Patent Document

CROSS-REFERENCE TO RELATED APPLICATION 
     This invention is a continuation-in-part of and claims priority to U.S. patent application Ser. No. 12/328,979, entitled “Method and Apparatus for Gastric Restriction of the Stomach to Treat Obesity,” filed Dec. 5, 2008 now U.S. Pat. No. 8,357,081, the entire contents of which is hereby incorporated by reference herein for all purposes. 
    
    
     BACKGROUND 
     1. Field 
     The invention relates to a method and apparatus for treating obesity and controlling weight gain in mammals, and more specifically, to an inflatable gastric skirt placed around the stomach to cause a reduced desire for eating for treating obesity and controlling weight gain in mammals. 
     2. Related Art 
     Extreme obesity is a major illness in the United States and other developed countries. More than half of Americans are overweight, while nearly one-third are categorized as obese. Obesity is the accumulation of excess fat on the body, and is defined as having a body mass index (BMI) of greater than 30. Many serious long-term health consequences are associated with obesity, such as, hypertension, diabetes, coronary artery disease, stroke, congestive heart failure, venous disease, multiple orthopedic problems and pulmonary insufficiency with markedly decreased life expectancy. 
     Medical management of obesity including dietary, psychotherapy, medications and behavioral modification techniques have yielded extremely poor results in terms of treating obesity. Several surgical procedures have been tried which have bypassed the absorptive surface of the small intestine or have been aimed at reducing the stomach size by either partition or bypass. These procedures have been proven both hazardous to perform in morbidly obese patients and have been fraught with numerous life-threatening postoperative complications. Moreover, such operative procedures are often difficult to reverse. 
     One procedure for treating morbid obesity is referred to as a “biliopancreatic diversion.” Biliopancreatic diversion surgery is a reduction of the stomach volume and a diversion of food from the stomach to the final segment of the small intestine, bypassing the beginning and middle portions of the small intestine to limit the amount of nutrients and calories absorbed by the body. This procedure removes about one half of the stomach, and then connects the stomach to the last 250 cm of the small intestine. Some disadvantages of this surgery include patients suffering from protein malnutrition, anemia, gastric retention, diarrhea, abdominal bloating, and intestinal obstruction. 
     Another bariatric surgery, “gastric bypass,” is a bypass connecting the lower compartment of the stomach to the initial portion of the small intestine. This procedure limits the amount of food that can be ingested at one sitting and reduces absorption of food across the small intestine. In addition to surgical complications, patients may also suffer from acute gastric dilation, anastomotic leak, anemia, and dumping syndrome. 
     Yet another bariatric surgical procedure is “vertical-banded gastroplasty,” which restricts the volume of the stomach by using staples. In this procedure, staples are placed in the upper stomach region to create a small pouch with a narrow outlet to the remaining portion of the stomach. A band is placed around the narrow outlet to provide support and inhibit stretching of the stomach. In addition to surgical complications, patients undergoing this procedure may suffer from vomiting, ulcers, band erosion, and leaks. 
     Recently, minimally invasive procedures and devices which create a feeling of early satiety have been introduced into the marketplace in an attempt to address some of the issues above. The LAP-BAND® is a band which encircles the stomach at the region of the fundus-cardia junction; it is a restrictive procedure similar to stomach stapling. The procedure requires general anesthesia, a pneumoperitoneum, muscle paralysis, and extensive dissection of the stomach at the region of the gastro esophageal junction. The procedure also requires continual adjustment of the band, or restriction of a portion of the device. Although less invasive than other bariatric surgical procedures and potentially reversible, the LAP-BAND® does not reduce the volume of the stomach by any great extent and some patients report a feeling of hunger most of the time. Furthermore, once implanted, the LAP-BAND®, although it is adjustable by percutaneous means, may require many iterative adjustments before it is optimally positioned. In addition, the port used to adjust the LAP-BAND® is left inside the patient&#39;s body. 
     Therefore, there is a need for minimally-invasive procedures and devices that eliminate the above-mentioned drawbacks of conventional methods and devices that are currently being used to treat obesity. 
     SUMMARY 
     In one embodiment, the invention includes a gastric restraining device for treating excessive weight or obesity in mammals. The gastric restraining device includes a skirt having an interior surface and an exterior surface having a surface area of at least 14 square centimeters, a chamber attached to the interior surface of the skirt and capable of holding a fluid, the chamber configured to be positioned around a stomach of a mammal so that the chamber covers a portion of a greater curvature of the stomach and a portion of a lesser curvature of the stomach, and a tube connected to the chamber for delivering the fluid into and out of the chamber to cause the chamber to expand and contract. 
     In one embodiment, the invention includes a gastric restraining device for treating excessive weight or obesity in mammals. The gastric restraining device includes an elastomeric sheet configured to be placed around a stomach of a mammal, an ablation device attached to the elastomeric sheet, the ablation device configured to emit energy toward an outer surface of the stomach when the elastomeric sheet is placed around the stomach, and an energy device coupled to the ablation device to generate the energy and to transfer the energy to the ablation device. 
     In one embodiment, the invention includes a method for treating excessive weight or obesity in mammals by gastric constriction or restraining. The method includes using an endoscopic device, inserting a bougie into the stomach adjacent to a lesser curvature of the stomach. The method also includes tucking a portion of a greater curvature of the stomach toward the bougie which results in a first untucked stomach portion, a second untucked stomach portion, and a cavity between the first untucked stomach portion and the second untucked stomach portion. The method also includes using a ligation device, inserting a ligature through the first untucked portion, the cavity, and the second untucked portion and using the endoscopic device, removing the bougie from the stomach. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       These and other embodiments of the invention will be discussed with reference to the following exemplary and non-limiting illustrations, in which like elements are numbered similarly, and where: 
         FIG. 1A  is a view of a stomach of a mammal; 
         FIG. 1B  is a view of a partially tucked-in stomach of a mammal; 
         FIG. 2A  is a view of a laid-open gastric skirt; 
         FIG. 2B  is a view of a modular laid-open gastric skirt; 
         FIG. 3  is a view of a rolled gastric skirt; 
         FIG. 4  is a view of a folded conical cylinder-shaped gastric skirt; 
         FIG. 5A  is a view of a gastric skirt placed in position around a stomach; 
         FIG. 5B  is a view of a modular gastric skirt placed in position around a stomach; 
         FIG. 5C  is a view of a gastric skirt placed in position around a stomach that shows a tucked-in portion of the stomach; 
         FIG. 6  is a view of a laid-open butterfly-shaped gastric skirt; 
         FIG. 7  is a view of a folded butterfly-shaped gastric skirt; 
         FIG. 8A  is a view of a laid-open oval or pear-shaped skirt; 
         FIG. 8B  is a view of a laid-open oval or pear-shaped skirt having a pouch that holds a balloon; 
         FIG. 8C  is a view of a modular laid-open oval or pear-shaped skirt having a pouch that holds a balloon; 
         FIG. 9A  is a view of a folded gastric skirt with locking clips; 
         FIG. 9B  is a view of a locking clip for a gastric skirt; 
         FIG. 10A  is a view of a gastric skirt with a harness system; 
         FIG. 10B  is a side-view of a gastric skirt with a harness system; 
         FIG. 11  is a view of a gastric wrap with a harness system in position around a stomach; 
         FIG. 12  is a view of an exemplary connector; 
         FIG. 13A  is a view of a collar with wings; 
         FIG. 13B  is a view of a locking clip for a collar; 
         FIG. 13C  is a view of a collar without wings; 
         FIG. 13D  is a view of a laid-open collar; 
         FIG. 14  is a cross-sectional view of a stomach and a balloon positioned within a greater curvature of the stomach when the greater curvature is tucked into the stomach; 
         FIG. 15A  is a view of the balloon of  FIG. 14 ; 
         FIG. 15B  is a view of a sealed balloon with a port; 
         FIG. 16  is a view of the gastric wrap of  FIG. 6  and the balloon in position around a stomach; 
         FIG. 17  is a view of one or more ropes wrapped around a tucked-in stomach; 
         FIG. 18  is a view of one or more tentacles wrapped around a tucked-in stomach where the tentacles can be independently pulled and locked in place using a ring and clip system or a tie lock; 
         FIG. 19  is a view of an inflatable gastric skirt positioned around a stomach; 
         FIG. 20  is a view of an inflatable gastric skirt and a triple-lumen tube; 
         FIG. 21  is a view of an inflatable gastric skirt without a harness system; 
         FIG. 22A  is a view of a gastric skirt having one or more inflatable chambers; 
         FIG. 22B  is a view of a cavity of a triple-lumen tube; 
         FIG. 23  is a view of the interior of a triple-lumen tube; 
         FIG. 24  is an interior view of an inflatable gastric skirt; 
         FIG. 25  is a view of a triple-lumen port inlet; 
         FIG. 26  is view of an inflatable gastric skirt and an inflation device; 
         FIG. 27  is a view of a laid-open inflatable gastric skirt; 
         FIG. 28  is a view of a connector strap; 
         FIG. 29  is a lateral view of an inflatable gastric skirt; 
         FIG. 30  is a view of an inflatable collar; 
         FIG. 31  is a view of an inflatable gastric skirt with dual inflatable collars; 
         FIG. 32  is a view of the internal surface of an inflatable gastric skirt; 
         FIG. 33  is a view of a valve and the steps of inflation and deflation; 
         FIG. 34  is a view of an inflatable antral skirt; 
         FIG. 35  is a laid-open view of an inflatable antral skirt; 
         FIG. 36  is a view of a double-side inflatable gastric skirt; 
         FIG. 37  is a view of an inflatable gastric skirt with radio frequency coils; 
         FIG. 38  is a view of an inflatable gastric skirt with steam ablation holes; 
         FIG. 39  is a lateral view of an inflatable gastric skirt with steam ablation holes; 
         FIG. 40  is a view of an inflatable gastric skirt with an ultrasound probe; 
         FIG. 41  is a view of an inflatable gastric skirt with alternating ablation and inflation chambers; 
         FIG. 42  is a view of a physiological connection between stomach receptors and a brain; 
         FIG. 43  is a view of a stomach prior to ligation; 
         FIG. 44  is a lateral view of a tucked-in stomach prior to ligation; 
         FIG. 45  is a view of a ligated stomach; 
         FIG. 46  is a lateral view of a gastric skirt positioned around a ligated stomach; 
         FIG. 47  is a flowchart illustrating a process of positioning a gastric skirt around a ligated stomach; 
         FIG. 48A  is a view of unconnected clip members; and 
         FIG. 48B  is a view of connected clip members. 
     
    
    
     DETAILED DESCRIPTION 
     Throughout this description, the term gastric “skirt” is used to refer to a device made of a flexible, semi-flexible, or minimally stretchable material that can be tightly wrapped around portions of a stomach to provide constriction to the stomach. The term “skirt” can be used interchangeably with “vest”, “wrap”, “wrapping”, “wrapper”, “bandage”, “blanket”, “cape”, “cloak”, “cover”, “jacket”, “envelope”, and equivalents thereof. 
       FIG. 1A  is a view of a stomach  100  of a mammal (e.g., human). As shown in  FIG. 1A , the stomach  100  has at least two curvatures, a lesser curvature  110  and a greater curvature  112 . The cardia or proximal stomach  108  is located in the upper left portion of the stomach  100  and serves as the junction between the esophagus  102  and the body of the stomach  106 . The fundus  104  is located in the upper right portion of the stomach  100 . The lower portion of the stomach  100  is known as the distal stomach and includes the antrum  114  and the pylorus  116 . The antrum  114  is where food is mixed with gastric juices. The pylorus  116  has a muscular pyloric sphincter that acts as a valve to control emptying of the stomach contents into the proximal segment of the small intestine  118  (partially shown). The inner lining  120  of the stomach  100  separates the body  106  from the outer wall  122 . 
     The invention is directed to a gastric skirt that is placed around the stomach  100  by a healthcare professional, such as a surgeon, a bariatric surgeon or a gastrointestinal specialist trained in laparoscopic and/or general surgery procedures. The gastric skirt can be positioned using a routine laparoscopic procedure or a conventional open-surgical procedure. Furthermore, the gastric skirt can be placed around the stomach  100  using newer techniques, methods and procedures for laparoscopic surgery. 
     The invention can be utilized in conjunction with the LAP-BAND® procedure and/or other post-gastric bypass procedures such as vertical gastric sleeve procedure treatments that provide reinforcement and restraining devices to prevent further expansion or re-expansion of the stomach  100 . 
       FIG. 1B  is a view of a partially tucked-in stomach  100  of a human. Prior to placing the gastric skirt around the stomach  100 , a linear portion of the greater curvature  112  is tucked inwards into the stomach  100 . As shown in  FIG. 1B , the inner lining  120  is depressed within the stomach  100  as a result of the tucking procedure, and the tucked-in portion occupies space within the stomach  100 . Thus, the internal volume of the stomach  100  is substantially decreased, creating a ridge like effect, leading to the slowing of the passage of food, and thus less food consumption, while still enabling absorption of vital fluids and nutrients (unlike a gastric bypass procedure). In addition, the internal volume of the fundus  104  is reduced. 
     In another embodiment, the tucked-in portion of the stomach  100  may be a linear portion of the lesser curvature  110 , a portion of the body  106 , or a portion of the fundus  104 , not along either the greater curvature  112  or the lesser curvature  110 . Therefore, any portion of the stomach  100  may be tucked-in and wrapped using the gastric skirts disclosed herein. 
       FIG. 2A  is a view of a laid-open gastric skirt  200 . The gastric skirt  200  may be formed as a sheet  224  prior to being wrapped around a patient&#39;s stomach. For illustrative purposes, the gastric skirt  200  has a left side  232 , a right side  230 , a bottom portion  220 , and a top portion  222 . Each connector  208 ,  210 , and  212  may be offset or staggered relative to its adjacent connector. Similarly, each receiver  214 ,  216 , and  218  may be offset or staggered relative to its adjacent receiver. In one embodiment, each offset may be approximately 1-3 centimeters. The bottom portion  220  and the top portion  222  may have an inward curved or concave edge. The gastric skirt  200  may have a length L of approximately 6-16 centimeters, a central width W 1  of approximately 3-7 centimeters, and an outer width W 2  of approximately 6-10 centimeters. 
     In a preferred embodiment, the length L is at least 8 centimeters, the central width W 1  is at least 4 centimeters, and the outer width W 2  is at least 7 centimeters. 
     The gastric skirt  200  may have a staggered step design and may be formed in the shape of a parallelogram when laid-open, where the opposing ends of the gastric skirt  200  interconnect in a stepped fashion when the gastric skirt  200  is folded. For example, step element  201  is staggered relative to immediately opposing step element  202 . Likewise, step element  203  and step element  205  are staggered relative to their immediately opposing step elements  204  and  206 , respectively. When the gastric skirt  200  is wrapped or folded into position around a patient&#39;s stomach  100 , the opposing step elements interconnect with each other, forming the end at the greater curvature  112  and the gastric skirt  200  is formed into a conical cylindrical shape, which is described in more detail below. 
     Attached to each step element is a male connector or a female receiver or vice versa. In the exemplary embodiment, a male connector  208  is attached to a female receiver  214 . When the gastric skirt  200  is folded into position, the male connector  208  couples with the female receiver  214 . The male connectors  210  and  212  couple with the female receivers  216  and  218 , respectively, when the gastric skirt  200  is wrapped or folded into position around the stomach. In other embodiments, the gastric skirt  200  may have one set of connectors (e.g., a single male connector  208  and a single female receiver  214 ) or two sets of connectors (e.g., 2 male connectors  208  and  210  and 2 female receivers  214  and  216 ). The connectors can be of various shapes and sizes, and are not limited to the connector design shown in  FIG. 2A . Furthermore, the connectors can be positioned at various locations on the gastric skirt  200 , and are not limited to being positioned at the left side  232  and the right side  230  of the gastric skirt  200 . 
     The gastric skirt  200  has a bottom portion  220  that is inward curving. Opposite the bottom portion  220 , the gastric skirt  200  has a top portion  222  that is inward curving. When the gastric skirt  200  is folded into position, the bottom and top portions  220  and  222  come into contact with the lesser curvature  110  and provide the gastric skirt  200  with a contoured, conical shape. The conical shape allows the gastric skirt  200  to properly fit around the stomach  100 . 
     Furthermore, one or more optional connectors or wings  226  and  228  are attached to the top portion  222  of the gastric skirt  200  and one or more optional connectors or wings  248  and  250  are attached to the bottom portion  220  of the gastric skirt  200 . The connectors or wings  226  and  228  may be used to attach the gastric skirt  200  to collar connector straps (shown in  FIGS. 10A ,  10 B, and  11 ). The connectors or wings  248  and  250  may be used to attach the gastric skirt  200  to connector straps (shown in  FIG. 11 ). 
     The body or sheet  224  of the gastric skirt  200  is relatively flexible, or semi-flexible, and may be made of an elastic polymer (“elastomer”), such as, but not limited to, silicone, polypropylene, polyethylene terephthalate, polytetrafluoroethylene, polyaryletherketone, nylon, fluorinated ethylene propylene, polybutester, or any combination thereof. Furthermore, the elastomer may be non-porous. Alternatively, the elastomer may be microporous or porous to allow for better expansibility and oxygenation and for tissue in-growth to better hold the gastric skirt  200  in place. 
     In a preferred embodiment, the elastomer is silicone. Silicone provides an ample amount of rigidity, while still providing flexibility to accommodate changes in stomach shape and size during peristalsis. A silicone body may be preferred over a porous body, as larger pores may allow the stomach muscles or tissue to seep through and grow onto the outside of the body  224 . This overgrowth of the stomach through the body  224  may make it difficult to remove the gastric skirt  200  from the patient if needed. Furthermore, the silicone allows some expandability of the stomach  100 , which is the stomach&#39;s natural function. Thus, the gastric skirt  200  allows the stomach to accommodate some gases and larger pieces of food or meat. 
     Alternatively, more rigid materials, such as Teflon®, Dacron®, ePTFE or wire mesh may be used if they provide an adequate level of flexibility, and do not significantly irritate or erode the stomach surface. That is, the gastric skirt  200  should be relatively flexible, as a very rigid stomach wrap may cause discomfort to the patient, as well as injury to the stomach and other gastric organs. The gastric skirt  200  is tightly positioned around the tucked-in stomach so little to no open space is provided between the gastric skirt  200  and the outer surface of the stomach. 
     In another embodiment, the body  224  of the gastric skirt  200  may be made of a biodegradable and absorbable polymer or copolymer, such as, but not limited to, polyglycolic acid (PGA), polylactic acid (PLA), polycaprolactone, polyhydroxyalkanoate, various thermoplastic materials, or any combination thereof. Once placed around the stomach  100 , the gastric skirt  200  stays in position for a predetermined amount of time. After the predetermined amount of time has elapsed, the gastric skirt  200  may be absorbed by the patient&#39;s bodily fluids, eliminating the need for a second procedure to remove the gastric skirt  100 . In this particular embodiment, the entire gastric skirt  200 , including the male connectors and the female receivers, are made of a biodegradable material. 
     The staggered step design allows the gastric skirt  200 , including all of the connectors and receivers, to be rolled into a highly compact fashion. In one embodiment, the gastric skirt  200  can be placed around a patient&#39;s stomach using a routine laparoscopic procedure, referred to as a laparoscopy. During a laparoscopy, the gastric skirt  200  is inserted into the patient via a trocar through a hole made in the patient&#39;s abdomen. The staggered step design minimizes the diameter of the gastric skirt  200  when it is rolled for insertion through the trocar. That is, the connectors and receivers are not positioned on top of each other in the rolled position to minimize the thickness for insertion. 
     In another embodiment, male connectors are connected to their respective female receivers with an elastic material. For example, male connector  208  is connected to female receiver  214  with a strap made from an elastic material. The strap is positioned within an internal channel that runs lengthwise from the left side  232  to the right side  230  within the gastric skirt  200 . The strap is preferably made of a more elastic material than the gastric skirt  200  so that the connectors can accommodate peristalsis and movement of the stomach. This embodiment allows stress to be placed on the strap rather than the gastric skirt  200 , thereby preventing the gastric skirt  200  from being overstretched due to peristalsis. 
       FIG. 2B  is a view of a modular laid-open gastric skirt  200 . The modular gastric skirt  200  may have two or more rectangular strips or modules  234 ,  236 , and  238 . Each strip may have a ridge  240  (and  244 ) and/or a groove  242  (and  246 ) for attachment to adjacent strips. The ridge  240  securely fits into the groove  242  along the length of each strip to prevent unwanted detachment of adjacent strips and any in-growth of tissue between adjacent strips. Some advantages of the strips include each strip can be inserted separately and the size of the gastric skirt  200  can be adjusted at the time of surgery to account for the amount of tucking, size and orientation of the stomach  100 . The modular gastric skirt  200  may have a width W 3  of approximately 1-3 centimeters, a width W 4  of approximately 1-4 centimeters, and a width W 5  of approximately 1-3 centimeters. The widths may vary depending on the size and amount of tucking needed. The modular gastric skirt  200  may have a length L of approximately 6-16 centimeters. 
     In an embodiment, the modular gastric skirt  200  may utilize only two of the rectangular strips or modules  234 ,  236 , and  238 . For example, module  234  can be connected to module  236  to form the modular gastric skirt  200 . Alternatively, module  234  can be connected to module  238  to form the modular gastric skirt  200 . 
       FIG. 3  is a view of a rolled gastric skirt  300 . The gastric skirt  300  is tightly rolled so that it can be inserted through a trocar as described above or other means. The staggered step design allows the male connectors  208 ,  210 , and  212 , and the female connectors  214 ,  216 , and  218  to not overlap with each other when the gastric skirt  300  is rolled. By not overlapping, the male connectors  208 ,  210 , and  212  and the female receivers  214 ,  216 , and  218  are evenly flush with each other, so the diameter of the rolled gastric skirt  300  is minimized. Similarly, the connectors, the cardia collar and the antral collar may be passed through the trocar into the stomach for connection to the gastric skirt  200 . 
       FIG. 4  is a view of a folded conical cylinder-shaped gastric skirt  400 . As shown, step elements  412 ,  410 , and  408  are each connected to their immediately opposing step elements  418 ,  416 , and  414 , respectively, to form a conical cylinder-shaped gastric skirt  400 . In an embodiment, the outer or upper curvature  403  has a convex shape and is outwardly curving. The inner or lower curvature  404  has a concave shape and is inwardly curving. The conical cylinder shape allows the gastric skirt  400  to properly fit around and contact the stomach. The upper portion of the stomach  100  is covered by the gastric skirt  400  near the upper curvature  403 , as the upper portion of the stomach has a larger diameter than the lower portion of the stomach. The lower portion of the stomach is covered by the gastric skirt  400  near the lower curvature  404 . 
     The diameter of the upper curvature opening  420  (i.e., cardia end) and the lower curvature opening  406  (i.e., antral end) are similar. The gastric skirt  400  can be a “one-size fits all” design, where a single-sized gastric skirt  400  is used for all or most stomach sizes. To adjust to a “one-size fits all” gastric skirt  400 , the stomach is tucked in per physician&#39;s preference and the gastric skirt  400  is simply tightened accordingly when it is being positioned around the stomach. 
     Furthermore, the one or more optional wings  422  and  424  are attached on the circumference of the upper curvature  403 . The wings  422  and  424  are used to attach the gastric skirt  400  to collar connector straps (see also  FIGS. 10A and 10B ). Similarly, the circumference of the lower curvature  404  can also have one or more wings  426  and  428  attached. In another embodiment, the gastric skirt  400  can have no wings attached, or wings only on one side, either on the upper curvature  403  or the lower curvature  404 . 
     In another embodiment, a healthcare professional can estimate or measure the size of the patient&#39;s stomach beforehand. Using this measurement, the gastric skirt  400  can be tailored to provide a customized fit (for example, 10-30% smaller in diameter than the measurement to accommodate the tuck). The prior measurement reduces the risk of overtucking or overstretching or damaging the gastric skirt  400  when it is being positioned around the stomach, and can allow for a smooth and even customized fit (see also  FIGS. 5A ,  5 B, and  5 C). 
     This conical cylinder design allows a single gastric skirt to properly hold various portions of the stomach, even though the stomach may vary in size throughout. The use of a single gastric skirt reduces the complexity of the system and reduces the possibility of complications which may arise due to uneven pressure resulting from multiple skirts around the stomach. Alternatively, multiple, separately-sized gastric skirts, such as, one for a larger portion of the stomach, and one for a smaller portion of the stomach, may be used. 
       FIG. 5A  is a view of a gastric skirt  500  placed in position around a stomach. The gastric skirt  510  is designed to cover substantially all of the greater or outer curvature  502 , and substantially all of the lesser or inner curvature  504 . As shown in  FIG. 5A , a portion of the fundus  506  and the antrum/pylorus  508  may be tucked or covered or restricted by the gastric skirt  510 . 
     In another embodiment, the gastric skirt  510  can be designed to cover a smaller portion of the greater curvature  502  and/or a smaller portion of the lesser curvature  504 , instead of covering the entire respective surfaces. Furthermore, the gastric skirt  510  can be designed to cover other surfaces of the stomach in addition to the greater curvature  502  and/or the lesser curvature  504 . For example, the gastric skirt  510  may have a larger surface area and cover the fundus  506  and/or the antrum/pylorus  508 , or portions thereof, in addition to portions of the greater curvature  502  and/or the lesser curvature  504 . 
     Unlike conventional gastric-restraint devices, such as the LAP-BAND®, the gastric skirt  510  is not placed between the cardia  514  and the fundus  506  forming a pouch. Furthermore, the gastric skirt  510  is not placed around the esophagus  512 . As described above, the gastric skirt  510  is instead fitted or positioned around the body of the stomach  500  (i.e., around surfaces of the greater curvature  502  and the lesser curvature  504  of the stomach  500 ). 
       FIG. 5B  is a view of a modular gastric skirt placed in position around a stomach  500 . The modular skirt  510  is shown as three strips  510 A,  510 B, and  510 C connected to one another. The male and female connectors are shown as  516 ,  518 , and  520 , respectively. 
       FIG. 5C  is a view of a gastric skirt  510  placed in position around a stomach  500  that shows a tucked-in portion of the stomach. In this example, the greater curvature  502  is tucked into the body of the stomach  500  and the gastric skirt  510  is placed around the tucked stomach to secure the tucked portion in place. The tucked portion is pushed into the body of the stomach, thus reducing the internal volume of the stomach. 
       FIG. 6  is a view of a laid-open butterfly-shaped gastric skirt  600 . The gastric skirt  600  has an indentation  602  on one side and an indentation  604  on the opposing side. The proximal end  606  and the distal end  608  can include connectors and receivers, respectively, so that when the gastric skirt  600  is folded, the proximal end  606  and the distal end  608  can be connected together. 
     Indentations  602  and  604  can be any shape such as an ellipse, oval, hourglass, or semicircular shape as shown in  FIG. 6 . For example, each of the indentations  602  and  604  can be formed in the shape of a square, a triangle, an oval, a semi-circle, an ellipse, a wave, a curve, or any other shape that creates an indentation. The size of each indentation  602  and  604  can be varied in order to provide an optimal fit around the stomach. Indentations  602  and  604  do not necessarily have to be the same shape or size as one another. 
     Furthermore, optional wing  610  is attached on one substantially horizontal portion adjacent to indentation  604 , and optional wing  612  is attached on the other substantially horizontal portion adjacent to indentation  604 . The wings  610  and  612  are used to attach the gastric skirt  600  to collar connector straps (shown in  FIGS. 10A ,  10 B, and  11 ). Similarly, the side of the gastric skirt  600  with indentation  602  has wings  614  and  616  attached. In another embodiment, the gastric skirt  600  can have no wings attached, or wings only on one side. The dashed line indicates that the gastric skirt  600  can have two or more modular pieces connected to one another similar to that shown in  FIG. 2B . 
       FIG. 7  is a view of a folded butterfly or step ladder-shaped gastric skirt  700 . Once the distal end  712  and the proximal end  714  are connected together by coupling the connectors and receivers, a narrow surface  702  fits the lesser curvature of the stomach and is formed on one side of the gastric skirt  700  between indentation  704  and indentation  706 . On the side opposite to the narrow surface  702  is the wide surface  708  which fits the greater curvature of the stomach. 
     In this embodiment, the narrow surface  702  of the butterfly-shaped gastric skirt  700  can be used to cover the lesser curvature of the stomach. Likewise, the broad surface  708  can be used to cover the greater curvature of the stomach. 
     In another embodiment, instead of having connectors and receivers to couple the gastric skirt  700 , the distal end  712  and the proximal end  714  can be sutured or stapled together. 
       FIG. 8A  is a view of a laid-open oval or pear-shaped skirt  800 . In this embodiment, the gastric skirt  800  has a protrusion  802  on one side and a protrusion  804  on the opposing side. The proximal end  806  includes female connectors  820  and  821 , and the distal end  808  includes male connectors  818  and  819 . Therefore, when the gastric skirt  800  is folded, the proximal end  806  and the distal end  808  can be connected by securing the male connectors  818  and  819  into the female connector  820  and  821 , respectively. In an embodiment, the width of the proximal end  806  and the distal end  808  is from about 4 centimeters to about 6 centimeters and the width between the protrusion  802  and the protrusion  804  is from about 8 centimeters to about 14 centimeters. 
     Outward protrusions  802  and  804  can be any shape, and not limited to, an oval, pear or semicircular shape as shown in  FIG. 8A . For example, each of the outward protrusions  802  and  804  can be formed in the shape of a square, a triangle, or any other shape. The size of each outward protrusion  802  and  804  can also be varied in order to provide an optimal fit around the stomach. Furthermore, the outward protrusions  802  and  804  do not necessarily have to be the same shape or size as one another. Optional wings  810  and  812  may be attached to outward protrusion  804 , and optional wings  814  and  816  may be attached to outward protrusion  802 . In another embodiment, the gastric skirt  800  can have no wings attached, or wings only on one side. 
       FIG. 8B  is a view of a laid-open oval or pear-shaped skirt  800  having a pouch  822  that holds a balloon  1500 . When the skirt  800  is wrapped around the stomach, the balloon  1500  can be secured in the pouch  822  or be inserted into the pouch  822  to keep the tucked-in portion within the stomach. 
       FIG. 8C  is a view of a modular laid-open oval or pear-shaped skirt  800  having a pouch  822 A and  822 B that holds a balloon. The modular gastric skirt  800  may have two or more strips or modules. Each strip may have a ridge  824  and/or a groove  826  for attachment to adjacent strips. The ridge  824  securely fits into the groove  826  along the length of each strip to prevent unwanted detachment of adjacent strips and any in-growth of tissue between adjacent strips. The pouch  822  comprises two pieces  822 A and  822 B since the skirt  800  is modular. 
       FIG. 9A  is a view of a folded gastric skirt  900  with locking clips. The gastric skirt  900  includes a proximal end  903  and a distal end  905 . When the gastric skirt  900  is folded so that the proximal end  903  and the distal end  905  connect, a hollow shaped gastric skirt  900  is formed with a skirt body  902 . Each locking clip comprises a male connector  904 ,  906 , or  908 , and a corresponding female receiver  914 ,  912 , or  910 , respectively. A right wing  916  and a left wing  918  are placed on opposite sides of one end of the skirt body  902 . The wings  916  and  918  are used to connect the gastric skirt  900  to a collar (see also  FIG. 11 ). 
       FIG. 9B  is a view of a locking clip for the gastric skirt  900  shown in  FIG. 9A . The locking clip  920  comprises the male connector  908 , which includes a connector strap pin  922 . The locking clip  920  also comprises the female connector  910 . To engage the locking clip  920 , the connector strap pin  922  interlocks with an opening in the female connector  910 . Once the male connector  908  and the female connector  910  are engaged, the locking clip  920  holds a portion of the skirt body together. Furthermore, the male connector  908  includes a lower portion  926  which extends outwards. The female connector  910  includes an upper portion  924  which also extends outwards. When the male connector  908  and the female connector  910  are engaged, the lower portion  926  rests underneath the upper portion  924 . 
       FIG. 10A  is a view of a gastric skirt  1002  with a harness system  1000 . The harness system  1000  may include a gastric skirt  1002 , an upper collar  1004 , and connector straps  1006  and  1008 . The gastric skirt  1002  is placed around the body of the stomach as previously described in  FIG. 5A . In another embodiment, a lower collar (not pictured) is also included, allowing the upper collar  1004  and the lower collar to work in conjunction to hold the gastric skirt  1002  in position. 
     The upper collar  1004  is connected to the gastric skirt  1002  via the connector strap  1006  and the connector strap  1008 , which are both, for example, connecting straps. The connector strap  1006  includes a skirt hook  1016  and a collar hook  1018 . Likewise, the connector strap  1008  includes a skirt hook  1020  and a collar hook  1022 . Regarding the connector strap  1008 , the skirt hook  1020  connects to the gastric skirt  1002  at a wing  1012 . The collar hook  1022  connects to the collar  1004  at a wing  1014 . Regarding the connector strap  1006 , the skirt hook  1016  connects to the gastric skirt  1002  at a wing  1010 . The collar hook  1019  connects to the collar at a wing (not shown) located at a substantially parallel location as wing  1014  on the opposite side of collar  1004 . 
     The connector strap  1006  has a flexible connector strap  1024  to accommodate angulations to various anatomical differences where the skirt hook  1016  and the collar hook  1018  connect with each other. Likewise, the connector strap  1008  has a flexible connector strap  1026  where the skirt hook  1020  and the collar hook  1022  connect with each other. The flexible connector straps  1024  and  1026  help to accommodate any angulations of the stomach in relation to the lower esophagus and the fundus or the stomach and the pylorus, as well as help to accommodate the angles and contractility or peristaltic movements of the stomach. In an embodiment, the connector straps  1024  and  1026  can bend from 1 degree to 90 degrees in any direction, and in a preferred embodiment, the connector straps  1024  and  1026  can bend from 10 degrees to 60 degrees in any direction to accommodate movements of the stomach. 
       FIG. 10B  is a side-view of the gastric skirt  1002  with a harness system  1000 . In an embodiment, the gastric skirt  1002 , the upper collar  1004 , the lower collar (not shown), the connector strap  1008 , and the connector strap  1006 , all have the same thickness and are all made of the same material. In an embodiment, this thickness is up to 1/35,000 of an inch. 
       FIG. 11  is a view of a gastric skirt  1102  with a harness system in position around a stomach  1100 . The gastric skirt  1102  is placed along the greater curvature  1122  and the lesser curvature  1120  of the stomach  1100 . An upper collar  1104 , also known as the cardia collar, is placed around the lower end of esophagus  1108  at a position near or adjacent to the cardiac receiver  1112 . The upper or cardia collar  1104  is large enough in diameter to encircle the lower esophagus  1108 , but small enough so that it cannot encircle the larger diameter portion of the esophagus  1110 . The upper collar  1104  is connected to the gastric skirt  1102  via a connector strap  1126 . The connector strap  1126  is attached to the upper or cardia collar  1104  at a wing  1122 , and the connector strap  1126  is attached to the gastric skirt  1102  at a wing  1124 . This design prevents the upper collar  1104  from moving very high up the esophagus  1110 , helps to hold the gastric skirt  1102  in place, and may help in reducing gastro esophageal reflux (“gastric reflux”) or achalasia or dysphagia after the procedure. 
     The lower collar  1106 , also known as the antral collar, is placed around a lower portion of the stomach near the angular receiver  1134  at the pylorus  1116 , also known as the pyloric antrum receiver. The lower collar  1106  is large enough in diameter to encircle part of the lower portion of the stomach near the pylorus  1116 , but small enough so that it cannot encircle the larger diameter portion of the small intestine  1118 . The lower collar  1106  is connected to the gastric skirt  1102  via connector strap  1132 . The connector strap  1132  is attached to the lower collar  1106  at a wing  1128 , and connector strap  1132  is attached to the gastric skirt  1102  at a wing  1130 . This design prevents the lower collar  1106  from moving down into the small intestine  1118 , and helps to hold the gastric skirt  1102  in place. Furthermore, the lower collar  1106  may assist in slowing the gastric emptying from the stomach into the small intestine  1118 . The lower collar  1106  may also assist in anchoring the gastric skirt  1102  in place. 
     In another embodiment, only the upper collar  1104  is attached to the gastric skirt  1102 , and a lower collar  1106  is not present. As the volume of the fundus  1114  fills with food, the fundus  1114  stretches and expands, preventing the gastric skirt  1102  from sliding upwards. Thus, the lower collar  1106  may not necessarily be required in all patients to help hold the gastric skirt  1102  in place around the stomach  1100 . Alternatively, in another embodiment, only the lower collar  1106  is attached to the gastric skirt  1102  and an upper collar  1104  is not present. 
     The gastric skirt  1102  and harness system are modular, and provides patients with at least three different options. In the first option, only the gastric skirt  1102  is utilized, without the collars  1104  and  1106  and the connector straps  1126  and  1132 . In this embodiment, the healthcare professional may decide to not include the collars  1104  and  1106  if there is not a high risk of gastric reflux or achalasia, or if there is not a high risk that the gastric skirt  1102  may be displaced. 
     In the second option, the gastric skirt  1102  is utilized along with the collar  1104 , but without the collar  1106  and without the connector straps  1126  and  1132 . In this embodiment, the gastric skirt  1102  and the collar  1104  are not connected to each other. The healthcare professional may decide on this option if there is a risk of gastric reflux, achalasia, dysphagia but not a high risk that the gastric skirt  1002  or the collar  1104  may be displaced. 
     In the third option, the gastric skirt  1102  is utilized with the collars  1104  and  1106  and the connector straps  1126  and  1132 . The healthcare professional may decide on this option if there is a risk of gastric reflux, or dysphagia and a risk of that the gastric skirt  1102  or collars  1104  and  1106  may be displaced. In this option, both the upper collar  1104  and the lower collar  1106  do not need be utilized, and only one of the collars  1104  or  1106  can be used. The upper collar  1104  not only serves to hold the gastric skirt  1102  in place, but is also a mechanism to help reduce gastric reflux and dysphagia. 
     The modular design allows the healthcare professional to decide which components of the gastric skirt system will be utilized, as well as the order of insertion of the various components. 
     In an embodiment, the upper collar  1104  and the lower collar  1106  each have a diameter from about 4 centimeters to about 6 centimeters. The upper collar  1104  can have a larger diameter up to about 11 centimeters in cases where the patient suffers from esophageal achalasia. In an embodiment, the length of the upper collar  1104  and the lower collar  1106  is up to about 4 centimeters. 
     The length of connector straps  1126  and  1132  can be varied to accommodate various stomach sizes. In a preferred embodiment, connector strap  1126  and connector strap  1132  have a length of about 5 centimeters. 
     The gastric skirt  1102  can have a length of about 6 centimeters to about 14 centimeters. In a preferred embodiment, the length of the gastric skirt  1102  is from about 8 centimeters to about 12 centimeters. The width of the greater curvature side of the gastric skirt  1102  is from about 7 centimeters to about 10 centimeters, and the width of the lesser curvature side of the gastric skirt  1102  is from about 3 centimeters to about 5 centimeters. 
     Some patients who undergo various gastric banding procedures experience gastric reflux, and it is believed that gastric banding procedures may cause or aggravate gastric reflux. Gastric reflux occurs when irritating stomach contents, such as acid, accumulate in the stomach outside of the lower esophagus entrance, and eventually, leak or regurgitate back into the esophagus. This leakage, over time, causes the lower esophagus to lose its tone, leaving the lower esophagus entrance poorly controlled, tortuous, unconstructed or floppy. 
     The upper collar  1104  may be approximately the same size as the lower esophagus or may be slightly larger. Once in position, the upper collar  1104  applies support by forming a significant wrap around the lower end of the esophagus  1108  or the cardia. The upper collar  1104  restricts the lower end of the esophagus opening  1108  and attempts to minimize regurgitation, thereby reducing gastric reflux. 
       FIG. 12  is a view of an exemplary connector strap. The connector strap  1200  has a lower portion  1232  and an upper portion  1234 . The lower portion  1232  corresponds to the skirt hook  1202 . The upper portion  1234  corresponds to the collar hook  1204 . The connector strap  1200  has a skirt hook  1202  and a collar hook  1204 . The skirt hook  1202  includes connector strap pin  1206 , connector strap pin  1208 , and extending portion  1226 . The collar hook  1204  includes a hole  1210  through ridge  1222  and a second hole (not shown) through ridge  1224 . The collar hook  1204  also includes a cavity  1220 . The connector strap pins  1206  and  1208  are smaller in diameter than the diameters of hole  1210  and the second hole through ridge  1224 . This design allows increased flexibility as the connector strap pins  1206  and  1208  have space to re-position with their respective holes when the connector strap  1200  is rotated or shifted. 
     To connect the skirt hook  1202  and the collar hook  1204  together, connector strap pin  1206  is inserted into hole  1210 , and connector strap pin  1208  is inserted into the second hole through ridge  1224 . The extending portion  1226  is inserted into the cavity  1220 . Once the skirt hook  1202  and the collar hook  1204  are connected, the connector strap  1200  is formed. 
     The skirt hook  1202  also includes hole  1216  and connector strap pin  1218 . To attach the connector strap  1200  to a wing (not shown) on the gastric skirt (not shown), the wing is placed inside the connector strap cavity  1228  so that connector strap pin  1218  is inserted through the wing. To secure the wing to the skirt hook  1202 , the connector strap pin  1218  is pushed through the hole  1216 . The connector strap pin  1218  has a triangular shape, with a narrow top and a wide base. The diameter of the base of the connector strap pin  1218  is larger than the diameter of hole  1216 . This design allows the connector strap pin  1218  to be securely fastened once it is inserted through hole  1216 . Likewise, the collar hook  1204  includes a hole  1212 , a connector strap pin  1214 , and a connector strap cavity  1230  to secure the collar hook  1204  to a wing on the collar (not shown). 
     In an embodiment, the connector strap  1200  is made of an elastomer, such as silicone. However, the connector can be made from other types of elastomers or thermoplastic polymers, ePTFE, Dacron®, or any combination thereof. 
       FIG. 13A  is a view of a collar. The collar  1300  includes a locking clip  1302 . The collar  1300  has a distal end  1304  and a proximal end  1306 . The distal end  1304  and the proximal end  1306  are connected by the locking clip  1302 . The collar  1300  further includes a first wing  1308  and a second wing  1310  that are used to secure the collar  1300  to the gastric skirt connector strap (not shown). 
     In order to place the collar  1300  around the lower esophagus or cardia, the locking clip  1302  is not engaged, so that the distal end  1304  and the proximal end  1306  are laid open. The collar  1300  is then fitted around a portion of the lower esophagus as described above. Once the collar  1300  is in place, the locking clip  1302  is engaged by connecting the distal end  1304  and the proximal end  1306  together. 
       FIG. 13B  is a view of a locking clip for a collar  1300 . The male connector  1312  includes a connector strap pin  1316  which interlocks with an opening in the female connector  1314 . Once the male connector  1312  and the female connector  1314  are engaged, the locking clip holds the collar in position. 
       FIG. 13C  is a view of a collar  1300  without wings. The collar  1318  is used when a collar is not required to be connected to the gastric skirt (not shown), such as in surgical option one discussed above. 
     The locking clip  1302  can be any type of locking, coupling, or clasping mechanism, and is not limited to the male connector  1312  and female connector  1314  designs shown in  FIGS. 13A-D . For example, the male connector may be an insertable clip, and the female connector can include an opening to receive and secure the insertable clip. In another embodiment, the clip can slide in and out of the body of the skirt, and can have an elastic component that stretches to accommodate the size and shape of the stomach. 
     In an embodiment, the collar  1300  and locking clip  1302  are made from a composition of silicone and PTFE/ePTFE. However, the collar  1300  and locking clip  1302  can be made from other elastomers or thermoplastic polymers, or any combination thereof. 
     In another embodiment, the distal end  1304  and proximal end  1306  can be sutured or stapled together at the time of positioning by the healthcare professional. 
     In yet another embodiment, the collar  1300  can be shaped as a semicircular ring, or in a “C” shape, and be made of a memory-retaining material. Once the collar  1300  is placed around a portion of the lower esophagus, it retains its shape. Thus, a locking clip is not required. 
       FIG. 13D  is a view of a laid-open collar  1300 . The collar  1300  is in a strap form when the male connector  1312  and the female connector  1314  are not connected. 
     As described above and shown in  FIG. 1B , a portion of the stomach is tucked inwards prior to application of the gastric skirt around the stomach. 
       FIG. 14  is a cross-sectional view of a stomach  1400  and a balloon  1402  positioned within a greater curvature  1406  of the stomach  1400  when the greater curvature  1406  is tucked into the stomach  1400 . In an embodiment, after the greater curvature  1406  of the stomach  1400  is tucked inwards, a cavity  1404  is formed as a result of the tucking procedure and a balloon  1402  is placed within the cavity  1404 , which can be left open, and a gastric skirt  1412  is tightly positioned around the stomach  1400  to hold the balloon  1402  in place within the cavity  1404 . Hence, the balloon  1402  is placed within the tucked-in portion of the stomach  1400 . Alternatively, the balloon  1402  may be placed within a pouch  1414  that is attached to the gastric skirt  1412 . The greater curvature  1406  of the stomach  1400  is pushed inwards to reduce the inner volume  1410  of the stomach  1400 . The balloon  1402  applies pressure against the greater curvature  1406  of the stomach  1400  and helps to maintain the shape of the cavity  1404 . Following the placement of the balloon  1402 , the gastric skirt  1412  is placed around the stomach  1400  as described above. In this embodiment, when the gastric skirt  1412  is positioned around the stomach  1400 , the connectors as shown in  FIG. 5B  connect with one another along the lesser curvature  1408  of the stomach  1400 . 
     As described above, the greater curvature  1406  of the stomach  1400  is the preferred tucking portion. However, the tucked-in portion of the stomach  1400  may be a portion of the lesser curvature  1408 , or any portion of the stomach  1400  not along either the greater curvature  1406  or the lesser curvature  1408 . If the tucked-in portion of the stomach  1400  is along the lesser curvature  1408 , then the connectors as shown in  FIG. 5B  connect with one another along the greater curvature  1406  of the stomach  1400 . 
       FIG. 15A  is a view of the balloon of  FIG. 14 . The balloon  1500  can be a sealed or open ended stent, cylindrical air filled or saline filled device with an ePTFE, Dacron®, or silicon coating or covering. The balloon  1500  is preferably made of an alloy of nickel and titanium (Nitinol) or stainless steel wire cage which provides the balloon  1500  with a self-expanding memory. The unique characteristic of this alloy, known generally as “Nitinol,” is that it has a thermally triggered shape memory. This allows the balloon cage to be crimped per a desired length, width, and volume based on the balloon size required per patient&#39;s stomach dimensions, and then the balloon  1500  is crimped into a sheath so that it can fit through a trocar (not shown). The balloon  1500  regains its desired shape when deployed at room temperature, such as the temperature of the human body or outer stomach lining. 
     The semi-rigid or rigid Nitinol or stainless steel wire frame is covered with ePTFE, silicone, Dacron® or any other elastomer or thermoelastic elastomer, nitinol cage. The balloon  1500  provides support to the outer lining of the stomach when the balloon  1500  is placed in position within the cavity  1404  of  FIG. 14 . The desired shape of the balloon  1500  is retained even under pressure from the stomach lining or the gastric skirt (not shown) since Nitinol or stainless steel or titanium wire cage is rigid and has memory. After the balloon  1500  is placed in position, the gastric skirt is placed around the stomach as described above. 
     In one embodiment, the self-expanding nitinol cage or stainless steel wire cage balloon  1500  is covered with silicone, and is formed in the shape of a cylindrical balloon, and can have open or closed ends. In another embodiment, the self-expanding nitinol balloon  1500  is covered with ePTFE, and can have open or closed ends. 
       FIG. 15B  is a view of a balloon  1502  with a port  1504 . The balloon  1502  is made entirely of silicone, other elastomers, thermoplastic polymers, or any combination thereof, and may be filled with air or liquid (e.g., saline) and methylene blue and has a closed end and a port  1504  to inject air, liquid or methylene blue. The methylene blue is used to detect leaks of the balloon  1502 . 
     The balloon  1500  has a length of about 7 centimeters to about 10 centimeters. In an embodiment, the diameter of the balloon  1500  is from about 1 centimeter to about 3 centimeters. However, the diameter of the balloon  1500  can be adjusted by the healthcare professional based on the amount of stomach that is tucked-in. 
       FIG. 16  is a view of the gastric skirt of  FIG. 6  and the balloon in position around a stomach. As seen in  FIG. 16 , connectors  1604  and  1606  are positioned on the lesser curvature side  1610  of the stomach  1600 . Balloon  1602  is positioned on the greater curvature side  1612  of the stomach  1600 . In this embodiment, the connectors  1604  and  1606  are not on the greater curvature side  1612  so that there is room for the balloon  1602  to be retained and held in place by the gastric skirt  1608  within the tucked-in portion (not shown) of the stomach. 
     Furthermore, optional wings  1612  and  1614  are attached to the gastric skirt  1608  to attach the gastric skirt  1608  to collar connector straps (not shown). 
       FIG. 17  is a view of one or more ropes  1702  wrapped around a tucked-in stomach  1700 . The ropes  1702  may be made of a biodegradable material or a woven silicon material or any other material described herein. The stomach  1700  is tucked-in and then the ropes  1702  are wrapped around the stomach  1700 . Each rope  1702  can be a silicone rope, a mesh made of biodegradable elastomer, a metal, an alloy, a silicone or thermo-elastic material to harness the stomach or to create the pouch proximally or distal to the body of the stomach or to produce the same effect as the gastric skirt by tucking the stomach. 
       FIG. 18  is a view of one or more tentacles  1802  wrapped around a tucked-in stomach  1800  where the tentacles  1802  can be independently pulled and locked in place using a ring and clip system  1808  or a tie lock (not shown). Each tentacle  1802  can be independently tighten and loosened to control the tension. Each tentacle  1802  can be pulled through a ring or hole and the clip can lock the tentacle in place. The tentacles  1802  can be wrapped around the greater curvature  1806  and the lesser curvature  1804  of the stomach  1800 . The tentacles  1802  can be any shape, such as straight or curved, and are not limited to the design shown in  FIG. 18 . Furthermore, the tentacles  1802  can be made of an expandable material originating from the body at the lesser curvature  1804  or the greater curvature  1806 . 
       FIG. 19  is a view of an inflatable gastric skirt  1902  positioned around a stomach. In an embodiment, the gastric skirt  1902  is positioned around the stomach along the lesser curvature  110  and the greater curvature  112 , similar to the gastric skirt  200  described above. The gastric skirt  1902  includes one or more fillable or inflatable chambers that are attached to an interior surface of the gastric skirt  1902 . 
     In an embodiment, the gastric skirt  1902  is inflated via a tube  1904  that is connected to the one or more inflatable chambers. The tube  1904  includes an inlet  1906  that can be located slightly beneath the skin of the patient. The tube  1904  also includes an outlet  1908  which is connected to the one or more inflatable chambers  2008  (see also  FIG. 20 ). In an embodiment, the inlet  1906  can be sutured or stapled beneath the skin so that it is accessible via an incision. 
     In another embodiment, the inlet  1906  can include an RFID tag with an antenna to assist a healthcare professional in locating the inlet  1906  for subsequent adjustments. An external RFID locator or reader, such as in a handheld device, can be used to locate the inlet  1906  so that a syringe can be inserted directly into an access cavity of the inlet  1906 . 
       FIG. 20  is a view of an inflatable gastric skirt and a triple-lumen tube  1904 . In an embodiment, the tube  1904  includes three separate lumens  2002 , with each lumen connected to a separate inflatable chamber  2008 . In another embodiment, the tube  1904  can include a single lumen or a double lumen. In yet another embodiment, the tube  1904  can include four or more lumens, with each lumen connected to a separate inflatable chamber that can be filled with a fluid. 
     In an embodiment, the gastric skirt  1902  can be positioned around the stomach and secured into place via clips  2010 . In an embodiment, the gastric skirt  1902  is configured to cover at least 14 square centimeters of the outer surface of the stomach  100 . Thus, the gastric skirt  1902  has a surface area of at least 14 square centimeters. Once in place, the gastric skirt  1902  can be further tightened around the stomach by inflating, filling, or expanding the chambers  2008 . Upon inflation of the inflatable chambers  2008 , the gastric skirt  1902  applies constriction pressure around or to the stomach. The level of inflation can be determined based on a desired stomach constriction level. 
     In an embodiment, the gastric skirt  1902  includes an inflatable collar  2006  configured to surround the lower esophageal/cardia portion of the stomach. The inflatable collar  2006  is coupled to the gastric skirt  1902  via two or more connector straps  2004 . The inflatable collar  2006  provides a harness and adds stability to the gastric skirt  1902  after the gastric skirt  1902  has been positioned around the stomach. 
     Referring to  FIGS. 48A-B , the clips  2010  can each include a male tooth  4802  and a female receiver  4804  configured to engage the male tooth  4802 . Upon insertion of the male tooth  4802  into the female receiver  4804 , the male tooth  4802  releasably locks with the female receiver  4804  as shown in  FIG. 48B . The clips  2010  may include a release tab  4806  which releases the male tooth  4802  from the female receiver  4804  upon the application of pressure to the release tab  4806 . Further, the locking mechanism can have a “pop-fit” design that provides a tactile indication that the gastric skirt  1902  is secured in place. The locking mechanism of the gastric skirt  1902  is not limited to the clips  2010  shown in  FIGS. 48A-B , but can be any type of connecting mechanism which can securely connect the two opposite ends of the gastric skirt  1902  around the stomach. 
     In another embodiment, the gastric skirt  1902  does not have connectors, but the ends of the gastric skirt  1902  are attached to one another by staples, sutures, or heat fusion after the gastric skirt  1902  is positioned around the stomach  100 . 
       FIG. 21  is a view of an inflatable gastric skirt without a harness system. The gastric skirt  1902  includes connector holes  2102  where the connector straps  2004  (not shown) are attached. The connector holes  2102  and corresponding tabs  2104  are optional depending on whether the harness system is being used. In an embodiment, the gastric skirt  1902  is a standalone device without the harness system, and can be positioned around the stomach without the collar  2006  and the connector straps  2004 . 
       FIG. 22A  is a view of a gastric skirt  1902  having one or more inflatable chambers  2008 . In an embodiment, each of the lumens  2002  is connected to a valve  2202 . Each valve  2002  is connected to a separate inflatable chamber. In another embodiment, a single valve is located on the tube  1904  near the inlet  1906 , and controls delivery to all of the chambers  2008 . Each lumen  2002  can also be directly connected to a separate inflatable chamber  2008  without a valve  2002 . 
       FIG. 22B  is a view of a cavity  2204  of a triple-lumen tube  1904 . The tube  1904  has a cavity  2204  that contains three separate lumens  2002 . Each of the lumens  2002  is connected via a valve  2002  to a separate inflatable chamber, as shown in  FIG. 22A . In an embodiment, each of the lumens  2002  has a separate inlet so that a different fluid can be administered through each of the lumens  2002 . In another embodiment, the tube  1904  can include switches which allow an operator to close or open certain lumens  2002 . Thus, a single inlet can be used to administer the fluid; however, a switch or valve can be used to close the second and third lumens, while allowing the fluid to pass through the first lumen and into the first chamber. 
       FIG. 23  is a view of the interior of a triple-lumen tube. The tube  1904  includes three separate lumens, a first lumen  2302 , a second lumen  2304 , and a third lumen  2306 . Surrounding the lumens  2002  is the tube  1904 . The tube  1904  and the lumens  2002  are relatively flexible and may be made of a non-porous elastomer, such as, but not limited to, silicone, polypropylene, polyethylene terephthalate, polytetrafluoroethylene, polyaryletherketone, nylon, fluorinated ethylene propylene, polybutester, or any combination thereof. In an embodiment, the tube  1904  and the lumens  2002  are made of the same material. In an alternative embodiment, the tube  1904  and the lumens  2002  are made of different materials. 
       FIG. 24  is an interior view of an inflatable gastric skirt. In an embodiment, the tube  1904  has a staggered lumen design, so that each of the three lumens has a different length. The first lumen  2302  outputs into the first chamber  2408 , the second lumen  2304  outputs into the second chamber  2410 , and the third lumen  2306  outputs into the third chamber  2412 . In an embodiment, the third lumen  2306  is longer than the second lumen  2304 , and the second lumen  2304  is longer than the first lumen  2302 , thus creating a staggered lumen design within the tube  1904 . In another embodiment, each of the lumens  2002  in the tube  1904  has approximately the same length, and each lumen directly connects to its respective chamber. 
     In an embodiment, the chambers  2008  are relatively flexible or semi-flexible and may be made of a non-porous elastomer such as, but not limited to, silicone, polypropylene, polyethylene terephthalate, polytetrafluoroethylene, polyaryletherketone, nylon, fluorinated ethylene propylene, polybutester, or any combination thereof. In an embodiment, certain chambers can be selectively filled with fluid. For example, fluid can be administered to only the first chamber  2408  and the third chamber  2412 , leaving the second chamber  2410  unfilled or deflated. In another embodiment, each of the chambers  2008  can be inflated to different fluid amounts resulting in different pressure levels within each chamber. 
     The fluid administered into each chamber  2008  can include saline, air, water, gel, gas, or any other biocompatible fluid or viscous solid. In a preferred embodiment, the fluid is concentrated saline. In another embodiment, the fluid includes methylene blue. Different fluids can be administered through each lumen, thus, allowing each chamber to be filled with a different amount and/or type of fluid. For example, the fluid administered through the first lumen  2302  and the second lumen  2304  can be saline, and the fluid administered through the third lumen  2306  can be a gas. 
       FIG. 25  is a view of a triple-lumen inlet port. The inlet  1906  includes an access hole  2502  or a septum  2502  that covers all the lumen openings. A needle may be used to pierce the septum  2502  and allow a healthcare professional to fill fluid into the lumens  2302 ,  2304 , and  2306 . The septum  2502  may have a visible marker on top to indicate where the needle should be positioned for filling each of the lumens. The septum  2502  may automatically be sealed when the needle is removed to prevent fluid for exiting the lumens. In one embodiment, the inlet  1906  is made of a semi-rigid elastomer. 
       FIG. 26  is a view of an inflatable gastric skirt and an inflation device. In an embodiment, to inflate the gastric skirt, a non-coring needle and syringe  2602  can be used to administer fluid to the access hole or septum  2502 . To deflate the chambers  2008 , the inlet  1906  is connected to a suction device  2602  which pulls the fluid out from the chambers  2008  or the needle  2602  can be reinserted through the septum  2502  which is used to remove the fluid from the lumens, which results in fluid being removed from the chambers  2008 . The suction device  2602  can be, for example, a syringe, a vacuum, or any other means to withdraw inflation fluid from the chambers  2008 . In another embodiment, the inlet  1906  can be connected to an automated system for inflation and deflation of the chambers, so that manual adjustment of the gastric skirt  1902  is not required. 
     In an embodiment, the inlet  1906  includes a reservoir which holds fluid. For example, the reservoir can be pre-filled during insertion of the gastric skirt  1902  around the stomach. The reservoir can automatically administer fluid to the lumens  2002  over a pre-determined time period. In another embodiment, the reservoir can include dual tanks, one tank to deliver fluid to the chamber, and another tank to remove fluid from the chamber. The dual tanks can automatically inflate or deflate the chambers  2008  based on fluid pressure changes resulting from movement of the patient and the stomach. 
     The gastric skirt  1902  can have a microprocessor and sensors attached thereto to determine the fluid pressure and free volume within each chamber. Upon receipt of the fluid pressure and free volume data, the microprocessor can be used to activate fluid transfer between the different chambers in order to compensate for fluid displacement due to patient and stomach movements. The fluid transfer can ensure that a desired amount of pressure is constantly being applied from each chamber to the stomach. In another embodiment, the microprocessor can control the reservoir, and administer or draw fluid based on the sensor readings. 
     The gastric skirt  1902  may include at least one pressure sensor located within the tube  1904  and at least one pressure sensors located within the chambers  2008  to measure fluid movement and fluid pressure within the chambers  2008 . A receiver located within the gastric skirt  1902  can transmit data to a remote controller, such as, for example, an external handheld computer, desktop computer, monitoring system, or an online web-based monitoring portal. 
     In an embodiment, the remote controller includes microprocessors to analyze the data for pressure variations and determine optimal fill volumes for the chambers  2008 . This analysis can assist a healthcare professional in adjusting the inflation levels in the chambers  2008 . Alternatively, the data can be used by the remote controller to automatically adjust the fluid levels based on pre-determined constriction pressures. In an embodiment, each of the different chambers can have a separate pressure sensor, allowing monitoring and adjustment of fluid within each individual chamber. 
     Each chamber can have multiple entry points for the lumens, so that a blockage in one portion of a lumen or a chamber will not prevent the chamber from being filled with fluid. For example, the first lumen  2302  can have multiple branches which allow inflation fluid into the first chamber  2408 . Thus, if one of the branches is blocked or obstructed, the other branches on the first lumen  2302  will continue to fill the first chamber  2408 . 
     In another embodiment, the reservoir can be controlled via an implantable pump that is powered by an implantable energy source, such as batteries or capacitors. Alternatively, the pump can be powered by a passive device located outside the body via energy transferred through, for example, radio frequency, induction, or electromagnetic energy. 
     In another embodiment, the tube  1904  is removable. After the gastric skirt  1902  has been placed around the stomach, and adjusted to provide a desired constriction pressure, the healthcare professional can remove the tube  1904 . In this embodiment, the gastric skirt  1902  is designed to be inflated and adjusted only at the time of insertion. Following the initial inflation and adjustment, the outlet  1908  can be detached from the gastric skirt  1902 , and the tube  1904  can be removed from the body. In order to inflate or deflate the gastric skirt  1902  after the initial surgery to insert the gastric skirt  1902 , the outlet  1908  of the tube  1904  needs to be re-attached to the gastric skirt  1902  via a surgical procedure. 
       FIG. 27  is a view of a laid-open inflatable gastric skirt. In an embodiment, the chambers  2408 ,  2410  and  2412  are attached to or integrated with an interior portion  2702  of the gastric skirt  1902 . The first lumen  2302  has an output into the first chamber  2408 , the second lumen  2304  has an output into the second chamber  2410 , and the third lumen  2306  has an output into the third chamber  2412 . In another embodiment, a single lumen can be utilized instead of multiple lumens. The single lumen can have outlets branching into each of the chambers  2408 ,  2410  and  2412 . 
       FIG. 28  is a view of a connector strap. The connector strap  2004  has buttons  2802  that are used to secure the connector strap  2004  to the upper collar  2006  and the gastric skirt  1902 . The buttons  2802  are configured to snap into the connector holes  2102  on the gastric skirt  1902  and corresponding connector holes on the upper collar  2006 . The connector strap  2004  is relatively flexible or semi-flexible and may be made of a non-porous elastomer, such as, but not limited to, silicone, polypropylene, polyethylene terephthalate, polytetrafluoroethylene, polyaryletherketone, nylon, fluorinated ethylene propylene, polybutester, or any combination thereof. The connection means between the upper collar  2006  and the gastric skirt  1902  is not limited to the connector strap  2004 , and can be any type of connector which allows a limited movement of the upper collar  2006  irrespective of the movement of the gastric skirt  1902 . 
       FIG. 29  is a lateral view of the inflatable gastric skirt. In an embodiment, the chambers  2008  can have a thickness of 0.05 millimeters to 0.5 millimeters in a collapsed state. In an inflated state, the chambers can have a thickness of 0.5 millimeters to 1.5 centimeters. The thickness of the chambers  2008  can be varied based on a desired constriction pressure. Furthermore, each of the different chambers  2008  can be inflated to a different thickness or filled to provide a different level of rigidity. 
       FIG. 30  is a view of an inflatable collar. In an embodiment, an inflatable collar  3002  can be utilized for a harness system. The inflatable collar  3000  has a chamber  3002  and a tube  3004 . In an embodiment, the inflatable collar  3000  has multiple chambers similar to the chambers  2008  described above for the gastric skirt  1902 . The tube  3004  can have a single lumen or multiple lumens similar to the tube  1904 . The inflatable collar  3002  can be used to apply pressure to the antral portion and/or to the lower esophageal/cardia portion of the stomach. 
       FIG. 31  is a view of an inflatable gastric skirt with dual inflatable collars. In an embodiment, the lower collar  3102 , also known as the antral collar, is placed around a lower portion of the stomach near the angular receiver at the pylorus, also known as the pyloric antrum receiver. In an embodiment, the lower collar  3102  is large enough in diameter to encircle part of the lower portion of the stomach near the pylorus, but small enough so that it cannot encircle the larger diameter portion of the small intestine. The lower collar  3102  is connected to the gastric skirt  1902  via the connector straps  2004 . This system prevents the lower collar  3102  from moving down into the small intestine, and helps to anchor the gastric skirt  1902  in place. Furthermore, the lower collar  3102  may assist in slowing the gastric emptying from the stomach into the small intestine. 
     In an embodiment, the lower collar  3102  and the upper collar  3000  are both inflatable. The lower collar has a port  3104 , and the upper collar has a separate port  3006 . These ports operate in a similar fashion to the port  1906  that is used to inflate the chambers of the gastric skirt  1902 . In another embodiment, the tube  1904  can be connected to the gastric skirt  1902 , the lower collar  3102 , and the upper collar  3000 , so that a single tube  1904  is used to fill or inflate all of the chambers. 
       FIG. 32  is a view of an internal surface of an inflatable gastric skirt. In an embodiment, the first chamber  2408 , the second chamber  2410 , and the third chamber  2412  may be enclosed within a covering  3202 . The lumens  2002  are enclosed within the covering  3202  in a staggered fashion as described above. In an alternative embodiment, a single inflatable chamber is utilized, and can be inflated using a single-lumen port. 
       FIG. 33  is a view of a valve and the steps of inflation and deflation. In an embodiment, the valve  3302  is fitted at the inlet  1906  of the tube  1904 . The valve  3302  has a slitted diaphragm to allow a syringe nozzle to enter. In step  3300 , the valve is in a closed position. In step  3304 , a syringe nozzle  3303  is inserted through the slitted diaphragm of the valve  3302 . The slitted diaphragm opens up and allows fluid to be inserted through the syringe nozzle  3303 . In step  3306 , the fluid is inserted through the open valve  3302 . In step  3308 , the syringe nozzle  3303  is removed from the valve  3302 , and the slitted diaphragm of the valve  3302  returns to a closed position. 
     In an embodiment, to deflate or remove fluid from the chambers, the syringe nozzle  3303  is inserted into the slitted diaphragm of the valve  3302  as shown in step  3310 . The syringe nozzle  3303  is used to aspirate the inflation fluid from the lumens and chamber, thereby deflating or removing fluid from the chambers. In step  3312 , the syringe nozzle  3303  is removed from the valve  3302  and the slitted diaphragm returns to a closed position. In another embodiment, the inlet  1906  can have a similar design as the valve described in  FIG. 33 . 
       FIG. 34  is a view of an inflatable antral skirt. In an embodiment, the antral skirt  3402  can be positioned around the pyloric antrum  114 , which is located between the pyloric sphincter  3408  and the angular receiver  3406  in the lower part of the stomach  3404 . In an embodiment, the antral skirt  3402  is designed to be placed around a stomach that has undergone a VSG procedure, which is also known as sleeve gastrectomy, vertical gastrectomy, greater curvature gastrectomy, parietal gastrectomy, gastric reduction, longitudinal gastrectomy, or vertical gastroplasty. In the VSG procedure, the stomach  3404  is restricted by stapling and dividing it vertically and removing more than 85% of its surface area. As shown in  FIG. 34 , the greater curvature  112  of the stomach  3404  is taken in closer to the lesser curvature  110 , creating a sleeve-shaped stomach  3404 . In an embodiment, the antral skirt  3402  is configured to cover at least 14 square centimeters of the outer surface of the pyloric antrum  114 . Thus, the antral skirt  3402  has a surface area of at least 14 square centimeters. In an embodiment, the antral skirt  3402  has a length of at least 10 centimeters and a width of at least 4 centimeters. In one embodiment, the thickness of the antral skirt  3402  is up to about 1/35,000 of an inch. 
     In an embodiment, the antral skirt  3402  is inflatable or fillable with fluid through a tube  3410 , which operates similar to the tube  1904  described above for the gastric skirt  1902 . The antral skirt  3402  can be inflated and deflated to provide a desired constriction level around the pyloric antrum  114 . In another embodiment, the antral skirt  3402  can be applied around the pyloric antrum  114  of a stomach that has not undergone a VSG procedure. In yet another embodiment, the antral skirt  3402  can be applied in conjunction with a gastric skirt or other type of gastric constriction device that is placed around the body or fundus of the stomach. 
     Inflation of the antral skirt  3402  constricts the pyloric antrum  114 . The pyloric antrum  114  is a portion of the stomach where food and particles are collected and pumped into the lower intestine. The pyloric antrum  114  also contains receptors that provide indications of fullness to the brain. When food is pumped into the pyloric antrum  114  from the stomach, the pyloric antrum  114  expands, and receptors provide an indication that the stomach is full. This results in a pumping action by the pyloric antrum  114  to empty the stomach contents into the intestine. The antral skirt  3402  provides a constant restriction to the pyloric antrum, which leads to early gastric emptying. This mechanism is described in more detail by the disclosure below. 
     The antral skirt  3402  is relatively flexible or semi-flexible and may be made of a non-porous elastomer, such as, but not limited to, silicone, polypropylene, polyethylene terephthalate, polytetrafluoroethylene, polyaryletherketone, nylon, fluorinated ethylene propylene, polybutester, or any combination thereof. In another embodiment, the antral skirt  3402  can be made of a biodegradable mesh. 
       FIG. 35  is a laid-open view of an inflatable antral skirt. In an embodiment, the antral skirt  3402  includes an inflatable chamber  3506 . The antral skirt  3402  may or may not include an inflatable chamber  3506 . The inflatable chamber  3506  can be inflated or filled with inflation fluid through the tube  3410 . The antral skirt  3402  includes a male connector  3502  and an opposing female connector  3504 . When then antral skirt  3402  is positioned around the pyloric antrum, the male connector  3502  and the female connector  3504  interlock to securely hold the antral skirt  3402  in place. The connection means is not limited to the embodiment shown in  FIG. 35 , and the antral skirt  3402  can be securely held in place by clips, straps, sutures, stitching, staples, other types of connectors, and/or other attachment means. 
       FIG. 36  is a view of a double-side inflatable gastric skirt. In an embodiment, the gastric skirt  1902  includes a top inflatable layer  3604  attached to an exterior surface of the gastric skirt  1902  and a bottom inflatable layer  3606  attached to an interior surface of the gastric skirt  1902 . The top inflatable layer  3604  provides cushions from pressure exerted onto the stomach from other body organs that are adjacent to the stomach. The bottom inflatable layer  3606  provides constriction pressure on the stomach as described above. A double-lumen port  3602  provides separate inflation fluid to each of the inflatable layers. In an embodiment, the top inflatable layer  3604  and bottom inflatable layer  3606  can include multiple inflatable or fillable chambers. Each of the lumens in the double-lumen port  3602  can each contain multiple lumens to deliver different fluids to each of the multiple chambers within each inflatable layer. 
       FIG. 37  is a view of an inflatable gastric skirt with radio-frequency (RF) coils. In an embodiment, each of the inflatable chambers  2008  has a RF coil  3702  surrounding the exterior of the chamber  2008 . The RF coils  3702  are activated when a RF receiver  3704 , either coupled to the gastric skirt  1902 , or embedded within the gastric skirt  1902 , receives an activation signal from an energy device, such as an RF generator, controller or transmitter. In an embodiment, the energy device is located outside of the patient&#39;s body and transmits wireless energy signals to the RF receiver  3704 . The RF receiver  3704  can be used to store energy or the energy signals. In another embodiment, the energy device can be located inside the patient&#39;s body. In an embodiment, the RF coils  3702  provide RF energy, such as heat and ultrasonic energy, to the exterior stomach wall, and create scarring in the shape of the RF coils  3702  in the exterior stomach wall. The scarred tissue reduces the stomach volume. 
     In an embodiment, immediately after the tissue scarring process in completed the chambers  2008  can be filled with a cooled fluid, such as cooled saline. The cooled fluid may assist in better healing of the scarred tissue. Furthermore, once the chambers  2008  are inflated, they inflate into the space created by the scarred tissue, providing localized cushioning of the scarred regions. When the chambers  2008  expand or fill into the scarred tissue region that has been indented into the exterior stomach wall, the gastric skirt  1902  is secured into its intended site. 
     In an embodiment, the RF coils  3702  may be covered with a sleeve or pouch made from Teflon®, Dacron®, ePTFE, or any combination thereof. The sleeve is glued or sutured to the gastric skirt  1902  and/or the chambers  2008 . In another embodiment, the sleeve is molded with the gastric skirt  1902  and/the chambers  2008  to form a single molded structure. 
       FIG. 38  is a view of an inflatable gastric skirt with steam ablation holes. Each of the inflatable chambers  2008  are covered with a thin ablation layer  3802 , which contain an ablation device, and have top holes  3804  to allow thermal energy in the form of steam to pass through and ablate the exterior stomach wall. Steam is delivered to the ablation layers  3802  via a steam receiver  3806 . In an embodiment, the steam can be delivered through the tube  1904  prior to delivery of fluid to the chambers  2008 . In another embodiment, thermal steam ablation can be used in conjunction with laser ablation to provide scarring of the stomach tissue. 
       FIG. 39  is a lateral view of an inflatable gastric skirt with steam ablation holes. The gastric skirt  1902  includes ablation layers  3802  on top of each of the chambers  2008 . The ablation layers  3802  include side holes  3902 . The top holes  3802  and the side holes  3902  allows steam ablation to create an indentation within the exterior stomach wall so that the stomach can accommodate the chambers  2008 . 
       FIG. 40  is a view of an inflatable gastric skirt with an ultrasound probe. The gastric skirt  1902  includes ultrasound layers  4002  on top of each of the chambers  2008 . The ultrasound layers include an ultrasound receiver  4004  which delivers ultrasound waves to the exterior stomach wall. The ultrasound energy, such as ultrasonic waves, creates indentations within the exterior stomach wall so that the stomach can accommodate the chambers  2008 . In an embodiment, the ultrasound receiver  4004  can be embedded within the gastric skirt  1902  and activated by a receiver or controller located outside of the patient&#39;s body. 
     In another embodiment, laser energy, heat, microwave radiation, high-intensity light, or other tissue scarring mechanisms can be used to deliver energy to scar the exterior stomach wall. In each of these embodiments, an implanted receiver and an external energy source, such as a generator located outside of the body, can be used to activate the tissue ablation device. 
     In another embodiment, the energy source is implanted with the body, and can be embedded within the gastric skirt  1902 , embedded within the ablation layers, or located adjacent to the gastric skirt  1902 . 
     In an embodiment, the ablation device can be activated by a remote or external controller, such as for example, an external handheld computer, desktop computer, monitoring system, or an online web-based monitoring portal. The remote controller ablation energy to be delivered remotely after the gastric skirt implantation surgery has been completed. The remote controller activates the transmission of energy from an external energy source to the transmitter, which in turn delivers energy to the ablation layer. The ablation device then emits the energy toward the outer surface of the stomach in order to ablate stomach tissue. In an embodiment, the energy emission to the stomach tissue can last from 0.5 seconds to 20 seconds, depending on a desired level of ablation or scarring. 
     In another embodiment, the ablation device is positioned on the exterior surface of the gastric skirt  1902 . In this embodiment, the ablation device, such as an ultrasound probe, transmits ultrasound energy signals towards the outer surface of the stomach through the gastric skirt  1902 . 
     In another embodiment, the gastric skirt  1902  is comprised of an interior elastomeric sheet and an exterior elastomeric sheet. The ablation device is sandwiched between the first elastomeric sheet and the second elastomeric sheet. In yet another embodiment, the ablation device is integral to an elastomeric casing, and is contained within the elastomeric casing. 
       FIG. 41  is a view of an inflatable gastric skirt with alternating ablation layers and inflation chambers. In an embodiment, the thermal ablation layers  4102  are positioned in an alternating fashion with the chambers  2008 . The thermal ablation layers  4102  are positioned between the chambers  2008 , so that the inner surface of the gastric skirt  1902  has a smooth and even surface. In another embodiment, the ablation layers can be an ultrasound probe or RF coils positioned between the chambers  2008  in an alternating fashion as described above. 
     In another embodiment, different ablation layers can be activated to selectively scar different portions of the exterior stomach wall. For example, in the gastric skirt shown in  FIG. 40 , only two of the four ablation layers can be activated based on a desired area and amount of scarring. Furthermore, different ablation layers can be activated at different times so that a large portion of the stomach is not undergoing scarring at once, and the scarring procedure can be spread out over time. 
     In yet another embodiment, the chambers can be semiporous, allowing for fluid to leak onto the exterior stomach wall. The inflation fluid can be a neurotoxin, such as botulinum toxin types A, B, C 1 , D, E, F and G. When the neurotoxin is administered at the site where the inflatable chambers contact the stomach, the site administered takes a relaxed muscle tone. The inflatable chambers would then fall into these regions with the relaxed muscle tone, securing the gastric skirt  1902  in its intended site. 
     In an alternative embodiment, the gastric skirt does not include inflatable or fillable chambers. Instead, the gastric skirt includes only an ablation or tissue scarring mechanism, such as, for example, RF coils, thermal ablation layers, or ultrasound layers, to deliver energy to the exterior tissue, surface, wall or lining of the stomach. In this embodiment, the gastric skirt can be applied around a portion of the stomach in order to ablate the stomach and reduce the internal volume of the stomach. The gastric skirt can provide a barrier between the scarred exterior stomach wall and other body organs. This allows the scarred tissue to heal faster and with a minimal risk of infections or complications, as opposed to normal scarring procedures where the scarred tissue is left exposed during healing. 
     In an embodiment, the antral skirt  3402  can include an ablation device, such as, for example, RF coils, thermal ablation layers, or ultrasound layers, in conjunction with fillable or inflatable chambers. The antral skirt  3402  can provide constriction as well as ablation or scarring to the pyloric antrum  114 . 
       FIG. 42  is a view of a physiological connection between stomach receptors and a brain. After a VSG procedure, many of the cardia stretch receptors  4202  and the stomach body stretch receptors  4204  are removed. However, the pyloric antrum  114  is not modified by the VSG procedure, and the antral stretch receptors  4204  in the pyloric antrum  114  remain intact. Upon being filled with food and stomach contents, the pyloric antrum  114  expands, and the stretch receptors  4206  in the pyloric antrum  114  send neurological signals to the hypothalamus  4210  in the brain  4208 , indicating the stomach is full. Upon receipt of these signals, the hypothalamus  4210  sends a signal via the afferent vagal nerve  4212  to the pyloric antrum  114  to pump out the food into the intestines. 
     The antral skirt  3402  provides a constant pressure around the pyloric antrum  114 , so that when pyloric antrum  114  even slightly expands, the antral stretch receptors  4206  are constrained from further expansion. Upon being prevented from further expansion, the antral stretch receptors  4206  send a signal to the brain  4208 , and in turn, the pyloric antrum  114  is caused to pump out food contents. The combination of the antral skirt  3402  and the antral stretch receptors  4206  create an equal and opposite reaction, causing a continual gastric emptying by the pyloric antrum  114 . Thus, the invention takes advantage of the antral stretch receptors  4206  that remain after a VSG procedure in order to provide an indication of fullness to the brain  4208  and cause rapid and early gastric emptying. 
       FIG. 43  is a view of a stomach prior to ligation. In an embodiment, the gastric skirt  1902  is designed to accommodate a stomach that has undergone tucking and ligation procedures. Prior to placing the gastric skirt  1902  around the stomach  100 , a linear portion of the greater curvature  112  is tucked inwards into the stomach  100  and towards the lesser curvature  110 . As shown above in  FIG. 1B , the inner lining  120  is depressed within the stomach  100  as a result of the tucking procedure, and the tucked-in portion  4302  occupies space within the body of the stomach  106 . After the tucking procedure, a first untucked stomach portion  4304  and a second untucked stomach portion  4306 . Thus, the internal volume of the stomach  100  is substantially decreased. 
     In an embodiment, in order to assist the healthcare provider in determining how far to tuck in the stomach, a bougie  4308  is endoscopically inserted through the esophagus  102  and into the stomach body  106  (Step  4702 ). The bougie  4308  is inserted adjacent to or along the lesser curvature  110 . Next, a portion of the stomach  100  is tucked or pushed inwards towards the lesser curvature  110  until the bougie  4308  is reached (Step  4704 ). The bougie  4308  prevents the tucked-in portion  4302  from completely blocking off the stomach body  106 , and allows for a channel to remain in the stomach body  106  after the stomach ligation procedure is completed. In another embodiment, a guidewire dilator, balloon dilator, or any other mechanism can be used to assist the healthcare professional in tucking in the stomach  100  without closing off the stomach body  106 . 
     After the stomach  100  has been tucked-in, a ligation procedure is performed (Step  4706 ). The first untucked stomach portion  4304  and the second untucked stomach portion  4306  are ligated by inserting a ligature, such as bioabsorbable surgical staples, sutures, stitches, thread, wired and/or clamps, using a ligation device. Thus procedure closes off any space which was created by the tucked-in portion  4302  between the first untucked stomach portion  4304  and the second untucked stomach portion  4306 . In another embodiment, the ligation procedure can be performed using bioabsorbable staples or stitches. The ligation procedure can be conducted either laparoscopically or during an open-surgical procedure. After the ligation procedure is completed, the bougie  4308  is removed from the stomach  100  (Step  4708 ) using the endoscopic device. In an embodiment, the stomach  100  is then covered with the gastric skirt  1902  (Step  4710 ), and the gastric skirt  1902  is filled or inflated to provide a desired level of constriction around the stomach (Step  4712 ). 
       FIG. 44  is a lateral view of a tucked-in stomach prior to ligation. The greater curvature  112  is tucked-in towards the lesser curvature  110 , until the greater curvature  112  comes into contact with the bougie  4308 . The tucked-in portion  4302  leaves the first untucked stomach portion  4304 , the second untucked stomach portion  4306 , and a cavity  4402  between the first untucked stomach portion  4304  and the second untucked stomach portion  4306 . 
       FIG. 45  is a view of a ligated stomach. After the ligation procedure is completed, the internal volume of the stomach  100  is reduced to approximately one-third of its original volume. The ligation procedure is reversible, as the sutures  4310  can be removed. In an embodiment, the gastric skirt  1902  is positioned around the ligated stomach as shown in  FIG. 19 . In another embodiment, the stomach  100  undergoes a VSG procedure instead of a ligation procedure prior to the gastric skirt  1902  being placed around the stomach. 
       FIG. 46  is a lateral view of a gastric skirt positioned around a ligated stomach. The volume of the stomach body  106  is approximately one-third of its original volume. The sutures  4310  are inserted through the first untucked portion of the stomach  4304 , the cavity  4402 , and the second untucked portion of the stomach  4306 . The sutures  4310  prevent food and stomach contents from entering and accumulating in the first untucked portion of the stomach  4304  and the second untucked portion of the stomach  4306 . In an embodiment, the stomach  100  is covered with the gastric skirt  1902 . 
     While the principles of the disclosure have been illustrated in relation to the exemplary embodiments shown herein, the principles of the disclosure are not limited thereto and include any modification, variation or permutation thereof.

Technology Category: a