologous progenitors will express their respective biological programs after interacting with proper microenvironment locus of the receptor tissue (Minguell, 2001; Wagers, 2002; Rafii, 2003). DETAILED DESCRIPTION OF THE INVENTION [0009] Results of experimental studies have shown that intramyocardial implantation of autologous mononuclear bone marrow cells induces neovascularisation, but not a robust improvement in heart function, after myocardial infarction. We propose that the above therapy in conjunction with one that provides a source of cardiomyocytes will represent a substantial promise as a cellular agent for cardiovascular therapy. [0010] As a source of cardiomyocyte progenitors and based on in vitro, ex vivo and in vivo studies, we propose the use of autologous ex vivo expanded bone marrow-derived mesenchymal stem cells (MSC). Encouraging preliminary efficacy data in large animal models of myocardial infarction (Minguell, 2006) and accumulating safety data from human studies of MSCs in non-cardiovascular applications is encouraging. [0011] In detail, our invention is the intracoronary injection (implant via catheter or direct injection) of a mixture of autologous bone marrow-derived mesenchymal stem cells (BM-MSCs) (cells that have the potential to differentiate and mature into mature cardiomyocytes) and autologous bone marrow-derived mononuclear cells (BM-MNCs) (cells that contain endothelial progenitors) that have the potential to differentiate and mature into cardiomyocytes and endothelial cells, representing an effective and enduring myocardial replacement therapy. See procedure below. [0012] Primary bone marrow aspirations from the iliac crest will be performed in patients twenty-five.+−.five days before receiving the cell infusion for preparation and expansion of BM-MSC. A secondary (25.+−. 5 days from primary aspiration) bone marrow aspiration from the iliac crest for preparation of BN-MNC will be performed within 5 hours of the intracoronary cell infusion to patients. For cell infusion, aliquots of autologous expanded BM-MSC and BM-MNC are taken and mixed together for a final volume of infusion medium. [0013] For a better understanding of procedures and schedule, please refer to the following Table. [0000] TABLE 1 DIAGRAM OF PROCEDURES AND SCHEDULE Days to Type of sample infusion Step to be taken Type of test to be performed −25 1 st Bone marrow aspirate cell suspension differential cell count; for preparation of MSC microbiological cells −25 Mononuclear cell fraction cell suspension differential cell count −20 Passage #0 (Primary BM- growth medium & cell number, viability, MSC culture) cell suspension microbiological −16 Passage #1 cell suspension cell number, viability −12 Passage #2 cell suspension cell number, viability −8 Passage #3 cell suspension cell number, viability −4 Passage #4 (Expanded growth medium & cell number, viability, MSC) cell suspension microbiological, mycoplasma 0 Final preparation of BM- BM-MSC cell number, viability MSC suspension microbiological, mycoplasma, Gram stain, immunotypification, differentiation potential 0 2 nd Bone marrow aspirate BM-MSC cell number, viability for preparation of MNC suspension microbiological, Gram stain, cells immunotypification 0 Cell product for infusion BM-MSC plus cell number, viability (final mixture of autogous BM-MNC microbiological, Gram stain, BM-MSC and BM-MNC) suspension endotoxin BM-MNC: bone marrow-derived mononuclear cell fraction BM-MSC: bone marrow-derived mesenchymal stem cells [0014] Cell infusion (transplantation) may be done in patients intraoperatively in conjunction with coronary artery bypass grafting by direct injection following the circumference of the infarct border or via intracoronary percutaneous balloon catheter designed for angioplasty. Subjects may include patients who fit criteria for acute myocardial infarction or patients with a defined region of myocardial dysfunction related to a previous myocardial infarction. [0015] Wall motion and left ventricular ejection fraction is evaluated by MRI and echocardiography. SPECT is used to assess viability and myocardial perfusion. [0016] A method for myocardial replacement therapy for a patient is disclosed. It involves acquiring two types of bone marrow-derived cells, a source of a therapeutically effective amount of mesenchymal stem cells that give rise to cardiomyocytes and a source of endothelial precursor cells either from mononuclear cells as such or after purification, that may give rise to new fine blood vessels. The therapeutically effective amount of mesenchymal stem cells and said mononuclear cells into an injection medium is combined. Such is injected into the patient. This method may be used wherein the step of acquiring a source of a therapeutically effective amount of mesenchymal stem cells that give rise to cardiomyocytes comprises performing a first bone marrow aspiration on said patient and producing a therapeutically effective amount of expanded bone marrow-derived mesenchymal stem cells. This method of myocardial replacement therapy may also include producing said therapeutically effective amount of autologous expanded bone marrow-derived mesenchymal stem cells, wherein the first bone marrow aspiration comprises performing said first bone marrow aspiration at least 20 days before the patient receives said injection medium, wherein said first bone marrow aspiration allows for expansion of a therapeutically effective amount of autologous expanded bone marrow-derived mesenchymal stem cells and where the performing of said first bone marrow aspiration from the patient's iliac crest. [0017] Further, the above method for myocardial replacement therapy for the patient may include acquiring a source of a therapeutically effective amount of the autologous expanded bone marrow-derived mononuclear as a source of endothelial precursor cells and comprises performing said second bone marrow aspiration from the patient's iliac crest. [0018] As an alternate, the method for myocardial replacement therapy for the patient of the last paragraph above may be accomplished to obtain said therapeutically effective amount of mesenchymal stem cells that give rise to cardiomyocytes and said therapeutically effective amount of endothelial precursors cells in mononuclear cells, by combining a therapeutically effective amount of aliquots of said therapeutically effective amount of autologous expanded bone marrow-derived mesenchymal stem cells and said therapeutically effective amount of endothelial precursors in mononuclear cells for a final volume of said injection medium. [0019] As another alternate, the method for myocardial replacement therapy for the patient of the paragraphs above may be accomplished by injecting said injection medium by intraoperatively injecting said therapeutically combination of cells in injection medium comprises directly to the heart in conjunction with coronary artery bypass grafting or by any other transendocardial delivery system similar to the circumference of the infarct border. [0020] As another alternate, the method for myocardial replacement therapy for the patient of the paragraphs above may be accomplished by injecting said injection medium by injection via intracoronary catheter. [0021] As another alternate, the method of the paragraphs above may be accomplished by said injection medium being said therapeutically effective amount of autologous expanded bone marrow-derived mesenchymal stem cells combined with said therapeutically effective amount of endothelial precursors cells in mononuclear cells. [0022] As another alternate, the method of the paragraphs above may be accomplished by the number of mesenchymal cells being increased in a first aspiration of bone marrow by ex vivo expansion. [0023] As another alternate, the method of the paragraphs above may be accomplished by the second aspiration being performed only to prepare the mononuclear cells. [0024] As another alternate, the method of the paragraphs above may be accomplished by the second aspiration occurring on the day when the amount of mesenchymal stem cells is sufficient to produce the therapeutically effective amount. REFERENCES [0000] Allers C, Sierralta W D, Neubauer S, Rivera F, Minguell J J, Conget P A. Dynamic of distribution of human bone marrow-derived mesenchymal stem cells after transplantation into adult unconditioned mice. Transplantation 78, 503, 2004 Assmus B, Schachinger V, Teupe C, Britten M, Lehmann R, Dobert N, Grunwald F, Aicher A, Urbich C, Martin H, Hoelzer D, Dimmeler S, Zeiher A M. Transplantation of Progenitor Cells and Regeneration Enhancement in Acute Myocardial Infarction (TOPCARE-AMI). Circulation 2002; 06: 3009-3017. Barbash I M, Chouraqui P, Baron J et al. Systemic delivery of bone marrow-derived mesenchymal stem cells to the infarcted myocardium. Circulation. 2003; 108: 863. Beltrami A P, Urbanek K, Kajstura J, Yan S M, Finato N, Bussani R, Nadal-Ginard B, Silvestri F, Leri A, Beltrami C A, Anversa P. Evidence that human cardiac myocytes divide after myocardial infarction. N Engl J. Med. 2001; 344:1750-1757. Bittira B, Kuang J Q, Al-Khaldi A, Shum-Tim D, Chiu R C. In vitro pre-programming of marrow stromal cells for myocardial regeneration. Ann Thorac Surg. 2002; 74: 1154-1159. Bittira B, Shum-Tim D, Al-Khaldi A, Chiu R C. Mobilization and homing of bone marrow stromal cells in myocardial infarction. Eur J Cardiothorac Surg. 2003; 24: 393-398. Herzog E L, Chai L, Krause D S. Plasticity of marrow-derived stem cells. Blood 2003; 102: 3483-3493. Husnain H K, Ashraf M. Bone marrow stem cell transplantation for cardiac repair. Am J Physiol Heart Circ Physiol 2005; 288: H2557-H2567. Jackson K A, Majka S M, Wang H, Pocius J, Hartley C J, Majesky M W, Entman M L, Michael L H, Hirshi K K, Godell M A. Regeneration of ischemic cardiac muscle and vascular endothelium by adult stem cells. J Clin Invest 2001; 107: 1395-1402 Makino S, Fukuda K, Miyoshi S, Konishi F, et al. Cardiomyocytes can be generated from marrow stromal cells in vitro. J Clin Invest. 1999; 103: 697-705. Minguell J J, Erices A, Conget P. Mesenchymal stem cells. Exp. Biol. Med. 2001; 226, 507-517. Minguell J J, Erices, A. Mesenchymal Stem Cells and the Treatment of Cardiac Disease. Experimental Biology and Medicine (in press) January issue, 2006. Min J Y, Sullivan M F, Yang Y, Zhang J P, Converso K L, Morgan J P, Xiao Y F. Significant improvement of heart function by cotransplantation of human mesenchymal stem cells and fetal cardiomyocytes in postinfarcted pigs. Ann Thorac Surg. 2002, 74: 1568-1575. Orlic D et al. Bone marrow cells regenerate infracted myocardium. Nature 2001; 410, 701-705. Perin E C, Dohmann H F, Borojevic R, Silva S A, Sousa A L, et al. Transendocardial, autologous bone marrow cell transplantation for severe, chronic ischemic heart failure. Circulation. 2003; 107:2294-2302 Pittenger M F, Martin B J. Mesenchymal stem cells and their potential as cardiac therapeutics. Circ Res. 2004; 95:9-20. Rafii S, Lyden D. Therapeutic stem and progenitor cell transplantation for organ vascularization and regeneration. Nat. Med. 2003; 9: 702-712. Sekiya, 2002 I, Larson B L, Smith J R, Pochampally R, Cui J G, Prockop D J. Expansion of human adult stem cells from bone marrow stroma: conditions that maximize the yields of early progenitors and evaluate their quality. Stem Cells, 2002; 20: 530-541. Shake J G, Gruber P J, Baumgartner W A, Senechal G, Meyers J, Redmond J M, Pittenger M F, Martin B J. Mesenchymal stem cell implantation in a swine myocardial infarct model: engraftment and functional effects. Ann Thorac Surg. 2002; 73: 1919-1925. Siminiak T, Kurpisz M. Myocardial replacement therapy. Circulation 2003; 108:1167-1171 Stamm C, Westphal B, Kleine H D et al. Autologous bone-marrowtem-cell transplantation for myocardial regeneration. Lancet, 2003; 361: 45-46 Strauer B E, Brehm M, Zeus T et al. Repair of infarcted myocardium by autologous intracoronary mononuclear bone marrow cell transplantation in humans. Circulation 2002; 106: 1913-1918 Tse H F, Kwong Y L, Chan J K, Lo G, Ho C L, Lau C P. Angiogenesis in ischaemic myocardium by intramyocardial autologous bone marrow mononuclear cell implantation. Lancet. 2003; 361: 47-49. Wagers A J, Christensen J L, Weissman I L. Cell fate determination from stem cells. Gene Therapy 2002; 9:606-612. Wang J S, Shum-Tim D, Galipeau J, Chedrawy E, Eliopoulos N, Chiu R C. Marrow stromal cells for cellular cardiomyoplasty: feasibility and potential clinical advantages. J Thorac Cardiovasc Surg. 2000; 20: 999-1005. Warejcka D J, Harvey R, Taylor B J, Young H E, Lucas P A. A population of cells isolated from rat heart capable of differentiating into several mesodermal phenotypes. J Surg Res 1996; 62:233-242. Wulf G G, Jackson K A, Goodell M A. Somatic stem cell plasticity: current evidence and emerging concepts. Exp. Hematol. 2001; 29: 1361-1370

The present invention is a method for improving cardiac function and myocardial regeneration in living subjects after the occurrence of myocardial infarction. The method is a combination stem cell therapy involving a mixture of bone marrow-derived mesenchymal stem cells and bone marrow derived mononuclear cells surgically implanted by using either a direct or catheter-mediated injection into damaged myocardium. Studies have shown that the implant improves heart function and myocardial regeneration and echocardiographic measurements.

CROSS-REFERENCE TO RELATED APPLICATION This application is a divisional of application Ser. No. 08/837,339, filed Apr. 11, 1997, now U.S. Pat. No. 6,036,639. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention generally relates to a hand held medical device. More particularly, the present invention relates to a laryngoscope, and still more particularly to a laryngoscope that is constructed of materials having relatively low magnetic susceptibilities. This provides the laryngoscope of the present invention as a useful instrument in the vicinity of a magnetic resonance scanner. 2. Prior Art Laryngoscopes generally comprise a detachable blade and a cooperating handle which are connected together in an L-shaped configuration. The handle serves as an enclosure for one or more batteries which energize a light source in the handle. The switch for energizing the light source is usually positioned at the top of the handle immediately adjacent to the light source and is activated by the blade when it is connected to the handle and moved into an operative position. Light from the light source is directed to the light conductor disposed in or on the blade. Light passes through the light conductor to the distal end thereof to illuminate the field of view such as a patient's mouth and larynx during the examination thereof by medical personnel and during the insertion of an endotracheal tube into the trachea of the lungs to administer anesthetic gases therein. The prior art is replete with various types of metallic laryngoscopes, some of which are capable of illumination. Additionally, U.S. Pat. No. 4,607,623 to Bauman describes a laryngoscope constructed of non-ferrous materials such as ABS with the electrically conductive portions provided by first applying a thin copper layer to the ABS followed by electroless plating and then electrolytically plating another copper layer to form a conductive layer about 0.5 to 2 mils thick. A thin layer of aluminum is subsequentially applied to the copper coating in those areas intended to be reflective. The batteries powering this device are not further described, but may be of a nickel/cadmium type commonly used for such application. Nickel/cadmium batteries are not considered to be relatively nonmagnetic and would not be useful with the laryngoscope of the present invention. U.S. Pat. Nos. 310,004 to Weston; 485,089 to Carhart; 2,282,979 to Murphy; 3,352,715 to Zaromb; 3,673,000 to Ruetschi and 4,318,967 to Ruetschi disclose anti- or non-magnetic materials in cells or batteries. Additionally, U.S. Pat. Nos. 2,864,880 to Kaye; 2,982,807 to Dassow et al.; 4,053,687 to Coiboin et al.; 4,264,688 to Catanzarite; 4,595,641 to Giutino; 5,104,752 to Baughman et al.; 5,149,598 to Sunshine; 5,173,371 to Huhndorff et al.; 5,194,340 Kasako; 5,418,087 to Klein; and 5,443,924 to Spellman relate to batteries having means for assuring that proper battery polarity is established. However, none of these patents describe power sources that are useful with the hand held medical device of the present invention because they either include at least some magnetic components, do not have sufficient energy density for extended use or do not have a terminal configuration similar to that of the present invention. U.S. Pat. No. 4,613,926 to Heitman et al. discloses an illuminating assembly for an MRI scanner. There is needed a lighted laryngoscope that is predominantly constructed of metal so that the instrument is capable of withstanding the abusive treatment conditions which surgical instruments are sometimes subjected to. For this purpose, the laryngoscope of the present invention is constructed largely of metal components. However, with ever increasing use of magnetic resonance scanning to aid medical personnel during pre- and post-clinical and surgical procedures, the metal components must be constructed of materials that have as low a magnetic susceptibility as possible. SUMMARY OF THE INVENTION The laryngoscope of the present invention is constructed of materials including metal components having very low magnetic susceptibilities. Those parts not made of metal are preferably formed of a thermoplastic material, for example an acetal compound such as DELRIN. The battery powering the laryngoscope lamp is also constructed of materials having low magnetic susceptibility. Lithium batteries are preferred, and all components such as the casing, terminal leads, current collectors and collector leads, some of which are typically made of nickel, are constructed of stainless steel nonmagnetic austenitic. The battery further includes a unique terminal configuration that prevents the inadvertent use of other batteries, including non-magnetic batteries, in the laryngoscope. A unique lamp retaining mechanism provides for quick and easy replacement of the lamp. These and other aspects of the present invention will become more apparent to those skilled in the art by reference to the following description and to the appended drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a laryngoscope 10 according to the present invention. FIG. 2 is an exploded view of the laryngoscope handle 12 and head assembly. FIG. 3A is a partial, cross-sectional view of a portion of the handle 12 and the head assembly for the laryngoscope 10 . FIG. 3B is a partial, cross-sectional view of the handle 12 and end cap 50 for the laryngoscope 10 . FIG. 4 is a plan view of the battery 32 for the laryngoscope 10 . FIG. 5 is a side, elevational view of the battery 32 . FIG. 6 is a perspective view of the head 100 for the laryngoscope 10 . FIG. 7 is a perspective, exploded view of the lamp retainer 124 for the laryngoscope 10 . DETAILED DESCRIPTION OF THE INVENTION Turning now to the drawings, FIGS. 1 to 7 show a laryngoscope 10 having low magnetic susceptibility characteristics according to the present invention and generally comprised of a handle 12 , a detachable blade 14 and an attachment means 16 for detachably securing the blade 14 to the handle 12 in a generally L-shaped configuration. The instrument is utilized to depress a patient's larynx during an examination thereof or during the insertion of an endotracheal tube. The blade is of stainless steel or a fiberglass composite commercially available from Heine under the trademark SANALON. With particular reference to FIGS. 2, 3 A, and 3 B, the handle 12 is a cylindrically-shaped tube comprising an intermediate section 18 meeting at a step 20 with a proximal section 22 having internal threads 24 , and the intermediate section 18 meeting at a chamfer 26 with a distal section 28 . The outer surface of the handle 12 is provided with raised, knurled ridges 30 (FIG. 1) to aid in gripping the laryngoscope 10 . The handle 12 is preferably constructed of chrome plated brass. A battery 32 (FIGS. 2, 3 A, 3 B, 4 and 5 ) is housed inside the intermediate handle section 18 for providing power to a lamp means as an assembly 34 , which will be described in detail hereinafter. The battery 32 is constructed of materials having relatively low magnetic susceptibility with a unique terminal configuration according to the present invention. The battery 32 is preferably an alkali metal battery and more preferably an alkali metal/liquid catholyte battery. A most preferred chemistry utilizes the lithium/thionyl chloride-bromine chloride (Li/BCX) couple. The battery casing adjacent to the distal handle section 28 is insulated to prevent electrical contact in the conventional manner. As shown in FIGS. 3A, 4 and 5 , the opposite end of the battery 32 includes a negative contact ring 36 that is permanently attached to the battery case to provide one terminal for the battery. The central, positive terminal 38 is recessed and insulated by material 40 around its perimeter to prevent accidental shortening. A non-magnetic fuse 42 prevents inadvertent run-away electrochemical reaction while a thermoplastic insulator plate 44 supported on a ledge of the insulated material 40 protects the positive terminal 38 and fuse 42 . A central opening 46 in plate 44 provides for access to the positive terminal 38 . To provide the battery 32 having a relatively low magnetic susceptibility, all external and internal electrical components such as the casing, the terminals 36 , 38 , the current collectors and the contact leads are of stainless steel. The unique terminal configuration prevents the inadvertent loading and discharge of batteries into the handle 12 not intended for use with the laryngoscope 10 . Such inadvertent battery use could have detrimental affects on the laryngoscope's low magnetic susceptibility characteristics. The battery 32 is secured inside the handle 12 by a cap spring 48 , preferably of silver plated beryllium copper, that biases between the battery and an end cap 50 snug-fitted into the distal handle section 28 extending part way into the intermediate handle section 18 . The end cap 50 is of a non-magnetic material, such as an acetal thermoplastic material with an enlarged head 52 that abuts the distal end of handle 12 . A groove 54 formed between the cap head 52 and an annular protrusion 56 of the cap receives an O-ring 58 of a flexible elastomeric material for sealing the cap 50 in the distal section 28 of the handle 12 in a fluid tight engagement. As shown in FIGS. 2 and 3A, a battery retainer assembly is threaded into the proximal handle section 22 and includes a battery retainer 60 , preferably of an acetal thermoplastic material, that threads into the handle 12 to capture a battery pin 62 , a battery spring 64 , a tube disk 66 and a pair of spring contacts 68 therein. The battery pin 62 is preferably of gold plated brass, the battery spring 64 is preferably of silver plated beryllium copper, the tube disk 66 is of an acetal thermoplastic material and the spring contacts 68 are of silver plated beryllium copper. The battery retainer 60 comprises a threaded portion 70 sized to threadingly mate with the internal threads 24 of the proximal handle section 22 . The threaded portion 70 of the battery retainer 60 meets a cylindrically-shaped portion 72 that extends to a chamfer 74 ending at an end face 76 . The battery retainer 60 has a first, cylindrically-shaped bore 78 that meets at an internal shoulder 80 with a second, lesser diameter cylindrically-shaped bore 82 extending to the end face 76 . A pair of diametrically opposed openings 84 are provided through the thickness of the threaded portion 70 . The battery retainer 60 receives the battery pin 62 having a cylindrically-shaped body 86 provided with an annular protrusion 88 adjacent to a proximal end 90 thereof. The internal threads 24 at the proximal handle section 22 terminate at an internal shoulder 92 . Shoulder 92 supports the tube disk 66 having a central opening 94 . The tube disk 66 also includes a pair of opposed channels 96 (shown in dashed lines in FIG. 2) that communicate between the outer edge thereof and diametrically opposed portions of the opening 94 . The tube disk 66 supports the pair of spring contacts 68 , each having a leg disposed in one of the disk channels 96 with a contact portion 98 of the springs extending from the opposite face of the tube disk 66 . As shown in FIG. 3A, with the tube disk 66 supported on the internal shoulder 92 , the spring contacts 68 are captured between the shoulder 92 and the disk 66 with the contact portions 98 contacting the annular, negative terminal 36 of battery 32 . The tube disk 66 and spring contacts 68 are secured in this position by the battery retainer 60 threaded into the proximal handle section 22 . The battery retainer 60 further captures the battery pin 62 between itself and the tube disk 66 with the proximal end side of the annular protrusion 88 abutted against the internal shoulder 80 of the battery retainer by the battery spring 64 surrounding the body 86 of the battery pin 62 and biasing between the tube disk 66 and the opposite side of the annular protrusion 88 . The pair of diametrically opposed openings 84 in the battery retainer 60 are provided to receive a tool (not shown) such as a spanner wrench for tightening the battery retainer 60 , battery pin 62 , battery spring 64 , tube disk 66 and spring contacts 68 into position. The battery retainer assembly together with the battery 32 loaded into the handle 12 and secured therein by the cap spring 48 and end cap 50 form the portion of the laryngoscope 10 of the present invention generally referred to as the battery pack assembly. After the battery retainer assembly is threaded into the proximal handle section 22 , the proximal section 22 threadingly receives a head 100 . As shown in FIGS. 2, 3 A, 4 and 6 , the head 100 includes a cap portion 102 having external threads 104 that threadingly mate with the internal threads 24 at the proximal handle section 22 , and the attachment means 16 for attaching the blade 14 to the handle 12 . The head 100 is preferably constructed of chrome plated brass. The head 100 further comprises an internal passage 106 extending from its threaded end through the cap portion 102 to the attachment means 16 . At the threaded end, the bore 106 has a beveled portion 108 tapering inwardly toward a first cylindrical portion 110 that meets with an internally threaded portion 112 at step 114 . The internal threaded portion 112 of head 100 meets with a second cylindrical portion 116 at step 118 which extends to a shoulder 120 that meets with an opening 122 (shown in dashed lines in FIG. 1) leading into the blade attachment means 16 . To provide illumination to a fiber optic blade light conductor 123 (shown in dashed lines in FIG. 1 ), the lamp assembly 34 is mounted in the internal bore 106 of head 100 . The lamp assembly 34 includes a lamp retainer 124 (FIGS. 2, 3 A and 7 ) having an interior cylindrically-shaped bore 126 extending to a shoulder 128 that meets with an outwardly beveled, reflector portion 130 . The lamp retainer 124 is preferably constructed of stainless steel. A lamp 132 is received inside the bore 126 with the lamp casing 134 abutted against the shoulder 128 so that the lamp 132 is disposed in a reflective relationship with the reflector portion 130 of lamp retainer 124 . A lamp 132 useful with the laryngoscope 10 of the present invention is commercially available from Boehm under model no. X02.88.044. Lamp retainer 124 is provided with an annular enlarged portion 136 opposite a portion of the interior cylindrically-shaped bore 126 and adjacent to shoulder 128 . An annular groove 138 in the enlarged portion 136 intersects an opening 140 communicating with the interior bore 126 . A stainless steel detent in the shape of a ball 142 serving as a lamp holder is disposed inside the opening 140 . Opening 140 is somewhat less in diameter than that of the detent 142 so that a portion of the detent protrudes into the bore 126 contacting the lamp casing 134 of lamp 132 received inside the bore 126 . The detent 142 is retained in this position by a beryllium copper spring clip 144 seated in groove 146 in the annular enlarged portion 136 to thereby removably hold or retain the lamp 132 in the lamp retainer 124 . The lamp retainer 124 is itself secured in the internal bore 106 of head 100 by a lamp retainer ring 148 having exterior threads 150 that threadingly mate with the internal threaded portion 112 of head 100 . The lamp retainer ring 148 is preferably constructed of chrome plated brass and further comprises an internal shoulder 152 meeting with an opening 154 that is only somewhat greater in diameter than the outer cylindrical side wall of the lamp retainer 124 . With the lamp retainer 124 received in the internal bore 106 of head 100 , a head spring 156 , preferably constructed of silver plated beryllium copper and sized to surround the outer side wall of the lamp retainer 124 , biases between the annular enlarged portion 136 of lamp retainer 124 and the shoulder portion 152 of the lamp retainer ring 148 threaded into the head 100 . The lamp 132 is provided with a contact 158 that extends beyond the retainer ring 148 and into the beveled portion 108 of head 100 with the external threads 24 of the cap portion 102 mated to the internal threads 24 at the proximal handle section 22 . In this position, a shoulder 160 intermediate the external threads 104 and an annular step 162 abuts the end of the proximal handle section 22 . An elastomeric O-ring 164 is received in the steps 162 , held tightly between the cap 102 and handle 12 . The blade 14 is attached to the handle 12 in a pivotal manner by the attachment means 16 which includes a base portion 166 of blade 14 , and a pair of opposed side walls 168 and 170 extending from a base plate 172 supported on the cap portion 102 of head 100 . The side walls 168 , 170 are provided with respective channels 174 , 176 that extend part way across the length of the side walls from an end thereof. Each side wall 168 , 170 further includes an opening 178 opposite the terminal end of the channels 174 , 176 . The base portion 166 of the blade 14 is sized to be received between the side walls 168 , 170 of head 100 . The base portion 166 also has a through bore (not shown) sized to receive a pin 180 , preferably constructed of stainless steel, and a pair of spring biased detents 182 (one shown in dashed lines in FIG. 1) that are receivable in the respective channels 174 , 176 . To fix the blade 14 with respect to the handle 12 in the generally L-shaped configuration, the base portion 166 of blade 14 is positioned between the side walls 168 , 170 of head 100 with the through bore aligned with the openings 178 . The pin 180 is moved through the openings 178 and bore to thereby pivotably attach the blade 14 to the handle 12 . FIG. 3A shows that when the head 100 is threaded onto the proximal handle section 22 , the contact 158 of lamp 132 contacts the proximal end 90 of the battery pin 62 . The opposite, distal end 166 of the battery pin 62 is in a raised position, out of contact with the central, positive terminal 38 of battery 32 . The lamp 132 is energized by pivoting the blade 14 with respect to the handle 12 about the pin 180 until the spring biased detents 182 seat in the opposed channels 174 , 176 in side walls 168 , 170 . This movement serves to releasibly lock the blade 14 in the generally L-shaped configuration with respect to the handle 12 . As the blade 14 is so pivoted, the base portion 166 contacts the lamp retainer 124 , moving it and the lamp 132 towards the battery 32 and against the biasing force of head spring 156 . The lamp contact 158 in turn forces the battery pin 62 towards the battery 32 against the biasing force of the battery spring 64 until the distal end 166 of the pin 62 contacts the central, positive terminal 38 of battery 32 (as shown in dashed lines in FIG. 3 A). The electrical circuit is completed through the annular, negative contact ring 36 , the spring contacts 68 , the handle 12 , the head 100 , lamp retainer ring 148 and the detent 142 contacting the lamp casing 134 . With the lamp 132 energized, light is directed to the blade light conductor 123 which transmits the light to the end of the blade 14 . When the laryngoscope 10 is utilized during a medical examination or during the insertion of an endotracheal tube, the conductor 123 helps to illuminate the zone of interest to thereby aid the physician. When the blade 14 is pivoted about pin 180 in the opposite direction to break the L-shaped configuration, the head spring 156 biases the lamp retainer 124 and lamp 132 away from the battery 32 and the battery spring 64 biases the battery pin 62 out of contact with the central, positive battery terminal 38 . In addition to serving as a portion of the electrical contact path for energizing the lamp 132 , the lamp assembly 34 including the lamp retainer 126 , detent 142 and spring clip 144 provide a structure for quickly and easily replacing the lamp 132 should it burn out or otherwise malfunction. To change the lamp 132 , the head 100 is unscrewed from the proximal handle section 22 and the lamp retainer ring 150 is unthreaded from the head 100 . This releases the lamp assembly 34 from the head 100 and the lamp 132 is easily moved out of the bore 126 in the lamp retainer 124 , releasing from contact with the spring clip 144 biased detent 142 . A new lamp 132 is then replaced inside the lamp retainer 124 and the lamp assembly 34 including spring 156 and lamp retainer ring 150 are then re-assembled inside the head 100 and the head is screwed onto the handle 12 . In accordance with the stated low magnetic susceptibility characteristics of the laryngoscope of the present invention, Table 1 lists the magnetic susceptibilities of the various materials used to construct the laryngoscope along with selected other materials. TABLE 1 Atomic or Density Molecular Susceptibility Material (g/cc) Weight (× 10 6 ) Carbon 2.26 12.011 −218 (polycrystalline graphite) Gold 19.32 196.97 −34 Beryllium 1.85 9.012 −24 Silver 10.50 107.87 −24 Carbon (diamond) 3.513 12.011 −21.8 Zinc 7.13 65.39 −15.7 Copper 8.92 63.546 −9.63 Water (37° C.) 1.00 18.015 −9.03 Human Soft ˜1.00- — ˜(−11.0 to Tissues 1.05 −7.0) Air (NTP) 0.00129 28.97 +0.36 Stainless Steel 8.0 — 3520-6700 (nonmagnetic, austenitic) Chromium 7.19 51.996 320 It is known that brass is an alloy of copper and zinc. In contrast, Table 2 lists the magnetic susceptibilities of various relatively highly magnetic materials. TABLE 2 Atomic or Density Molecular Material (g/cc) Weight Susceptibility Nickel 8.9 58.69    600 Stainless 7.8 — 400-1100 Steel (magnetic, martensitic) Iron 7.874 55.847 200,000 The data use to construct Tables 1 and 2 was obtained from a paper authored by John Schneck of General Electric Corporate Research and Development Center, Schenectady, N.Y. 12309, entitled “The Role of Magnetic Susceptibility In Magnetic Resonance Imaging:Magnetic Field Compatibility of the First and Second Kinds”. The disclosure of that paper is incorporated herein by reference. Thus, the laryngoscope of the present invention is an instrument which is useful for pre and post clinical and surgical applications, especially in an environment proximate the strong magnetic field emitted by a magnetic resonance scanner. It is appreciated that various modifications to the inventive concepts described herein may be apparent to those of ordinary skill in the art without departing from the spirit and scope of the present invention as defined by the appended claims.

A laryngoscope constructed of materials including metal components having very low magnetic susceptibilities is described. The battery powering the laryngoscope lamp is a lithium battery also constructed of materials having low magnetic susceptibilities. The battery further includes a unique terminal configuration that prevents the inadvertent use of other batteries, including non-magnetic batteries, in the laryngoscope. A unique lamp retaining mechanism provides for quick and easy replacement of the lamp.

[0001] The present invention relates to a stuffed chair with one or more seats, in particular an armchair or a couch. BACKGROUND OF THE INVENTION [0002] In the interior design field stuffed chairs are known, which comprise a seat for one or more people; a backrest; a fixed part; and at least one mobile part (e.g. a footrest, a headrest, and/or a massaging device), which is configured to move relative to the fixed part due to the action of an actuating device (e.g. an electric motor), which is supplied with power by an electrical circuit. [0003] The electrical circuits used to supply power to the actuating device generally are of two types. [0004] According to a first type, the electrical circuit comprises an electrical cable that is connected, on one side, to the actuating device and, on the other side, to the electrical grid and, therefore, to a wall power socket. [0005] According to the other one of the two know types described above, the electrical circuit comprises a rechargeable battery, which is mounted inside the stuffed chair, and a plug, which is connected to the battery and extends through the stuffed chair so as to be accessible from the outside and allow a user to recharge the battery itself. [0006] Known stuffed chairs of the type described above have some drawbacks, which are mainly due to the fact that, in one case, the electrical cable is relatively long and hard to move and, therefore, is constantly in the way during the normal use of the stuffed chair and, in the other case, the access to the battery is relatively difficult and its replacement necessarily requires the presence of skilled personnel and the restoration of the electrical connection among the new battery, the actuating device and the recharging plug. SUMMARY OF THE INVENTION [0007] The object of the present invention is to provide a stuffed chair with one or more seats, in particular an armchair or a couch, which is designed to eliminate the aforementioned drawbacks in a straightforward, relatively low-cost manner. [0008] The present invention provides a stuffed chair with one or more seats, in particular an armchair or a couch, according to the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS [0009] The present invention will now be described with reference to the accompanying drawings, which show a non-limiting embodiment thereof, wherein: [0010] FIGS. 1 and 2 are two schematic perspective views of a preferred embodiment of the stuffed chair according to the present invention; [0011] FIG. 3 is a schematic perspective view of a first detail of the stuffed chair of FIGS. 1 and 2 ; and [0012] FIGS. 4 and 5 are two schematic perspective views of a second detail of the stuffed chair of FIGS. 1 and 2 , which is shown in two different operating positions. DETAILED DESCRIPTION OF THE INVENTION [0013] With reference to FIGS. 1 and 2 , number 1 indicates, as a whole, a stuffed armchair having a seat 2 , a backrest 3 , and a pair of lateral armrests 4 . [0014] According to a variant that is not shown herein, the stuffed armchair 1 can be removed and replaced with a stuffed couch with multiple seats. [0015] The stuffed armchair 1 comprises, especially, a front footrest 5 , which is mobile relative to a fixed part 6 of the stuffed armchair 1 between a lowered rest position ( FIG. 2 ) and a raised operating position (not shown). [0016] Obviously, the stuffed armchair 1 can comprise further mobile parts, such as, for example, a headrest and/or a massaging device. [0017] The footrest 5 is moved between its lowered rest position and its raised operating position by an actuating device 7 , which comprises, in this special case, an electric motor, which is housed inside the stuffed armchair 1 . [0018] The stuffed armchair 1 is also delimited by an outer surface 8 , and has a cavity 9 , which, in this special case, is obtained in one of the armrests 4 , has an oblong, substantially parallelepiped-like shape, and opens up outwards in correspondence to the surface 8 itself. [0019] According to a variant that is not shown herein, the cavity 9 is obtained in other parts of the stuffed armchair 1 . [0020] According to FIGS. 4 and 5 , the device is supplied with power by a power supply 10 device comprising a containing box 11 , which is cup-shaped, is housed inside the cavity 9 and, furthermore, has an inlet 12 that opens up outwards in correspondence to said outer surface 8 . [0021] The box 11 is provided, furthermore, with an annular flange 13 , which extends around the inlet 12 , allows the box 11 to be fixed to the stuffed armchair 1 by means of a pair of fixing screws (not shown) screwed into the surface 8 , and is covered by a finishing frame 14 . [0022] The box 11 is delimited by a bottom wall 15 and, furthermore, is also delimited by two main lateral walls 16 , which are substantially parallel to one another and perpendicular to the wall 15 , and by two minor lateral walls 17 , which are substantially parallel to one another and perpendicular to the wall 15 and the to the walls 16 . [0023] The device 10 comprises, furthermore, a rechargeable battery 18 , which, in use, is mounted inside the box 11 through the inlet 12 , substantially has the shape of the cavity 9 and of the box 11 , and is delimited by an end face 19 , which is visible on the outside of the stuffed armchair 1 . [0024] The actuating device 7 and the battery 18 are connectable to one another by means of a connection device 20 comprising a first plurality of electrical contacts 21 obtained on a bottom wall 22 of the battery 18 and a second plurality of electrical contacts 23 , which are obtained on the wall 15 and are connected to the device 7 by means of the interposition of an electrical cable 24 . [0025] The battery 18 is engaged in the box 11 in a sliding manner and is mobile, in a moving direction 25 that is substantially perpendicular to the walls 15 and 22 , between an operating position ( FIGS. 1 and 5 ), in which the battery 18 is substantially held inside the box 11 , and an extracted position ( FIGS. 3 and 4 ), in which the battery 18 projects outside of the box 11 . [0026] When the battery 18 is arranged in its operating position, the wall 22 is substantially arranged in contact with the wall 15 and the contacts 21 and 23 are connected to one another, whereas, when the battery 18 is arranged in its extracted position, the wall 22 is arranged at a given distance from the wall 15 and the contacts 21 and 23 are disconnected from one another. [0027] The battery 18 is locked in its operating position on the inside of the box 11 by a coupling device 26 comprising an elastically deformable tooth 27 , which is obtained through one of the main lateral walls 16 of the box 11 . [0028] The tooth 27 is normally arranged in a locking position, in which, when the battery 18 is inserted into the box 11 , the tooth 27 hooks a rib 28 made on the battery 18 and locks the battery 18 in its operating position so as to ensure the connection between the contacts 21 and 23 and the power supply of the device 7 . [0029] The tooth 27 is moved from its locking position to a release position for releasing the battery 18 by a release push button 29 , which extends in the direction 25 and projects outwards from the box 11 in correspondence to the inlet 12 , so as to be operated by the user. [0030] The push button 29 is mobile, relative to the box 11 , in the direction 25 between an operating position, in which the push button 29 lifts the tooth 27 and disengages it from the rib 28 , and a rest position. [0031] The push button 29 is moved to—and normally kept in—its rest position by a spring 30 , which is mounted between the box 11 and the push button 29 parallel to the direction 25 . [0032] When the tooth 27 is moved to its release position, the battery 18 is moved to its extracted position by a spring 31 , which is hooked to the wall 15 and is interposed between the walls 15 and 22 . [0033] The face 19 of the battery 18 is provided with a power supply connector 32 to charge the battery 18 , with a first light indicator 33 to display the charge state of the battery 18 , and with a second light indicator 34 to display the charge mode of the battery 18 itself. [0034] The power supply device 10 leads to some advantages that are mainly due to the fact that: [0035] the box 11 opens up outwards in correspondence to the outer surface 8 of the stuffed armchair 1 and, therefore, allows the user to easily replace the battery 18 after having uncoupled it from the box 11 itself; and [0036] the position of the face 19 of the battery 18 allows the user to easily see the charge state and the charge mode of the battery 18 . [0037] According to a variant that is not shown herein, the connection device 20 , the bottom wall 15 of the box 11 and the electrical cable 24 can be removed and replaced with a first electrical cable, which is connected to the actuating device 7 , and with a second electrical cable, which is connected to the battery 18 and is connectable to the first electrical cable. The extraction of the battery 18 from the box 11 allows users to disconnect the two electrical cables, replace the battery 18 with a new battery 18 and reconnect the two electrical cables to one another. [0038] Although the present invention has been described with reference to exemplary implementations thereof, the present invention is not limited by or to such exemplary implementations.

A stuffed chair with one or more seats, in particular an armchair or a couch, has a seat, a backrest, and at least one mobile part, which is configured to move relative to a fixed part due to the action of an actuating device supplied with power by a rechargeable battery housed inside a containing box; the containing box being mounted in the stuffed chair and opening up outwards in correspondence to an outer surface of the stuffed chair to allow access to the rechargeable battery.

This invention relates primarily to knock-down structure components for use in the building of a structural unit, such as for instance a storage rack for warehousing systems, and especially automatic warehousing systems, and wherein the storage rack comprises a plurality of spaced columns secured by a novel arrangement to connecting assemblies extending laterally between the columns, for improving the rigidity of the storage rack, and increasing its resistance to joint separation of the columns and connecting assemblies, and with generally standard structural components being utilized to form the storage rack structure. In one embodiment, prestressing or predetermined initial deformation of certain components of the connecting assemblies is provided for, to increase the rigidity of the structure. In another embodiment, the arrangement is such that no substantial initial deformation or prestressing occurs in the confronting parts at the connections, but the connections are such that substantial rigidity is still provided for. The component parts of the storage rack are adapted for assembly at the site of use, resulting in expeditious manufacture, handling, transporting and assembly of the storage rack. The need for conventional diagonal bracing in the "ladders" of the storage rack, is eliminated. BACKGROUND OF THE INVENTION In U.S. Pat. No. 3,840,124 issued Oct. 8, 1974, to Wayne G. Atwater and entitled Knock-Down Storage Frame, Components Therefor, and Method of Assembly, there is disclosed a storage rack for warehousing systems wherein the connection of the columns with the laterally extending connecting assemblies include deformation of a web-like portion of the confronting members at the connection, by actuation of fastener means, which prestresses the web-like portion, and enhances the rigidity of the connection. U.S. patent application, Ser. No. 555,800, filed Mar. 6, 1975, which is a continuation of U.S. Ser. No. 484,427 (abandoned) which in turn was a division of aforementioned U.S. Pat. No. 3,840,124, concerns the method disclosed in U.S. Pat. No. 3,840,124. SUMMARY OF THE INVENTION The present invention provides various structural components and assemblies for forming a structural unit such as a storage rack for use in warehousing systems, wherein the column members are of fabricated construction, being in certain embodiments basically of generally U-shape in horizontal section with a bridging plate connecting the arms of the U, and with a fastener stud secured to said bridging plate and projecting outwardly therefrom intermediate the arm portions, and with a cross portion on the column confronting laterally extending connecting member being adapted for engagement with the bridging plate, said cross portion having an opening therethrough receiving the respective stud on the bridging plate. In certain embodiments, the bridging plate is recessed with respect to the free end portions of the arms of the column configuration, whereby the cross portion bridges the end portions, and is deformed inwardly toward the column member upon tightening actuation of the associated stud fastener, thus prestressing the connection and enhancing the rigidity of the connection at the fastener. Also an arrangement of the columns and the connecting member is provided which does not embody prestressing of the connecting member, but still provides a highly rigid connection between the laterally extending connecting member and the spaced respective outer and inner column members of the storage rack. The need for diagonal bracing in the "ladders" of the storage rack is eliminated. Accordingly, an object of the invention is to provide a storage framework which can be readily assembled on site and wherein a simplified arrangement is provided for providing for highly rigid connections in the framework. Another object of the invention is to provide a storage framework which can be readily assembled on site and wherein the columns of the storage framework have laterally spaced projecting elements thereon, with an actuatable fastener means disposed intermediate the projecting elememts adapted for coaction with a generally planar end plate of a confronting laterally extending connecting member assembly, for providing for deformation and prestressing of the plate at the respective fastener connection, in order to enhance the rigidity of the structure. A still further object of the invention is to provide a storage framework wherein the load bearing connecting members projecting laterally from the column members of the framework are of a structure and are attached thereto in a manner which provides for improved rigidity of the connections. Another object of the invention is to provide a fabricated column member for a storage rack of the above discussed type wherein the column member comprises a series of vertically stacked sections each of which has a thinner wall thickness as compared to the underlying section, and which are rigidly connected together, with such column member basically being generally U-shaped in horizontal section, and with vertically spaced plates bridging the arms of the U generally adjacent the distal ends thereof, with fastener means secured to the bridging plates and projecting therefrom. A further object of the invention is to provide an arrangement of the latter type wherein the bridging plates are recessed to provide laterally spaced projecting portions on the column member, with the fastener means comprising studs welded to the bridging plates and intermediate the projecting portions of the column. Another object is to eliminate any need for diagonal bracing members in the "ladders" of the storage rack. Other objects and advantages of the invention will be apparent from the following description taken in conjunction with the accompanying drawings wherein: BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a fragmentary generally diagrammatic perspective illustration of a storage rack and associated mechanized load carrier in an automatic warehousing system which includes the connection arrangements of the invention. FIG. 2 is an enlarged sectional view taken generally along the plane of line 2--2 of FIG. 3 looking in the direction of the arrows. In phantom lines there is shown the deformed condition of the end or cross member of the connecting member assembly upon tightening actuation of the associated fastener means. FIG. 3 is a fragmentary partially broken elevational view of the connection illustrated in FIG. 2, illustrating the deformed condition of the cross member. FIG. 4 is a broken elevational view of one of the ladder sub-assemblies which may be assembled in the form illustrated at the site of use and which forms one of the components of the completed storage rack. The ladder assembly illustrated is comprised of vertical load bearing columns connected by laterally extending connecting members or assemblies, fastened with mechanical fasteners to the confronting columns. The connecting members are so constructed and arranged that upon tightening actuation of the fasteners, a highly rigid connection is formed between the generally load bearing laterally extending connecting members or assemblies and the associated columns. FIG. 5 is a broken side elevational view of one embodiment of the column members, formed of stacked sections secured together. FIG. 6 is a broken front elevational view of the sectional column member of FIG. 5. FIG. 7 is a sectional view taken generally along the plane of line 7--7 of FIG. 6 looking in the direction of the arrows. FIG. 8 is a sectional view taken generally along the plane of line 8--8 of FIG. 6 looking in the direction of the arrows. FIG. 9 is a sectional view taken generally along the plane of line 9--9 of FIG. 6 looking in the direction of the arrows. FIG. 10 is a fragmentary side elevational view of a modified form of load supporting connecting member or assembly, and having a reinforcing strut secured thereto. FIG. 11 is a fragmentary, sectional view taken generally along the plane of line 11--11 of FIG. 10, looking in the direction of the arrows. FIG. 12 is a fragmentary top plan view of the FIG. 11 assembly. FIG. 13 is a broken top plan view of one of the load carrying connecting members or assemblies utilized in the FIG. 4 ladder structure. FIG. 14 is a side elevational view of the FIG. 13 connecting member assembly. FIG. 14A is an end elevational view taken generally along line 14A--14A of FIG. 14. FIG. 15 is a sectional view generally similar to FIG. 2, but illustrating a modification. FIG. 16 is a view similar to FIG. 15 but showing a further modification. FIG. 17 is a view generally similar to FIGS. 15 and 16, but illustrating a tubular column of polygonal horizontal section, with the illustrated stud of the connection secured to a pad or plate, which in turn is attached to a face of the column; FIG. 17 is enlarged and taken generally along the plane of line 17--17 of FIG. 18. FIG. 18 is a fragmentary, broken, side elevational view of a portion of a ladder assembly embodying connecting member assemblies of the general type of FIG. 17. FIG. 19 is a broken, end elevational view of one of the fabricated travel zone columns of the FIG. 18 ladder, taken generally along the plane of line 19--19 of FIG. 18, looking in the direction of the arrows. FIG. 20 is a broken, side elevational view of the column of FIG. 19. FIG. 21 is a broken, end elevational view of one of the outer columns of the FIG. 18 ladder, taken generally along the plane of line 21--21 of FIG. 18. FIG. 22 is a broken, side elevational view of the column of FIG. 21. FIG. 23 is a broken top plan view of a load supporting, connecting member assembly, generally similar to FIG. 13, but showing a thin gage modification thereof. FIG. 24 is a broken side elevational view of the FIG. 23 assembly. FIG. 25 is an end elevational view taken generally along the plane of line 25--25 of FIG. 24. FIGS. 26 and 27 are diagrammatic illustrations of respectively "ladder" structure embodying conventional diagonal bracing (FIG. 26) and "ladder" structure embodying no diagonal bracing (FIG. 27), and illustrating floor settling conditions. DESCRIPTION OF PREFERRED EMBODIMENTS Referring now again to the drawings, there is illustrated in FIG. 1 a portion of a storage rack of an automatic warehousing system comprising opposing storage sections 10 and 12 defining a plurality of horizontally and vertically arranged storage volumes or bins 14, which are adapted to store loads L therein, with the loads disposed in bridging relation across the associated load carrying members of the respective storage volume. In FIG. 1, there is a storage rack section disposed on each side of a centrally located travel zone 16 in which an automatic load carrier 18 is adapted to move on tracks 20, for handling loads at selected storage bin locations in the selected storage rack section. The load carrier mechanism 18 may comprise a horizontally movable load carrier 21 on which is mounted a vertically movable elevator 24, which in turn carries a transversely or laterally movable extractor mechanism 26, for placing loads into or removing loads from a selected storage volume. Reference may be had to U.S. Pat. No. 3,139,994, issued July 17, 1964, in the name of A. R. Chasar and 3,402,835 issued Sept. 24, 1968, in the name of Sanford Saul, for more detail disclosures of automatic warehousing arrangements of the general type of which the present invention may be used. Each storage frame section may be formed of a plurality of interconnected ladder assemblies (e.g. 28 -- FIG. 4) which in turn are each comprised of an aisle post or column 30 adapted for disposal along a travel zone 16, and in longitudinal alignment with the aisle columns in the adjacent ladder assembly, and a laterally spaced outer column or post 32, which is adapted for alignment with the corresponding outer column in the adjacent ladder assembly. Connecting member assemblies 34, 34a, 34b (FIG. 4) extend between and are adapted for connection to the respective aisle and outer column, to form the respective ladder assembly. Connecting members 34, 34a, 34b may be of the fabricated construction illustrated. The ladder components are so constructed and arranged that they can be expeditiously produced at a place of manufacture utilizing in line processes and procedures, and can be readily painted and handled during the manufacture thereof, and then can be bundled into compact bundles and shipped to the site of use, where the frame components can be readily assembled together into "ladders" and thence into complete storage racks, thereby obviating many of the problems associated with the manufacturing and shipping of the storage rack components. The columns 30, 32 of the ladder assemblies may be cold formed from plate stock into the generally U-shaped (in horizontal section) configuration, with the arms of the U being connected by bridging portions 36, secured to the inner surfaces of the arms of the U as by welds 36a (FIG. 2). In the embodiment illustrated in FIG. 2, the bridging member 36 is recessed inwardly from the projecting outer end extremities of the arms 38a of the U configuration, to provide a predetermined spacing 40 between the bridging member 36 and the confronting cross member 42 of the associated connecting member assembly 34, 34a, 34b. Fastener means 44, which in the embodiment illustrated are threaded studs, are secured, as by welds 44a, to the bridging member 36. Referring now in particular to FIGS. 13, 14 and 14A, a connecting member load support assembly 34 or 34a defining the respective storage volume or bin within the storage rack and for supporting loads thereon, is illustrated in detail. Lateral pairs of the assemblies support loads thereon in bridging relation, with the loads being deposited on or removed from the load support assemblies by means of the aforementioned mechanized load carrier 18, with the extractor 26 on elevator 24 being extendible out into and retractable from the selected bin or volume, to handle a load L thereat. Each connecting member load support assembly is adapted for attachment to the spaced associated columns 30, 32 of an associated ladder, (FIG. 4). In the connecting member load support assembly of FIGS. 13 and 14, the end cross members 42 are secured as by welds 46 to lateral elongated load support rails 48 which may be of angle configuration in end elevation (FIGS. 3 and 14A). The columns 30, 32 are received in generally nested relation between the outer ends of the assembly 34, as shown in FIG. 2, and are attached to the respective cross member 42 by fasteners 44. A nut 50 coacts with the stud in threaded relation. End abutment plates 52 may be provided for limiting movement of a load along rails 48. The cross member or web 42 is relatively thin as compared to the thickness of the bridging plate or portion 36, and upon predetermined tightening actuation of fastener means 44, as by threaded tightening of nut 50, the cross member or web 42 of connecting member assembly 34 is deformed inwardly toward the confronting bridging member 36 adjacent the stud of the fastener means 44, as at 52 (FIGS. 2 and 3). This inward bulging of cross member 42 generally circumferentially of the fastener stud is continued preferably until engagement occurs between the bulge and the confronting surface of bridging portion 36. Opening 54 in cross portion or web 42 is preferably of such size or diameter so as to be able to receive the weld 44a of the stud (as well as the stud) without interference, so that engagement of the conical-like bulge on the cross member 42 can occur with the confronting surface of bridging member 36. Thus cross member 42 is prestressed, at the respective connection, whereby the rigidity of the connection is enhanced. Spacing 40 may be in the order to 1/16 to 1/8 inch which has generally been found adequate to provide for prestressing deformation of the connecting member assembly web 42. As can be seen from FIG. 3 there is preferably provided a pair of vertically spaced fastener means 44 on the respective bridging member 36, coacting with a respective opening 54 in cross member 42. The assembly 34 may include bottom plates 56 (FIG. 13) having openings therein adapted to receive fastener means such as a bolt and associated nut, for attaching diagonal cross struts 58 and stringer struts 58a (FIG. 4), for aiding in rigidifying adjacent ladder assemblies. As can be seen from FIG. 3, cross members 42 are preferably in the form of channels, and are vertically elongated, so as to extend in the embodiments of assemblies 34, 34a well below the level of the load supporting rails 48. In the usual automatic warehousing environment, the vertical height of cross members 42 is preferably in the order of 8 to 10 inches. Such elongated cross members of assemblies 34, 34a, 34b coacting with the vertically spaced fastening means, provides for considerable rigidity of the connection of the columns 30, 32 with the laterally projecting connecting member assemblies 34, 34a, 34b. Assembly 34b on the upper portion of the ladder 28 is not adapted to directly support storage loads thereon, as are assemblies 34 and 34a, but instead is a "spreader" coupled to the spaced columns 30, 32 by fasteners 44, coacting with the cross member channels 42 in a similar manner as for assemblies 34, 34a. Rail 48a extending between the end cross members 42 is secured as by welds, interiorly of the channels, rather than exteriorly thereof. Referring now to FIGS. 5 through 9, there is illustrated another embodiment of column structure 30' or 32', which may be used to form a ladder assembly of the general type illustrated in FIG. 4. Each column 30' or 32' may be formed from sections of generally U-shaped (in horizontal section) channel which may be fabricated from plate similarly to that in the first described embodiment. The sections 62, 64, 66 (FIG. 5) forming the respective columns are stacked vertically on one another and secured as by welds. Each channel section in horizontal cross section comprises a base 68 with arm portions 68a projecting outwardly from the base. Bridging plate 36' extends between the inner surfaces of the arms and is secured thereto as by means of the welds 36a. In the embodiment illustrated, bridging plate 36' is recessed inwardly from the forward or outer extremities 35 of the arms 68a. A pair of threaded studs 44 are secured to the bridging plate 36' intermediate the outer ends of the arms 68a and as by means of welds 44a. Bridging plate 36' is preferably of sufficient thickness and strength so that upon tightening actuation of the fastener 44, the bridging plate will not be visibly deformed. The recessed condition of the bridging plate with respect to the outer ends of the arms provides clearance for the deformation of the cross portion 42 of a connecting member assembly 34, 34a upon securing of the latter by the fastener means 44. Section 64 of the column is stacked on top of section 62, and is welded thereto as at 70, but is of a slightly different wall thickness as compared to section 62. When stacked upon the lower section and welded thereto, such arrangement provides a rigid column. In the embodiment illustrated there is a further section 66 stacked on top of section 64, which further section is of a thinner wall thickness as compared to the thickness of the lower section 64, thereby providing for the effective welding as at 72 of the upper column section 66 to the lower, thicker wall section 64. The bridging plate 36' of lowermost column section 62 is preferably thicker than the bridging plates 36" of the middle and upper column sections. However, bridging plates 36" are still of sufficient thickness to support the studs 44 welded thereto without visible deformation, upon tightening actuation of the associated nuts. Preferably the bridging plates 36" on the middle and upper column sections extend downwardly into the respective underlying middle and lower column section, as can be seen in FIGS. 5 and 6. Such a stacked sectional column construction provides a high-strength rigid column for use in high rise storage structures. and which columns can be readily fabricated on a production line basis. Referring now to FIGS. 15 and 16 there are illustrated modified arrangements of column members, which may be utilized in a storage structure of the general type illustrated for instance in FIG. 1. Such arrangements do not provide for the preliminary deformation of the cross members of the connecting member assemblies, and thus provide no prestressing of the cross members. The bridging member 36b of the column is welded as at 36a, to the arms of the basically U-shaped column, with the front surface of the bridging plate being disposed outwardly of the outer ends 38 of the column arms. Thus the cross member 42 of the connecting member assembly 34 or 34a engages in flat surface-to-surface engagement with the front face of the bridging plate 36b which preferably extends vertically at least an extent equal to the vertical height of the respective cross member 42, with there being a pair of vertically spaced studs on the bridging plate received through a corresponding opening in the cross member 42, for drawing the bridging plate and cross member into tight engagement upon tightening of fasteners 50. In the FIG. 16 embodiment, the bridging plate 36b' engages the outer ends 38 of the arms of the column, and is welded as at 38a. Some additional clearance may be provided for welds 38a, with the column between the load rails 48. Otherwise, this embodiment is similar to that of FIG. 15. Referring to FIGS. 10 through 12, there is shown a modification 34' of connector assembly. The basic difference in this modified arrangement is that it has an additional strengthening web 80 secured as by welds 82 to the end cross members 42 of the connector assembly, with such strengthening member 80 being secured to the inner surface of the cross channel (FIG. 11). The purpose of web 80 is to provide additional diagonal rigidity to the assembly to eliminate or reduce the need for separate supplemental diagonal bracing, as commonly used, in ladder assemblies, as will be hereinafter discussed. The strengthening member 80 preferably has ribs or embossments 84, 84a formed thereon by deforming the web 80 out of its plane. Embossments 84 are formed inwardly, while embossments 84a are formed outwardly, as best shown in FIG. 11. Such embossments materially strengthen the web 80 and thus aid in rigidifying the connector assembly 34'. As can be seen, the top and bottom edges of the strengthening member 80 have been bent inwardly to form generally horizontal shoulder portions 88, which additionally strengthen the web and the connector assembly against stress. As can be seen in FIG. 10, the strengthening members are of such length that they do not necessarily engage the inner end surface of the respective end cross member, but are spaced somewhat therefrom as at 90. In other respects, the FIGS. 10 to 12 assembly may be generally similar to that of the first mentioned connector assembly 34. Referring now to FIGS. 17 and 18, there is illustrated another embodiment wherein the posts or columns 30, 32 each comprises a hollow, polygonal (in horizontal cross section) relatively thin walled tubular member which is of a narrower width W as compared to the depth D. Secured as by welds 92 to one face of the tubular column 30 or 32 are a plurality of facial plates 94 disposed in predetermined spaced relation along the height of the associated column (FIGS. 18 through 22) and which have the studs 44 secured to the exterior face thereof, as by means of the welds 44a. The thickness T (FIG. 17) of plate 94 should be at least 1/3 the base diameter of the associated welded stud 44. The studs 44 are threaded at their distal ends, similarly to the other described embodiments, and are adapted to receive thereon a coacting threaded nut when the studs are received through the complementary openings 54 in the cross member of the associated connecting member assembly 34, 34a, or 34b. Hereagain, and as can be seen in FIG. 18, the cross member 42 of the connecting member assembly engages in flat surface-to-surface engagement with the front face of the associated facial plate 94, the latter extending substantially the same vertical distance as the vertical height of the respective cross member 42 and being coextensive therewith. As best illustrated in FIGS. 18 through 22, there are preferably a pair of vertically spaced studs 44 associated with each of the facial plates 94, for drawing the associated cross member 42 of the connecting member assembly into tight surface-to-surface engagement. As can be best seen from FIGS. 18 through 21, aisle or travel zone column 30 (FIGS. 19 and 20) is substantially identical to the outer column 32 (FIGS. 21 and 22) except that the outer column 32 embodies anchor plates 98 secured to the rearward face thereof, for attaching thereto the diagonal stringers 100 (FIG. 1) which aid in rigidifying the storage frame structure. Anchor plates 98 have openings 102 therein which are adapted to receive suitable fastener means for securing the anchor plates 98 to the stringers 100. It will be seen that with such an arrangement the columns can be mass produced in an assembly line procedure, providing for automatic welding operations of the facial plates 94 and the studs 44 to the column, as well as facilitating attachment of the anchor plates 98 to the opposite face of the respective column. Footer plates 104 (FIGS. 19 through 22) may also be secured to the respective column for facilitating attachment of the column to the supporting floor surface. Referring now to FIGS. 23 to 25 there is illustrated another embodiment 34C of connecting assembly, which is usable in the storage rack in the same general manner as are the other described connecting assemblies. Assembly 34C is formed of thin gage metal such as for instance sheet metal of a gage of at least 16 or greater, thus resulting in a relatively light-weight connecting member assembly. Also, while in this embodiment, the load support members 48' are of generally angle shape in vertical cross section, similarly to the corresponding members in the first described embodiments, it will be seen that members 48' also embody a sloping section 106 at the juncture of the walls thereof, which is adapted to provide for sliding movement of an associated load, such as for instance a pallet on which a load of stock rests, downwardly away from the vertical wall section of the load support member, into generally centered relationship with respect to the horizontal load supporting section of each supporting member 48'. Sections 106 preferably have approximately a 60° slope. Moreover, angle shaped strengthening ribs 110 underlie each of the load supporting members 48', and is secured thereto as by means of spot welds, thus strengthening the rigidity of the supporting members 48' and their ability to support loads thereon in bridging relation thereacross. Load stop plate sections 52' associated with the rear end of each of the load supporting members 48', may be attached as by welds 107 (FIG. 23) to the associated supporting member 48' with such load stops preferably having an opening 112 therethrough, for a purpose to be hereinafter set forth. Separable anchor plates 114 may be provided, which have openings therein which are complementary located with respect to the openings 112, in the end stops 52', with such aligned openings being adapted to receive fasteners, such as threaded bolts and nuts, which will not only secure the anchor plate 114 to the end stops 52' of the associated connecting assembly, but also can be used to secure the diagonal strengthening stringers 100 (FIG. 1) to the anchor plates 114. It will be seen therefore that the anchor plates 114 take the place of the anchor plates 98 on the outer columns, as shown for instance in FIGS. 21 an 22, with the anchor plates 114 being detachably secured to the respective connecting member assembly. Use of detachable anchor plates 114 eliminates the need for a difference between the aisle columns (e.g. 30) and the outer columns (e.g. 32) and therefore the columns for forming all of the ladders in the storage rack structure can be identical in construction as manufactured at the manufacturing plant, rather than having to weld additional anchor arms 98 to the outer columns. Accordingly, manufacture of the columns is materially facilitated simplifying the manufacturing, handling, storage and shipping problems associated therewith. It will be understood that if it is found necessary to further rigidify the connecting member assembly 34C, that a rigidifying strut (e.g. 80) similar to that disclosed in FIGS. 10 through 12 may be added to the assembly 34C, and in a similar manner as disclosed in the aforementioned FIGS. 10 through 12. Referring now to FIGS. 26 and 27, there is illustrated diagrammatically "ladders" of a storage rack, with, in FIG. 26, the "ladders" including diagonal bracing members 116 of known construction. If a floor settling condition occurs, as indicated in exaggerated form at 118, leaving unsupported columns of the "ladders", substantial internal stresses are created. FIG. 27 illustrates "ladders" of a storage rack embodying connecting member assemblies 38', 34a' which include strengthening means (e.g. 80 -- FIGS. 10, 11 and 12) for aiding in maintaining the diagonal integrity of the connecting member assemblies. As can be seen, not all of the connecting member assemblies in the FIG. 27 embodiment necessarily include a strengthening web means 80. In the event of a floor settling condition (shown in exaggerated form at 118) the post or columns 30, 32 may assume a slight O.G. curve shape, averaging generally to perpendicular, as necessary to avoid internal stresses set up in the FIG. 26 ladder assemblies under a similar floor settling condition. Moreover, it will be seen that with an arrangement as shown in FIG. 27, the commercial tolerances available to a rack installation contractor would be considerably broadened. For instance instead of requiring a tolerance of + or - 1/64 inch, for leveling the connecting member assemblies in a storage rack installation, a tolerance of for instance + or - 1/16 inch might be set forth, thus materially aiding in lowering the installation costs of a storage rack. When the various parts of the storage rack are assembled on site by assembling the various parts and tightening the fastener means, a highly rigid and uniform storage rack is produced. As can be readily seen from the drawings, most of the components for the rack are of generally linear configuration facilitating the handling thereof during the manufacturing process and the shipping and handling at the site. From the foregoing description and accompanying drawings, it will be seen that the invention provides a novel storage rack for use in a warehousing system and one which includes generally linear, economically desirable components which when assembled together give a highly rigid assembly, which is resistant to joint separation of the columns and associated laterally extending connector assemblies. The invention also provides in one embodiment, for prestressing of the connections between the laterally extending connector assemblies and the columns, which increases the rigidity of the connections of the storage rack. The invention also provides a novel method for the production of ladders for a storage rack, without the necessity for vertical plane diagonal bracing in the ladder structure. The terms and expressions which have been used are used as terms of description and not of limitation and there is no intention in the use of such terms and expressions of excluding any equivalents of any of the features shown or described or portions thereof and it is recognized that various modifications are possible within the scope of the invention claimed.

A structural unit, such as for instance a storage framework composed of a plurality of storage frame components assembled into a storage rack, for use, for example, in warehousing systems. The framework comprises generally vertical column members which in certain embodiments are basically of a generally U-shaped configuration in horizontal cross section, but having a connecting or bridging plate or member disposed between and connected to the arms of the U, with the bridging member being preferably recessed inwardly from the distal ends of the arms. A fastener means, such as for instance a threaded stud, is secured to the bridging plate and projects generally perpendicularly outwardly therefrom. In other embodiments the column members are tubular and of polygonal configuration in horizontal cross section with the studs secured to spaced plates attached to one face of the respective column. Laterally extending connecting assemblies including load carrying means, are connected to and spaced vertically along the columns, and define the storage volumes in the storage rack. The connecting assemblies include vertically elongated end members having an opening therethrough through which is received a respective stud. In certain embodiments the end members are adapted to be deformed or prestressed upon tightening actuation of an associated fastener such as for instance a threaded nut, on the stud, thereby enhancing the rigidity of the connection at the fastener. One advantage of this arrangement over prior art is that generally standard structural components can be utilized in the formulation of the framework rather than requiring the necessity of substantial amounts of custom made components, and mass production of the framework components is facilitated. A method of eliminating the need for diagonal bracing in the ladders of the storage framework is likewise disclosed, and in a manner whereby the diagonal integrity of the load supporting assemblies of a storage rack is maintained.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to golf club design. More particularly, the present invention relates to a method for designing a golf club by applying pendulum technology engineering physics and the laws of physics to create an optimally fabricated golf club. 2. Description of the Prior Art Golf clubs have historically been made by attaching a wood or iron type head to the end of an elongated flexible shaft having a grip on the opposite end thereof. The head is provided with a flat ball striking face whereby a golf ball may be propelled in a forward direction toward a target when the club strikes the ball. Little regard was previously given to the physical structure of the club other than the flexibility of the shaft, the overall weight, and the swing weight of the club head. In fact, many early golf clubs, used by successful tournament players, were selected solely based on the feel of the club in the players' hands. This was done totally without regard for the technical and physical characteristics of the golf club. As modern technology has advanced, attention has been directed to the development of more technically precise golf clubs which are matched to an individual golfer's swing. Specifically, methods have been developed to account for the mass of the head, shaft, and grip, and their relationship in the design of golf clubs. These methods enable proper balancing for each of the individual clubs and allow a golfer to develop a single swing. Algebraic and differential equations have been previously used to match components of a golf club for dynamic balancing the clubs in a set. Specifically, and in accordance with such procedures, different lengths and weights of the individual components of a golf club are analyzed with respect to the moment of inertia about a pivot point. However, the distribution of masses within golf clubs designed in accordance with these prior balancing procedures only provides a golfer with a similar feel among the golf clubs in a set of golf clubs, and does not generate a more efficiently weighted golf club. By analyzing a golfer's swing, attempts have been made to adjust the weights and moments within a golf club to provide the golfer with a club ideally suited for his or her specific swing. A major drawback to this golf club design technique is its focus on a specific golfer. That is, only custom clubs can be manufactured in accordance with these methods. Golf clubs made in mass production cannot benefit from these methods. The present invention overcomes these problems by adjusting the mass within a golf club to provide the golfer the opportunity for a longer and more accurate shot. Also, the present invention may be implemented for one specific club or for the manufacture of a complete set of clubs. SUMMARY OF THE INVENTION The present invention is directed to an improvement in the design of golf clubs. In accordance with the present invention, the laws of statics and dynamics are applied to create a precisely and efficiently balanced golf club. Golf clubs manufactured in accordance with the present invention are constructed such that the moment generated at the center of mass of the entire club is essentially equal to the moment at the club head's center of percussion. This is accomplished by analyzing and adjusting the mass distribution within the golf club to move the relative moment of the center of mass close to the moment of the club head's center of percussion. The analysis is performed under the assumption that a golf club acts as a pendulum with the pendulum's pivot point located at a position along the grip of a golf club where a golfer's grip would commonly end. As such, the invention relates to the design and manufacture of a golf club, and a golf club set, providing more positive power and control in the club head by applying superior physical characteristics to the construction of the golf club within the standards established by traditional golf club guidelines and the rules of golf. The first step in accordance with the present design technique is to select a club length. The club length is necessary to determine which type of golf club wood or iron is to be designed. The second step is to select a swing weight and determine the center of mass for the golf club. Next, the pivot point of the golf club is defined. Finally, the mass of the shaft, grip and club head are adjusted to bring the ratio l h2 m h /l c m c as close to one (1) as possible. More specifically, by setting the moments of the center of mass and the center of percussion equal around the pivot point 10, the mass of the shaft, grip and head of the golf club are adjusted to move the center of mass 12 such that the moment at the center of mass is made substantially equal to the moment at the center of percussion 14. In order to achieve the highest degree of effectiveness, and in accordance with the present invention, the golf club is constructed such that the moment at its center of mass is substantially equal to the moment at the club head's center of percussion. When this occurs, and according to pendulum technology, the club acts as though 100% of the mass of the golf club is concentrated in the club head itself. Moving the moment at the center of mass closer to the moment at the center of percussion adds desirable momentum to the club head of the golf club, providing the opportunity for the golfer to have greater accuracy and longer drives. As discussed above, the present analysis is dictated by the fact that a golf club acts as a pendulum with the pendulum's pivot point located at a position just below the grip of a golfer; that is, a golf club obeys pendulum technology as the heavy club head swings on the shaft. A physical characteristic of a pendulum is that it does not have any reaction at the pivot point around which the pendulum swings. Further to the preceding discussion, the pivot point is located according to a golfer's hand placement. In the conventional use of a golf club, the pivot point is located below the golfer's hands and above the end of the grip. The center of mass is defined to be that point of the golf club located below the pivot point and is generally located on the shaft spaced a short distance from the club head. The center of percussion, the ideal spot to strike a golf ball, is located on the club head dimensionally correct for the pendulum used for striking heavy blows. The most important requirement of pendulum technology as applied to the present technique is that the mass of the club is minimized to achieve equality of moment of the club head with the total moment of the club itself (i.e., the grip, shaft and head). This is primarily achieved by reducing the weight of shaft and by reducing, or changing the weight of the grip. Other objects and advantages of the present invention will become apparent from the following detailed description when viewed in conjunction with the accompanying drawings, which set forth certain embodiments of the invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an illustration of the principle dimensions and mass a golf club. FIG. 2 is a further illustration of the principle dimensions of a golf club while applying pendulum technology in accordance with the present invention. FIG. 3 is a flow chart depicting the method for designing a golf club. DESCRIPTION OF THE PREFERRED EMBODIMENTS The detailed embodiments of the present invention are disclosed herein. It should be understood, however, that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, the details disclosed herein are not to be interpreted as limited, but merely as the basis for the claims and as a basis for teaching one skilled in the art how to make and/or use the invention. Referring to FIG. 1, the principle dimensions and mass distribution of a golf club 2 are illustrated. The golf club 2 is composed of three sections including the grip 4, the shaft 6, and the club head 8. The golf club 2, and a set of golf clubs (not shown), are within the standards of physical limits established by traditional golf club guidelines and the rules of golf. The grip 4, shaft 6, and club head 8 are designed using materials common to the art of golf club making. The golf club 2 usually weighs between 10.0 and 13.5 ounces, or more. An example of a weight distribution of a 42" standard driver weighing 12.9 ounces is as follows: the grip 4 weighs 3.0 ounces, the shaft 6 weighs 1.4 ounces, and the club head 8 weighs 8.5 ounces. In designing a golf club 2 in accordance with the present invention, it is first necessary to select a club length and determine which type of golf club wood or iron is to be designed. Next, a swing weight is selected and the pivot point location determined on the golf club. The center of mass and the center of percussion are also determined. In order to optimize the application of the present invention, a club head with a center of percussion located substantially at the center of the striking face should be used in constructing the golf club head. With reference to FIG. 1, the center of mass for a golf club is defined as: L=(A.sub.G W.sub.G +A.sub.S W.sub.S +A.sub.P W.sub.P)/W where: A G =the distance from the butt end 13 of the club 2 to the center of mass for the grip W G ; A S =the distance from the butt end 13 of the club 2 to the center of mass for the shaft W S ; A P =the distance from the butt end 13 of the club 2 to the center of mass for the club head W P ; W G =the mass of the grip 4; W S =the mass of the shaft 6; W P =the mass of the club head 8; L=the distance from the butt end 13 of the club 2 to the center of mass for the entire golf club 12; and W=the mass of the entire golf club 2. As also discussed above, a swing weight for the golf club 2 must be selected. The swing weight preference depends upon the individual using the golf club 2, although it normally ranges from a C-5 to a D-5 classification. The parameters of the swing weight are well known in the golf industry and are measured by a number of available swing weight scales, and the like. The swing weight is generally defined by the equation: W(L-12) =Swing Weight Before beginning the mass analysis in accordance with the present invention, a few assumptions are made. With reference to FIG. 2, a golf club 2 acts as a pendulum. That being said the laws of pendulum technology govern the motion of the golf club 2 with the pendulum's pivot point 10 being approximately located at a position below the golfer's hands and above the grip end 11 of the grip 4. Those skilled in the art will, however, understand that the pivot point 10 may be varied depending upon specific swing preferences of the golfer and the specific use of the golf club 2. Based upon the assumptions described above, and in accordance with the laws of statics and dynamics, the mass of the grip 4, the shaft 6, and the club head 8 are adjusted such that the moment at the center of mass 12 is substantially the same as the moment at the center of percussion 14. More specifically, by setting the moment of the center of mass 12 and the moment of the center of percussion 14 substantially equal around the pivot point 10, the mass of the shaft 6 is minimized and the mass of the grip 4 is minimized to move the moment of the center of mass 12 closer to the moment of the center of percussion 14 while maintaining the swing weight of the golf club 2 substantially the same. Specifically, and as briefly discussed above, the highest degree of effectiveness in a golf club 2 is achieved when the moment at the center of mass 12 of the golf club 2 is essentially equal to the moment at the club head's center of percussion 14. When this occurs, the golf club 2 acts as though the total mass of the club 2 is concentrated in the club head 8. With reference to FIG. 2, this relation of moments is represented in the following equation: l.sub.c m.sub.c =l.sub.h2 m.sub.h where: m c =the mass at the center of mass 12; l c =the length from the pivot point 10 to the center of mass 12; l h2 =the length from the pivot point 10 to the center of percussion 14; and m h =the mass of club head 8. The following other components of the golf club 2 are also disclosed in FIG. 2 and are introduced so as to present a complete picture of the mass distribution of a golf club 2 in accordance with the present invention: l c =the length from pivot point 10 to the center of mass 12; l g1 =the length from pivot point 10 to the butt end 13 of the club 2; l g2 =the length from pivot point 10 to the grip end 11 (where l g1 +l g2 =the length of the grip 4); l s1 =the length from pivot point 10 to the butt end 13 of the club 2; l s2 =the length from pivot point 10 to the distal end of the shaft 6 (where l s1 +l s2 =the length of the shaft 6) l h1 =the length from pivot point 10 to the butt end 13 of -=the club 2; l h2 =the length from pivot point 10 to center of percussion 14 (where l h1 +l h2 =the length of the from the butt end 13 of the club 2 to the center of percussion 14".) m s1 =the mass of shaft 6 from pivot point 10 to the butt end 13 of the shaft 6; m s2 =the mass of shaft 6 from pivot point 10 to the distal end of the shaft 6 (where m s1 +m s2 =the mass of the shaft m s ); m g1 =the mass of grip 4 from pivot point 10 to the butt end 13 of the shaft 6; m g2 =the mass of grip 4 from pivot point 10 to the grip end 11 (where m g1 +m g2 =the mass of the grip mg); and m h =the mass of the club head 8. By respectively adjusting the mass of the grip 4, the shaft 6, and the club head 8, the ratio l h2 m h /l c m c can be made to equal approximately one (1), thereby making the moment of the center of mass substantially equal to the moment of the center of percussion. More specifically, by setting the moments substantially equal around the pivot point 10, mass m s and mass m g are decreased to move the center of mass 12 while maintaining the swing weight substantially the same. With this in mind, it may be desirable to increase the mass of the portion of the grip 4 above the pivot point 10 to maintain the golf club's swing weight within a desired and predetermined range. Comparison with actual dimensions confirms the fact that golf clubs are designed as physical pendulums insofar as dimensions are concerned. By applying pendulum technology to improve the design of golf clubs in accordance with the present invention, the resulting golf club is designed as if the total mass of the golf club 2 is concentrated in the club head 8 substantially in line with the center of percussion 14. The pivot point 10 is defined as the point around which the pendulum swings. On the golf club 2, the pivot point 10 is typically on the grip 4 and often about 1.5" from the bottom of the grip 4 or about 8.5" from the butt end 13 of the grip 4 according to the golfer's hands when the golf club 2 is gripped in a conventional manner. Referring to FIG. 3, a flow chart for the method of designing a golf club, or set of golf clubs, in accordance with the present invention is illustrated. The first step is to select a club length. The club length is necessary to determine which type of golf club wood or iron is to be designed. The second step is to select a swing weight and determine the center of mass for the golf club. Next, the pivot point of the golf club is defined. Finally, the mass of the shaft, grip and club head are adjusted to bring the ratio l h2 m h /l c m c as close to one (1) as possible. More specifically, by setting the moments of the center of mass and the center of percussion substantially equal around the pivot point 10, mass m s and mass m g are decreased to move the center of mass 12 closer to the pivot point and thereby bring the moment at the center of mass substantially equal to the moment at the center of percussion 14. After adjusting the mass within the golf club, the user has the choice to design another golf club or to end the procedure. This invention can be adapted for use on a computer or the like. A computer could aid in the calculations to allow for a faster and more efficient design. The present invention has been described with reference to the moments about the center of mass and the center of percussion. As those skilled in the art are well aware, moments are directly mathematically related to momentum. With this in mind, the preceding calculations could readily be performed using the momentum about the center of mass and center of percussion as the basis for designing a golf club in accordance with the present invention. Such a variation would not alter the resulting golf club and would certainly be considered to fall within the spirit of the present invention. While various preferred embodiments have been shown and described, it will be understood that there is no intent to limit the invention by such disclosure, but rather, is intended to cover all modifications and alternate constructions falling within the spirit and scope of the invention as defined in the appended claims.

The present invention relates to still another improvement in golf club design. In accordance with the present invention, the laws of statics and dynamics are applied to create a precisely and efficiently balanced gold club head. The golf club of the present invention is constructed so that the moment generated at the center of mass of the entire club is essentially equal to the moment at the club head. This is accomplished by analyzing and adjusting the mass distribution within the golf club to move the relative positioning of the moment of the center of mass closer to the moment of the center of percussion on the club head. The invention thereby relates to the design and manufacture of a golf club, and a golf club set, which provides more positive power and control in the club head by applying superior physical characteristics in the construction of the golf club within the standards established by traditional golf club guide lines and the rules of golf.

BACKGROUND OF THE INVENTION The present invention relates to a device for delivering a substance to an internal portion of a body that has been acted on by a procedure performing instrument such as a catheter, trocar, laparoscopic instrument or a biopsy device. The invention more particularly relates to a biopsy device for obtaining one or more tissue samples and for applying at least one substance to the biopsy site in one operation. The biopsy device is particularly adapted to remove a core or segment of tissue from the biopsy site and then apply a surgical adhesive comprised of a first component containing fibrinogen and a second component containing thrombin to the biopsy site to seal the site and control bleeding. If required, multiple tissue samples may be collected before applying the surgical adhesive. The biopsy device described may be operated manually or used in a semi-automatic or automatic mode. The biopsy device may also be adapted to remove a tissue sample from the biopsy site by aspiration. An excision or coring biopsy is commonly carried out by inserting a needle such as that needle set disclosed in U.S. Pat. No. 3,477,423 into the organ or tissue to be biopsied. That needle is comprised of an outer hollow cutting cannula with an inner stylet needle having a semi-circular notch ground away at the distal end. As the stylet is advanced into the tissue, the tissue is pierced and relaxes or prolapses into the notched cut out or recess. When the cannula is slid forward, the tissue in the notch of the stylet is sliced off and retained in the notch until the cannula is drawn back. The needle yields a core tissue sample which is semi-circular in cross section with its length determined by the length of the notch. An aspiration biopsy is commonly carried out using an aspiration device known as a Menghini needle as described in U.S. Pat. No. 4,850,373 which is hereby incorporated by reference in its entirety. A biopsy aspirating device is also described in U.S. Pat. No. 3,938,505 which is also incorporated by reference herein in its entirety. In an aspiration biopsy, the Menghini needle or other compatible soft-tissue biopsy aspirating device is directed to the biopsy site and positioned so that the distal end of the needle is located in the tissue or cyst to be biopsied. A syringe is then attached to the proximal end of the needle and tissue or fluid is aspirated from the site. The needle is then withdrawn. Under certain circumstances, several complications can develop when biopsy samples are collected with known devices. For example, excision biopsies from lung tissue are associated with a relatively high complication rate due to hemorrhage and pneumothorax (McEvey, R. D., Bagley, M. D., Antic. R. 1983: Percutaneous Biopsy of Intrapulmonary Mass Lesions, Cancer 51, 2321). Profuse bleeding is also considered the most important complication associated with excision biopsies of the kidney and other organs. Profuse bleeding can be a particular problem during the biopsy of patients with hemophilia or other clotting disorders as well as those patients under treatment with anti-coagulants such as heparin or coumadin. Aspiration and core biopsies of the liver can also be complicated by profuse bleeding. To minimize these possible complications, biopsy devices adapted to deliver a surgical adhesive to the biopsy site after aspiration or excision of a tissue sample have been developed. For example, U.S. Pat. No. 4,850,373 is directed to a manual aspiration biopsy device including a two- or multi-lumen biopsy cannula which has a biopsy channel of constant cross-section over its entire length and at least one application channel. On its proximal end, the device is provided with connection facilities for an aspiration device and at least one application device. At least one application channel is formed by a tube eccentrically slipped over the biopsy channel wall. After tissue is collected, a substance such as a blood coagulation material may be introduced directly to the biopsy site. European Patent 0 455 626 is directed to a manual biopsy device for obtaining a tissue sample and for applying at least one substance in one operation. The biopsy device comprises a biopsy channel having a cutting edge for cutting off tissue and an application channel for applying a blood-clotting substance. The application channel is defined by an application tube slipped over the biopsy cannula. The front end of the application tube is rearwardly offset relative to the cutting edge of the biopsy cannula. At the opposite end of the application channel, a tightly joined connecting piece is provided for connecting at least one duct to convey the blood-clotting substance to the application channel. The biopsy device can be connected to a suction device to collect tissue samples by aspiration. Alternatively, the device can be adapted to perform excision biopsies by longitudinally displaceably mounting a needle with a tissue-penetrating tip within the biopsy cannula as illustrated in U.S. Pat. No. 3,477,423. The design of the device disclosed in EP 0 455 626 has several potential drawbacks. The clearance between the inner wall of the application tube and the outer wall of the biopsy cannula is small. Consequently, when injecting a substance with a viscous component or components such as a fibrin sealant into the application channel, the user must exert substantial pressure on the injector device to force the components into the application channel for delivery to the biopsy site. As a result, tissue sealant can leak out from the connection between the injector device and the applicator tip. The surgical sealant can also leak out at the connection point between the applicator tip and the cantilevered portion of the connecting tube leading to the application channel. A second potential drawback of the excision biopsy device disclosed in EP 0 455 626 is contamination of the biopsy sample with the surgical sealant. Since surgical sealant is injected through the application channel while the stylet is still in the biopsy cannula, surgical sealant flows back over the cored tissue sample contained within the biopsy cannula after the surgical sealant is delivered to the biopsy site. As a result, the biopsy sample becomes coated with the surgical sealant such as a fibrin tissue sealant thereby complicating any diagnosis based on analyis of the excised tissue sample. Theoretically, sample contamination by tissue sealant in the excision biopsy device described in EP 0 455 626 could be avoided by withdrawing the stylet needle containing the excised tissue and the biopsy cannula from the device, leaving only the application tube in place. If the user determined that the tissue sample excised was not of sufficient size or quality for histological examination, the stylet needle could be re-inserted and additional samples obtained. When the biopsy was completed, surgical sealant could then be applied to the biopsy site through the relatively unconstricted application tube. However, withdrawal of the stylet needle/biopsy cannula assembly from the device would provide an unrestricted pathway for blood and sealant to flow back through the application tube by capillary action and severely compromise any attempt by the user to harvest additional biopsy samples or to seal off the biopsy site with a surgical sealant. SUMMARY OF THE INVENTION In accordance with the invention, a device is described for delivering a substance to an internal portion of a body which has been acted on by a procedure performing instrument such as a catheter, a trocar, a laparoscopic instrument or a biopsy device. The device includes an application tube having a proximal end, a distal end and an internal lumen for receiving the substance to be delivered and at least a portion of the procedure performing instrument. A housing assembly is disposed on the proximal end of the application tube and has an internal lumen extending from a proximal end of the housing assembly to a distal end of the housing assembly. The housing assembly lumen is in communication with the internal lumen of the application tube so as to define a flow passage A flow control member is disposed in the flow passage and has a first position that opens the flow passage and a second position that closes the flow passage. A variety of substances including surgical sealants and adhesives can be delivered to an internal portion of the body using this device. In addition, the surgical sealants and adhesives can themselves act as matrices for the delivery of antibiotics, drugs and other therapeutic agents. Preferably, the device of the invention is a device for obtaining a tissue sample from an internal portion of a body and for applying at least one substance to an internal portion of a body. The device comprises a biopsy cannula having an internal lumen and a distal cutting edge for cutting off tissue. A needle member is slideably mounted within the internal lumen and has a recess for receiving the tissue sample. A driver, which may be manually, semi-automically or automatically operable, is associated with the cannula and the needle member for effecting relative movement between the cannula and the needle and cutting of the tissue. An application tube having a proximal end, a distal end and an internal lumen is disposed around the cannula with the distal end of the application tube rearwardly offset relative to the cutting edge of the cannula. A housing assembly is sealingly engaged to the proximal end of the application tube. The housing assembly includes an internal lumen through which the cannula and needle are slidingly moveable. The housing assembly lumen is in communication with the internal lumen of the application tube so as to define a flow passage. A flow control member is disposed in the flow passage and has a first position that opens the flow passage and a second position that closes the flow passage. In another embodiment, the device may be provided with a back housing which is engaged to the proximal end of the housing assembly and which is also engageable with the driver. The back housing includes a bore through which the cannula and the needle are slidingly moveable. A flow control member is positioned between the engagingly affixed proximal end of the housing assembly and the back housing to prevent backflow of flowable material. The biopsy cannula and the needle member are slidingly moveable through the flow control member. In another embodiment of the invention, a device for obtaining a tissue sample from an internal portion of a body and for applying at least one substance to an internal portion of a body is provided as described above with a housing assembly that is sealingly engaged to the proximal end of the application tube which contains an internal lumen through which the biopsy cannula and needle member are slidingly moveable and a substance supply tube communicating with the internal lumen of the application tube which is engageable with a substance supply for applying the substance to the application tube. In an alternate embodiment of the invention, the device for obtaining a tissue sample from an internal portion of a body and for applying at least one substance to an internal portion of a body comprises a Menghini needle or an equivalent soft tissue biopsy aspirating device as described in U.S. Pat. Nos. 4,850,373 and 3,938,505 respectively. The needle or aspirating device is attachable to a source of suction for aspiration of tissue or sample from the internal portion of a body. An application tube having a proximal end, a distal end and an internal lumen is disposed around the needle or aspirating device with the distal end of the application tube rearwardly offset relative to the cutting edge of the needle or aspirating device. A housing assembly is sealingly engaged to the proximal end of the application tube. The housing assembly includes an internal lumen through which the needle or aspirating device is slidingly moveable. The housing assembly lumen is in communication with the internal lumen of the application tube so as to define a flow passage. A flow control member is disposed in the flow passage and has a first position that opens the flow passage and a second position that closes the flow passage. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a manual biopsy device according to the invention; FIG. 2 is a perspective view of a semi-automatic biopsy device according to the invention; FIG. 3 is a perspective view of an automatic biopsy device according to the invention; FIG. 4 is a sectioned view of the housing assembly of the biopsy device of FIG. 1; and FIG. 5 is a perspective view of an alternative embodiment of a manual biopsy device according to the invention shown with the applicator device in place. FIG. 6 is a sectioned view of the housing assembly of the biopsy device of FIG. 1 showing the split sheath protecting the flow control member as the biopsy needle set is passed through it. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to FIG. 1, a manual biopsy device 20 of the present invention comprises a biopsy cannula 1 having an internal lumen which defines a biopsy channel and having a distal cutting edge 22 for shearing off tissue. Longitudinally displaceably mounted and concentric with biopsy cannula 1 is a needle member 2 having a distal cutting tip or a tissue-penetrating tip 23 . Needle member 2 is provided with a recess 3 at its distal end so as to accomodate a tissue sample. The tissue sample recess 3 is displaceable from a position located within the biopsy cannula 1 to a position located outside of the biopsy cannula 1 and back using a driver 21 connected to the biopsy cannula 1 and the needle member 2 . Driver 21 controls relative movement between the biopsy cannula 1 and the needle member 2 during tissue sample removal. An example of a manual biopsy needle set is set forth in U.S. Pat. No. 3,477,423 which is herein incorporated by reference in its entirety. FIGS. 2 and 3, respectively, illustrate a semi-automatic 30 and an automatic biopsy device 40 embodiment of the invention wherein relative movement between the biopsy cannula and the needle member during tissue sample removal is controlled using semi-automatic driver 31 and automatic driver 41 respectively. A description of the construction and operation of the driver of a semi-automatic biopsy device is described in U.S. Pat. No. 5,313,958. A description of the construction and operation of the driver of an automatic biopsy device is disclosed in U.S. Pat. Nos. 4,958,625, 4,944,308 and 5,172,702. These four patents are incorporated by reference herein in their entirety. Referring again to FIG. 1, an application tube 4 having a proximal end, a distal end and an internal lumen is slipped over and concentrically positioned around the biopsy cannula 1 such that the biopsy cannula 1 and needle member 2 can be freely withdrawn through the application tube 4 . The distal end of the application tube 4 is rearwardly offset relative to the cutting edge of the biopsy cannula 1 and terminates in a blunt cut end or an angled cutting surface 28 . At the proximal end of the application tube 4 , a housing assembly 5 is tightly joined by gluing or sealing. Referring to FIG. 4, the housing assembly 5 includes a preferably straight tube portion 6 having an internal lumen 24 through which the biopsy cannula 1 and needle member 2 extend therethrough. A substance supply tube 7 enters into tube portion 6 of the housing assembly 5 and includes at least one lumen 25 leading into and communicating with the internal lumen 24 of the tube portion 6 so as to form a flow passage through which a substance can be delivered into the application tube 4 for application to the biopsy site Substance entry port 8 of substance supply tube 7 is fitted with a luer slip, luer lock or a similar type connection for lockingly engaging an applicator device (not shown) containing the substance to be applied to the biopsy site. As noted above, the application tube 4 is sealingly fixed to the distal end of the tube portion 6 of the housing assembly 5 . The proximal end of the tube portion 6 preferably flares out to an integrally molded hub housing 9 having a central bore 26 . Hub housing 9 preferably mates to a back housing 10 comprised of a central bore 27 , a guide channel 29 , a distal portion 11 for connection to the hub housing 9 and a proximal portion 12 comprising an interface 13 for engaging a mating surface on a manual, semi-automatic or automatic biopsy device driver. The interface 13 includes but is not limited to prongs, fingers and equivalent structures. Preferably, housing assembly tube portion 6 , substance supply tube 7 and the hub housing 9 are molded as one piece. Alternatively, tube portion 6 , substance supply tube 7 and hub housing 9 are bonded together using glue, adhesive or ultrasonic welding or equivalent bonding means. The housing assembly is preferably constructed of a hard plastic such as ABS (Lustran ) which can be machined into the shape required for the invention. Interposed within the space created by the mating of the hub housing 9 and the back housing 10 is a flow control member 14 , preferably a one-way valve which is positioned within the space so that it rests and is centered upon an annular shelf 15 molded on the interior wall of the hub housing 9 . The flow control member 14 is always closed to the backflow of blood and surgical sealant and only opens when the biopsy cannula 1 containing the needle member 2 is withdrawn from the device. Guide channel 29 in back housing 9 positions the biopsy cannula 1 and the needle member 2 as they are inserted through the flow control member 14 so that the biopsy cannula 1 and the needle member 2 pass through the center of the flow control member 14 and do not shear off or otherwise damage the flow control member 14 while passing through it. The flow control member 14 is preferably a rubber duck-bill valve. However, the flow control member 14 can also be replaced by any other device which allows the biopsy needle set comprised of the biopsy cannula 1 and the needle member 2 to be completely withdrawn from the device while simultaneously stopping any backflow of flowable material such as blood or tissue sealant from the proximal end of the device. The hub housing 9 and the back housing 10 are preferably joined together using adhesive, glue, ultrasonic welding, a snap fit or by using equivalent joining means FIG. 5 illustrates another embodiment of the invention 50 with an applicator device 52 in place. In this embodiment, the substance supply tube 7 is eliminated. After the biopsy cannula 1 and needle member 2 have been withdrawn from the biopsy device, the surgical sealant is applied to the application channel 4 directly through the flow control member 14 and into the internal lumen 24 of the tube portion 6 where it flows into the application tube 4 for delivery to the biopsy site. This embodiment of the invention can also be used with a semi-automatic or automatic driver. FIG. 6 illustrates another embodiment of the invention in which the sharp tips 22 and 23 of the biopsy cannula 1 and the needle member 2 respectively are shielded by a split sheath 32 which covers the distal end of the biopsy needle set as it is inserted through the flow control member 14 . The split sheath 32 has a distal end 33 which may be open or closed and a proximal end 34 which is affixed onto the biopsy cannula 1 by a hub or other affixation means. The split sheath 32 also has perforations 35 along each side of its length for removing the sheath from the biopsy needle set after it has passed through the flow control member 14 . The manual biopsy device of the invention 20 is used as follows. The user first prepares the patient for the biopsy procedure. Then, the substance or substances to be delivered to the biopsy site are prepared and loaded into the applicator device. For example, the substance may be the fibrin tissue sealant and application device described in U.S. Pat. Nos. 4,909,251 and 5,464,396 respectively which are incorporated by reference in their entirety herein. The user next attaches the applicator device to the substance entry port 8 of the substance supply tube 7 . In an alternative procedure, where greater maneuverability of the device in the surgical field is desired or required, the applicator device can be affixed to the substance entry port 8 after the biopsy sample has been collected and withdrawn from the device. If this procedure is used, the substance entry port should be plugged to prevent backflow or leakage of blood from the entry port. The user guides the coaxially disposed application tube 4 , biopsy cannula 1 and needle member 2 of the biopsy device to the biopsy site through the tissue with means well known in the art such as ultrasound, computerized tomography or magnetic resonance imaging equipment. Preferably, both the application tube 4 and the biopsy needle 1 have depth marks evenly spaced along their length to assist the user in identifying the exact location of the distal end of the device. The biopsy device is also preferably equipped with a depth stop that allows the user to lock the biopsy device if need arises. After the biopsy device is accurately positioned, the needle member 2 is pushed forward into the tissue to be biopsied, allowing a sample of tissue to relax or prolapse into the recess or notch 3 cut out at the distal end. The biopsy cannula 1 is then pushed forward and the core of tissue caught in the notch cut or recess 3 is shorn off from the rest of the tissue by the cutting edge 22 of the biopsy cannula 1 . The user then withdraws the biopsy needle set comprised of the biopsy cannula 1 and the needle member 2 proximally through the application tube 4 , through the tube portion 6 , through the flow control member 14 and through the back housing 10 until the complete needle set and the biopsy sample have cleared the flow control member 14 leaving only the application tube 4 in place at the biopsy site. After the biopsy cannula 1 and needle member 2 are withdrawn, the flow control member 14 will return to its normally closed position and will prevent blood or subsequently applied surgical sealant from exiting the device. The biopsy sample is now removed from the notch or recess 3 in needle member 2 and reserved for whatever analysis is appropriate to the sample. Alternatively, the user may collect an additional biopsy sample or samples by re-inserting the needle set into the device and repeating the procedure as required. After the user has collected the final biopsy sample, surgical sealant is injected through the flow path beginning at the substance entry port 8 , and extending down the substance supply tube 7 , the distal end of the tube portion 6 and distally down the application tube 4 until it is delivered to the biopsy site. After an effective amount of tissue sealant is delivered to seal the biopsy site, the application tube 4 is slowly withdrawn from the tissue while simultaneously continuing to inject tissue sealant into the path traversed by the application tube 4 through the tissue. This withdrawal procedure allows a plug of tissue sealant to be deposited in the tissue in the track cut by the biopsy device. In another embodiment of the invention 50 illustrated in FIG. 5, the biopsy sample is first collected as described above. After the user has collected the final biopsy sample and completely withdrawn the biopsy cannula 1 and needle member 2 from the application tube 4 , surgical sealant is injected into the application tube 4 through the flow control member 14 . After an effective amount of surgical sealant has been applied to the site, the application tube 4 can be withdrawn while continuing to inject surgical sealant as described above for embodiment 20 . In another embodiment of the invention illustrated in FIG. 6, the split sheath 32 protects flow control member 14 as the biopsy cannula 1 and needle member 2 are inserted through the flow control member 14 . Once the needle tips 22 and 23 have cleared the flow control member 14 , the split sheath 32 is peeled away from the needle assembly beginning at the proximal end of the sheath 34 and continuing down toward the distal end of the sheath 33 along the perforations 35 and withdrawn in two parts from the device as illustrated in FIG. 6 . The biopsy sample or samples are then collected and the substance applied to the biopsy site as described below. The split sheath 32 can be used with any embodiment of the invention 20 , 30 , 40 or 50 set forth above or with the alternative embodiment for obtaining a tissue sample from an internal portion of a body by aspiration through a Menghini needle or equivalent soft tissue biopsy aspirating device In an alternate embodiment of the invention where a tissue sample is removed from an internal portion of the body by aspiration, surgical sealant is injected into the application tube 4 through the flow control member 14 after the Menghini needle or equivalent soft tissue biopsy aspirating device has been completely withdrawn from the application tube 4 and out the proximal end of the housing assembly 5 . After an effective amount of surgical sealant has been applied to the site, the application tube 4 can be withdrawn while continuing to inject surgical sealant as described above for embodiment 20 . Although use of the device has been described in detail for the manual version of the device, one of ordinary skill in the art will be able to make the necessary adaptations to use the biopsy device and the described procedure with a semi-automatic or automatic biopsy device. In addition to tissue sealant, other substances which may be advantageously applied to a biopsy site using the device of the invention include collagen-based hemostatic agents and any other surgical sealant or hemostatic agents. While the invention has been ilustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character. All changes and modifications that come within the spirit of the invention are contemplated as within the scope of the invention.

A device for delivering a substance such as a surgical sealant or adhesive to an internal portion of the body that has been acted on by a procedure performing instrument such as a catheter, trocar, laparoscopic instrument or a biopsy device is described. The invention more particularly relates to a biopsy device for obtaining one or more tissue samples and for applying at least one substance to the biopsy site in one operation.

This application is a continuation-in-part of application Ser. No. 07/735,995, filed Jul. 25, 1991 now abandoned. BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to an assembly for mixing and dispensing preparations of two or more components. 2. Description of the Related Art A number of devices have been developed which are intended to serve as a shipping, storage, mixing and dispensing container for small quantities of preparations made of two or more components. Some of these devices are particularly desirable for single-use applications such as one-patient applications in the medical and dental fields. Certain devices, for example, are used in dentistry for two-component glass ionomer cement systems that serve as adhesives, bases, liners, luting agents, sealants, and filling materials for restorative or endodontic use. Ionomer cement systems typically are made by mixing a small quantity of glass powder with an aqueous solution of polycarboxylic acid. Representative ionomer cement systems are described in U.S. Pat. Nos. 4,872,936, 4,209,434 and 3,814,714 as well as European Patent Application Nos. 0 323 120 and 0 329 268. Dental ionomer cement systems are often characterized as having relatively short working times (e.g., on the order of one to two minutes) and as a consequence preferably are applied directly to the tooth cavity or other work site from a capsule or other small container that is used for both mixing and dispensing the cement. Mixing and dispensing capsules for two-component dental preparations are described in U.S. Pat. Nos. 3,595,439 and 4,648,532 and U.K. Patent Application No. 2 220 914. In brief, such capsules include a hollow capsule body having an outlet on one end, a piston received in an opposite end, and a barrier within the body that initially separates the two components. When desired, the barrier is ruptured and the components are mixed by placing the capsule in an amalgamator. The capsule is then placed in a dispensing device to advance the piston and eject the mixed preparation through the outlet. The barrier of the capsule described in U.S. Pat. No. 3,595,439 is ruptured by placing the capsule in a pressure-inducing device that together advances a cap and plunger toward a tubular body portion. After the components are mixed in an amalgamator, the capsule is placed in a receptacle of a hand extruder having a ram which is movable through a hole in the capsule cap for advancement of the plunger to dispense the preparation while the cap remains stationary. Advantageously, the overall length of the capsule shown in U.S. Pat. No. 3,595,439 is too large to fit within the receptacle of the extruder unless the barrier has been ruptured by advancement of the cap and plunger toward the tubular body of the capsule. Such construction serves to remind the user that there are two components in the capsule that should be mixed by the amalgamator before beginning the dispensing operation. However, the mixing and dispensing capsule described in U.S. Pat. No. 3,595,439 is used with two tools: the pressure-inducing device to rupture the barrier and "activate" the capsule, and the hand extruder for discharging the mixed preparation from the capsule. The purchase, handling and cleaning of two tools results in additional time and expense. U.K. Patent Application No. 2 220 914 describes in one embodiment an assembly of a capsule and a single dispensing device, wherein the dispensing device is placed in a first position to rupture a barrier and then placed in a second position to eject the contents. However, there is a possibility that a ram of the dispensing device may be advanced too far when such a capsule is in its first position, resulting in unintentional discharge of the contents of the capsule before the contents have been properly mixed. SUMMARY OF THE INVENTION An assembly in accordance with the invention for mixing and dispensing a preparation comprises a capsule including a body having a chamber and a front end portion with outlet structure. The capsule includes a piston received in the chamber. The piston is movable in the chamber along a limited path of travel toward the front end portion. The capsule includes a barrier in the chamber. The assembly further includes a dispensing device including a housing having a receptacle with a reference axis. The receptacle includes structure for detachably receiving the capsule in either a first orientation or a second orientation spaced from the first orientation in a direction along the axis. The device includes a lever movably coupled to the housing and a ram connected to the lever. The ram is operable to move the piston in a direction along the axis when the capsule is received in the receptacle and the lever is moved relative to the housing. When the capsule is received in the first orientation, the ram is operable to move the piston to a certain location wherein the barrier opens as the piston reaches the certain location. When the capsule is received in the second orientation, the ram is operable to move the piston to a certain position that is substantially the same as the forwardmost limit of the path of travel of the piston in the chamber. The first orientation is spaced from the second orientation a distance that is at least as great as the distance between the certain location and the certain position. The barrier provides initial separation of a first component from a second component of the preparation. Preferably, the ram of the device reaches its limit of travel once the barrier is opened and the capsule is in the first orientation, in order to avoid undue reduction in the space available for mixing the components. Reaching the end of possible movement of the ram also provides tactile feedback to the user that the first stage of operation is essentially complete. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side cross-sectional view of a capsule and a dispensing device in accordance with one embodiment of the invention; FIG. 2 is a view somewhat similar to FIG. 1 except that a lever of the dispensing device has been pivoted to advance a ram of the device to its limit of forward movement; FIG. 3 is a fragmentary, enlarged top view of the capsule and dispensing device shown in FIG. 1; FIG. 4 is a fragmentary, enlarged top view of the capsule and dispensing device depicted in FIG. 2, showing a piston of the capsule moved forward to expel a second component of a preparation into a chamber that contains a first component; FIG. 5 is a view somewhat similar to FIG. 3 except that the capsule has been moved to a second orientation in a receptacle of the dispensing device; FIG. 6 is a view somewhat similar to FIG. 5 except that the ram of the dispensing device has been advanced to move a piston of the capsule forward in the chamber and expel a preparation from the chamber; FIG. 7 is a perspective view of the capsule shown in FIGS. 1-6; FIG. 8 is a fragmentary, perspective view of a front end portion of the dispensing device shown in FIGS. 1-6; FIG. 9 is a fragmentary, plan view of a capsule and a dispensing device in accordance with another embodiment of the invention; FIG. 10 is a fragmentary, side cross-sectional view of the capsule and dispensing device illustrated in FIG. 9; FIG. 11 is a view somewhat similar to FIG. 10 except that a ram of the dispensing device has been advanced to move a piston of the capsule to a certain location to open a barrier; FIG. 12 is a view somewhat similar to FIG. 11 except that the capsule has been placed in a second orientation in the dispensing device and the ram has been retracted; FIG. 13 is a view somewhat similar to FIG. 12 except that the ram has been advanced to move the piston forward and expel a preparation through outlet structure; and FIG. 14 is an enlarged perspective view of an inner cup of the capsule. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A capsule 10 for mixing and dispensing a preparation made of two or more components is shown in FIGS. 1-7. Preferably, the capsule is used in combination with a dispensing device 12 that is illustrated in FIGS. 1 and 2. The capsule 10 and the device 12 constitute a two-stage mixing and dispensing assembly 13. As can be observed in, for example, FIG. 3, the capsule 10 includes a generally cylindrical, tubular body 14 having an internal, cylindrical chamber 16 that contains a first component 18 of the preparation. Additionally, the body 14 has a front end portion 20 with outlet structure 22 that comprises a projecting nozzle. Although not shown, the outlet structure 22 is initially covered by a cap, and has partial Luer-type threads for twist-on connection with a nozzle extension useful for reaching areas of the oral cavity that might otherwise be difficult to access. As shown for example in FIG. 7, the periphery of the body 14 is somewhat star-shaped, and presents a plurality of elongated, front-to-back ridges 24 for enhancing the user's grip on the capsule body 14 when turning the body 14 and/or the nozzle extension relative to the dispensing device 12. The body 14 also includes a first peripheral, circumscribing flange 26 that extends radially outwardly from a longitudinal, central axis of the body 14. The first flange 26 has a first wall section 28 that faces the front end portion 20. The body has a second flange 30 that is similar to the first flange 26 and has a second wall section 32 that also faces the front end portion 20. A cylindrical piston 34 is initially received in a rear end portion 36 of the body 14 as shown in FIG. 3, and has an outer diameter that is complemental and approximately equal to the inner diameter of the chamber 16. The piston 34 is movable in the chamber 16 along a path coincident with the central, longitudinal axis of the chamber 16 and the body 14. A generally circular disc 38 is received in the chamber 16 and has a central opening 40 as well as four tabs 42 spaced equally around the periphery of the disc 38. When assembling the disc 38 and the body 14, the tabs 42 are guided along four mating slots 44 until reaching the front end of the latter. The disc 38 is similar to a disc of a two-component capsule of Ernst Muhlbauer KG (Hamburg, Germany). As illustrated in FIG. 3, a barrier in the nature of a pouch or pillow 46 is made of a layered polyethylene and aluminum foil material. The pillow 46 is located between the disc 38 and the piston 34 and has an internal, initially closed compartment 48 that receives a second component 50 of the preparation. The capsule 10 may be conveniently used to dispense dental ionomer cement systems such as the system described in the aforementioned European Patent Application No. 0 323 120. In such an instance, the first component 18 comprises a glass powder and the second component 50 comprises an aqueous solution of polycarboxylic acid. However, the capsule 10 is also useful for mixing and dispensing other preparations made of two or more components. The dispensing device 12 is preferably used in combination with the capsule 10 and is similar to the device described in U.S. Pat. No. 4,198,756. The device 12 includes a housing 52 having a transverse grip 54 as shown in FIGS. 1 and 2. A rear lever 56 is connected to the grip 54 by a pivotal connection 58 for swinging movement between the positions shown in FIGS. 1 and 2. The housing 52 includes a cylindrical channel that slidably receives a ram 60 having a necked-down, cylindrical front section with a flat front end. A rear end of the ram 60 has a somewhat semi-spherical, enlarged head 62, and a coiled compression spring 64 surrounding the ram 60 between the head 62 and the grip 54 urges the ram 60 in a rearward direction toward the lever 56. A curved cam surface 66 is formed on the lever 56 and is in sliding engagement with the head 62. As the lever 56 is moved toward the grip 54 in arc about the pivotal connection from its orientation shown in FIG. 1 and to its orientation shown in FIG. 2 (as would occur when the hand of the user squeezes the lever 56 against the grip 54), the head 62 rides along the cam surface 66 and moves the ram 60 in a forward direction toward a front portion of the dispensing device 12. When the lever 56 is released, the spring 64 moves both the ram 60 and the lever 56 from the respective positions shown in FIG. 2 and to the positions shown in FIG. 1. The front end portion of the dispensing device 12 includes a receptacle 68 having a longitudinal reference axis that is collinear with the central axis and the path of sliding movement of the ram 60 and its necked-down front portion. The receptacle 68 terminates at its front end by a generally U-shaped retention wall member 70 (see FIGS. 3-6 and 8) and at its rear end by a rear wall having a hole 71 (FIG. 8) for receiving the front necked-down section of the ram 60. In use, the capsule 10 is initially placed in the receptacle 68 in a first orientation that is shown in FIGS. 1-4 wherein the first wall section 28 is in abutting contact with a rear-facing wall surface 72 of the retention member 70. Next, the lever 56 is moved in an arc about the pivotal connection 58 to advance the ram 60 and cause the front end of the ram 60 to engage the rear end of the piston 34. Continued movement of the lever 56 to its orientation shown in FIG. 2 shifts the ram 60 and the piston 34 therewith to the respective positions shown in FIG. 4. As the piston 34 is moved from its initial position shown in FIG. 3 and to its intermediate position shown in FIG. 4, the pillow 46 is compressed against the disc 38, causing the pillow 46 to rupture and open. Continued movement of the piston 34 to its position shown in FIG. 4 compresses the pillow 46 against the disc 38, and causes the second component 50 to be expelled from the compartment 48 and discharged into the chamber 16 through the opening 40. As can be appreciated, the disc 38 serves as a means to open the barrier or pillow 46, discharge the second component 50 from the compartment 48, and bring the second component 50 into substantial contact with the first component 18 when the piston 34 is moved to the position shown in FIG. 4. As the piston 34 continues to advance toward the front end portion 20 and flatten the pillow 46 against the disc 38, the disc 38 breaks away from the tabs 42 and advances from its position shown in FIG. 3 to its position shown in FIG. 4. The severed tabs 42 remain in the slots 44. The ram 60 has an overall, limited extent of forward movement that is determined by the position of the ram 60 when the spring 64 is fully compressed as shown in FIG. 2. When the ram 60 has reached its forward limit of travel, the rear face of the piston 34 is flush with the rear surface of the first flange 26 and the disc 38 is in the position shown in FIG. 4 with the tabs 42 severed and the second component 50 substantially fully expelled into the chamber 16. Such construction ensures that the user cannot continue to advance the ram 60 and prematurely dispense the first component 18 and the second component 50 from the chamber 16 through the outlet structure 22. Next, the capsule 10 is removed from the receptacle 60 and placed in an amalgamator. The amalgamator is activated for a sufficient amount of time to thoroughly mix the first component 18 and the second component 50 in the chamber 16 to form a preparation. The capsule 10 is then returned to the receptacle 68, but in this instance is placed in a second orientation that is illustrated in FIGS. 5 and 6 wherein the second wall section 32 of the second flange 30 is in abutting contact with the rear surface 72 of the retention member 70. It should be noted, however, that if the user accidentally returns the capsule 10 to the first orientation (as shown in FIGS. 1-4), the user will soon realize that the capsule is in the wrong orientation for dispensing since the ram 60 will be unable to advance the piston 34 past its position shown in FIG. 4 and discharge of the preparation will not occur. As can be appreciated, the wall sections 28, 32 together with the retention member 70 comprise structure for detachably receiving the capsule 10 in either a first orientation or a second orientation spaced from the first orientation in a direction along the longitudinal reference axis of the receptacle 68. Once the capsule 10 is in its second orientation as depicted in FIGS. 5 and 6, the lever 56 is pivoted toward the grip 54 to advance the ram 60 and move the piston 34 from its position shown in FIG. 5 and toward its position shown in FIG. 6. During such movement, the disc 38 and the pillow 46 are moved with the piston 34 toward the front end portion 20, and as the chamber 16 is reduced in volume the mixed preparation is extruded through the outlet structure 22, preferably directly to an application site such as a tooth cavity. As the ram 60 is moved by the lever 56 to its forwardmost allowable position, the piston 34 is advanced toward the front end portion 20 to a position wherein a front surface of the disc 38 is in firm, face-to-face contact with a flat, rear facing annular wall 74 of the chamber 16. As a result, substantially all of the preparation is expelled from the chamber 16 when the ram 60 and the piston 34 reach their forward limits of travel. Further, forward movement of the ram 60 is restricted by the fully compressed spring 64 so that the piston 34 and disc 38 do not burst through the front end portion 20 of the capsule 10. When the ram 60 is in its forwardmost position and the capsule 10 is in its first orientation as shown in FIG. 4, the piston 34, and particularly the front end of the piston 34, is located a certain dimension that is marked A in FIG. 4 from the first wall section 28 of the first flange 26. When the capsule 10 is in its second orientation and the ram 60 is advanced to its forwardmost position (that is shown in FIG. 6), the front end of the piston 34 is located a dimension marked B in FIG. 6 from the second wall section 32 of the second flange 30. Advantageously, dimension A is equal to dimension B, so that in either instance the ram 60 travels along the same limited path of travel, and the entire extent of the mechanical advantage offered by the lever 56 is utilized. (Dimensions A and B could be taken from a portion of the piston other than its front end so long as the same portion was used for each measurement.) Rearward movement of the ram 60 is normally limited by detents formed in the pivotal connection 58 such that, in normal use, the front end of the ram 60 retracts only to its position shown in FIGS. 1, 3 and 5. Consequently, the effective length of the receptacle 68 for reception of the capsule 10 is limited by the distance E (see FIG. 3) between the front end of the ram 60 and the rearwardly facing surface 72 of the retention member 70. In addition, as can be observed in FIG. 3, the rear end of the piston 34 initially projects a certain distance marked C in FIG. 3 from the first wall section 28 of the first flange 26. Also, the first wall section 28 is spaced from the second wall section 32 by a dimension D (see FIG. 3). The sum of dimensions C and D is greater than the dimension E (measured between the surface 72 and the front end of the ram 60 when in its rearwardmost position) in order to prevent the capsule 10 from being placed in its second orientation until such time as the piston 34 has been advanced. Preferably, the dimension E is only slightly greater than the sum of dimension D and the thickness of the first flange 26 to ensure that the piston 34 has moved to its orientation shown in FIG. 4 with the contents of the compartment 48 fully expelled and the tabs 42 severed from remaining portions of the disc 38. The overall limited movement of the ram 60 is not greater than dimension E regardless of whether the capsule 10 is in its first orientation or its second orientation in order to provide a relatively compact arrangement and still utilize in either instance the substantial mechanical advantage provided by the lever 56. As an alternative, the dimension A may be greater than the dimension B if desired. The foregoing assembly 13 ensures that the user removes the capsule 10 from the receptacle 68 after the pillow 46 is ruptured. As a result, the user is reminded to place the capsule in an amalgamator to thoroughly mix the components 18, 50 and avoid discharging the components 18, 50 through the outlet structure 22 before thorough mixing in an amalgamator has occurred. Fracture of the tabs 42 from the remaining portions of the disc 38 when the capsule 10 is in the first orientation provides tactile as well as audible feedback to the user that the proper position of the piston 34 has been reached and that the second component 50 is substantially discharged from the compartment 48. Further, if desired, the tolerance between the piston 34 and the chamber 16 may be selected to allow the user to shift the piston 34 to its position shown in FIG. 4 by using the thumb rather than the dispensing device 12. An assembly 113 according to a second, currently preferred embodiment of the invention is shown in FIGS. 9-13. The assembly 113 includes a capsule 110 and a dispensing device 112. The device 112 is substantially similar to the device 12 except for a front portion of the device 112 that is adjacent a receptacle 168 for receiving the capsule 110. The capsule 110 includes a cylindrical, tubular polyethylene body 114 having an inner chamber 116. A first component 118 (FIG. 10) of a preparation is received in a front end portion 120 of the capsule 110 next to curved outlet structure 122 having a removable plug 123 with a tail that initially extends to the forward end of the chamber 116. A rear portion of the capsule body 114 is circumscribed by two spaced apart flanges. The flanges present a pair of spaced apart wall sections that define a peripheral groove 127 having a U-shaped configuration in cross-section. A polyethylene cup 129 (illustrated alone in FIG. 14) is received in the rear portion of the chamber 116. The cup 129 includes a rear ring 131 that is initially connected in integral fashion at spaced apart locations by tabs 133 to a central cup section 135 that defines a compartment 148 (FIG. 10) for receiving a second component 150 of a dental preparation. A frangible forward wall or barrier 137 of the cup 129 is provided with lines of weakness 139 (FIG. 14) having a pattern of a square with somewhat weaker (i.e., more pronounced) lines extending along both diagonals of the square. A cylindrical piston 134 is received in the compartment 148 and has a rear section that initially projects outwardly from the capsule 110 as illustrated in FIGS. 9-10. In use, the capsule 110 is initially placed in a first orientation that is shown in FIGS. 9-11, wherein the groove 127 receives a first, forward, generally U-shaped retention member 170 of the device 112. A lever of the device 112 is then moved to advance a longitudinally movable ram 160 to a position as depicted in FIGS. 9-10 wherein the forward end of the ram 160 contacts the rear end of the piston 134. Additional movement of the ram 160 shifts the piston 134 forwardly until the pressure within the compartment 148 causes the lines of weakness of the barrier 137 to rupture. The barrier opens in petal-like fashion and, once opened, enables passage of the second component 150 into the chamber 116. Continued advancement of the ram 60 causes the front end of the piston 134 to bear against remaining outer, unruptured regions of the barrier 137 and causes the cup section 135 along with the barrier 137 to advance toward the outlet structure 122. As the cup section 135 advances, the tabs 133 break, detaching the ring 131 from the cup section 135. The lines of weakness of the barrier 137 are constructed to open under the influence of pressure within the compartment 148 of a value that is less than the pressure needed to fracture the tabs 133. As a result, the second component 150 is discharged from the compartment 148 before the ring 131 detaches from the cup section 135. Breakage of the tabs 133 provides both visual and tactile feedback to the user that the capsule 110 has been "activated" by bringing the second component 150 into contact with the first component 118. Further, the ram 160 reaches its forwardmost limit of travel (as depicted in FIG. 11) once the barrier 137 opens and the tabs 133 fracture. As a consequence, sufficient space is available in the chamber 116 for mixing the first component 118 with the second component 150 and undue reduction in the space is avoided. The forwardmost limit of movement of the ram 160 also essentially prevents dispensing of the components 118, 150 through the outlet structure 122 when the capsule 110 is in the first orientation, so that dispensing of an unmixed preparation is not likely to occur. Next, the capsule 110 and the ring 131 are removed from the receptacle 168. The capsule 110 is placed in an amalgamator and the amalgamator is activated for a sufficient amount of time to thoroughly mix the components 118, 150 in the chamber 116 to form a preparation. Subsequently, the capsule 110 is returned to the receptacle 168 in a second orientation as shown in FIGS. 12 and 13 wherein the groove 127 engages a second generally U-shaped retention member 173 of the device 112. Next, the plug 123 is removed from the outlet structure 122. The lever of the device 112 is then moved to advance the ram 160 and thereby shift the piston 134 from its position as shown in FIG. 12 and toward its position as shown in FIG. 13, causing the preparation to be dispensed through the outlet structure 122. To ease use, the handles of the dispensing device are not fully closed (i.e., are not adjacent one another) when the ram 160 reaches the end of its necessary path of travel to advance the piston 134 to the position shown in FIG. 11 when the capsule 110 is in its first orientation, or to the position shown in FIG. 13 when the capsule 110 is in its second orientation. Preferably, one of the handles has a protrusion that contacts the other handle and precludes further closing of the handles if an attempt is made to advance the ram 160 past the position shown in FIG. 11. The first orientation of the capsule 110 in the receptacle 168 is spaced from the second orientation of the capsule 110 by a distance represented by the letter F in FIG. 13 (for exemplary purposes, the location of each orientation is determined by the location of the groove 127 when the capsule 110 is placed in either orientation). The letter G in FIG. 13 represents the dimension of the distance between the certain location of the piston 134 as shown in FIG. 11 and the certain position of the piston 134 as shown in FIG. 13 (as determined for exemplary purposes from the forward end of the piston 134). The dimension F is equal, or at least as great as the dimension G so that (1) the space available in the chamber 116 for mixing the components 118, 150 after the barrier 137 is ruptured is not unintentionally reduced, and (2) dispensing of the components 118, 150 is essentially precluded when the capsule 110 is in the first orientation.

An assembly for mixing and dispensing preparations such as dental cements includes a capsule and a lever actuated dispensing device. The capsule is received in a first orientation of the dispensing device for initial movement of a piston of the capsule to combine two components in a mixing chamber of the capsule. The capsule is received in a second orientation when dispensing of the components is desired. The capsule includes flanges engageable with one or more retention members of the dispensing device, and the flanges are positioned to substantially utilize the mechanical advantage provided by the dispensing device regardless of whether the capsule is in the first orientation or in the second orientation. The flanges are also arranged to substantially prohibit bursting of the capsule when the components are discharged from the mixing chamber, and essentially preclude dispensing of the components when the capsule is in the first orientation.

BACKGROUND OF THE INVENTION The present invention relates to surgical cassettes and more particularly to a system for latching surgical cassettes. The use of cassettes with surgical instruments to help manage irrigation and aspiration flows into a surgical site are well-known. U.S. Pat. Nos. 4,493,695, 4,627,833 (Cook), 4,395,258 (Wang, et al.), 4,713,051 (Steppe, et al.), 4,798,580 (DeMeo, et al.), 4,758,238, 4,790,816 (Sundblom, et al.) and 5,267,956, 5,364,342 (Beuchat) all disclose tubeless or tube-type surgical cassettes and are incorporated herein in their entirety by reference. One of the primary function of the cassettes disclosed above is to control aspiration (vacuum) level at the surgical site. The vacuum generating device generally is contained within the surgical system control console and may be a venturi, diaphragm or peristaltic pump. Other mechanical interactions between the cassette and the console are also required, for example, to control fluid flow within the cassette and for monitoring the vacuum level within the cassette. These interaction require that the cassette be held securely within the console, with positive, aligned contact between the cassette and the console. Prior to the present invention, cassettes generally were secured within the console by a tight, friction fit or by a spring tab. These frictional methods of securing the cassette within the console can make the cassette difficult to insert and remove from the cassette from the console. In addition, these frictional methods do not positively lock the cassette within the console, so inadvertent removal of the cassette is possible. Accordingly, a need exists for a mechanism to assist in latching a surgical cassette within a surgical console. BRIEF DESCRIPTION OF THE INVENTION The present invention generally includes an articulating clamp mounted on the end of a pneumatic or hydraulic cylinder. The clamp interacts with a slot, tab or tang on the cassette housing to hold the cassette firmly within a surgical console. The clamp articulates in response to extension or contraction of the cylinder to grasp securely the cassette tab and hold the cassette within the console. Accordingly, one objective of the present invention is to provide a mechanism for latching a cassette within a surgical console. Another objective of the present invention is to provide an articulating clamp that cooperates with a slot, tab or tang on a surgical cassette to hold the cassette firmly within a surgical console. Still another objective of the present invention is to provide an articulating clamp mounted on the end of a cylinder that cooperates with a slot, tab or tang on a surgical cassette to hold the cassette firmly within a surgical console. These and other objectives and advantages of the present invention will become apparent from the detailed description and claims which follow. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an exploded perspective view of the present invention and also illustrating one type of surgical cassette that can be used with the present invention. FIG. 2 is an exploded perspective view of the articulating clamp and cylinder illustrated in FIG. 1. FIG. 3 is a perspective view of the articulating clamp and cylinder similar to FIG. 2, but with the clamp assembled on the cylinder. FIG. 4 is a perspective, partial cross-sectional view of the clamp of present invention cooperating with a recess in the surgical cassette illustrated in FIG. 1. FIG. 5 is a perspective, partial cross-sectional view of the clamp of the present invention, similar to FIG. 4, but illustrating the movement of the clamp during clamping and unclamping of the cassette. FIG. 6 is a front elevational, partial cross-sectional view of the clamp of present invention cooperating with a recess in the surgical cassette illustrated in FIG. 1. FIG. 7 is a front elevational, partial cross-sectional view of the clamp of the present invention, similar to FIG. 6, but illustrating the clamp in the unclamped position. FIG. 8 is a partial side elevational view of the clamp of present invention cooperating with a recess in the surgical cassette illustrated in FIG. 1. FIG. 9 is a partial side elevational view of the clamp of the present invention, similar to FIG. 8, but illustrating the clamp in the unclamped position. DETAILED DESCRIPTION OF THE INVENTION As best seen in FIGS. 1-3, latching apparatus 10 of the present invention generally includes clamp 12 and cylinder 14. Clamp 12 may be of any suitable size and shape and includes passage 54, slotted mounting hole 16, prongs 18, flange 38 and fittings 20 and 22. Passage 54 and fittings 20 and 22 allow fluid communication between console 24 and cassette 26 through clamp 12. Clamp 12, prongs 18 and flange 38 preferably are made from steel, stainless steel, aluminum or titanium and formed in a single piece by machining, casting or forging. Fitting 22 preferably is formed of a resilient material such as silicone rubber or other equivalent elastomer and press fit into a recess (not shown) in clamp 12. Fitting 20 preferably is a slip fitting and made from steel, stainless steel, aluminum, titanium or suitable plastic. Fitting 20 may be mounted on clamp 12 by a press fit or threaded coupling and may include sealing washer 56. Cylinder 14 may be any suitable pneumatic or hydraulic cylinder, such as pneumatic cylinder Model No. 56255-1173 manufactured by American Cylinder, and generally includes yoke 28, housing 30, rod 48, fittings 32 and pin 34. Yoke 28 is sized to cradle flange 38 on clamp 12 and may be threadably attached to rod 48. Flange 38 is held within yoke 28 by pin 34, which telescopes through slotted hole 16 so that pin 34 is frictionally held in yoke 28, but slides easily within slotted hole 16. Clamp 12 is attached to console 24 and held within recess 42 on console 24 by pin 40, which allows clamp 12 to pivot on pin 40 about hole 44 within recess 42, as shown in FIGS. 4-9. Yoke 28, housing 30, fittings 32 and pins 34 and 40 may be made of any suitable material such as brass, steel, stainless steel, aluminum or titanium. As seen in FIGS. 4, 6 and 8, in its relaxed state, cylinder 14 is extended. Causing cylinder 14 to be extended in its relaxed state ensures that cassette 26 cannot be removed from console 24 if the power to console 24 is temporarily interrupted. When cylinder 30 is extended, rod 48 pushes yoke 28 forward, causing clamp 12 to pivot downward about pin 40 while pin 34 rides within slotted hole 16. The downward pivot of clamp 12 about pin 40 causes prongs 18 to rest below top edge 46 of cassette 26 and against recessed clamping faces 50 on cassette 26, thereby holding cassette 26 rigidly wig console 24. As best seen in FIGS. 6 and 8, when cassette 26 is held wig console 24, fitting 22 is held tightly against mating fitting 52 on cassette 26, allowing fitted communication with cassette 26 through fitting 22, passage 54 in clamp 12 and fitting 20. Cassette 26 may be any suitable surgical cassette having clamping faces 50 sized and shaped to receive prongs 18 on clamp 12. As seen in FIGS. 5, 7 and 9, to insert or remove cassette 26, a control means (not shown) within console 24 causes cylinder 14 to draw back on rod 48 and yoke 28, allowing clamp 12 to pivot about pin 40 while pin 34 rides within slotted hole 16. The pivoting action of clamp 12 allows prongs 18 to be raised about top edge 46 of cassette 26. In this position, cassette 26 may be easily removed or inserted. This description is given for purposes of illustration and explanation. It will be apparent to those skilled in the relevant art that changes and modifications may be made to the invention described above without departing from its scope or spirit.

A cassette latching mechanism generally including an articulating clamp mounted on the end of a pneumatic cylinder. The clamp interacts with a slot, tab or tang on the cassette housing to hold the cassette firmly within a surgical console.

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Ser. No. 60/488,857 filed Jul. 18, 2003. FIELD OF THE INVENTION This invention is generally in the field of compositions and methods for electrically stimulating the dorsal horn and other regions of the spinal cord to interfere with or otherwise block transmission of neural signals concerned with pain. The technique involves placement of electrodes directly into the spinal cord in order to activate selectively the target region. This technique improves delivery of electrical stimuli to the desired portion of the spinal cord and serves to decrease power requirements. BACKGROUND OF THE INVENTION Spinal Cord Injury. Pain resulting from trauma or other diseases of the nervous system is termed neuropathic pain. The abnormal pain includes ongoing (spontaneous or stimulus independent pain) and heightened pain to stimuli (hyperalgesia). Spinal cord injury (SCI), one cause of neuropathic pain, can result from a variety of causes including (among others) trauma, tumor, infection, congenital malformations, multiple sclerosis, and vascular lesions. Pain after SCI is a frequent occurrence. The development of pain can have devastating effects on the patients and even be of greater concern than the coincident loss of neurological function (paralysis). An important factor in the pathogenesis of SCI pain is the development of hyperexcitable cells near the site of injury (Christensen et al, J Neurotrauma 1997; 14:517-37). This hyperexcitability occurs in cells, activity in which is ordinarily concerned with pain. The abnormal spontaneous discharge leads to ongoing pain and accounts also for heightened pain (hyperalgesia) to natural stimuli (touch, heat, cold) at the border zone of the SCI. Patients feel pain at the level of spinal injury (“at level pain”) and at regions below the injury (“below level pain”). The distal pain is typically stimulus independent and in a sense represents a “phantom” pain, since the patient may have no feeling in this area. There are many factors that cause this change in neuronal excitability at the region of injury. One factor could include changes in receptor expression in neurons in the dorsal horn (Mills et al, Exp. Neurol. 2001; 170:244-257; Chen et al, Neuroscience 2002; 111:761-773; Eide et. al, J Neurol Neurosurg Psychiatry 1996; 60:411-415.) Numerous therapies have been attempted to treat SCI pain. Drug trials even with high doses of opioids are generally ineffective. (Burcheil and Hsu, Spine 2001 26:S161; Sjolund, Brain Res Rev 2002 40:250-6). Antidepressant, and anticonvulsant medications are also ineffective. Interventional approaches have largely proved ineffective as well. These have included neuro-destructive procedures, implantation of drug pumps into the lumbar intrathecal space, and various forms of electrical stimulation of the nervous system. For example, clinicians have tried implantation of catheters into the spinal fluid for purposes of targeted drug delivery. Though different drugs have been implanted, the results have proven disappointing. Neuro-destructive procedures have been largely unsuccessful (Sjolund, Brain Res Rev 2002 40:250-6). Some clinicians have advocated lesions of the dorsal root entry zone in the region of SCI (DREZ operation), but whether this surgery is successful is controversial. It has been suggested that the success rates can be improved if dorsal horn recordings are used. (Falci et al. J Neurosurg 2002, 97(2 Suppl):193-200). However this approach contributes to the damaged state and pain may recur or even become worse in the long term. In any case further spinal cord destruction leads to further permanent loss of spinal cord function and therefore is an unsavory choice for a patient with SCI (Denkers et al, Spine 2002 27:E177-84; Sjolund, Brain Res Rev 2002 40:250-6; Burcheil and Hsu, Spine 2001 26:S161). Electrical stimulation of the spinal cord with electrodes placed in the epidural space (or within the dura) is commonly used to treat a variety of pain problems. It has been scientifically tested and approved by the United States Food and Drug Administration (FDA) as a safe and effective treatment for certain types of chronic pain associated with the trunk and/or limbs. This technique, sometimes termed dorsal column stimulation (but distinct from the present invention which involves intramedullary spinal cord stimulation in the dorsal horn and other spinal cord structures), has proven ineffective for pain from SCI (Kumar et al; Surg Neurol 1996; 46:363-369). Subdural spinal stimulation has also been tried as a technique to stimulate the surface of the spinal cord (Hunt et al 1975 Surg Neurol 4:153-156), but this technique became obsolete with the development of better epidural electrodes. There remains a need for better pain control in patients with chronic pain. It is therefore an object of the present invention to provide a device and methods for use thereof for alleviation of chronic pain. SUMMARY OF THE INVENTION Electrodes placed directly into the spinal cord (in contradistinction to surface stimulation as is provided by epidural stimulation) are used to provide spinal cord stimulation for pain control. Electrodes are placed directly into the dorsal horn, dorsal column, spinothalamic tract, nucleus cuneatus, nucleus gracilis, spinal tract of V, or spinal nucleus of V (nucleus caudalis) depending on the source of pain. This “intramedullary” stimulation “jams” or otherwise prevents the pain signal from being transmitted. The placement of the electrodes is accomplished through an open surgical procedure in which the dura is opened to allow the surgeon direct access to the spinal cord. In the case of SCI (or disease), the electrodes are positioned in the dorsal horn of the spinal cord within several dermatomal segments of the lesioned site. Direct stimulation of the dorsal horn should be effective to relieve pain arising from diseases and/or injury of the peripheral nervous system as well, and thus represents an alternative to dorsal column stimulation with epidural electrodes. Stimulation with intramedullary electrodes may be used to treat other types of pain where stable stimulation of the dorsal columns (and the analogous structures for the face), or their nuclear counterparts (nucleus cuneatus, nucleus gracilis, nucleus caudalis) should relieve pain. Stimulation of the spinothalamic tract may also be achieved by intramedullary placement of electrodes. The method provides a means to stimulate the targeted area directly, creating a stable means of stimulating the desired area, and decreasing stimulation of other structures. Each intramedullary electrode lead may be composed of one of more contact points. There may be one or more electrodes. The multiple leads and contact points provide a number of potential stimulus permutations. The ideal stimulus configuration can be determined after electrode implantation. The electrodes can be stably anchored in the spinal cord dorsal horn to prevent electrode migration. The electrodes are positioned in the spinal cord with electrode leads of sufficient length to prevent movement of the electrode from its fixed position during movements of the neck and torso. In some cases affixing the electrodes to the dentate ligament or dura or other extradural structures may be of use to prevent further the problem of electrode migration. BRIEF DESCRIPTION OF DRAWINGS FIG. 1 is a schematic of how the dorsal horn in the region of SCI develops the capacity to signal pain in body regions at and below the level of SCI. Data indicate that increased discharges occur in the dorsal horn area subjacent to the site of SCI (e.g., Falci S, Best L, Bayles R, Lammertse D, Starnes C. J Neurosurg. 2002 September;97(2 Suppl):193-200. Dorsal root entry zone microcoagulation for SCI-related central pain: operative intramedullary electrophysiological guidance and clinical outcome). Cells in the thalamus that have lost inputs from distal regions (as a result of the SCI) recruit inputs from the abnormal dorsal horn cells near the SCI. Thus, the inputs from this spinal cord region acquire the capacity to signal pain in the distal regions of the body. The electrodes provide a means to block the inputs from these abnormal cells to the brain and thus control pain felt by the patient at and below the level of SCI. FIG. 2 is a perspective drawing showing that one or more electrodes are placed into the dorsal horn immediately adjacent to the region of SCI. Multiple contacts permit various stimulation paradigms to be employed to maximize effectiveness and minimize untoward side effects. In cases of bilateral pain, the electrodes are placed bilaterally. FIG. 3 is a perspective drawing showing electrodes placed into the portion of the dorsal column that serves the painful region. If pain is bilateral the electrodes are placed bilaterally. DETAILED DESCRIPTION OF THE INVENTION I. Devices A. Electrodes Electrodes can be obtained from a variety of commercial sources. These are typically characterized by small size and flexibility. Flexible electrodes are described by U.S. Pat. Nos. 6,024,702 and 5,012,810 incorporated by reference herein. Flexible conductive materials can also be used in making the electrodes as described in U.S. Pat. No. 6,495,020. For example, an electrode member can comprise a strip of material having a thickness of about 10-20 micrometers, such as IMPERIAL® lapping film No. 15 MIC LF S/C (3M Co®, St. Paul, Minn.), having a coating of silver/silver chloride of about 0.3-0.7, and preferably about 0.5, micrometers thick thereon. The electrodes must be small enough to be implanted into the dorsal horn and other areas of the spinal cord. One such device is, for example, the MEDTRONIC® Model 3387 quadripolar lead, which has been approved by the FDA for several years for unilateral deep brain stimulation for treating tremor. There are four platinum-iridium contacts that are 1.5 mm in length and separated by 1.5 mm. Stimulus parameters such as amplitude, duration, and frequency can all be adjusted externally. In a preferred embodiment, multi-contact electrodes are used with an array placed in a target area. The electrode leads are several millimeters in length with open contacts along the electrode. These electrodes are very similar to the deep brain stimulation electrodes that have open contacts. Each contact can be post-hoc programmed to be anodal or cathodal. For example, if three separate electrodes are implanted into the spinal cord, and each electrode has three open contacts, it is possible to program many thousands of potential combinations (each electrode may be anodal, cathodal, or inactive). One or more electrodes are placed into the spinal cord in the appropriate position (e.g., in the dorsal horn immediately adjacent and rostral to the region of SCI). Multiple contacts permit various stimulation paradigms to be employed to maximize effectiveness and minimize untoward side effects. In cases of bilateral pain, the electrodes are placed bilaterally. B. Stimulators Spinal cord and brain stimulators represent a large group of electrical stimulators that are implanted for a wide variety of indications. Existing spinal and brain stimulators can affect dorsal roots, dorsal columns, and other sites within the brain. The technical and surgical aspects have been reviewed by Simpson ( Brit J Neurosurg 1997; 11:5-11). The method is designed to work with existing spinal cord and brain stimulation devices. These stimulators typically consist of three components: the power source, an implanted receiver, and electrodes. An external controller allows the device to be custom programmed to idealize the electrical stimulation parameters. Stimulators delivering charge-balanced pulses, either by constant-current or constant-voltage, are preferred. These devices can also be either microprocessor-controlled impedance-sensitive pulse generators, or piezo-electric current devices. Appropriate stimulators and electrodes for this method include, but are not limited to, those made by MEDTRONICS® (Minneapolis, Minn.) and ADVANCED NEUROMODULATION SYSTEMS, INC® (Plano, Tex.), NEUROMED® (Ft. Lauderdale, Fla.) and EXONIX™ (Miami, Fla.). Examples of these are described in U.S. Pat. Nos. 4,044,774, 5,501,703, 6,027,456, 6,314,325 and PCT application WO 99/56818. II. Methods of Use A. Patients to be Treated 1. Spinal Cord Injury. Pain occurs frequently as a complication of SCI. SCI may result from congenital anomalies (e.g., syringomyelia), tumor, trauma, infection, disc herniation, degenerative disease (e.g., spinal stenosis), vascular disease, and demyelinating diseases (multiple sclerosis), and other autoimmune disorders. The damaged site is also called a lesion. Patients describe pain in areas that have lost afferent input to the brain as well as at the border zone of the spinal cord lesion. The pain can vary in intensity, frequency of episodes, duration of episodes, and quality of pain experienced. Chronic pain problems can occur in individuals with neurologically complete or incomplete injuries. Two types of pain may develop after SCI: 1) segmentally distributed pain (“at level pain”), and 2) pain in the body below the lesion (“below level pain”). In cases of complete spinal cord lesions this second type of pain by definition is stimulus-independent. 2. Other pain conditions affecting the arms and legs. Dorsal column stimulation is accomplished currently with electrodes placed into the epidural space. This technique is useful for treatment of many pain conditions, including lumbar radiculopathy. A requirement for this technology to work is that there has to be “coverage.” This means that the patient must feel paresthesias in the area felt to be painful. Electrodes must be positioned precisely to achieve this coverage. In certain instances coverage is difficult or impossible to obtain. One reason for this problem is that electrodes may migrate with spinal movements. The problem is especially apparent in regards to spinal cord stimulation for treatment of neck and upper extremity pain conditions. Neck motion changes the contact with the epidural space such that in one position the stimulation may be too strong, and in another the stimulation may be too weak. The result is that clinical efficacy is lost. Even if the electrodes are fixed to the dura, the spinal cord distance from the dura also varies with bodily movement. This leads to variations in delivery of electrical stimulation of the spinal cord. These problems are overcome by placing the electrodes directly into the dorsal columns or their nuclear equivalents (nuclei cuneatus and gracilis). Evoked potential measurements help establish the ideal locations for electrode placement in patients that are under general anesthesia for the surgery required to place the electrodes. 3. Facial pain. The pain processing pathways for the face involve the nucleus caudalis and descending tract of V, both located in the upper part of the cervical spinal cord. Patients with facial pain can not be treated with conventional “dorsal column” epidural stimulation because these targets are not accessible. The electrodes can be implanted directly into the pain processing pathways for the face in the upper cervical spinal cord. This provides a direct means of stimulating the appropriate target without over stimulating other targets. Evoked potential monitoring can provide a physiological means intraoperatively to guide placement of the electrodes into the appropriate target. B. Targets for Electrode Implantation The method of treatment of pain involves: (a) targeting areas of the spinal cord that generate signals that lead to pain; and (b) ways to apply direct stimulation to the spinal cord of targets that are involved in pain inhibition (such as the dorsal columns) in situations where epidural activation of these targets is technically not feasible or is associated with untoward side effects. 1. Targeting the dorsal horn with electrical stimulation at the level of injury in cases of SCI. Whereas stimulation of the dorsal columns (with epidural electrodes) has proved efficacious in treating a variety of pain disorders, this technique has failed to help with pain from SCI. A major region for this is that the region of the dorsal column that conducts signals from the painful region has been disconnected. Thus stimulation fails to provide coverage given that the appropriate targets have undergone Wallerian degeneration. It is clear that a radically different approach must be considered to treat pain from SCI. The region responsible for initiating the neural signals responsible for pain must be rostral to the transection site of the spinal cord, since involvement of the brain is ultimately necessary to have pain, and because signals below the level of injury have no way of reaching the brain ( 18 ). One consideration is that the pain signals arise in the brain itself The following lines of evidence suggest that this conclusion is incorrect. (a) If the pain signals arise in the supraspinal region independent of the injured spinal cord then spinal anesthesia should have no effect on the pain. The opposite, however, is true. Loubser and Donovan (Loubser and Donovan; Paraplegia. 1991 January 29(1):25-36) noted that application of spinal anesthesia often relieved distal pain. Intrathecal lidocaine was delivered to paraplegic and quadriplegic patients in concentrations such that the highest effect of the anesthesia would be T4. In this blinded protocol, the anesthetic had a significant pain relieving effect. Thus, the pain signaling neurons must be in the region of the spinal cord transection. (b) Other investigators have found that spinal cord ablative procedures may correct pain from SCL Of particular interest is the finding that thermal destruction of the dorsal horn near the region of spinal injury may relieve pain in distal regions (Falci et al; J Neurosurg 2002 September; 97:193-200). This can be explained if the dorsal horn region at the level of SCI has developed the capacity to signal pain in the distal regions. Dorsal horn neurons in the region of the SCI are known to become abnormally active ( 14 ). The dorsal horn is the primary relay center in the spinal cord for painful stimuli to the brain. The nociceptors synapse on neurons in the marginal zone, substantia gelatinosa and deeper layers and from these regions information ascends to the brain. Normally the spinothalamic tract transmits the nociceptive information with nerve fibers ascending in the contralateral ventrolateral spinal cord to the brainstem and ventroposterolateral thalamus. Since these dorsal horn cells normally signal pain at the respective segmental level, it is clear that these cells likely generate the “at level” pain ( 10 ). In that the dorsal horn region just above the SCI may also still have connections with peripheral nerve inputs, this hyperexcitability also accounts for why hyperalgesia (including allodynia) is also present at the level of injury. The reasons why pain develops in distal body regions (viz., legs, feet, and sacral region) after spinal cord transection may be understood by considering two interrelated mechanisms: (1) abnormal spontaneous activity in pain generating neurons in the dorsal horn of the spinal cord at (and near) the level of injury ( 14 ); and (2) acquired capacity of these cells to activate neurons in the brainstem/thalamus/cortex that signal sensation in the body regions that have lost input to the brain as a result of the SCI ( 16 ). FIG. 1 illustrates these concepts. The neurons in the dorsal horn near the area of injury develop abnormal spontaneous activity ( 14 ). This spontaneous activity accounts for the so called “at level” pain ( 10 ). Normally these neurons signal pain confined to their segmental inputs. The areas in the brain, such as the thalamus, that receive inputs from the spinal cord caudal to the region of SCI ( 18 ) demonstrate plasticity such that they now receive inputs from the cells of the dorsal horn at the level of injury ( 16 ). The inputs from the segmental dorsal horn neurons near the area of SCI acquire the capacity to activate the neurons that signal pain in the caudal areas of the body by way of synaptic sprouting and/or physiological changes in synaptic efficacy ( 16 ). This concept of SCI pain accounts for the findings of Falci et al (2002) that destruction of the dorsal horn near the transection site may eliminate “at level” as well as “below level” pain. Additionally this concept explains why spinal anesthesia may eliminate below level pain. For example, the T7 level of the dorsal horn provides pain and temperature sensation at the T7dermatome. If the cord is severed just below the T7 region, the T7 dorsal horn cells become hyperexcitable. Ordinarily these cells would simply signal pain at the T7 (mid-thoracic) regions. It is the border zone at the lesion site, or immediately proximal to the lesion, that is the site of aberrant neuronal activity ( 14 ). The abnormal activity in the dorsal horn cells is relayed not only to the regions in the thalamus that normally receive the T7 input but also regions of the thalamus that ordinarily serve the distal regions. This rearrangement (from sprouting and/or changes in synaptic efficacy) in the thalamus occurs because the thalamic area that serves the distal region has been denervated ( 20 ). The changes might also occur in other areas such as the cortex. Thus the abnormal activity at T7 leads to abnormal pain at in the T7 dermatome but also the regions distal to the SCI. Given that the culprit in SCI pain is the dorsal horn, a potential therapy is to block that abnormal neural activity in the dorsal horn. This might be achieved by lesioning the dorsal horn as advocated by Falci et al (2002). The disadvantages of this approach are that this technique extends the level of SCI, is irreversible, and potentially establishes a new zone of SCI that could create new sources of pain. Stimulation of the generator site in the dorsal horn provides a non-destructive means of blocking the pain signaling. In the field of movement disorders, (e.g., Parkinson's disease) certain brain targets can be stimulated at high frequency (>100 Hz) with an implanted microstimulator and achieve a therapeutic effect (Starr et al Neurosurg. Clin. N. Am. (1998) 9(2):381-402). It is important to note that the targets for stimulation are the same as the targets for ablation. As described herein, the target for stimulation (dorsal horn) is also the same as the target for lesioning in treatment of pain from SCI. Although not critical to the method of treatment, possible mechanisms that would account for how stimulation relieves pain include: (1) activation of nearby inhibitory cells, and (2) a jamming mechanism in which the rate of stimulation leads to loss of conductive capacity in the neurons (Magarinos-Ascone C, Pazo J H, Macadar O, Buno W. Neuroscience. 2002;115(4):1109-17 High-frequency stimulation of the subthalamic nucleus silences subthalamic neurons: a possible cellular mechanism in Parkinson's disease; Beurrier C, Bioulac B, Audin J, Hammond C.); J Neurophysiol. 2001 April;85(4):1351-6. High-frequency stimulation produces a transient blockade of voltage-gated currents in subthalamic neurons); (3) an alteration of the pattern of discharge such that the rostrally conducted impulses no longer activate brain areas concerned with pain signalling. Thus, implantation of an electrode and stimulation offers an alternative to ablation and avoids destruction of spinal cord tissue. This reversible intervention can be removed or stop being used at a later time if other therapies emerge. The stimulation parameters can also be adjusted so that the therapy can be graded to a certain level as opposed to the all-or-none action of surgical ablation. Multiple implant sites can be used and post-hoc programming can be used to determine the ideal electrode configuration. 2. Technique for Dorsal Horn Stimulation. Dorsal horn stimulation preserves the hyperexcitable neurons at the level of the lesion while inactivating their function or capacity to transmit signals to the brain. As shown in FIG. 2 , the electrodes ( 24 ) are inserted into the gray matter of the spinal cord, preferably at the level of the lesion ( 22 ). Since the border zone is the target site for dorsal horn stimulation, it is most preferable that the electrodes ( 24 a, 24 b, 24 c ) be positioned at and within 2-3 spinal segments rostral to the lesion ( 22 ). Placement of the electrodes must be done precisely and requires surgical exposure of the dorsal horn through a laminectomy. Anatomical landmarks are used to guide placement of the electrodes. It is possible that electrophysiological monitoring can be used as well to guide placement as described by Falci et al (2002). Programming of the electrical stimulation paradigm post-operatively with the patient awake will determine the ideal configuration of stimulation. The variety of electrode placements intraoperatively allows the best electrical stimulation paradigm to be used in order to maximize pain relief and minimize side effects. 3. Use of Intramedullary Electrodes to Stimulate Targets in the Spinal Cord Other than the Dorsal Horn. Spinal cord stimulation is a frequent therapeutic tool to treat a variety of pain states. Electrodes are placed into the epidural space and positioned so that the patient feels parethesias in the region of pain. The patient indicates whether there is pain relief and the decision is made to do a permanent implant. Electrodes have been placed in the subdural space and intradural compartment, but because of ease of use epidural stimulation is the prevailing technique presently utilized. This technique, though effective, suffers from problems with obtaining stable stimulation. The electrodes may move or the electrical connectivity with the desired target may be such that excessive stimulation has to be applied to unwanted regions of the spinal cord in order to stimulate the desired target (Barolat Arch Med Res 2000 31:258-262; Holsheimer et, al., Neurosurg 1998 42:541-547). While somewhat a problem for the lower extremities, this problem with inadequate stimulation of the desired targets in the dorsal column is especially limiting for the upper extremities. Neck motion changes the conduction properties in patients such that the patient experiences sags and surges in the intensity of the stimulation with normal neck motion. Several attempts have been tried to circumvent these technical problems. For example, suturing of the electrode to the adjacent soft tissue or bone is one method. Another method provides a lead anchor (LA) and/or suture sleeve (SS) that may be used after insertion of the electrode array into the spinal canal in order to secure and maintain the position of the electrode and prevent its dislodgement due to axial loads that are placed upon the lead (described in U.S. Pat. No. 6,516,227). A paddle lead has also been used with a variety of electrode contact configurations or arrays so that a combination can be used if the first stimulus combination becomes inactive (U.S. Pat. No. 6,308,103). These techniques are still insufficient because other factors affect the stimulation efficacy. The conduction to the dorsal columns is also affected by the distance between the dura and the spinal cord. It is well known that with different head position or trunk positions that the space between the dura and the spinal cord varies. This is a further factor that gives rise to sags and surges in the stimulation afforded by durally based electrodes. Therefore, the method described herein involves placement of intramedullary electrodes into the desired target. Intramedullary refers to the substance of the spinal cord. Potential targets include the dorsal columns, the nucleus cuneatus (arm), nucleus gracilis (leg and sacral regions), nucleus caudalis and spinal tract of V (face and neck), and the spinal-thalamic tract. The dorsal horn may also be included as a target for stimulation in cases other than SCI. As shown in FIG. 3 , electrodes ( 30 ) can be inserted directly into the spinal cord white matter ( 36 ) comprising the dorsal column projection pathway. The lead ( 34 ) is connected to a stimulator. The cuneate fascicle ( 38 ) is one of the nerve pathways relaying sensory information from the spinal cord to the brain. This provides more stable stimulation. Fibers in the dorsal column pathway normally relay touch and position sense information and ascend to the medulla where they synapse onto neurons in the nucleus cuneatus and nucleus gracilis. Neurons in these two nuclei project along the medical lemniscus and synapse on cells in the ventroposterolateral (VPL) thalamus. The VPL thalamus is the central receiving area for sensory information before transmission to the cortex. The position of cathodes and anodes, and configuration of the stimulation are the major determinants of whether the patient will experience “coverage.” Coverage refers to the desired goal of having the patient feel paresthesias in the painful area in the case of dorsal column stimulation (including here stimulation of nuclear areas, nuclues cuneatus, and nucleus gracilis). Stimulation of the nuclues cuneatus and nucleus gracilis provides a way to obtain results similar to dorsal column stimulation. These nuclei receive inputs from the dorsal columns. In particular, stimulation in these areas would be expected to provide widespread coverage with less power requirements if the patient has widespread pain. A further use of the intramedullary spinal cord stimulating electrodes is to stimulate the nucleus caudalis and spinal trigeminal tract. These structures are immediately lateral to the cuneate fasciculus below the level of the medulla, and are the facial analogs of the dorsal horn. Implantation of electrodes in these structures should relieve facial pain in a similar fashion to how pain is relieved by dorsal horn stimulation. Stimulation with implanted electrodes for treatment of facial pain is presently unsatisfactory. The dorsal column equivalent for the face region is sufficiently far from the epidural space that epidural electrodes would not be expected to provide selective stimulation of the relevant target. Recently neurosurgeons working with implantation of epidural electrodes over motor cortex observed some promising results. There are potential liabilities for stimulation of the cortex of the brain, however, including the possibility, for example, of inducing epilepsy. Moreover, the mechanism by which motor cortex stimulation works is unknown. The types of patients helped with this technique may be completely different from the patients who should derive benefit from intramedullary stimulation of the spinal cord. C. Electrode Implantation The electrodes are inserted by the surgeon directly into the spinal cord tissue with direct visual control. Electrophysiological recordings may be made as well to ensure that the electrode positioning is accurate. Typically, the leads are implanted in a procedure called a bilateral laminectomy. This procedure is considered major surgery and entails removing two or three spinous processes and one or more full set of lamina. The dura is opened and the surgeon visualizes the spinal cord directly. The anatomic target is selected and the electrodes are placed (this may require use of the operating microscope). The electrodes will be placed directly by the surgeon into the appropriate region of the spinal cord. The surgeon can be aided by electrophysiological data. The nerve that serves the painful area can be stimulated intraoperatively and the evoked potentials associated with this stimulation can be used to place the electrodes into the ideal regions of the dorsal columns as well as other targets. Such methods are known in the art and are described in U.S. Pat. No. 6,027,456. Electrophysiological recordings are used in cases of SCI to guide spinal cord lesioning (Falci, 2002). Similar guidance should be useful for electrode positioning. In a preferred embodiment, the electrodes are implanted at and just above the SCI site in the dorsal horn. Recent advances in electrode arrays with multiple contacts have allowed for optimal combinations of contacts to be stimulated after implantation. D. Connection to and Use of the Stimulator The stimulator is hermetically sealed from the external environment except for the electrode leads and is sterile packaged to minimize potential for infection after implantation. The electrodes may be connected to existing stimulator systems in one of two ways. One version consists of an external (to the body) radio frequency transmitter and antenna, with an implanted radiofrequency receiver and stimulation leads. In an alternative version the transmitter is implanted and thus an external antenna is not needed. The electrodes are connected to an implanted receiver via conductive leads. The stimulation at a range of potential frequencies and voltages is provided in similar fashion as what is provided with conventional dorsal column and deep brain stimulation devices. Multiple contacts permit various stimulation paradigms to be employed to maximize effectiveness and untoward side effects. In cases of bilateral pain, the electrodes are placed bilaterally. The dorsal horn stimulation will lead to relief of pain. The intensity of the stimulation must be in an amount effective to provide coverage of the areas where the patient describes feeling pain. For example, if the patient is experiencing pain in the right arm, but stimulation evokes sensation in the right leg, coverage is not adequate. Paresthesia coverage can be altered by proper positioning of the anodes and cathodes and by programming the electrical stimulation configuration. In a preferred embodiment, multiple electrode leads and contacts permit a “stimulation array” wherein effective coverage is obtained to relieve pain by stimulating different contacts. Stimulus parameters can be adjusted to manipulate the strength, duration and frequency of stimulation. The parameters (electrode or electrodes used, number of pulses, amplitude, pulse to pulse interval, duration of pulses, etc.) of the stimulation may be set or varied as a result of the detection of signals from the patient's body including the nervous system or set by a physician. Typical stimulus parameters include pulse duration between 60-120 microseconds, pulse amplitude between 0.1-7V, and stimulus frequency between 10-300 Hz. Observations in the treatment of movement disorders have shown that on a behavioral level, a stimulation of >100 Hz gives the same results as lesioning the area (Starr et al. 1998 Neurosurg Clin N Am 9(2):381-402). A stimulation regimen can be determined empirically to give a certain amount of “on time,” and “off time” to give optimal balance between analgesia, prolonged battery life and patient satisfaction. An external programming device can be used to adjust all stimulus parameters and also determine which electrodes are activated, and furthermore which electrodes serve as cathodes and anodes. In summary, the method typically includes the steps of implanting the electrodes, attaching the electrode leads to the receiver and power source and applying a stimulus in an effective amount to decrease pain due to the disease or injury. In one embodiment, different electrodes are positioned rostral to, and at the level of spinal cord disease or injury. In another embodiment, the electrodes are positioned in the dorsal column, to treat pain from the neck down. In still another embodiment, the electrodes are positioned in the nucleus cuneatus for treatment of pain in the arm. In additional embodiments, the electrodes are positioned in the nucleus gracilis for treatment of pain in the leg and sacral regions or in the nucleus caudalis and spinal tract of V for treatment of pain in the face and neck. In other embodiments, the electrodes are positioned in the spinal-thalamic tract or into the spinothalamic tract to treat pain in the contralateral arm, trunk, leg, or sacral area. In yet another embodiment, the electrodes are positioned in the dorsal horn of the spinal cord within several dermatomal segments of the lesion site. In the preferred method, the electrodes directly stimulate the dorsal horn in an amount effective to relieve pain, usually by a pulse duration between 60 and 120 microseconds, a pulse amplitude up to 7 volts, and a stimulation frequency greater than 20 Hz. There are drawbacks to caring for a chronically implanted device, but these are known in the art. There is always the risk of infection and migration of the electrodes with any implanted foreign object. If a power supply is worn externally and if batteries are used, they must be changed regularly. A single stimulator may also be limited to a particular effective field. Operative risks including spinal cord injury are associated with implantation of the electrodes. Despite these drawbacks, intramedullary stimulation may provide pain relief where other alternatives are ineffective. Modifications and variations of the present invention will be obvious to those skilled in the art from the foregoing detailed description. Such modifications and variations are intended to come within the scope of the following claims.

The method disclosed herein entails spinal cord stimulation via electrodes placed directly into the dorsal horn, dorsal column, spinothalamic tract, nucleus cuneatus, nucleus gracilis, spinal tract of V, or spinal nucleus of V (nucleus caudalis) depending on the source of pain. This “intramedullary” stimulation “jams” or otherwise prevents the pain signal from being transmitted. The method provides a means to stimulate the targeted area directly, creating a stable means of stimulating the desired area, and decreasing stimulation of other structures.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention concerns a method as well as a device to implement the method to localize regions, in particular focal lesions in a biological tissue section that, at least during the examination, exhibits a fluorescence property distinct from the tissue section, due to which, given an exposure with light of a first wavelength, light of another wavelength is emitted. [0003] 2. Description of the Prior Art [0004] In Umar Mahmood et al., “Near Infrared Optical Imaging of Protease Activity for Tumor Detection”, Radiology 213:3, 866-870 (1999), it is specified that fluorescing metabolic markers either accumulate exclusively in specific regions, for example tumors, inflammations or other specific metastases, or are distributed throughout the body, but are activated only in specific regions, for example by tumor-specific enzyme activities and by additional exposure by means of light. [0005] This principle of optical fluorescence imaging is explained using FIG. 1, in which a tumor is visible given the exposure with NIR light (light in the near-infrared range) after a marker whose fluorescence properties are activated by specific enzymes was administered to a mouse. [0006] The recognition of a tumor or another marked region then ensues by exposure of the region with light in the special excitation wavelengths of the fluorescent dye, and detection of the emitted light in the corresponding emission wavelength of the fluorophore. Given authorization for use on humans, these markers can be used in early cancer detection, for example. [0007] By exciting the dye with at least one temporally varied excitation light signal, for example by temporal variation of irradiation location and/or light wavelength and/or intensity modulation of the excitation light, data can be acquired (for example by means of CCD or photomultiplier, photon flux on the surface of the tissue section, such as, for example, the female breast) at different measurement points at different variations. In this manner, variation-dependent and location-dependent—meaning spatially two-dimensional—measurement data are acquired. In the case of M measurement data of N variations, these are M×N data. [0008] From these data, spatially delimited lesions such as, for example, focal fluorescing marked tumors with different fluorescence properties than the surrounding tissue can be located three-dimensionally. [0009] The method is provided in cancer (screening) examinations of the breast, lymph nodes, thyroid, prostate, and has intraoperative applications, and in general is applicable for all organs near the surface that lie in the range of the penetration of light and that develop carcinoma (or other diseases) for which (now or at a future point in time) corresponding fluorescent markers exist. [0010] Various approaches are known for fluorescence reconstruction or localization. [0011] Britton Chance proposed a method to localize fluorescing absorbers in homogenous medium known as phased arrays. This method localizes fluorescing inhomogeneities (spots) only in absolutely homogenous media, meaning media with homogenous light absorption properties and scatter properties (as they rarely occur in the application), and offers no information at all about the depth at which the spot is located. [0012] Otherwise, various methods for fluorescence reconstruction have been proposed. In the reconstruction, the complete fluorescence activity in the entire (mostly discretized) medium is determined (similar to methods in nuclear medicine), while in the localization exclusively the regions emphasized from the background are sought. Reconstruction methods thus are based on the (often iterative) solution of large equation systems and are thus, in contrast to the localization operating in real-time that is proposed here, very time-consuming. The reconstruction methods further predominantly assume that the medium (similar to computer tomography) to be examined is enclosed by a ring of light sources and detectors. [0013] Some of the known methods are tomography with frequency-modulated light (U.S. Pat. No. 6,304,771 and U.S. Pat. No. 5,865,754), which requires a reconstruction time of 5 min. on a 1 GHz Pentium computer or 45 min. on a SUN Sparc 2 workstation, and tomography with light (PCT Application WO 02/41760) that likewise requires a reconstruction time of 5 min. on a 1 GHz Pentium computer. [0014] All of these known methods are characterized by a high calculation effort and relatively small reconstruction volumes; a calculation in real-time is not possible. SUMMARY OF THE INVENTION [0015] An object of the present invention is to enhance the localization precision fluorescing marked tumors in a localization method of the above-described type as well as a device to implement the method, as well as to enable an evaluation in deep tissue slices, and to drastically reduce the calculation expenditure and, as a result, the calculation time. [0016] With the inventive method, the problem of the localization of fluorescing subjects in optically blurred media can be quickly solved. Furthermore, the precision is increased via the variation of the excitation location. [0017] In the inventive method light emission of tissue sections in which fluorescence markers are accumulated is excited by irradiation by laser light of suitable wavelength. Fluorescence light can then be measured at the proximate skin surface. In order to determine locations and optical parameters of marked tissue sections, a sequence of fluorescence excitations of the surface, for example of various locations with different modulation frequencies (including zero frequency), is radiated into the tissue, and then the fluorescent light is measured with one or more arrangements of suitable light sensors distributed on the surface, in order to thus acquire two-dimensional measurement value distributions which are dependent on the type of the excitation. [0018] In accordance with the invention, frequency-independent signal portions are determined in the response signals, obtained by measuring the fluorescence light, and these frequency-independent signal portions are further-processed into input values for localization. The tissue section is modeled and a set of guide fields is determined from the model. The guide field are transformed, and the transformed guide fields are compared with the input values processed from the frequency-independent signal portions. A location of the transformed guide fields that best reproduces the frequency-independent signal portions is emitted, as an output, as a location of the region to be localized. [0019] It has proven to be advantageous when, to generate the various fluorescence properties, the regions are marked with fluorescing markers (fluorophores). [0020] The spatial resolution is enhanced when the fluorescence-exciting light signals are generated with various modulation frequencies and are irradiated into the tissue section. [0021] It is advisable to first normalize and then transform the guide fields, whereby the guide fields can be transformed into orthogonal guide fields. Furthermore, the orthogonal guide fields can be determined from the guide fields by a singular-value decomposition. [0022] The optical parameters can be determined in accordance with the invention by reference measurements by means of estimating methods, given non-fluorescence-exciting wavelengths. [0023] A device for implementing the above-described method has at least one arrangement of light sensors distributed on the surface of the tissue section to measure the fluorescence light emitted by the fluorescing marked region, and laser diodes are provided to generate the light for exciting the marked region, so that a two-dimensional measurement value distribution is obtained as a result of the excitation. The output signals from the sensor arrangement are supplied to a processor for implementing the above-described method to localize the region or regions. [0024] A measurement system can, for example, include 8×8 regular light sensors arranged on a planar measurement surface. However, it can be advantageous to measure with a number of such planar systems at the same time. Thus, for example, two arrangements of light sensors can be provided that can be applied on both sides of the tissue section to be examined. Given measurements of the female breast, two measurement surfaces can be applied to opposite sides of the mamma. An advantageous embodiment is the integrated arrangement of the measurement surfaces in pressing plates of an x-ray mammography device. [0025] In general, any curved or curvable or flexible measurement surface can be used with any arrangement of light sensors. DESCRIPTION OF THE DRAWINGS [0026] [0026]FIG. 1 is exposure to explain the principle of optical fluorescence imaging. [0027] [0027]FIG. 2 is an overview of the basic components of a device to localize and classify a focal lesion in a tissue section in accordance with the invention. [0028] [0028]FIG. 3 shows the substantial method steps to localize a focal lesion in accordance with the invention. [0029] [0029]FIG. 4 is a schematic illustration of an inventive applicator with 8×8 sensors as well as 8 light sources arranged near the measurement surface to generate the excitation light. [0030] [0030]FIG. 5 is a schematic illustration of a double system in accordance with the invention with two applicators positioned opposite one another. [0031] [0031]FIG. 6 is a two-dimensional measurement value distribution of a data configuration designated as the configuration 1 , for the first four excitation locations. [0032] [0032]FIG. 7 shows a singular-value decomposition of the configuration 1 . [0033] [0033]FIG. 8 is a basis map of the configuration 1 . [0034] [0034]FIG. 9 shows localization functions of two fluorochrome-marked lesions. [0035] [0035]FIG. 10 illustrates the localization of lesions of different depths with a planar measurement system. [0036] [0036]FIG. 11 illustrates the localization of lesions of different depths with two planar measurement systems placed opposite to one another. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0037] The overview representation in FIG. 2 shows a measurement and evaluation arrangement with which a delimited spatial area 2 arranged in a biological tissue section 1 can be localized and identified. It is assumed that the spatial area 2 possesses a fluorescent property different from the remaining tissue section 1 . These assumptions are fulfilled sufficiently well when the biological tissue section 1 is a female breast and the delimited spatial area 2 is a tumor to which, for example, a fluorescing metabolic marker was supplied whose fluorescent properties are activated by specific enzymes. [0038] The measurement arrangement includes an applicator 3 with a number of spatially distributed photo sensors, as well as additional laser diodes arranged in a line. [0039] The recognition of a tumor or another marked region ensues by exposure of the region with light of the laser diodes in the specific excitation wavelength of the fluorescent dye, and detection of the emitted light by the photo sensors in the corresponding wavelength of the fluorophore. [0040] The photo sensors and laser diodes of the applicator 3 are connected via electrical connection lines 4 with an electrical control device 4 , and with a measurement value processor 7 via electrical connection lines 6 . [0041] With the control device 5 , pulses of NIR light are supplied to the biological tissue section 1 via a number (K) laser diodes, whereby 1≦K≦M, in order to excite to fluorescence an existing marked tumor. [0042] To localize and identify spatially delimited areas 2 , the light emitted from the areas 2 is measured by photo sensors on the surface of the tissue section 1 at M locations and supplied to the processor 7 . [0043] The measurement value processor 7 includes, for example, measurement amplifiers, filters and A/D converters. The measurement value processor 7 is connected with one or more data inputs of an electronic computer 8 . In addition to the measurement values, a model 9 of the tissue section 1 is available to the computer, with which the above-cited fluorescing areas 2 are localized and identified, as is specified further below. The result, for example in the form of a graphical representation of the anatomy of the tissue section wherein the location of the light sources (and thus of the spatial areas 2 ) is marked, ensues via a monitor 10 . Since the calculation, among other things, is determined by the model 9 and the location of the exposure, a supervisory input and control 11 is provided with which the number and the location of the photo sensors are determined, as well as the number and location of the laser diodes, the value of the frequency, and the model. [0044] The localization method is explained using FIG. 3 as an example. Explained first are its input dimensions, meaning the measurement data and model data, and then the calculation steps of the method. [0045] The input dimensions for the localization method are, per measurement surface. [0046] a) An M×N data matrix D with measurement values (reference number 21 ) which are dependent on the M sensor locations {overscore (r)} S,m , (m=1, . . . , M) and the N excitation parameters (N 1 excitation locations {overscore (r)} A,n 1 , (n 1 =1, . . . , N 1 ) and/or N 2 excitation modulation frequencies f n 3 , (n 2 =1, . . . , N 2 ) whereby N=N 1 +N 2 ), and which can result from the actual measurement data by post-processing. [0047] The M-dimensional column vectors of the data matrix can be reformatted corresponding to the arrangement of the sensors on the measurement surface. A graphical representation of the reformed column vector provides a visualization of the measurement value distribution over the considered measurement surface for a given excitation type. In the case of the above cited 8×8 sensor distribution, the 64-dimensional column vector is reformed into an 8×8 matrix. [0048] b) A set of K guide fields or lead fields L k ({overscore (r)} m ,{overscore (n)} m ,{overscore (r)} 1 ,μ a ,μ z ),(k=1, . . . , K), for example multipole lead fields which are characterized with the reference number 22 in FIG. 3, and which for their part are dependent [0049] the model of the optical medium of the examination area 1 , [0050] the measurement system, for example location {overscore (r)} m and/or normal vector {overscore (n)} m of the m- th sensor, [0051] the location {overscore (r)} f of the f- th excitable fluorochrome, [0052] the type of the measurement (frequency modulation yes/no) and [0053] optical parameters such as the absorption and scatter coefficients μ a ,μ z of the medium surrounding the lesion(s). [0054] The photons impacting on a sensor are transduced (converted) into electrical signals and then supplied to the further evaluation. In the case of frequency-modulated excitation, light intensity and phase shifts with regard to the input wave are measured. Both real measurement values can be combined into a complex measurement value. The data matrix is then—in the mathematical sense—complex. In the following, in the general case a complex data matrix is assumed. [0055] It may be necessary to supply post-processed measurement data to the localization algorithm. For example, edge artifacts are eliminated via truncation of edge data. They could simulate a nonexistent dependency on the modulation frequency location or the excitation frequency. [0056] The data matrix can result from a linear combination of at least two data sets. For example, the difference of a data set with fluorescence signals and a spatially adjacent data set without fluorescence signal can be considered. It is to be expected that possible contributions of background excitations are reduced in the difference data, if not completely eliminated. [0057] Guide fields, known as lead fields, are known quantities from bioelectric magnetism. They describe the measurement value distribution of a standard signal source that can be acquired with a given measurement system. [0058] Lead fields, which specify the light intensity that can be acquired with a measurement system or a number of measurement systems based on optically excited focal lesions marked with fluorochromes, are suitable as input quantities for the method to localize such focal lesions. [0059] For example, in the exemplary embodiment only a lead field is used. It describes the light intensity of a punctiform light source measurable with a given measurement system. Corresponding to the expanded electrically-polarized lesion areas addressed in B. Scholz, “Towards Virtual Electrical Breast Biopsy: Space-Frequency MUSIC for Trans-Admittance Data”, IEEE Trans. Med. Imag., Vol. 21, No. 6, pp. 588-595, spatially expanded fluorescence sources can likewise be acquired by multipole lead fields. In the following, it is assumed that exemplary lead fields, meaning a set of a number of lead fields, are available. [0060] For the further steps, it is helpful to combine the values of the k- th lead field L k (k=1, . . . , K) at the M measurement locations into an M-dimensional vector in data space (symbolized by the underline under L). L k ({overscore (r)})=(L k ({overscore (r)},{overscore (r)} 1 ), . . . , L k ({overscore (r)},{overscore (r)} M )) T   (1) [0061] with k=1, . . . , K [0062] wherein {overscore (r)} is the focal point of the lesion. For clarity, in equation (1) the dependency on the optical parameters of the medium surrounding the lesion(s) is not specified. [0063] The optical parameters that, as noted above, enter into the lead fields, can be determined by reference measurements by means of estimation methods, given non-fluorescence-exciting wavelengths. [0064] The signal processing of the method involves per measurement surface [0065] 1. the singular-value decomposition of the data matrix D (reference number 23 in FIG. 3), [0066] 2. the analysis of the singular-value decomposition (reference number 24 in FIG. 3), and [0067] 3. the actual localization method (reference number 25 in FIG. 3). [0068] The singular-value decomposition 28 of a matrix is a known mathematical method from G. Golub, Ch. Van Loan, Matrix Computations , 3rd edition, J. Hopkins University Press, 1996, Page 70 et seq. For the above data matrix, the singular-value decomposition is D=U S V H   (2) [0069] wherein [0070] U a unitary M×M matrix dependent only on the indices of the sensor locations, [0071] S the M×N singular value matrix with min(M,N) real singular values in the diagonal and otherwise vanishing elements and [0072] V a unitary N×N matrix dependent only on the excitation location indices or, respectively, frequency indices and [0073] H the hermetic conjugation of the appertaining matrix. [0074] The singular values are ordered corresponding to their decreasing numerical value, meaning s 1 ≧s 2 ≧ . . . ≧s min(M,N)   (3) [0075] If the q-th column vectors of the matrixes U and V are designated by u q , v q , then the alternative tonsorial notation ({circle over (x)} designates the tensor product) D = ∑ q = 1 min ( M , N  s q  u _ q ⊗    v _ _ q H ( 4 ) [0076] clearly shows that the q-th singular value is exclusively linked with the q-th column vectors of U and V. The single and the double underline in u and v should indicate that it concerns an M- or, respectively, N-dimensional vector. [0077] The M indices of the column vectors u q correspond to the successively numbered indices of the measurement sensors. As a result, these column vectors—as noted above—can be reformed In matrices corresponding to the arrangement of the measurement sensors and represented as two-dimensional measurement value distributions. These column vectors are excitation-independent or frequency-independent orthonormalized basis vectors in M-dimensional data space and are here designated as basis maps or eigenmaps. [0078] For singular value analysis, the number Q dom of the significant singular values is determined that specifies the number of the acting fluorescence sources linearly independent with regard to the excitation type. [0079] A punctiform inhomogeneity in the otherwise homogenous optical medium generates, for example, a singular value spectrum with a significant singular value ( Q dom =1). [0080] The associated column vectors u q are considered as basis vectors of a—frequency-independent—Q dom -dimensional signal space in M-dimensional data space. The remaining M-Q dom column vectors are then the basis vector of the orthogonal signal space. [0081] The identification of fluorochrome-marked lesions, i.e., the localization, corresponds to the search for locations or focal point locations of excited signal sources. This search by means of computers requires the subdividing (rastering) of the adopted model medium, which should mathematically reproduce the body region to be examined. [0082] One search strategy is to generate, at each raster location, excitation-independent and frequency-independent model data and/or a model data space with the excitation-independent and frequency-independent lead fields, and to compare this and/or these with the excitation-independent and frequency-independent signal space acquired from the measurement data. Comparison measures can be defined such that they display the degree of the “agreement” between signal space and model data/model data space. Locations at which the measure reaches a local maximum are viewed as locations of actual signal sources. [0083] An alternative second search strategy exists in the comparison between the orthogonal signal domain—also called noise domain in the older literature—and the model data or the model data domain. Comparison measures can then be defined such that they display the degree of the “non-agreement” between the orthogonal signal space and model data/model data domain. Locations at which the measure reaches a local minimum are considered to be locations of actual signal sources. [0084] The model data are given by the lead fields: they are either used directly or post-processed. [0085] An individual lead field represents a model data set that reflects a specific property of the signal source. For example, the lead field of a punctiform fluorescence source describes the measurable light intensity given isotropic light emission by this source. [0086] The entirety of the considered lead fields (number: K) defines, due to its linear independence, a K-dimensional model data space. In other words, the lead fields are non-orthogonal basis vectors of this model data space. Orthogonal basis vectors can be acquired by suitable orthogonalization methods, i.e. by post-processing of the lead fields. They do not change the model data domain. However, new individual model data sets result with the new basis vectors (see above). These basis vectors can be additionally normalized. This ensures that lead fields with different separation behavior can be accounted for in the same manner for localization. In addition, it has the advantage of considering physically dimensionless quantities. [0087] An advantageous lead field post-processing is, for example, to normalize the K lead fields L k (k=1, . . . , K) from equation (1) (processing step 27 ). The individual guide fields are respectively referenced to their normalization, such that the normalized guide fields L k (n) result as follows: L _ k ( n ) = L _ k  L _ k  ( 4  a ) [0088] For example, by means of a singular-value decomposition of the M×K lead field matrix L, orthogonalized lead fields are acquired. The normalization is displayed by the index (n). L (n) =( L 1 (n) , . . . , L K (n) )=U L S L V L T   (5) [0089] For clarity, the arguments of the lead fields (the spatial vectors of the source location) have been omitted. The first K column vectors U ({overscore (r)}) L,k , (k=1, . . . , K) of the matrix U L are the desired source location-dependent orthonormalized lead fields. In the case of a single lead field, the singular-value decomposition is omitted from equation (5). [0090] For example, for the comparison measure a model data set or the model data domain and the signal or the orthogonal signal domain are known from other biomedical applications, analysis of biometric data, or analysis of electrical trans-admittance data. Such methods are projection methods and angular separation methods. [0091] With the aid of projection matrices, individual model data sets or the model data domain are projected either on the signal space or, respectively, on the orthogonal signal domain, and determined for each raster location of the corresponding projection value. [0092] Based on the algorithm to calculate angles between two sub-spaces, a technique known as the angular method (specified in G. Golub et al., page 584 et seq., the angle between the signal domain or the orthogonal signal domain and individual model data sets or the model data domain are calculated search location by search location. Here, a small angle (thus a small value of the comparison measure) between, for example the signal domain and the model data domain, gives a large “agreement”. A transformation of the comparison measure in the form of a 90° angle then again yields maxima of the comparison function at the location of the actual signal sources. The statements can be correspondingly transferred to angular comparison measures between other sub-spaces. [0093] At each location {overscore (r)} of the discrete optical model medium, it is tested how large the separation is between the orthogonalized lead field U ({overscore (r)}) L,k and the signal space. A suitable measure is the function F k ( {overscore (r)} )=[Σ i=1 Q dom c i u − U L,k ] 2 .  (6) [0094] The output equation of (6) is the equation to be considered in the sense of the quadratic mean Σ i=1 Q dom c i u i = U L,k k=1, . . . , K.  (7) [0095] If the solution for the coefficients c i is used in the evaluation measure, then F k ({overscore (r)})=1−[Σ i=1 Q dom ( u i H , U ( {overscore (r)} ) L,k )] 2 .  (8) [0096] This measure corresponds to a projection of the considered lead field on the orthogonal signal domain. Using the projection matrix P OS =1 −Σ u i {circle over (x)} u i H   (9) [0097] projected on the orthogonal signal domain results in F k ({overscore (r)})=|P OS U ({overscore (r)}) L,k | 2 .  (10) [0098] The actual localization function F is the minimal value of the separations F k . It is defined by [0099] [0099] F  ( r ⇀ ) = min k  { F k  ( r _ ) } ( 11 ) [0100] The local minima of the localization function are monotonically ordered in ascending order corresponding to their number values. The locations, which are to be associated with the first Q dom local minima, are considered as locations of signal generators. [0101] In the case of a number (M sys ) of measurement surfaces, the above-cited calculation steps for the data of each measurement surface are executed separately. An objective function then results per measurement surface according to equation (11). From these individual objective functions, an overall objective function F (overall) can be defined according to F (overall) ({overscore (r)})=Σ μ=1 M sys F (μ) ({overscore (r)})  (12) [0102] wherein F (μ) is the objective function of the μ-th measurement surface. [0103] The local minima of the overall localization function are monotonically ordered as above, in ascending order corresponding to their number values. The locations, which are to be associated with the first Q dom local minima, are considered as locations of signal sources. The exemplary embodiment confirms the expectation that, given a plurality of non-trivial arranged measurement surfaces, the local minima of the individual objective functions are clearly formed, and thus make the localization result most reliable. [0104] The exemplary embodiments were acquired with planar measurement systems arranged in the applicator 3 , which has 8×8 regularly arranged photo sensors 31 as schematically shown in FIG. 4. The sensors 31 were assumed to be punctiform. Their separation along a direction is 8 mm, such that a measurement field surface of 56×56 mm 2 results. The locations at which 8 laser diodes 32 which radiate the NIR light exciting fluorescence in the body region are located can, for example, be arranged near the measurement surface. The excitation can be, but does not have to be frequency-modulated. Such a measurement arrangement can be guided by hand over a tissue section 1 of interest. The laser diodes 32 emit excitation rays 33 that impinge upon the fluorescing spatial area 2 . The fluorescence rays 34 are acquired by the photo sensors 31 . [0105] In FIG. 5, a double system of an applicator 3 is shown, with two planar measurement surfaces of the same dimensions (8×8 sensors) arranged opposite one another. For example, they can be integrated into the pressing plate of an x-ray mammography device. The fluorescence excitation ensues at 8 excitation locations that are located near the measurement surface (z=0) of the upper applicator 3 . The separation of the two applicators 3 is 64 mm. [0106] As an optical tissue model, in the present invention the following models are used: [0107] A) The simplest model is a borderless area with punctiform fluorescing subjects, which is otherwise optically homogenous (constant optical parameters such as absorption coefficient and scatter coefficient). [0108] B) As a second model, an optically inhomogeneous cuboid area with punctiform fluorescing subjects was considered. It was assumed that absorption coefficient and scatter coefficient can vary locally by 100%. FIG. 9 shows the localization functions of 32 mm and 48 mm deep, fluorochrome-marked lesions. The absorption contrast difference of the surrounding tissue is 100% (image in image). [0109] The simulation of the data is based on the following configurations: Configuration 1 Measurement/excitation system: see FIG. 4, the excitation is not frequency-modulated Tissue model: inhomogeneous cuboid (5.2.B) Fluorescence source: location at (x, y, z) = (28, 28, 32) mm, meaning central position beneath the measurement surface at a depth of 32 mm (coordinate system see FIG. 4) Data: see FIG. 6 Configuration 2 Measurement/excitation system: see FIG. 4, the excitation is not frequency-modulated Tissue model: inhomogeneous cuboid (5.2.B) Fluorescence source: location at (x, y, z) = (28, 28, 48) mm, meaning central position beneath the measurement surface at a depth of 48 mm (coordinate system see FIG. 4) Configuration 3a, 4a and 5a Measurement/excitation system: individual measurement system, see FIG. 4, the excitation is not frequency-modulated Tissue model: homogenous, unbordered medium (5.2.A) Individual fluorescence sources: locations at (x, y, z) = (28, 28, 16) mm, (28, 28, 32) mm, (28, 28, 48) mm, meaning central positions beneath the measurement surface at depths of 16 mm, 32 mm and 48 mm (coordinate system see FIG. 4) Configuration 3b, 4b and 5b Measurement/excitation system: double measurement system, see FIG. 5, the excitation is not frequency-modulated Tissue model: homogenous, unbordered medium (5.2.A) Individual fluorescence sources: locations at (x, y, z) = (28, 28, 16) mm, (28, 28, 32) mm, (28, 28, 48) mm, meaning central positions beneath the measurement surface at depths of 16 mm, 32 mm and 48 mm (coordinate system see FIG. 5) [0110] Due to the singular-value decomposition 23 (corresponding to the number of the existing fluorescence sources), the singular value spectrum shown in FIG. 7 of the data of the configuration 1 comprises a numerically dominant singular value. The remaining singular values reproduce noise, in this case numeric noise. [0111] [0111]FIG. 8 shows the associated basis maps or eigenmaps. There is a structured basis map corresponding to the single numerically dominant singular value. Here it defines the one-dimensional signal domain of the (here 64-dimensional) data space. [0112] The above-defined objective functions for localization 25 , meaning the localization functions, the configurations 1 and 2 , are shown in FIG. 9. [0113] The influence of a second, oppositely-placed measurement surface on the localization is shown using the objective functions of the configurations 3 a/b , 4 a/b , 5 a/b , whereby FIG. 10 shows the localization of lesions of different depths with a planar measurement system, and FIG. 11 shows the localization of lesions of different depths with two planar measurement systems lying opposite one another. The positions of the measurement probes are marked by thick lines at the left edge or, respectively, at both sideways edges. With reference to FIG. 10, a clearer specification of the minima is visible. It should be noted that the scale according to FIG. 11 is different from that of FIG. 10. [0114] The problem of the localization of fluorescing subjects in optically bleary media can be rapidly solved with the inventive method. Furthermore, the precision is increased by the variation of the excitation location. [0115] This inventive localization method operates in real time, is patient-independent, and is robust with regard to estimation of optical parameters. [0116] Although modifications and changes may be suggested by those skilled in the art, it is the intention of the inventors to embody within the patent warranted hereon all changes and modifications as reasonably and properly come within the scope of their contribution to the art.

In a method and a device to localize regions in a biological tissue section, at least during the examination the tissue section exhibits one fluorescence property differing from the tissue section, due to which, given an exposure with light of a first wavelength, light of another wavelength is emitted. A sequence of fluorescence-exciting light signals at different locations on the tissue-section is applied. Fluorescence light is measured at a number of measurement locations on a surface of the tissue section, which appears there due to the light signals. Frequency-independent signal portions in the response signals are determined and are further processed into input values of a localization step. The tissue section is modeled and a set of guide fields is determined. The guide fields are transformed that in a localization step the frequency-independent signal portions are compared with the transformed guide fields, and the location of the transformed guide fields that best reproduce the frequency-independent signal portions is output as the location of the region to be localized.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This patent application claims priority to provisional atent pplications Application No. 61/325,339, filed Apr. 18, 2010, entitled “ULTRASOUND NEUROMODULATION OF THE BRAIN, NERVE ROOTS, AND PERIPHERAL NERVES.” The disclosures of this patent application are herein incorporated by reference in their entirety. INCORPORATION BY REFERENCE [0002] All publications, including patents and patent applications, mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. FIELD OF THE INVENTION [0003] Described herein are systems and methods for Ultrasound Neuromodulation of the occipital nerve and related neural structures. BACKGROUND OF THE INVENTION [0004] It has been demonstrated that focused ultrasound directed at neural structures can stimulate those structures. If neural activity is increased or excited, the neural structure is said to be up-regulated; if neural activated is decreased or inhibited, the neural structure is said to be down-regulated. One or a plurality of neural elements can be neuromodulated. [0005] Potential application of ultrasonic therapy of deep-brain structures has been covered previously (Gavrilov L R, Tsirulnikov E M, and I A Davies, “Application of focused ultrasound for the stimulation of neural structures,” Ultrasound Med Biol. 1996; 22(2):179-92. and S. J. Norton, “Can ultrasound be used to stimulate nerve tissue?,” BioMedical Engineering OnLine 2003, 2:6). It was noted that monophasic ultrasound pulses are more effective than biphasic ones. [0006] The effect of ultrasound is at least two fold. First, increasing temperature will increase neural activity. An increase up to 42 degrees C. (say in the range of 39 to 42 degrees C.) locally for short time periods will increase neural activity in a way that one can do so repeatedly and be safe. One needs to make sure that the temperature does not rise about 50 degrees C. or tissue will be destroyed (e.g., 56 degrees C. for one second). This is the objective of another use of therapeutic application of ultrasound, ablation, to permanently destroy tissue (e.g., for the treatment of cancer). An example is the ExAblate device from InSightec in Haifa, Israel. The second mechanism is mechanical perturbation. An explanation for this has been provided by Tyler et al. from Arizona State University (Tyler, W. J., Y. Tufail, M. Finsterwald, M. L. Tauchmann, E. J. Olsen, C. Majestic, “Remote excitation of neuronal circuits using low-intensity, low-frequency ultrasound,” PLoS One 3(10): e3511, doi:10.137/1/journal.pone.0003511, 2008)) where voltage gating of sodium channels in neural membranes was demonstrated. Pulsed ultrasound was found to cause mechanical opening of the sodium channels, which resulted in the generation of action potentials. Their stimulation is described as Low Intensity Low Frequency Ultrasound (LILFU). They used bursts of ultrasound at frequencies between 0.44 and 0.67 MHz, lower than the frequencies used in imaging. Their device delivered 23 milliwatts per square centimeter of brain—a fraction of the roughly 180 mW/cm 2 upper limit established by the U.S. Food and Drug Administration (FDA) for womb-scanning sonograms; thus such devices should be safe to use on patients. Ultrasound impact to open calcium channels has also been suggested. [0007] Alternative mechanisms for the effects of ultrasound may be discovered as well. In fact, multiple mechanisms may come into play, but, in any case, this would not effect this invention. [0008] Patent applications have been filed addressing neuromodulation of deep-brain targets (Bystritsky, “Methods for modifying electrical currents in neuronal circuits,” U.S. Pat. No. 7,283,861, Oct. 16, 2007 and Deisseroth, K. and M. B. Schneider, “Device and method for non-invasive neuromodulation,” U.S. patent application Ser. No. 12/263,026 published as US 2009/0112133 A1, Apr. 30, 2009). [0009] Transcranial Magnetic Stimulation (TMS) has been used for characterization of the motor system. TMS stimulation of the motor cortex is employed to see the motor response in the periphery. The response can be in alternative ways such as Motor Evoked Potentials (MEPs) or measurement of mechanical output. One application is the measurement of conduction time from central to peripheral loci, which can have diagnostic significance. Another is the demonstration of the degree of functional connectivity between the loci. Stimulation more distally such as in the spinal cord nerve roots or the spinal cord itself to measure connectivity from the spinal cord to the periphery. Irrespective of the point of stimulation with the central nervous system, an application is the monitoring of the level of anesthesia present. [0010] While motor-system functions performed using TMS are valuable, they use expensive units, typically costing on the order of $50,000 in 2010 that are large, take a relatively high power, require cooling of the electromagnet stimulation coils, and may be noisy. It would be highly beneficial to be able to perform the same functions using lower-cost stimulation mechanism. SUMMARY OF THE INVENTION [0011] It is the purpose of this invention to provide methods and systems and methods for ultrasound stimulation of the cortex, nerve roots, and peripheral nerves, and noting or recording muscle responses to clinically assess motor function. In addition, just like Transcranial Magnetic Stimulation, ultrasound neuromodulation can be used to treat depression by stimulating cortex and indirectly impacting deeper centers such as the cingulate gyms through the connections from the superficial cortex to the appropriate deeper centers. Ultrasound can also be used to hit those deeper targets directly. Positron Emission Tomography (PET) or fMRI imaging can be used to detect which areas of the brain are impacted. Compared to Transcranial Magnetic Stimulation, Ultrasound Stimulation systems cost significantly less and do not require significant cooling. BRIEF DESCRIPTION OF THE DRAWINGS [0012] FIG. 1 shows ultrasound transducers and EMG sensors at various portions of the nervous system. [0013] FIG. 2 shows a diagram of the ultrasound sensor, ultrasound conduction medium, ultrasound field, and the target. [0014] FIG. 3 shows a block diagram of the control circuit. DETAILED DESCRIPTION OF THE INVENTION [0015] It is the purpose of this invention to provide methods and systems and methods for ultrasound stimulation of the cortex, nerve roots, and peripheral nerves, and noting or recording muscle responses to clinically assess motor function. In addition, just like Transcranial Magnetic Stimulation, ultrasound neuromodulation can be used to treat depression by stimulating cortex and indirectly impacting deeper centers such as the cingulate gyms through the connections from the superficial cortex to the appropriate deeper centers. Ultrasound can also be used to hit those deeper targets directly. Positron Emission Tomography (PET) or fMRI imaging can be used to detect which areas of the brain are impacted. In addition to any acute positive effect, there will be a long-term “training effect” with Long-Term Depression (LTP) and Long-Term Potentiation (LTD) depending on the central intracranial targets to which the neuromodulated cortex is connected. [0016] Ultrasound stimulation can be applied to the motor cortex, spinal nerve roots, and peripheral nerves and generate Motor Evoked Potentials (MEPs). MEPs elicited by central stimulation will show greater variability than those elicited stimulating spinal nerve roots or peripheral nerves. Stimulation results can be recorded using evoked potential or electromyographic (EMG) instrumentation. Muscle Action Potentials (MAPs) can be evaluated without averaging while Nerve Action Potentials (NAPs) may need to be averaged because of the lower amplitude. Such measurements can be used to measure Peripheral Nerve Conduction Velocity (PNCV). Pre-activation of the target muscle by having the patient contract the target muscle can reduce the threshold of stimulation, increase response amplitude, and reduce response latency. Another test is Central Motor Conduction Time (CMCT), which measures the conduction time from the motor cortex to the target muscle. Different muscles are mapped to different nerve routes (e.g., Abductor Digiti Minimi (ADM) represents C8 and Tibialis Anterior (TA) represents L4/5). Still another test is Cortico-Motor Threshold. Cortico-motor excitability can be measured using twin-pulse techniques. Sensory nerves can be stimulated as well and Sensory Evoked Potentials (SEPs) recorded such as stimulation at the wrist (say the median nerve) and recording more peripherally (say over the index finger). Examples of applications include coma evaluation (diagnostic and predictive), epilepsy (measure effects of anti-epileptic drugs), drug effects on cortico-motor excitability for drug monitoring, facial-nerve functionality (including Bell's Palsy), evaluation of dystonia, evaluation of Tourette's Syndrome, exploration of Huntington's Disease abnormalities, monitoring and evaluating motor-neuron diseases such as amyotrophic lateral sclerosis, study of myoclonus, study of postural tremors, monitoring and evaluation of multiple sclerosis, evaluation of movement disorders with abnormalities unrelated to pyramidal-tract lesions, and evaluation of Parkinson's Disease. As evident by the conditions that can be studied with the various functions, neurophysiologic research in a number of areas is supported. Other applications include monitoring in the operating room (say before, during, and after spinal cord surgery). Cortical stimulation can provide relief for conditions such as depression, bipolar disorder, pain, schizophrenia, post-traumatic stress disorder (PTSD), and Tourette syndrome. Another application is stimulation of the phrenic nerve for the evaluation of respiratory muscle function. Clinical neurophysiologic research such as the study of plasticity. [0017] When TMS is applied to the left dorsal lateral prefrontal cortex and depression is treated ‘indirectly” (e.g., at 10 Hz, although other rates such as 1, 5, 15, and 20 Hz have been used successfully as well) due to connections to one or more deeper structures such as the cingulate and the insula as demonstrated by imaging. The same is true for ultrasound stimulation. [0018] A benefit of ultrasound stimulation over Transcranial Magnetic Stimulation is safety in that the sound produced is less with a lower chance of auditory damage. Ironically, TMS produces a clicking sound in the auditory range because of deformation of the electromagnet coils during pulsing, while ultrasound stimulation is significantly above the auditory range. [0019] The acoustic frequency (e.g., typically in that range of 0.3 MHz to 0.8 MHz or above whether cranial bone is to be penetrated or not) is gated at the lower rate to impact the neuronal structures as desired. A rate of 300 Hz (or lower) causes inhibition (down-regulation) (depending on condition and patient). A rate in the range of 500 Hz to 5 MHz causes excitation (up-regulation)). Power is generally applied at a level less than 60 mW/cm2. Ultrasound pulses may be monophasic or biphasic, the choice made based on the specific patient and condition. Ultrasound stimulators are well known and widely available. [0020] FIG. 1 illustrates placement of ultrasound stimulators EMG and sensors related to head 100 , spinal cord 110 , nerve root 120 , and peripheral nerve 130 . Ultrasound transducer 150 is directed at superficial cortex (say motor cortex). For any ultrasound transducer position, ultrasound transmission medium (e.g., silicone oil in a containment pouch) and/or an ultrasonic gel layer. When the ultrasound transducer is pulsed [typically tone burst durations of (but not limited to) 25 to 500 μsec, the conduction time to the sensor at nerve root 170 and/or associated muscles further in the periphery 190 . Alternatively ultrasound transducer 160 may be positioned at a nerve root 120 and the conduction time to the electromyography sensor 190 measured. Further, an ultrasound transducer 180 may be positioned over peripheral nerve 130 and the conduction tine to electromyography sensor 190 measured. [0021] Cortical excitability can be measured using single pulses to determine the motor threshold (defined as the lowest intensity that evokes MEPs for one-half of the stimulations. In addition, such single pulses delivered at a level above threshold can be used to study the suppression of voluntarily contracted muscle EMG activity following an induced MEP. [0022] Ultrasound transducer 200 with ultrasound-conduction-medium insert 210 are shown in front view in FIG. 2A and the side view in FIG. 2B . FIG. 2C again shows a side view of ultrasound transducer 200 and ultrasound-conduction-medium insert 210 with ultrasound field 220 focused on the target nerve bundle target 230 . Depending on the focal length of the ultrasound field, the length of the ultrasound transducer assembly can be increased with a corresponding increase in the length of ultrasound-conduction-medium insert. For example, FIG. 2D shows a longer ultrasound transducer body 250 and longer ultrasound-conduction-medium insert 260 . The focus of ultrasound transducer 200 can be purely through the physical configuration of its transducer array (e.g., the radius of the array) or by focus or change of focus by control of phase and intensity relationships among the array elements. In an alternative embodiment, the ultrasonic array is flat or other fixed but not focusable form and the focus is provided by a lens that is bonded to or not-permanently affixed to the transducer. In a further alternative embodiment, a flat ultrasound transducer is used and the focus is supplied by control of phase and intensity relationships among the transducer array elements. [0023] Keramos-Etalon can supply a 1-inch diameter ultrasound transducer and a focal length of 2 inches, which with 0.4 Mhz excitation will deliver a focused spot with a diameter (6 dB) of 0.29 inches. Typically, the spot size will be in the range of 0.1 inch to 0.6 inch depending on the specific indication and patient. A larger spot can be obtained with a 1-inch diameter ultrasound transducer with a focal length of 3.5″ which at 0.4 MHz excitation will deliver a focused spot with a diameter (6 dB) of 0.51.″ Even though the target is relatively superficial, the transducer can be moved back in the holder to allow a longer focal length. Other embodiments are applicable as well, including different transducer diameters, different frequencies, and different focal lengths. In an alternative embodiment, focus can be deemphasized or eliminated with a smaller ultrasound transducer diameter with a shorter longitudinal dimension, if desired, as well. Other embodiments have mechanisms for focus of the ultrasound including fixed ultrasound array, flat ultrasound array with lens, non-flat ultrasound array with lens, flat ultrasound array with controlled phase and intensity relationships, and ultrasound non-flat array with controlled phase and intensity relationship. Ultrasound conduction medium will be required to fill the space. Examples of sound-conduction media are Dermasol from California Medical Innovations or silicone oil in a containment pouch. If patient sees impact, he or she can move transducer (or ask the operator to do so) in the X-Y direction (Z direction is along the length of transducer holder and could be adjusted as well). [0024] Transducer arrays of the type 200 may be supplied to custom specifications by Imasonic in France (e.g., large 2D High Intensity Focused Ultrasound (HIFU) hemispheric array transducer)(Fleury G., Berriet, R., Le Baron, O., and B. Huguenin, “New piezocomposite transducers for therapeutic ultrasound,” 2nd International Symposium on Therapeutic Ultrasound—Seattle— 31 / 07 -Feb. 8, 2002), typically with numbers of ultrasound transducers of 300 or more. Keramos-Etalon in the U.S. is another custom-transducer supplier. The design of the individual array elements and power applied will determine whether the ultrasound is high intensity or low intensity (or medium intensity) and because the ultrasound transducers are custom, any mechanical or electrical changes can be made, if and as required. Blatek in the U.S. also supplies such configurations. [0025] FIG. 3 illustrates the control circuit. Control System 310 receives its input from Intensity setting 320 , Frequency setting 330 , Pulse-Duration setting 340 , and Firing-Pattern setting 350 . Control System 310 then provides output to drive Ultrasound Transducer 370 and thus deliver the neuromodulation. [0026] The various embodiments described above are provided by way of illustration only and should not be construed to limit the invention. Based on the above discussion and illustrations, those skilled in the art will readily recognize that various modifications and changes may be made to the present invention without strictly following the exemplary embodiments and applications illustrated and described herein. Such modifications and changes do not depart from the true spirit and scope of the present invention.

Disclosed are methods and systems for non-invasive ultrasound neuromodulation of superficial cortex of the brain or stimulation of nerve roots or peripheral nerves. Such stimulation is used for such purposes as determination of motor threshold, demonstrating whether connectivity to peripheral nerves or motor neurons exists and performing nerve conduction-speed studies. Neuromodulation of the brain allows treatment of conditions such as depression via stimulating superficial neural structures that have connections to deeper involved centers. Imaging is optional.

TECHNICAL FIELD The present disclosure generally relates to the field of implantable ocular devices, pharmaceutics, and methods of drug delivery to the eye. More particularly, the present disclosure relates to implantable ocular devices for sustained delivery of a therapeutic compound to the eye. BACKGROUND Glaucoma is the leading cause of blindness worldwide and the most common cause of optic neuropathy. Various forms of glaucoma leads to elevated intraocular pressure, and may also lead to damage to the optic nerve. If glaucoma or ocular hypertension is detected early and treated promptly with medications that effectively reduce elevated intraocular pressure, loss of visual function or its progressive deterioration can generally be ameliorated. Drug therapies that have been proven useful for the reduction of intraocular pressure include both agents that decrease aqueous humor production and agents that increase the outflow facility. Such therapies may be administrated in a number of different ways. One example of administrating suitable therapies includes topical application to the eye, such as eye drops. However, one of the limitations of topical therapy is inadequate and irregular delivery of the therapeutic agent to the eye. For example, when an eye drop is applied to the eye, a substantial portion of the drop may be lost due to overflow of the lid margin onto the cheek. Moreover, compliance with a necessary drug regime is also always an issue with this method. For example, for some medications, 4 to 5 applications a day are required to achieve therapeutic drug levels. Other suitable delivery mechanisms for therapeutic devices include injection at the pars plana. However, aside from discomfort for the patient, this method also requires that the patient return monthly. Various ocular drug delivery implants have also been employed in an effort to improve and prolong drug delivery. One such example includes a reservoir drug-delivery device. A reservoir drug-delivery device is a device that contains a receptacle or chamber for storing the drug while implanted in the eye. However, reservoir drug devices are difficult to manufacture, difficult to achieve drug content uniformity (i.e., device to device reproducibility, particularly with small ocular devices), and carry the risk of a “dose dump” if they are punctured. Another type of drug delivery device is a punctal plug device that is inserted into one or more of the tear ducts within the eye. However, because the geometry of the tear duct varies from person to person, there have been problems with plugs migrating within the tear duct. Other issues occur whereby the punctal plugs may inadvertently fall out of the eye. Accordingly, there exists a need for a therapeutic delivery mechanism that allows for controlled and sustained release of ophthalmic drugs over a predetermined period of time, while sufficiently securing the delivery device within the eye so as to prevent inadvertent migration or removal of the delivery device. BRIEF SUMMARY A punctal plug is disclosed, wherein the punctal plug includes a body portion and a retaining portion. The body portion is defined by an open distal end, an open proximal end and a wall portion. The wall portion further includes at least one window extending therethrough. The retaining flange is configured to have an outer periphery that is larger than the outer periphery of the body portion. A method of delivering a therapeutic agent to a patient using a punctal plug is also disclosed. BRIEF DESCRIPTION OF THE DRAWINGS Exemplary embodiments of the present disclosure will now by described by way of example in greater detail with reference to the attached figures, in which: FIG. 1 is a perspective view of a distal end of a delivery device with a punctal plug releasably connected thereto; FIG. 2 is a perspective view of an exemplary embodiment of a punctal plug; FIG. 3 is a perspective view of the punctal plug of FIG. 2 with an exemplary therapeutic compound disposed therein; FIG. 4 is a front, partially sectional view of a lacrimal duct system of a mammalian eye with a punctal plug disposed therein; and FIG. 5 is an enlarged front sectional view of the lacrimal canaliculi of FIG. 4 , with a punctal plug disposed therein. DETAILED DESCRIPTION Referring now to the discussion that follows and also to the drawings, illustrative approaches to the disclosed devices and methods are shown in detail. Although the drawings represent some possible approaches, the drawings are not necessarily to scale and certain features may be exaggerated, removed, or partially sectioned to better illustrate and explain the present disclosure. Further the descriptions set forth herein are not intended to be exhaustive or otherwise limit or restrict the claims to the precise forms and configurations shown in the drawings and disclosed in the following detailed description. Referring to FIGS. 1-5 , an exemplary arrangement of a punctal plug 10 is illustrated. Punctal plug 10 includes a body portion 12 and a retaining flange 14 . Body portion 12 includes an open distal end 16 and an open proximal end 18 that is in communication with retaining flange 14 . Formed within body portion 12 is at least one window 20 . In one exemplary arrangement, a plurality of windows 20 are formed, separated by land members 22 . Windows 20 may be formed so as to be spaced equi-distant from one another. Body portion 12 of punctal plug 10 may be made from a biocompatible material such as titanium, stainless steel, plastics, elastomers or any other material which may be formed into body portion 12 . In one exemplary arrangement, at least one cross-member 24 is disposed within body portion 12 . Alternatively, a pair of cross-members 24 is provided. Each cross-member 24 is defined by ends 25 that are fixedly secured to an inner wall 26 of body portion 12 . In one exemplary arrangement, cross-members 24 are arranged within body portion 12 in an intersecting manner, such that one cross-member 24 a is disposed above the other cross-member 24 b . In another exemplary arrangement, cross-members 24 a , 24 b are integrally connected together so as to lie along a common plane (not shown). Cross-members 24 are also constructed of a biocompatible material, whereby the material allows for some degree of flexibility, as will be explained below in further detail. Retaining flange 14 is defined by a distal end 28 and a proximal end 30 . Distal end 28 is defined by a diameter that generally corresponds to the diameter of proximal end 18 of body portion 12 . Proximal end 30 is defined by a diameter that is larger than the diameter of distal end 28 and body portion 12 . In one exemplary arrangement, an interior surface 32 slopes outwardly from distal end 28 to proximal end 30 . As shown in FIG. 1 , a delivery device 34 is shown releasably connected to punctal plug 10 . More specifically, delivery device 34 includes a delivery cannula 36 having a distal end that secures to interior surface 32 of retaining flange 14 . In one exemplary arrangement, the distal end of delivery cannula 36 includes retaining apertures (not shown) that releasably receives retaining members 38 that extend from interior surface 32 . More specifically, retaining members 38 may be constructed of a flexible material that permits selective engagement and disengagement between punctal plug 10 and delivery cannula 36 . Alternatively, the distal end of delivery cannula 36 may be provided with retaining members that engage complementary retaining apertures (not shown) formed on interior surface 32 . Other suitable mechanisms for releasably securing punctal plug 10 to deliver cannula 36 are also within the scope the present disclosure. Turning now to FIGS. 4 and 5 , the lacrimal duct system 100 of a mammalian eye 102 will be described. System 100 includes a lower punctum 104 connected to a lower lacrimal canaliculus 106 , and an upper punctum 108 connected to an upper lacrimal canaliculus 110 . Canaliculli 106 and 110 are connected to a lacrimal sac 112 and a nasolacrimal duct 114 . A lacrimal gland 116 is connected to eye 102 via a lacrimal duct 118 . In general, tears are produced by lacrimal gland 116 and are provided to eye 102 via lacrimal duct 118 , and tears are drained from 102 via punctum 108 and canaliculus 110 , punctum 104 and canaliculus 106 , and nasolacrimal duct 114 . In operation, punctal plug 10 is secured to the distal end of delivery cannula 36 . Delivery cannula 36 is secured to a suitable drug supply. Once secured to delivery cannula 36 , but before a drug 40 is injected into punctal plug 10 via delivery cannula 36 , distal end 16 is implanted into either lower or upper punctums 104 , 106 . In FIGS. 4 and 5 , distal end 16 of body portion 12 of punctal plug 10 is implanted into lower punctum 104 until retaining flange 14 contacts an outer surface of the eye. Once positioned, a suitable therapeutic drug is injected through delivery cannula 36 and into punctal plug 10 . More specifically, a phase transition drug formulation 40 is injected through delivery cannula 36 into punctal plug 10 . Because body portion 12 includes at least one window 20 , a portion of phase transition drug formulation 40 flows through window 20 and some also flows out distal end 16 of body portion 12 , as shown in FIG. 3 . This action causes drug formulation to conform to the irregular shape of the walls of lower punctum 104 . As drug formulation 40 cools, it solidifies into a drug bolus such that the drug formulation 40 serves to lock punctal plug 10 into place in lower punctum 104 , thereby preventing migration of punctal plug 10 , as well as preventing inadvertent dislodgement of punctal plug 10 from punctum 104 . As shown in FIG. 5 , because drug formulation is able to conform to the irregularities in shape of the punctum, puntal plug 10 is able to adapt to various contours of the respective punctums without requiring unique geometry for each plug 10 for each individual into which the puntal plug 10 is inserted. Further, when injected, drug formulation 40 also flows around cross-members 24 . Because cross-members 24 have some degree of flexibility, as drug formulation 40 flows into punctal plug 10 , cross-members 24 serve to generally retain the basic shape of punctal plug 10 to keep punctal plug 10 properly positioned within the punctum 104 , but allow some degree of flexing of body portion 12 . Further, as drug formulation 40 cools, the drug bolus attaches to cross-members 24 , thereby locking the drug bolus into punctal plug 10 , such that the drug bolus itself is prevented from migrating down punctums 104 and 106 . Windows 20 also may aid in the locking effort. Once drug formulation 40 has been injected and permitted to solidify, punctal plug 10 is released from delivery cannula 36 , thereby leaving punctal plug 10 in place within the eye. In one embodiment, forceps may be utilized to release delivery cannula 36 from punctal plug 10 . Drug formulation 40 , which is retained within punctal plug 10 , is configured to allow for sustained release of ophthalmic drugs over a predetermined period of time (e.g., 3-6 months). Other predetermined time periods are also possible (e.g., 1-2 days, 1-2 months, 1 year, etc). As drug formulation 40 is released into the patient over time, the drug bolus shrinks such that punctal plug detaches from the interior wall of punctum 104 , 106 . Once so released, punctal plug 10 may be easily removed in a non-invasive manner. It will be appreciated that the devices and methods described herein have broad applications. The foregoing embodiments were chosen and described in order to illustrate principles of the methods and apparatuses as well as some practical applications. The preceding description enables others skilled in the art to utilize methods and apparatuses in various embodiments and with various modifications as are suited to the particular use contemplated. In accordance with the provisions of the patent statutes, the principles and modes of operation of this invention have been explained and illustrated in exemplary embodiments. It is intended that the scope of the present methods and apparatuses be defined by the following claims. However, it must be understood that this invention may be practiced otherwise than is specifically explained and illustrated without departing from its spirit or scope. It should be understood by those skilled in the art that various alternatives to the embodiments described herein may be employed in practicing the claims without departing from the spirit and scope as defined in the following claims. 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 arts discussed herein, and that the disclosed systems and methods will be incorporated into such future examples. Furthermore, all terms used in the claims are intended to be given their broadest reasonable constructions and their ordinary meanings as understood by those skilled in the art unless an explicit indication to the contrary is 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. It is intended that the following claims define the scope of the invention and that the method and apparatus within the scope of these claims and their equivalents be covered thereby. In sum, it should be understood that the invention is capable of modification and variation and is limited only by the following claims.

A punctal plug is disclosed, wherein the punctal plug includes a body portion and a retaining portion. The body portion is defined by an open distal end, an open proximal end and a wall portion. The wall portion further includes at least one window extending therethrough. The retaining flange is configured to have an outer periphery that is larger than the outer periphery of the body portion. A method of delivering a therapeutic agent to a patient using a punctal plug is also disclosed.

CLASSIFICATION [0001] The present invention relates to a new Pinus thumbergiana plant. VARIETY DENOMINATION [0002] The new plant has the varietal denomination ‘Kanemi’. BACKGROUND [0003] This invention relates to a new and distinct variety of P. thumbergiana plant named ‘Kanemi’, discovered as a sport in a controlled planting of Japanese Black Pine in Nipomo, Calif. The sport parent is unknown. The new variety was discovered in approximately 2001 in a planted row of Japanese Black Pine, all of the same age, when it was observed that one of the plants was distinctively different, smaller in size and with shorter needles. SUMMARY OF THE INVENTION [0004] Among the features which distinguish the new variety from other presently available and commercial Japanese Black Pine cultivars known to the inventor are the following combination of characteristics: [0005] 1. Smaller size than same-aged members of other Japanese Black Pine cultivars; after 1-2 years growth, plants of the new variety have an average height of approximately 70 cm while other Japanese Black Pine cultivars of the same age have an average height of approximately 142 cm to 213 cm. [0006] 2. Smaller trunk diameter, with 1- to 2-year old plants of the new variety having an average trunk diameter of approximately 1.6 cm while other Japanese Black Pine cultivars of the same age have an average trunk diameter of approximately 3.5 cm to 5.7 cm. [0007] 3. Shorter needle length, with 1- to 2-year old plants of the new variety having an average needle length of approximately 12.5 mm to 25 mm, while other Japanese Black Pine cultivars of the same age have an average needle length of approximately 10 cm to 15.2 cm. [0008] Asexual reproduction of the new variety ‘Kanemi’ by grafting on a regular Japanese Black Pine P. thumbergiana rootstock was performed in Nipomo, Calif., and shows that the foregoing and other distinguishing characteristics come true to form and are established and transmitted through succeeding asexual propagations. BRIEF DESCRIPTION OF THE DRAWINGS [0009] FIG. 1 shows a close-up of the new variety. [0010] FIG. 2 shows the new variety growing along side commercially-available Japanese Black Pine cultivars of the same age. [0011] FIG. 3 shows the new variety grafted onto a commercially-available Japanese Black Pine cultivar, illustrating the difference in needle-length. DETAILED DESCRIPTION OF THE INVENTION [0012] The following detailed description of the new variety is based upon observations taken of ten year old plants grown outdoors in fields in Nipomo, Calif., with a range of day temperatures from 60° to 85° F., and a range of night temperatures from 30° to 55° F. [0013] The following description is in accordance with UPOV terminology and the color terminology herein is in accordance with The Royal Horticultural Society Colour Chart (R.H.S.). The color descriptions and other phenotypical descriptions may deviate from the stated values and descriptions depending upon variation in environmental, seasonal, climatic and cultural conditions. Plant: Shape.— Normal shape of the new variety is pyramidal, but is typically pruned to become a bonsai. The tree has a long leader at top and all branching is low, as shown in FIGS. 1 and 2 . Height.— About 70 cm. Diameter.— About 22 cm. Growth rate.— Slower than found in other Japanese Black Pine varieties. Roots: Time to initiate.— About 2 to 4 weeks. Form.— Roots start out fine, becoming larger as plant grows. New fine roots develop from older roots. Trunk: Diameter.— Trunk is about 18 mm at 25 mm from soil level narrowing to 10 mm at 30 cm from soil level. Texture.— Rough, slightly raised bark structure. Color.— Greyed-green varying around Group 188B-D. Branches: Habit.— Branches grow approximately 3 to 4 cm, then new branch shoots form, radiating from the older branch. Number.— Typically 10 lateral branches are observed (some are pruned to provide the bonsai shape). Length.— About 6 to 12 cm. Diameter.— About 4 to 5 mm. Internode length.— About 3 to 4 cm. Color.— Greyed-green varying around Group 188B-D. Foliage: Needle arrangement.— two needles per sheath, as shown in FIG. 3 . Size.— Needle length varies from about 1 cm in new growth to about 2 cm for needles aged one year or older. Cones: Cones form, but seeds have not yet been collected. Dimensions.— unopened cone is 20 mm long and 15 mm in diameter. Shape.— ovoidal. Color.— Greyed-orange varying around Group 164C-D.

A new and distinct variety of Pinus thumbergiana named ‘Kanemi’, being distinctively different, smaller in size and with shorter needles, than known Pinus thumbergiana cultivars.

BACKGROUND OF THE INVENTION [0001] 1. Technical Field [0002] The invention is in the field of bed covering for two or more users that permits a user to adjust coverage and, if two or more layers are used, thickness of his or her bed covering without discomforting another user of the bed covering. [0003] 2. Related Art [0004] When one person sleeping in a bed under common bed covering with a second person rolls away from the second person, the first person often pulls the bed covering off the second person, thereby uncovering and discomforting the second person. When two persons sleep on their sides in a bed under common bed covering, there is often a gap between the persons that allows drafts to enter the space between the persons, thereby discomforting both persons, especially in cold ambient air. Moreover, one person can not partially or completely remove one or more layers of that person's portion of common bed covering without discomforting the second. The general technical problems to be solved are to prevent the pulling off of bed covering in the first case, prevent the entry of drafts in the second case, and to give each person independent control of the coverage and thickness of bed covering in the third case. [0005] The existing art of split-top bed covering involves two or more separate panels attached together to form a whole covering. For instance, U.S. Pat. No. 6,311,347, to Limardi, has left and right upper panels of a split bed covering sewn to a foot panel using a transverse seam. The inner longitudinal, or medial, edges of the upper panels overlap each other. The present invention avoid the need for a transverse seam and separate upper left, upper right, and foot panels. [0006] U.S. Pat. No. 6,698,043, to Fabian, has left and right panels of a split bed covering sewn directly to each other at the bottom of the panels to form a short, central, longitudinal seam. The description in Fabian requires the upper end of the longitudinal seam (joined portion) of the panels to be positioned in a bed at the top edge of the foot of the mattress so that a user can completely remove a left or right, first or second, upper panel. Fabian has no “foot panel”, per se. The left and right upper panels of Fabian's invention must be sewn together, and the top covering comprises two sheets in each left and right panel of the bed covering. The present invention avoids the need for a longitudinal seam, separate left and right panels, and two sheets in each left and right panel of the bed covering. Fabian's invention also lacks a means of fastening the left and right panels in the upper portion of the bed covering. [0007] Similarly, U.S. Pat. No. 7,200,883 to Haggerty, U.S. Pat. No. 6,862,760 to Bradley, and U.S. Pat. No. 6,643,871 to Robke use multi-panel, sewn, construction, rather than an integral, non-woven textile. [0008] Unlike the bed coverings disclosed in the patents cited above, the instant invention can be manufactured as a single sheet, without any sewn seams, thereby reducing the structural elements that comprise the article of manufacture and greatly reducing the cost of manufacture. Moreover, the instant invention can be manufactured for use by three concurrent users, e.g., parents and a child disposed between them. [0009] Split-top bed covering has not been widely adopted, in part because of the additional cost of production of split-top bed covering compared with traditional, integrally manufactured bed covering makes split-top bed covering significantly more expensive. The general technical problem to be solved is to provide a split-top bed covering that is less expensive to manufacture, specifically one that takes advantage of non-woven textile technology and does not require sewing together of separate, prefabricated panels. The present invention solves both the general and the specific technical problems. SUMMARY OF THE INVENTION [0010] The split-top, integral bed covering invention comprises left and right upper portions and a foot portion made from a single, integral piece of textile. In embodiments for two users, the left and right upper portions each have inner, medial wings that are free of the foot portion. In normal use, the inner, medial wings of the left and right upper portions overlap each other. The overlap of the medial wings of the left and right upper portions, and freedom of the medial wings from the foot portion, is achieved in the original manufacturing of the textile, as opposed to fastening separate left and right elements to each other or to a foot panel by sewing, bonding, or other fastening means. The edges of the bed covering can be hemmed, or for simplicity, unhemmed. Optional embodiments include a means for reversibly fastening left and right medial wings, which facilitates spreading the bed covering on a bed, hanging the bed covering for air drying, and providing traditional bed covering functionality. Additional elements, such as hems and ornamentation, can be added to the textile. The left, right, and foot portions can optionally have the same or different textural, insulative, ornamental, decorative, or other treatments. Embodiments of the invention can be manufactured with more than two top portions. Multiple layers of the split-top, integral bed covering can optionally be joined at the foot during manufacturing, e.g., by heat bonding. The split-top, integral bed covering can optionally be manufactured in fitted foot versions. BRIEF DESCRIPTION OF THE DRAWINGS [0011] FIG. 1 shows a plan view of a split-top, integral bed covering, with left medial wing open and right medial wing closed. [0012] FIG. 2 shows a plan view of a split-top, integral bed covering, with medial wings open. [0013] FIG. 3 shows a plan view of a split-top, integral bed covering, covering two users, with medial wings closed. [0014] FIG. 4 shows a cross section of FIG. 2 in the area of the medial wings, depicting how the medial wings conform to the users' bodies. [0015] FIG. 5 shows a plan view of a split-top, integral bed covering, with left medial wing open and right medial wing closed, showing with hook and loop fasteners. [0016] FIG. 6 shows a cross section of a split-top, integral bed covering, with medial wings open and with hook and loop fasteners in the area of the medial wings. [0017] FIG. 7 shows a plan view of a split-top, integral bed covering, with left medial wing open and right medial wing closed, showing with hook and loop fasteners with protective flaps. [0018] FIG. 8 shows a cross section of hook and loop fasteners of FIG. 6 , with protective flap opened to allow the fasteners to engage, in the area of the medial wings. [0019] FIG. 9 shows a plan view of a three person, split-top, integral bed covering, with medial wings open. [0020] FIG. 10 shows a plan view of a three person, split-top, integral bed covering, with medial wings closed. [0021] FIG. 11 shows a cross section of FIG. 10 in the area of the medial wings, depicting how the medial wings conform to the users' bodies. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0022] “Longitudinal” means along the head to foot axis with respect to a split-top bed covering as it covers a person lying in a bed. “Mattress” means herein any top substrate provided in a bed and on which a person lies. “Latitudinal” means the axis perpendicular to the longitudinal axis of the split-top bed covering. “Left” and “right” are referenced as if the viewer were overhead a split-top bed covering as it covers a bed. The “top edge” of a split-top bed covering is the latitudinal edge of the bed covering placed along the head of the bed on which a split-top bed covering is placed. The “foot edge” of a split-top bed covering is the edge opposite the top edge and is typically tucked under the mattress on which the split-top bed covering is placed. The top edge and the foot edge are typically parallel. “Sheet” means herein any bed-covering textile, e.g., comforter, blanket, duvet, sheet, quilt, etc. “Wing” means herein the medial part of an upper portion of a split-top, integral bed covering is that is free of (i.e., is not attached to and moves independently of) the foot portion. “Transverse line” means herein the latitudinal line formed by the top, medial part of the foot portion of a split-top bed covering, which portion is not integral with a wing or an upper portion, wherein such latitudinal line is extended transversely to the left and right edges of the split-top bed covering. The left edge and the right edge of the split-top bed covering are typically parallel. “Wing hinge” means herein the longitudinal line formed by extending longitudinally, to the top edge of the split-top bed covering, the most medial point at which an upper portion is integral with the foot portion of a split-top bed covering. The transverse line and wing hinge are for descriptive purposes only and are not actually creased or otherwise formed in the split-top bed covering during manufacturing. [0023] The split-top, integral bed covering invention comprises left and right upper portions and a foot portion made from a single, integral sheet of textile. In embodiments for two users, the left and right upper portions each have inner, medial wings that are free of the foot portion. In normal use, the inner, medial wings of the left and right upper portions overlap each other. The overlap of the medial wings of the left and right upper portions, and freedom of the medial wings from the foot portion, is achieved in the original manufacturing of the textile, as opposed to fastening separate left and right elements to each other or to a foot panel by sewing, bonding, or other fastening means. [0024] The invention (1) allows one user to roll in bed without pulling off the bed covering of a second person (the medial wing of the rolling person is pulled along with the rolling motion, but not the medial wing or upper bed covering portion of the second person), (2) prevents entry of drafts between two persons sleeping on their sides (the medial wings contour around the first and second persons, rather than forming a canopy above the mattress like traditional bed covering), and (3) gives each person independent control of the thickness of bedding covering (a first user can remove one or more layers of split-top, integral bed covering without disturbing the layers on a second person in bed). [0025] The split-top, integral bed covering can be produced as a non-woven textile. Non-woven textiles (“non-wovens”) are textiles that are manufactured by putting small fibers together in planar form and then binding the fibers together mechanically (e.g., interlocking the fibers using serrated needles, by hydroentanglement by water jets, etc.), with an adhesive (e.g., latex polymers), or thermally (calendering through heated rollers). A mesh backing or core is normally introduced in the laying of the fiber for bed coverings to produce stronger non-woven textiles. Non-woven textiles used in the invention can be carded, weblaid, or spunlaid. Non-wovens are typically produced from synthetic fibers; spunlaid non-woven manufacturing can combine a stage that produces synthetic fiber with immediate laying of the fiber in planar form, which greatly reduces manufacturing costs. [0026] The fibers used to made the split-top, integral bed covering include cashmere, chenille, flannel, cotton, silk, fleece, mink, wool, and synthetic fibers. Synthetic fibers used to make the split-top, integral bed covering include polypropylene and polyesters, particularly polyethylene terephthalate. [0027] The split-top, integral bed covering can also be produced using specially fitted weaving looms and knitting looms, by crocheting, by knotting, tufting, by composite (i.e., more than one textile manufacturing method), and by other known methods of textile production. Most woven textiles are made on looms and consequently are rectilinear when weaving is finished. The split-top, integral bed covering invention, with its “hinged” medial wings, is particularly suited for production as a non-woven textile made of synthetic fiber, since non-woven textiles can be easily laid and finished in odd shapes. [0028] The invention solves the technical problem of reducing the cost of manufacturing split-top bed covering by providing a design that is especially suited to non-woven textile technology, has fewer structural elements, and does not require sewing together of separate, prefabricated panels. [0029] As shown in FIG. 1 , the width of overlap (“Wing Width”) of a wing is defined by the distance ( 11 ) from a wing hinge ( 12 ) to the medial edge ( 13 ) of the wing. Normally, the width of a left wing ( 14 ) is the same as the width of a right wing ( 11 ). The “Overall Length”( 15 ) is the distance from the top edge to foot edge of the bed covering deployed planarly. [0030] As shown in FIG. 2 , the length of a foot portion ( 21 ) (“Foot Portion Length”) is defined by the distance ( 22 ) from the transverse line ( 23 ) to the foot edge ( 24 ) of a split-top bed covering. The “Overall Width” ( 25 ) is the distance from the left edge to right edge of the bed covering deployed planarly. [0031] The split-top, integral bed covering is normally manufactured in an embodiment for two users, and therefore is most commonly made in queen, king, and California king sizes. The Wing Width ranges from 20% to 60% of the Overall Width, more preferably from 25% to 40% of the Overall Width, and most preferably from 30% to 35% of the Overall Width. The Foot Portion Length ranges from 20% to 50% of the Overall Length, more preferably from 20% to 40% of the Overall Length, and most preferably from 25% to 30% of the Overall Length for normal mattresses and from 30% to 35% for pillow-top mattresses. [0032] The transverse line does not need to be precisely positioned during use. If the user wants the foot portion to cover the feet of the user, less of the foot portion is tucked under the mattress so that the transverse line is placed more headward, past the top of the foot of the mattress, e.g., the transverse line may be placed in the area of the user's calves or knees. If the user wants to be able to completely remove the upper portion as a bed covering on his or her portion of the bed, the transverse line is placed no higher than the top of the foot of the mattress. The split-top, integral bed covering can be made in various configurations that have different combinations of Wing Widths, Overall Widths, Overall Lengths, and Foot Portion Lengths to accommodate user preferences and mattress sizes. [0033] As shown in FIGS. 3 and 4 , the wings conform to the contours of users' bodies. [0034] As shown in FIGS. 5 and 6 , alternative embodiments include the hook and loop fasteners ( 61 , 62 ), or other means, to reversibly fasten the left and right medial wings to each other. As shown in FIG. 6 , reversible fasteners (when fastened) improve the ability to position the bed covering on a bed, hang the bed covering for air drying, and provide traditional bed covering functionality. Other fastening means include buttons and corresponding button holes, snaps, knotted rope and loops, and magnetic strips embedded in the medial edges and near the wing hinge. [0035] As shown in FIGS. 7 and 8 , the hook and loop fasteners are covered with displaceable flaps ( 71 , 81 ). The interior of the flaps has fastening matching the fastener on the wing, e.g., a hook fastener on a wing mates with a loop fastener on the flap. Using flaps prevents unintentional engagement of the fasteners, e.g., while the users are sleeping. If a user wishes to join the wings together, a flap is displaced to expose the relevant fastener, and the exposed fasteners on the wings are mated. [0036] Although FIGS. 5 to 8 show two columns of fasteners on each wing, only one column of fasteners can be used. Using one column does not immobilize the medial edges of both wings, however, and is not preferred. [0037] Additional elements, such as hems and ornamentation, can be added to the split-top, integral bed covering. The left, right, and foot portions can optionally have different textural, insulative, decorative, or other treatments, e.g., sports logos, pictures, “his and her” colors or decoration, etc. [0038] Multiple split-top, integral bed coverings can be used simultaneously, e.g., top sheet, first blanket, and quilt. A user may remove one or more layers of bed covering without disturbing the bed covering of the other user. [0039] The split-top bed covering can be made with a fitted foot portion, i.e., the split-top, integral bed is made with a pocket in the foot portion that accommodates the depth and width of a mattress. In fitted foot portion embodiments, the position of the transverse line is fixed. Not only bedsheets, but blankets, quilts, and other bedcovering can be made in fitted embodiments. [0040] Although the medial wings described above and shown in the Figures have the left medial wing overlapping the right medial wing, the invention can also be constructed with the right medial wing overlapping the left medial wing. This distinction is of importance only when fasteners are incorporated in the design; the manner of overlap determines which medial wing has fasteners on the bottom surface of a given wing, which requires the opposite wing to have fasteners on the top surface of such opposite wing. [0041] The split-top, integral bed covering can be manufactured with more than two upper portions. As shown in FIG. 9 , a three person, split-top, integral bed covering, has three upper portions. The upper left portion has a medial wing ( 91 ), the upper right portion has a medial wing ( 92 ); the wings overlap an upper center portion ( 93 ). [0042] As shown in FIGS. 10 and 11 , the wings of an embodiment of the invention for three users conform to the bodies of the three users. [0043] Embodiments of the split-top, integral bed covering can be made in which the longitudinal and latitudinal axes are reversed so that the top edge runs along the long side of a mattress (i.e., the head and foot of the bed mattress are rotated 90 degrees). This “landscape” mode (versus “portrait” mode) of use is especially suited for split-top, integral bed coverings with three or more upper portions. The principal use of such embodiments is when more than two children share a large bed. Given the split-top nature of the bed covering, barriers (e.g., tubular pillows) can be placed in the splits to separate the sleeping spaces of the children. The barriers can be integral with the bed-covering, or independent. [0044] The split-top, integral bed covering of the invention enables each of the users to determine his or her comfort level without affecting the other users. For example, each of the users can begin sleeping with their covering moved aside. Then as the night progresses, and more warmth is needed, each user can easily reach down and independently retrieve his or her bed covering. This can be done without disturbing another user in the bed. [0045] Multiple layers of the split-top, integral bed covering can optionally be joined at the foot during manufacturing, e.g., by heat bonding. In a multi-layer embodiment of a fitted foot version, only the bottommost layer needs to have a fitted foot. [0046] Variations, modifications, equivalents and substitutions for components of the specifically described embodiments of the invention may be made by those skilled in the art without departing from the spirit and scope of the invention as set forth in the appended claims.

A split-top, bed covering for two users comprising a single, integral sheet of textile with a left upper portion with medial wing, a right upper portion with medial wing, and a foot portion is described. All portions, including wings, are formed seamlessly during manufacturing of the textile. The medial wings of upper left and right portions overlap. The textile may be, inter alia, of woven, non-woven, crocheted, knitted, knotted, tufted, or composite construction.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] Priority is claimed to U.S. Provisional Application Ser. No. 60/552,577 filed Mar. 12, 2004 and U.S. Provisional Application Ser. No. 60/562,683 filed Apr. 15, 2004. BACKGROUND OF THE INVENTION [0002] This invention is generally in the field of ocular lubricants, and in particular relates to a formulation for treatment of the symptoms of dry eye. [0003] The surface of the eye requires constant lubrication for proper function. This includes quality of vision as well as comfort. The eye becomes irritated and vision blurs when inadequately lubricated. This condition is frequently referred to as dry eye. Inadequately treated severe dry eye can lead to cornea scarring, blindness and even loss of the eye. Dry eye is a common condition and many over-the-counter and even prescription therapies are available to mitigate this at times difficult and annoying condition. Many patients are unable to find relief with present therapies. [0004] It is well recognized that the meibomian gland secretions of the eyelid provide the lipid layer of the tear film. The major component of the meibomian gland lipid secretions are wax esters (Driver and Lemp, Meibomian Gland Dysfunction, Surv Ophthalmol 40:343-367, 1996). It is also known that the natural product jojoba is comprised of over 97% wax esters of the long chain variety similar to that of the lipid tear film. [0005] It is therefore an object of the present invention to provide a formulation for alleviating the symptoms of dry eye. [0006] It is a further object of the present invention to provide an over the counter formulation for alleviating the symptoms of dry eye. SUMMARY OF THE INVENTION [0007] A formulation has been developed for treatment of the symptoms of dry eye which incorporates the natural product jojoba wax, or components thereof, to enhance the spreading of the artificial tear as well as stabilize the tear film. The jojoba wax tear relieves irritation and discomfort as well as sharpens the blurred vision. DETAILED DESCRIPTION OF THE INVENTION [0008] A jojoba liquid wax formulation providing comfort and clarity of vision to patients with dry eye has been developed. The wax esters of the jojoba improve and enhance the spreading, stability and lubricating effect of the artificial tear on the tear film. [0000] I. Formulation [0009] A. Wax [0010] In the preferred embodiment, the formulation contains jojoba wax in an emulsion. The jojoba wax performs as lubricant and evaporation retardant for the tear film. Jojoba wax is a liquid wax composed of long chain wax esters. [0011] The components of the jojoba wax esters include long chain alcohols esterified with long chain fatty acids with a total of 38 to 44 carbon atoms. Exemplary long chain fatty acids include gadoleic, palmitic, palmitoleic, stearic, oleic, linoleic, arachidic, linolenic, eicosenoic, behenic, erucic, lignoceric, lactic, decate, acetic and myristic fatty acids. The fatty acids typically have carbon chains of C12 to C30, with or without various degrees of saturation or unsaturation. The alcohol components of the wax ester contain carbon chains between C16 and C32 with or without various degrees of saturation or unsaturation. The alcohol component may be eicos-11-enol, docos-13-enol, tetracos-15-enol, myristyl alcohol, octyldodecyl stearoyl alcohol or cetyl alcohol. [0012] Jojoba's melting point is about 6° C. It is extracted from seeds and leaves of the jojoba tree ( Simmondsia chinensis ) cultivated in the desert conditions of Arizona and California as well as Northern Mexico and other locations. The chemical structure does not vary with plant type, growing location, soil type, rainfall or altitude. The oil produced by jojoba lacks triglycerides. It does not contain glycerol combined with fatty acids. Rather the jojoba combines fatty alcohols with fatty acids to produce a vegetable oil which is actually a liquid wax, having its own type of molecular size and shape with unusual anti-evaporative properties which protect the shrub from its severe arid natural habitat. Jojoba wax or the wax esters therein keep the shrub well lubricated and moisturized yet it is non occlusive. The non-occlusive property is related to its porosity. In the shrubs and trees it is derived from, the porosity allows for evaporative exchange of vapors thus cooling the jojoba tree in its hot native climate. [0013] The natural jojoba is 97% wax esters with few impurities. There are no resins, tars, or alkaloids and only a trace amount of saturated wax, alcohols, fatty acids, and hydrocarbons. Jojoba wax is non toxic and biodegradable and is pasteurized to kill microorganisms (National Research Council. 1985. Jojoba: New Crop for Arid Lands, New Material for Industry . National Academy Press, Washington, D.C.). The liquid wax commercially available does not include those solid components of the seed which have toxic effects; the glycosides simmondsin and simmondsin-2-ferulate. [0014] The wax esters are comprised of alcohols esterified with long chain fatty acids with a total of 38 to 44 carbon atoms. The fatty alcohols are predominantly 20 and 22 carbon atoms with one double bond. Its fatty acids are mostly 20:1 (70%), with some 22:1 (20%) and the remainder 18:1 (10%). All double bonds have a cis configuration and are spaced widely apart equidistant from the ester linkage creating an especially stable molecule resistant to oxidation. The cis double bond configuration is also felt to give the jojoba its porosity. [0015] Oils having similar properties to jojoba wax, or its components, may be substituted for the jojoba oil. Jojoba has been identified as chemically similar to sperm whale oil, an unsaturated wax. Sperm whales were sought for their oil throughout the 20 th century since it is considered a fine lubricant oil. Due to the near extinction of the sperm whale, alternative lubricants were sought. Although jojoba was known to similar to sperm whale oil since the 1930's, the advanced study of its chemistry was not available until the 1970's and 1980's due to advances in technology. Both are fine lubricants as they are stable at high temperatures and high pressures. However, jojoba is now felt to be a superior lubricant to sperm whale oil (National Academy of Sciences. 1975. Products from Jojoba: A Promising New Crop for Arid Lands . National Research Council Washington D.C.). Another similar oil to sperm whale oil is from the fish Orange Roughy. This oil and other fish oils may be used in place of or in combination with the jojoba. [0016] Jojoba wax is approved by the Food and Drug Administration (“FDA”) for use in cosmetics and other formulations for application around the eyes, although not for direct application to the eye. Jojoba wax is used extensively in the cosmetic industry in up to at least a 10% in water emulsion, in eye makeup remover, as well as for skin and hair products. It is also used in therapeutic massage. Primary eye irritation studies have been performed in rabbits using undiluted refined jojoba liquid wax. Slight irritation was noted which resolved within 24 hours. A 20% natural jojoba wax dropped in rabbit eyes was concluded a nonirritant (Final Report on the Safety Assessment of Jojoba Oil and Jojoba Wax, J Amer College Toxicology, 11 (1), 1992, 57-74.) The Environmental Protection Agency (EPA) in the Federal Register 40 CFR Part 180, 1995 acknowledged the wide distribution of Jojoba in commerce and availability to the general public throughout the United States without any evidence of significant adverse effects to humans or the environment. The Cosmetic Ingredient Review lists Jojoba as safe to use. [0017] Jojoba wax has also been shown to help break down sebum in plugged up sebaceous pores of the skin. It may prove to also be able to break down and unplug the modified sebaceous (meibomian) glands of the lid when applied as a drop or an ointment or other topical therapy. [0018] Jojoba wax also has intrinsic antimicrobial properties which include activity against envelope viruses, mold, fungus and bacteria. U.S. Pat. Nos. 4,585,656 and 6,559,182 describe the efficacy of treating envelope viruses with jojoba wax esters. In vitro experiments in the literature showed jojoba has an intense inhibiting effect on Mycobacterium tubercle bacilli. It may be useful as a prophylactic as well as therapeutic agent to prevent and treat ocular or periocular infections. It may be used as therapy for infection of any part of the eye or adnexal structure. [0019] Other jojoba derivatives which may be incorporated into an ophthalmic delivery system include jojoba esters, jojoba alcohols, and the hydrogenated jojoba solid wax. Jojoba esters are the result of an inter-esterification of various ratios of jojoba liquid wax and hydrogenated jojoba solid wax. The physical consistency ranges from liquid to semi-solid paste or creams. Jojoba solid wax is derived from the hydrogenation and complete reduction of the unsaturated wax esters. It is a hard crystalline wax comparable to beeswax with a melting point of 69° C. and can be prepared in a wax in water emulsion. This wax-in-water emulsion emulsifies easily and may also be used in an ophthalmic preparation. Possible emulsifying agents for the ophthalmic preparation include stearic acid (4%) and triethanolamine (2%). Jojoba alcohols are generated from a sodium reduction of jojoba liquid wax and hydrogenated jojoba solid wax with subsequent additional refinement. Jojobutter-51 is an isomorphous mixture of jojoba liquid wax, partially isomerized jojoba liquid wax and hydrogenated jojoba solid wax (J Amer College Toxicology, 11 (1), 1992). Sulfurization of jojoba results in enhanced lubricant properties which is further enhanced with phosphorus, bromine or chlorine. (Wisniak J The Chemistry and Technology of Jojoba Oil, Am Oil Chemist Society, 1987) and may optimize the lubrication of an ophthalmic tear supplement. [0020] B. Artificial Tears [0021] The wax is mixed with an aqueous solution for application to the eye. Typically the aqueous solution may be sterile water or hypotonic or isotonic saline and will contain buffer to physiological pH, in the range of about 7-7.5. It may also be cell culture media such as Dulbecco's Media (DMEM). It will also contain a surfactant/lubricant/demulcent such as polysorbate 80. Ancillary ingredients to establish the desired tonicity with tears may include electrolytes. Preservatives such as sodium bisulfite, ascorbic acid, alpha-tocopherol, benzalkonium chloride, ethylenediaminetetraacetic acid (EDTA) and chlorhexidine can be used as well as chlorbutanol, sodium perborate and stabilized oxy-chloro complex. Other preservatives include polyquad, polyhexamethyl biguanide, chlorhexidine, propylparabens and methylparabens and others. Other additives may include humectants such as propylene glycol and sorbitol. Representative pH buffers include sodium borate or mono and di-sodium phosphate or other phosphate, carbonate or acetate salts. [0022] The jojoba wax concentration in an aqueous carrier will typically be between 0.001% to 50%. The jojoba in aqueous emulsion may include a second emollient such as mineral or light mineral oil. Other emollients may be used in the emulsion such as white petrolatum, white ointment, paraffin, and beeswax or other wax. These emollients may be used to increase the viscosity of the emulsion. The ratio of jojoba to the second emollient is from greater than 1:5 to 500:1. Jojoba is also available as a clear, water colored refined liquid wax which may also be used as a second emollient in the above ratios. [0023] The formulation may further include a sterol, hydroxycarotenoid or Vitamin A optionally esterified with fatty acids of various chain lengths between C10 and C30. The formulation may also include polar lipids including glycolipids, sphingolipids and/or phospholipids including phosphatidylinositol, phosphatidylethanolamine, sphingomyelin, phosphatidylglycerol, and diphosphatidylglycerol, Triglycerides may also be included. [0024] Suitable lubricants used with the wax ester in a concentration between 0.01% to 20% include cellulose derivatives. Examples of cellulose derivatives include carboxymethylcellulose sodium 0.2 to 2.5%, hydroxyethyl cellulose 0.2% to 2.5%, hydroxypropyl methylcellulose 0.2% to 2.5%, and methylcellulose 0.2% to 2.5%. Other examples of lubricants include Dextran 70, (0.1%), gelatin, 0.01%, glycerin, 0.2 to 1%, polyethylene glycol 300, 0.2 to 1%, polyethylene glycol 400, 0.2 to 1%, polysorbate 80, 0.2 to 5%, propylene glycol, 0.2 to 5%, polyvinyl alcohol 0.1 to 5%, and povidone 0.1 to 5%. These lubricants can increase viscosity of the artificial tear as a mucomimetic and may be added to the formulation. The formulation can be thought of as a tear replacement therapy. Additional mucomimetics include carbomer and hyaluronic acid. [0025] Ophthalmic astringents may also be included. One example is zinc sulfate, 0.25%. A hypertonicity agent may be used such as sodium chloride 2 to 5%. An ophthalmic vasoconstrictor may be used including ephedrine hydrochloride, 0.123%, naphazoline hydrochloride, 0.01 to 0.03%, phenylephrine hydrochloride, 0.08 to 0.2% and tetrahydrozoline hydrochloride, 0.01 to 0.05%. [0026] The eye drop can also include a further emulsifier. [0027] Proteins normally found in the tear may be included in the formulation to further increase stability. These may include amongst others, prealbumin, albumin, lyzozyme, lactoferrin, beta lactoglobulin, IgA as well as lipocalins. [0028] Suitable electrolytes include sodium chloride, potassium chloride, sodium phosphate, potassium phosphate, sodium and potassium sulfates and sodium and potassium bicarbonates. Suitable non electrolytes such as glycerin and sugars such as urea, sorbitol, glucose and sucrose can also be added. [0029] In another embodiment, the jojoba wax, up to 70%, is formulated as an ointment emollient. A suitable carrier includes a mixture of mineral oil and petrolatum in a ratio of about 70% to 30%, paraffin up to 5%, white ointment up to 100%, white petrolatum up to 100%, petrolatum up to 100%, white wax up to 5%, yellow wax up to 5%, colorless jojoba wax up to 50%, lanolin 1 to 10% and anhydrous lanolin 1 to 10%. [0030] The formulation can also be used as a platform to deliver other active agents. Other active ingredients that could be used include anti-glaucoma therapies, antibiotics, antimicrobial peptides, antivirals, antiparasitics, antifungals, antiinflammatories, antihistamines, anti-allergy therapies, hormones such as androgens and others, vitamins, growth factors, cytokines, mucins, surface stimulating drugs, immunomodulators, immune response modifiers, cytokine modifying agents, immunosuppressive agents, antineoplastic agents, eyelash growth stimulators and other medicaments. [0031] Additional classes of additives include lubricants, preservatives, stabilizers, wetting agents, emulsifiers, buffers, and different salts to alter osmotic pressure, as well as solubilizing agents, dispersants, and detergents. [0032] The wax can also be added to artificial tears obtained over the counter (“OTC”). Examples include VISINE™ marketed by Pfizer, REFRESH TEARS™ product line marketed by Allergan, SYSTANE™ marketed by Alcon, GENTEAL™ marketed by Novartis, and OCUCOAT™ marketed by Bausch and Lomb. [0000] II. Methods of Use [0033] In the preferred embodiment, the formulation is administered once to four times a day directly to the eyes of the individual in need thereof. The frequency will vary depending on the severity of symptoms. The formulation may be applied as a drop in the form of an emulsion or suspension, liposome, lotion, ointment, cream, gel, salve or powder and sustained or slow release, as well as eyelid lotion. It may also be used as an eye wash or rinse to irrigate the eye. The formulation may also be applied in a sprayable form. This lubricant will be extremely helpful in eradicating the symptoms of dry eye in the various settings it occurs. This includes the most common settings of age related so called dry eye syndrome, computer related dry eye, dry eye after Lasik, and dry eye associated with reading, driving or watching a movie or television. Patients with contact lens intolerance or who use an ocular prosthesis will also greatly benefit from the enhanced lubrication. Other examples include patients with a history of eye surgery and dry eye. This includes cataract surgery, cornea surgery and cornea transplants. Patients with neurologic disorders such as Bell's Palsy or other neuroparalytic as well as neurotrophic disease will also benefit. Lagophthalmous characterized by an exposed ocular surface which can occur while sleeping or even during waking hours will be improved with the ointment, and/or gel form of this lubricant. Devastating although rare mucous membrane blistering diseases as Stevens Johnson Syndrome are also associated with both a watery and lipid dry eye due to fibrotic changes associated with glandular tissues. The jojoba formulation should be especially helpful to replace lipid and aqueous deficiencies and help relieve suffering to comfort an otherwise extremely painful eye. [0034] Other types of dry eye characterized by plugged, inflamed and/or dysfunctional sebaceous glands of the lid known as meibomian gland dysfunction should also be mproved with use of this formulation applied to the eyelids. [0035] Patients with eye infections of the lid, conjunctiva, cornea and tear apparatus and lacrimal gland should also benefit with application of this formulation in one or more forms to the eyelids, conjunctiva, and cornea as well as tear film and other adnexal structures including lacrimal gland, and tear outflow system including puncta, canaliculi, and lacrimal sac. [0036] In preliminary studies on skin, Jojoba wax has been shown to relieve pain and reduce swelling from superficial thermal and chemical burns. There may also be a therapeutic effect on ocular burns. [0037] The formulation can also be used to prevent, treat or alleviate the symptoms of envelope viruses including herpes simplex keratitis, and varicella zoster keratitis which causes chicken pox and shingles. Other viral infections of the eye that may be treated include human herpes virus 8 (HSV 8), Kaposi sarcoma as well as Epstein-Barr virus, cytomegalic inclusion virus (CMV) and Human Immunodeficiency Virus (HIV). [0038] Non-ocular uses of the formulation include use to treat or prevent accumulation of ear canal wax, treatment of vaginal dryness or other symptoms of perimenopausal dryness, moisturizing dry nasal mucosa or where the patient has a sinus condition, including inflammation or infection. EXAMPLES [0039] In a preferred embodiment, the formulation contains 0.5-5% jojoba wax, most preferably 0.5 to 2% jojoba, 1% polysorbate 80 in a aqueous buffered saline based liquid wax emulsion. [0040] The 2% jojoba formulation was administered to a total of 16 volunteer individuals with different types of irritated eyes. The drop was reported to be extremely comfortable for all individuals without causing visual blur. [0041] Three volunteers had painful dry eye after Lasik. None of the conventional therapies had helped them thus far. For PC, AS, and KA, relief was immediate and lasted about 8-10 hours. [0042] For TB who said his irritation was allergic in nature, none of the presently available OTC drops had helped relieve his severe symptoms. One drop of the jojoba wax formulation applied to each eye relieved all symptoms for the entire day. [0043] For JR who said his eyes are always irritated in the morning, get red and stay red for hours and who has yet to find a comfortable and effective OTC eyedrop, one drop of the jojoba wax formulation applied to each eye eliminated the red eyes and comforted his eyes for the entire day. [0044] Two individuals (RD and AM) used the jojoba wax formulation in the setting of soft contact lens wear and found its comforting properties to be truly unique. They enjoyed instant relief of eye discomfort which lasted the entire day. [0045] One individual (ST) used the jojoba wax formulation in the setting of rigid contact lens wear and also had instant relief of eye irritation lasting the whole day. [0046] In summary, the volunteers were extremely pleased by the comfort, immediate and lasting relief of the jojoba wax formulation. [0047] Three additional patients (HK, LF, and IM) with cornea erosions were placed on this formulation using 1% jojoba wax. The drop was used four times per day. The drop was well tolerated, and was found to be soothing and very comfortable. Within one to two weeks the erosions were markedly and almost completely resolved. [0048] A formulation consisting of 5% jojoba in aqueous with additional 0.05% white petrolatum USP was created using a heating stir plate and was placed in the right eye of 6 volunteers. For MB, MH, DN, HL, AM, and SM the drop was well tolerated, comfortable and felt thicker than 5% jojoba in aqueous emulsion without the petrolatum. [0049] The formulation was also evaluated on two volunteers using lipid tear interferometry. A drop of the formulation was placed in one eye and an artificial aqueous tear in the other. The interferometry pattern showed thick blue waves of liquid wax quickly mixing with the volunteer's own lipid tear within seconds. The resultant lipid tear pattern showed a healthy enhanced film at least three hours later. Breakup times were also prolonged therapeutically in the eye receiving the emulsion compared to the fellow eye. [0050] Modifications and variations of the present invention will be obvious to those skilled in the art from the foregoing detailed description and are intended to come within the scope of the following claims. All references herein are expressly incorporated by reference.

A formulation has been developed for treatment of the symptoms of dry eye which incorporates the natural product jojoba wax, or components thereof, to enhance the spreading of the artificial tear and eyedrop as well as stabilize the eyedrop. The improved performance of the jojoba wax supplemented tear relieves irritation and discomfort as well as sharpens the blurred vision.

REFERENCE TO RELATED APPLICATIONS This application claims priority to provisional application Serial No. 60/336,002, filed Nov. 1, 2001, entitled “Devices, Methods and Assemblies for Intervertebral Disc Repair and Regeneration”, and provisional application Serial No. 60/336,332, entitled “Pretreatment of Cartilaginous Endplates Prior to Treatment of the Intervertebral Disc with an Injectable Biomaterial”, filed on Nov. 2, 2001, and the disclosure of which are both incorporated herein by reference. BACKGROUND OF THE INVENTION The present invention relates generally to the treatment of spinal diseases and injuries, and more specifically to the restoration of the spinal disc following surgical treatment. The invention contemplates devices and methods for restoring the normal intervertebral disc space height and for facilitating the introduction of biomaterials for use in the repair and restoration of the intervertebral disc. The intervertebral disc is divided into two distinct regions: the nucleus pulposus and the annulus fibrosus. The nucleus lies at the center of the disc and is surrounded and contained by the annulus. The annulus contains collagen fibers that form concentric lamellae that surround the nucleus and insert into the endplates of the adjacent vertebral bodies to form a reinforced structure. Cartilaginous endplates are located at the interface between the disc and the adjacent vertebral bodies. The intervertebral disc is the largest avascular structure in the body. The disc receives nutrients and expels waste by diffusion through the adjacent vascularized endplates. The hygroscopic nature of the proteoglycan matrix of the nucleus operates to generate high intra-nuclear pressure. As the water content in the disc increases, the intra-nuclear pressure increases and the nucleus swells to increase the height of the disc. This swelling places the fibers of the annulus in tension. A normal disc has a height of about 10–15 mm. There are many causes of disruption or degeneration of the intervertebral disc that can be generally categorized as mechanical, genetic and biochemical. Mechanical damage includes herniation in which a portion of the nucleus pulposus projects through a fissure or tear in the annulus fibrosus. Genetic and biochemical causes can result in changes in the extracellular matrix pattern of the disc and a decrease in biosynthesis of extracellular matrix components by the cells of the disc. Degeneration is a progressive process that usually begins with a decrease in the ability of the extracellular matrix in the central nucleus pulposus to bind water due to reduced proteoglycan content. With a loss of water content, the nucleus becomes desiccated resulting in a decrease in internal disc hydraulic pressure, and ultimately to a loss of disc height. This loss of disc height can cause the annulus to buckle with non-tensile loading and the annular lamellae to delaminate, resulting in annular fissures. Herniation may then occur as rupture leads to protrusion of the nucleus. Proper disc height is necessary to ensure proper functionality of the intervertebral disc and spinal column. The disc serves several functions, although its primary function is to facilitate mobility of the spine. In addition, the disc provides for load bearing, load transfer and shock absorption between vertebral levels. The weight of the person generates a compressive load on the discs, but this load is not uniform during typical bending movements. During forward flexion, the posterior annular fibers are stretched while the anterior fibers are compressed. In addition, a translocation of the nucleus occurs as the center of gravity of the nucleus shifts away from the center and towards the extended side. Changes in disc height can have both local and global effects. On the local (or cellular, level) decreased disc height results in increased pressure in the nucleus, which can lead to a decrease in cell matrix synthesis and an increase in cell necrosis and apoptosis. In addition, increases in intra-discal pressure create an unfavorable environment for fluid transfer into the disc, which can cause a further decrease in disc height. Decreased disc height also results in significant changes in the global mechanical stability of the spine. With decreasing height of the disc, the facet joints bear increasing loads and may undergo hypertrophy and degeneration, and may even act as a source of pain over time. Decreased stiffness of the spinal column and increased range of motion resulting from loss of disc height can lead to further instability of the spine, as well as back pain. The outer annulus fibrosus is designed to provide stability under tensile loading, and a well-hydrated nucleus maintains sufficient disc height to keep the annulus fibers properly tensioned. With decreases in disc height, the annular fibers are no longer able to provide the same degree of stability, resulting in abnormal joint motion. This excessive motion can manifest itself in abnormal muscle, ligament and tendon loading, which can ultimately be a source of back pain. Radicular pain may result from a decrease in foraminal volume caused by decreased disc height. Specifically, as disc height decreases, the volume of the foraminal canal, through which the spinal nerve roots pass, decreases. This decrease may lead to spinal nerve impingement, with associated radiating pain and dysfunction Finally, adjacent segment loading increases as the disc height decreases at a given level. The discs that must bear additional loading are now susceptible to accelerated degeneration and compromise, which may eventually propagate along the destabilized spinal column. In spite of all of these detriments that accompany decreases in disc height, where the change in disc height is gradual many of the ill effects may be “tolerable” to the spine and may allow time for the spinal system to adapt to the gradual changes. However, the sudden decrease in disc volume caused by the surgical removal of the disc or disc nucleus may heighten the local and global problems noted above. Many disc defects are treated through a surgical procedure, such as a discectomy in which the nucleus pulposus material is removed. During a total discectomy, a substantial amount (and usually all) of the volume of the nucleus pulposus is removed and immediate loss of disc height and volume can result. Even with a partial discectomy, loss of disc height can ensue. Discectomy alone is the most common spinal surgical treatment, frequently used to treat radicular pain resulting from nerve impingement by disc bulge or disc fragments contacting the spinal neural structures. In another common spinal procedure, the discectomy may be followed by an implant procedure in which a prosthesis is introduced into the cavity left in the disc space when the nucleus material is removed. Thus far, the most prominent prosthesis is a mechanical device or a “cage” that is sized to restore the proper disc height and is configured for fixation between adjacent vertebrae. These mechanical solutions take on a variety of forms, including solid kidney-shaped implants, hollow blocks filled with bone growth material, push-in implants and threaded cylindrical cages. In more recent years, injectable biomaterials have been more widely considered as an augment to a discectomy. As early as 1962, Alf Nachemson suggested the injection of room temperature vulcanizing silicone into a degenerated disc using an ordinary syringe. In 1974, Lemaire and others reported on the clinical experience of Schulman with an in situ polymerizable disc prosthesis. Since then, many injectable biomaterials or scaffolds have been developed as a substitute for the disc nucleus pulposus, such as hyaluronic acid, fibrin glue, alginate, elastin-like polypeptides, collagen type I gel and others. A number of patents have issued concerning various injectable biomaterials including: cross-linkable silk elastin copolymer discussed in U.S. Pat. No. 6,423,333 (Stedronsky et al.); U.S. Pat. No. 6,380,154 (Capello et al.); U.S. Pat. No. 6,355,776 (Ferrari et al.); U.S. Pat. No. 6,258,872 (Stedronsky et al.); U.S. Pat. No. 6,184,348 (Ferrari et al.); U.S. Pat. No. 6,140,072 (Ferrari et al.); U.S. Pat. No. 6,033,654 (Stedronsky et al.); U.S. Pat. No. 6,018,030 (Ferrari et al.); U.S. Pat. No. 6,015,474 (Stedronsky); U.S. Pat. No. 5,830,713 (Ferrari et al.); U.S. Pat. No. 5,817,303 (Stedronsky et al.); U.S. Pat. No. 5,808,012 (Donofrio et al.); U.S. Pat. No. 5,773,577 (Capello); U.S. Pat. No. 5,773,249 (Capello et al.); U.S. Pat. No. 5,770,697 (Ferrari et al.); U.S. Pat. No. 5,760,004 (Stedronsky); U.S. Pat. No. 5,723,588 (Donofrio); U.S. Pat. No. 5,641,648 (Ferrari); and U.S. Pat. No. 5,235,041 (Capello et al.); protein hydrogel described in U.S. Pat. No. 5,318,524 (Morse et al.); U.S. Pat. No. 5,259,971 (Morse et al.): U.S. Pat. No. 5,219,328 (Morse et al.); and U.S. Pat. No. 5,030,215; polyurethane-filled balloons discussed in No. 60/004,710 (Felt et al.); U.S. Pat. No. 6,306,177 (Felt et al.); U.S. Pat. No. 6,248,131 (Felt et al.) and U.S. Pat. No. 6,224,630 (Bao et al.); collagen-PEG set forth in U.S. Pat. No. 6,428,978 (Olsen et al.); U.S. Pat. No. 6,413,742 (Olsen et al.); U.S. Pat. No. 6,323,278 (Rhee et al.); U.S. Pat. No. 6,312,725 (Wallace et al.); U.S. Pat. No. 6,277,394 (Sierra); U.S. Pat. No. 6,166,130 (Rhee et al.); U.S. Pat. No. 6,165,489 (Berg et al.); U.S. Pat. No. 6,123,687 (Simonyi et al.); U.S. Pat. No. 6,111,165 (Berg); U.S. Pat. No. 6,110,484 (Sierra); U.S. Pat. No. 6,096,309 (Prior et al.); U.S. Pat. No. 6,051,648 (Rhee et al.); U.S. Pat. No. 5,997,811 (Esposito et al.); U.S. Pat. No. 5,962,648 (Berg); U.S. Pat. No. 5,936,035 (Rhee et al.); and U.S. Pat. No. 5,874,500 (Rhee et al.); chitosan in U.S. Pat. No. 6,344,488 to Chenite et al.; a variety of polymers discussed in U.S. Pat. No. 6,187,048 (Milner et al.; recombinant biomaterials in No. 60/038,150 (Urry); U.S. Pat. No. 6,004,782 (Daniell et al.); U.S. Pat. No. 5,064,430 (Urry); U.S. Pat. No. 4,898,962 (Urry); U.S. Pat. No. 4,870,055 (Urry); U.S. Pat. No. 4,783,523 (Urry et al.); U.S. Pat. No. 4,783,523 (Urry et al.); U.S. Pat. No. 4,589,882 (Urry); U.S. Pat. No. 4,500,700 (Urry); U.S. Pat. No. 4,474,851 (Urry); U.S. Pat. No. 4,187,852 (Urry et al.); and U.S. Pat. No. 4,132,746 (Urry et al.); and annulus repair materials described in U.S. Pat. No. 6,428,576 to Haldimann. These references disclose biomaterials or injectable scaffolds that have one or more properties that are important to disc replacement, including strong mechanical strength, promotion of tissue formation, biodegradability, biocompatibility, sterilizability, minimal curing or setting time, optimum curing temperature, and low viscosity for easy introduction into the disc space. The scaffold must exhibit the necessary mechanical properties as well as provide physical support. It is also important that the scaffold be able to withstand the large number of loading cycles experienced by the spine. The biocompatibility of the material is of utmost importance. Neither the initial material nor any of its degradation products should elicit an unresolved immune or toxicological response, demonstrate immunogenicity, or express cytoxicity. Generally, the above-mentioned biomaterials are injected as viscous fluids and then cured in situ. Curing methods include thermosensitive cross-linking, photopolymerization, or the addition of a solidifying or cross-linking agent. The setting time of the material is important—it should be long enough to allow for accurate placement of the biomaterial during the procedure yet should be short enough so as not to prolong the length of the surgical procedure. If the material experiences a temperature change while hardening, the increase in temperature should be small and the heat generated should not damage the surrounding tissue. The viscosity or fluidity of the material should balance the need for the substance to remain at the site of its introduction into the disc, with the ability of the surgeon to manipulate its placement, and with the need to assure complete filling of the intradiscal space or voids. Regardless of the injectable scaffold material used, it is critical that the completed procedure restore the disc height. It is thus important that the proper disc height be maintained while the biomaterial is being introduced into the intradiscal space. Ideally, the disc height will be restored to levels equivalent to the heights of the adjacent discs and representative of a normal spinal disc height for the particular patient. However, if disc height is not re-established prior to introduction of the scaffold material, it will become impossible to replace the lost disc volume and at least restore the disc height to what it was prior to the discectomy. Failure to hold a proper disc height as the biomaterial is introduced and cured in situ can eventually lead to a collapse of the disc space. This phenomenon is illustrated by a comparison of a proper intervertebral disc height in FIG. 1 a versus a reduced disc height in FIG. 1 b . The reduced disc height of FIG. 1 b will ordinarily follow a substantially complete discectomy, unless the adjacent vertebrae are distracted. The patient can be placed in certain positions that tend to open the disc space, particularly at the posterior side of the disc D. However, it has been found that even with hyper-flexion of the spine the intervertebral space does not approach its proper volume, and consequently the intervertebral height does not approach the proper disc height of FIG. 1 a. Prior procedures for the implantation of a curable disc prosthesis have relied upon the physical positioning of the patient or upon pressurized injection of the biomaterial to obtain some degree of distraction. However, these prior approaches do not achieve repeatable restoration of proper anatomical disc height, either during the surgical procedure or afterwards. Consequently, there remains a need for a method and system that provides a high degree of assurance that a proper disc height will be established and maintained when the intervertebral disc is replaced or augmented by an injectable biomaterial. SUMMARY OF THE INVENTION In order to address the unresolved needs of prior spinal procedures, the present invention contemplates a method for injecting a fluent material into a disc space. The method includes the steps of creating a portal in the annulus pulposus in communication with the intradiscal space and impacting a cannulated distractor into the portal. In accordance with one feature of the invention, the distractor is configured to distract the vertebrae adjacent the intradiscal space and to establish a disc space height between the adjacent vertebrae. The method includes the further step of introducing the fluent material into the intradiscal space through a lumen of the cannulated distractor while the distractor maintains the established disc space height. In certain embodiments, the inventive method includes the step of performing a discectomy after the portal is created, in which the discectomy forms a cavity within the intradiscal space. In this embodiment, the step of impacting a cannulated distractor includes positioning the distractor so that the lumen is in communication with the cavity, and the step of introducing the fluid includes introducing the fluid into the cavity. The discectomy can be a total discectomy in which substantially all of the nucleus pulposus is removed from the disc space. In a further feature of the invention, the fluent material is a curable biomaterial that is particularly suited as a disc replacement or augmentation material. In this case, the step of introducing the fluent material can include maintaining the distractor in its impacted position until the biomaterial cures in situ. In other words, the cannulated distractor maintains the adjacent vertebrae in their distracted position until the biomaterial has set. In this way, the proper disc height can be maintained and retained once the biomaterial has set and the distractor removed. In certain embodiments, the fluent material can be introduced into the disc cavity under pressure. In another feature of the invention that is particularly useful where the fluent material is under pressure, the cannulated distractor is configured to seal the portal when the distractor is impacted therein. In some embodiments, the distractor has a portion sized to substantially block or seal the annular portal. In other embodiments, the distractor includes a sealing feature that bears against the adjacent vertebrae and/or the annulus fibrosus material surrounding the portal. The sealing feature can be integral with the cannulated distractor or can include a separate component, such as a seal ring, mounted on the distractor. In still another aspect of the invention, and again one that is particularly suited where the fluent material is under pressure, a vent is provided in the cannulated distractor. Thus, the fluent material can be introduced into the intradiscal space until the fluent material seeps from the vent. Thus, the vent can provide an immediate indication that the disc cavity is full. In some embodiments of the invention, the cannulated distractor is engaged to a fluid injector apparatus. This apparatus can be in a variety of forms, including a pump, a syringe and a gravity feed system. In other embodiments, the step of introducing the fluent material includes extending an tube through the lumen in the cannulated distractor, with the tube fluidly connected to a source of the fluent material. The tube can be manipulated through the distractor lumen to direct the fluent material to specific locations within the disc cavity. For instance, the tube can be moved through a seeping motion so that the fluent material is completely dispersed throughout the disc space. At the same time, the tube can be gradually withdrawn from the distractor lumen as the fluent material nears the lumen opening. In a preferred embodiment, a seal is provided between the tube and the lumen. A vent can then be provided separate from the lumen so that the fluent material can seep from the vent to indicate that the cavity is full. In another embodiment of the invention, a device for injecting a fluent material into a disc space comprises a distraction member having opposite surfaces configured to distract adjacent vertebrae to the disc space. The distraction member has a proximal end and a distal end portion, in which at least the distal end portion configured to be disposed within the disc space. The distraction member further defines a fluid passageway between the proximal end and the distal end portion, the passageway having an opening at the proximal end and at the distal end portion. In some embodiments, the distraction member can include a fitting associated with the proximal end of the distraction member for fluidly connecting the distraction member to a source of the fluent material. In accordance with another aspect of the invention, the device further comprises an elongated cannula defining a lumen therethrough. The cannula can have a first fitting at one end thereof configured for fluid tight connection to the fitting of the distraction member, and a second fitting at an opposite end thereof configured for fluid connection to a source of the fluent material. In specific embodiments, the distraction member is integral with the cannula and the second fitting is the fitting associated with the proximal end of the distraction member. In other embodiments, the distraction member is removable from the cannula. In a preferred embodiment, at least the distal end portion of the distraction member is bullet-shaped. In alternative embodiments, the distal end portion of is wedge-shaped with opposite substantially flat sides, cruciate-shaped, I-beam shaped and C-shaped. The fluid passageway of the distraction member includes a central lumen with a number of openings communicating therewith. The openings can be arranged in the variously shaped distal end portion to direct the fluent material to appropriate locations within the disc cavity. The distraction member can also define a vent opening separate from the fluid passageway. In certain embodiments, the fluid passageway can be in the form of interconnected interstices throughout the distraction member material. In the preferred embodiment, the distraction member is formed of a biocompatible material, such as stainless steel or titanium. In alternative embodiments, other biocompatible materials can be used, such as polymeric materials and even bioresorbable materials. In accordance with one aspect, the distraction member is configured to be removed from the disc space once the fluent material has been introduced into the disc cavity, and has cured, if necessary. In other aspects, the distraction member is configured to remain within the disc space, most preferably if the member is formed of a bioresorbable material. The distraction member can include a sealing element associated with a proximal portion of the distal end portion, wherein the sealing element is configured to provide a substantially fluid-tight seal within the disc space. The sealing element can include a number of seal rings disposed on the distal end portion. The seal rings can be integral with the distal end portion or can be elastomeric rings mounted on the distal end portion, for example. It is one object of the invention to provide a system and device for maintaining and enforcing a proper intervertebral spacing or disc height when a disc prosthesis is introduced into a cavity within the intradiscal space. Another object is achieved by features of the invention that allow introduction of a fluent material into the disc space while maintaining the adjacent vertebrae distracted and the disc height intact. Other objects and certain benefits of the invention can be discerned from the following written description and accompanying figures. DESCRIPTION OF THE FIGURES FIGS. 1 a – 1 b are lateral views of a disc and adjacent vertebrae showing a proper intervertebral disc height ( FIG. 1 a ) and a reduced disc height ( FIG. 1 b ) following a substantially complete discectomy. FIG. 2 is a lateral view a disc and adjacent vertebrae with a guide wire placed in accordance with one aspect of the present invention. FIG. 3 is a sagittal view of the disc space shown in FIG. 2 with a trephine forming a portal in the annulus fibrosus of the disc. FIG. 4 is a sagittal view of the disc space shown in FIG. 3 with a tissue extraction device positioned within the nucleus pulposus of the disc. FIG. 5 is a sagittal view of the disc space shown in FIGS. 2–4 with a cannulated distractor in accordance with one embodiment of the present invention. FIG. 6 is a side view of a cannulated distractor in accordance with one embodiment of the present invention. FIG. 7 is a lateral view of the disc space shown in FIGS. 2–5 with the cannulated distractor of FIG. 6 positioned within the disc space. FIG. 8 is a perspective view of a distraction tip forming part of the cannulated distractor shown in FIGS. 6 and 7 . FIG. 9 is a perspective view of a distraction tip according an alternative embodiment of the invention. FIG. 10 is a side view of an injector apparatus for use in one embodiment of the invention. FIG. 11 is lateral view of a disc space with a cannulated distractor in accordance with a further embodiment of the invention. FIG. 12 is a cross-sectional view of a cruciate distraction tip according to one embodiment of the cannulated distractor of the present invention. FIG. 13 is a cross-sectional view of an I-beam shaped distraction tip according to another embodiment of the cannulated distractor of the present invention. FIG. 14 is a cross-sectional view of a C-shaped distraction tip according to a further embodiment of the cannulated distractor of the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and described in the following written specification. It is understood that no limitation to the scope of the invention is thereby intended. It is further understood that the present invention includes any alterations and modifications to the illustrated embodiments and includes further applications of the principles of the invention as would normally occur to one skilled in the art to which this invention pertains. The present invention contemplates a procedure and device that is implemented following removal of a portion or substantially all of the natural nucleus pulposus of an intervertebral disc. One important purpose of the invention is to maintain the proper disc height during the introduction of a biomaterial that is intended to replace the removed nuclear material. Removal of disc material can be accomplished chemically, such as by the use of Chymopapain. However, the more common approach is by discectomy, which can be conducted as an open surgical procedure, via microscope-assisted visualization, or through percutaneous access. A typical percutaneous discectomy procedure is illustrated in FIGS. 2–4 . In the first step, a guide wire G is directed into an affected disc D between two vertebrae, such as the L 2 and L 3 lumbar vertebrae. As shown in FIG. 3 , the guide wire G penetrates the annulus fibrosus A and the nucleus pulposus N, and it preferably anchored at opposite sides of the annulus A. The guide wire G can be positioned and placed under indirect vision, such as fluoroscopy, or stereotactically, or using other known procedures for properly orienting the guide wire within the spinal disc D. The procedure shown in the figures utilizes a posterior approach, which is preferable for implementation of the present invention. Of course, other approaches may be utilized for the discectomy in accordance with known surgical procedures. In addition, the access location may be dictated by the location of a fissure or herniation of the disc. A trephine T is advanced over the guide wire and driven through the annulus A, thereby forming a portal into the disc nucleus. As shown in FIG. 4 , a tissue removal device R can be advanced through the trephine T or through a working channel cannula aligned with the disc portal. The device R can then be used to remove all or part of the nucleus N of the disc D. As depicted in dashed lines in FIG. 4 , a second trephine T′ can be used to create a second annular portal to facilitate complete removal of the nucleus pulposus of the disc. The tissue removal device R can be of a variety of types, such as a rongeur, tissue morcellator, rotary and/or reciprocating vacuum-assisted cutter, and even a chemical introducer to direct a chemical such as Chymopapain into the nuclear space. Removal of the nucleus leaves a cavity C (see FIG. 5 ) surrounded by the substantially intact annulus A The present invention contemplates the introduction of a biomaterial into the disc cavity C that is capable or restoring disc height and preferably substantially normal disc function. For instance, any of the biomaterials discussed above can fill the newly formed cavity. In accordance with the preferred embodiment, the biomaterial is a fluid with an appropriate flowability and/or viscosity. In particular, the biomaterial must have sufficient flowability to permit relatively easy introduction into the disc cavity C, but with sufficient viscosity to hold its shape within the disc. Since the material being used to fill the disc cavity C is a fluid, the present invention provides means for holding a proper disc height as the material flows into the cavity, to thereby ensure that the cavity is filled—i.e., that the volume of implant biomaterial is the same as the volume of nucleus pulposus removed in the discectomy. Moreover, the methods and devices of the invention provide a means for maintaining the cavity volume as the biomaterial transforms to its solid state. Thus, in accordance with one embodiment of the invention, a cannulated distractor 10 is provided as shown in FIGS. 5–8 . The distractor 10 includes a distal end 12 that extends into the disc cavity C and a proximal end 14 that is configured to engage a device for injecting the biomaterial into the disc space. The distractor 10 includes a cannula 11 that terminates in a distraction tip 18 at the distal end of the device. A lumen 16 is defined along the entire length of the device from the proximal end 14 to the and through the distraction tip 18 . The distraction tip 18 is sized to extend through the portal formed in the disc annulus A (see FIG. 3 ). The distractor 10 can include a shoulder 20 proximal to the distraction tip 18 , in which the shoulder is sized to prevent passage through the annular portal. The shoulder 20 can operate to limit the distance that the distraction tip 18 extends into the disc cavity C. The distractor 10 can be provided with means for temporarily fixing the distractor in position or supporting the distractor on the adjacent vertebrae. As shown in FIG. 7 , the distraction tip 18 is intended to be inserted through the annular portal and is configured to restore the appropriate intradiscal height in the cavity C. Thus, in one embodiment, the distraction tip 18 can include a tapered leading portion 24 . This leading portion 24 can be introduced into the cavity C and as the tip is advanced further into the cavity the leading portion will gradually distract the adjacent vertebrae as the leading portion 24 bears against the disc endplates E. In a specific embodiment, the tapered portion 24 can be substantially bullet-shaped, as shown in FIG. 8 . With this configuration, the distraction tip 18 can have any rotational orientation when the tip is inserted through the annular portal. Alternatively, the distraction tip can be configured like the tip 40 shown in FIG. 9 . With this embodiment, the tip includes opposing generally flat sides 50 and intermediate edges 52 of the wedge portion 42 . The tip 40 can be introduced into the disc space with the flat sides 50 of the wedge facing the disc endplates E. Once the tip is fully within the disc cavity C, the tip can be rotated so that the edges 52 contact and distract the endplates. The edges 52 themselves can be wedge-shaped, having a greater width at their proximal end than at their distal end. Returning to FIGS. 6–8 , in accordance with one feature of the invention, the distraction tip 18 includes a number of side orifices 30 and an end orifice 32 that all communicate with the central lumen 16 . As depicted in FIG. 7 , the orifices 30 , 32 provide an exit path for fluid injected through the lumen 16 . Preferably, the orifices are oriented to be unobstructed by the vertebral endplates E. The distraction tip 40 shown in FIG. 9 is also provided with side orifices 46 in the flat sides 50 and an end orifice 48 . With this embodiment, the edges 52 need not include orifice(s) because the edges will be occluded by contact the endplates. Since fluid is intended for introduction through the distraction tip 30 , it is preferable that some feature be provided to ensure a substantially fluid-tight seal at the entrance to the disc cavity C through the annular portal. Thus, in one embodiment of the invention, the distraction tip 30 can include annular rings 26 that are intended to bear against the disc endplates E and/or the disc annulus A in a sealing relationship. The rings 26 can be integral with the distraction tip 30 , or can be separate components mounted on the distraction tip, such as in the form of elastomeric seal rings. The seal rings can be mounted within annular grooves formed in the distraction tip. The distractor 10 includes a fitting 36 defined at the proximal end 14 of the cannula 11 . The fitting 36 provides means for making a fluid-tight connection with a device adapted to inject the biomaterial into the disc. One exemplary device 70 is shown in FIG. 10 . The injector 70 includes a chamber 72 for storage of the biomaterial. In some cases, the chamber 72 may constitute multiple chambers where the injectable biomaterial is obtained by mixing various constituent materials. For instance, certain materials may be curable in situ and may require combining a curing agent with a base material. To facilitate mixing of the biomaterial constituents, the injector 70 can include a mixing chamber 74 . A manual control 76 can be provided that forces the contents of the chamber 72 into the mixing chamber 74 . Alternatively, the injector 70 can incorporate a mechanism that drives the fluid from the injector under pressure, such as a syringe or a pump. The injector 70 includes a fitting 80 that is configured for fluid-tight engagement with the fitting 36 of the cannulated distractor 10 . In a preferred embodiment, the two fittings 36 , 80 represent mating components of a LUER® fitting. The injector can include a nozzle 78 that extends into the cannula 11 , or more specifically into the lumen 16 , when the injector 70 is engaged to the cannulated distractor. A grip 82 can be provided to allow manual stabilization of the injector. As explained above, the cannulated distractor 10 of the present invention may be utilized after a discectomy procedure. For purposes of illustration, it has been assumed that a total discectomy has been performed in which substantially all of the nucleus pulposus has been removed, leaving a disc cavity C as shown in FIG. 5 . Of course, the principles of the invention can apply equally well where only a portion of the disc nucleus has been removed through a partial discectomy. If a bilateral approach has been used (as represented by the first and second trephines T and T′), one of the annular portals can be sealed with a material compatible to the disc annulus fibrosus. When the nucleus has been cleared, the guide wire G can be repositioned within the disc D, again preferably using known guidance and positioning instruments and techniques. The cannulated distractor 10 can then be advanced over the guide wire until the distraction tip 18 is properly situated within the nuclear cavity C. Preferably, the proper depth for the distraction tip 18 can be determined by contact of the shoulder 20 with the outer annulus A, or by contact of an associated depth feature with the adjacent vertebral bodies. With the distraction tip 18 , the tapered portion 24 gradually separates the adjacent vertebral endplates E as the distraction tip is driven further into the disc space. A mallet, impactor or other suitable driver can be used to push the tapered portion 24 into position against the natural tension of the disc annulus. It is understood that the goal of this step is to fully distract the intervertebral space to a proper disc height for the particular spinal level. For instance, for the L 2 –L 3 disc space, the appropriate disc height may be 13–15 mm, so that the distraction tip is positioned within the cavity C to achieve this amount of distraction. As shown in FIG. 5 , preferably only one cannulated distractor 10 is utilized, since the distraction tip 18 necessarily occupies a certain portion of the volume of the cavity C. However, a second cannulated distractor and associated distraction tip may be necessary (such as through a second annular portal as shown in FIG. 4 ) to achieve the proper disc height. It should be understood that the process thus far would be similar for the distraction tip 40 . However, unlike the tapered distraction tip 18 , the distraction tip 40 requires an additional step to distract the disc space. Specifically, the distraction tip 40 is initially inserted with its flat sides 50 facing the endplates E. The tip must then be rotated until the edges 52 bear against and support the endplates. The flat sides 50 can include an angled transition to the edges, or the edges 52 can be rounded to facilitate the distraction as the distraction tip is rotated in situ. When the distraction tip, such as tip 10 , is inserted to its proper depth within the disc cavity C, the annular portal is sealed, whether by contact with the shoulder 20 , or by engagement of the rings 26 with the endplates E or the interior of the annular portal. At this point, the biomaterial fluid can be injected into the cannulated distractor, and specifically into the lumen 16 . To accomplish this step, the injector, such as injector 70 , can be mated with the fitting 36 at the proximal end 14 of the cannulated distractor. Optimally, the guide wire G is removed and the fitting 80 of the injector engages the fitting 36 . The nozzle 78 extends into the lumen 16 . The nozzle can be sized so that the exit end of the nozzle is near or within the distraction tip 18 . At this point, the injector 70 can be actuated in accordance with its construction so that the biomaterial fluid is displaced from the injector and into the lumen 16 . The biomaterial exits through the orifices 30 , 32 in the distraction tip 18 to fill the cavity C. The orifices 30 , 32 are preferably positioned and sized to achieve complete and rapid dispersion of the biomaterial throughout the cavity. Again, the goal of this step of the process is to completely fill the entire volume of the cavity, or to replace the entire volume of nucleus pulposus removed during the discectomy. Where the fluid biomaterial is an in situ curable or settable material, time may also be of the essence to ensure a homogeneous mass once the material is completely cured. It should be apparent that the distraction tip 18 , 40 maintains the proper disc height while the biomaterial is injected. The tip can be retained in position until the injected material cures or sets. Once the material has sufficiently cured, the distraction tip 18 , 40 can be removed. Since the distraction tip occupies a certain volume, additional biomaterial can be injected through the tip as it is being withdrawn, if required, thereby filling the gap left by the tip. In certain embodiments, the distraction tip 18 can be a modular and removable from the cannula 11 , as shown in FIG. 8 . Thus, the tip 18 and cannula 11 can be provided with a removable mating element 19 , such as a press-fit (as shown in FIG. 9 ) or a threaded or LUER® type fitting (not shown) as would occur to a person of skill in this art. A removable distraction tip can serve several purposes. In one purpose, the injected biomaterial may require a lengthy curing time. While the material is curing, it is of course necessary to keep the distraction tip in position to maintain the proper disc height. However, it may not be necessary to retain the other components of the system in position, such as the injector 70 and cannula 11 . A modular distraction tip allows the cannula 11 to be removed while the tip remains in position, acting as a disc spacer while the biomaterial cures. In another purpose, a number of differently sized tips can be mounted to a commonly sized cannula. Each patient has a different spinal anatomy, which means the appropriate disc height at a given spinal level may vary between patients. Moreover, the disc height can vary with spinal level. Thus, a plurality of differently sized distraction tips 18 can be provided to ensure proper spacing across the spinal disc D. Another purpose behind a removable distraction tip 18 is achieved by embodiments in which the tip is formed of a biocompatible material that allows the tip to remain resident within the disc space. In this embodiment, the distraction tip material must be compatible with the biomaterial used to replace the natural nucleus. For instance, if the biomaterial is only intended to restore disc height, but not the natural biomechanical properties of the natural nucleus, then the material of the distraction tip 18 may provide a generally rigid scaffolding. On the other hand, and most preferably, the injected biomaterial is intended to emulate the biomechanical characteristics of the disc to allow the spinal segment to operate as close to a normal spinal segment as possible. In this instance, a rigid scaffold would of course frustrate the normal flexion, compression and torsional responses of the disc. Thus, the distraction tip 18 in embodiments where the tip is left in situ can be formed of a biodegradable or bioresorbable material that absorbs into the matrix of the cured biomaterial forming the disc nucleus prosthesis. Whether the distraction tip is removed or remains within the disc space, it is preferable that the tip occupy as little volume as possible. On the other hand, the distraction tip must be sufficiently strong to sustain the compression loads that it will face while distracting adjacent vertebrae and holding the disc space height while the injected biomaterial cures. In the specific embodiments shown in FIGS. 5 and 7 , the distraction tip 18 is shown traversing across a substantial portion of the nuclear cavity C. Alternatively, the distraction tip can have a reduced length from the shoulder 20 so that the tip extends only partially into the cavity. Distraction of the disc space can be abetted by certain positions of the patient on the operating table where, for instance, the anterior aspect of the disc space is naturally distracted by the position of the spine. Proper distraction of the disc space may be better accommodated by an anterior approach, rather than the posterior approach shown in FIGS. 5 and 7 . In alternative embodiments, the distraction tip can assume a wide range of geometries, some dictated by the annular portal formed during the discectomy procedure. In the embodiment of FIGS. 5–8 , a circular annular portal has bee created and a circular distraction tip 18 utilized to seal the portal. In some cases, a planar or wedge-shaped distraction tip, similar to the tip 40 shown in FIG. 9 , can be utilized where the opening through the annulus has an area greater than the tip itself. In these cases, the extra space between the tip and the interior surface of the portal can provide an opening for a direct visualization instrument, or some other appropriate instrument. Preferably, this approach is better suited where the biomaterial is not injected under pressure, such as cases where a gravity feed is employed (see FIG. 11 and associated discussion below). In other cases, surgeons perform the discectomy through rectangular or cruciate portals in the disc annulus. A complementary shaped distraction tip can be utilized to conform to and fill the annular portal. For instance, the distraction tip can assume the configuration shown in FIGS. 12–14 . A cruciate-shaped tip 55 is shown in FIG. 12 with a central lumen 56 communicating with a number of openings 56 . It is understood that the arms of the cruciate-shaped tip can have a thinner cross-section than shown in the figure, provided they are sufficiently strong to support the adjacent vertebrae in their proper distracted position. Likewise, the openings 56 can be distributed in a variety of patterns through the hub and legs of the cruciate shape. An I-beam distraction tip 60 is shown in FIG. 13 having a central lumen 61 communicating with a number of openings 62 . The distraction tip 63 in FIG. 14 has a C shape and includes a lumen 64 and openings 65 . These two beam configurations provide sufficient support for the necessary distraction. Again, the thickness of the arms of the beams can be reduced as necessary to minimize the cross-section of the distraction tip 60 , 63 . Regardless of the overall configuration of the distraction tip, it is most preferable that volume of the tip within the nuclear cavity C be minimized. The bullet-shaped tip, such as tip 18 , may be less desirable from that standpoint, while the wedge type, such as tip 40 , may be preferable. In addition, regardless of the overall configuration, the distraction tip must communicate with the lumen 16 and must provide some means for discharge of the biomaterial fluid through the tip. In the illustrated embodiments, the distraction tips 18 , 40 include orifices 30 , 31 and 46 , 48 , respectively, that communicate with the corresponding lumens 16 , 44 . Alternatively, the distraction tips can be in the form of an open scaffold or skeletal framework. Again, the scaffold or framework must be sufficiently strong, especially in compression, to properly distract the disc space and hold the disc height for an appropriate length of time. In some embodiments, the distraction tip can be formed of a material having interconnected interstices, such as a porous material. The porous distraction tip can present a solid scaffold with a multitude of fluid flow paths through the material. The porous material can be a metal, such as a porous tantalum; however, a porous polymer, such as polylactic acid, is preferred so that the scaffold does not obscure visualization of the disc space after the procedure is completed. In the procedures discussed above, the distraction tip has been described as providing an avenue for the injection of a biomaterial into the nuclear cavity C following a discectomy procedure. The distraction tips of the present invention serve equally well as a conduit for the introduction of other fluids to the disc space. For instance, the distraction tips can be used to inject a biomaterial such as the material disclosed in provisional application Ser. No. 60/336,332, entitled “Pretreatment of Cartilaginous Endplates Prior to Treatment of the Intervertebral Disc with an Injectable Biomaterial”, mentioned above, the disclosure of which is incorporated herein by reference. This provisional application discloses materials for the pretreatment of the disc endplates, for instance, to improve the biological functioning of a degenerative disc. The cannulated distractors of the present invention, such as distractor 10 , can be initially used for the disc pretreatments disclosed in the above-mentioned provisional application. Once the pretreatment has been completed, the cannulated distractor can then be used for the injection of the curable biomaterial. Likewise, the present inventive cannulated distractor can be used for multiple fluid injections, including multiple injections to effect curing of a biomaterial within the nuclear cavity C. For instance, certain biomaterials may include a first constituent that is introduced into the disc space, followed by a second constituent or curing agent. The second constituent can initiate curing of the resulting composition. An alternative embodiment of the invention is depicted in FIG. 11 . In this embodiment, a cannulated distractor 85 is provided that includes a generally frusto-conical distraction tip 86 and a shoulder 87 . The tip 86 is configured to act as a wedge to distract the disc space as the cannulated distractor 86 is impacted into the disc space. The shoulder 87 acts as a stop against the adjacent vertebral bodies to limit the distance that the tip is driven into the disc space. Preferably, the distraction tip 86 has a length from the shoulder 87 to its distal end that is sufficient to span the length of the portal in the disc annulus A, but is limited in its extent into the nuclear cavity C. With this embodiment, the distraction tip 86 does not displace any significant volume within the cavity C. The cannulated distractor 85 defines a lumen 88 extending the entire length of the distractor. The lumen 88 is sized to receive an injection tube 94 therethrough. The injection tube 94 can include a fitting 96 for engaging an injection apparatus 98 . The fitting 96 can be of any suitable type, such as the LUER® fitting mentioned above. The injection apparatus can be similar to the injector 70 shown in FIG. 10 , or can assume a variety of configurations for the introduction of a fluid into the disc cavity. In one embodiment of the invention, the biomaterial fluid is introduced into the cavity by way of gravity feed. In this instance, the injection apparatus 98 can be simply in the form of a reservoir with an atmospheric vent to allow the biomaterial to flow downward into the disc space by gravity alone. Of course, the patient must be properly presented to accommodate gravity filling of the disc cavity C. In this embodiment, the cannulated distractor 85 operates as a support or guide for the injection tube 94 . The tube 94 can be in the form of a smooth tipped, relatively large gauge needle that is sized to accommodate optimum flow of the biomaterial into the disc space. The tube 94 can be introduced through and gradually withdrawn from the cannulated distractor 85 (as indicated by the arrow in FIG. 11 ) as the biomaterial flows into the cavity C. In addition, the diameter of the tube 94 can be sized relative to the diameter of the lumen 88 so that the discharge opening 95 of the tube 94 can be pivoted with a sweeping motion through the cavity C. This aspect of this embodiment facilitates complete direct filling of the disc cavity C with the biomaterial. Where the cannulated distractor is used to introduce pre-treatment materials, such as those discussed above, this feature allows positioning of the discharge opening 95 to direct the pre-treatment materials where they are needed. In certain embodiments, the lumen 88 can be provided with a seal 89 , which can be in the form of an elastomeric seal ring. The seal 89 can form a fluid-tight seal around the injection tube 94 , which can be especially important where the biomaterial is injected under pressure. In addition, the seal 89 can operate as a form of joint to support the injection tube 94 as the discharge opening 95 is manipulated within the disc cavity. In another feature of the invention, the cannulated distractor can provide a vent for the discharge of excess biomaterial when the disc cavity C is full. The vent is particularly useful where the biomaterial is introduced under gravity feed. In one specific embodiment, a vent hole 92 is provided in the distractor 85 . When the disc cavity is full, the biomaterial will seep through the vent opening 92 , providing a direct visual indication that the cavity is full. Preferably, the vent opening 92 includes a tube that projects away from the cannulated distractor 85 to improve the visibility of the vent in situ. Alternatively, the vent can be formed by a difference in diameter between the injection tube 94 and the lumen 88 , and in the absence of the seal 89 . The vent 92 is well-suited to procedures involving gravity feed of the biomaterial into the disc space. However, the vent can also be useful where the material is fed under pressure. For example, the vent 92 can be maintained initially open as the biomaterial is injected into the cavity C through the injection tube 94 . When the cavity is completely full, biomaterial will seep from the vent 92 . As this point, the vent can be closed and additional biomaterial injected into the disc space to increase the pressure within the cavity C. The seeping through the vent provides an immediate indication that the cavity is full, and can provide a starting point for the introduction of a calibrated amount of additional biomaterial to achieve a proper cavity pressure. With each of the embodiments, once the biomaterial has cured and the cannulated distractor removed, the portal or portals in the disc annulus can be filled to prevent herniation of the newly formed prosthetic disc material. The annular portal can be sealed with any suitable material, such as fibrin glue, or a polymerizable material, or the like. The material used to seal the annulus should be sufficiently strong to remain intact as the intradiscal pressure is increased due to hydration or biomechanical movement of the spine. In accordance with certain embodiments, the cannulated distractors, and particularly the distraction tips, described above can be formed a variety of biocompatible materials. As explained above the distraction tips must be sufficient strong to maintain proper distraction of the disc space until the biomaterial has been fully injected and cured, if necessary. In certain embodiments, the distraction tips are formed of a bio-compatible metal, such as stainless steel or titanium. In other embodiments, the distraction tips are formed of a polymer or plastic that is preferably radiolucent to permit visualization of the distraction tip in situ to verify the position of the component. While the invention has been illustrated and described in detail in the drawings and foregoing description, the same should be considered as illustrative and not restrictive in character. It is understood that only the preferred embodiments have been presented and that all changes, modifications and further applications that come within the spirit of the invention are desired to be protected.

A system and method is provided for maintaining a proper intervertebral disc height during the replacement or augmentation of the spinal disc. In one embodiment, a cannulated distractor is used to distract the adjacent vertebrae and maintain a proper disc space height. The cannulated distractor is fluidly connected to a source of fluent material for injection into the disc space. The distraction includes a distraction tip resident within the disc space that includes a central lumen and a number of openings communicating with the lumen to dispense the fluent material within the disc space.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a tension-adjustable mechanism for the earpieces of a stethoscope. The present invention also relates to a stethoscope headset comprising this mechanism. 2. Brief Description of the Prior Art A tension-adjustable mechanism for the earpieces of a stethoscope has been proposed in the following prior art patent: U.S. Pat. No. 5,561,275 (Savage et al.) Oct. 1, 1996 According to this prior art mechanism, the two earpieces comprise respective weakened proximal end portions inserted side by side in a longitudinally movable sleeve. Longitudinal movement of the sleeve on the weakened end portions of the earpieces change the amplitude of the tension on the earpieces when these earpieces are spread apart from each other. Although this prior art tension-adjusting mechanism is efficient, further adjustment capability is often required to meet with the requirements, needs and/or preferences of a wide range of users. Therefore, need exists for a more versatile tension-adjusting mechanism capable of fulfilling the requirements, needs and/or preferences of a wide range of users. SUMMARY OF THE INVENTION In accordance with the present invention, there is provided a tension-adjusting mechanism for an elongated stethoscope earpiece having a proximal end. This tension-adjusting mechanism comprises a stethoscope neckpiece, a pivot mechanism portion, a spring mechanism portion, and a tension-adjusting mechanism portion. The pivot mechanism portion is interposed between the proximal end of the earpiece and the neckpiece, and defines a pivot axis about which the earpiece pivots relative to the neckpiece. The spring mechanism portion is interposed between the proximal end of the earpiece and the neckpiece, and comprises a spring member which deforms upon pivoting of the earpiece about the neckpiece in an outward direction. Deformation of the spring member produces a tension on the earpiece opposing to further pivoting of the earpiece in the outward direction. Regarding the tension-adjusting mechanism portion, it is interposed between the spring member and the neckpiece and defines a plurality of interchangeable point of contacts with the spring member. These points of contacts with the spring member have different positions relative to the neckpiece. The above mentioned pivot mechanism portion, spring mechanism portion, and tension-adjusting mechanism portion provide for the level of versatility required to fulfill the requirements, needs and/or preferences of a wide range of users. Preferably, the pivot mechanism portion comprises abutment surfaces restricting, by abutment, free pivotal movement of the earpiece about the neckpiece within given limits. According to other preferred embodiments of the tension-adjusting mechanism: the pivot mechanism portion comprises a pivot pin pivotally mounted on the neckpiece, and a pivot tube pivotally mounted on the pivot pin and connected to the proximal end of the earpiece; the spring member comprises a resilient blade having one end formed with the pivot pin; the pivot tube has an open, axial slot through which the resilient blade extends when the pivot pin is inserted in that pivot tube, the resilient blade has a thickness, and the slot has a width larger than the thickness of the blade to allow limited pivotal movement of the pivot tube about the pivot pin; and the pivot tube has an annular end face provided with a lug, the neckpiece has a pair of abutment surfaces situated on opposite sides of the lug, and the lug abuts on either abutment surface to restrict pivotal movement of the pivot tube about the neckpiece within predetermined limits. The present invention further relates to a headset for electronic stethoscope, comprising first and second elongated stethoscope earpieces each having a proximal end, and the above described tension-adjusting mechanism for each elongated stethoscope earpiece. Preferably, the stethoscope neckpiece is common to both the first and second elongated stethoscope earpieces, the neckpiece comprises a hollow shell formed with openings for the proximal ends of the earpieces, and the hollow shell comprises a front shell portion and a rear shell portion assembled together to form that hollow shell. In accordance with a preferred embodiment: the resilient blade associated to the first earpiece has a first distal end section opposite to the pivot pin; the resilient blade associated to the second earpiece has a second distal end section opposite to the pivot pin; the tension-adjusting mechanism portion associated to both the first and second earpieces comprises a tension-adjusting cam having a geometrical axis, rotatable about this geometrical axis and lockable in either first, second and third angular positions; the tension-adjusting cam comprises an axial member having an outer tubular surface and two first points of contact with the first and second distal end sections, respectively, formed by two points of this outer tubular surface, respectively, when the tension-adjusting cam is locked in the first angular position; the axial member of the tension-adjusting cam comprises, on its outer tubular surface, first and second diametrically opposite, axial and radial fins of intermediate height having respective first and second free axial edge surfaces, and two second points of contact with the first and second distal end sections, respectively, formed by these first and second free axial edge surfaces of the first fin, respectively, when the tension-adjusting cam is locked in the second angular position; the axial member of the tension-adjusting cam comprises, on its outer tubular surface, third and fourth geometically opposite, axial and radial fins of larger height with third and fourth free axial edge surfaces, respectively, and two third points of contact with the first and second distal end sections, respectively, formed by these third and fourth free axial edge surfaces of the second fin, respectively, when the tension-adjusting cam is locked in the third angular position; the neckpiece comprises a hole with peripheral notches, and the tension-adjusting cam comprises lugs engaging the peripheral notches of the hole in the neckpiece to lock the tension-adjusting cam in either the first, second and third angular positions; and the tension-adjusting mechanism associated to both the first and second earpieces comprises a spring element interposed between the neckpiece and the tension-adjusting cam and spring biasing the lugs of this tension-adjusting cam in the notches of the hole in the neckpiece, whereby, to be rotated, the tension-adjusting cam is moved against the spring-biasing force produced by the spring element to disengage the lugs from the notches and is rotated and then released to engage the lugs with other notches. The foregoing and other objects, advantages and features of the present invention will become more apparent upon reading of the following non-restrictive description of a preferred embodiment thereof, given for the purpose of illustration only with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS In the appended drawings: FIG. 1 is an exploded view of a headset for electronic stethoscope in accordance with the present invention; FIG. 2 is a first inner elevation view of a rear shell portion of a neckpiece of the headset of FIG. 1, showing a tension-adjusting cam in a first angular position; FIG. 3 is an inner elevation view of a front shell portion of the neckpiece of the headset of FIG. 1; FIG. 4 is a second inner elevation view of the rear shell portion of the neckpiece of the headset of FIG. 1, showing the tension-adjusting cam in a second angular position; and FIG. 5 is a third inner elevation view of the rear shell portion of the neckpiece of the headset of FIG. 1, showing the tension-adjusting cam in a third angular position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Preferred embodiments of the tension-adjustable mechanism for an elongated stethoscope earpiece and headset for electronic stethoscope according to the present invention will now be described with reference to the appended drawings. Just a word to mention that the present invention equally apply to non electronic stethoscopes. In the appended drawings, the tension-adjustable headset for electronic stethoscope is generally identified by the reference 10 . The headset 10 comprises two earpieces 11 a and 11 b . Since these two earpieces 11 a and 11 b and the associated mechanisms are identical but symmetrical, they will be described concurrently. In the appended figures, the references related to the earpiece 11 a bear the indicia “a” while the references related to the earpiece 11 b bear the indicia “b”. The earpiece 11 a , 11 b is constituted by an elongated, arched member advantageously made of slightly flexible plastic material. The earpiece 11 a , 11 b comprises a distal cup-shaped end 12 a , 12 b to receive an earphone assembly 13 a , 13 b . The earphone assembly 13 a , 13 b comprises a speaker 14 a , 14 b , a speaker housing 15 a , 15 b and an eartip 16 a , 16 b. The distal cup-shaped end 12 a , 12 b comprises an inner shouldered rim 17 a , 17 b . In the same manner, the speaker housing 15 a , 15 b comprises a proximal cup-shaped portion 21 a , 21 b with an outer shouldered rim 18 a , 18 b . The shouldered rims 17 a , 17 b and 18 a , 18 b are configured to mate each other. The speaker housing 15 a , 15 b finally comprises an axial, distal tube 19 a , 19 b with a distal, externally protruding rim 20 a , 20 b. To assemble the earphone assembly 13 a , 13 b , the speaker 14 a , 14 b is first placed in the cup-shaped end 12 a , 12 b of the earpiece 11 a , 11 b . The shouldered rim 18 a , 18 b of the speaker housing 15 a , 15 b is then glued or otherwise secured to the shouldered rim 17 a , 17 b of the cup-shaped end 12 a , 12 b . The cup-shaped end 12 a , 12 b and portion 21 a , 21 b then define a cavity in which the speaker 14 a , 14 b snugly fits. Finally, the eartip 16 a , 16 b is placed on the tube 19 a , 19 b . Of course, the eartip 16 a , 16 b is tubular and has an inner configuration adapted to fit on the tube 19 a , 19 b . Those of ordinary skill in the art will appreciate that the distal, externally protruding rim 20 a , 20 b will hold the eartip 16 a , 16 b on the tube 19 a , 19 b. Just a word to mention that the eartip 16 a , 16 b is made of soft, resilient material such as foam, for ensuring comfort of the user's ear. The earpiece 11 a , 11 b has a longitudinal channel 22 a , 22 b on the inner face of that earpiece 11 a , 11 b . Also, the shouldered rims 17 a , 17 b and 18 a , 18 b are structured to form an opening (see 23 a , 23 b ) through which the channel 22 a , 22 b communicates with the cavity defined by the cup-shaped end 12 a , 12 b and portion 21 a , 21 b when secured to each other. This opening 23 a , 23 b and the channel 22 a , 22 b define a passage for electrical wires connected to the speaker 14 a , 14 b along the earpiece 11 a , 11 b. Pivot Mechanism Portion The proximal end of the earpiece 11 a , 11 b is provided with an integral, transversally extending pivot tube 24 a , 24 b . Therefore, the earpiece 11 a , 11 b and the pivot tube 24 a , 24 b are made of a single piece of plastic material. On a first side, the pivot tube 24 a , 24 b includes an annular flat face 25 a , 25 b with a semicircular lug 26 a , 26 b . On the second side, the pivot tube 24 a , 24 b has also an annular face 27 a , 27 b from which an open, axial slot 28 a , 28 b extends. In the preferred embodiment, the position and width of the slot 28 a , 28 b corresponds to the position and length of the semicircular lug 26 a , 26 b . A relatively thin wall 29 a , 29 b is left between the inner end of the slot 28 a , 28 b and the annular face 25 a , 25 b. A spring blade 30 a , 30 b will now be described. This spring blade 30 a , 30 b is made of molded and resilient plastic material and has at the proximal end thereof an integral, proximal and transversally extending cylindrical pivot pin 31 a , 31 b . Accordingly, the spring blade 30 a , 30 b and the pivot pin 31 a , 31 b are made of a single piece of plastic material. The spring blade 30 a , 30 b has a constant width but a thickness which gradually thins from the pivot pin 31 a , 31 b to the distal end of that blade. The blade 30 a , 30 b further comprises a lateral extension 32 a , 32 b adjacent to the pivot pin 31 a , 31 b . Finally, the pivot pin 31 a , 31 b has a semicircular groove 33 a , 33 b. The pivot pin 31 a , 31 b is inserted in the pivot tube 24 a , 24 b , with the blade 30 a , 30 b including the lateral extension 32 a , 32 b extending through the slot 28 a , 28 b . As can be seen in FIG. 2, the width of the blade 30 a , 30 b and lateral extension 32 a , 32 b is equal to the length of the slot 28 a , 28 b . Also, the width of the slot 28 a , 28 b is larger that the thickness of the blade 30 a , 30 b whereby free pivotal movement of the pivot tube 24 a , 24 b about the pivot pin 31 a , 31 b is allowed within predetermined limits. The electrical wires connected the speaker 14 a , 14 b and running through the channel 22 a , 22 b leave the channel 22 a , 22 b at the proximal end of the earpiece 11 a , 11 b through a first hole 37 a , 37 b in the pivot tube 24 a , 24 b , the semicircular groove 33 a , 33 b in the pivot pin 31 a , 31 b, and a hole 38 a , 38 b in the pivot tube 24 a , 24 b to thereby reach the inside of a shell 35 , 36 of a neckpiece 34 , common to the two earpieces 11 a and 11 b. The headset 10 comprises the stethoscope neckpiece 34 of which the shell 35 , 36 comprises a rear triangular shell portion 35 and a front triangular shell portion 36 . When assembled together, the triangular shell portions 35 and 36 define an opening 39 a , 39 b at an upper corner thereof and through which the proximal end of the earpiece 11 a , 11 b and the pivot tube 24 a , 24 b extend. In the proximity of the opening 39 a , 39 b , the shell portion 36 comprises an inner cylindrical blind hole 40 a , 40 b to receive a first end of the pivot pin 31 a , 31 b . In the same manner, the shell portion 35 comprises an inner cylindrical blind hole 41 a , 41 b (FIG. 3) coaxial with blind hole 40 a , 40 b and receiving the second end of pivot pin 31 a , 31 b. Accordingly, when shell portion 35 is assembled to shell portion 36 , the pivot pin 31 a , 31 b is free to pivot in the blind holes 40 a , 40 b and 41 a , 41 b . Pivotal movement of the pivot pin 31 a , 31 b in the coaxial blind holes 40 a , 40 b and 41 a , 41 b is restricted within a given angle, that is within predetermined limits by the semicircular lug 26 a , 26 b which abuts on faces 42 a , 42 b and 43 a , 43 b situated on opposite sides of the lug 26 a , 26 b. It should be pointed out here that the pivot pin 31 a , 31 b , the pivot tube 24 a , 24 b , and the cylindrical blind holes 40 a , 40 b and 41 a , 41 b define a pivot axis about which the earpiece 11 a , 11 b pivots relative to the neckpiece 34 . Tension-Adjusting Mechanism Portion The shell portion 36 further comprises a lower cylindrical hole 44 defining an inwardly extending cylindrical wall 45 having an inner annular edge formed with three 60° spaced apart pairs of diametrically opposite notches such as 46 . A tension-adjusting cam 47 is disposed in the cylindrical hole 44 and is rotatable about its geometrical axis. Cam 47 comprises a circular flat wall 48 and an outer cylindrical wall 89 inwardly extending from the periphery of the circular flat wall 48 and having an annular edge surface formed with a pair of diametrically opposite and outwardly radially extending lugs 49 . Cam 47 finally comprises a central inner tube 50 coaxial with the cylindrical wall 89 and inwardly extending from the flat wall 48 . When the diametrically opposite lugs 49 are disposed in a first pair of diametrically opposite notches 46 as shown in FIG. 2, the cam is locked in a first angular position. The point of contact with the distal end section of the blade 30 a , 30 b is therefore a point of the outer tubular surface of the tube 50 when the tension-adjusting cam 47 is locked in the first angular position. This corresponds to the larger extent of spreading apart of the earpieces 11 a and 11 b before the blades 30 a , 30 b deform and produce a spring action on these earpieces 11 a and 11 b. When the diametrically opposite lugs 49 are disposed in a second pair of diametrically opposite notches 46 as illustrated in FIG. 4, the cam is locked in a second angular position. The blades 30 a and 30 b then rest on respective, diametrically opposite, axial and radial fins 51 of intermediate height formed on the outer tubular surface of the tube 50 . The points of contact with the distal end sections of the blade 30 a and 30 b are therefore the free axial edge surfaces of the fins 51 when the tension-adjusting cam 47 is locked in the second angular position. This corresponds to an intermediate extent of spreading apart of the earpieces 11 a and 11 b before the blades 30 a and 30 b deform and produce a spring action on the earpieces 11 a and 11 b. When the diametrically opposite lugs 49 are disposed in a third pair of diametrically opposite notches 46 as illustrated in FIG. 5, the cam 47 is locked in a third angular position. The blades 30 a and 30 b then rest on respective, diametrically opposite, axial and radial fins 52 of larger height formed on the outer tubular surface of the tube 50 . The points of contact with the distal end sections of the blade 30 a and 30 b are therefore the free axial edge surfaces of the fins 52 when the tension-adjusting cam 47 is locked in the second angular position. This corresponds to an intermediate extent of spreading apart of the earpieces 11 a and 11 b before the blades 30 a and 30 b deform and produce a spring action on the earpieces 11 a and 11 b. The shell portion 36 further comprises pegs 54 to receive a printed circuit board 53 . Of course, the printed circuit board 53 comprises corresponding notches and/or holes such as 55 to receive the pegs 54 . The electric wires from hole 38 a and 38 b can be connected to this printed circuit board 53 . The shell portion 35 comprises holes 62 and 63 for receiving push-buttons 64 and 65 , respectively. Push-buttons 62 and 63 operate corresponding switches such as 66 mounted on the printed circuit board. The headset 10 further comprises a T-shaped anchor 56 formed of a transversal section 57 and a vertical tube 58 perpendicular to section 57 . The tube 58 fits in a bottom opening of the shell 35 , 36 . This bottom opening is formed by semi-cylindrical opening portion 60 (FIG. 3) of shell portion 35 and semi-cylindrical opening portion 61 (FIGS. 1 and 4) of shell portion 36 . Regarding the section 57 , it is shaped to fit inside the shell portions 35 and 36 just above the bottom opening 60 , 61 . Finally, wires from the printed circuit board 53 can run toward the exterior through a hole 59 in the transversal section 57 and then through the tube 58 . Just a word to mention that the outer surface of the tube 58 is structured to connect to a biological or other sound sensor (not shown). Referring to FIG. 1, the shell portion 35 comprises four holes 67 for receiving four screws 68 . Referring to FIG. 3, the shell portion 35 comprises four threaded holes 69 in which the four screws 68 are screwed upon assembling the shell portions 35 and 36 together. Finally, the shell portion 35 comprises, as shown in FIG. 3, an inwardly extending tube 70 in which a coil spring 71 is installed. When the shell portions 35 and 36 are assembled together, the tube 70 is inserted in tube 50 through a circular hole 73 in the printed circuit board 53 , whereby the coil spring extends in both tubes 50 and 70 to push and hold (spring bias) the lugs 49 in one pair of notches 46 and therefore the cam 47 in position in the cylindrical hole 44 . To rotate the cam 47 and displace the diametrically opposite lugs 49 from one pair of diametrically opposite notches 46 to the other, one has only to push from the outside the cam 47 until the lugs 49 are withdrawn form the notches 46 and, then, rotate cam 47 clockwise or counterclockwise about its axis until the pair or diametrically opposite lugs 49 can be released to engage the desired pair of diametrically opposite notches 46 . The outside face of the circular flat wall 48 can be grooved along a diameter in the same manner as the head of a screw. A coin can then be used in cooperation with this groove (not shown) to facilitate this operation. To assemble the neckpiece 34 , the following operations are performed: Cam 47 is positioned in cylindrical hole 44 from the inside of the shell half 36 with the pair of diametrically opposite lugs 49 inserted in one of the pair of diametrically opposite notches 46 ; The pivot pin 31 a is disposed in pivot tube 24 a , with the blade 30 a and lateral extension 32 a in the slot 28 a and with the blade 30 a lying on the same side of the tube 50 as blind hole 40 a; The corresponding end of pivot pin 31 a is positioned in blind hole 40 a; The pivot pin 31 b is disposed in pivot tube 24 b , with the blade 30 b and lateral extension 32 b in the slot 28 b and with the blade 30 a lying on the same side of tube 50 as blind hole 40 b; The corresponding end of pivot pin 31 b is positioned in blind hole 40 b; The tube 58 of anchor 56 is placed in semicircular opening portion 61 with one end of the transversal section 57 fitted inside the shell portion 36 above this opening portion 61 ; The notches and/or holes 55 of the printed circuit board 53 are engaged with the pegs 54 of the shell portion 36 to thereby mount this printed circuit board 53 in the shell portion 36 ; The push-buttons 64 and 65 are placed in the holes 62 and 63 , respectively; One end of the spring 71 is placed in the tube 70 ; The shell portion 35 is placed on the shell portion 36 with: The free end of the coil spring 71 and the tube 70 of the shell portion 35 inserted in tube 50 of the cam 47 ; The corresponding end of pivot pin 31 a positioned in blind hole 41 a; The corresponding end of pivot pin 31 b positioned in blind hole 41 b; The tube 58 of anchor 56 placed in semicircular opening portion 60 , and the corresponding end of the transversal section 57 fitted inside the shell portion 35 above this opening portion 60 ; The push-buttons 64 and 65 above the switches 66 ; and Finally, the four (4) screws 68 are placed in the four (4) respective holes 67 and, then, screwed in the four (4) respective threaded holes 69 . In operation, restricted free pivotal movement of the pivot tube 24 a about the pivot pin 31 a , and restricted free pivotal movement of the pivot tube 24 a about the pivot pin 31 b , restricted pivotal movement of the pivot tube 24 a about the neckpiece 34 due to the abutment action of the semicircular lug 26 a and surface 42 a , restricted pivotal movement of the pivot tube 24 b about the neckpiece 34 due to the abutment action of the semicircular lug 26 b and surface 42 b allow the earpieces 11 a and 11 b to freely move about the neckpiece 34 about a given, relatively small angle. Spring Mechanism Portion When the diametrically opposite lugs 49 of the cam 47 are disposed in the first pair of diametrically opposite notches 46 as shown in FIG. 2, spreading apart of the earpieces 11 a and 11 b will cause the distal end sections of the resilient blades 30 a and 30 b to rest on the outer face of the tube 50 . The earpieces are then separated by a larger angular spacing. From this larger angular spacing, further spreading apart of the earpieces 11 a and 11 b will bend the blades 30 a and 30 b to produce a tension on these earpieces 11 a and 11 b. When the diametrically opposite lugs 49 of the cam 47 are disposed in the second pair of diametrically opposite notches 46 as shown in FIG. 4, spreading apart of the earpieces 11 a and 11 b will cause the distal end sections of the blades 30 a and 30 b to rest on the free axial edge surface of the respective, diametrically opposite, axial and radial radial fins 51 of intermediate height. The earpieces 11 a and 11 b are then separated by an intermediate angular spacing. From this intermediate angular spacing, further spreading apart of the earpieces 11 a and 11 b will bend the blades 30 a and 30 b to produce a tension on these earpieces 11 a and 11 b. When the diametrically opposite lugs 49 of the cam 47 are disposed in the third pair of diametrically opposite notches 46 as shown in FIG. 5, spreading apart of the earpieces 11 a and 11 b will cause the distal end sections of the blades 30 a and 30 b to rest on the free axial edge surfaces of the respective, diametrically opposite, axial and radial fins 52 of larger height. The earpieces 11 a and 11 b are then separated by a smaller angular spacing. From this smaller angular spacing, further spreading apart of the earpieces 11 a and 11 b will bend the blades 30 a and 30 b and will produce a tension on these earpieces 11 a and 11 b. Accordingly, rotation of the cam 47 about its axis to displace the diametrically opposite lugs 49 from one pair of diametrically opposite notches 46 to the other, will change the angular spacing between the earpieces 11 a and 11 b allowed prior tension is applied to these earpieces. The user can thereby adjust the angular position of the button 47 in accordance with his requirements, needs and/or preferences. Although the present invention has been described hereinabove by way of a preferred embodiment thereof, this embodiment can be modified at will, within the scope of the appended claims, without departing from the spirit and nature of the subject invention.

A tension-adjusting mechanism for the elongated earpieces of a stethoscope comprises a neckpiece and, for each earpiece, a pivot mechanism portion between the proximal end of the earpiece and the neckpiece, a spring mechanism portion between the proximal end of the earpiece and the neckpiece, and a tension-adjusting mechanism portion between the spring member and the neckpiece. For each earpiece, the pivot mechanism portion defines a pivot axis about which the earpiece pivots, and the spring mechanism portion comprises a resilient blade deforming upon spreading apart of the earpieces. This deformation produces a tension on the earpieces opposing to further spreading apart thereof. The tension-adjusting mechanism portion defines a plurality of interchangeable point of contacts with the resilient blades, which contact points having different positions relative to the neckpiece.

This is a continuation of application Ser. No. 07/668,644 filed Mar. 13, 1991, now abandoned. BACKGROUND OF THE INVENTION This invention relates generally to eye surgery and more particularly to fiber optic handpieces used for laser eye surgery. The treatment of glaucoma and its symptoms has resulted in a wide variety of approaches. Surgical treatment methods include the use of cryotherapy, ultrasound, microwave heating, microsurgery and a number of laser wavelengths and target structures. Much recent laser glaucoma treatment has concentrated on techniques to reduce aqueous production and intraocular pressure by selective destruction of the ciliary body and related processes. The ciliary processes include the ciliary muscle and the blood vessels within the ciliary body. The term ciliary body is hereinafter to be understood to refer to the ciliary body as a whole and its related processes. Infrared lasers, predominantly Nd:YAG lasers operating at 1.06 μm, have been used to deliver laser energy of a few joules per treatment site. Laser delivery for such cyclophotocoagulation has been accomplished both by free beams directed through air to a patient seated at a special slit lamp and by fiber optic handpieces placed in contact with the patient's eyeball. Handpieces have been used both with and without beamshaping contact tips. These techniques have advantages as well as drawbacks to their widespread clinical use. Delivery of a freely propagating laser beam to a patient seated at a slit lamp has higher clinical safety margins than with other techniques. This is notable, since thermal damage to the lens has been commonly encountered by researchers applying laser energy in the region of the ciliary body. Drawbacks to the slit lamp technique are several. Since the ciliary body targets are not visible to the doctor during the procedure, aiming of the laser is by visual estimation, which contributes to variation in result from patient to patient and from doctor to doctor. Also, clinical efficiency of free beam delivery through air is less than that of contact methods, as tissue coupling efficiency is reduced by 10-50%. Current contact handpieces deliver laser energy via a fiber optic, usually held by the surgeon normal to the surface of the eyeball at a point immediately above the ciliary body. Laser access to the ciliary body is good, but inadvertent thermal damage to the crystalline lens is an undesirable side effect typical to this method. The laser contact method is more efficient than the noncontact method, however, accomplishing similar results with less laser energy, thus affording the possibility of using more compact laser sources. Additionally, direct placement of the laser handpiece against the eyeball makes positioning easier and more consistent than with a slit lamp. SUMMARY OF THE INVENTION The present invention provides a fiber optic handpiece and method of use for contact cyclophotocoagulation. The present invention provides substantially all the advantages and none of the disadvantages of prior art techniques. Briefly, the main advantage of the present invention results from the recognition that the higher clinical safety margins of the slit lamp treatment method are a consequence of the direction of the laser beam being coaxial with the eye's optic axis; contact cyclophotocoagulation in accordance with the present invention is performed with the laser beam directed parallel to the eye's optic axis. A handpiece according to the present invention has portions formed with special contours that facilitate consistent placement of the probe in an axial rather than radial orientation, thus decreasing the likelihood of incidental laser exposure to unintended structures while maintaining the intrinsically higher laser-tissue coupling efficiency of a contact technique. One particular embodiment incorporates features that permit rapid and consistent positioning relative to visible landmark structures such as the limbus, thereby reducing treatment variability. A further understanding of the nature and advantages of the invention may be realized by reference to the remaining portions of the specification and the drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a cross-sectional side view of a human eyeball; FIG. 2 is a side view of a fiber optic handpiece in accordance with a particular embodiment of the present invention, shown positioned against an eye; FIGS. 3A, 3B and 3C are a front, side and top views, respectively, of a particular embodiment of the present fiber optic handpiece invention; and FIG. 4 is a front view of another particular embodiment of the present fiber optic handpiece invention. DETAILED DESCRIPTION OF THE INVENTION As mentioned, current contact handpieces deliver laser energy through a fiber optic usually held by a surgeon normal to the surface of the eyeball at a point immediately above, or proximal, the ciliary body. Laser beam direction in this modality is therefore, nearly radial. Laser access to the ciliary body is good, but the radial propagation direction jeopardizes structures adjacent to and near the ciliary body targets. Inadvertent thermal damage to the crystalline lens is an undesirable side effect with this method, as mentioned earlier. Delivery of a freely propagating laser beam to a patient seated at a slit lamp forces the surgeon to apply laser energy in a direction essentially coaxial with, but offset from, the optic axis of the eyeball. This aiming condition, a fortuitous result of a clinical device designed for one procedure being adapted for an entirely new application, allows laser access to the ciliary body while keeping other important structures, e.g. the crystalline lens, out of the direct beam path, increasing clinical safety margins. FIG. 1 shows an adult human eye, 1, with relevant parts labeled. The sclera, 2, is a tough sheath around the eye which meets the cornea, 3, at a circular junction called the limbus, 4. Behind the cornea lie the iris, 5, the lens, 6, and the ciliary body and related processes, 7. Over the cornea and part of the sclera lies the conjunctiva, 8. A fiber optic handpiece 100 in accordance with the present invention is shown in FIG. 2 positioned against an eye 1. The output tip of the handpiece has a contact surface contoured to register against the eye at the limbus, with the handpiece aligned so as to direct laser energy parallel to the eye's optic axis. FIGS. 3A, 3B and 3C are front, side and top views, respectively, of a particular embodiment of the present invention as directed to a fiber optic handpiece. Mention will be made to the top, bottom, and sides of the device, which gets rotated about during use. Such references shall refer to its typical position when properly registered at 12:00 on a patient's eye. In FIG. 3A, all of the visible surfaces are part of the output tip. A contact surface, or end surface, 105 contains an opening 110 for the fiber optic and is contoured to conform to the shape of the eye at the limbus when the axis of the handpiece is parallel to the optic axis of the eye. This can be very closely approximated as a concave spherical section of radius 12.5 mm to 12.7 mm, the spherical center being located about 6.7 mm to 6.9 mm below the opening for the fiber optic. With the contact surface so shaped, correct alignment of the handpiece, as in FIG. 2, is made easier. The width of contact surface 105 is determined by side reliefs 115. In one particular embodiment, in which the fiber opening is equidistant from either side of the contact surface, this half width is chosen to be roughly equal to the desired treatment site spacing. After a first site is treated, each successive site can be selected by aligning a side edge of the probe contact surface with the lesion created at the previous site. In its simplest form, one lateral edge may be a treatment spacing edge; used in the above described manner the distance between treatment sites would be equal to the distance between the treatment spacing edge and the fiber optic. The side relief must extend back from the treatment spacing edge so that it is visible during use. Along the bottom of the contact surface is a lower surface having a placement edge 120 with a placement contour 125 extending away from the placement edge to the body of the handpiece. This placement edge is shaped to conform to the limbus, circularly concave with a radius of about 5.5-6.0 mm and about 1.2 mm from opening 110 at its closest approach; it can thus be used to facilitate optimal alignment of the probe's fiber optic with the eye's ciliary body. An alignment groove 130 is cut into placement contour 125 and indicates the lateral position of opening 110. In FIG. 3B output tip 101 and handpiece body 102 are indicated generally. An eyelid lifting contour 135 is shown as a circular concavity in an upper surface, with a radius about 25 mm and a center of curvature located about 31 mm above the axis of the handpiece. The eyelid lifter may be any generally concave or scoop shaped relief of roughly the same size. Placement contour 125 is shown to extend away from placement edge 120, and an unsleeved fiber optic 200 is shown within a narrow bore 150 extending slightly out from the contact surface. The output tip of fiber optic 200 is normally polished flat. When the contact surface is registered against the eye, the protruding fiber optic indents the surface of the eye at that point, squeezing out extracellular water and improving the transmission efficiency of the laser beam. This protrusion may be anywhere from about 0.5 mm to about 1.0 mm, and in the particular embodiment shown is 0.75 mm. Also shown is a sheathed fiber optic portion 210 within a wide bore 160. Side reliefs 115 are shown in more detail, along with eyelid lifter 135, in FIG. 3C. It is to be understood that the above description is intended to be illustrative and not restrictive. Many embodiments will be apparent to those of skill in the art upon reviewing the above description. For instance, instead of being parallel as in FIG. 3A, the lateral edges of the contact surface may be as shown in FIG. 4. In FIG. 4 the lateral edges are aligned as ray segments from the optic axis of the eye. They may still be used as treatment spacing edges, and they also aid in the visual alignment of the handpiece around the eye. Additionally, the fiber optic could be equipped with a beamshaping surface, contour, device or crystal tip, and such might also extend past the contact surface instead of the fiber optic itself. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

A fiber optic handpiece has portions formed with special contours that facilitate consistent placement of the probe in an axial rather than radial orientation, thus decreasing the likelihood of incidental laser exposure to unintended structures while maintaining the intrinsically higher laser-tissue coupling efficiency of a contact technique. One particular embodiment incorporates features that permit rapid and consistent positioning relative to visible landmark structures such as the limbus, thereby reducing treatment variability.

This application is a continuation of application Ser. No. 043,909, filed May 30, 1979, now abandoned. BACKGROUND OF THE INVENTION This invention relates to portable hair dryers used in close proximity to the user's hair. More specifically, this invention relates to axial fan driven portable hair dryers with means for preventing hair entanglement of the user when the hair dryer is used in close proximity with the hair, such as during a styling or drying maneuver. In the past, most electrically heated forced-air hair dryers included a transverse flow fan when used with styling attachments such as a comb or a brush. Axial fan hair dryers when used with attachments were typically bulky in nature and inconvenient to use. If a more compact design of a portable axial fan hair dryer with or without attachments was desirable, a problem resulted in that the working end would be within a few inches of the axial fan. This may result in hair entanglement through the air inlet of the hair dryer. The prevention of hair entanglement through the air inlet may be somewhat helped by including a mesh screen over the air inlet. However, the mesh may not be too fine since it will cause lint or the like to clog up the air inlet screen and thus restrict air flow causing the unit to overheat. When a compact hair dryer, with a relatively short air flow portion, is used with or without styling implements, the hair of the user may readily enter through the air inlet portion of the hair dryer either when still attached to the user's head or as separate pieces of hair. The aerodynamics of the hair dryer system and the presenting of the center of rotation of the axial fan very proximate the air inlet is believed to create hair entanglement problems more serious than those associated with a transverse flow hair dryer used with styling attachments. There are two basic types of hair entanglement problems which will effect the operation of the hair dryer and/or the safety or ease of use of the hair dryer. The first type deals with hair entanglement when the hair remains attached to the user's head. If hair enters through the air inlet portion of the hair dryer, the hair strands may engage the fan shaft or its associated bearing and result in the fan stalling. Such an entanglement may cause the user to be pulled toward the dryer, and if the fan stalls, a situation may momentarily exist where the user is attached to the hair dryer and the heat of the hair dryer is increasing. Another hair entanglement problem occurs when hair strands of the user enter through the air inlet in front of the fan. Because the center of rotation of the axial fan faces the air inlet, the hair strands tend to find the center of the system and start to twist. If such a twisting occurs among several strands, the hair may become twisted together and form a knot inside the screen thus causing the user to either pull free or cut the entangled hair. Further problems result when loose hair falls into the air inlet portion through the screen. These loose hairs may eventually wrap around the shaft beneath the fan until they fill up whatever space is available. When the loose hair builds up, the fan may slow down and cause an associated thermostat to open which ultimately may result in consumer dissatisfaction and excessive returns. These prior art difficulties have been substantially overcome by providing a compact axial fan hair dryer suitable for use as a dryer or styler in close proximity to the hair. The hair dryer includes a stationary guard or shield assembly in the air inlet portion of the hair dryer and a collar affixed to the downstream portion of the fan blades and disposed about the motor. SUMMARY OF THE INVENTION It is an object of this invention to provide an axial fan hair dryer which may be used in a safe and convenient manner in close proximity to the hair. It is another object of this invention to provide a compact axial fan hair dryer which substantially prevents hair knotting and tangling problems. It is a further object of this invention to provide an axial fan compact hair dryer which may be used with a plurality of styling attachments which includes means for substantially preventing hair entanglement of the user without unreasonably interfering with the air flow dynamics of the system. Briefly stated, and according to an aspect of this invention, an axial fan hair dryer is provided which substantially prevents hair entanglement problems by means of a stationary shield and a rotating collar without detrimentally affecting the air flow characteristics of the system. BRIEF DESCRIPTION OF THE DRAWINGS The invention both as to its organization and principles of operation, together with further objects and advantages thereof, may better be understood by referring to the following detailed description of an embodiment of the invention taken in conjunction with the accompanying drawings in which: FIG. 1 is a perspective view of a compact axial fan hair dryer and an associated styling attachment, in accordance with this invention. FIG. 2 is a cross-sectional top view of the air flow portion of the hair dryer of FIG. 1, in accordance with this invention. FIG. 3 is an end view, partial in section, of the air inlet of the air flow portion of the hair dryer of FIG. 1, in accordance with this invention. DETAILED DESCRIPTION Referring now to FIG. 1, the hair dryer includes a dryer housing 10 which is preferably made of plastic and comprises separate mating sections 11 and 12. The sections 11 and 12 are connected together by means of snap locks located along their respective periphery and also by means of screws (not shown) or the like. The housing 10 includes handle portion 13 which is generally cylindrical or eliptical in cross section to provide a comfortable grip for the user, and an air flow portion 14. The handle portion 13 provides an aperture for access to an on/off switch 15. The on/off switch 15 is electrically connected to an AC line cord 16 extending from the bottom of the handle portion 13 in the manner well known in the art. Other types of control circuitry which provide a variety of fan speed/heating settings, as well as a dual voltage capability, may be provided in a manner well known in the art. The upper part of the handle portion 13 is integrally molded at about the mid-point of the air flow portion 14 to provide for a balanced easy-to-manipulate hair dryer 10. The air flow portion 14, which may be approximately three inches in length, defines an air inlet 17 and an air exhaust or outlet 18. Preferably the air inlet 17 is generally circular in shape and the air flow portion 14 gradually forms an air outlet 18 of a generally rectangular cross section. The generally rectangular cross section of air outlet 18 includes shorter upper and lower parallel sides which each include an integrally molded stud or post such as posts 19 and 20 to be used with snap-on attachments, in a manner well known in the art. Attachment 21, which includes a styling portion 22 such as a comb or brush, has upper and lower plastic resilient arms 23 and 24. Apertures 25 and 26 are defined respectively in upper and lower arms 23 and 24 to provide a snap fit over posts 19 and 20, all in a manner well known in the art. Other types of mounting arrangements for styling attachments are suitable when the hair dryer is to be used for styling the hair. Referring now to FIGS. 2 and 3 of the drawings, air is drawn in through the air inlet 17 of the air flow portion 14 through a wire mesh screen 27. The screen 27 is interlocked at its generally circular periphery into the cabinet sections 11 and 12 in a manner well known in the art. Disposed downstream from the screen 27 is a screen support 28 best seen when referring to FIG. 3. The screen support 28 is made up of a piece of metal, plastic or the like preferably in a generally cross configuration and of minimum size in order to block as little of the air passageway as possible. The crosslike screen support 28 is bowed out toward the screen 27 to provide structural rigidity to the screen 27. The center point of the support 28 defines an aperture 29 through which a securing member such as screw 30 fixes a guard or shield 31 to the support 28. The screen support 28 may be interlocked into the sections 11 and 12 of housing 10 or otherwise affixed thereto in any manner well known in the art. The guard or shield 31 may be made of a plastic and is generally dome shaped. The shield 31 is connected to the screen support 28 through its integrally molded threaded mounting post 32. The shield 31 is positioned such that it provides proper clearance to the fan blades 33 and fan hub 34. The smooth downstream outer surface of the shield 31 provides minimum air flow restriction. The shield 31 is fixed only to the center portion of the screen support 28 to minimize air flow restriction problems and also to substantially prevent the knotting problem previously described. That is, if loose hair gets through the screen 27, it tends to collect or wind about the mounting post 32. The resulting hair causes little air flow restriction and does not detrimentally affect the operation or safety of the hair dryer. Further, when hair connected to the user finds its way through the screen 28 onto the outer surface of the shield 31, the aerodynamic forces that are present still cause the hair to migrate toward the center of the system. However, because the shield 31 is present, the user's hair tends to lay across the outer surface of the shield 31. Since the hub is not spinning, the hair tends not to get knotted. Thus, when the dryer is moved away from the hair, the hair strands in the dryer laying on the surface of the shield 31 will tend to ease readily through the mesh of the screen 27. Disposed within the upstream inner surface of the dome shaped shield 31 is a brass bushing 35 which, in a manner well known in the art, mounts the fan 33 with its hub 34 to the motor shaft 36. The fan 33 is a stamped aluminum fan having a plurality of blades 33, such as four in number, all joined by means of the generally circular fan hub 34. The fan hub 34 has a centrally defined aperture through which the motor shaft 36 is disposed. Between the upstream portion of the motor 37 in the bushing 35 and the downstream side of the fan hub 34 and connected to the downstream portion of the fan blades 33 is a rotating collar 38. The collar 38 which may be integrally formed of plastic or formed as a stamped metal piece with the fan assembly (fan 33 and fan hub 34) is generally cylindrical in shape and comprises a wall portion 39, concentrically disposed about part of a motor mount 44, and a top portion 40. The top portion 40 is, of course, generally circular and defines a central aperture for receiving the motor shaft 36 and motor bearing 42. The length of the wall portion 39 of the collar 38 is preferably long enough to extend beyond the most downstream portion of the fan blades 33 such as extended portion 41. The extended portion 41 of the collar 38 beyond the fan blades 33 is believed to aid in the prevention of hair entanglement problems previously described. In general, the collar 38 on its upstream surface is affixed to fan blades 33 and bushing 35 and accordingly rotates in unison with the fan blades 33 about the motor axis 36. The collar 38 substantially prevents hair connected to the user from wrapping around the motor shaft 36 on the downstream side of bushing 35 and pulling the user toward the hair dryer. In addition, the collar 38 substantially prevents loose hairs from being disposed about the motor shaft 36 and interfering with the normal operation of the system and causing premature breakdown and customer dissatisfaction. The motor 37 is capable of driving the associated fan assembly, made up of blades 33 and fan hub 34, and collar 38 at about 15,000 to 18,000 rpm. The motor 37 is a DC permanent magnet motor such as that manufactured by Mabuchi in Japan as Model RS-365. However, it is understood that the choice of a motor is not critical in practicing this invention. If desired, in order to take the spin out of the air flow, a fixed vane assembly is provided. Although not necessary for the practice of this invention, the fixed vane assembly provides a more efficient hair dryer system. In general, the fixed vane assembly may be formed of a plastic such as polycarbonate and comprises an integrally formed generally cylindrical shroud 43 disposed about the outside of the fan/motor assembly and a generally cylindrical motor mount 44 disposed about an upstream portion of motor 37. The inner surface of the shroud 43 and the outer surface of the motor mount 44 are interconnected through a plurality of air foils or fixed vanes 45, such as nine in number, all in a manner well known in the art. The shroud 43 may extend about the fan blades 33 and also about the fixed vanes 45 located downstream from the fan blades 33. Located downstream from the fixed vane assembly are concentrically wound iron chrome resistance wire heater coils 46 disposed in the downstream portion of the air flow portion 14 and partially disposed about the motor 37. The coils 46 are mounted in appropriate slots of Micaboards 47 and 48 in a manner well known in the art. The Micaboards 47 and 48 in turn are connected to the inner walls of sections 11 and 12 of housing 10. An air exhaust grill 49 is disposed over the air exit or outlet 18 and is interconnected to sections 11 and 12 of housing 10 and Micaboards 47 and 48 through interlocks or the like. While an embodiment and application of the invention has been shown and described, it will be apparent to those skilled in the art that many more modifications are possible without departing from the inventive concepts herein described. The invention, therefore, is not to be restricted except as is necessary by the prior art and by the spirit of the appended claims.

A hand-held portable axial fan hair dryer having an air inlet and an air outlet is provided with a shield and collar assembly proximate the air inlet to substantially prevent hair knotting and tangling. Hair styling attachments, such as a comb or brush, may be removably attached proximate the air outlet.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an ophthalmic apparatus for photographing various images of the eye to be diagnosed. 2. Description of Related Art Conventionally, there are some kind of ophthalmic photographing apparatuses which photograph the anterior eye or fundus of the eye in order to submit its photographed images as data of diagnose. When using the above apparatus, it is important that the photographing condition is kept stable so as to be able to find delicate changes of the affected part of the eye. Particularly, an apparatus for photographing an anterior eye is requested to find a minute successive change as opacity of the crystalline lens, so that the quality of the photographing apparatus depends on whether its photographing condition can be kept stable. Because it is most important for the photographing apparatus to provide the photographing light at a constant amount, there are usually following methods to correct changes of the amount of the light emitted from the photographing light source during photograph. The first method is to adjust the amount of the light so as to be constant by monitoring the amount of the light emitted from the light source during photograph and feeding it back. The second method is to compensate the density and brightness of the image based on gray scale image projected over the image. Therefore, if using the above methods, it takes much time to photograph and diagnose the affected part of the eye. SUMMARY OF THE INVENTION The present invention has been made in view of the above circumstances and has an object to overcome the above problems and to provide an ophthalmic photographing apparatus which is able to photograph the eye to be examined precisely for a short time. Additional objects and advantages of the invention will be set forth in part in the description which follows and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention may be realized and attained by means of the instumentalities and combinations particularly pointed out in the appended claims. To achieve the objects and in accordance with the purpose of the invention, as embodied and broadly described herein, ophthalmic photographing apparatus of this invention comprises memory means for memorizing the image data of the photographed eye, light detecting means for detecting an amount of the light emitted from a light source for photographing, and correcting means for correcting a density of the image data memorized in the memory means by comparing the amount of the light detected by the light detecting means with the amount of predetermined reference light, wherein a constant density of the image is obtained even though the amount of the light emitted from the light source for photographing changes. According to the ophthalmic photographing apparatus of this invention, even though the amount of the light emitted from the photographing light source changes, the image having the constant density is able to be displayed by correcting the density of the photographed image. Further, the density of the photographed image is corrected after actual photographing process, it does not take much time to photograph, therefore the photographer can precisely photograph the eye to be examined by simple operation for a short time. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and constitute a part of this specification illustrate an embodiment of the invention and, together with the description, serve to explain the objects, advantages and principles of the invention. In the drawings, FIG. 1 is a schematic view of the ophthalmic photographing apparatus on the basis of Scheimpflug's principle. FIG. 2 is a front view of the alignment monitor. FIG. 3 is a block diagram of the image signal level control system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A detailed description of one preferred embodiment of an ophthalmic photographing apparatus embodying the present invention will now be given referring to the accompanying drawings. In FIG. 1, an optical system of a photographing apparatus for photographing sectionally the anterior eye on the basis of the Scheimpflug's principle is shown schematically. The optical system comprises the slit projection optical system, the photographing optical system, the alignment fixation projection system, the alignment observing system, and the reticule projection system for alignment. First, the slit projection optical system consists of a illumination light source 1 for projecting a slit image onto an anterior eye 12, an infrared irradiation transmitting filter 2, condenser lenses 3 and 4, a flash photographing light source 5, a slit 6 changeable its width as a conventional slit lamp, a polarizing filter 7 preventing the slit light from being incident into CCD camera for alignment 14 as mentioned later, a slit projection lens 8, a rectangular aperture diaphragm 9 by which the depth of focus of the slit projected image is made deeper, and a polarized beam splitter 10. The light emitted from the flash light source 5 in the slit projection optical system is introduced into a (brightness level) detector 26 through a filter Z5 for reducing the amount of the light. On receiving the reduced light, the (brightness level) detector 26 monitors its amount. In the photographing optical system, a focusing lens 13 and a CCD camera 14 are arranged so that an optical sectional plane of the projection image of the slit 6, an extended plane of a principal plane of the focusing lens 13 and that of a plane of CCD camera 14 intersect each other by one intersectionline. The photographing optical axis is arranged so as to be inclined to the slit projection optical axis with 45 degrees. The alignment fixation projection optical system includes a light source for alignment 15 consisted of visible ray as LED, a index for fixation and for alignment 16 taking the form of a pin hole, a index projection lens 17, and a half mirror 18. The alignment observing optical system is provided with a focusing lens 19, a half mirror 20 and a CCD camera for alignment 21. The reticule projection optical system for alignment consists of a light source for reticule projection 22 using an infrared light, a reticule for alignment 23 having a ring form, and a reticule projection lens 24. Further, in the above mentioned apparatus, the slit projection optical system of numerals 1˜10, the photographing optical system of 13, 14 and the alignment fixation projection system of 15˜18 are able to revolve around a visual axis of the eye to be examined 11, therefore the anterior eye can be sectionally photographed at two or more positions. In FIG. 2, a monitor image photographed by the CCD camera 21 is shown, wherein numeral 16a is a reflected image of the index for fixation and for alignment on the front surface of cornea, and numeral 23a is the reticule image for alignment. A block diagram of an image signal level control system for correcting changes of the amount of the light emitted from the photographing light source is shown in FIG. 3. The image signal detected by the CCD camera 14 is amplified by an amplifier 31, converted into a digital signal through an analog/digital converter 32, and stored in a frame memory 33 as a picture element data "c". The monitor signal of the (brightness level) detector 26 which receives the amount of light emitted from the flash light source 5 is amplified by an amplifier 27, and converted into a digital signal data "a" through an analog/digital converter 28, after that transmitted into the microcomputer 29. On the other hand, a reference data of the amount of the light "b" is memorized in a nonvolatile memory 30 in advance, which data "b" is an average calculated of several monitor data of the amount of the light emitted from the light source. Further, microcomputer 29 reads out the picture element data "c" from frame memory 33, and converts it into the picture element data "d" by calculating as a following formula, after that rebacks it to frame memory 33. d=(b/a)×c Next, the picture data "d" in the frame memory 33 is converted into a analog image signal through the digital/analog converter 34, and amplified by an amplifier 35, and then displayed on CRT display 36. As mentioned above, in CRT display 36, the image corrected changes of the amount of light of the flash light source 5 is displayed, therefore photographer can diagnose the eye to be examined more precisely. According to the above apparatus, the operation is explained as follows. First, since the image of the index for fixation and alignment 16 is projected onto the patient's eye to be examined 11, the patient should fixedly stare at the image. On the other hand, the reflected image of the index 16 on the front surface of the cornea of the eye 11 is monitored in the CCD camera 21 for alignment through an focusing lens 19. To set the alignment, while watching the monitored image in the CCD camera 21, the apparatus is moved in the right or left direction, further up or down so as to put the point reflected image 16a of the index 16 into the small circle of the reticule image 23a for alignment. Further, to set the alignment in the optical axis direction, the apparatus is moved forward or backward so that the point image 16a comes into focus. It is possible to bring the photographing system in focus by moving the focusing lens 13 in the extending direction of its principal plane or by moving CCD camera 14 in that of the focus point, while watching the monitor of photographing CCD camera 14 (not shown). Usually, the depth of focus is deep because the F-number of the focusing lens 13 is large, so that it is almost unnecessary to focus if the alignment is finally fixed. After confirming that arrangement for photographing is complete, the photographer depresses a button for photographing (not shown) in order to emit the flash light source 5, so that the flash light emitted from the flash light source 5 illuminates the anterior eye through the same optical path as the slit illumination light. Synchronous to the emitting light from the flash light source 5, the image signal detected by the CCD camera 14 is given to the frame memory 33, and the light monitor signal of the (brightness level) detector 26 is fetched. The image signal detected and the light monitor signal are calculated in the image signal level control system (microcomputer 29) mentioned above in order to display the image corrected a change of the amount of the light emitted from the flash light source 5 on the CRT display 36. Furthermore, because the corrected image signal can be kept by applying conventional methods, for example to store it in a disc, it is possible to find correctly the successive change of the image by previously comparing with the image stored. The present invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. For instance, in the above embodiment, although the image correcting operation in the photographing apparatus for photographing sectionally the anterior eye is explained, the same operation can be put in the other ophthalmic photographing apparatus. Further, the (brightness level) detector for monitoring the amount of the light can be arranged in any position where is able to receive the light emitted from the photographing light source. In the above embodiment, although the image signal and the light monitor signal are calculated in microcomputer by being converted into digital signals, it is possible to process the obtained analog signal or the analog signal and digital signal in hardware. Furthermore, although in the correcting calculation mentioned above, the ratio of the reference light monitor value and light monitor value obtained by photographing is applied to, the same result can be obtained by calculating with another coefficient obtained under considerating the character of the (brightness level) detector or with another functional equation. The foregoing description of the preferred embodiment of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed, and modifications and variations are possible in light of the above teachings or may be acquired from practice of the invention. The embodiment chosen and described in order to explain the principles of the invention and its practical application to enable one skilled in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims appended hereto, and their equivalents.

Ophthalmic photographing an image of an eye to be examined comprises: frame memory for memorizing the image data of the photographed eye, light detecting device for detecting an amount of the light emitted from a light source for photographing, correcting device for correcting a density of the image data memorized in the frame memory by comparing the amount of the light detected by the light detecting device with predetermined amount of reference light. Therefore the ophthalmic photographing apparatus can display the image having a constant density, even though the amount of the light emitted from the light source for photographing changes.

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates generally to surgical instruments, and more particularly relates to laryngoscopes having opposed blades on distal end thereof. 2. Description of the Prior Art In anesthesiology, the laryngoscope is used for endotracheal intubation. A rubber or plastic tube is introduced through the larynx into the trachea under direct or indirect optical control. Earlier laryngoscopes, such as the MacIntosh or Foregger have only one blade. The blade may be strait or curved and is fixedly secured to a hollow handle which houses the batteries. A lamp for providing light for the direct laryngoscopy is mounted on the blade. No optical system was provided. These earlier laryngoscopes can be introduced orally and used properly only if the patient's mouth is fully opened. If the patient's mouth is fully opened, then the sole blade can slide from the teeth and tongue to the pharynx, pulling or pushing the epiglottis and thus expose the entrance of the larynx. Intubation is difficult or impossible for those patients with abnormalities, whose mouth could not be fully opened. In recent times a trial was made to produce laryngoscopes with optical systems to be used in difficult intubations. These newer instruments are not very practical and are not a real progress in anesthesiology. ______________________________________Laryngoscopes and similar instruments forendotracheal intubation patented earlier:Inventor Patent No. Year______________________________________F. Haslinger (U.S.A.) 1,568,732 1926D. T. Atkinson (U.S.A.) 1,607,788 1926A. S. Pogosyan (U.S.S.R.) 898,849/31-16 1964H. J. Zukowski (U.S.A.) 3,677,262 1972H. Feldbarg (U.S.A.) 3,754,554 1973L. Lepelletier (France) 2,361,855 1976J. A. Moses (U.S.A.) 4,114,609 1977J. R. Bullard (U.S.A.) 4,086,919 1978K. Storz (U.S.A.) 4,294,235 1981______________________________________ SUMMARY OF THE INVENTION The deficiencies of the existing laryngoscopes are overcome by a laryngoscope having a hollow body terminating in a pair of opposed blades. At least one of the blades is pivotal about an axis so that the blades may assume a closed beak position or an opened beak position or, of course, any position there in between. When the opposed blades are in the closed beak position, the laryngoscope may be introduced into the patient's mouth that is only minimally opened. After the introduction, the distal end of the blades are moved apart into the open beak position without the necessity to further open the patient's mouth. Preferably, the movable blades pivot about their axes thereby pressing against the base of the tongue and the soft palate creating a large space where all details of larynx could be observed without obstruction even in major malformations. Disposed between the blades and extending from the elongate hollow body of the laryngoscope, are a tube introducer, a light conducting system and an optical system. The larynx is observed through an objective disposed at the distal end of the optical system. It is therefore seen to be an important object of the invention to provide a laryngoscope for use with patients with anomalies of the jaws, tongue, larynx or neck, or where the mouth could not be opened fully or where the viewing and reaching of the larynx is difficult or impossible. Another object of the invention is to provide a laryngoscope having at least one light conducting means for illuminating the larynx during the intubation procedure. Still another object is to provide an endotracheal tube riding on a flexible and steerable tube introducing member that is fixed in the steering mechanism in the proximal end of the handle of the laryngoscope. The introducing member is located in its hollow tube of the handle and disposed between the opposite blades of the laryngoscope on its distal end. BRIEF DESCRIPTION OF THE DRAWINGS Further objects and advantages of the present invention will become apparent as the following description proceeds, taken in conjunction with the accompanying drawings in which: FIG. 1 is a side plan, FIG. 2 is a side plan showing the disconnected upper part of the laryngoscope, FIG. 3 is showing the side plan of the disconnected lower part of the laryngoscope, FIG. 4 is showing the side plan of the laryngoscope with dilated blades and extended and flexed introducer, FIG. 5 is a plan of the longitudinal view from the proximal end of the laryngoscope, FIG. 6 is the side plan, partially cut away view of one embodiment illustrative of the invention, FIG. 7 is the frontal plan of the laryngoscope, FIG. 8 is showing the introducer and its steering and moving mechanism together with the endotracheal tube, FIG. 9 is the frontal plan showing the details between the blades in open position, FIG. 10 is the frontal plan of the connector between the endotracheal tube and the Y-piece of the anesthesia machine. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1 shows an illustrative embodiment of the laryngoscope. It comprises an elongate hollow laryngoscope body 10, two blades, inferior 14 and superior 16. The blades are forming a right angle to the body of the laryngoscope. A lever causes the movable blades 14 and 16 to pivot about the axes 18 and 19. As the distance between the lever 20 and the laryngoscope body 10 is narrowed, the distance between the free ends of the blades 14 and 16 is increased. The hollow laryngoscope body consists of two tubes, the anterior 21 is the place for the batteries, the posterior 22 is the receptacle for the introducer 23 and the endotracheal tube 24. Also contained within the anterior tube 21 are the light emitting source and light conducting system with the optical fibres for illuminating the larynx region. The optical system, generally designated 26, is positioned in lower, distal portion of the laryngoscope body 10, parallel to the blades 14 and 16 and perpendicular to the body 10. It has a system of lenses for forming an image on the ocular of the optical system 26 so that the physician can observe the target larynx and the progress of the introducer 23 and the endotracheal tube 24 into the trachea during the intubating performance. If the patient can fully open his or her mouth, and no major anomalies of the jaws, pharynx, tongue, neck and larynx are present, the laryngoscopes conceived earlier are usually adequate because the physician can observe the larynx directly. Should this for many reasons be not possible, the new laryngoscope could be the perfect tool for a difficult intubation. It has united the good viewing, illumination, space creating and tube steering for a successful placement of the tube 24 into the trachea during the intubation performance. The introducer 23 and its lever 25 are basically constructed like the conventional flexible bronchoscope. By moving the lever 25 forward, pivoting on its axis, the tip of the introducer 23 bends down and vice versa, when the lever 25 is moved backward the tip of the introducer 23 bends up. By turning the proximal end of the tube 28 left or right, the tip of the introducer follows left or right. By pushing or pulling the proximal end of the tube 28 the introducer 23 moves along and inside the posterior tube 28 and 22, forward or backward. Thus, any location of the entrance to the larynx could be reached. Technically the bending of the tip of the introducer 23 as well as in conventional bronchoscopes, is achieved by moving the lever 25 pivotally on its axis. This action is transferred over a wheel to its connections with two wires located and embeded each in a longitudinal half of the plastic, flexible body of the introducer 23. These wires are freely gliding in the body of the introducer except on its tip where the wires are connected and fixed. If one wire is pulled and the other pushed with the help od the lever 25 and its wheel, the tip of the introducer 23 is bending. An elongate slot 31 is formed in the laryngoscope body 10 to allow the movement of the endotracheal tube connector 30 and its protrusion 29 together with the tube 24 on the introducer 23 into the trachea. Thus, it is seen that a total of three levers must be manipulated by the physician to perform the intubation procedure. The intubation is performed with the new laryngoscope as follows: First, the laryngoscope body 10 is held with the left hand and the laryngoscope blades 14 and 16 in "closed beak" position are introduced into the mouth of the patient and, reaching the right position in the valecula, the left hand holding the laryngoscope body 10 moves the lever 20. This action opens the "beak", creating a free space in the pharynx and the larynx could be easily observed with the optical system 26 and good illumination with the system 27. The right hand is steering the introducer 23 by changing the direction of its tip with the lever 25. Simultaneously the right hand is holding the upper end of the posterior tube 28 pushing it downward. This action brings the telescopic part of the posterior tube 28 into the distal part 22, and the introducer 23, with the endotracheal tube 24 riding on it, down and between the open blades 14 and 16 into the larynx. The right hand then pushes the tube connector 30, holding the protrusion 29, along the slot 31. With this movement the endotracheal tube 24 is brought deeper to its optimal position. The left hand is releasing then the lever 20 and the "beak" is almost closed. The left hand pulls then the laryngoscope body 10 and takes the blades 14 and 16 out of the mouth. In the same time the right hand is holding the endotracheal tube 24 in place, by holding the protrusion 29 of the tube connector 30. A bias mechanism,such as a spring (not shown) is employed to keep the laryngoscope blades 14 and 16 in the closed "beak" position when the lever 20 is not moved. The movement of the lever 20 is transferred to a rack 33 and pinions 34 and 35 and also to the both blades 14 and 16 rotating on axes 18 and 19. Although these mechanical means have been described, it is understood that electrical or pneumatical means could also be employed. FIG. 2 represents the detached upper part of the laryngoscope body 10 comprising the anterior tube 21 as housing for the batteries and the posterior tube 22 as housing for the introducer 23 and its steering mechanism 25. As the upper part of the laryngoscope body 10 is detached from the lower part of the laryngoscope body 13, the connecting rail 36 and the arresting knob 32 become visible. FIG. 3 represents the detached lower part of the laryngoscope body 10 generally designated 13, comprising the optical system 26 and the blades 14 and 16 as well as the lever 20 and its mechanism for the movement of the blades 14 and 16. This detachment is necessary for it makes possible to sterilise the contaminated part of the laryngoscope. The detachment makes also possible to use different sizes of the blades 14 and 16 if necessary. FIG. 4 represents the same lateral view of the laryngoscope as on FIG. 1 but with the lever 20 moved to the body of the laryngoscope 10 and, as the result of this movement the separation of the distal ends of the blades 14 and 16. The telescopic part of the posterior tube 28 is moved into the body of the laryngoscope 10, described as the posterior tube 22. The movement of the telescopic part of the posterior tube 28 into the fixed tube 22 slides the introducer 23 between the blades 14 and 16. FIG. 5 is the view of the laryngoscope from its proximal end, showing the steering mechanism 25 of the introducer 23, the protrusion lever 29 of the endotracheal tube connector 30, the lever 20 for moving the blades 14 and 16, and the upper blade 16 as well as the optical system 26. FIG. 6 shows in detail how the movement of the lever 20 is transferred to the axes 18 and 19 and to the blades 14 and 16 over the rack 33 and pinions 34 and 35. FIG. 7 represents the frontal view of the laryngoscope with the extended telescopic part 28 out of the posterior tube (not visible), the protruding lever 29, the steering mechanism 25 of the introducer 23, the anterior tube 21 and the lever 20. On the lower part of the laryngoscope the closed blades 14 and 16 are visible, as well as the ocular part of the optical system 26. FIG. 8 represents the introducer 23 and its steering mechanism 25 taken out of the posterior tube 22 of the laryngoscope body 10. This detachment makes the cleaning and sterilisation of the introducer 23 possible. Also visible is the protrusion 29 and, in phantom lines, the endotracheal tube connector 30 with the endotracheal tube 24. FIG. 9 is showing the frontal view of the lower part of the laryngoscope in detail. By open "beak" and its blades 14 and 16 apart, visible are the distal end of the optical system 26 and its objective, the light conducting system 27 and the distal end of the introducer 23 with the endotracheal tube 24. Further visible are the tip of the rack 33 and pinions 34 and 35 fixed on their axes on the left side of the laryngoscope body only. FIG. 10 is showing the tube connector 30 and its protrusion lever 29 narrow enough to bypass the axes 18 and 19. Although the particular embodiments of the invention have been shown and described in full here, there is no intention to thereby limit the invention to the details of such embodiments. On the contrary, the intention is to cover all modifications, alternatives, embodiments, usages and equivalents of the subject invention as fall within the spirit and scope of the invention, specification and the appended claims.

A laryngoscope for use in difficult intubation due to malformation of the jaws, tongue, pharynx, larynx or neck as a result of trauma, edema, inflammation or congenital anomalies. An elongate hollow body terminates in a pair of opposed blades perpendicular to the said hollow body being pivotal on two axes. The endotracheal tube used for the intubation rides within the hollow tube on the introducing means disposed in the cavity of the said hollow body. Light conducting means illuminate the larynx and optical means are provided for inspecting the larynx during the intubation procedure.

This non-provisional application claims the benefits of provisional application Serial No. 60/229,622 entitled the same and filed Aug. 31, 2000 on behalf of Craig D. Linderoth. FIELD OF INVENTION The present invention relates to a medical safety device and, more particularly, to a tracheostomy safety device and its use. BACKGROUND OF THE INVENTION Tracheostomy devices are extensively used within the medical field to ventilate or assist patients with respiratory problems. Many patients with advanced stages of gas exchange impairment (e.g. COPD, multiple sclerosis, emphysema, etc.) are dependent upon effective utilization of the tracheostomy devices to supply oxygen and discharge exhaled gases from the respiratory system. Any inadvertent or unwanted cessation of the respiratory exchange by the tracheostomy devices within the medical unit can lead to irreparable injury or death of the patient. The ventilator units are usually equipped with sensory or alarm systems designed to detect certain abnormalities such as gas pressure loses within the device. Typically a sudden operational decrease in back pressure activates a remote alarm system so as to alert the medical staffing so that the device may be restored to a life sustaining operation. One of the most popular tracheostomy devices is a device referred to as a Shiley disposal cannula low pressure cuffed tracheostomy device manufactured and distributed by Mallinokrodt, Inc. (St. Louis, Mo. 63134) fitted with a rigid neck plate and what is referred to as a STRONGHOLD retainer for harnessing the tracheostomy device so that the inner cannula cannot be inadvertently separated from the outer cannula. The SHLEY device includes an inner cannula and an outer cannula operatively connected to an oxygen or air supply and a low pressure sensory for the alarm system. The outer cannula includes a larger tubular section with an inflatable cuff encompassing a distal end section of the tube and a notched flanged rim at a proximate tube end with a flared seating collar for connecting to the inner cannula. The inner cannula comprises a tubular passageway fitted with a projecting tubular portion and a collared seat for seating and sealing onto the flanged collar of the outer cannula. The projecting tubular portion of the inner cannula is sized to concentrically fit within the outer cannula passageway. The inner cannula functions as an air passageway for ventilating the patient. An enlarged hollow cylindrical extension capped with a brim which anchors the stem of the projecting tubular portion completes the air pathway of the inner cannula. The enlarged tubular air line cylindrical extension having a larger external diameter than the outer diameter of the outer cannula serves as a connecting site for a ventilator connecting elbow which connects the ventilator gas supply lines to the tracheostomy device. The cylindrical extension also serves as a mounting site for mounting the outer cannula onto the inner cannula. The brim of the cylindrical extension includes a pair of aligning ledges which mate onto notched sections of the notched rim. The extension has the appearance of a hollow cylindrical member with the tubular section spouting outwardly from the stem of the opposite end. The cylindrical member serves as a connecting site for a connecting elbow for the air supply lines. The cylindrical extension includes a flared seat on the latching side which sealingly fits against flared collar of the outer cannula. A pair of jutting ledges extending outwardly from the top edge of brim of the cylindrical extension of the inner cannula serves as a support for the latching assembly. The cylindrical member is equipped with a pair of latching assemblies which latched the outer cannula to the inner cannula. The latching assemblies outwardly extending ledges are laterally positioned at a sufficient outwardly position so as to provide annular clearance for the latches from the outer cannula rim. The undersides of the extending bridges are notched with channeled grooves to impart improved hingeability to the latches. The latching assemblies of the inner cannula include a pair of flexible latches in the form of extending arms along the outer peripheral margin of the jutting ledges which extend upwardly and inwardly terminated by L-shaped latching tab or claw which engage onto the notched rim of the outer cannula so as to snuggly hold the outer cannula rim onto the inner cannula rim. The arms extend downwardly and outwardly from the ledges to form depressing tabs which, when depressed, place the latches in an unlatched position. When used, the outer cannula is inserted into the trachea of the patient with the inflatable cuff inflated to seal the outer cannula to the trachea. The inner cannula tube with the connected or unconnected gas supply lines is then inserted onto the outer cannula in a seating position and then latched together with the latches. Normally the harness for the neck plate is secured to the patient to hold the tracheostomy unit in place when ventilation of the patient is commenced. A ventilating elbow connector forms a connecting elbow between the inner cannula and the air lines to the air sources. When the STRONGHOLD anti-disconnect device is used, it straps the elbow connector to the neck plate so as to prevent the elbow connector and the inner cannula from being inadvertently separated from the outer cannula. Unfortunately, the aforementioned tracheostomy device creates problems for an impaired patient which, if uncorrected, can cause irreparable damage or death to the patient. The ventilating device, with or without the STRONGHOLD, creates serious health risks to patients using the Shiley ventilating device. Without the STRONGHOLD, the latches for latching the inner cannula to outer cannula can become unlatched causing a disruption of the crucial air supply to the patient. Obese patients with excessive neck fat or double chins can unknowingly manipulate the latches with the neck excess sufficiently to unlatch the latching system. This causes a break in the air passageway and a severance of air supply to the patient. Since the inner cannula remains connected to the air source, the sensing system will not detect any appreciable decrease in gas back pressure and, therefore, will not sound the alarm system. Consequently, the medical staffing will be unaware that the patient is in distress and will die if the problem remains uncorrected. Another particularly serious problem arises in the case of those tracheostomy devices equipped with the STRONGHOLD when the unattended patient becomes restless, startled or panicked by respiratory or ventilating irregularities. Panicky or startled patients will often grasp the connecting elbow of the tracheostomy device with such force so as to pull the entire device, including the inflated cuff, from the trachea causing the ventilating gases to escape into the atmosphere. Since the inner cannula remains connected, there is no detectable back pressure decrease so that the alarm system will not normally detect and sound the alarm under these life-threatening conditions. When an ambulatory patient coughs to clear a plug in the throat, the startled patient will often unconsciously grasp or elbow the device so as to dislodge the entire device, including inflated cuff, from the trachea often causing serious harm or injury to the patient. Thus, the addition of the STRONGHOLD anti-disconnect device does not alleviate those problems associated with the tracheostomy device. There exists a need to avoid unwanted disconnection of the inner cannula from the outer cannula. There exists a need for an anti-disconnect device which prevents unlatching but yet permits a detectable separation at the connecting elbow. There exists a need for an anti-disconnect device which prevents unwanted unlatching of the inner cannula from the outer cannula and unwanted disengagement of the entire tracheostomy device including the inflated cuff from the patient's trachea. If the latching system could be maintained latched until knowingly unlatched by hospital or medical staffing, patients needlessly suffering of loss of life or serious injury could be avoided. Crucial notice of a failure of a patient's tracheostomy unit by timely sounding of the alarm system would avoid catastrophic injury or death to the user of the device. SUMMARY OF THE INVENTION Safety of using a tracheostomy device by preventing unauthorized or undetected separation of the inner cannula from the outer cannula can be achieved by installing a latching stop against the latches so as to prevent unwanted unlatching. An annular retaining ring buttressed against the latches effectively prevents an unlatching movement of the latches and maintains the latches in the latching position. The latch retaining ring is positioned so as to prevent a patient from intentionally or unintentionally removing the latching stop from the unlatching position. This allows only the authorized personnel to remove the latching stop from the latching position. The latch retaining ring prevents only separation or unlatching of the inner cannula from the outer cannula. If separation of ventilating passageway occurs, it occurs at the connecting elbow, thus, preserving the inflated trachea cuff and the alarm system. The latching stop mechanism allows the low pressure alarming system to perform its intended function of alarming medical personnel in crucial life-threatening situations. Failure of the alarming system to notify medical staffing of an undetectable separation of the inner cannula from the outer cannula is effectively avoided by the inclusion of the latching stop mechanism of this invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a frontal view of an assembled tracheostomy unit equipped with the safety locking embodiments of this invention. FIG. 2 is a frontal view of the unit shown in FIG. 1 attached to a patient. FIG. 3 is a top view showing in part the assembled tracheostomy unit of FIG. 2 . FIG. 4 depicts FIG. 3 without the safety locking attachment. FIG. 5 is a side view of the tracheostomy unit shown in FIG. 1 . FIG. 6A is a side view of the locking attachment used to interlock the outer cannula to the inner cannula as shown in FIGS. 1-3 and 5 . FIG. 6B is a top view of the interlocking attachment shown in FIG. 6 A. FIG. 7 is a side view of the inner cannula shown in FIGS. 1-5. FIG. 8 is a cross-sectional view taken along line 8 — 8 of FIG. 1 . FIG. 9 is a partial cross-sectional view as shown in FIG. 8 with the inner cannula being shown as separated from the outer cannula DETAILED DESCRIPTION OF THE INVENTION Pursuant to the present invention, there is provided a tracheostomy device (generally referred as 1 ) equipped with an interlocking stop (generally referenced as a 40 series number) which prevents an inner cannula 20 from being accidentally separated from an outer cannula 30 without first removing the interlocking stop 40 from the assembled inner 20 and outer 30 cannulas. The tracheostomy device as depicted without the interlocking 40 stop as shown in FIG. 4 is manufactured and distributed by Mallinokrodt, Inc., Critical Care Division, St. Louis, Mo. 63134, in various sizes (e.g., men, women, children, etc.) such as a Shiley adult model fitted with a rigid neck plate 34 and a neck strap 34 S which straps the tracheostomy device to the patient's neck. An anti-disconnect accessory identified as STRONGHOLD (not shown) for strapping elbow E to neck plate 34 has heretofore been used to anchor the inner cannula 20 and the outer cannula 30 together and, thereby, prevent unlatching. The present invention incorporates an interlocking stop 40 which avoids inadvertent disconnection of the inner cannula 20 from the outer cannula 30 while allowing the connecting elbow E to separate from the inner cannula 20 . The inner 20 and outer 30 cannulas comprise concentric tubular members adapted to interlock onto one another when the tracheostomy device 1 is assembled for use by a patient. The outer cannula 30 comprises an outer tube 31 fitted with an inflatable cup 33 or bag, which circumscribes the distal end of the outer tubular section cannula 30 and, when inserted in the trachea of a patient P, may be inflated via pumping air pressure bulb 32 to pump air through inflating lines 22 A so as to seal the tracheostomy device 1 against the trachea opening of the patient P. The opposite (proximate) end of tube 31 includes a flanged rim 35 equipped with a pair of seating grooves 36 which, as explained later, seat onto mating ledges of latching legs 26 L and 26 R of the inner cannula 20 . A beveled annular flared female seat 38 buttressed against the inward side of rim 35 forms airtight union when drawn snuggly against a mating male flared fitting 28 of the inner cannula 20 . An attachable neck rest 34 seated onto the outer cannula tube 31 permits the device 1 to be attached to the patient's neck with drawstrings 34 S as illustrated in FIG. 2 . The inner cannula 20 comprises a hollowed cylindrical base 25 and tubular section 21 adapted to sealingly seat within an open passageway 37 of the outer cannula 30 . The inner cannula 20 thus includes a smaller diameter tubular section 21 adapted to seat within passageway 37 of the outer cannula 30 and open at both ends so as to provide a passageway 21 A for gases from and to the trachea to flow therethrough. The proximate end of the inner cannula 20 comprises a hollowed cylindrical base 25 equipped with a brim 29 of a larger diameter than the outer cannula tube 31 . Brim 29 includes a centrally disposed spouting orifice 23 C spouting and connecting tubular section 21 to hollowed base 25 at stem 23 . Circumscribing tubular section 21 at stem 23 (the interfacing of base 23 and tubular section 21 ) is a flared male seat 28 for seating onto a mating female flanged seat 38 of the outer cannula 30 . Cylindrical base 25 is hollowed in the center so as to provide an air passageway 21 B which interconnects onto air passageway 21 A of the inner cannula 20 . The cylindrical base 25 supports the inner cannula tube 20 . The anterior portion of cylindrical base 25 extends perpendicularly outwardly from the stem 23 of the inner cannula tube 21 to form brim 29 and the interfacing top surface of cylindrical base 25 closure which spouts onto the stem 23 of the inner cannula tube 21 A. The interfacing top surface of brim 29 is circular and flat (except for seats 28 ) so as to rest flushly against outer cannula rim 35 and form a sealed passageway therewith. The perimeter of cylindrical top surface of brim 29 is equipped with a pair of outwardly extending ledges or bridges 22 B and 24 B which respectively support latching legs 26 L and 26 R. The brim 29 of cylindrical base 25 of the inner cannula 20 includes a pair of hinged latches 22 and 24 which latch the inner cannula 20 onto the outer cannula 30 . Latches 22 and 24 are positioned about the peripheral margin of brim 29 of inner cylindrical base 25 cannula. Latches 22 and 24 respectively include bridged sections 22 B and 24 B of molded plastic which interconnect legs 26 L and 26 R of latches 22 and 24 to the cylindrical base 25 with each of legs 26 L and 26 R of the latches 22 and 24 including a projecting legged tab 22 T and 24 T of legs 26 L and 26 R which extends outwardly and downwardly from hinged bridges 22 B and 24 B. The underside of bridged regions 22 B and 24 B include notched grooves 22 V and 24 V which impart hingeability and flexibility to latches 22 and 24 . Notched grooves 24 V and 26 V also serve as a nesting channel for retaining stop ring 40 so as to prevent hinging and downward depression of tabs 22 T and 24 T. The terminating end of each latching member 22 and 24 is equipped with a latching hook 22 H and 24 H adapted to engage onto lip 35 L of flanged rim 35 of the outer cannula 30 and connect the inner cannula 20 and outer cannula 30 together as shown in FIGS. 3-5 and 8 . Interconnecting latching legs 26 L and 26 R project upwardly and inwardly from the hinged bridged regions 22 B and 24 B at a sufficiently outwardly distance for latching hooks 22 H and 24 H to hook and latch onto lip 35 L of rim 35 of the outer cannula 30 . When the inner cannula 20 and outer cannula 30 are connected in this manner without the protective unlatching stop of this invention as shown in FIG. 4, the inner 20 and outer 30 cannula may be inadvertently separated from one another by disconnecting neck movement of the patient. When the patient P unwantedly disconnects the inner cannula 20 from the outer cannula 30 , the inner cannula 20 remains connected to the vent tubing or elbow E which, in turn, fails to create sufficient back pressure to activate the ventilator's low pressure alarm circuitry which, in turn, if not corrected, can cause serious injury or death to the patient. By inserting the interlocking stop 40 (e.g. in the form of a detachable annular ring such as a snap ring shown in FIGS. 6A, 6 B, and 9 ) into the recesses of notched grooves 22 V and 24 V (as shown in FIGS. 1-3, 5 and 7 - 8 ), inadvertent or unwanted separation of the inner cannula 20 from the outer cannula 3 is prevented. As may be seen with reference to FIGS. 1-3, 5 , and 7 - 8 , the latching stop 40 biases the latching members 22 and 24 into a secure latching position, which requires an advertent removal of latching stop 40 in order to effectuate any separation of the inner cannula 20 from the outer cannula 30 . As may be observed in particular from FIGS. 1-3 and 8 , the latching stop 40 prevents the latching tabs 22 T and 24 T of the inner cannula 20 from being depressed downwardly and inwardly towards the cylindrical base 25 which, in turn, unlatches the latching lips or hooks 22 H and 24 H of the latching members 24 of the inner cannula 20 from latching lip 35 L of the flanged rim 35 of the outer cannula 30 . Thus, as may be observed from the embodiments of the invention as disclosed, if the latching stop 40 is not removed from the tracheostomy device 1 , inner cannula 20 cannot be dislodged from the outer cannula 30 . Separation of the air supply can occur if connecting elbow E is removed from the interconnecting cylindrical base 25 passageway 21 B which, in turn, creates a sufficiently low pressure so as to sound the low pressure alarming units within the hospital staffing or nursing unit. Unlike the conventional anti-disconnecting devices which cannot be separated at the connecting elbow causing tearing away of the inflated cuff and the whole tracheostomy assembly, separation occurs at the elbow E which also allows the alarm system to sound. A rigid annular latching and seating member serves as a mounting site for mounting the inner cannula 20 onto the outer cannula 30 and an air line connecting site for connecting the air line to the tracheostomy device 1 . The annular latching and seating member is laterally positioned inwardly from the terminating end of the cannula so as to provide a connecting site for mounting and latching the outer cannula 30 thereto. An inward beveled seat configured so as to matingly seal the corresponding flanged passageway seating site of the outer cannula provides an airtight seal when the outer cannula 30 and inner cannula 20 are coupled together.

Unwanted separation of an inner cannula from an outer cannula in tracheostomy devices can be achieved by installing a retaining ring which prevents the inner cannula from unwantingly being unlatched from the outer cannula. The retaining ring allows the air supply elbow to be separated which, in turn, permits the sensory alarms to properly sound when a disconnection of the air supply arises.

BACKGROUND OF THE INVENTION Replacement of defective or severely injured tissues and organs has been a medical objective as long as medicine has been practiced. Grafts from an individual to himself almost invariably succeed, and are especially important in the treatment of burn patients. Likewise, grafts between two genetically identical individuals almost invariably succeed. However, grafts between two genetically dissimilar individuals would not succeed without immunosuppressive drug therapies. The major reason for their failure is a T cell mediated immune response to cell-surface antigens that distinguish donor from host. Immunosuppressive agents are also indicated in the treatment of autoimmune diseases such as rheumatoid arthritis or type I diabetes mellitus. One particular condition worth mentioning here is psoriasis. This disease is characterized by erythematous patches of skin accompanied by discomfort and itching. Hyperplasia of the epidermis involving proliferation of keratinocytes is also a hallmark feature of psoriasis. An inflammatory component is suggested by: (i) the finding of lymphocytic infiltration of epidermis, and (ii) the fact that immunosuppressive agents such as cyclosporin and corticosteroids have beneficial effect on the disease. A number of drugs are currently being used or investigated for their immunosuppressive properties. Among these drugs, the most commonly used immunosuppressant is cyclosporin A. However, usage of cyclosporin has numerous side effects such as nephrotoxicity, hepatotoxicity and other central nervous system disorders. Thus, there is presently a need to investigate new immunosuppressive agents that are less toxic but equally as effective as those currently available. SUMMARY OF THE INVENTION This invention relates to novel ruthenium complexes that are useful as immunosuppressive agents to prevent or significantly reduce graft rejection in organ and bone marrow transplantation. The ruthenium complexes can also be used as an immunosuppressant drug for T lymphocyte mediated autoimmune diseases, such as diabetes, rheumatoid arthritis, multiple sclerosis, lupus erythematosus and steroid resistant asthma. In another aspect, other diseases with suspected inflammatory components, such as psoriasis, contact dermatitis and hyperplasia of the epidermis, can be treated with a ruthenium complex of this invention to alleviate symptoms associated with these disease states. DETAILED DESCRIPTION OF THE INVENTION This invention is based upon the discovery that ruthenium complexes can inhibit antigen specific T lymphocyte proliferation in vitro. The data suggest that ruthenium complexes have potential use as immunosuppressants to reduce undesirable immune responses in humans. Ruthenium complexes can be used to facilitate organ transplantation, and to treat human autoimmune disorders where the specific activation of T cells is responsible for, or contributes to the pathology and progression of the diseases, such as diabetes, rheumatoid arthritis, multiple sclerosis, lupus erythematosus and steroid resistant asthma. This invention pertains to novel ruthenium complexes that have immunosuppressive properties of the general formula: RuM.sub.m B.sub.b T.sub.t !Z.sub.n wherein Ru is ruthenium having an oxidation state of 2, 3 or 4; wherein M is a monodentate ligand that is a heterocyclic aromatic amine; wherein m is 0, 1, 2, 3, 4 or 6; wherein b is 0, 1, 2 or 3; wherein t is 0, 1 or 2; wherein B is a bidentate ligand that is a heterocyclic aromatic amine; wherein T is a tridentate ligand that is a heterocyclic aromatic amine; wherein Z is a counterion, for example a counterion selected from the group consisting of F - , Cl - , Br - , I - , NO 3 - , NH 4 + , NR 4 1+ , PF 6 - , SO 4 -2 , R 1 ImH + , BPh 4 - and ClO 4 - ; wherein Im is imidazole wherein n is 0, 1, 2, 3 or 4; and wherein R 1 is a linear or branched alkyl of 1-4 carbon atoms or aryl; provided that the ligands cannot be pyridine or pyrazine or derivatives of these. The coordination sphere of the metal center may contain all six ligands (referred to as monodentate) to be equivalent or a mixture of different ligands. The mixture of ligands can consist of different monodentate ligands; a mixture of bidentate/monodentate in a ratio of 1:4 or 2:2; three bidentate ligands; a mixture of bidentate/tridentate/monodentate in a ratio of 1:1:1; two tridentate ligands; or tridentate/monodentate in a 1:3 ratio. For the purposes of this application, the terms "monodentate", "bidentate" and "tridentate" will have their generally accepted meaning in the art. That is, a monodentate ligand is defined as a chemical moiety or group which has one potential coordinating atom. More than one potential coordinating atom is termed a multidentate ligand where the number of potential coordinating atoms is indicated by the terms bidentate, tridentate, etc. The ruthenium metal can have different oxidation states, e.g., Ru(II), Ru(III) or Ru(IV). The complex will also contain a counterion of appropriate charge to render the overall charge of the complex neutral. Suitable counterions for cationic complexes, include but are not limited to, halide (F - , Cl - , Br - or I - ), SO 4 -2 , PF 6 - , BPh 4 - , ClO 4 - and NO 3 - . Examples of suitable counterions for anionic complexes include but are not limited to NH 4 + , NR 4 1+ and R 1 ImH + where R 1 is a linear or branched alkyl of 1 to 4 carbons or aryl group and Im is imidazole. In one embodiment, the ruthenium complex can comprise six monodentate heterocyclic aromatic amine ligands. Examples of suitable heterocyclic aromatic amine ligands include but are not limited to imidazole, triazole, pyrazole, quinoline, pyridazine, pyrimidine, quinoxaline, quinazoline and isoquinazoline. Derivatives of these ligands can also be incorporated into the complex in various combinations with the non-substituted ligands. A derivative is a ligand in which one or more of the hydrogen atoms has been substituted with a moiety, such as C1-C5 alkyl, C2-C4 alkenyl, hydroxy, nitro, amino, carboxyl, ester, di-C1-C4 alkyl amine, phenyl, benzyl, imidazole and combinations of these. Preferred ligands are imidazole derivatives having the general formula: ##STR1## where R 2 and R 3 are independently selected from the group consisting of aryl, heteroaryl, linear and branched alkyl (e.g., 1 to 8 carbons), --C(O)H, --COOR 1 , --CONR 1 , --COOH, H, Cl, Br, I NO 2 and methyl; wherein R 1 is defined above. Examples of preferred ruthenium complexes having monodentate ligands are shown below. Ru(Im) 6 !Cl 2 where Im=imidazole Ru (1-MeIm) 6 !Cl 2 where 1-MeIm=1-methyl imidazole Ru(1-MeIm) 6 !(PF 6 ) 3 Ru(1-MeIm) 6 !Cl 3 Ru(Im) 6 !Cl 3 General procedures for making ruthenium complexes having six monodentate ligands are described in the exemplification section. In another embodiment, a ruthenium complex can be made having multidentate ligands, in combination with other multidentate ligands and/or monodentate ligands. Suitable heterocyclic aromatic amine bidentate ligands will include, but are not limited to, imidazole based ligands (e.g., 2,2'-bis-(1-methylimidazolyl)phenylhydroxymethane); pyrazole based ligands (e.g., potassium-bis-pyrazolyl borate, bispyrazolyl methane); quinoline based ligands (e.g., 2,2'-bis(quinolinyl)phenylmethoxymethane); and quinazoline based ligands (2,2'-bis-(quinazolinyl)phenylmethoxymethane). Preferred are imidazole based ligands having the general formula: ##STR2## where each R 4 to R 9 may be the same or different and are independently selected from the substituents defined above for R 2 and R 3 . Examples of tridentate aromatic heterocyclic amine ligands include imidazole based ligands (e.g., bis-(2,-imidazolylmethyl)amine); pyrazole based ligands (e.g., potassium tris pyrazolyl borate); quinoline based ligands (e.g., 2,2'-bis-(quinolinylmethyl)amine, tris-(quinolinyl)methane). It has now been discovered that the ruthenium complexes of this invention possess immunosuppressive activity as confirmed through a drug screen. Specific T cell proliferation was measured in response to antigen exposure in the presence or absence of ruthenium complexes. It was found that ruthenium complexes inhibited T cell proliferation by 50% (IC 50 ) at a concentration of about 10 to 100 nM. This compares favorably with cyclosporin A, which has an IC 50 at 15 nM. In an in vitro toxicity study, ruthenium complexes were found to be nontoxic to a Jurkat cell line when tested at the same concentrations that markedly inhibit T cell activation (Table 1). Additional ruthenium complexes that have immunosuppressive capability are described in U.S. patent application entitled "Methods for Inhibiting Immune Response" U.S. Ser. No. 08/331,204, filed Oct. 28, 1994, the entire teachings of which are incorporated herein by reference. Ruthenium complexes can be administered orally, parenterally (e.g. intramuscularly, intravenously, subcutaneously), topically, nasally or via slow releasing microcarriers in dosage formulations containing a physiologically acceptable vehicle and optional adjuvants and preservatives. Suitable physiologically acceptable vehicles include saline, sterile water, creams, ointments or solutions. Ruthenium complexes can be applied topically as a cream or ointment to locally deliver immunosuppressive concentrations of the drug without significant systemic exposure. Topical application may be the ideal way to deliver the compound in psoriasis and perhaps other inflammatory skin diseases such as contact dermatitis and pemphigus vulgaris. The specific dosage level of active ingredient will depend upon a number of factors, including biological activity of the ruthenium complexes, age, body weight, sex, general health, severity of the particular disease to be treated and the degree of immune suppression desired, as well as appropriate pharmacokinetic properties. It should be understood that ruthenium complexes can be administered to mammals other than humans for immunosuppression of mammalian autoimmune diseases. Ruthenium complexes can be administered in combination with other drugs to boost the immunosuppressive effect. Compounds that can be coadministered include steroids (e.g. methyl prednisolone acetate), NSAIDS and other known immunosuppressants such as azathioprine, 15-deoxyspergualin, cyclosporin, mizoribine, mycophenolate mofetil, brequinar sodium, leflunomide, FK-506, rapamycin and related molecules. Dosages of these drugs will also vary depending upon the condition and individual to be treated. The assay used to measure T cell growth inhibition was a human peripheral blood lymphocyte (PBL) proliferation assay using standard procedures known in the art. PBL's were chosen due to their known ability to proliferate in the presence of antigens derived from herpes simplex virus (HSV), Rubella or tetanus toxoid (TT). PBL growth inhibition was measured in terms of ruthenium complexes's ability to interfere with antigen induced lymphocyte proliferation. Ruthenium complexes can be used to produce antibodies (e.g., polyclonal and monoclonal) against the complexes. Methods for making antibodies are well known. The antibodies can be used as a diagnostic tool for monitoring the amount of ruthenium complex in patient blood levels. The ability to closely monitor the amount of ruthenium complex provides a suitable means for controlling drug delivery to patients in both preclinical and clinical settings. The invention will be further illustrated by the following non-limiting Examples: EXAMPLE 1--Preparation of Ru(1-MeIm) 6 !Cl 2 RuCl 3 (1.871 g, 9.04 mmol) was added slowly to 1-MeIm (10 mL, 125 mmol, 14 eq.). The mixture was placed in a preheated oil bath (230° C.), and the mixture was refluxed for 2 hours. The mixture was cooled down to room temperature and acetone (50-70 mL) was added to the mixture. The mixture was filtered and the solid washed with acetone (3×10 mL). The product was dried under vacuum. The product was dissolved in MeOH (30 mL), and filtered over celite. The product was obtained as a light yellow crystalline (3.27 g, 55%) solid after triple crystallization from MeOH/ether. Ru(1-MeIm) 6 !Cl 2 was characterized by X-ray crystallography, 1H NMR, UV/Vis and elemental analysis. EXAMPLE 2--Preparation of Ru(1-MeIm) 6 !Cl 3 Ru(1-MeIm) 6 !Cl 2 (0.405 g, 0.609 mmol) was dissolved in HCl (0.25M, 30 mL) and H 2 O 2 was added slowly until the starting material had disappeared (reaction followed by UV/Vis spectroscopy). The solvent was removed to dryness and the product was purified by recrystallization from MeOH/ether. The product was characterized by UV/Vis. EXAMPLE 3--PBL Antigen Specific Proliferation Assay The lymphocytes were prepared by first separating them from the blood samples of several donors by Ficoll gradient separation as described by standard procedure known in the art. The isolated lymphocytes were then grown in RPMI 1640 medium containing 5% human AB serum, glutamine (2 mM), penicillin/streptomycin, 50 μ/ml/50 μg/ml sodium pyruvate (1 mM) and HEPES buffer (10 mM). For assay purposes, PBL's were incubated at a density of 10 5 per 200 μl of medium per well of a 96-well plate. Tetanus toxoid (TT; Connaught Labs, Willow Dale, ON) was used as a stimulating antigen at a concentration of 5 LF/ml. The test wells containing PBL's, were exposed to tetanus toxoid antigen, along with various dilutions of the ruthenium complexes solutions, as shown in Table 1. Subsequently, TT antigen/ruthenium complexes exposed PBL's were pulsed with 1 μCi/well of 3 H-thymidine on day 5 using a standard procedure known in the art. The cells were then harvested 16 hours later onto a glass fiber filter using a TOMTEC cell harvester. Thymidine incorporation was measured by liquid scintillation counting using a Beta plate counter (Pharmacia, Inc., Piscataway, N.J.). The results of the assay are shown in Table 1. TABLE 1______________________________________ Cytotoxicity IC.sub.50 (Jurkat cell)Structure (μg/mL IC.sub.50 (μg/mL)______________________________________ Ru(1-MeIm).sub.6 !Cl.sub.2 0.052 ± 0.03 2000 Ru(1-MeIm).sub.6 !(PF.sub.6).sub.3 0.19 ± 0.16 115 Ru(1-MeIm).sub.6 !Cl.sub.3 0.12 ± 0.1 >300 Ru(Im).sub.6 !Cl.sub.2 0.0067 ± 0.003 200 Ru(4-MeIm).sub.6 !Cl.sub.2 0.09 ± 0.07 1040.sup.a Ru(Im).sub.6 !Cl.sub.3 0.005 ± 0.004 530.sup.a______________________________________ a. values are extrapolated EQUIVALENTS 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:

Novel ruthenium complexes for use as immunosuppressive agents to prevent or significantly reduce graft rejection in organ and bone marrow transplantation are described. The ruthenium complexes can also be used as an immunosuppressant drug for T-lymphocyte mediated autoimmune diseases, such as diabetes, and may be useful in alleviating psoriasis and contact dermatitis.

[0001] The present application claims priority from U.S. Provisional Application No. 61/406,775, filed Oct. 26, 2010, which is hereby incorporated by reference in its entirety, including all tables, figures and claims. BACKGROUND OF THE INVENTION [0002] The following discussion of the background of the invention is merely provided to aid the reader in understanding the invention and is not admitted to describe or constitute prior art to the present invention. [0003] The external application of negative pressure to patients for palliative or therapeutic purposes is well established in the medical arts. These “negative pressure” methods have in common a requirement for some apparatus to create and maintain the differential negative pressure (relative to atmospheric pressure for example) at the desired location on the patient. [0004] In one example, “negative pressure wound therapy” (“NPWT”), also known as topical negative pressure, sub-atmospheric pressure dressings or vacuum sealing technique, is a therapeutic technique used to promote healing in acute or chronic wounds, fight infection and enhance healing of burns. A vacuum source is used to create sub-atmospheric pressure in the local wound environment. A dressing, containing a drainage tube, is fitted to the contours of a deep or irregularly-shaped wound and sealed with a transparent film. The tube is connected to the vacuum source, turning an open wound into a controlled, closed wound while removing excess fluid from the wound bed to enhance circulation and remove waste. As noted, NPWT has been used to treat both acute and chronic wounds, including diabetic foot ulcers, decubitus ulcers, surgical wounds, burns, traumatic wounds, etc. [0005] In another example, external negative pressure may be applied to patients for purposes of maintaining or enhancing patency of the upper respiratory passages (referring to the nasopharynx, oropharynx, hypopharynx, and larynx). A therapeutic appliance is provided that has a surface which is configured to enclose an external area of the throat (the term “throat” as used herein referring to the anterior portion of the neck extending approximately from the chin to the top of the sternum and laterally to a point posterior to the external jugular vein) overlying a portion of the upper respiratory passage, thereby providing a chamber (e.g., a hollow space filled with air molecules) lying between the surface and the throat. The appliance is configured to fit under the chin of a subject adjacent to the subject's throat at an external location corresponding approximately with the subject's soft tissue associated with the neck's anterior triangle. The therapy appliance is operably connected to an air pump which is configured to produce a partial vacuum in this chamber by removal of at least a portion of the gas molecules in this volume. Such methods and apparatuses may be used to support airway patency, for example, in patients with sleep apnea, airway tumors, inflammatory or traumatic damage to the upper respiratory passages, during surgery or sedation, to assist in intubations, extubations, aerosol delivery of drugs to the pulmonary tract, etc. SUMMARY OF THE INVENTION [0006] It is an object of the present invention to provide devices and methods for assisting in establishing a region of negative pressure on an external portion of a subject. [0007] In a first aspect of the invention, an apparatus is provided that is configured to seat against the chin and neck of a patient to define a space-filled chamber between an inner surface of the apparatus and the skin of the user at an external location approximately at the soft tissue of a patient associated with the anterior triangle of the neck. The apparatus is adapted to maintain or increase patency of the upper airway by applying a vacuum-derived force to a surface of the neck of the patient when a therapeutic level of negative pressure is applied within the chamber, wherein the apparatus is sufficiently rigid to withstand the therapeutic level of negative pressure within the space. [0008] In various embodiments, the apparatus comprises a flange attached to the apparatus edge which, when the apparatus is seated against the patient, is positioned to contact the patient's skin around at least a portion of the periphery of the apparatus. The flange is attached at its midregion to the apparatus edge by a pivoting member, said pivoting member configured to provide movement of the flange relative to the apparatus edge in order to allow the flange to adjust the skin contact surface of the flange to the contour of the patient's skin. This apparatus may be operably connected to an air pump in order to produce the desired negative pressure within the chamber. The flange may be formed as an integral part of the apparatus edge (e.g., moulded in a continuous fashion during production of the apparatus), or may be joined in a replaceable fashion (e.g., by providing a joining system on the flange and on the apparatus which may be pressed, snapped, zipped, etc. together to form the completed apparatus). [0009] In certain embodiments, the apparatus comprises a peripheral edge configured to contact the skin of the user in order to enclose the chamber; and a supporting member positioned inward from a subregion of the peripheral edge which positions proximate to the patient's chin (i.e., the central forward portion of the lower jaw), the supporting member providing registration of the apparatus on the patient's chin. [0010] Load forces from pressures lower than ambient pressure (e.g., a partial vacuum) within the chamber are carried by the apparatus and imparted on the user's skin through the edge of the apparatus and, in certain embodiments, by the supporting member providing registration of the apparatus on the patient's chin. [0011] In order to improve compliance, comfort, and wear characteristics, the flange may comprise a nonlinear transverse profile over at least a portion of the flange in an unloaded state. This nonlinear transverse profile is configured to provide improved force distribution, relative to a linear transverse profile, when the apparatus is seated against the patient and the negative pressure is applied within the chamber. The nonlinear transverse profile may be, for example, concave or convex relative to the patient's skin. This is not meant to be limiting. [0012] Alternatively, or together with this nonlinear transverse profile, the apparatus may comprise a breathable material inherent in, or positioned on, all or a portion of the skin contact surface of the flange, wherein the breathable material is configured to provide a controlled flow of air through the breathable material and into the chamber when the therapeutic level of negative pressure is applied within the chamber. Inclusion of such a breathable material can reduce accumulation of heat and/or moisture within the chamber. [0013] As noted, the breathable material may be an inherent structure of the flange material. For example, the tooling used to form the flange (e.g., a mould) may provide a roughened or microchanneled surface to a portion of the flange which contacts the wearer's skin. As an example, the textured surface may comprise features having a depth from about 0.0005 inches to about 0.020 inches. Alternatively, the breathable material may comprise a separate porous material which may be joined in a replaceable (and therefore potentially disposable) fashion (e.g., with an adhesive strip). Examples of suitable breathable materials are described hereinafter. Preferred breathable material provides a controlled airflow rate greater than about 0.1 liters per minute (LPM), in certain embodiments between about 0.1 and about 56 LPM, and in other embodiments between about 0.1 and about 10 LPM, in each case when the apparatus is under a therapeutic level of negative pressure. [0014] In another alternative, or together with one or both of the foregoing, the apparatus may comprise a low friction material having a coefficient of friction of about 0.65 or less, and in certain embodiments about 0.5 or less, on all or a portion of the skin contact surface of the flange, wherein the low friction material is configured to provide local movement of the flange relative to the skin surface. [0015] In another alternative, or together with one or more of the foregoing, the apparatus may comprise a tacky material at an edge thereof, and preferably positioned on the patient contact surface of the flange. A “tacky material” as that term is used herein refers to a material which requires a measurable separation force for removal, e.g., of the flange from the patient's neck. Various standard test methodologies (e.g., ASTM D3121-94 or ASTM D2979-95) are known in the art for measuring tack of an adhesive material. [0016] In another alternative, or together with one or more of the foregoing, the apparatus may comprise a peripheral edge configured to contact the skin of the user in order to enclose the chamber, wherein all or a portion of the wearer contact surface of the edge comprises a fluid-filled enclosure (e.g., in the form of a fluid filled tube). As used herein, “fluid-filled” is intended to include materials which are fluids (including without limitation liquids and gasses), gels, foams, waxes, flowing particulate solids, etc., which provide a compliant patient contact surface on the apparatus when a negative pressure is applied within the chamber. This fluid-filled, compliant material can assist in both sealing and comfort of the apparatus in use. The fluid filled enclosure can be separated intro zones circumferentially and/or radially around the contact surface of the apparatus to prevent migration of the filling to lower pressure areas within the enclosure. In the case where there are multiple zones, the zones may be configured to provide independent levels of resistance to loading. This resistance may be adjusted during manufacture, or controlled during use as desired. In addition, certain areas of the apparatus, such as the peripheral edge proximate to the chin, may lack the fluid-filled enclosure in order to more positively position the apparatus in registration zones. [0017] In certain embodiments, the apparatus is configured to seat against the chin and neck of a patient to define a chamber at an external location approximately at the soft tissue of a patient associated with the anterior triangle of the neck. In these embodiments, the apparatus is adapted to maintain patency of the upper airway by applying a vacuum-derived force to a surface of the neck of the patient to draw the surface into the chamber when a therapeutic level of negative pressure is applied within the chamber. [0018] In other embodiments, the apparatus is configured to seat against the skin of a patient to define a chamber at an external location overlying a wound. [0019] A variety of additional elements may be provided in the apparatus of the present invention. These elements may include one or more of the following: [0000] (i) flexural elements located within the flange configured to reduce longitudinal stress within the flange; (ii) a radiused flange edge over at least a portion of the flange; (iii) a variable thickness across the flange in a tangential direction, preferably with a minimum thickness at the edge of the flange; for example, the flange thickness may vary from a maximum thickness of between about 0.4 inches to about 0.1 inches, and a minimum thickness of about 0.02 inches or less. In certain embodiments, the maximum thickness is between about 0.312 inches and about 0.25 inches, and the minimum thickness is between about 0.01 and about 0.005 inches. The measurements are exclusive of any additional structures or coatings which may be reversibly applied to the flange. (iv) an air pump connected to the apparatus via a hose or tube; (v) an air pump which is wearable by the patient and is self-powered (that is, does not require connection to mains power for operation); (vi) an air handling system which controls temperature, humidity, and air flow within the chamber. (vii) an integral sealing member external to the flange which forms an enclosed air channel around all or a portion of the apparatus edge; (viii) when the apparatus is adapted to maintain patency of the upper airway, a subregion of the apparatus edge which is proximate to the patient's chin which does not comprise the low friction material; (ix) in the a subregion of the apparatus edge which is proximate to the patient's chin, a supporting member positioned inward from the apparatus edge which is configured to mate with the patient's chin; and (x) an integral sealing member underlying all or a portion of the skin contact surface of the flange, wherein the interface between the sealing member and the flange provides a low friction region configured to provide local movement of the of the flange relative to the skin surface. In these embodiments, a lubricating fluid may be placed between the sealing member and the flange to reduce friction at the interface. [0020] Those skilled in the art will appreciate that the conception upon which this disclosure is based may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention. BRIEF DESCRIPTION OF THE FIGURES [0021] FIG. 1 and two depict cross sectional views through the apparatus at the level of the patient contact area. As depicted, the flange-to-apparatus connection point can be configured as integral to the apparatus body ( FIG. 1 ) or as a reversibly attached component ( FIG. 2 ). [0022] FIGS. 3 and 4 schematically depict force loading at the patient contact area of the apparatus when in use. [0023] FIG. 5 schematically depict the effects of an alternative flange shape (a radiused edge) on force loading at the patient contact area of the apparatus when in use. [0024] FIG. 6 schematically depict the effects of an alternative flange shape (a cantilevered lip) on force loading at the patient contact area of the apparatus when in use. [0025] FIG. 7 depicts a section view of the apparatus showing the lower flange having a concave profile. [0026] FIG. 8 depicts various projection views depicting the effect of circumferential stiffness on the shape of the apparatus. [0027] FIG. 9 depicts various embodiments to reduce the circumferential stiffness of the apparatus. [0028] FIG. 10 depicts the use of a vent layer to control levels of heat and humidity which can accumulate within the apparatus when in use. [0029] FIG. 11A depicts an embodiment in which the vent layer is formed from a lamination stack composed of materials. [0030] FIG. 11B depicts an embodiment in which a microchanneled surface is used as a component of a vent layer. [0031] FIGS. 12 and 13 depict in schematic form a system for managing environmental quality in an apparatus of the present invention. [0032] FIG. 14 depicts an alternative embodiment for managing environmental quality in an apparatus of the present invention. [0033] FIG. 15 depicts an apparatus of the present invention having regions of differing friction characteristics on the patient contact area of the apparatus. [0034] FIG. 16 depicts an apparatus of the present invention configured to provide modified shear forces during head movement. [0035] FIG. 17 depicts embodiments in which the patient contact area of the apparatus of the present invention is modified to control friction characteristics. [0036] FIGS. 18 and 19 depict the use of a collar to secure the apparatus of the present invention to the user. [0037] FIGS. 20 and 21 depict an embodiment of the apparatus of the present invention comprising a cup-shaped registration element to assist in proper placement of the apparatus by registering the apparatus on the wearer's chin. DETAILED DESCRIPTION [0038] External Negative Pressure Therapy Appliances [0039] The minimal design for a negative pressure therapy appliance is a structure configured to provide a space-filled chamber between an inner surface of the appliance and the skin of the user, where the structure is sufficiently rigid to withstand a desired partial vacuum created within the space; and to provide a peripheral rim that seals to the skin of the user in order to enclose the chamber. A vacuum in the range of about 7.62 to about 60.96 cm H 2 O is applied to a skin surface area of about 32.90 cm 2 to about 210.58 cm 2 in order to apply the desired therapeutic level of vacuum. These external therapy appliances have typically required a port connecting the enclosed space to an external vacuum source and power supply in order to achieve the desired therapeutic benefit for an entire treatment period. [0040] A. The Therapy Appliance [0041] The therapy appliance of the present invention comprises a structural member that provides a chamber between an inner surface of the appliance and the skin of the throat, where the structure is sufficiently rigid to withstand the required partial vacuum created within the space, and a peripheral rim that seals to the skin of the user in order to enclose the space. The vessel may be formed, molded, or fabricated from any material or combination of materials. Non-limiting examples of such materials suitable for constructing the therapy appliance include plastics, metals, natural fabrics, synthetic fabrics, and the like. The appliance may also be constructed from a material having resilient memory such as silicone, rubber, or urethane. [0042] The only limitations on material(s) used for manufacture of the therapy appliance is that the appliance must be nontoxic (or “biocompatible,” as it is in contact with the skin), and must be sufficiently rigid to maintain the space while carrying the desired partial vacuum load. The durometer or hardness is a unit of a material's resistance to indentation. The durometer of common materials is provided in the following table: [0000] Material Durometer Shore Scale Bicycle gel seat 15-30 OO Chewing Gum 20 OO Sorbothane 40 OO Rubber band 25 A Door seal 55 A Automotive tire tread 70 A Soft skateboard wheel 75 A Hydraulic O-Rings 70-90 A Hard skateboard wheel 98 A Ebonite Rubber 100  A Solid truck tires 50 D Hard Hat 75 D [0043] The peripheral contact surfaces of the therapy appliance may be made of a softer, more compliant material than the structural regions of the appliance. A reduction in durometer to between 15 and 30 (Shore OO; roughly the hardness of chewing gum or rubber band) can permit the contact surface to better fill the contours of the skin. Numerous semi-cured or uncured rubbers having an almost gel-like consistency are known in the art. In the case of materials which in and of themselves do not have sufficient structural characteristics (e.g., ELASTOSIL® P 7616-160 A/B RTV-2 rubber, Wacker Chemie), the material may be encased, e.g., using a thin bladder (such as 1 mm polyurethane). These materials may be joined to the structural regions of the appliance in a 2-part molding process. [0044] All or a portion of the contact surface of the therapy appliance may provide a tacky material which improves adhesion of the appliance to the wearer's skin. This tacky material may be formed as an integral part of the appliance, or as a material that is replaceable by the user. Certain pressure sensitive adhesives (“PSA's”) come in many forms such as acrylic, silicone, rubber and hydrocolloid adhesives. The standard ways to classify adhesive strength is a 90 degree coupon peel test per PSTC or ASTM methods. Pressure sensitive adhesives in the range from 0.2 to 2.0 pounds per lineal inch are ideal. Excessive strength result in adverse affects associated with apparatus removal. Preferred materials include RTV silicones such as ELSATOSIL® (Wacker Silicones), including ELASTOSIL® P7671 A/B or SILPURAN® 2120 A/B. Such materials are biocompatible, sterilizable by gamma irradiation, and the tackiness may be controlled by varying the amount of catalyst added to the vulcanizing reaction. RTV-2 elastomers are two-component products that, when mixed, cure at room-temperature to a solid elastomer, a gel, or a flexible foam. RTV-2 is cured by mixing two components A and B. Through incomplete curing, the silicone rubber material remains soft and tacky. [0045] Because the contact surface of the appliance applies a force to the user's skin (which may be perceived by the user as pressure against the skin) due to the forces generated by the therapeutic vacuum, a lack of comfort may result in a failure to use the appliance. Under certain circumstances, the capillaries, arterioles, and venules in the skin underlying the edge or lip may also collapse under prolonged use. Thus, the present invention describes several technologies that can enhance the comfort associated with using negative external pressure (cNEP) therapy. While the following discussion focuses on devices for maintaining or enhancing airway patency, the skilled artisan will understand that these concepts are generally applicable to negative pressure devices. [0046] A. Flange to Dome Joint and Shape [0047] The apparatus is preferably made of a soft and compliant material, albeit one that is regionally of sufficient stiffness so as to withstand a therapeutic level of vacuum without collapsing. Due to a wide range of anatomical shapes, several apparatus sizes and shapes may be necessary. To make the user feel the apparatus is securely positioned, the apparatus is designed to intimately register with the mandible by provision of a registration element (“shelf”) which rests under the chin. A “cup” shaped region which received the chin is formed by the edge of the apparatus and this shelf, as depicted in FIG. 20 (dotted region). The chin cup formed thereby can provide a visual feature that helps ensure proper placement of the collar onto the chin as depicted in FIG. 21 . Additionally, by imparting a portion of the load created at the apparatus/patient interface onto the relatively rigid structure of the chin, improved leverage can be gained on the soft tissue overlying the pharynx which is sought to be moved. [0048] Advantageously, the flange areas near ear and neck are constructed to be compliant and self-aligning to the anatomy of the wearer. FIG. 1 depicts a transverse section through the dome and flange. In this figure, the flange is depicted as integral to the apparatus edge. The juncture shows a very thin section at point A, which is approximately at the midpoint of the flange contact surface with the skin. This thin section is very weak and allows the flange to pivot freely. This is advantageous as areas of high contact pressure due to flange misalignment with the neck are reduced. FIG. 2 shows alternative embodiments of the design in which the flange is reversibly attached to the apparatus edge by a snap-in joint. [0049] A properly aligned flange can still impose high contact pressure points unless it is designed to address the behavior of the tissue beneath it. The primary characteristic of human tissue that is important is its compressive stiffness. This term varies with the thickness of tissue captured between the apparatus and very stiff structure such as bone or cartilage. Individuals with extra fatty tissue will have a less stiff or softer system. In traversing the periphery of the apparatus flange, the tissue stiffness varies associated with skin toughness and underlying substructure. Relative compressive stiffness may therefore vary from one anatomical region to another, and exhibit individual user variation. Comfort is the absence of pain. Pain is incurred by high contact pressure over time. The actual offending area can be very small; it can be an edge or even a point. [0050] FIG. 3 shows an enlarged view of the apparatus flange loaded on to human tissue in a typical fashion. The unloaded flange is designed with a nonlinear transverse profile that bends distal to the apparatus. The loaded shape of the flange is established on the basis of load, material properties, width and human tissue properties. The shape of the loaded flange (in reference to flat human tissue) is preferred to be approximately flat for the central 80% of the flange and curved upward for each 10% edge condition. When load from the dome of the apparatus is applied to the flange, the distal ends of the flange flex back and become straight. For purposes of clarity, a cross-section view of the flange will show the contact surface as straight. In reality, straight means to follow the anatomical curves of the body. It also maintains the structure under the flange is skin, muscle/fatty tissue and bone respectively and that this structure possesses a nonlinear spring rate behavior. Therefore uniform compression of the tissue structure will yield uniform contact pressure. However due to the structural cohesiveness of the tissue, a flange edge condition exists that imparts higher stress on the tissue. This is denoted as point A. FIG. 4 shows an area C. This is the potential energy associated with compressing the tissue as associated with the natural curvature of the skin surface. The displaced tissue of the natural curve translates to a tensile term at point B. [0051] This load is carried under the flange and the tissue will feel the addition. The total stress imparted in or on the skin is the vectorial sum of the compressive stress and the lateral tensile stress. FIG. 5 shows a flange edge design that includes a radiused edge. This radius reduces the peak stress in two ways; first, the potential energy area highlighted in FIG. 4 is reduced and the contact pressure term is less at Point A. The ideal solution is to select the smallest radius that will yield a flange edge total stress condition that matches the nominal stress within the central regions of the flange. The variables considered in designing the ideal radius include, for example, anatomical shape and thickness of tissue. Based on direct measurement, the flange edge radius advantageously varies from 0.02 to 0.25 inches. Additionally, the radius may preferentially be tangential with the skin contact surface of the flange and the center point located 70 percent of the radius value from the flange edge. While this design is a simple radius, other embodiments can offer benefit. They may take the form of a bevel or any mathematical expression that depicts a curve from the flange surface to the edge. [0052] FIG. 6 shows a design where the desired radiused curve is established by cantilever flexing of a thin lip of silicone material or the like. The feature may or may not be integral with the apparatus and/or flange. The advantage of the design is the thin lip in the unloaded state is curved distal to the apparatus. This inherently maintains an effective seal against air leakage. [0053] B. Methods to Reduce the Negative Effects of Longitudinal (Circumferential) Stiffness [0054] The lower flange of the apparatus that crosses in front of the neck is curved to match the shape of the neck. This curvature inhibits the flange from self aligning with the neck. When the flange attempts to pivot, the circumferential length of the top and bottom edges of the flange would respectively have to lengthen and shorten. Since the material is relatively stiff it simply inhibits the alignment. FIG. 7 is a section view of the apparatus showing the lower flange having a concave profile, and the rotational pivot point. FIGS. 8A and 8B is a two projection view of the flange. It shows the stretching and bunching of flange edge material. FIG. 9A shows methods to reduce longitudinal (circumferential) stiffness by adding discontinuities in the form of local slits. The slits are orientated normal to the flange length and therefore do not influence the beneficial load distribution characteristics of the flange. FIG. 9B shows alternative embodiments. [0055] C. Conditioning the Air within the Apparatus [0056] Sleep apnea is a chronic condition that requires continuous therapy during sleep. The apparatus will enclose regions of the neck, which may tend to feel hot and moist to the user. These uncomfortable conditions may drive the user to attempt to relocate the apparatus leading to air leakage and general increase in arousals from sleep. Promoting air flow through the apparatus will help mitigate the negative effects of moisture and temperature especially in applications where the apparatus is worn for long periods of time. [0057] FIG. 10 is a sketch of a vent layer that promotes outside air to flow across the seal flange and into the apparatus cavity. The vent layer is made of biocompatible semi-porous material that has sufficient structure to resist collapse thereby maintaining air passage. Not only is the material to provide an air conduit into the apparatus but also provide air access to the skin such that free exchange of gasses and moisture can occur. This can serve to mitigate skin injury caused or worsened by heat and humidity. The preferred airflow rate through the apparatus is greater than about 0.1 standard cubic feet per minute (LPM), in certain embodiments between about 0.1 and about 56 LPM, and in other embodiments between about 0.1 and about 10 LPM. Typical materials may be foams, woven cloths and nonwoven layups. In the case where the apparatus flange is specifically designed to minimize peak tissue contact pressures, the vent must be thin so as to not negate the flange effectiveness. Air flow rate can be varied based on the flow characteristics of the material chosen. For example, reducing the air path length by ½ should result in doubling of the flow rate; reducing the thickness of the material by ½ should halve the flow rate. [0058] Since this vent layer (liner) is in intimate contact with the skin, the product life may be limited to just a few days. This will benefit from a simple means to remove and reapply a new liner. Pressure sensitive adhesives are ideal for this application. The old liner is simply removed from the apparatus by pulling a special tab, thereby peeling the liner off. The new liner is applied by peeling off the backing paper, positioning the liner on the apparatus, and applying mild contact pressure. The liner may be constructed from more than just a single layer of porous material. It may consist of many laminated components. See, e.g., the exploded view in FIG. 11A . The apparatus is made of silicone rubber and thus may require special adhesives. A typical lamination stack would consist of; a vent layer, acrylic adhesive, polyurethane film, silicone adhesive and finely the apparatus. The acrylic adhesives should be stronger than the silicone adhesive to insure clean removal of the liner from the apparatus. Also, the silicone adhesive formulation must have greater adhesion to the polyurethane film than the silicone material of the apparatus. [0059] An additional layer of low friction material may also be applied to the vent layer of the liner in strategic areas to mitigate chaffing on the skin. Preferred locations will be discussed hereinafter. The following are examples of likely adhesives: 1. Acrylics 2. Silicone 3. Hydrocolloid [0060] FIG. 11B depicts another embodiment of ventilating the apparatus and seal area. In this case the skin contact side of the apparatus flange would contain a lattice of micro channels that provide a conduit for airflow. The aspect ratio of the channels would be sufficiently deep to prevent neck tissue from migrating to the bottom and blocking the airflow. Channel depth to width ratios may vary from 1 to 4. Channel width may vary from 0.0005 to 0.020. The flange surface area dedicated to the channel opening may range from 5 to 20 percent. The lattice would likely be configured in the injection mold tooling. Various techniques may be employed such as micromachining, chemical photo etching, or laser etching. Also secondary manufacturing process steps such as laser etching could be used on the apparatus flange directly. [0061] Simply drawing air across the flange may not be enough for some users. Conditioning the air in the apparatus may involve heating, cooling and controlling the humidity. FIG. 12 shows a system consisting of a dual line tubing, and an integrated vacuum and air conditioning unit. The system would meter conditioned air into the apparatus and exhaust air with the vacuum pump. The connecting tube may be two tubes in a sheath, integrally molded side by side, or concentric. FIG. 13 show a typical control scheme consisting of microcontroller, pump, inlet valve, heater, cooler, and pressure, temperature and humidity sensors. The microcontroller would compare sensor input 4 with target values and adjust the pump flow, inlet valve, heater and cooler accordingly. For example, to lower humidity and/or temperature the inlet valve would open increasing the air flow rate through the apparatus. Some individuals may like warm air when first going to bed. This could be done with electric heating or by utilizing the inherent heat caused by the pump and motor. Others may like additional cooling benefits that bring temperature levels in the apparatus below room temperature. The system would utilize solid-state thermoelectric (Peltier) cooling. In addition, a short duration maximum cooling feature could be incorporated that would cycle with every detected apnea event. Other means to reduce humidity may involve a closed air system circulated in the presence of a replaceable desiccant. [0062] A two tube system that ports both the supply and exhaust in the central region of the apparatus is the simplest air flow system. Any apparatus design which requires higher air exchange rate, however, may drive the need for higher pump capacities. A more efficient design locates the supply and exhaust ports near the ends of the apparatus. Forced air currents will then traverse approximately 8 square inches of skin surface prior to exhausting the apparatus. This will maximize effectiveness in managing moisture and temperature. [0063] FIG. 14 details a method that ports supply (conditioned) air to an annular channel that runs the complete periphery of the apparatus. The supply tube connection and the annular cavity are connected via integral cores in the apparatus or through external means. The advantage of this design is the conditioned air is forced under the flange. Since the flange area increases the total skin conditioning surface area by 30 to 50 percent the effectiveness is improved. The air supply annular channel is isolated from the outside by a lip seal. [0064] Many thick vent materials such as foams are ideally suited to enhance comfort but may pass too much air. However, they can be used by controlling the airflow rate with a secondary device. A secondary device could be an orifice or control valve. The apparatus design would have a full or partial annular channel as depicted in FIG. 14 . Air access to the channel would be controlled by one or more orifices or similar flow control device. [0065] C. Apparatus Positional Stability and Friction Reduction [0066] The apparatus when applied at therapeutic vacuums is securely held in position by the vacuum forces and the friction between skin and the silicone rubber material. The apparatus is preferably designed to match the profound shape of the mandible which causes the apparatus to follow natural head movement. While this establishes good positional stability, it is not favorable for the neck. When head/apparatus movement is greater than the flaccidity of the skin, sliding occurs. This causes chaffing and discomfort to the user. [0067] There are two approaches described in this disclosure for avoiding such chafing; the first is to reduce the friction of the materials used in the neck region and secondly to eliminate neck sliding by decoupling the mandible and neck flanges. FIG. 15 defines the different regions on the flange that high and low friction characteristics can be utilized in optimizing apparatus positional stability and user comfort. While this is a single approach, there are numerous embodiments that can yield similar results. There are many materials that exhibit a wide range of friction properties. They include but not limited to woven fabrics, non-wovens, plastic films and adhesives. The table below is a limited listing of materials and their coefficient of friction properties against human skin. [0000] Material Coefficient of Friction Rip-Stop Nylon 0.71 Silk 0.70 Spandex, loosely woven 0.69 Spandex, tightly woven 0.66 Black spandex 0.56 Crinkle cotton 0.69 Cotton 0.77 Loosely woven chiffon 0.56 Tightly woven chiffon 0.53 Light weight cotton 0.68 Cotton(1) 0.73 Cotton(2) 0.62 Satin 0.41 Medifoam #30 0.81 Neoprene soft side 0.61 Neoprene hard side 0.55 Laminate sample (1) 0.74 Laminate sample (2) 0.67 [0068] For example Medifoam #30 placed in the mandible region and satin placed in the neck region offer good positional stability without neck discomfort. In addition the apparatus flange itself may be conditioned with secondary process to influence the coefficient of friction. [0069] FIG. 16 shows a method of apparatus construction that minimizes lateral forces the flange imposes on the neck with head sideways rotation. The current apparatus design incorporates a simple dome to effectively react vacuum forces. A simple dome creates a stiff relationship between the upper and lower flange in the lateral shear direction due to the material being substantially in plane. To reduce this, the section modulus properties need to be softened by adding vertical invaginations in the dome. The arch of the dome will be maintained to carry the vacuum loads. [0070] FIGS. 17A and B shows several images of an apparatus with an integrally attached thin film or membrane. This membrane is situated between the apparatus support flange and the user's skin and ranges from 0.004 to 0.032 inches thick. With head motion, the apparatus flange will move while the flexible membrane remains fixed with respect to the skin. This forces the relative motion to occur between the apparatus flange and the membrane eliminating abrasion marks on the user's neck. The coefficient of friction between the flange and the membrane is reduced by use of any conventional liquid, gel or dry film lubricant. [0071] FIG. 18 shows a method to securely position the apparatus while providing a cloth vent layer between the apparatus flange and the user's skin. The outer fabric is a soft open weave mesh that promotes air circulation on the neck. It fastens in the back with snaps or Velcro tape. The inner fabric is the vent layer and likely thin cotton or similar. The inner layer is sewn to the outer fabric at the periphery of the apparatus. Additional material is tucked in the apparatus to provide clearance for tissue that enters the apparatus at vacuum. FIG. 19 depicts such an embodiment in cross section. [0072] B. Creating a Partial Vacuum—the Air Pump [0073] The term “air pump” as used herein refers to a device that removes gas molecules from a sealed chamber in order to leave behind a partial vacuum. [0074] A vacuum may be created within the chamber formed by the appliance and the user's skin surface in a number of ways. A simple method is to manufacture the therapy appliance using a resilient memory-shaped material that may be compressed like a bulb, mated to the user's throat, and then released. In this case, when the appliance is mated to the throat and the appliance released, return of the appliance to its original shape creates a partial vacuum within the space. [0075] A preferred powered design for a pump module utilizes a positive displacement pump, most preferably a diaphragm pump driven by either a linear motor, or a brushed or brushless DC rotational motor drive. In particularly preferred examples in which a linear motor is used, the linear motor is operatively linked to control circuitry configured to drive single discrete strokes of the pump as well as multiple strokes. In particularly preferred examples in which a DC motor is used, the motor is operatively linked to a controller configured to drive single discrete revolutions of the motor as well as multiple rotations. Examples of these and other suitable air pumps are described below. [0076] Another preferred powered design for a pump module utilizes a disc pump as described in WO2009/112866, which is hereby incorporated by reference in its entirety. In such a disc pump, a main cavity is defined by end walls and a side wall. The cavity is preferably circular in shape, although elliptical and other shapes could be used. The cavity is provided with a nodal air inlet and a valved air outlet. The actuator comprises a piezoelectric disc attached to a disc. When an appropriate electrical drive is applied, the actuator is caused to vibrate in a direction substantially perpendicular to the plane of the cavity, thereby generating radial pressure oscillations within the fluid in the cavity. The lowest resonant frequency of radial fluid pressure oscillations in the main cavity is preferably greater than 500 Hz, and the frequency of the oscillatory motion may be within 20% of the lowest resonant frequency of radial pressure oscillations in the main cavity. [0077] a. Air Pump Types [0078] The term “positive displacement pump” as used herein refers to a mechanism to repeatedly expand a cavity, allow gas molecules to flow into the cavity from the chamber, seal off the cavity, and exhaust the gas molecules to the atmosphere. Of the “positive displacement” type of vacuum pumps there are preferred candidates: vane pumps and diaphragm pumps. [0079] Vane pumps move gas through the pump using a rotating assembly in the pumping chamber that move the gas from inlet to outlet. As the rotor turns, the ends of the vane barely touch the housing, creating a seal from inlet to outlet. The gas is pressurized as the volume between the vanes lessens during one half-cycle and is suctioned through an intake port during the other half-cycle. Vane pumps create pressure pulses equal to the number of vanes contained within the pump and the speed at which the vanes are turned. The vane type pump does not maintain a vacuum throughout the pump circuit, and therefore the system would include a check valve between the pump and the enclosed partial vacuum chamber to prevent vacuum loss. Such pumps have very low starting torque and would be well suited for use with a DC motor. In comparison with other pumps, the noise frequency created will be higher and therefore may work well with sound abatement technologies described below. [0080] Diaphragm pumps are popular for small to medium size applications as an alternative to vane pumps. Diaphragm pumps can be extremely low maintenance and quiet. Diaphragm pump function by mechanically moving a diaphragm which displaces air. A pair of one way valves is provided to direct the movement of air, thereby creating the vacuum. These valves will also provide the necessary function of sealing the pump circuit from the enclosed partial vacuum chamber. [0081] Within this pump category there are several ways in which diaphragm movement is achieved. Linear pumps can connect the diaphragm directly to an armature and vibrate the armature in a linear direction. Motor control in this type of pump can be very simple. A linear motor driving a linear pump can move a diaphragm very slowly, which may be advantageous from the point of view of noise and vibration creation. Rotary diaphragm pumps stroke the diaphragm with a rotary to axial mechanical converter. They have low starting torque and can be coupled with DC motors. These pumps are inexpensive. [0082] In another alternative, an air pump may be a dynamic pump such as a regenerative pump. In a regenerative pump, an impeller rotates, creating a centrifugal force which moves the air molecules from the blade root to its tip. Leaving the blade tip, the air flows around the housing contour and back down to the root of a succeeding blade, where the flow pattern is repeated. This action provides a quasi-staging effect to increase pressure differential capability. The speed of the rotating impeller determines the degree of pressure change. Such pumps are best used for external (e.g., table-top) vacuum sources, as opposed to a vacuum source supported on the user as described herein. [0083] A particularly preferred pump is a diaphragm pump having a single stroke displacement of between 0.001 and 0.01 in 3 , and most preferably in the range of 0.003 to 0.005 in 3 . A pump with a displacement of about 0.004 in 3 will yield a maximal evacuation rate of 12 in 3 /min when driven at 3000 rpm using a rotary brushless DC motor or 60 Hz using a linear DC motor. This could completely evacuate an appliance enclosing a volume of between 0.5 and 2 in 3 in 2.5 to 60 seconds. Of course, complete evacuation of the chamber enclosed by the appliance is not required to generate a therapeutic level of vacuum. For example, in an appliance providing an 8 in 3 chamber, removal of about 1.6 in 3 can provide an appropriate working pressure. Thus, a full pumping mode of 1 to 25 in 3 /min can quickly generate therapeutic vacuum levels within the appliance. [0084] Following the initial evacuation, the air pump is driven only as needed to maintain the partial vacuum above the desired threshold. Assuming a leakage rate of air into the enclosed chamber at a rate of between 0.005 and 0.5 in 3 /min, the diaphragm pump could be driven to pulse a single stroke only once every few seconds to few minutes. This dual evacuation/quiet mode approach has numerous advantages, including being extremely quiet and low in both vibration and battery consumption. For example, a preferred pump can run in quiet mode at a rate of between 0.005 and 0.5 in 3 /min (most preferably at 0.01 and 0.1 in 3 /min), which can remove between 2.4 and 240 in 3 of air in an 8 hour night. Given a pumping rate of 5 strokes a second and a pump displacement of 0.004 in 3 /stroke, such a pump could run 0.25 to 25 seconds out of each minute and still deliver the desired performance. [0085] b. Electric Motor Types [0086] This application requires both slow and fast operation, low sound production, and efficient battery usage. In a DC motor, when the motor is provided with its rated voltage, the motor operates at full rpm. To control speed, one must turn the motor off for a short period of time. This motor voltage is provided typically as a square wave. The frequency of this square wave is typically very fast (optimally in a range of from 2,000 to 18,000 Hz), and the amount of power the motor receives is proportional to the percentage of time the square wave is “on” versus “off.” This technique is called pulse width modulation (PWM). PWM accommodates the slow motor speed operation required of the “quiet mode” as short pulses of full voltage create strong magnetic fields that force highly controlled partial rotations. Running in the very slow speed range may require the addition of an encoder to provide feedback to a controller for accurate speed control. [0087] C. Vacuum Control [0088] Vacuum control may be provided by both mechanical and/or electronic control mechanisms. A simple mechanical mechanism to control the vacuum within the appliance chamber is to provide a miniature vacuum relief valve press fit into a port in the appliance. The relief valve is selected to admit air when a preselected vacuum level is exceeded. The air pump is then driven at a constant speed, with the vacuum release valve controlling the partial vacuum by opening when the vacuum exceeds a desired level and closing below that level. Preferred operational vacuum levels are selected within a range of between about 7.6 cm to about 61 cm of water by inserting an appropriate vacuum relief valve to eliminate undesirable over-pressure conditions above a predetermined range. No monitoring of internal vacuum or control of the motor driving the air pump is necessary in this embodiment. However, this embodiment would tend to provide unnecessary noise and to use battery power at a potentially undesirable rate. A preferred electronic/mechanical vacuum control mechanism may comprise a microcontroller coupled to a vacuum or pressure sensor, motor control circuitry, and a battery pack module. [0089] Numerous optional components can be employed to improve the performance and control of the device. For example, because the volume enclosed by the appliance and the user's skin is approximately known, the time to achieve the partial vacuum can be calculated. The vacuum or pressure sensor detects a drop in vacuum that requires energizing the pump and motor. If it is determined that the partial vacuum has not been achieved in some appropriate time, the vacuum source can be deactivated, and optionally an alarm condition indicated. Suitable alarms can include visual (e.g., a light), auditory (e.g., a tone), and/or tactile (e.g., vibration) indicators. [0090] The partial vacuum can be cycled during at least part of the therapy period to a lower level to vary the force load at the contact surface with the user's skin. Optionally, the controller circuitry is programmable, allowing the user or medical personnel to alter various parameters, such as vacuum levels, alarms, sensor types, etc., as well certain optional features such as noise compensation. [0091] a. Vacuum/Pressure Sensor(s) [0092] As discussed above, a vacuum sensor to determine the differential between the chamber partial vacuum and ambient atmospheric pressure may be connected to the controller, and is used to maintain the partial vacuum at a desired level. Suitable micromachined silicon sensors in pc board-mountable packages are known in the art. These sensors may include temperature compensation or calibration circuitry, or such circuitry may be optionally provided as separate electronic components. A vacuum pressure transducer typically provides a voltage output that is proportional to changing pressure (e.g., increasing vacuum), while an absolute pressure transducer typically provides a voltage output proportional to increasing pressure (e.g., decreasing vacuum). [0093] D. Data Import and Export [0094] The microcontroller is preferably operably connected to a data input device such as a keypad or touchscreen to allow the user or medical personel to, among other things, set the desired level of partial vacuum. In simple form, a single button may be repeatedly depressed, with the number of button presses counted and converted to a vacuum setting by the microcontroller. In more complicated devices, a display might provide a digital readout of the current setting, and up/down arrow keys used to increase/decrease the setting. Finally, a keypad may be employed to simply type in a desired setting. In all cases, the data input device may communicate with the control module in a wired or wireless manner. In the case where the caregiver is setting the vacuum level, it may be advantageous to have the data input device be either separate or removable from the control module so that alterations cannot be made in an uncontrolled manner. [0095] The apparatuses of the present invention may be configured to record and/or respond to various characteristic sensors. The term “characteristic sensor” as used herein refers to a sensor which detects some characteristic of the user and generates an electronic result corresponding to that characteristic. As noted above, numerous sensor types, such as thermistors, acoustic sensors, oximiters, vibration sensors, etc. are known in the art for sensing respiratory cycles, apnea events, and snoring events. U.S. Patent Publication 2006/0009697, which is hereby incorporated by reference in its entirety, discloses a single, low-profile, disposable system that measures a variety of vital signs, including blood pressure, without using a cuff. This and other information can be easily transferred from a patient to a central monitor through a wired or wireless connection. For example, with the system a medical professional can continuously monitor a patient's blood pressure and other vital signs during their day-to-day activities, or while the patient is admitted to a hospital. This system can also characterize the patient's heart rate and blood oxygen saturation using the same optical system for the blood-pressure measurement. This information can be wirelessly transmitted along with blood-pressure information and used to further diagnose the patient's cardiac condition. [0096] Such sensors may be worn by the user during use of the therapy appliances described herein, and information gathered therefrom transmitted to caregivers or others selected to receive telemetry regarding the appliance. The resulting information has many uses for patients, medical professional, insurance companies, pharmaceutical agencies conducting clinical trials, and organizations for home-health monitoring. [0097] Data import and export may be by wired and/or wireless means. The term “wired” in this context refers to any method in which there is a physical contact which operably connects the control module to an external device, such as a PDA, computer, cellular telephone, network connection, etc., which sends data to or retrieves data from the control module. The term “wireless” refers to any method in which data is sent to or retrieved from the control module without a physical connection. [0098] In the case of a wired data transfer, a cabled USB connection between the control module and the external device is one example that may be provided. While USB type connections have become ubiquitous, any form of connection where contacts on one device physically meet contacts on another device. Alternatively, a memory card, such as a Memory Stick, Secure Digital, Flash memory drive, etc., may be used to transfer data by moving the memory card between the control module and the external device. [0099] In the case of a wireless data transfer, numerous standards well known in the art may be used. Such wireless connections include various radio frequency and optical (e.g., infrared) connections that are known in the art. For relatively short distance RF communications, Bluetooth, HomeRF, IEEE 802.11b, IEEE 802.11a, and IEEE 802.15.4 are well known standard communications protocols that may be used. For somewhat longer range data transfers, cellular telephone protocols such as CDMA, TDMA, GSM, and WAP may be employed. [0100] These methods need not be used in isolation, but instead may be advantageously employed in combination. For example, the control module may communicate at a short distance with a local “base station” by a wired or wireless mechanism, and the base station may then communicate with an external device, for example at a caregiver's office or central data collection point, using one of the cellular telephone protocols, or through telephone twisted pair, cable TV, or other wiring existing in the user's location. This can extend battery life in the control module by lowering power requirements for communication, while the base station may be powered by line voltage. [0101] Numerous battery technologies are known in the art, including common alkaline batteries, oxyride batteries, lithium batteries, etc. There are three preferred battery technologies that could be employed: Nickel Cadmium (NiCad), Nickel Metal Hydride (NiMH) and Lithium Ion (Li-ion), and most preferred are Li-ion batteries. An exemplary power consumption for a battery-powered system will be 45 mA per hour at 4.8 volts. In such a configuration, which can be provided by a 4 cell AAA size NiMH battery pack, the systems described herein could easily operate for an 8-hour sleep period. Alternatively, a 2 cell 300 mAh Li-ion battery pack operating at 7.4 volts can provide similar performance. A most preferred system would operate for an 8-hour period using a single 3.7 volt Li-ion cell providing at least 600 mAh. [0102] In the case of rechargeable batteries, the battery could be provided with a wired plug in to a conventional charger, with contacts which mate with contacts on a battery charging “station,” or with an inductive coupling using an inductive coil that would be located on the surface of the vacuum module. [0103] F. Compensating for Movement-Induced Changes Vacuum [0104] Simple body movements can substantially change the force applied to the user's neck, due to movement-induced changes in the internal volume of the appliance. For example, if one considers an appliance having an internal chamber volume of 8.6 cubic inches affixed to an adult male, the act of swallowing can increase the volume of the chamber by some 1.7 cubic inches due to displacement of the throat, a nearly 20% increase. [0105] Although the therapy appliance may have some ability to flex, the appliance must be sufficiently rigid to maintain a spacing between the appliance and the throat. As a result, the movement-induced increase in volume is felt as a sudden increase in the pressure applied to the throat of the user. The air pressure within the therapy appliance may be modeled using the ideal gas law, which provides that the pressure of a gas is related to the volume occupied by that air. The state of an amount of gas is determined by its pressure, volume, and temperature according to the equation PV=nRT, where P is the absolute pressure, V is the volume of the vessel, n is the number of moles of gas, R is the universal gas constant, and T is the absolute temperature. [0106] If one assumes that a partial vacuum greater than about 7.6 cm H2O is required to establish a beneficial therapeutic effect, and that movement can suddenly increase the volume enclosed by the therapy appliance by 20% or more due to displacement of the throat, one skilled in the art will recognize that the increase in enclosed volume causes an equivalent 20% increase in the partial vacuum within the therapy appliance. The resulting sudden increase in the forces exerted on the tissues of the throat at the contact surfaces of the appliance can cause discomfort to the wearer, arousal from sleep, etc. [0107] This movement-induced increase in vacuum can be particularly problematic in the case of an integrated ambulatory appliance design, as the vacuum source and associated connections to the vacuum chamber are minimized in volume. As a result, the movement-induced volume changes are more pronounced in percentage terms in comparison to the total vacuum space volume. Said another way, the smaller the volume of the appliance's internal chamber and associated vacuum system, the greater the added force caused by swallowing or coughing. [0108] Thus, a buffering component may be provided to dampen these movement-induced swings in the partial vacuum created within the appliance. This may be modeled most simply as a moveable diaphragm attached to a spring. The spring tension is configured to hold the diaphragm in place when the partial vacuum is within a designed tolerance. That is, if the appliance is designed to produce a partial vacuum of about 18 cm H 2 O, the spring would not compress or expand at this pressure. The buffer spring may be preloaded at the therapeutic vacuum level by a predetermined amount so that the diaphragm of the appliance is maintained in a predetermined position at that vacuum level. If the desired vacuum level is exceeded, as in the case of the user swallowing, the spring would allow the diaphragm to move to compensate at least in part for the sudden increase in enclosed volume. If the spring is mounted inside the diaphragm (relative to the partial vacuum), the spring would compress; if the spring is mounted outside the diaphragm, the spring would expand. Once the movement had ended, the spring would return to its original shape, thereby returning the diaphragm to its original position. The result is to buffer the increase in pressure felt by the user. [0109] Although described in terms of a spring and diaphragm, other configurations will be readily apparent to those of skill in the art. For example, a buffering component can be provided as a portion of the appliance surface which can flex inward when the internal vacuum exceeds a desired level, and then return to its original position when the vacuum increase subsides. [0110] G. Sound Management and Abatement [0111] As the devices described herein are primarily intended for use during sleep, the ability to minimize disruptions due to noise and/or vibrations can provide clear advantages to the user. Many of the pumping technologies available in the art create substantial noise during use. Moreover, when the pump is cycled on and off during the night, the abrupt changes in sound levels can be particularly disruptive to sleep. In certain embodiments therefore, the devices described herein are coupled with devices that provide improved comfort by managing the sound, masking the sound, and/or cancelling the sound produced during use of the therapeutic appliance. [0112] The term “sound management” as used herein refers to reducing the sound level produced by the device. Motors running at high speed tend to be noisy; low speeds tend to be quiet. As discussed above, DC motor speed is typically controlled by pulse width modulation (PWM). Most positive displacement pumps do not impose a constant torque load on the motor as it rotates 360 degrees. Rather, they have an up stroke and down stroke. When running fast this variation in torque gets lost in the rotor inertia and the motor sounds noisy. [0113] But in a DC motor that is externally commutated, the electronics can determine exactly where in the 360 degree rotation the pump/motor is. In preferred embodiments, the controller is used to increase the electrical pulse width during the rotational portion of the pumping stroke, and decrease the pulse width in the remaining portion of the pumping stroke. By mapping the pump-imposed torque profile of the motor and replicating that with pulse width profile, the pump/motor can be made to run slower, resulting in lower noise and vibration. [0114] In certain embodiments, the therapy appliances of the present invention are combined with sound masking electronics to at least partially mask the noise created by the mechanical and electronic components. The term “sound masking” as used herein refers the addition of natural or artificial sound of a different frequency (more commonly though less-accurately known as “white noise” or “pink noise”) into an environment to “mask” or cover-up unwanted sound by using auditory masking. Sound masking reduces or eliminates awareness of pre-existing sounds in a given area and can make a work environment more comfortable, while creating speech privacy so workers can be more productive. Sound masking can also be used in the out-of-doors to restore a more natural ambient environment. [0115] Sound masking is often used in the field of architectural acoustics and in the production of electronic music to mask distracting, undesirable noises. Simple “white noise” machines can be very simple, involving an enclosed fan and (optionally) a speed switch. This fan drives air through small slots in the machine's casing, producing the desired sound. More complex machines may be electronic, and offer a variety of “nature sounds.” A Sound generator may be carried on the appliance itself, as depicted in FIG. 9 , or may be provided as a separate unit. [0116] Similarly, in certain embodiments, the therapy appliances of the present invention are combined with sound cancelling electronics to at least partially mask the noise created by the mechanical and electronic components. The term “sound cancellation” as used herein refers to the provision of phase cancellation pressure waves. Sound may be considered a pressure wave, which consists of a compression phase and a rarefaction phase. A noise-cancellation speaker emits a sound wave with the same amplitude and the opposite polarity (in antiphase) to the original sound. The waves combine to form a new wave, in a process called interference, and effectively cancel each other out—an effect which is called phase cancellation. Depending on the circumstances and the method used, the resulting sound wave may be so faint as to be inaudible to human ears. [0117] Cyclic sounds, even complex ones, are easier to cancel than random sounds due to the repetition in the wave form. Thus, sound cancellation is particularly applicable to the present invention. In preferred embodiments, a microphone is placed near the ear, and electronic circuitry which generates an “antinoise” sound wave with the opposite polarity of the sound wave arriving at the microphone is delivered through speakers placed at the ear in the form of headphones or earbuds. This results in destructive interference, which cancels out the noise within the enclosed volume of the ear. Noise cancellation circuitry or sound masking circuitry may be carried on the appliance itself, or may be provided as a separate unit. Sound from the circuitry can be provided through small speakers or earbuds. [0118] H. Additional Elements [0119] WO08/076,421 and WO09/143,259, each of which is hereby incorporated by reference in its entirety including all tables, figures and claims, describe negative pressure therapy appliances for relieving airway obstruction. These publications describe various elements which may be provided in various combinations with the apparatus of the present invention. These elements include the following. [0120] A first combination provides a therapy appliance comprising a peripheral surface configured to mate with and thereby enclose an external area of the throat overlying the upper respiratory passage, whereby, when mated, said therapy appliance provides a space-filled chamber lying between the inner surface of the therapy appliance and the throat having an enclosed volume of between 0.5 and 12 in 3 ; and an air pump operably connected to the chamber and configured to maintain a partial vacuum within said chamber at a level between 7.6 cm and 61 cm of water while generating a sound level of less than 40 dB SPL. [0121] A second combination provides a therapy appliance comprising a peripheral surface configured to mate with and thereby enclose an external area of the throat overlying the upper respiratory passage, whereby, when mated, said therapy appliance provides a space-filled chamber lying between the inner surface of the therapy appliance and the throat having an enclosed volume of between 0.5 and 12 in 3 ; and an air pump operably connected to the chamber and configured to maintain a partial vacuum within said chamber, wherein said air pump comprises a positive displacement pump. [0122] A third combination provides a therapy appliance comprising a peripheral surface configured to mate with and thereby enclose an external area of the throat overlying the upper respiratory passage, whereby, when mated, said therapy appliance provides a space-filled chamber lying between the inner surface of the therapy appliance and the throat having an enclosed volume of between 0.5 and 12 in 3 , wherein said therapy appliance comprises a buffering component configured to dampen swings in the partial vacuum created within the appliance by user movement; and an air pump operatively connected to the space-filled chamber to provide a partial vacuum within the chamber. [0123] A fourth combination provides a therapy appliance comprising a peripheral surface configured to mate with and thereby enclose an external area of the throat overlying the upper respiratory passage, whereby, when mated, said therapy appliance provides a space-filled chamber lying between the inner surface of the therapy appliance and the throat having an enclosed volume of between 0.5 and 12 in 3 , wherein said peripheral edge is configured to provide a pressure along the contact surface with the user's skin of 60 mm Hg or less at a partial vacuum level within said enclosed volume of between about 7.6 cm to about 61 cm of water; and an air pump operably connected to the chamber and configured to maintain a partial vacuum within said chamber [0124] A fifth combination provides a therapy appliance comprising a peripheral surface configured to mate with and thereby enclose an external area of the throat overlying the upper respiratory passage, whereby, when mated, said therapy appliance provides a space-filled chamber lying between the inner surface of the therapy appliance and the throat having an enclosed volume of between 0.5 and 12 in 3 and having a vacuum control module comprising a microcontroller coupled to a vacuum or pressure sensor and motor control circuitry which controls the pump on/off cycles and/or speed. [0125] A sixth combination provides a therapy appliance which is a biocompatible single integral element that provides a seal at the skin interface having a low leakage rate of air into the enclosed chamber, preferably a rate of between 0.005 and 0.5 in 3 /min, and most preferably at 0.01 and 0.1 in 3 /min; a diaphragm pump having a single stroke displacement of between 0.001 and 0.01 in 3 , and most preferably in the range of 0.003 to 0.005 in 3 , driven using a rotary brushless DC motor or a linear DC motor; and a vacuum control module comprising a microcontroller coupled to a vacuum or pressure sensor and motor control circuitry which controls the pump on/off cycles and/or speed. [0126] While the invention has been described and exemplified in sufficient detail for those skilled in this art to make and use it, various alternatives, modifications, and improvements should be apparent without departing from the spirit and scope of the invention. The examples provided herein are representative of preferred embodiments, are exemplary, and are not intended as limitations on the scope of the invention. Modifications therein and other uses will occur to those skilled in the art. These modifications are encompassed within the spirit of the invention and are defined by the scope of the claims. [0127] It will be readily apparent to a person skilled in the art that varying substitutions and modifications may be made to the invention disclosed herein without departing from the scope and spirit of the invention. [0128] All patents and publications mentioned in the specification are indicative of the levels of those of ordinary skill 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. [0129] The invention illustratively described herein suitably may be practiced in the absence of any element or elements, limitation or limitations which is not specifically disclosed herein. Thus, for example, in each instance herein any of the terms “comprising”, “consisting essentially of” and “consisting of” may be replaced with either of the other two terms. The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention that in the use of such terms and expressions of excluding 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. Thus, it should be understood that although the present invention has been specifically disclosed by preferred embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this invention as defined by the appended claims. [0130] Other embodiments are set forth within the following claims.

A device and a method for creating and/or maintaining an obstruction free upper respiratory passages. The device is configured to fit under the chin of a subject adjacent to the subject's neck at an external location corresponding approximately with the subject's soft tissue associated with the neck's anterior triangle. The device is capable of exerting negative pressure on the surface of a subject's neck, displacing the soft tissue forward and enlarging the airway.

FIELD OF THE INVENTION The present invention relates to the game of golf and in particular to a method and facility for playing a game at a golf range. BACKGROUND OF THE INVENTION Golf is becoming an increasingly popular sport around the world. It can often be difficult, however, for various reasons for players to find a golf course where they can play. Also, a conventional round of golf takes at least several hours to play which can be prohibitive for many players. For these reasons, many people attend golf practice ranges to practice their golf shots without playing an actual round of golf. Hitting golf shots at a practice range can become monotonous, however, and there is a desire to incorporate a game into the practice routine. Various forms of games played at golf ranges are known. Examples of such games are taught in U.S. Pat. Nos. 1,851,423 (Ely) and 2,248,053 (Bales) and in Japanese Patent 06-182011 (Buruusu). In each of these games, players hit golf balls from a tee area to a range area. The range area is adapted in various ways to facilitate the playing of a game. In the Ely patent, the range area is divided into spaced transverse rows which are marked to indicate distances from the tee area. A number of target greens are located at various distances and positions about the range area. The Ely patent teaches a game where a player hits a golf ball toward the farthest target green and observes where it lands. If the ball lands on the green, the player determines how far the ball is from the pin (with the aid of concentric circles marked on the green) and the player then moves to a putting green (located behind the tee area) to attempt to sink a putt from a distance equivalent to the observed distance. If the player's drive does not reach the farthest green, the player determines how far the ball is from the pin (with the aid of the rows of distance markings). The player then hits another ball towards a target green that is located at a distance from the tee that approximates the observed distance for the player's first shot. The player continues until the ball reaches a target green and then he putts out at the putting green as described above. The Bales and Buruusu patents each teach modified range areas that are divided into a grid pattern made up of spaced rows and columns. The rows are positioned at clearly marked distances from the tee area. The columns intersect the rows and define three areas corresponding to a fairway, a rough area and an out-of-bounds area similar to an actual golf course. A player is given a scorechart containing conventional distance markings for each hole of an 18 hole course. The player then utilizes the distance markings and grid pattern of the range area to play a modified form of an actual golf game. For instance, for a par 4 hole of 375 yards, the player attempts to hit a drive as close to the full 375 yards as possible within the fairway. If the player observes the ball landing in the 200 yard grid of the fairway, he knows that his next shot should be for the 175 yard grid to equate to landing his ball on the green. If the player drives into the rough portion of the fairway, he is assessed a distance penalty, and if the player drives out of bounds, he is assessed a stroke penalty. Optional chipping areas and putting greens are also contemplated for completing the hole. While the above-described games permit a modified form of golf to be played at a range area, they are relatively complicated to play. Also, the games do not provide an optimum means for scoring that allows for healthy competition between players. Moreover, the known games do not satisfactorily measure and reward a player's accuracy in driving and chipping or promote the development of the skills that yield accuracy. The known games also do not facilitate imitation of a variety of different courses, whose fairways may feature not only a variety of different overall distances, but also a variety of different layouts, hazards and obstacles that require the golfer to combine different combinations of long, short and medium drives to get from the tee to the green of each hole. The object of the present invention is to provide an alternative golf range game that is simple to play and incorporates a straightforward scoring system so that players may compete against each other to increase their enjoyment, and that promotes development of the players' golfing skills to achieve accuracy in driving and chipping as well as distance. SUMMARY OF THE INVENTION According to one aspect, the present invention provides a method for playing a game at a golf range facility. The method comprises a number of steps. First, a designated target region is determined from scoring means that sets out a sequence of target identifiers, each of which is associated with one of a plurality of contiguous, visibly divided target regions in a range area of the facility. Second, a golf ball is hit with a golf club from a tee of the facility toward the designated target region as determined in the first step. Third, a point score is recorded by the scoring means, the score being awarded according to the observed resting position of the golf ball hit in the second step relative to said designated target region as determined in the first step. Then, these three steps are repeated until the sequence of target identifiers set out by the scoring means has been completed in order. According to another aspect, the invention also provides a facility for playing a game with a golf club and golf balls. The facility comprises a site and a scoring means. The site has at least one tee, and also has a range area visibly divided into a plurality of contiguous target regions, each said target region being associated with a target identifier. The scoring means sets out a sequence of such target identifiers so as to establish a series of designated target regions to which golf balls are to be hit from the tee with a golf club in order, and provides means for recording a point score for each time a player hits a golf ball, the score being awarded according to the observed resting position of the golf ball relative to the designated target region. Preferably, the target regions are arranged in a grid of intersecting rows and columns, with each target region being identified by a row identifier and a column identifier. More preferably, the scoring means includes a chart with an arrangement of target identifiers for 18 holes of golf. The target identifiers are arranged in spaced relationship with blank writing areas adapted to record point scores. Most preferably, a plurality of scorecharts are provided for a player to select. The scorecharts would set out different sequences of target identifiers corresponding to different golf courses. It has been found that the golf game method and facility of the present invention is simpler to play than prior known games and provides for healthier competition among players and promotes development of playing skills. BRIEF DESCRIPTION OF THE DRAWINGS For a better understanding of the present invention, and to show more clearly how it may be carried into effect, reference will now be made, by way of example, to the accompanying drawings. The drawings show a preferred embodiment of the present invention, in which: FIG. 1 is a plan view of a golf range facility in accordance with the present invention; FIG. 2 is a sectional view of the golf range facility taken along lines 2--2 of FIG. 1; and FIG. 3 is a plan view of a scorechart in accordance with the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT A golf facility in accordance with the present invention is shown generally at 10 in FIG. 1. The golf facility includes a club house 12, a tee area 14 and a range area 16. Referring to FIGS. 1 and 2, the tee area 14 is divided into a series of tees 18 which are each sized to allow a player sufficient space to hit a golf ball towards the range area 16. Each tee is preferably also provided with seating and golf bag holders so that a group of players (preferably four players) can play a game from the same tee. The tees may be covered to protect players from the rain. Also, the tees may be stacked one above the other to allow more players to play at one time. The tees are arranged in a radius relative to a point 20 on an imaginary longitudinal centre line 22 of the range area 16. This arrangement of tee area 14 allows each tee to face generally toward the centre of the range area 16. The range area 16 is formed over a substantially open area such as a field 24. In the preferred embodiment, it is contemplated that approximately ten acres of area is required to house the entire golf facility. The range area 16 preferably includes diverging side boundaries 26 in plan view so that the widest portion of the range area 16 is located furthest from the tee area 14. Nets 27 may be positioned outside the side boundaries 26 to prevent golf balls from travelling beyond the grounds of the golf facility. The range area 16 is divided into target regions 28 that are arranged in a grid of intersecting rows 30 and columns 32. Thus, a particular target region within the grid may be identified by a row marking 34 and a column marking 36. The row and column markings are displayed on signs (not shown) in the range area 16 that are visible from the tee area 14. The boundary lines 40 for the rows and columns are clearly marked on the grass so that they are visible from the tee area 14. For instance, the lines could be marked by paint, lime or lengths of tape or rope. To aid visibility, the range area 16 preferably is positioned northwards relative to the tee area 14 along a gradual upward slope. Also, the tee area 14 is preferably elevated relative to a substantial portion of the range area 16. The rows and columns of the grid are arranged such that the target regions 28 increase in area the further they are located from the tee area 14. In this way, the increased difficulty in accurately driving a golf ball over increasingly long distances is taken into account. The gradual increase in area of the target regions 28 is accomplished by increasing the spacing between the boundary lines 40 of the rows and/or diverging the boundary lines 40 of the columns 32. In the preferred embodiment, the row boundaries would be set at 35, 50, 70, 100, 140, 180, 220, 260 and 300 yards from the tee area 14. Furthermore, the column boundaries are preferably spaced 18 yards apart along the 35 yard row boundary and 35 yards apart at the 300 yard row boundary. Thus, the range area 16 diverges from a width of 90 yards at the 35 yard boundary to 175 yards at the 300 yard boundary. Referring to FIG. 1, it may be seen that centre zones 42 are arranged in many of the target regions 28. The centre zones are marked with boundary lines 40 so that they are visible from the tee area 14. In the preferred embodiment, the centre zones have a diameter of approximately twenty feet. In the preferred embodiment, the range area 16 is divided into five columns 32. The centre zones are located in the inner three columns 32 beginning at the 50 yard row boundary and ending at the 220 row boundary. The target regions 28 located beyond the 220 row boundary do not require centre zones. As will be explained in more detail below, points are awarded according to where a player's ball rests relative to a designated target region. Referring to FIG. 3, a scorechart 60 is depicted. The scorechart 60 includes eighteen scoring columns 62 corresponding to the eighteen holes of a conventional golf course. Several grid marking rows 63 intersect the scoring columns 62. Each of the scoring columns 62 have at least one grid marking 64 for identifying a particular target region in the range area 16. It will be noted that some scoring columns 62 include three grid markings along the row while other columns have one or two grid markings. This different arrangement of grid markings corresponds to the number of full shots required to reach a golf green in regulation for a particular par-rated hole. A par five hole would require three full shots, a par four hole would require two full shots and a par three hole would require one full shot. Accordingly, the front and back nine holes depicted on the game card each correspond to a conventional golf course arrangement of holes. For a conventional nine holes of par 36, the arrangement would consist of two par five holes, two par three holes and five par four holes. Of course, a different par course (e.g. par 71) would have a different arrangement of holes. Several rows of grid markings are provided to account for players of different skill levels. In addition, the scorechart includes an information row 65 adjacent to each grid marking row for identifying whether the grid marking is scored as a distance shot (explained further below). Also, a handicap row 66 is provided for handicapping regular players of the game. A topography row 67 is provided so that the topography of each hole may be depicted in each scoring column. This is especially desirable when the scorechart is designed to mimic the shots made on an existing golf course which the player may be familiar with. The scorechart includes a multiplicity of score recording rows 69 for recording each player's score as the game is played. The score recording rows are divided by columns to define a shot score recording space 71 and a hole score recording space 73. A point score is inserted in the shot score recording space for each shot attempted for a particular hole. After a player has completed his or her shots for a particular hole, the individual shot scores are added up and the sum is placed into the hole score recording space. The scores from each of the hole score recording spaces are then summed up at the end of 9 and 18 holes and the sum totals are placed in the front nine recording space 75, back nine recording space 77 and game total recording space 79, as known in the art. It is contemplated that the scorechart could be electronically displayed along with a computer animated depiction of the course. A player could then select a desired golf course and the computer would generate a scorechart directed specifically to the holes of the desired course. The number of players and their respective skill levels and handicaps could be entered upon the computer so that a customized game can be generated. It will now be appreciated how the game is to be played. Before playing the game, the player chooses a scorechart and positions himself at a tee. The player then refers to the grid marking on the scorechart, selects an appropriate club and attempts to hit the golf ball into the target region identified by the grid marking. The player observes where his ball rests relative to the designated target region and then places a score in the scorechart according to a designated scoring system. One preferred scoring system is as follows: ______________________________________Points Result______________________________________0 points Ball rests in centre zone of designated target region1 point Ball rests in designated target region2 points Ball rests in adjacent target region3 points Ball rests anywhere else______________________________________ Once the player has scored his shot, he refers to the scorechart to determine the next designated grid marking and repeats the above exercise. Once a player has attempted each of the one to three grid markings of a hole, the player adds the individual scores for each grid marking and the sum is awarded as the player's score for the hole. The player continues until all 18 holes are completed. Once all 18 holes are completed, the player with the fewest number of points would be declared the winner. Players who have played a specific game a number of times may average their scores to determine a handicap as known in conventional golf. In a modified (and more preferred) version of the above scoring system, certain grid markings are scored as distance shots and certain grid markings are scored as target shots. The distance shot grid markings are those generally corresponding to longer distance shots on a golf course. These may vary according to a player's skill level. Accordingly, for a par five hole, the first two shots may be considered distance shots and for a par four hole, the first shot may be considered a distance shot. On certain courses, however, the first shot of a par five may require a layup. In such cases the first shot may instead be scored as a target shot. The designation of a distance shot is made in the distance shot information row 65. If no marking appears in the distance shot information row then the shot is a target shot. A preferred scoring system for the modified version is as follows: ______________________________________Points Result______________________________________Distance Shot0 points Balls rest in further row and same column as designated target region1 point Ball rests in designated target region2 points Ba1l rests in adjacent target region3 points Ball rests anywhere elseTarget Shot0 points Ball rests in centre zone of designated target region1 point Ball rests in designated target region2 points Bali rests in adjacent target region3 points Ball rests anywhere else______________________________________ The game would be played in the same manner as described previously and the player with the fewest points at the end of 18 holes would be declared the winner. It is to be understood that what has been described is a preferred embodiment of the invention. The invention is nonetheless susceptible to certain changes and alternative embodiments fully comprehended by the spirit of the invention as described above, and the scope of the claims set out below. For instance, the scale of the game may be adjusted to facilitate playing the game in one's backyard or over a small body of water (such as at a cottage). Also, a virtual simulation of the game could be developed for playing the game by computer with the player controlling a simulated golfer hitting golf balls.

A method and a facility for playing a game with a golf club and golf balls, the facility comprising: a site having a range area visibly divided into a plurality of contiguous target regions, each said target region being associated with a target identifier, and a tee area having a plurality of contiguous tees from which golf balls may be hit toward said range area; scoring means located at said site for scoring a game, said scoring means setting out a sequence of said target identifiers so as to establish a corresponding sequence of designated target regions to which golf balls are to be hit from the tee with a golf club in order, and said scoring means providing means for recording a point score for each time a player hits a golf ball; and a scoring system associated with said scoring means for awarding a point score according to the observed resting position of the golf ball relative to the designated target region.