Abstract:
The invention generally relates to a method and apparatus to treat obesity. In an exemplary embodiment, the invention relates to tucking a portion of the greater curvature of the stomach inwards, and covering the stomach around the greater curvature and lesser curvature with a silicone skirt to induce satiety and reduce the volume of the stomach body.

Description:
BACKGROUND 
       [0001]    1. Field 
         [0002]    The invention relates to a method and apparatus for treating obesity and controlling weight gain in mammals, and more specifically, to a gastric skirt placed around the stomach to cause a reduced desire for eating for treating obesity and controlling weight gain in mammals. 
         [0003]    2. Related Art 
         [0004]    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. 
         [0005]    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. 
         [0006]    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. 
         [0007]    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. 
         [0008]    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. 
         [0009]    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 
       [0010]    In one embodiment, the invention includes: a sheet having a top portion, a bottom portion, a left portion, and a right portion; a first connector attached to the right portion of the sheet; a second connector attached to the left portion of the sheet; a first attachment wing attached to the top portion of the sheet; a connector having an upper portion and a lower portion, the lower portion of the connector attached to the first attachment wing; a strap having a distal end and a proximal end; and a second attachment wing attached to the distal end of the strap, the second attachment wing also attached to the upper portion of the connector. 
         [0011]    In one embodiment, the invention includes a gastric constriction device for treating obesity in mammals. The device includes an elastomeric sheet formed in the shape of a cylinder and having a top portion, a bottom portion, a left portion, and a right portion, the sheet configured to be wrapped around a tucked-in stomach of a mammal so that the left portion is in contact with the right portion when the sheet is wrapped around the stomach. The device may also include a first connector attached to the right portion of the sheet, a second connector attached to the left portion of the sheet, the second connector attachable to the first connector, a connecting strap having an upper portion and a lower portion, the lower portion of the connecting strap configured to be attached to the top portion of the sheet, and a collar configured to be attached to the upper portion of the connecting strap, the collar further configured to be placed around an esophagus of the mammal. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]    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: 
           [0013]      FIG. 1A  is a view of a stomach of a mammal; 
           [0014]      FIG. 1B  is a view of a partially tucked-in stomach of a mammal; 
           [0015]      FIG. 2A  is a view of a laid-open gastric skirt; 
           [0016]      FIG. 2B  is a view of a modular laid-open gastric skirt; 
           [0017]      FIG. 3  is a view of a rolled gastric skirt; 
           [0018]      FIG. 4  is a view of a folded conical cylinder-shaped gastric skirt; 
           [0019]      FIG. 5A  is a view of a gastric skirt placed in position around a stomach; 
           [0020]      FIG. 5B  is a view of a modular gastric skirt placed in position around a stomach; 
           [0021]      FIG. 5C  is a view of a gastric skirt placed in position around a stomach that shows a tucked-in portion of the stomach; 
           [0022]      FIG. 6  is a view of a laid-open butterfly-shaped gastric skirt; 
           [0023]      FIG. 7  is a view of a folded butterfly-shaped gastric skirt; 
           [0024]      FIG. 8A  is a view of a laid-open oval or pear-shaped skirt; 
           [0025]      FIG. 8B  is a view of a laid-open oval or pear-shaped skirt having a pouch that holds a balloon; 
           [0026]      FIG. 8C  is a view of a modular laid-open oval or pear-shaped skirt having a pouch that holds a balloon; 
           [0027]      FIG. 9A  is a view of a folded gastric skirt with locking clips; 
           [0028]      FIG. 9B  is a view of a locking clip for a gastric skirt; 
           [0029]      FIG. 10A  is a view of a gastric skirt with a harness system; 
           [0030]      FIG. 10B  is a side-view of a gastric skirt with a harness system; 
           [0031]      FIG. 11  is a view of a gastric wrap with a harness system in position around a stomach; 
           [0032]      FIG. 12  is a view of an exemplary connector; 
           [0033]      FIG. 13A  is a view of a collar with wings; 
           [0034]      FIG. 13B  is a view of a locking clip for a collar; 
           [0035]      FIG. 13C  is a view of a collar without wings; 
           [0036]      FIG. 13D  is a view of a laid-open collar; 
           [0037]      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; 
           [0038]      FIG. 15A  is a view of the balloon of  FIG. 14 ; 
           [0039]      FIG. 15B  is a view of a sealed balloon with a port; 
           [0040]      FIG. 16  is a view of the gastric wrap of  FIG. 6  and the balloon in position around a stomach; 
           [0041]      FIG. 17  is a view of one or more ropes wrapped around a tucked-in stomach; and 
           [0042]      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. 
       
    
    
     DETAILED DESCRIPTION 
       [0043]      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 . 
         [0044]    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. 
         [0045]    The invention can be utilized in conjunction with the LAP-BAND® procedure and/or other post-gastric bypass procedures such as gastric sleeve procedure treatments that provide reinforcement and restraining devices to prevent further expansion or re-expansion of the stomach  100 . 
         [0046]      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  106  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. 
         [0047]    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. 
         [0048]      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. 
         [0049]    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. 
         [0050]    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. 
         [0051]    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 . 
         [0052]    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 . 
         [0053]    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 ). 
         [0054]    The body or sheet  224  of the gastric skirt  200  is relatively 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. 
         [0055]    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. 
         [0056]    Alternatively, more rigid materials, such as Teflon®, Dacron® or ePTFE or Teflon 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. 
         [0057]    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. 
         [0058]    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. 
         [0059]    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. 
         [0060]      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. 
         [0061]    In an embodiment, the modular gastric skirt  200  may have 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 . 
         [0062]      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 . 
         [0063]      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 . 
         [0064]    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. 
         [0065]    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 . 
         [0066]    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). 
         [0067]    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. 
         [0068]      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 . 
         [0069]    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 ). 
         [0070]      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. 
         [0071]      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. 
         [0072]      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. 
         [0073]    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. 
         [0074]    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 . 
         [0075]      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. 
         [0076]    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. 
         [0077]    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. 
         [0078]      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. 
         [0079]    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. 
         [0080]      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. 
         [0081]      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. 
         [0082]      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 ). 
         [0083]      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 hinge pin  922 . The locking clip  920  also comprises the female connector  910 . To engage the locking clip  920 , the hinge 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 . 
         [0084]      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. 
         [0085]    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 . 
         [0086]    The connector strap  1006  has a flexible hinge  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 hinge  1026  where the skirt hook  1020  and the collar hook  1022  connect with each other. The flexible hinges  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. 
         [0087]      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 1/35,000th of an inch. 
         [0088]      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 notch  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. 
         [0089]    The lower collar  1106 , also known as the antral collar, is placed around a lower portion of the stomach near the angular notch  1134  at the pylorus  1116 , also known as the pyloric antrum notch. 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. 
         [0090]    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. 
         [0091]    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. 
         [0092]    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. 
         [0093]    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. 
         [0094]    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. 
         [0095]    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. 
         [0096]    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. 
         [0097]    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. 
         [0098]    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. 
         [0099]    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. 
         [0100]      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 hinge pin  1206 , hinge 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 hinge 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 hinge pins  1206  and  1208  have space to re-position with their respective holes when the connector strap  1200  is rotated or shifted. 
         [0101]    To connect the skirt hook  1202  and the collar hook  1204  together, hinge pin  1206  is inserted into hole  1210 , and hinge 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. 
         [0102]    The skirt hook  1202  also includes hole  1216  and hinge 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 hinge cavity  1228  so that hinge pin  1218  is inserted through the wing. To secure the wing to the skirt hook  1202 , the hinge pin  1218  is pushed through the hole  1216 . The hinge pin  1218  has a triangular shape, with a narrow top and a wide base. The diameter of the base of the hinge pin  1218  is larger than the diameter of hole  1216 . This design allows the hinge pin  1218  to be securely fastened once it is inserted through hole  1216 . Likewise, the collar hook  1204  includes a hole  1212 , a hinge pin  1214 , and a hinge cavity  1230  to secure the collar hook  1204  to a wing on the collar (not shown). 
         [0103]    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. 
         [0104]      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). 
         [0105]    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. 
         [0106]      FIG. 13B  is a view of a locking clip for a collar  1300 . The male connector  1312  includes a hinge 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. 
         [0107]      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. 
         [0108]    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. 
         [0109]    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. 
         [0110]    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. 
         [0111]    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. 
         [0112]      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. 
         [0113]    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. 
         [0114]      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 . 
         [0115]    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 . 
         [0116]      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. 
         [0117]    The semi-rigid or rigid Nitinol or stainless steel wire frame is covered with ePTFE, silicone, Dacron® or any other elastomer or thermoelastic elstomer, 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. 
         [0118]    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 ballon  1500  is covered with ePTFE, and can have open or closed ends. 
         [0119]      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 . 
         [0120]    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. 
         [0121]      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. 
         [0122]    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). 
         [0123]      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. 
         [0124]      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 . 
         [0125]    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.