Abstract:
The present invention relates to a nano-enhanced device for substance transfer between the device and a tissue. The device comprises a substrate with substantially aligned carbon nanotubes anchored within the substrate, and with at least one end of the carbon nanotubes protruding from the substrate. The protruding nanotube ends may be coated with a drug for delivery of the drug into body tissue. The present invention may be incorporated into an angioplasty catheter balloon or into a patch that is worn on the skin. The carbon nanotubes can be grouped in clusters to effectively form nano-needles which can transfer fluid to or from the subdermal tissue. The nano-needles can be used in conjunction with a sensor to ascertain body fluid information such as pH, glucose level, etc.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of U.S. application Ser. No. 13/053,018 filed Mar. 21, 2011, which is a continuation of U.S. application Ser. No. 10/876,397 filed Jun. 24, 2004, now U.S. Pat. No. 7,909,839, which claims the benefit of U.S. Provisional Ser. No. 60/574,741 filed on May 26, 2004, which applications are fully incorporated herein by reference. 
     
    
     FIELD OF INVENTION 
       [0002]    The present invention pertains to devices for performing gastric bypass surgery for morbidly obese individuals, and more specifically, to a gastric bypass band which creates a small gastric pouch from the esophagus and a portion of the proximal stomach. This invention also details the gastric bypass surgery method that is performed in conjunction with the application of the gastric bypass band. 
       BACKGROUND 
       [0003]    In the United States, obesity affects the health of 80 million adults, or 35 per cent of the adult population, according to statistics from the Centers for Disease Control and Prevention. American children are also becoming increasingly affected by obesity, as 9 million, or 15 per cent of the child population has fallen victim to this disease in recent years. 
         [0004]    Morbidly obese individuals are identified as those where the disease of obesity has advanced to where the individual has a Body Mass Index (BM1) of over 40 or a BMI of over 35 along with other “co-morbidities” such as diabetes or high blood pressure. To reach a BMI of 35, a 5-foot-10-inch man or a 5-foot-4-inch woman would need to weigh 243 pounds and 204 pounds, respectively. For these individuals, dieting has often become a futile effort, as while some pounds may be shed, over time it has been found that these pounds are often quickly regained. Due to the health threats posed by their condition, morbidly obese individuals have turned to gastric bypass surgery in increasing numbers as an effective method to lose weight. 
         [0005]    There are a number of methods of gastric bypass surgery, as well as a number of medical appliances which have been developed to assist in the application of these methods. However, most methods of gastric bypass surgery operate on the theme of creating a reduced-size “gastric” pouch” out of the stomach, which remains connected to the small intestine. The pouch restricts the amount of food entering the body to a fraction of what would normally enter an unrestricted stomach. Once the pouch is full, the patient often experiences the same feelings of fullness and satiety as would be experienced with an unrestricted stomach. 
         [0006]    U.S. Pat. No. 5,771,903 issued to Jakobsson involves a method of gastric bypass surgery where the lower part of the esophagus is dissected and a band is applied around the lower part of the esophagus and an upper part of the stomach to form a small gastric pouch which upon filling with minimal food gives the patient a feeling of fullness or satiety. The band is inflatable and serves as a type of restrictor valve to regulate the amount of food passing from the banded upper gastric pouch to the unrestricted lower stomach. The band can be selectively inflated or deflated, depending upon the amount of food that is desired to be passed from the upper to lower stomach. 
         [0007]    U.S. Pat. No. 6,572,627 issued to Gabbay discloses a system to inhibit the expansion of the stomach. The system involves placing a band about midway along the patient&#39;s stomach to create a restricted, smaller stomach. The system also employs a section of webbing that is placed around the upper half of the now restricted stomach. The webbing helps limit the expansion of the upper stomach. 
         [0008]    Other inflatable band devices include the Lap Band™ System from Inamed Health of Santa Barbara, Calif.; the Heliogast™ gastric band from Helioscopie of Vienne Cedex, France; the Midband™ from Medical Innovation Development of Villeurbanne, France; and the Swedish Adjustable Gastric Band (SAGB) from Ethicon Endo-Surgery of the United States. These devices are placed around the stomach at its top or midpoint to create a smaller stomach. 
         [0009]    The Proring® and Siliband® are gastric bands, both from Innovative Obesity Care of Saint Etienne, France, which require that the top of the stomach and esophagus first be stapled to form a small stomach pouch. The Proring® and Siliband® are then placed at the bottom of the pouch to form a restrictor valve for regulating the passage of food materials into the lower stomach. The Proring® has a closeable latch with a male-female engagement which is locked by the placement of a suture. The Siliband is closed and attached with sutures. 
         [0010]    The prior art gastric band devices and their associated medical procedures have a success rate of about 65%, with many patients experiencing weight gain again after 5 years. Also, the following complications can result from existing devices and procedures. 
         [0011]    First, the adjustable band devices can have a cross sectional contact width as large as 1″ which has been found to cause the leakage of pouch contents into the peritoneal cavity, should these devices erode into the gastric pouch. The body is unable to form scar tissue around, and seal off, such a wide band device. This erosion problem is serious in that some deaths have occurred, and in lesser cases, these prior art bands have had to be removed, or else additional surgeries were necessary to repair leakage problems. 
         [0012]    Second, the adjustable band devices have a tendency to accidentally enlarge, thereby letting more food through the restricted area than desired, and causing weight gain to return. 
         [0013]    Therefore, a need exists for a gastric bypass band which does not promote leakage of pouch contents into the peritoneal cavity and which further does not accidentally enlarge, thereby allowing weight gain to return. 
         [0014]    The foregoing reflects the state of the art of which the inventor is aware, and is tendered with a view toward discharging the inventor&#39;s acknowledged duty of candor, which may be pertinent to the patentability of the present invention. It is respectfully stipulated, however, that the foregoing discussion does not teach or render obvious, singly or when considered in combination, the inventor&#39;s claimed invention. 
       SUMMARY OF THE INVENTION 
       [0015]    The invention is a method for performing gastric bypass surgery and an inventive gastric bypass band used along with the method. 
         [0016]    The method of surgery involves separating the esophagus and a portion of the proximal stomach from the top of the remaining major portion of the stomach. The separated portion is used to form a small gastric pouch that can hold between 20-30 cc (about ⅛ cup) of food material. The inventive gastric bypass band is then placed in the mid-portion of the pouch to create a valve-like opening which will cause solid foods to stay in the gastric pouch for awhile, to give the sensation of a “full stomach.” The band also prevents stomal dilation, that is the stoma, or opening between the pouch and small intestine (described further below) is prevented from dilating. 
         [0017]    Still in reference to the inventive method, the small intestine is bisected to create a top section and a bottom section. Preferably, the top section includes the duodenum which retains all of its capability to receive liver bile, enzymes, and pancreatic secretions. The bottom section is connected to the bottom of the gastric pouch so that any food materials that pass by the gastric band restriction will empty directly into the small intestine for further digestion. The top section is then connected to the bottom section of the intestine which allows liver bile and pancreatic secretions from the top section to come into contact with the partially digested food materials that have been traveling from the gastric pouch down to the bottom section. Liver bile begins fat digestion for the first time and as a result, fats are only partially absorbed, contributing to greater weight loss. 
         [0018]    The majority portion of the stomach comprising the remaining stomach and duodenum is completely separated from the manufactured digestive tract consisting of the gastric pouch and bottom section of the small intestine. The majority portion is sewed against the inner body cavity wall of the patient, and a radiopaque marker band is placed between the majority portion and the body cavity wall. A gastrostomy tube is placed through the marker band for immediate post operative care and the radiopaque marker band functions as a marker to locate this stomach site if it becomes necessary to place a gastrostomy tube for decompression or to feed the patient normally through the stomach or else to allow the surgery to be reversed and the stomach reconnected at a later date. The inventive gastric bypass band is also radiopaque. 
         [0019]    The gastric band device which also comprises the invention is comprised of an expansion-resistant section that is attached to a latching mechanism. Preferably, the latching mechanism is of a one-way, male-female design, which comes together from opposite ends of the expansion-resistant section. When the latch is engaged, the band device assumes a radial shape which encircles the gastric pouch at a location selected by the surgeon. The radial shape and small width of the band helps prevent the device from becoming ingrown into the gastric pouch and/or causing tissue necrosis. The radial shape is best achieved if the opposite components of the latch are curved to aid in forming the radial shape upon joining the ends of the latch together. 
         [0020]    It has been found that over time, using experimental fore runners of the inventive device and method, when employed together, resulted in patients maintaining their weight loss in 90% of the cases that are followed beyond 5 years post-surgery. This, compared with a success rate of only 65% of weight loss beyond 5 years post-surgery for the prior art gastric bypass surgery methods and banding devices, illustrates a large advantage of the inventive device and method. 
         [0021]    As such, the following objects and advantages are sought to be achieved by the inventive gastric bypass band device and medical method: 
         [0022]    An object of the invention is to provide a gastric bypass surgical method which bypasses the majority of the stomach and duodenum, thereby resulting in less post-surgery expansion of the gastric pouch. 
         [0023]    Another object of the invention is to provide a gastric bypass band device which is available in multiple sizings to be able to meet any surgical situation. 
         [0024]    Still another object of the invention is to provide a medical method and associated gastric band device which results in maintaining a 90% weight loss, beyond 5 years post-surgery, in morbidly obese patients. 
         [0025]    Another object of the invention is to provide a device that can be easily placed and removed less invasively, laparoscopically, thereby reducing surgical recovery time to around three weeks. 
         [0026]    Further objects and advantages of the invention will be brought out in the following portions of the specification, wherein the detailed description is for the purpose of fully disclosing preferred embodiments of the invention, without placing limitations thereon. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0027]    The invention will be more fully understood by reference to the following drawings which are for illustrative purposes only: 
           [0028]      FIG. 1  is a frontal view of a human esophagus, stomach and partial small intestine to illustrate the body locations near the esophagus and small intestine where the inventive medical procedure is performed. 
           [0029]      FIG. 2  is a frontal view of a human body cavity showing the esophagus connected to the lower portion of the small intestine and the upper portion of the small intestine, containing the duodenum, being connected to the lower portion of the small intestine. 
           [0030]      FIG. 3  is an elevated perspective view of the inventive gastric bypass band shown in its engaged state. 
           [0031]      FIG. 4  is a cross sectional view through the expansion resistant section of the inventive gastric bypass band. 
           [0032]      FIG. 5A  is a closeup elevated perspective view of the female portion of the latch. 
           [0033]      FIG. 5B  is a closeup elevated perspective view of the male portion of the latch. 
           [0034]      FIG. 5C  is a closeup elevated perspective view of the male portion of the latch fully engaged within the female portion. 
           [0035]      FIG. 6  is a side view of the gastric bypass band device shown in an engaged position, illustrating the radial shape of the device. 
           [0036]      FIG. 7A  is a side view of a protective cover for engaging with the female portion of the gastric bypass band device. 
           [0037]      FIG. 7B  is a front elevated perspective view of the cover. 
           [0038]      FIG. 8  is an elevated perspective view of the radiopaque marker band of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0039]    Referring to  FIGS. 1 and 2 , the preferred embodiment of the inventive medical method can be shown. The medical method is performed laparoscopically in 90% of the cases. In  FIG. 1 , the organs of the esophagus  10 , stomach  14 , duodenum  16 , small intestine  18  and gall bladder  20  are shown. The focus of the medical method is upon the modifications made to the esophagus  10 , stomach  14  and small intestine  18 . As first shown in  FIG. 1 , a gastric pouch is manufactured by preferably separating the esophagus  10  and part of the lesser curvature  22  of the stomach from the remainder of the stomach  14  at point A. The small intestine  18  is bisected at point B. The location of point B is preferred because it results in the duodenum  16  being completely bypassed along with the stomach  14 . Bypassing the duodenum results in selective fat malabsorption which results in more weight loss than in prior art gastric bypass methods. The duodenum remains fully functional and continues to receive liver bile from the hepatic ducts  24  and enzymes from the pancreatic duct  26 . 
         [0040]    Referring now to  FIG. 2 , the formation of the gastric pouch and the re-connection of the small intestine can be described. The proximal stomach is bisected on the lesser curvature  22  just below the esophagus  10 , leaving a small stomach segment  28  that is connected to the proximal jejunum  18 , this esophogeal and small stomach segment is what will eventually form the gastric pouch  30  having a size of between 20-30 cc. The bottom section of the small intestine (proximal jejunum)  18  below the duodenum  16  is connected to the small stomach segment  28  through a hand sewn closure to form an anastomosis (not shown) that is 1.5 to 2 cm wide. The anastomosis is impervious to air and water and allows direct entry of the contents of the gastric pouch  30  into the small intestine  18 , which causes the release of satiety stimulating chemicals known as enterokinins. This release of enterokinins is even induced by the obese individual&#39;s salivary secretions that go from the gastric pouch  30  to the small intestine  18 . This feeling of satiety, or “fullness” results in anorexia and enhances initial weight loss as well as the maintenance of weight loss over time. 
         [0041]    Above the anastomosis and above the bottom of the pouch  30 , about 2 cm, is placed the inventive gastric bypass band device  32 . The gastric band device acts as a restrictor valve which controls the emptying of partially digested food materials from the gastric pouch  30 . The gastric band  32  is preferably placed at the distal portion of the gastric pouch  30 . When the inventive gastric band is in place, the portion of the pouch above the gastric band is 15 to 20 cc in capacity and the portion of the pouch below the band is about 8 to 10 cc in capacity. This compared to the normal 2000-3000 cc capacity of the stomach illustrates the restriction in food intake provided by the gastric pouch. Once the gastric pouch is full of food materials, a feeling of satiation is experienced, resulting in anorexia. The gastric band device  32  preferably ranges in size between 5.5-7.0 cm in inner circumference. In addition to its function as a restrictor valve, the gastric band  32  prevents stomach dilation, meaning that the restricted opening provided by the band never expands in size due to the expansion-resistant construction of the device. Moreover, the pouch  30  is more resistant to expansion than the stomach. The relative size of the pouch ensures that excessive expansion does not occur. Patients that have been X-rayed five years post-surgery show that the pouch has not expanded by much. Moreover, the small size of the pouch insures that if a patient over-eats, the food will back up into the esophagus, thereby causing the patient to regurgitate the food. This factor operates as a self-regulating feature, and for this reason, patients are counseled to keep their food intake to a minimum. 
         [0042]    The duodenum  16  is re-joined to the small intestine  18  to form a Y-limb  34 , with one deviation of the limb going upward to the duodenum and the other deviation proceeding upward to the gastric pouch  30 . The intestine-intestine connection  36  forms an anastomosis (not shown) of approximately 2 cm, that is wide enough to allow food to pass through easily. At the point of anastomosis, pancreatic juices and liver bile from the duodenum can now come into contact with the partially digested food that travels down the second section of the intestine from the pouch. Liver bile begins fat digestion for the first time, and as a result, fats are only partially absorbed, thereby helping contribute to weight loss. Sugars are absorbed, but discouraged as part of the patient&#39;s diet, because with the stomach disconnected, they go directly into the intestines, causing some patients to have “Dumping Syndrome.” This is a very uncomfortable feeling of cramps, flushing, fast beating heart, weakness and sometimes watery stools. 
         [0043]    The stomach  14 , although disconnected, remains fully functional, and if necessary can be reactivated by reversing the surgery and re-connecting the stomach segment  28  and small intestine  18  to their prior, natural, state. The stomach  14  can also be reactivated by placing a temporary gastrostomy tube  38 , as shown, through which food can be routed, should this be necessary. To facilitate the reactivation of the stomach  14 , the stomach opening  40  can be marked with a radiopaque marker band  42  or disk, that is sutured to the abdominal wall, thereby making it clearly visible to allow the surgeon to find the stomach entry site  40  on an X-ray, to allow easy reactivation. 
         [0044]    The inventive gastric bypass band device  32  that was introduced previously, as being crucial to the successful result of the inventive surgical method, will now be described in terms of its preferred embodiment. Referring to  FIG. 3 , the gastric bypass band  32  is comprised of an expansion-resistant section  44  mated to a latch  46 , which locks upon full engagement, thereby preventing the device  32  from opening up while positioned within the body. The latch  46  is of a one-way variety and can only be released through the application of a specialized surgical tool (not shown). The expansion-resistant section  44  prevents the device from expanding too far, thereby restricting the amount of food traveling from the gastric pouch  30  to the small intestine  18 . It is important for the device to retain food within the pouch long enough for the patient to feel sated, thereby reducing hunger and preventing further eating. The expansion-resistant section  44  is preferably made from implant grade silicone rubber surrounding a monofilament core. The monofilament can be polypropylene suture material, which is resistant to expansion. The latch is preferably made from surgical-grade plastics such as polypropylene or acetal, which gives both strength and lubricity to the latch. 
         [0045]      FIG. 4  shows a transverse cross section of the expansion-resistant section  44  which illustrates the monofilament core  48  surrounded by silicone material  50 . Alternatively, the silicone material can be a silicone tube having a monofilament core therein. The expansion-resistant section  44  preferably has a flat-faced inner side  52  as shown. This flat face  52  continues longitudinally along the length of the expansion-resistant section  44 . The flat face  52  forms a flat-sided inner circumference when the latch of the device is engaged, as shown in  FIG. 3 . It has been found that the flat face prevents the expansion-resistant section from migrating into the patient&#39;s tissue and prevents tissue erosion. Also crucial with regard to preventing leakage caused by the device eroding into the internal lumen of the gastric pouch is that the cross-sectional diameter of the expansion-resistant section  44  is kept to 0.125″, or less. If erosion occurs, it has been found that if the cross section is kept to these approximate dimensions the pouch tissue will form a scar around the band device  32 , and in essence seal off the device, thereby preventing any leakage. 
         [0046]    Erosion is caused by tissue necrosis, where tissue dies when the supply of blood to the area is cut off. Prior art larger, thicker, band devices, have been known to necrose when the food pouch begins to sag, making a deep sack out of which food has difficulty being passed. This food begins to decay in the pouch, which can lead to necrotic complications. The larger, thicker, prior art devices penetrate the necrosed area in time, creating a break in the gastric pouch, which can lead to leakage of the pouch contents into the interior of the body cavity. In the worst cases this can lead to death; in the minor cases, additional surgery is necessary to repair the breached pouch. Contrastingly, fewer pouch breaches are experienced with the present invention than with the prior art devices. 
         [0047]    Referring now to  FIGS. 5A ,  5 B and  5 C the latch  46  can be examined. The latch is preferably a one-way latch employing a one-way male-female engagement. The opposite ends  54 ,  56  of the expansion-resistant section  44  are each mated to one-half of the male-female latch as shown in  FIG. 3  and a preferred method of mating is further described below. 
         [0048]    As shown in  FIG. 5A , the female portion  58  of the latch  46  is illustrated in detail. The female portion has an exterior body  60  and an interior lumen  62  for receiving the male portion  64  of the latch. The lumen  62  is sized to compress the lateral prongs  66  of the male portion  64 . Under surgical conditions, engagement of the male and female portions is performed with a forceps, laparoscopically. The preferred interior lumen  62  dimensions are approximately height=0.082″×width=0.190×length=0.300″. A pair of openings  68  are placed in each side  70  of the female portion  58  to allow for the expansion of the lateral catches  72  of the male portion. 64 . The lateral catches  72  engage fully and laterally within the side openings  68 , in a one-way fashion. Side openings  68  have top, bottom, rear and front walls, which engage catches  72 . The engagement is such that the latch can be released only after applying a special surgical tool (not shown) to disengage the latch  46 , by placing inward force upon catches  72  through side openings  68 . The lumen  62  opens outward and the face  74  of the opening of the lumen is inwardly beveled so as to receive the outward bevels  76  of the male portion  64 . The corner facings  78  of the female portion  58  are rounded so as to present a non-irritating surface to the patient. 
         [0049]    Still referring to  FIG. 5A , the body  60  of the female portion  58  is longitudinally curved  80 . The curvature of the female portion  58  mates with the longitudinally curved male portion  64  to form the device  32  into a radial shape as shown in  FIG. 6 . This radial shape is crucial for preventing the device from becoming ingrown within a patient&#39;s tissue, as this shape applies equal pressure to the enclosed tissue at every point along the inside circumference of the device  32 . Shapes that are non-circular (e.g. oblong shapes) tend to apply unequal pressure along their inside circumference, thereby resulting in a cutoff of blood supply, necrosis, and eventual tissue erosion and leakage as discussed previously. For each graduation in inner circumference of the inventive device  32 , a corresponding radius of curvature applies which contributes to the forming of the proper radial shape in each case. The radii of curvature in inches is listed after each graduation in inner circumference (centimeters) as follows: 5.5 cm=0.398″; 6.0 cm=0.422″; 6.5 cm=0.460″ and 7.0 cm=0.492″. Also, for the same graduations, the following diameters apply: 5.5 cm=1.75 cm dia; 6.0 cm=1.91 cm dia; 6.5 cm=2.07 cm dia; 7.0 cm=2.23 cm dia. The inner circumference that is used is open to the discretion of the surgeon, but generally, men require 6.5 and 7.0 cm sizes while women require 5.5 and 6.0 cm devices. 
         [0050]    Referring now to  FIG. 5B , the male portion of the latch is shown as comprising a pair of lateral prongs  66 , the prongs being longitudinally curved to mate efficiently within the lumen  62  of the female portion  58 . Preferably, prongs  66  are approximately 0.076″ thick, by 0.040″ wide. The prongs terminate at their front with lateral catches  72  which are molded integrally with the prongs  66 . Lateral catches  72  are angled longitudinally along their side face  84 , the angled attitude allowing easy entry of the prongs  66  into the lumen  62  of the female portion  58 , which is an important feature under surgical conditions. Side faces  84  having steeper angles give a mechanical advantage when locking. The preferred angle of side faces is 36 degrees or less. The catches  72  further comprise lateral catch faces  86 , which engage the front walls of the side openings  68  of the female portion  58 . When the catches  72  of prongs engage, it is preferred that they remain engaged under a pulling stress of at least 5 pounds of force. The prongs  66  are separated by inner space  88 , which allows the prongs to travel inward and outward. The prongs  66  terminate rearwardly at prong body  90 , which provides a base of structural integrity from which prongs can confidently travel inward and outward as they engage the interior walls of lumen. Prong body  90  migrates further rearward to become outwardly beveled face  76  which mates with inwardly beveled face  74  of the female portion  58 . The beveled face  76  migrates further rearward to become hilt  92 . Hilt  92  is where the front opening of the female portion  58  fully engages against. This engagement is shown in  FIG. 5C  which illustrates lateral catches  72  seated in the side openings  68  of female portion  58 , the hilt being  92  engaged with the front opening of female portion. The circumference of the body  60  of female portion  58  and the circumference of the hilt  92  of the male portion  64  are preferably identical so as to provide a fairly uninterrupted surface traveling from one to the other. 
         [0051]    Also shown in  FIGS. 5A and 5B  are anchor arms  94 , which are used to attach the male and female portions of latch to the expansion-resistant section  44 . Anchor arms  94  retain the curved theme of the male and female portions,  58 ,  64  of the latch  46 . Anchor arms  94  are molded integrally with their corresponding latch portion and curve rearwardly so as to retain the radii of curvature of the inventive device noted previously. The expansion-resistant section which is comprised of surgical grade silicone and monofilament is attached to the anchor arms as follows. Referring again to  FIG. 5B , the front opening  96  of lumen  98  is shown, and its rearward path of travel through anchor arm is shown in phantom. A similar arrangement exists for female portion. Monofilament  48  enters the rear of anchor arm and is fed through lumen until it protrudes through the front opening of lumen. The monofilament  48  is then tied off in a manner so as to anchor it in place along with the silicone material as seen in phantom, in  FIG. 3 . 
         [0052]    As  FIGS. 7A-7B  show, the body  60  of female portion  58  may also be fitted with a disposable cover  100  so as to reduce its potential to snag upon tissue as it is being fed through and positioned around the gastric pouch  30  during laparoscopic surgery. As the device is fed through the tissue and around the new pouch, it is led by the female portion  58 . Cover  100  provides a streamlined shape which can be grasped by a forceps and easily led through the tissue.  FIG. 7A  is a side view showing the female end  58  positioned in the cover  100 , with the remainder of the device trailing out the back end  102  of cover  100 . Back end  102  of cover includes a lumen (see  FIG. 7B )  104  for receiving female end  58 , the lumen being sized to snugly grasp female end without coming loose during surgical placement. The sides of lumen are preferably ringed with small ridges  106  to reduce the frictional engagement between female portion  58  and the cover  100  to a level that allows easy removal of the cover once the device is in place. As seen in  FIG. 7B , cover  100  further comprises a blunt front end  108  which extends into an elongate portion  110 . The blunt front end  108  facilitates easy movement through tissue. The elongate portion  110  is for grasping by the surgeon&#39;s forceps to allow the cover to be threaded through tissue. Past the elongate portion  110 , the cover  100  has a gently tapered region  112 , which, again contributes to easy movement through tissue. At its widest point, the cover is about 0.250 to allow easy movement through a trocar during laparoscopic surgery. The cover is preferably made from a radiopaque material for easy sighting on an X-ray. The cover is removed and discarded once the device has been positioned around the gastric pouch. 
         [0053]    Referring now to  FIG. 8 , the radiopaque marker band  42  previously shown in  FIG. 2  can be more precisely described. The band&#39;s inside diameter is approximately 0.8″ and the outside diameter is approximately 1″ with a thickness of approximately 0.06″. The band is preferably flat along its major surfaces  114 ,  116 . The marker band  42  can be made from polyester mesh that is coated with surgical grade silicone. Also, it is envisioned by the inventor that the inventive device  32  can be combined with the radiopaque marker band  42  shown in  FIG. 8 , as well as with the disposable cover  100  to form a surgical kit. This kit can then be installed surgically using the method previously described. 
         [0054]    Finally, although the description above contains many specificities, these should not be construed as limiting the scope of the invention but as merely providing illustrations of some of the presently preferred embodiments of this invention. Other modifications by those skilled in this art are possible and are included within the scope of the appended claims.