US20210298935A1 - Gastric restriction devices for treating obesity - Google Patents

Abstract

A gastric restriction device for treating excessive weight or obesity in mammals. The gastric restriction devices includes a skirt having a left portion, a right portion, a top edge with a first indentation located at a center of the top edge, and a bottom edge with a second indentation located at a center of the bottom edge. The skirt has a narrow surface located between the first indentation and the second indentation and a broad surface formed from the left portion connecting to the right portion. The skirt is configured to envelop and fit a stomach of a mammal. The gastric restriction device includes a first attachment device and a second attachment device. The second attachment device is adapted to engage the first attachment device so that the skirt envelops and fits the stomach of the mammal.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a continuation of U.S. patent application Ser. No. 16/020,423, entitled “Gastric Restriction Devices for Treating Obesity,” filed Jun. 27, 2018 and now U.S. Pat. No. 11,033,415, which is a continuation of U.S. patent application Ser. No. 14/571,144, entitled “Gastric Restriction Devices for Treating Obesity,” filed Dec. 15, 2014 and now U.S. Pat. No. 10,010,441, which is a continuation of U.S. patent application Ser. No. 12/474,254, entitled “Gastric Restriction Devices with Fillable Chambers and Ablation Means for Treating Obesity,” filed May 28, 2009 and now U.S. Pat. No. 8,911,346, which is a continuation-in-part of 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 the applications are hereby incorporated by reference herein for all purposes.
BACKGROUNDField
• 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.
Description of the 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'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 restriction device for treating excessive weight or obesity in mammals. The gastric restriction device has a skirt. The skirt has a left portion, a right portion, a top edge with a first indentation located at a center of the top edge, and a bottom edge with a second indentation located at a center of the bottom edge. The skirt has a narrow surface located between the first indentation and the second indentation and a broad surface formed from the left portion connecting to the right portion. The skirt is configured to envelop and fit an internal stomach organ of a mammal. The gastric restriction device has a first attachment device that is attached to or part of the right portion of the skirt. The gastric restriction devices has a second attachment device that is attached to or part of the left portion of the skirt and adapted to engage the first attachment device so that the skirt envelops and fits the internal stomach organ of the mammal.
• In one embodiment, the invention includes a gastric constriction device for treating excessive weight or obesity in mammals. The gastric constriction device has a skirt. The skirt has a left portion, a right portion, a top portion, and a bottom portion. The top portion has a top edge with a first indentation and the bottom portion has a bottom edge with a second indentation. The skirt has a narrow surface located between the first indentation and the second indentation and a broad surface formed from the left portion connecting to the right portion. The narrow surface and the broad surface are operable to cover different portions of a stomach. The gastric constriction device has a first attachment device that is attached to or part of the right portion of the skirt. The gastric constriction device has a second attachment device that is attached to or part of the left portion of the skirt and adapted to engage the first attachment device and maintain a left edge of the left portion in proximity to a right edge of the right portion.
• In one embodiment, the invention includes a gastric restriction device for treating excessive weight or obesity in mammals. The gastric restriction device has a skirt. The skirt has a left portion, a right portion, a top portion having a top edge with a first indentation located at the top edge, and a bottom portion having a bottom edge with a second indentation located at the bottom edge. The skirt has a narrow surface located between the first indentation and the second indentation and a broad surface formed from the left portion connecting to the right portion. The narrow surface is operable to envelop a lesser curvature of an internal stomach organ of a mammal and the broad surface is operable to envelop a greater curvature of the internal stomach organ. The gastric restriction device has a first attachment device that is attached to or part of the right portion of the skirt and a second attachment device that is attached to or part of the left portion of the skirt and adapted to engage the first attachment device and maintain the left portion in proximity to the right portion.
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 ofFIG. 14;
• FIG. 15B is a view of a sealed balloon with a port;
• FIG. 16 is a view of the gastric wrap ofFIG. 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 astomach100 of a mammal (e.g., human). As shown inFIG. 1A, thestomach100 has at least two curvatures, alesser curvature110 and agreater curvature112. The cardia orproximal stomach108 is located in the upper left portion of thestomach100 and serves as the junction between theesophagus102 and the body of thestomach106. Thefundus104 is located in the upper right portion of thestomach100. The lower portion of thestomach100 is known as the distal stomach and includes theantrum114 and thepylorus116. Theantrum114 is where food is mixed with gastric juices. Thepylorus116 has a muscular pyloric sphincter that acts as a valve to control emptying of the stomach contents into the proximal segment of the small intestine118 (partially shown). Theinner lining120 of thestomach100 separates thebody106 from theouter wall122.
• The invention is directed to a gastric skirt that is placed around thestomach100 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 thestomach100 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 thestomach100.
• FIG. 1B is a view of a partially tucked-instomach100 of a human. Prior to placing the gastric skirt around thestomach100, a linear portion of thegreater curvature112 is tucked inwards into thestomach100. As shown inFIG. 1B, theinner lining120 is depressed within thestomach100 as a result of the tucking procedure, and the tucked-in portion occupies space within thestomach100. Thus, the internal volume of thestomach100 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 thefundus104 is reduced.
• In another embodiment, the tucked-in portion of thestomach100 may be a linear portion of thelesser curvature110, a portion of thebody106, or a portion of thefundus104, not along either thegreater curvature112 or thelesser curvature110. Therefore, any portion of thestomach100 may be tucked-in and wrapped using the gastric skirts disclosed herein.
• FIG. 2A is a view of a laid-opengastric skirt200. Thegastric skirt200 may be formed as asheet224 prior to being wrapped around a patient's stomach. For illustrative purposes, thegastric skirt200 has aleft side232, aright side230, abottom portion220, and atop portion222. Eachconnector208,210, and212 may be offset or staggered relative to its adjacent connector. Similarly, eachreceiver214,216, and218 may be offset or staggered relative to its adjacent receiver. In one embodiment, each offset may be approximately 1-3 centimeters. Thebottom portion220 and thetop portion222 may have an inward curved or concave edge. Thegastric skirt200 may have a length L of approximately 6-16 centimeters, a central width W1 of approximately 3-7 centimeters, and an outer width W2 of approximately 6-10 centimeters.
• In a preferred embodiment, the length L is at least 8 centimeters, the central width W1 is at least 4 centimeters, and the outer width W2 is at least 7 centimeters.
• Thegastric skirt200 may have a staggered step design and may be formed in the shape of a parallelogram when laid-open, where the opposing ends of thegastric skirt200 interconnect in a stepped fashion when thegastric skirt200 is folded. For example,step element201 is staggered relative to immediately opposingstep element202. Likewise,step element203 andstep element205 are staggered relative to their immediately opposingstep elements204 and206, respectively. When thegastric skirt200 is wrapped or folded into position around a patient'sstomach100, the opposing step elements interconnect with each other, forming the end at thegreater curvature112 and thegastric skirt200 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, amale connector208 is attached to afemale receiver214. When thegastric skirt200 is folded into position, themale connector208 couples with thefemale receiver214. Themale connectors210 and212 couple with thefemale receivers216 and218, respectively, when thegastric skirt200 is wrapped or folded into position around the stomach. In other embodiments, thegastric skirt200 may have one set of connectors (e.g., a singlemale connector208 and a single female receiver214) or two sets of connectors (e.g.,2male connectors208 and210 and2female receivers214 and216). The connectors can be of various shapes and sizes, and are not limited to the connector design shown inFIG. 2A. Furthermore, the connectors can be positioned at various locations on thegastric skirt200, and are not limited to being positioned at theleft side232 and theright side230 of thegastric skirt200.
• Thegastric skirt200 has abottom portion220 that is inward curving. Opposite thebottom portion220, thegastric skirt200 has atop portion222 that is inward curving. When thegastric skirt200 is folded into position, the bottom andtop portions220 and222 come into contact with thelesser curvature110 and provide thegastric skirt200 with a contoured, conical shape. The conical shape allows thegastric skirt200 to properly fit around thestomach100.
• Furthermore, one or more optional connectors orwings226 and228 are attached to thetop portion222 of thegastric skirt200 and one or more optional connectors orwings248 and250 are attached to thebottom portion220 of thegastric skirt200. The connectors orwings226 and228 may be used to attach thegastric skirt200 to collar connector straps (shown inFIGS. 10A, 10B, and 11). The connectors orwings248 and250 may be used to attach thegastric skirt200 to connector straps (shown inFIG. 11).
• The body orsheet224 of thegastric skirt200 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 thegastric skirt200 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 thebody224. This overgrowth of the stomach through thebody224 may make it difficult to remove thegastric skirt200 from the patient if needed. Furthermore, the silicone allows some expandability of thestomach100, which is the stomach's natural function. Thus, thegastric skirt200 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, thegastric skirt200 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. Thegastric skirt200 is tightly positioned around the tucked-in stomach so little to no open space is provided between thegastric skirt200 and the outer surface of the stomach.
• In another embodiment, thebody224 of thegastric skirt200 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 thestomach100, thegastric skirt200 stays in position for a predetermined amount of time. After the predetermined amount of time has elapsed, thegastric skirt200 may be absorbed by the patient's bodily fluids, eliminating the need for a second procedure to remove thegastric skirt100. In this particular embodiment, the entiregastric skirt200, including the male connectors and the female receivers, are made of a biodegradable material.
• The staggered step design allows thegastric skirt200, including all of the connectors and receivers, to be rolled into a highly compact fashion. In one embodiment, thegastric skirt200 can be placed around a patient's stomach using a routine laparoscopic procedure, referred to as a laparoscopy. During a laparoscopy, thegastric skirt200 is inserted into the patient via a trocar through a hole made in the patient's abdomen. The staggered step design minimizes the diameter of thegastric skirt200 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 connector208 is connected tofemale receiver214 with a strap made from an elastic material. The strap is positioned within an internal channel that runs lengthwise from theleft side232 to theright side230 within thegastric skirt200. The strap is preferably made of a more elastic material than thegastric skirt200 so that the connectors can accommodate peristalsis and movement of the stomach. This embodiment allows stress to be placed on the strap rather than thegastric skirt200, thereby preventing thegastric skirt200 from being overstretched due to peristalsis.
• FIG. 2B is a view of a modular laid-opengastric skirt200. The modulargastric skirt200 may have two or more rectangular strips ormodules234,236, and238. Each strip may have a ridge240 (and244) and/or a groove242 (and246) for attachment to adjacent strips. Theridge240 securely fits into thegroove242 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 thegastric skirt200 can be adjusted at the time of surgery to account for the amount of tucking, size and orientation of thestomach100. The modulargastric skirt200 may have a width W3 of approximately 1-3 centimeters, a width W4 of approximately 1-4 centimeters, and a width W5 of approximately 1-3 centimeters. The widths may vary depending on the size and amount of tucking needed. The modulargastric skirt200 may have a length L of approximately 6-16 centimeters.
• In an embodiment, the modulargastric skirt200 may utilize only two of the rectangular strips ormodules234,236, and238. For example,module234 can be connected tomodule236 to form the modulargastric skirt200. Alternatively,module234 can be connected tomodule238 to form the modulargastric skirt200.
• FIG. 3 is a view of a rolled gastric skirt300. The gastric skirt300 is tightly rolled so that it can be inserted through a trocar as described above or other means. The staggered step design allows themale connectors208,210, and212, and thefemale connectors214,216, and218 to not overlap with each other when the gastric skirt300 is rolled. By not overlapping, themale connectors208,210, and212 and thefemale receivers214,216, and218 are evenly flush with each other, so the diameter of the rolled gastric skirt300 is minimized. Similarly, the connectors, the cardia collar and the antral collar may be passed through the trocar into the stomach for connection to thegastric skirt200.
• FIG. 4 is a view of a folded conical cylinder-shapedgastric skirt400. As shown,step elements412,410, and408 are each connected to their immediately opposingstep elements418,416, and414, respectively, to form a conical cylinder-shapedgastric skirt400. In an embodiment, the outer orupper curvature403 has a convex shape and is outwardly curving. The inner orlower curvature404 has a concave shape and is inwardly curving. The conical cylinder shape allows thegastric skirt400 to properly fit around and contact the stomach. The upper portion of thestomach100 is covered by thegastric skirt400 near theupper curvature403, 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 thegastric skirt400 near thelower curvature404.
• The diameter of the upper curvature opening420 (i.e., cardia end) and the lower curvature opening406 (i.e., antral end) are similar. Thegastric skirt400 can be a “one-size fits all” design, where a single-sizedgastric skirt400 is used for all or most stomach sizes. To adjust to a “one-size fits all”gastric skirt400, the stomach is tucked in per physician's preference and thegastric skirt400 is simply tightened accordingly when it is being positioned around the stomach.
• Furthermore, the one or moreoptional wings422 and424 are attached on the circumference of theupper curvature403. Thewings422 and424 are used to attach thegastric skirt400 to collar connector straps (see alsoFIGS. 10A and 10B). Similarly, the circumference of thelower curvature404 can also have one ormore wings426 and428 attached. In another embodiment, thegastric skirt400 can have no wings attached, or wings only on one side, either on theupper curvature403 or thelower curvature404.
• In another embodiment, a healthcare professional can estimate or measure the size of the patient's stomach beforehand. Using this measurement, thegastric skirt400 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 thegastric skirt400 when it is being positioned around the stomach, and can allow for a smooth and even customized fit (see alsoFIGS. 5A, 5B, and 5C).
• 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 agastric skirt500 placed in position around a stomach. Thegastric skirt510 is designed to cover substantially all of the greater orouter curvature502, and substantially all of the lesser orinner curvature504. As shown inFIG. 5A, a portion of thefundus506 and the antrum/pylorus508 may be tucked or covered or restricted by thegastric skirt510.
• In another embodiment, thegastric skirt510 can be designed to cover a smaller portion of thegreater curvature502 and/or a smaller portion of thelesser curvature504, instead of covering the entire respective surfaces. Furthermore, thegastric skirt510 can be designed to cover other surfaces of the stomach in addition to thegreater curvature502 and/or thelesser curvature504. For example, thegastric skirt510 may have a larger surface area and cover thefundus506 and/or the antrum/pylorus508, or portions thereof, in addition to portions of thegreater curvature502 and/or thelesser curvature504.
• Unlike conventional gastric-restraint devices, such as the LAP-BAND®, thegastric skirt510 is not placed between thecardia514 and thefundus506 forming a pouch. Furthermore, thegastric skirt510 is not placed around theesophagus512. As described above, thegastric skirt510 is instead fitted or positioned around the body of the stomach500 (i.e., around surfaces of thegreater curvature502 and thelesser curvature504 of the stomach500).
• FIG. 5B is a view of a modular gastric skirt placed in position around astomach500. Themodular skirt510 is shown as threestrips510A,510B, and510C connected to one another. The male and female connectors are shown as516,518, and520, respectively.
• FIG. 5C is a view of agastric skirt510 placed in position around astomach500 that shows a tucked-in portion of the stomach. In this example, thegreater curvature502 is tucked into the body of thestomach500 and thegastric skirt510 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-shapedgastric skirt600. Thegastric skirt600 has anindentation602 on one side and anindentation604 on the opposing side. The proximal end606 and thedistal end608 can include connectors and receivers, respectively, so that when thegastric skirt600 is folded, the proximal end606 and thedistal end608 can be connected together.
• Indentations602 and604 can be any shape such as an ellipse, oval, hourglass, or semicircular shape as shown inFIG. 6. For example, each of theindentations602 and604 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 eachindentation602 and604 can be varied in order to provide an optimal fit around the stomach.Indentations602 and604 do not necessarily have to be the same shape or size as one another.
• Furthermore,optional wing610 is attached on one substantially horizontal portion adjacent toindentation604, andoptional wing612 is attached on the other substantially horizontal portion adjacent toindentation604. Thewings610 and612 are used to attach thegastric skirt600 to collar connector straps (shown inFIGS. 10A, 10B, and 11). Similarly, the side of thegastric skirt600 withindentation602 haswings614 and616 attached. In another embodiment, thegastric skirt600 can have no wings attached, or wings only on one side. The dashed line indicates that thegastric skirt600 can have two or more modular pieces connected to one another similar to that shown inFIG. 2B.
• FIG. 7 is a view of a folded butterfly or step ladder-shapedgastric skirt700. Once thedistal end712 and theproximal end714 are connected together by coupling the connectors and receivers, anarrow surface702 fits the lesser curvature of the stomach and is formed on one side of thegastric skirt700 betweenindentation704 andindentation706. On the side opposite to thenarrow surface702 is thewide surface708 which fits the greater curvature of the stomach.
• In this embodiment, thenarrow surface702 of the butterfly-shapedgastric skirt700 can be used to cover the lesser curvature of the stomach. Likewise, thebroad surface708 can be used to cover the greater curvature of the stomach.
• In another embodiment, instead of having connectors and receivers to couple thegastric skirt700, thedistal end712 and theproximal end714 can be sutured or stapled together.
• FIG. 8A is a view of a laid-open oval or pear-shapedskirt800. In this embodiment, thegastric skirt800 has aprotrusion802 on one side and aprotrusion804 on the opposing side. Theproximal end806 includesfemale connectors820 and821, and thedistal end808 includesmale connectors818 and819. Therefore, when thegastric skirt800 is folded, theproximal end806 and thedistal end808 can be connected by securing themale connectors818 and819 into thefemale connector820 and821, respectively. In an embodiment, the width of theproximal end806 and thedistal end808 is from about 4 centimeters to about 6 centimeters and the width between theprotrusion802 and theprotrusion804 is from about 8 centimeters to about 14 centimeters.
• Outward protrusions802 and804 can be any shape, and not limited to, an oval, pear or semicircular shape as shown inFIG. 8A. For example, each of theoutward protrusions802 and804 can be formed in the shape of a square, a triangle, or any other shape. The size of eachoutward protrusion802 and804 can also be varied in order to provide an optimal fit around the stomach. Furthermore, theoutward protrusions802 and804 do not necessarily have to be the same shape or size as one another.Optional wings810 and812 may be attached tooutward protrusion804, andoptional wings814 and816 may be attached tooutward protrusion802. In another embodiment, thegastric skirt800 can have no wings attached, or wings only on one side.
• FIG. 8B is a view of a laid-open oval or pear-shapedskirt800 having apouch822 that holds aballoon1500. When theskirt800 is wrapped around the stomach, theballoon1500 can be secured in thepouch822 or be inserted into thepouch822 to keep the tucked-in portion within the stomach.
• FIG. 8C is a view of a modular laid-open oval or pear-shapedskirt800 having apouch822A and822B that holds a balloon. The modulargastric skirt800 may have two or more strips or modules. Each strip may have aridge824 and/or agroove826 for attachment to adjacent strips. Theridge824 securely fits into thegroove826 along the length of each strip to prevent unwanted detachment of adjacent strips and any in-growth of tissue between adjacent strips. Thepouch822 comprises twopieces822A and822B since theskirt800 is modular.
• FIG. 9A is a view of a foldedgastric skirt900 with locking clips. Thegastric skirt900 includes aproximal end903 and adistal end905. When thegastric skirt900 is folded so that theproximal end903 and thedistal end905 connect, a hollow shapedgastric skirt900 is formed with askirt body902. Each locking clip comprises amale connector904,906, or908, and a correspondingfemale receiver914,912, or910, respectively. Aright wing916 and aleft wing918 are placed on opposite sides of one end of theskirt body902. Thewings916 and918 are used to connect thegastric skirt900 to a collar (see alsoFIG. 11).
• FIG. 9B is a view of a locking clip for thegastric skirt900 shown inFIG. 9A. Thelocking clip920 comprises themale connector908, which includes aconnector strap pin922. Thelocking clip920 also comprises thefemale connector910. To engage thelocking clip920, theconnector strap pin922 interlocks with an opening in thefemale connector910. Once themale connector908 and thefemale connector910 are engaged, thelocking clip920 holds a portion of the skirt body together. Furthermore, themale connector908 includes alower portion926 which extends outwards. Thefemale connector910 includes anupper portion924 which also extends outwards. When themale connector908 and thefemale connector910 are engaged, thelower portion926 rests underneath theupper portion924.
• FIG. 10A is a view of agastric skirt1002 with aharness system1000. Theharness system1000 may include agastric skirt1002, anupper collar1004, andconnector straps1006 and1008. Thegastric skirt1002 is placed around the body of the stomach as previously described inFIG. 5A. In another embodiment, a lower collar (not pictured) is also included, allowing theupper collar1004 and the lower collar to work in conjunction to hold thegastric skirt1002 in position.
• Theupper collar1004 is connected to thegastric skirt1002 via theconnector strap1006 and theconnector strap1008, which are both, for example, connecting straps. Theconnector strap1006 includes askirt hook1016 and acollar hook1018. Likewise, theconnector strap1008 includes askirt hook1020 and acollar hook1022. Regarding theconnector strap1008, theskirt hook1020 connects to thegastric skirt1002 at awing1012. Thecollar hook1022 connects to thecollar1004 at awing1014. Regarding theconnector strap1006, theskirt hook1016 connects to thegastric skirt1002 at awing1010. The collar hook1019 connects to the collar at a wing (not shown) located at a substantially parallel location aswing1014 on the opposite side ofcollar1004.
• Theconnector strap1006 has aflexible connector strap1024 to accommodate angulations to various anatomical differences where theskirt hook1016 and thecollar hook1018 connect with each other. Likewise, theconnector strap1008 has aflexible connector strap1026 where theskirt hook1020 and thecollar hook1022 connect with each other. Theflexible connector straps1024 and1026 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, theconnector straps1024 and1026 can bend from 1 degree to 90 degrees in any direction, and in a preferred embodiment, theconnector straps1024 and1026 can bend from 10 degrees to 60 degrees in any direction to accommodate movements of the stomach.
• FIG. 10B is a side-view of thegastric skirt1002 with aharness system1000. In an embodiment, thegastric skirt1002, theupper collar1004, the lower collar (not shown), theconnector strap1008, and theconnector strap1006, 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.
• FIG. 11 is a view of agastric skirt1102 with a harness system in position around astomach1100. Thegastric skirt1102 is placed along thegreater curvature1122 and thelesser curvature1120 of thestomach1100. Anupper collar1104, also known as the cardia collar, is placed around the lower end ofesophagus1108 at a position near or adjacent to thecardiac receiver1112. The upper orcardia collar1104 is large enough in diameter to encircle thelower esophagus1108, but small enough so that it cannot encircle the larger diameter portion of theesophagus1110. Theupper collar1104 is connected to thegastric skirt1102 via aconnector strap1126. Theconnector strap1126 is attached to the upper orcardia collar1104 at awing1122, and theconnector strap1126 is attached to thegastric skirt1102 at awing1124. This design prevents theupper collar1104 from moving very high up theesophagus1110, helps to hold thegastric skirt1102 in place, and may help in reducing gastro esophageal reflux (“gastric reflux”) or achalasia or dysphagia after the procedure.
• Thelower collar1106, also known as the antral collar, is placed around a lower portion of the stomach near theangular receiver1134 at thepylorus1116, also known as the pyloric antrum receiver. Thelower collar1106 is large enough in diameter to encircle part of the lower portion of the stomach near thepylorus1116, but small enough so that it cannot encircle the larger diameter portion of thesmall intestine1118. Thelower collar1106 is connected to thegastric skirt1102 viaconnector strap1132. Theconnector strap1132 is attached to thelower collar1106 at awing1128, andconnector strap1132 is attached to thegastric skirt1102 at awing1130. This design prevents thelower collar1106 from moving down into thesmall intestine1118, and helps to hold thegastric skirt1102 in place. Furthermore, thelower collar1106 may assist in slowing the gastric emptying from the stomach into thesmall intestine1118. Thelower collar1106 may also assist in anchoring thegastric skirt1102 in place.
• In another embodiment, only theupper collar1104 is attached to thegastric skirt1102, and alower collar1106 is not present. As the volume of the fundus1114 fills with food, the fundus1114 stretches and expands, preventing thegastric skirt1102 from sliding upwards. Thus, thelower collar1106 may not necessarily be required in all patients to help hold thegastric skirt1102 in place around thestomach1100. Alternatively, in another embodiment, only thelower collar1106 is attached to thegastric skirt1102 and anupper collar1104 is not present.
• Thegastric skirt1102 and harness system are modular, and provides patients with at least three different options. In the first option, only thegastric skirt1102 is utilized, without thecollars1104 and1106 and theconnector straps1126 and1132. In this embodiment, the healthcare professional may decide to not include thecollars1104 and1106 if there is not a high risk of gastric reflux or achalasia, or if there is not a high risk that thegastric skirt1102 may be displaced.
• In the second option, thegastric skirt1102 is utilized along with thecollar1104, but without thecollar1106 and without theconnector straps1126 and1132. In this embodiment, thegastric skirt1102 and thecollar1104 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 thegastric skirt1002 or thecollar1104 may be displaced.
• In the third option, thegastric skirt1102 is utilized with thecollars1104 and1106 and theconnector straps1126 and1132. The healthcare professional may decide on this option if there is a risk of gastric reflux, or dysphagia and a risk of that thegastric skirt1102 orcollars1104 and1106 may be displaced. In this option, both theupper collar1104 and thelower collar1106 do not need be utilized, and only one of thecollars1104 or1106 can be used. Theupper collar1104 not only serves to hold thegastric skirt1102 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, theupper collar1104 and thelower collar1106 each have a diameter from about 4 centimeters to about 6 centimeters. Theupper collar1104 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 theupper collar1104 and thelower collar1106 is up to about 4 centimeters.
• The length ofconnector straps1126 and1132 can be varied to accommodate various stomach sizes. In a preferred embodiment,connector strap1126 andconnector strap1132 have a length of about 5 centimeters.
• Thegastric skirt1102 can have a length of about 6 centimeters to about 14 centimeters. In a preferred embodiment, the length of thegastric skirt1102 is from about 8 centimeters to about 12 centimeters. The width of the greater curvature side of thegastric skirt1102 is from about 7 centimeters to about 10 centimeters, and the width of the lesser curvature side of thegastric skirt1102 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.
• Theupper collar1104 may be approximately the same size as the lower esophagus or may be slightly larger. Once in position, theupper collar1104 applies support by forming a significant wrap around the lower end of theesophagus1108 or the cardia. Theupper collar1104 restricts the lower end of theesophagus opening1108 and attempts to minimize regurgitation, thereby reducing gastric reflux.
• FIG. 12 is a view of an exemplary connector strap. Theconnector strap1200 has alower portion1232 and anupper portion1234. Thelower portion1232 corresponds to theskirt hook1202. Theupper portion1234 corresponds to thecollar hook1204. Theconnector strap1200 has askirt hook1202 and acollar hook1204. Theskirt hook1202 includesconnector strap pin1206,connector strap pin1208, and extendingportion1226. Thecollar hook1204 includes ahole1210 throughridge1222 and a second hole (not shown) throughridge1224. Thecollar hook1204 also includes acavity1220. Theconnector strap pins1206 and1208 are smaller in diameter than the diameters ofhole1210 and the second hole throughridge1224. This design allows increased flexibility as theconnector strap pins1206 and1208 have space to re-position with their respective holes when theconnector strap1200 is rotated or shifted.
• To connect theskirt hook1202 and thecollar hook1204 together,connector strap pin1206 is inserted intohole1210, andconnector strap pin1208 is inserted into the second hole throughridge1224. The extendingportion1226 is inserted into thecavity1220. Once theskirt hook1202 and thecollar hook1204 are connected, theconnector strap1200 is formed.
• Theskirt hook1202 also includeshole1216 andconnector strap pin1218. To attach theconnector strap1200 to a wing (not shown) on the gastric skirt (not shown), the wing is placed inside theconnector strap cavity1228 so thatconnector strap pin1218 is inserted through the wing. To secure the wing to theskirt hook1202, theconnector strap pin1218 is pushed through thehole1216. Theconnector strap pin1218 has a triangular shape, with a narrow top and a wide base. The diameter of the base of theconnector strap pin1218 is larger than the diameter ofhole1216. This design allows theconnector strap pin1218 to be securely fastened once it is inserted throughhole1216. Likewise, thecollar hook1204 includes ahole1212, aconnector strap pin1214, and aconnector strap cavity1230 to secure thecollar hook1204 to a wing on the collar (not shown).
• In an embodiment, theconnector strap1200 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. Thecollar1300 includes alocking clip1302. Thecollar1300 has adistal end1304 and aproximal end1306. Thedistal end1304 and theproximal end1306 are connected by thelocking clip1302. Thecollar1300 further includes afirst wing1308 and asecond wing1310 that are used to secure thecollar1300 to the gastric skirt connector strap (not shown).
• In order to place thecollar1300 around the lower esophagus or cardia, thelocking clip1302 is not engaged, so that thedistal end1304 and theproximal end1306 are laid open. Thecollar1300 is then fitted around a portion of the lower esophagus as described above. Once thecollar1300 is in place, thelocking clip1302 is engaged by connecting thedistal end1304 and theproximal end1306 together.
• FIG. 13B is a view of a locking clip for acollar1300. Themale connector1312 includes aconnector strap pin1316 which interlocks with an opening in thefemale connector1314. Once themale connector1312 and thefemale connector1314 are engaged, the locking clip holds the collar in position.
• FIG. 13C is a view of acollar1300 without wings. Thecollar1318 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.
• Thelocking clip1302 can be any type of locking, coupling, or clasping mechanism, and is not limited to themale connector1312 andfemale connector1314 designs shown inFIGS. 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, thecollar1300 and lockingclip1302 are made from a composition of silicone and PTFE/ePTFE. However, thecollar1300 and lockingclip1302 can be made from other elastomers or thermoplastic polymers, or any combination thereof.
• In another embodiment, thedistal end1304 andproximal end1306 can be sutured or stapled together at the time of positioning by the healthcare professional.
• In yet another embodiment, thecollar1300 can be shaped as a semicircular ring, or in a “C” shape, and be made of a memory-retaining material. Once thecollar1300 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 collar1300. Thecollar1300 is in a strap form when themale connector1312 and thefemale connector1314 are not connected.
• As described above and shown inFIG. 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 astomach1400 and aballoon1402 positioned within agreater curvature1406 of thestomach1400 when thegreater curvature1406 is tucked into thestomach1400. In an embodiment, after thegreater curvature1406 of thestomach1400 is tucked inwards, a cavity1404 is formed as a result of the tucking procedure and aballoon1402 is placed within the cavity1404, which can be left open, and agastric skirt1412 is tightly positioned around thestomach1400 to hold theballoon1402 in place within the cavity1404. Hence, theballoon1402 is placed within the tucked-in portion of thestomach1400. Alternatively, theballoon1402 may be placed within apouch1414 that is attached to thegastric skirt1412. Thegreater curvature1406 of thestomach1400 is pushed inwards to reduce theinner volume1410 of thestomach1400. Theballoon1402 applies pressure against thegreater curvature1406 of thestomach1400 and helps to maintain the shape of the cavity1404. Following the placement of theballoon1402, thegastric skirt1412 is placed around thestomach1400 as described above. In this embodiment, when thegastric skirt1412 is positioned around thestomach1400, the connectors as shown inFIG. 5B connect with one another along thelesser curvature1408 of thestomach1400.
• As described above, thegreater curvature1406 of thestomach1400 is the preferred tucking portion. However, the tucked-in portion of thestomach1400 may be a portion of thelesser curvature1408, or any portion of thestomach1400 not along either thegreater curvature1406 or thelesser curvature1408. If the tucked-in portion of thestomach1400 is along thelesser curvature1408, then the connectors as shown inFIG. 5B connect with one another along thegreater curvature1406 of thestomach1400.
• FIG. 15A is a view of the balloon ofFIG. 14. Theballoon1500 can be a sealed or open ended stent, cylindrical air filled or saline filled device with an ePTFE, Dacron®, or silicon coating or covering. Theballoon1500 is preferably made of an alloy of nickel and titanium (Nitinol) or stainless steel wire cage which provides theballoon1500 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's stomach dimensions, and then theballoon1500 is crimped into a sheath so that it can fit through a trocar (not shown). Theballoon1500 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. Theballoon1500 provides support to the outer lining of the stomach when theballoon1500 is placed in position within the cavity1404 ofFIG. 14. The desired shape of theballoon1500 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 theballoon1500 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 steelwire cage balloon1500 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-expandingnitinol balloon1500 is covered with ePTFE, and can have open or closed ends.
• FIG. 15B is a view of aballoon1502 with aport1504. Theballoon1502 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 aport1504 to inject air, liquid or methylene blue. The methylene blue is used to detect leaks of theballoon1502.
• Theballoon1500 has a length of about 7 centimeters to about 10 centimeters. In an embodiment, the diameter of theballoon1500 is from about 1 centimeter to about 3 centimeters. However, the diameter of theballoon1500 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 ofFIG. 6 and the balloon in position around a stomach. As seen inFIG. 16,connectors1604 and1606 are positioned on thelesser curvature side1610 of thestomach1600.Balloon1602 is positioned on thegreater curvature side1612 of thestomach1600. In this embodiment, theconnectors1604 and1606 are not on thegreater curvature side1612 so that there is room for theballoon1602 to be retained and held in place by thegastric skirt1608 within the tucked-in portion (not shown) of the stomach.
• Furthermore,optional wings1612 and1614 are attached to thegastric skirt1608 to attach thegastric skirt1608 to collar connector straps (not shown).
• FIG. 17 is a view of one ormore ropes1702 wrapped around a tucked-instomach1700. Theropes1702 may be made of a biodegradable material or a woven silicon material or any other material described herein. Thestomach1700 is tucked-in and then theropes1702 are wrapped around thestomach1700. Eachrope1702 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 ormore tentacles1802 wrapped around a tucked-instomach1800 where thetentacles1802 can be independently pulled and locked in place using a ring andclip system1808 or a tie lock (not shown). Eachtentacle1802 can be independently tighten and loosened to control the tension. Eachtentacle1802 can be pulled through a ring or hole and the clip can lock the tentacle in place. Thetentacles1802 can be wrapped around thegreater curvature1806 and thelesser curvature1804 of thestomach1800. Thetentacles1802 can be any shape, such as straight or curved, and are not limited to the design shown inFIG. 18. Furthermore, thetentacles1802 can be made of an expandable material originating from the body at thelesser curvature1804 or thegreater curvature1806.
• FIG. 19 is a view of an inflatablegastric skirt1902 positioned around a stomach. In an embodiment, thegastric skirt1902 is positioned around the stomach along thelesser curvature110 and thegreater curvature112, similar to thegastric skirt200 described above. Thegastric skirt1902 includes one or more fillable or inflatable chambers that are attached to an interior surface of thegastric skirt1902.
• In an embodiment, thegastric skirt1902 is inflated via atube1904 that is connected to the one or more inflatable chambers. Thetube1904 includes aninlet1906 that can be located slightly beneath the skin of the patient. Thetube1904 also includes anoutlet1908 which is connected to the one or more inflatable chambers2008 (see alsoFIG. 20). In an embodiment, theinlet1906 can be sutured or stapled beneath the skin so that it is accessible via an incision.
• In another embodiment, theinlet1906 can include an RFID tag with an antenna to assist a healthcare professional in locating theinlet1906 for subsequent adjustments. An external RFID locator or reader, such as in a handheld device, can be used to locate theinlet1906 so that a syringe can be inserted directly into an access cavity of theinlet1906.
• FIG. 20 is a view of an inflatable gastric skirt and a triple-lumen tube1904. In an embodiment, thetube1904 includes threeseparate lumens2002, with each lumen connected to a separateinflatable chamber2008. In another embodiment, thetube1904 can include a single lumen or a double lumen. In yet another embodiment, thetube1904 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, thegastric skirt1902 can be positioned around the stomach and secured into place via clips2010. In an embodiment, thegastric skirt1902 is configured to cover at least 14 square centimeters of the outer surface of thestomach100. Thus, thegastric skirt1902 has a surface area of at least 14 square centimeters. Once in place, thegastric skirt1902 can be further tightened around the stomach by inflating, filling, or expanding thechambers2008. Upon inflation of theinflatable chambers2008, thegastric skirt1902 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, thegastric skirt1902 includes aninflatable collar2006 configured to surround the lower esophageal/cardia portion of the stomach. Theinflatable collar2006 is coupled to thegastric skirt1902 via two or more connector straps2004. Theinflatable collar2006 provides a harness and adds stability to thegastric skirt1902 after thegastric skirt1902 has been positioned around the stomach.
• Referring toFIGS. 48A-B, theclips2010 can each include amale tooth4802 and afemale receiver4804 configured to engage themale tooth4802. Upon insertion of themale tooth4802 into thefemale receiver4804, themale tooth4802 releasably locks with thefemale receiver4804 as shown inFIG. 48B. Theclips2010 may include arelease tab4806 which releases themale tooth4802 from thefemale receiver4804 upon the application of pressure to therelease tab4806. Further, the locking mechanism can have a “pop-fit” design that provides a tactile indication that thegastric skirt1902 is secured in place. The locking mechanism of thegastric skirt1902 is not limited to theclips2010 shown inFIGS. 48A-B, but can be any type of connecting mechanism which can securely connect the two opposite ends of thegastric skirt1902 around the stomach.
• In another embodiment, thegastric skirt1902 does not have connectors, but the ends of thegastric skirt1902 are attached to one another by staples, sutures, or heat fusion after thegastric skirt1902 is positioned around thestomach100.
• FIG. 21 is a view of an inflatable gastric skirt without a harness system. Thegastric skirt1902 includesconnector holes2102 where the connector straps2004 (not shown) are attached. The connector holes2102 and correspondingtabs2104 are optional depending on whether the harness system is being used. In an embodiment, thegastric skirt1902 is a standalone device without the harness system, and can be positioned around the stomach without thecollar2006 and the connector straps2004.
• FIG. 22A is a view of agastric skirt1902 having one or moreinflatable chambers2008. In an embodiment, each of thelumens2002 is connected to avalve2202. Eachvalve2002 is connected to a separate inflatable chamber. In another embodiment, a single valve is located on thetube1904 near theinlet1906, and controls delivery to all of thechambers2008. Eachlumen2002 can also be directly connected to a separateinflatable chamber2008 without avalve2002.
• FIG. 22B is a view of acavity2204 of a triple-lumen tube1904. Thetube1904 has acavity2204 that contains threeseparate lumens2002. Each of thelumens2002 is connected via avalve2002 to a separate inflatable chamber, as shown inFIG. 22A. In an embodiment, each of thelumens2002 has a separate inlet so that a different fluid can be administered through each of thelumens2002. In another embodiment, thetube1904 can include switches which allow an operator to close or opencertain lumens2002. 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. Thetube1904 includes three separate lumens, afirst lumen2302, asecond lumen2304, and athird lumen2306. Surrounding thelumens2002 is thetube1904. Thetube1904 and thelumens2002 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, thetube1904 and thelumens2002 are made of the same material. In an alternative embodiment, thetube1904 and thelumens2002 are made of different materials.
• FIG. 24 is an interior view of an inflatable gastric skirt. In an embodiment, thetube1904 has a staggered lumen design, so that each of the three lumens has a different length. Thefirst lumen2302 outputs into thefirst chamber2408, thesecond lumen2304 outputs into thesecond chamber2410, and thethird lumen2306 outputs into thethird chamber2412. In an embodiment, thethird lumen2306 is longer than thesecond lumen2304, and thesecond lumen2304 is longer than thefirst lumen2302, thus creating a staggered lumen design within thetube1904. In another embodiment, each of thelumens2002 in thetube1904 has approximately the same length, and each lumen directly connects to its respective chamber.
• In an embodiment, thechambers2008 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 thefirst chamber2408 and thethird chamber2412, leaving thesecond chamber2410 unfilled or deflated. In another embodiment, each of thechambers2008 can be inflated to different fluid amounts resulting in different pressure levels within each chamber.
• The fluid administered into eachchamber2008 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 thefirst lumen2302 and thesecond lumen2304 can be saline, and the fluid administered through thethird lumen2306 can be a gas.
• FIG. 25 is a view of a triple-lumen inlet port. Theinlet1906 includes anaccess hole2502 or aseptum2502 that covers all the lumen openings. A needle may be used to pierce theseptum2502 and allow a healthcare professional to fill fluid into thelumens2302,2304, and2306. Theseptum2502 may have a visible marker on top to indicate where the needle should be positioned for filling each of the lumens. Theseptum2502 may automatically be sealed when the needle is removed to prevent fluid for exiting the lumens. In one embodiment, theinlet1906 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 andsyringe2602 can be used to administer fluid to the access hole orseptum2502. To deflate thechambers2008, theinlet1906 is connected to asuction device2602 which pulls the fluid out from thechambers2008 or theneedle2602 can be reinserted through theseptum2502 which is used to remove the fluid from the lumens, which results in fluid being removed from thechambers2008. Thesuction device2602 can be, for example, a syringe, a vacuum, or any other means to withdraw inflation fluid from thechambers2008. In another embodiment, theinlet1906 can be connected to an automated system for inflation and deflation of the chambers, so that manual adjustment of thegastric skirt1902 is not required.
• In an embodiment, theinlet1906 includes a reservoir which holds fluid. For example, the reservoir can be pre-filled during insertion of thegastric skirt1902 around the stomach. The reservoir can automatically administer fluid to thelumens2002 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 thechambers2008 based on fluid pressure changes resulting from movement of the patient and the stomach.
• Thegastric skirt1902 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.
• Thegastric skirt1902 may include at least one pressure sensor located within thetube1904 and at least one pressure sensors located within thechambers2008 to measure fluid movement and fluid pressure within thechambers2008. A receiver located within thegastric skirt1902 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 thechambers2008. This analysis can assist a healthcare professional in adjusting the inflation levels in thechambers2008. 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, thefirst lumen2302 can have multiple branches which allow inflation fluid into thefirst chamber2408. Thus, if one of the branches is blocked or obstructed, the other branches on thefirst lumen2302 will continue to fill thefirst chamber2408.
• 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, thetube1904 is removable. After thegastric skirt1902 has been placed around the stomach, and adjusted to provide a desired constriction pressure, the healthcare professional can remove thetube1904. In this embodiment, thegastric skirt1902 is designed to be inflated and adjusted only at the time of insertion. Following the initial inflation and adjustment, theoutlet1908 can be detached from thegastric skirt1902, and thetube1904 can be removed from the body. In order to inflate or deflate thegastric skirt1902 after the initial surgery to insert thegastric skirt1902, theoutlet1908 of thetube1904 needs to be re-attached to thegastric skirt1902 via a surgical procedure.
• FIG. 27 is a view of a laid-open inflatable gastric skirt. In an embodiment, thechambers2408,2410 and2412 are attached to or integrated with aninterior portion2702 of thegastric skirt1902. Thefirst lumen2302 has an output into thefirst chamber2408, thesecond lumen2304 has an output into thesecond chamber2410, and thethird lumen2306 has an output into thethird chamber2412. In another embodiment, a single lumen can be utilized instead of multiple lumens. The single lumen can have outlets branching into each of thechambers2408,2410 and2412.
• FIG. 28 is a view of a connector strap. Theconnector strap2004 hasbuttons2802 that are used to secure theconnector strap2004 to theupper collar2006 and thegastric skirt1902. Thebuttons2802 are configured to snap into the connector holes2102 on thegastric skirt1902 and corresponding connector holes on theupper collar2006. Theconnector strap2004 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 theupper collar2006 and thegastric skirt1902 is not limited to theconnector strap2004, and can be any type of connector which allows a limited movement of theupper collar2006 irrespective of the movement of thegastric skirt1902.
• FIG. 29 is a lateral view of the inflatable gastric skirt. In an embodiment, thechambers2008 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 thechambers2008 can be varied based on a desired constriction pressure. Furthermore, each of thedifferent chambers2008 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, aninflatable collar3002 can be utilized for a harness system. Theinflatable collar3000 has achamber3002 and atube3004. In an embodiment, theinflatable collar3000 has multiple chambers similar to thechambers2008 described above for thegastric skirt1902. Thetube3004 can have a single lumen or multiple lumens similar to thetube1904. Theinflatable collar3002 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, thelower collar3102, 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, thelower collar3102 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. Thelower collar3102 is connected to thegastric skirt1902 via the connector straps2004. This system prevents thelower collar3102 from moving down into the small intestine, and helps to anchor thegastric skirt1902 in place. Furthermore, thelower collar3102 may assist in slowing the gastric emptying from the stomach into the small intestine.
• In an embodiment, thelower collar3102 and theupper collar3000 are both inflatable. The lower collar has aport3104, and the upper collar has aseparate port3006. These ports operate in a similar fashion to theport1906 that is used to inflate the chambers of thegastric skirt1902. In another embodiment, thetube1904 can be connected to thegastric skirt1902, thelower collar3102, and theupper collar3000, so that asingle tube1904 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, thefirst chamber2408, thesecond chamber2410, and thethird chamber2412 may be enclosed within acovering3202. Thelumens2002 are enclosed within the covering3202 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, thevalve3302 is fitted at theinlet1906 of thetube1904. Thevalve3302 has a slitted diaphragm to allow a syringe nozzle to enter. Instep3300, the valve is in a closed position. Instep3304, asyringe nozzle3303 is inserted through the slitted diaphragm of thevalve3302. The slitted diaphragm opens up and allows fluid to be inserted through thesyringe nozzle3303. Instep3306, the fluid is inserted through theopen valve3302. Instep3308, thesyringe nozzle3303 is removed from thevalve3302, and the slitted diaphragm of thevalve3302 returns to a closed position.
• In an embodiment, to deflate or remove fluid from the chambers, thesyringe nozzle3303 is inserted into the slitted diaphragm of thevalve3302 as shown instep3310. Thesyringe nozzle3303 is used to aspirate the inflation fluid from the lumens and chamber, thereby deflating or removing fluid from the chambers. Instep3312, thesyringe nozzle3303 is removed from thevalve3302 and the slitted diaphragm returns to a closed position. In another embodiment, theinlet1906 can have a similar design as the valve described inFIG. 33.
• FIG. 34 is a view of an inflatable antral skirt. In an embodiment, theantral skirt3402 can be positioned around thepyloric antrum114, which is located between thepyloric sphincter3408 and theangular receiver3406 in the lower part of thestomach3404. In an embodiment, theantral skirt3402 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, thestomach3404 is restricted by stapling and dividing it vertically and removing more than 85% of its surface area. As shownFIG. 34, thegreater curvature112 of thestomach3404 is taken in closer to thelesser curvature110, creating a sleeve-shapedstomach3404. In an embodiment, theantral skirt3402 is configured to cover at least 14 square centimeters of the outer surface of thepyloric antrum114. Thus, theantral skirt3402 has a surface area of at least 14 square centimeters. In an embodiment, theantral skirt3402 has a length of at least 10 centimeters and a width of at least 4 centimeters. In one embodiment, the thickness of theantral skirt3402 is up to about 1/35,000th of an inch.
• In an embodiment, theantral skirt3402 is inflatable or finable with fluid through atube3410, which operates similar to thetube1904 described above for thegastric skirt1902. Theantral skirt3402 can be inflated and deflated to provide a desired constriction level around thepyloric antrum114. In another embodiment, theantral skirt3402 can be applied around thepyloric antrum114 of a stomach that has not undergone a VSG procedure. In yet another embodiment, theantral skirt3402 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 theantral skirt3402 constricts thepyloric antrum114. Thepyloric antrum114 is a portion of the stomach where food and particles are collected and pumped into the lower intestine. Thepyloric antrum114 also contains receptors that provide indications of fullness to the brain. When food is pumped into thepyloric antrum114 from the stomach, thepyloric antrum114 expands, and receptors provide an indication that the stomach is full. This results in a pumping action by thepyloric antrum114 to empty the stomach contents into the intestine. Theantral skirt3402 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.
• Theantral skirt3402 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, theantral skirt3402 can be made of a biodegradable mesh.
• FIG. 35 is a laid-open view of an inflatable antral skirt. In an embodiment, theantral skirt3402 includes aninflatable chamber3506. Theantral skirt3402 may or may not include aninflatable chamber3506. Theinflatable chamber3506 can be inflated or filled with inflation fluid through thetube3410. Theantral skirt3402 includes amale connector3502 and an opposingfemale connector3504. When then antralskirt3402 is positioned around the pyloric antrum, themale connector3502 and thefemale connector3504 interlock to securely hold theantral skirt3402 in place. The connection means is not limited to the embodiment shown inFIG. 35, and theantral skirt3402 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, thegastric skirt1902 includes a topinflatable layer3604 attached to an exterior surface of thegastric skirt1902 and a bottominflatable layer3606 attached to an interior surface of thegastric skirt1902. The topinflatable layer3604 provides cushions from pressure exerted onto the stomach from other body organs that are adjacent to the stomach. The bottominflatable layer3606 provides constriction pressure on the stomach as described above. A double-lumen port3602 provides separate inflation fluid to each of the inflatable layers. In an embodiment, the topinflatable layer3604 and bottominflatable layer3606 can include multiple inflatable or Tillable chambers. Each of the lumens in the double-lumen port3602 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 theinflatable chambers2008 has aRF coil3702 surrounding the exterior of thechamber2008. The RF coils3702 are activated when aRF receiver3704, either coupled to thegastric skirt1902, or embedded within thegastric skirt1902, 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's body and transmits wireless energy signals to theRF receiver3704. TheRF receiver3704 can be used to store energy or the energy signals. In another embodiment, the energy device can be located inside the patient's body. In an embodiment, the RF coils3702 provide RF energy, such as heat and ultrasonic energy, to the exterior stomach wall, and create scarring in the shape of the RF coils3702 in the exterior stomach wall. The scarred tissue reduces the stomach volume.
• In an embodiment, immediately after the tissue scarring process in completed thechambers2008 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 thechambers2008 are inflated, they inflate into the space created by the scarred tissue, providing localized cushioning of the scarred regions. When thechambers2008 expand or fill into the scarred tissue region that has been indented into the exterior stomach wall, thegastric skirt1902 is secured into its intended site.
• In an embodiment, the RF coils3702 may be covered with a sleeve or pouch made from Teflon®, Dacron®, ePTFE, or any combination thereof. The sleeve is glued or sutured to thegastric skirt1902 and/or thechambers2008. In another embodiment, the sleeve is molded with thegastric skirt1902 and/thechambers2008 to form a single molded structure.
• FIG. 38 is a view of an inflatable gastric skirt with steam ablation holes. Each of theinflatable chambers2008 are covered with athin ablation layer3802, which contain an ablation device, and havetop holes3804 to allow thermal energy in the form of steam to pass through and ablate the exterior stomach wall. Steam is delivered to the ablation layers3802 via asteam receiver3806. In an embodiment, the steam can be delivered through thetube1904 prior to delivery of fluid to thechambers2008. 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. Thegastric skirt1902 includesablation layers3802 on top of each of thechambers2008. The ablation layers3802 include side holes3902. Thetop holes3802 and the side holes3902 allows steam ablation to create an indentation within the exterior stomach wall so that the stomach can accommodate thechambers2008.
• FIG. 40 is a view of an inflatable gastric skirt with an ultrasound probe. Thegastric skirt1902 includesultrasound layers4002 on top of each of thechambers2008. The ultrasound layers include anultrasound receiver4004 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 thechambers2008. In an embodiment, theultrasound receiver4004 can be embedded within thegastric skirt1902 and activated by a receiver or controller located outside of the patient'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 thegastric skirt1902, embedded within the ablation layers, or located adjacent to thegastric skirt1902.
• 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 thegastric skirt1902. In this embodiment, the ablation device, such as an ultrasound probe, transmits ultrasound energy signals towards the outer surface of the stomach through thegastric skirt1902.
• In another embodiment, thegastric skirt1902 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, thethermal ablation layers4102 are positioned in an alternating fashion with thechambers2008. Thethermal ablation layers4102 are positioned between thechambers2008, so that the inner surface of thegastric skirt1902 has a smooth and even surface. In another embodiment, the ablation layers can be an ultrasound probe or RF coils positioned between thechambers2008 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 inFIG. 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, Ci, 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 thegastric skirt1902 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, theantral skirt3402 can include an ablation device, such as, for example, RF coils, thermal ablation layers, or ultrasound layers, in conjunction with fillable or inflatable chambers. Theantral skirt3402 can provide constriction as well as ablation or scarring to thepyloric antrum114.
• FIG. 42 is a view of a physiological connection between stomach receptors and a brain. After a VSG procedure, many of thecardia stretch receptors4202 and the stomachbody stretch receptors4204 are removed. However, thepyloric antrum114 is not modified by the VSG procedure, and theantral stretch receptors4204 in thepyloric antrum114 remain intact. Upon being filled with food and stomach contents, thepyloric antrum114 expands, and thestretch receptors4206 in thepyloric antrum114 send neurological signals to the hypothalamus4210 in thebrain4208, indicating the stomach is full. Upon receipt of these signals, the hypothalamus4210 sends a signal via the afferentvagal nerve4212 to thepyloric antrum114 to pump out the food into the intestines.
• Theantral skirt3402 provides a constant pressure around thepyloric antrum114, so that whenpyloric antrum114 even slightly expands, theantral stretch receptors4206 are constrained from further expansion. Upon being prevented from further expansion, theantral stretch receptors4206 send a signal to thebrain4208, and in turn, thepyloric antrum114 is caused to pump out food contents. The combination of theantral skirt3402 and theantral stretch receptors4206 create an equal and opposite reaction, causing a continual gastric emptying by thepyloric antrum114. Thus, the invention takes advantage of theantral stretch receptors4206 that remain after a VSG procedure in order to provide an indication of fullness to thebrain4208 and cause rapid and early gastric emptying.
• FIG. 43 is a view of a stomach prior to ligation. In an embodiment, thegastric skirt1902 is designed to accommodate a stomach that has undergone tucking and ligation procedures. Prior to placing thegastric skirt1902 around thestomach100, a linear portion of thegreater curvature112 is tucked inwards into thestomach100 and towards thelesser curvature110. As shown above inFIG. 1B, theinner lining120 is depressed within thestomach100 as a result of the tucking procedure, and the tucked-inportion4302 occupies space within the body of thestomach106. After the tucking procedure, a firstuntucked stomach portion4304 and a seconduntucked stomach portion4306. Thus, the internal volume of thestomach100 is substantially decreased.
• In an embodiment, in order to assist the healthcare provider in determining how far to tuck in the stomach, abougie4308 is endoscopically inserted through theesophagus102 and into the stomach body106 (Step4702). Thebougie4308 is inserted adjacent to or along thelesser curvature110. Next, a portion of thestomach100 is tucked or pushed inwards towards thelesser curvature110 until thebougie4308 is reached (Step4704). Thebougie4308 prevents the tucked-inportion4302 from completely blocking off thestomach body106, and allows for a channel to remain in thestomach body106 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 thestomach100 without closing off thestomach body106.
• After thestomach100 has been tucked-in, a ligation procedure is performed (Step4706). The firstuntucked stomach portion4304 and the seconduntucked stomach portion4306 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-inportion4302 between the firstuntucked stomach portion4304 and the seconduntucked stomach portion4306. 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, thebougie4308 is removed from the stomach100 (Step4708) using the endoscopic device. In an embodiment, thestomach100 is then covered with the gastric skirt1902 (Step4710), and thegastric skirt1902 is filled or inflated to provide a desired level of constriction around the stomach (Step4712).
• FIG. 44 is a lateral view of a tucked-in stomach prior to ligation. Thegreater curvature112 is tucked-in towards thelesser curvature110, until thegreater curvature112 comes into contact with thebougie4308. The tucked-inportion4302 leaves the firstuntucked stomach portion4304, the seconduntucked stomach portion4306, and acavity4402 between the firstuntucked stomach portion4304 and the seconduntucked stomach portion4306.
• FIG. 45 is a view of a ligated stomach. After the ligation procedure is completed, the internal volume of thestomach100 is reduced to approximately one-third of its original volume. The ligation procedure is reversible, as thesutures4310 can be removed. In an embodiment, thegastric skirt1902 is positioned around the ligated stomach as shown inFIG. 19. In another embodiment, thestomach100 undergoes a VSG procedure instead of a ligation procedure prior to thegastric skirt1902 being placed around the stomach.
• FIG. 46 is a lateral view of a gastric skirt positioned around a ligated stomach. The volume of thestomach body106 is approximately one-third of its original volume. Thesutures4310 are inserted through the first untucked portion of thestomach4304, thecavity4402, and the second untucked portion of thestomach4306. Thesutures4310 prevent food and stomach contents from entering and accumulating in the first untucked portion of thestomach4304 and the second untucked portion of thestomach4306. In an embodiment, thestomach100 is covered with thegastric skirt1902.
• 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.

Claims (20)

What is claimed is:

1. A gastric restriction device for treating excessive weight or obesity in mammals, comprising:

a skirt having a left portion, a right portion, a top edge with a first indentation located at a center of the top edge, and a bottom edge with a second indentation located at a center of the bottom edge, the skirt having a narrow surface located between the first indentation and the second indentation and a broad surface formed from the left portion connecting to the right portion, the skirt being configured to envelop and fit an internal stomach organ of a mammal;

a first attachment device that is attached to or part of the right portion of the skirt; and

a second attachment device that is attached to or part of the left portion of the skirt and adapted to engage the first attachment device so that the skirt envelops and fits the internal stomach organ of the mammal.

2. The gastric restriction device ofclaim 1, wherein the skirt has a surface that is of at least 14 square centimeters.

3. The gastric restriction device ofclaim 2, wherein the narrow surface is operable to envelop a lesser curvature of the internal stomach organ and the broad surface is operable to envelop a greater curvature of the internal stomach organ.

4. The gastric restriction device ofclaim 3, wherein the skirt or the first and second attachment devices completely cover an entire area between a left edge of the left portion and a right edge of the right portion when the second attachment device is engaged with the first attachment.

5. The gastric restriction device ofclaim 4, wherein the skirt is adapted to be positioned around and in direct contact with the internal stomach organ of the mammal to tightly engage the internal stomach organ when the left edge is in proximity to the right edge.

6. The gastric restriction device ofclaim 1, wherein the top edge is a concave edge and the bottom edge is a concave edge.

7. The gastric restriction device ofclaim 1, wherein the skirt is made of an implantable silicon material or an ePTFE material.

8. A gastric constriction device for treating excessive weight or obesity in mammals, comprising:

a skirt having a left portion, a right portion, a top portion, and a bottom portion, the top portion having a top edge with a first indentation, the bottom portion having a bottom edge with a second indentation, the skirt having a narrow surface located between the first indentation and the second indentation and a broad surface formed from the left portion connecting to the right portion, the narrow surface and the broad surface operable to cover different portions of a stomach;

a first attachment device that is attached to or part of the right portion of the skirt; and

a second attachment device that is attached to or part of the left portion of the skirt and adapted to engage the first attachment device and maintain a left edge of the left portion in proximity to a right edge of the right portion.

9. The gastric constriction device ofclaim 8, wherein the skirt or the first and second attachment devices completely covers an entire area between the left edge and the right edge when the left edge is in proximity to the right edge and the first and second attachment devices are adapted to be positioned around a greater curvature of the stomach, thereby preventing expansion of the stomach when the first attachment device is fastened to the second attachment device.

10. The gastric constriction device ofclaim 8, wherein the skirt is adapted to be positioned around and in direct contact with the stomach of the mammal to tightly engage the stomach when the left edge is in proximity to the right edge.

11. The gastric constriction device ofclaim 8, wherein the skirt is made of silicone.

12. The gastric constriction device ofclaim 8, wherein the skirt is made of a biodegradable and absorbable polymer.

13. The gastric constriction device ofclaim 8, wherein the skirt has a parallelogram shape.

14. The gastric constriction device ofclaim 8, wherein the first indentation has a concave shape and the second indentation has a concave shape.

15. A gastric restriction device for treating excessive weight or obesity in mammals, comprising:

a skirt having a left portion, a right portion, a top portion having a top edge with a first indentation located at the top edge, and a bottom portion having a bottom edge with a second indentation located at the bottom edge, the skirt having a narrow surface located between the first indentation and the second indentation and a broad surface formed from the left portion connecting to the right portion, the narrow surface operable to envelop a lesser curvature of an internal stomach organ of a mammal and the broad surface operable to envelop a greater curvature of the internal stomach organ;

a first attachment device that is attached to or part of the right portion of the skirt; and

a second attachment device that is attached to or part of the left portion of the skirt and adapted to engage the first attachment device and maintain the left portion in proximity to the right portion.

16. The gastric restriction device forclaim 15, wherein the skirt or the first and second attachment devices completely covers an entire area between the left portion and the right portion when the left portion is in proximity to the right portion and the first and second attachment devices are adapted to be positioned around the greater curvature of the internal stomach organ, thereby preventing expansion of the internal stomach organ when the first attachment device is fastened to or inserted into the second attachment device.

17. The gastric restriction device ofclaim 15, wherein the skirt is adapted to be positioned around and in direct contact with the internal stomach organ of the mammal to tightly engage the internal stomach organ when the left portion is in proximity to the right portion.

18. The gastric restriction device ofclaim 15, wherein the top edge is a concave edge and the bottom edge is a concave edge.

19. The gastric restriction device ofclaim 15, wherein the skirt is made of an implantable silicon material or an ePTFE material.

20. The gastric restriction device ofclaim 15, wherein the first attachment device is a receiver and the second attachment device is a connector, wherein the connector is adapted to be inserted into the receiver to maintain the left portion in proximity to the right portion.

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