Obesity treatment tool

(Cross-reference of related applications) This application claims the priority benefit to US patent application No. 09 / 871,297 filed May 30, 2001, and US patent application "Overtube SFP For Insertion Into A Body" filed May 23, 2002.

The present invention generally relates to tools and methods for the treatment of obesity. More specifically, the present invention relates to tools and methods for performing less traumatic gastric dysplasia procedures.

Obesity is considered a major health problem in the United States alone, with annual associated costs of up to $ 100 billion. Pathological obesity is a condition of obesity with the presence of a secondary debilitating progressive disease, and is generally 40 kg / m.²It is related to the above body mass index (BMI). The basic mechanism of obesity is the non-equilibrium between simple caloric intake and burning rate, but the underlying factors are diverse and complex, and conventional attempts at sustained weight loss in this population have been Almost always unsuccessful. Often, there are genetic and other biological effects that can dominate environmental factors. As a result, obesity is a disease that escapes simple treatment and has a recurrence rate of over 90% for people who try to lose weight. Moreover, the long-term consequences of using conventional treatments for morbid obesity are generally unsuccessful, and typically with further loss of self-respect due to regaining weight. Hypertension, cardiovascular disease, and diabetes, along with numerous other comorbidities, all only make morbid obesity the second leading cause of preventable death to smoking.

<p> From the surgical procedure for obesity dating back to its early equivalent, 1889 (Billroth), to the Ileojejunal Bypass procedure in 1954 (Kreman). Successful procedures are commonly defined as procedures that result in at least 50% excess weight loss at 2 years. The most common surgery performed today is Lou Y Gastric Bypass (RYGB), which is performed in the United States in approximately 35,000 cases annually. Other forms of obesity surgery include Fobi sac (pouch), bile (bilio) -pancreatic diversion, and gastroplasty or "stomach stapling". A single existing procedure involving the implanted device is the Lap-Band, which is laparoscopically placed and inflatable, located around the upper part of the stomach just below the lower esophageal sphincter (LES). It is a cuff. This device only affects satiety (does not reduce caloric absorption). Obesity is more than just overeating, so Lap-Band itself is probably not as effective as surgery involving other physiological feedback mechanisms.</p><p> The RYGB procedure is a very common procedure in obesity surgery. This procedure facilitates the movement of the jejunum to a higher position by using the Lou Y loop behind the colon. This procedure is generally performed through a 6-8 inch incision extending from the end of the sternum just above the navel. The stomach is completely divided into two non-uniform parts (small upper and large lower gastric sac) using an automatic stapling device with an untreated surface reinforced with additional sutures. The upper pouch is typically about 1 ounce or less than 20 cc, while the lower pouch generally remains intact and continues to secrete gastric juice flowing through the intestinal tract.</p><p> The small intestinal compartment (immediately distal to the duodenum or proximal to the jejunum) is then brought from the lower abdomen and anastomotic end-to-end made through a 0.5-inch opening (also known as the small intestine). Is connected to the upper sac to form. This section of the small intestine is called the "ruloop" and carries food from the upper sac to the rest of the intestine, where food is digested. The remaining lower sac and associated compartment of the duodenum then, typically using a stapling device, make another anastomotic connection to the ruloop at a location approximately 50-150 cm (1.6-4.9 ft) from the small cavity. Reconnected to form. At this connection, the bypassed digestive juices from the stomach, pancreas and liver enter the jejunum or ileum and assist in the digestion of food. Due to the small size of the upper sac, patients are forced to eat at a slower rate and fill up fairly quickly, thereby resulting in caloric intake (typically about 1000-1200). Reduce (between calories).</p><p> Since food enters the intestines directly, a condition known as "dumping syndrome" is created when certain types of "junk food" (usually confectionery and other simple carbohydrates) are consumed. This causes unpleasant moods of nausea, diarrhea, nervousness and sweating, which in turn prevent the patient from developing unhealthy eating patterns. Using the RYGB procedure, loss of at least 50% excess body weight (EBW) is maintained in about 60% of patients at 5 years and has a reduced complication rate compared to other procedures.</p><p> Several methods have been previously developed to maintain channel integrity in the creation of anastomosis in the RYGB procedure. However, conventional RYGB procedures require long surgical times, and due to the degree of invasiveness, post-surgery recovery times can be very long and painful.</p><p> Apart from the RYGB procedure, another gastrointestinal disorder associated with the stomach is gastroesophageal reflux disease (GERD). The lower esophageal sphincter is located in the distal part of the esophagus adjacent to the connection between the esophagus and the stomach. When food is digested, the properly functioning lower esophageal sphincter allows food to pass from the esophagus to the stomach, preventing reflux. However, GERD is a disorder in which the esophageal sphincter causes the stomach contents, including stomach acid and bile, to flow back into the distal part of the esophagus. Some complications associated with GERD include heartburn, lung damage, chest pain, esophageal ulcer, esophagitis, Barrett's esophagus and esophageal carcinoma.</p><p> Common treatments for GERD include administration of prescribed acid blockers. Although these drugs can only provide short-term relief; in addition, these drugs can be expensive and can have long-term side effects. Surgical procedures include a procedure called Nissen fundus fold plasty, in which part of the bottom of the stomach wraps around the esophagus. The wrapped bottom applies pressure to the esophagus to limit the regurgitation of stomach contents. Effective extension of the stomach, either by fundus fold plasty or by extending the esophagus through the staple line, can be done to treat GERD. While conventional fundal fold formation procedures can be effective in treating GERD, they also have drawbacks. For example, many of these procedures require a large incision in the patient. The laparoscopic procedure typically requires several smaller incisions made in the abdominal wall for insertion of the device into the patient's body. However, such procedures can be expensive and can increase the risk of postoperative hernias, accidental organ perforations and other related drawbacks.</p><p> Examples in the field of gastrodysplasia are described below.</p><p> U.S. Pat. No. 5,549,621 to Bessler et al. (Which is incorporated herein by reference in its entirety) relates to a staple-free device and method for performing vertical band gastrostomy. The described device uses at least two clamping bars to create a tubular pouch. However, the device is laparoscopically placed on the outer surface of the stomach.</p><p> U.S. Pat. No. 5,382,231 to Shlain, which is incorporated herein by reference in its entirety, is transesophageal gastric by a device with a decompression port utilized to retract the stomach beyond this device. Describe the device for regression. However, this device is used to manipulate and retract the patient's stomach from the inside during various surgical procedures, and is not a permanent procedure for creating an internal sac inside the stomach itself.</p><p> U.S. Pat. No. 5,345,949 to Shlain, which is incorporated herein by reference in its entirety, is a band that allows the walls of the stomach to be adjacent to each other between the proximal and distal regions of the stomach. Concerning laparoscopic methods and tools for inserting fixation devices. However, there is no procedure for creating an internal brain that is created internally from the stomach.</p><p> Examples relating to the field of GERD treatment are given below.</p><p> U.S. Pat. No. 6,159,146 to El Gazayerli, which is incorporated herein by reference in its entirety, is transesophageally inserted and engages the medial posterior wall of the bottom to esophagus this device. Regarding the device, which is fixed to the side of the.</p><p> U.S. Pat. No. 6,113,609 to Adams, which is incorporated herein by reference in its entirety, is of a distal anchor through a hole formed in the wall of the esophagus and through a hole formed in the wall of the stomach. For systems involving placement, these holes are then fastened together.</p><p> U.S. Pat. No. 5,571,116 to Bolanos et al., Which is incorporated herein by reference in its entirety, relates to an invagination device that approaches the lower esophagus and the bottom of the stomach.</p><p> However, all of these examples are limited to the treatment of GERD, which includes attachment to the esophagus at the bottom or top of the stomach.</p>

<p> The present invention provides, for example,: (Item 1) A method of forming a lumen from inside an organ, such as: The step of installing at least a first anchor on the first region of the interior; The step of installing at least a second anchor on the second region of the interior; and The step of pulling at least the first anchor and at least the second anchor proximal to each other so that the lumen is formed, Including, methods. (Item 2) The method of item 1, wherein the organ comprises a stomach. (Item 3) The method of item 1, wherein the first anchor comprises a fastener selected from the group consisting of staples, ratchet wires, zip ties, clips, tags, eyelets, crimps, and screws. (Item 4) The method of item 1, wherein the second anchor comprises a fastener selected from the group consisting of staples, ratchet wires, zip ties, clips, tags, eyelets, crimps, and screws. (Item 5) The method of item 1, wherein the step of placing at least a second anchor on the internal second region comprises the step of placing a second anchor in parallel with the first anchor in the organ. (Item 6) The step of pulling the at least the first anchor and the at least the second anchor proximally is the step of threading the suture through each of the anchors and the step of pulling the first region and the second region together. The method of item 1, comprising the step of pulling a suture. (Item 7) 6. The method of item 6, wherein the suture passes through each of the anchors in a Z-shaped fashion. (Item 8) The method according to item 1, wherein each of the first anchor and the second anchor includes a pressure welding member. (Item 9) The method according to item 8, wherein each of the pressure welding members is arranged so as to be interlocked with each other. (Item 10) The method of item 1, further comprising connecting the first anchor to the second anchor so that the first and second regions on the inner surface are aligned. (Item 11) A fixation device for fixing tissue inside an organ, such as: A helical member having a coil length between the distal and proximal ends, wherein at least two coils at the distal end of the helical member each contain the same diameter. The helical member is arranged for delivery through a lumen defined by the length of an elongated member having a proximal end and a distal end. A fixed device. (Item 12) The fixed device according to item 11, wherein the diameters of the two coils are longer than the diameter of the proximal coil. (Item 13) The fixed device according to item 11, wherein the portion of the coil length is tapered. (Item 14) The fixing device according to item 11, wherein the diameters of the two coils are equal to the diameter of the lumen of the elongated member. (Item 15) 11. The fixation device of item 11, wherein the distal end of the helical member is configured to penetrate tissue. (Item 16) 11. The fixation device of item 11, wherein the helical member is configured to maintain a direction parallel to the longitudinal axis of the elongated member during delivery. (Item 17) The fixing device according to item 11, wherein the portion of the coil length is at least partially covered with a fixing member. (Item 18) 17. The device of item 17, wherein the anchoring member is selected from the group consisting of spines and whisker-like filaments. (Item 19) 11. The fixation device of item 11, wherein the helical member comprises a bioabsorbable or biocompatible material. (Item 20) 19. The fixation device of item 19, wherein the bioabsorbable or biocompatible material is selected from the group consisting of polymers and superelastic alloys. (Item 21) A marking device for marking positions on the inner surface of an organ, such as: An elongated member having proximal and distal ends and a length portion between them. The length defines the shape that brings the lumens close together so that they are formed from the inner surface. The length further defines at least one dye port, a marking device configured such that the dye port contacts an area of the inner surface and delivers the dye. (Item 22) 21. The marking device of item 21, further comprising an inflatable balloon at the distal end of the elongated member. (Item 23) 21. The marking device of item 21, wherein the length further defines at least one vacuum port that communicates with the distal end of the elongated member. (Item 24) 21. The marking device of item 21, wherein the length further defines a plurality of additional dye ports. (Item 25) 21. The marking device according to item 21, wherein the organ comprises a stomach. (Item 26) The marking device according to item 21, wherein the elongated member is curved. (Item 27) 26. The marking device of item 26, wherein the curved elongated member is configured to follow a stomach with a lower curvature. (Item 28) 26. The marking device of item 26, wherein the dye port is defined along the outer diameter of the curved surface of the curved elongated member. (Item 29) 21. The marking device of item 21, wherein the elongated member is configured to be delivered to an internal surface via the esophagus. (Item 30) A method for marking the position on the inner surface of an organ, such as: In the step of inserting the marking device into the organ, the marking device is an elongated member having proximal and distal ends and the length of the lumen so that it is formed from an internal surface. A marking device that defines the shape in close proximity, the length further defines at least one dye port, the dye port being configured to contact and deliver dye to a region of the inner surface. Process; The step of reducing the volume of the organ so that the internal surface is in contact with the elongated member; The step of passing the dye through the dye port; and Steps to increase the volume of the organ; Including, methods. (Item 31) 30. The method of item 30, wherein the step of reducing the volume of the organ so that the internal surface is in contact with the elongated member comprises the step of removing the contents of the organ by vacuum. (Item 32) 31. The method of item 31, wherein the vacuum is created by a vacuum port defined along the length of the elongated member. (Item 33) The method according to item 30, wherein the step of passing the dye through the dye port includes a step of bringing the dye into contact with the region of the inner surface. (Item 34) The method according to item 30, wherein the dyes are methyl blue, thionin, acridine orange, acridine yellow, acriflavine, quinacrine, and derivatives thereof, brilliant green, gentiana violet, crystal violet, triphenylmethane, bisnaphthalene. A method comprising a biocompatible dye selected from the group consisting of, trypan blue, and trypan red. (Item 35) A method of forming a lumen from inside an organ, such as: The step of drawing the first boundary of the lumen in the first region of the membrane and the second boundary of the lumen in the second region of the membrane using the method of item 30; The step of removing the marking device from the organ; The step of installing at least the first anchor along the first boundary; The process of installing at least a second anchor along the second boundary; and The step of pulling at least the first anchor and at least the second anchor proximal to each other so that the lumen is formed. Including, methods. (Item 36) 35. The method of item 35, wherein the first anchor comprises a fastener selected from the group consisting of staples, ratchet wires, zip ties, clips, tags, eyelets, crimps, and screws. (Item 37) 35. The method of item 35, wherein the second anchor comprises a fastener selected from the group consisting of staples, ratchet wires, zip ties, clips, tags, eyelets, crimps, and screws. (Item 38) The step of pulling the at least the first anchor and the at least the second anchor proximal to each other includes the step of threading the suture through each of the anchors, the first region, and the second region of the inner surface. 35. The method of item 35, comprising pulling the suture so as to be attracted to. (Item 39) 38. The method of item 38, wherein the suture passes through each of the anchors in a Z-shaped fashion. (Item 40) 35. The method of item 35, wherein the first anchor and the second anchor include a pressure contact member. (Item 41) The method according to item 40, wherein each of the pressure contact members is configured to be interlocked with each other. (Item 42) A device for forming a lumen from inside an organ, including: A tissue adhesive member having a length between the proximal and distal ends, the member at least leaping the first region of the interior near the second region of the interior. Has two openable adhesive areas, This device forms the lumen when the first region is secured to the second region. (Item 43) 42. The device of item 42, comprising the second region with at least one disposable fastener in the tissue adhesive member to secure the first region. (Item 44) 42. The device of item 42, wherein the first region is positioned in parallel with the second region. (Item 45) 42. The device of item 42, wherein the first region is positioned in parallel with the second region. (Item 46) 42. The device of item 42, wherein the tissue adhesive member defines a slot along the length and the slot is adapted to accept a retractable partition wall. (Item 47) 46. The device of item 46, wherein the retractable bulkhead defines at least one surface adapted to cut off adjacent portions of the interior. (Item 48) 47. The device of item 47, wherein adjacent portions of the inner surface are excised by a retractable partition using a method selected from the group consisting of cutting, knurling, heating, freezing and chemical ablation. .. (Item 49) 42. The device of item 42, wherein each of the two openable adhesive regions is separated at an angle between about 20 ° and about 180 ° about a longitudinal axis defined by said length. (Item 50) 49. The device of item 49, wherein the two openable adhesive regions are separated by an angle between about 90 ° and about 180 ° with respect to the longitudinal axis defined by the length. (Item 51) 42. The device of item 42, wherein the first and second regions are attached to the tissue adhesive member via a vacuum created in each of the two openable adhesive regions. (Item 52) 51. The device of item 51, wherein each of the two openable adhesive regions is in fluid contact with a common channel defined within the tissue adhesive member. (Item 53) 42. A device of item 42, further comprising a proximal and distal ends and a delivery member having a length between them, wherein the tissue adhesive member is adhered to the distal end of the delivery member. The device according to item 42. (Item 54) 53. The device of item 53, wherein the tissue adhesive member is in fluid contact with the proximal end of the delivery member. (Item 55) 43. The device of item 43 comprising a wedge that is slidably arranged within an internal channel defined by the tissue adhesive member, wherein the wedge is a second closed from an open first arrangement. A device that is adapted to propel the fasteners into place. (Item 56) 55. The device of item 55, wherein the fastener comprises a mechanical fastener selected from the group consisting of C-staples, U-staples, clips and tags. (Item 57) 55. The device of item 55, further comprising a wire attached to the wedge. (Item 58) 42. The device of item 42, wherein the length portion of the tissue adhesive member is straight. (Item 59) 42. The method of item 42, wherein the length of the tissue adhesive member defines an arc that approximates the curvature of the organ. (Item 60) 42. The device of item 42, wherein the shape of the tissue adhesive member is adjustable. (Item 61) 42. The device of item 42, wherein the distal end of the tissue adhesive member overhangs away from the curved surface of the organ. (Item 62) 42. The device of item 42, wherein the organ comprises the stomach. (Item 63) 62. The device of item 62, wherein the tissue adhesive member is adapted to be inserted into the stomach endoscopically through the passage of the esophagus. (Item 64) 43. The device of item 43, wherein the fastener comprises a screw having a helical shape. (Item 65) 64. The device of item 64, wherein the diameter of the distal end of the screw is greater than the diameter of the proximal end of the screw. (Item 66) 65. The device of item 65, wherein the portion of length between the distal end of the screw and the proximal end of the screw is tapered. (Item 67) 64. The device of item 64, wherein each of at least two coils at the distal end of the screw has an equal diameter. (Item 68) 64. The device of item 64, wherein the distal end of the screw is configured to penetrate tissue. (Item 69) 64. The device of item 64, wherein the screw is at least partially covered with a fixing member. (Item 70) 69. The device of item 69, wherein the anchoring member is selected from the group consisting of spines and whisker-like filaments. (Item 71) 64. The method of item 64, wherein the screw comprises the bioabsorbable material and the biocompatible material. (Item 72) The fixation device of item 71, wherein the bioabsorbable or biocompatible material is selected from the group consisting of polymers and superelastic alloys. (Item 73) The device of item 66, wherein the screws are arranged to alternately penetrate a first region of tissue and a second region of tissue, while the first region of tissue and the first region of tissue and the second region of tissue. A device that brings the second area of tissue closer to each other. (Item 74) 43. The device of item 43, further comprising a plurality of additional fasteners, each of which is parallel on a line such that the first region forms a continuous fixed line in the second region. 43. The device of item 43, which is configured to be fixed while allowing. (Item 75) A method for forming a lumen from inside an organ, including: The step of openly adhering the first region of the interior to the tissue adhesive member; The step of moving the first region inside the tissue through the tissue adhesive member; The step of openly adhering the internal second region to the tissue adhesive member so that the first region is located proximal to the second region; The step of fixing the first region to the second region to form the lumen. Including, methods. (Item 76) The method of item 75, wherein the first and second regions are created in at least two openable adhesive regions defined in the tissue adhesive member by vacuum. The method of being openly glued to. (Item 77) The method of item 75, wherein the first region is located adjacent to the second region. (Item 78) The method of item 75, wherein the first region is parallel to the second region. (Item 79) The step according to item 75, wherein the second region of the inner surface is openly bonded to the tissue adhesive member so as to position the first region proximal to the second region. Further, a method comprising removing a partition wall arranged in the tissue adhesive member such that the first region is in contact with the second region. (Item 80) 79. The method of item 79, comprising the step of inducing a healing response in the first or second region while removing the septum. (Item 81) 79. The method of item 79, further comprising excising the first or second region while removing the septum. (Item 82) Item 81, wherein the step of excising the first or second region comprises a method selected from the group consisting of cutting, knurling, heating, freezing and chemical ablation. ,Method. (Item 83) The method of item 75, wherein the step of fixing the first region to the second region further comprises a step of sliding a wedge disposed within an internal channel defined by the tissue adhesive member. A method of including and, as a result, advancing the mechanical fastener so that the wedge tightens the first area to the second area. (Item 84) 83. The method of item 83, wherein the mechanical fastener is selected from the group consisting of C-staples, U-staples, clips and tags. (Item 85) The method of item 75, wherein the first and second regions are released from the tissue adhesive member. (Item 86) 75. The method of item 75, wherein the organ comprises a stomach. (Item 87) 86. The method of item 86, wherein the adhesive member is inserted into the stomach endoscopically through a passageway in the esophagus before the adhesive member is openly bonded to the tissue adhesive member. .. (Item 88) The method of item 75, wherein the step of fixing the first region to the second region defines a boundary between the lumen and the rest of the organ. (Item 89) 88. The method of item 88, wherein the boundary is straight. (Item 90) 88. The method of item 88, wherein the boundary is adjacent to the curved surface of the organ. (Item 91) 88. The method of item 88, wherein the boundary is adjustable. (Item 92) 88. The method of item 88, wherein the boundary projects with respect to the rest of the organ. (Item 93) The step of fixing the first region to the second region to form the cavity propels the fastener through an internal channel defined in the tissue adhesive member to propel the fastener to the first region and the second region. The method of item 75, comprising the step of fixing together with the region. (Item 94) 93. The method of item 93, wherein the fastener has a gradually tapered spiral shape with a penetrating end. (Item 95) The step of propelling the fastener through the internal channel is the step of rotating the fastener around a longitudinal axis defined by the fastener so that the first region and the second region are tightened together. 93. The method of item 93. (Item 96) A system for forming a lumen from the inside of an organ and dilating the opening defined by the organ, the system: A tissue adhesive member having a proximal end and a distal end with a length between the proximal end and the distal end, the member having the inner first region near the inner second region. With a tissue adhesive member that has at least two openly adhereable regions for openly positioning in, thereby forming the lumen when the first region is secured to the second region. ; An elongated device having a proximal end and a distal end with a length between the proximal end and the distal end, the elongated device contacting tissue in or near the opening. With an elongated device having a modified region for delivering stimuli to the tissue to and to dilate the opening; The system. (Item 97) The system of item 96, further comprising at least one fastener that can be placed in the tissue adhesive member to secure the first region to the second region. (Item 98) The system according to item 96, wherein the tissue adhesive member defines a slot along the length. (Item 99) The system according to item 98, wherein the slot is adapted to receive a retractable bulkhead. (Item 100) The system of item 98, wherein the retractable bulkhead defines at least one surface adapted to excise the inner flanking portion. (Item 101) The system of item 100, wherein the inner flanking portion is provided by the retractable bulkhead using a method selected from the group consisting of cutting, knurling, heating, freezing, and chemical ablation. The system to be excised. (Item 102) The system according to item 96, wherein the first region and the second region are adhered to the tissue adhesive member via a vacuum generated in each of the two openly adhesive regions. (Item 103) The system of item 102, wherein each of the two openly adhesive regions is in fluid contact with a common channel defined in the tissue adhesive member. (Item 104) The system of item 96, wherein the opening defined by the organ comprises a pylorus located at the distal end of the organ. (Item 105) The system of item 96, wherein the modified region comprises a cutting member adapted to cut tissue in or near the opening. (Item 106) The system according to item 96, wherein the stimulus comprises a form of energy selected from the group consisting of thermal energy, electrical energy, chemical energy, RF energy, and pressure. (Item 107) The system according to item 96, wherein the elongated device comprises an expansion device located near the distal end. (Item 108) The system according to item 107, wherein the expansion device comprises an angioplasty balloon. (Item 109) The system of item 96, wherein the elongated device comprises an angioplasty balloon located near the distal end, the balloon having the modified region located on the outer surface of the balloon. ,system. (Item 110) The system according to item 109, wherein the modified region comprises at least one cutting member disposed on the outer surface. (Item 111) The system according to item 110, wherein the cutting member is selected from the group consisting of blades and wires. (Item 112) The system of item 96, wherein the elongated device comprises an expansion wire basket located near the distal end, the expansion wire basket being adapted to deliver the stimulus to the tissue. ,system. (Item 113) The system according to item 112, wherein the stimulus comprises a temperature change. (Item 114) In the system of item 96, the modified region comprises at least one probe extending from the distal end of the elongated device so that the probe penetrates tissue in or near the opening. The system is adapted to. (Item 115) The system of item 114, wherein the distal end of the probe is adapted to deliver a stimulus selected from the group consisting of thermal energy, electrical energy, chemical energy, and RF energy. (Item 116) The system according to item 96, wherein the stimulus comprises a chemical substance delivered through an opening defined in the modified region. (Item 117) The system according to item 116, wherein the chemical excises tissue in or near the opening. (Item 118) The system according to item 117, wherein the chemical is selected from the group consisting of alcohol, sotrodecol, and botox virus. (Item 119) The system of item 96, wherein the modified region comprises a cutting wire extending between the distal end of the elongated device and the region proximal to the distal end of the elongated device. (Item 120) In the system of item 96, the modified region is located at the distal end of the elongated device, the region comprising a slot for receiving tissue in and near the opening. A system that defines a cutting edge that is placed between a plurality of staples that are slidably held in the slot. (Item 121) A method for forming a lumen from the inside of an organ and dilating the opening defined by the organ, the method of which is: The step of openly adhering the inner first region to the tissue adhesive member; The step of moving the inner first region through the tissue adhesive member; A step of openly adhering the inner second region to the tissue-bonding member so that the first region is located near the second region; The step of fixing the first region to the second region so as to form the lumen; and The step of dilating the opening defined at the distal end of the organ; Including, methods. (Item 122) The method of item 121, wherein the inner first region is openly adhered to the tissue adhesive member via a vacuum generated in a first opening defined in the tissue adhesive member. ,Method. (Item 123) The method of item 121, wherein the inner second region is openly adhered to the tissue adhesive member via a vacuum generated in a second opening defined in the tissue adhesive member. ,Method. (Item 124) The first step of the method according to item 121, wherein the inner second region is openly bonded to the tissue adhesive member so that the first region is located in the vicinity of the second region. A method further comprising removing a partition wall arranged in the tissue adhesive member such that the region contacts the second region. (Item 125) 121, wherein the opening comprises the pyloric sphincter. (Item 126) The method of item 121, wherein the step of expanding the opening includes the step of applying a stimulus to the tissue in or near the opening via an elongated device, wherein the elongated device. , A method of having a proximal end and a distal end with a length between the proximal end and the distal end. (Item 127) The method of item 126, wherein the stimulus comprises a form of energy selected from the group consisting of thermal energy, electrical energy, chemical energy, RF energy, and pressure. (Item 128) 126. The method of item 126, wherein the elongated device comprises an expansion device located near the distal end. (Item 129) 138. The method of item 128, wherein the expansion device comprises an angioplasty balloon. (Item 130) 138. The method of item 128, wherein the angioplasty balloon comprises an expandable surface, the surface having at least one cutting member disposed on the surface. (Item 131) Item 121, wherein the step of dilating the opening defined at the distal end of the organ penetrates the tissue in or near the opening with at least one elongated probe. A method comprising the step of applying a stimulus via the elongated probe. (Item 132) 131. The method of item 131, wherein the stimulus comprises a chemical delivered through an opening defined at the distal end of the probe. (Item 133) The method of item 132, wherein the chemical removes tissue in or near the opening. (Item 134) The method of item 133, wherein the chemical is selected from the group consisting of alcohol, sotrodecol, and botox virus. (Item 135) 126. The method of item 126, wherein the elongated device comprises a combination of a cutting edge and a stapler located near the distal end. (Item 136) A system for forming a lumen from the inside of an organ, the system comprising a rotatable device for insertion into the organ, the device being along a longitudinal axis defined by the device. A system that is specifically adapted to adhere onto an internal surface while being rotated on an internal surface that is rotated. (Item 137) The system of item 136, further comprising a fixation device specifically adapted to anchor the rotated portion of the organ to the rest of the organ. (Item 138) The system according to item 136, wherein the device is rotated at least about 180 °. (Item 139) The system according to item 136, wherein the device is rotated at least 360 °. (Item 140) The system of item 136, further comprising a side-to-side anastomosis device for connecting adjacent regions of the gastrointestinal tract, wherein the anastomosis device comprises a distal segment and a proximal segment, the distal segment and the said. A system in which the proximal segments are each adapted to align with each other in place while maintaining a region of the gastrointestinal tract between the distal segment and the proximal segment. (Item 141) In the system of item 137, the rotating portion is mechanically attached to the remaining portion by a fastener selected from the group consisting of staples, blind staples, clips, tags, screws, and adhesives. The system to be fixed. (Item 142) The system according to item 136, wherein the rotatable device for insertion is inserted into the organ by an endoscope through the esophageal passage. (Item 143) The system of item 140, wherein the anastomotic device is inserted into the gastrointestinal tract by an endoscope through the esophageal passage. (Item 144) The system according to item 140, wherein the anastomosis device is inserted into the gastrointestinal tract by a laparoscope. (Item 145) The system of item 136, wherein the rotatable device for insertion has a proximal end and a distal end with a lumen defined between the proximal end and the distal end. A system comprising a tube, wherein the outer tube defines an opening proximal to the distal end. (Item 146) 145. The system of item 145, wherein the internal surface within the organ is adhered to the device via a vacuum created in the opening. (Item 147) 145. The system of item 145, wherein the distal end comprises a closed tapered end. (Item 148) The system according to item 145, wherein the rotatable device for insertion has a proximal end and a distal end with a lumen defined between the proximal end and the distal end. A system further comprising a tube, wherein the inner tube defines an opening at the proximal end of the distal end. (Item 149) 148. The system according to item 148, wherein the opening of the inner tube is configured to align with the opening of the outer tube. (Item 150) The system according to item 149, wherein the inner tube is reversible around the outer tube and the longitudinal direction. (Item 151) In the system of item 145, the outer tube further comprises a plurality of attachment points located adjacent to the opening, and the inner surface within the organ is the outer tube via the attachment point. Adhesion to the system. (Item 152) The system according to item 151, wherein the attachment point is selected from the group consisting of dentate, spiny and hook. (Item 153) The system of item 136, wherein the rotatable device for insertion comprises a separation tube having at least two halves, each of which is in a section defined along the tube. Separable along, the separation tube comprises a proximal end and a distal end with a lumen defined between the proximal end and the distal end, and the separation tube is the distal end. A system with additional attachment points located on each half of the vicinity. (Item 154) 153. The system of item 153, wherein the attachment point is selected from the group consisting of dentate, spiny and hook. (Item 155) The system according to item 136, wherein the rotatable device for insertion comprises at least two adjacent tubes, each of which has a proximal end and a distal end of the proximal end and the distal end. A system comprising with a defined lumen between the distal end and each of the tubes defining an opening proximal to the distal end. (Item 156) The system according to item 155, wherein the two adjacent tubes are adapted to rotate in the opposite direction. (Item 157) The system according to item 155, wherein the internal surface within the organ is adhered to the device via a vacuum generated in each of the openings. (Item 158) The system of item 136, wherein the rotatable device for insertion comprises at least one attachment tube and at least two compression members, the attachment tube adhering to the internal surface within the organ. The system is specifically adapted so that the two compression members are adapted to compress a portion of the internal surface within the organ between the two compression members. (Item 159) The system according to item 158, wherein the attachment tube defines an opening proximal to the distal end. (Item 160) 159. The system of item 159, wherein the internal surface within the organ is adhered to the mounting tube via a vacuum created in the opening. (Item 161) In the system of item 140, the distal and proximal segments are magnetically coupled together while maintaining a region of the gastrointestinal tract between the distal and proximal segments. There is a system. (Item 162) 161 of the system, wherein the distal and proximal segments are further coupled by mechanical fasteners. (Item 163) The system of item 162, wherein the mechanical fastener is selected from the group consisting of grommet swages, snap lock fits, staples, screws, clips, and friction fittings. (Item 164) The system of item 140, further comprising a deployable device, the deployable device having a proximal end and a distal end with a lumen defined between the proximal end and the distal end. A system comprising a member, wherein the distal end is specifically adapted to hold the proximal segment to align with the distal segment in place. (Item 165) 164. The system according to item 164, wherein the deploying device further comprises a coring ring in the distal end, the coring ring being a gastrointestinal region between the distal segment and the proximal segment. A system adapted to pass through the distal segment and the center of the proximal segment to remove. (Item 166) The system according to item 164, wherein the distal end of the deployable device is adapted to be operable through the proximal end. (Item 167) The system according to item 140, further comprising a positioning device adapted to drive the distal segment into a predetermined position in the gastrointestinal tract. (Item 168) 167. The system of item 167, wherein the positioning device comprises a magnetizing device that can be selected from the group consisting of magnetic wands and magnetic pickups. (Item 169) A side-to-side anastomosis device for connecting adjacent regions of the gastrointestinal tract, the anastomosis device is: Distal segment and proximal segment, the distal segment and the proximal segment, respectively, aligned with each other in place, maintaining the gastrointestinal region between the distal segment and the proximal segment. With the distal and proximal segments, which are adapted to A deployable device, the deployable device comprising a lumen in which the proximal and distal ends are defined between the proximal and distal ends, the distal end being the distal segment. And with deployment devices, specifically adapted to hold the proximal segment to align in place; Anastomotic device. (Item 170) 169. The anastomotic device of item 169, wherein the distal segment and the proximal segment are magnetically coupled together while maintaining the gastrointestinal tract between the distal segment and the proximal segment. ,device. (Item 171) The anastomotic device according to item 170, wherein the distal segment and the proximal segment are further coupled by mechanical fasteners. (Item 172) 171. The anastomotic device of item 171 wherein the mechanical fastener is selected from the group consisting of grommet swages, snaplock fits, staples, screws, clips, and friction fittings. (Item 173) 169. The anastomotic device of item 169, wherein the deploying device further comprises a coring ring in the distal end, which is the gastrointestinal tract between the distal segment and the proximal segment. An anastomotic device adapted to pass through the distal segment and the center of the proximal segment to remove the region. (Item 174) 169. The anastomosis device according to item 169, wherein the distal end of the deployable device is operably adapted via the proximal end. (Item 175) 169. The anastomosis device according to item 169, further comprising a positioning device adapted to drive the distal segment into a predetermined position in the gastrointestinal tract. (Item 176) 175. The anastomosis device according to item 175, wherein the positioning device comprises a magnetizing device that can be selected from the group consisting of a magnetic wand and a magnetic pickup. (Item 177) A system for reducing the volume of organs: A device for insertion into an organ, the device being specifically adapted to draw up the inner part of the organ; With a fixed device, which is specifically adapted to fix the inner part; The system. (Item 178) 177. The system of item 177, further comprising a side-to-side anastomosis device for connecting adjacent regions of the gastrointestinal tract, wherein the anastomosis device comprises a distal segment and a proximal segment, the distal segment and the said. A system in which the proximal segments are each adapted to align with each other in place while maintaining a region of the gastrointestinal tract between the distal segment and the proximal segment. (Item 179) The system of item 177, wherein the rotatable device for insertion is inserted into the organ by an endoscope through the esophageal passage. (Item 180) The system of item 178, wherein the anastomotic device is inserted into the gastrointestinal tract by an endoscope through the esophageal passage. (Item 181) The system of item 178, wherein the anastomotic device is inserted into the gastrointestinal tract by a laparoscope. (Item 182) The system of item 177, wherein the rotatable device for insertion has a proximal end and a distal end with a lumen defined between the proximal end and the distal end. A system in which the lumen defines a passage for pulling an inner portion of the organ through a vacuum. (Item 183) 182. An elastic band according to item 182, wherein the fixation device is located around the distal end of the tube and is adapted to slide over the inner portion to secure the inner portion. The system. (Item 184) The system of item 177, wherein the device for insertion comprises at least two elongated members, each member having a proximal end and a distal end between the proximal end and the distal end. A system that has with the length of the members and is rotatably coupled at its proximal and distal ends so as to be urged towards each other. (Item 185) The system according to item 184, wherein the elongated member defines a non-uniform surface. (Item 186) 177. The system according to item 177, wherein the insertion device comprises an instrument having an operable grasping member at the distal end to grasp the inner portion of the organ. (Item 187) 186. The system of item 186, wherein the fixation device comprises a catheter with a tightening distal end adapted to tighten the medial portion of the organ. (Item 188) 177. The system for insertion comprising a tube having a proximal end and a distal end with a lumen defined between the proximal end and the distal end. A system in which the distal end defines at least two slots. (Item 189) The system of item 188, wherein the slots are defined in place with respect to each other. (Item 190) 188. The system according to item 188, wherein the insertion device further comprises a plug adapted to fit into the distal end. (Item 191) The system according to item 190, wherein the plug is biodegradable. (Item 192) 191. The system of item 191 wherein the plug comprises a biodegradable polymer selected from the group consisting of polyactide, polyactide copolymers, polyglycolides, and polyglycolide copolymers. (Item 193) The system of item 177, wherein the fixation device comprises a clip adapted to be inserted into the lumen. (Item 194) The system of item 193, wherein the clip comprises two adjacent members attached to the proximal end, the distal end of each member being configured to penetrate tissue. (Item 195) 177. The system of item 177, wherein the fixed device comprises a screw that is processed to be inserted into a channel defined within the device. (Item 196) The system according to item 177, wherein the screw has a helical shape. (Item 197) The system according to item 196, wherein the diameter of the distal end of the screw is greater than the diameter of the proximal end of the screw. (Item 198) The system according to item 197, wherein the length portion between the distal end of the screw and the proximal end of the screw is tapered. (Item 199) In the system of item 198, the screw penetrates the first region of the tissue and the second region of the tissue alternately, bringing the first region of the tissue and the second region of the tissue together. The system is configured in. (Item 200) 177. The system of item 177, further comprising a plurality of additional fixation devices, each of which is linearly parallel to form a continuous fixation line while anchoring the inner portion. The system that is configured. (Item 201) A method of making a side-to-side anastomosis in the gastrointestinal tract, which is described below: A step of providing an anastomotic device comprising a distal segment and a proximal segment, wherein each of the segments is adapted to align in parallel with each other; The step of placing the distal segment into a section of the gastrointestinal tract; The step of placing the proximal segment into the gastric sac; and The step of aligning the distal segment with the proximal segment so that the proximal segment comprises a portion of the gastrointestinal tract and a portion of the gastric sac with the distal segment and the proximal segment. The process, which is connected together while maintaining between Including, methods. (Item 202) The method of item 201, wherein the distal segment and the proximal segment are magnetically aligned and connected. (Item 203) 202. The method of item 202, wherein the distal segment and the proximal segment are further connected by mechanical fasteners. (Item 204) 203. The method of item 203, wherein the mechanical fastener is selected from grommet swages, snaplock fits, staples, screws, clips, and friction fits. (Item 205) 201. The method of item 201, wherein the distal segment is endoscopically positioned through the passage of the esophagus into the section of the gastrointestinal tract. (Item 206) 205. The method of item 205, wherein the distal segment is located in the section of the gastrointestinal tract by a magnet located outside the gastrointestinal tract. (Item 207) 201. The method of item 201, wherein the distal segment is laparoscopically positioned into the section of the gastrointestinal tract. (Item 208) 201. The method of item 201, wherein the proximal segment is endoscopically positioned through the passage of the esophagus into the gastric sac. (Item 209) 201. The method of item 201, further comprising the step of advancing the coring device through the proximal segment and the center of the distal segment. (Item 210) A method of creating a separate gastric lumen from a gastric sac having a main lumen, the method of which is: The process of gluing a portion of the inside of the gastric sac to a device particularly suitable for rotation; The step of rotating the device around a longitudinal axis defined by the device while maintaining adhesion to the inner portion, until the device has a separate gastric lumen defined. Rotated, process; and A step of immobilizing a portion of the inside of the gastric sac so that the gastric lumen is maintained. Including, methods. (Item 211) 210. The device comprises a tube having a proximal end and a distal end, and a defined lumen between them, wherein the tube defines an opening proximal to the distal end. the method of. (Item 212) The method of item 211, wherein the inner portion is adhered to the device via suction provided at the opening. (Item 213) The method of item 211, wherein the inner portion is adhered to the device via a plurality of attachment points located adjacent to the opening. (Item 214) 213. The method of item 213, wherein the attachment point is selected from the group consisting of dentate, spiny, and hook. (Item 215) 210. The method of item 210, wherein the inner portion is secured to the gastric sac by a mechanical fastener selected from the group consisting of staples, blind staples, clips, tags, screws, and adhesives. (Item 216) A method for gastrectomy, the method of which is: The step of making a first side-to-side anastomosis between the first part of the gastrointestinal tract and the gastric sac using the anastomosis device described in item 169; The step of making a second side-to-side anastomosis between the second part of the gastrointestinal tract and the third part of the gastrointestinal tract using the anastomosis device described in item 169; and A method comprising the step of making a separate gastric lumen from a gastric sac, using the system described in item 136. (Item 217) 216. The method of item 216, wherein the first portion of the gastrointestinal tract comprises a predetermined section selected from the group consisting of the duodenum and jejunum. (Item 218) 216. The method of item 216, wherein the second portion of the gastrointestinal tract comprises a predetermined section of the duodenum. (Item 219) 216. The method of item 216, wherein the third portion of the gastrointestinal tract comprises a predetermined section of the ileum. (Item 220) 216. The step of making the second side-to-side anastomosis further comprises the step of closing a section of the gastrointestinal tract located between the first and second portions. Method. (Item 221) 220. The method of item 220, wherein the section of the gastrointestinal tract located between the first and second portions comprises the duodenum. (Item 222) 216. The method of item 216, wherein the first anastomosis is located approximately 20-50 cm from the pylorus of the gastric sac. (Item 223) 216. The method of item 216, wherein the second anastomosis is located approximately 15-55 cm from the pylorus of the gastric sac. (Item 224) 216. The method of item 216, wherein the second anastomosis is located approximately 150-200 cm along the gastrointestinal tract from the pylorus of the gastric sac. (Item 225) A modified gastric sac, below: The outer and inner surfaces that define the main lumen, as well as the gastric sac with a proximal gastric sac opening proximal to the main lumen; A gastric sac having proximal and distal ends, as well as an internal surface between these ends, the ends of which are formed from the rotated portion of the internal surface of the gastric sac, resulting in the said. The gastric lumen defines a volume separate from the main lumen, which is the gastric sac that maintains contact with the esophagus. (Item 226) 225. The modified gastric sac according to item 225, further comprising a plurality of fasteners attached to the gastric lumen and the interface defined by the gastric sac. (Item 227) 226. The modified gastric sac according to item 226, wherein the fastener comprises a biocompatible mechanical fastener selected from the group consisting of staples, tags, clips, sutures, screws, and adhesives. (Item 228) 225. The modified gastric sac according to item 225, wherein the gastric lumen is straight. (Item 229) 225. The modified gastric sac of item 225, wherein the gastric lumen is tapered, resulting in the distal end being larger than the proximal end. (Item 230) 225. The modified gastric sac of item 225, wherein the gastric lumen is tapered, resulting in the proximal end being larger than the distal end. (Item 231) 225, wherein the proximal gastric lumen defines a proximal gastric lumen opening, and the proximal gastric lumen and the proximal gastric lumen opening are located coaxially. Modified gastric sac. (Item 232) An overtube system for insertion into the body, which is described below: An elongated overtube having a length between the proximal end, the distal end, and between them, where the overtube is located near or at the distal end of the overtube, at least one. An overtube that defines two openings, where the openings are adapted to attach tissue to the openings; An annular member that is adjustablely disposed within a first lumen defined within the overtube, where the annular member defines an annular member that defines a second lumen through the annular member. Parts; as well A fixation assembly, which is placed in the first lumen and adapted to anchor the tissue attached to the opening. The system. (Item 233) 232. The system of item 232, wherein the overtubes are in parallel with each other, defining at least two openings near or at the distal end of the overtube. (Item 234) 233. The system of item 233, wherein the opening is a slot defined longitudinally along the length of the overtube. (Item 235) 233. The overtube further comprises a wall extending longitudinally within the overtube, which at least partially separates the first lumen between the two openings. system. (Item 236) The overtube defines a plurality of openings in the vicinity of the distal end, where each of the openings defines an alternating pattern and a parallel pattern between adjacent openings. The system described in 232. (Item 237) 232. The system of item 232, wherein the distal end of the overtube is in fluid communication with the proximal end through the first lumen. (Item 238) 232. The system of item 232, wherein the elongated overtube is adapted to follow any configuration in the relaxed state and selectively maintains any configuration in the rigid state. (Item 239) The elongated tube further comprises at least one tension member disposed over the entire length of the overtube, the tension member being operable at its proximal end, thereby applying tension to the member. In addition, the system of item 238, which stiffens the overtube and relaxes the member to make the overtube flexible. (Item 240) The distal end portion of the elongated overtube is adapted to be operable via a control device located proximal to the distal end portion and in contact with the distal end portion. The system described in item 232. (Item 241) 232. The system of item 232, wherein the annular member is disposed within the overtube so that the tubular member is rotatable about a longitudinal axis defined by the annular member. (Item 242) 232. The system of item 232, wherein the second lumen of the annular member is adapted to slide and receive the shaft of the endoscope. (Item 243) 232. The system of item 232, wherein the proximal end of the overtube comprises a fluid port communicating with the distal end of the overtube via a first lumen. (Item 244) The proximal end of the overtube comprises an inlet port on which the annular member is located, wherein the inlet port is adapted to form a liquidtight seal with the outer surface of the annular member. The system described in 232. (Item 245) 232. The system of item 232, wherein the fixation assembly comprises a fastener having a spirally formed elongated member having a tapered distal end. (Item 246) Item 245, wherein the fastener is located distal to the annular member, where the distal end of the annular member is adapted to engage and advance the fastener distally. Described system. (Item 247) The distal end of the annular member comprises an engaging surface adapted to engage the proximal end of the fastener, wherein the annular member is rotated about its longitudinal axis. 245. The system of item 245, which rotates and advances the fastener distally. (Item 248) 232. The system of item 232, wherein the fixation assembly comprises an elongated shaft having a proximal end and a distal end, and a staple device is attached to the assembly. (Item 249) 232. The system of item 232, wherein the fixed assembly comprises staples. (Item 250) 232. The system of item 232, wherein the fixation assembly comprises an elongated member having a tapered distal end. (Item 251) 232, wherein the system further comprises a guard member slidably arranged along the length of the overtube, wherein the guard member provides structural support to the overtube. A system that is adapted to the placement around the opening into the body to provide. (Item 252) The overtube comprises at least one marker defined near the proximal end of the overtube or on the outer surface of the proximal end, wherein the marker is at the distal end of the overtube. The system of item 232, corresponding to a position near or around the distal opening. (Item 253) 232. The system of item 232, further comprising a mandrel that can be inserted within the length of the overtube to define the shape of the distal end of the overtube. (Item 254) 253. The system of item 253, wherein the mandrel has a linear configuration and, if inserted within the length of the overtube, constrains the overtube to a linear configuration. (Item 255) 253. The system of item 253, wherein the mandrel has a distal end that defines a curved shape. (Item 256) An overtube system for insertion into the body, the system is: An elongated overtube having a length at the proximal end, the distal end, and between them, where the overtube is located near or at the distal end of the overtube, at least one. An overtube that defines one opening and the opening is adapted to attach tissue to the opening; An annular member that is adjustablely disposed within a first lumen defined within the overtube, where the annular member defines an annular member that defines a second lumen through the member. ; A fixation assembly placed in the first lumen and adapted to anchor the tissue attached to the opening; A pump that is in fluid contact with the first lumen of the overtube, The system. (Item 257) 256. The system of item 256, wherein the pump is connected to the overtube via a fluid port defined near or to the proximal end of the overtube. (Item 258) 256. The system of item 256, wherein the pump comprises a negative pressure pump. (Item 259) 256. The system of item 256, wherein the pump comprises a positive pressure pump. (Item 260) The proximal end of the overtube comprises an inlet port on which the tube member is located, wherein the inlet port is adapted to form a liquidtight seal with the outer surface of the annular member, item 256. The system described in. (Item 261) 256. The system of item 256, further comprising an endoscope for insertion of the annular member into a second lumen. (Item 262) An overtube system for insertion into the body, the system is: An elongated overtube having a length between the proximal end, the distal end, and between them, wherein the overtube is near or in parallel with each other at the distal end of the overtube. Define at least a first opening and a second opening, where the openings are separated from each other by a wall that extends at least partially in the longitudinal direction within the overtube, and as a result, A first and second lumen are defined within the overtube, where the opening is adapted to attach tissue to the opening; An annular member that is adjustablely located proximal to the wall within the overtube, where the annular member defines an internal lumen through the member; and A fixation assembly, which is placed within the internal lumen and adapted to anchor the tissue attached to the opening. The system. (Item 263) 262. The system of item 262, wherein the first opening is in fluid contact with the first lumen and the second opening is in fluid contact with the second lumen. (Item 264) 262. The system of item 262, wherein the opening is a slot defined longitudinally along the length of the overtube. (Item 265) A method of treating a hollow body organ, the method of which is: A step of advancing the distal end of an overtube into the hollow body organ, wherein the overtube defines at least one opening in the vicinity of or at the distal end, and Here, the opening is adapted to attach tissue from the hollow body organ to the opening, step; The step of drawing a parallel region from the tissue of interest within the at least one opening; An annular member is advanced distally through a lumen defined within the overtube so that a fixed assembly located within the lumen and engaged to the distal end of the annular member is distal. Advance to, process; and The step of engaging the parallel region of tissue within the lumen with a fastener, Including, methods. (Item 266) The step of advancing the overtube so that the step of advancing the distal end of the overtube follows an arbitrary configuration in a relaxed state, and further, the over of the overtube so as to maintain the arbitrary configuration. 265. The method of item 265, which comprises the step of stiffening the tube. (Item 267) 266. The method of item 266, wherein any configuration is defined by a controllable distal end portion of the endoscope inserted into the overtube. (Item 268) 266. The method of item 266, wherein the step of stiffening the overtube further comprises the step of applying tension to a tension member disposed within the overtube. (Item 269) 265. The method of item 265, wherein the step of pulling the juxtaposed region from the tissue of interest comprises the step of pulling out the tissue in the opening via suction. (Item 270) 269. The method of item 269, wherein the tissue is drawn from at least two parallel regions. (Item 271) 269. The method of item 269, wherein the tissue is drawn from alternating and parallel regions. (Item 272) The method of item 265, wherein the endoscope is moved distally through the lumen defined in the overtube to pull the parallel region out of the tissue of interest. A method that further comprises the step of identifying at least one region of the. (Item 273) 272. The method of item 272, wherein the step of advancing the endoscope distally comprises the step of advancing the distal end of the endoscope beyond the distal end of the overtube. (Item 274) 272. The method of item 272, further comprising retracting the endoscope proximally into the lumen before advancing the annular member distally. (Item 275) 272. The method of item 272, wherein the annular member is advanced distally beyond the endoscope placed in the lumen. (Item 276) 265. The method of item 265, wherein the step of advancing the annular member distally comprises the step of advancing the annular member in the longitudinal direction. (Item 277) 276. The method of item 276, wherein the step of advancing the annular member distally further comprises the step of rotating the annular member around a longitudinal axis defined by the annular member. (Item 278) 265. The method of item 265, wherein the step of engaging the parallel regions of the tissue further comprises the step of bringing the tissue closer to the fastener. (Item 279) 265. The method of item 265, wherein the step of engaging the parallel regions of the tissue comprises the step of piercing the tissue with the fastener. (Item 280) The method of item 265, wherein at least one marker defined on the overtube is a landmark located outside the hollow body organ prior to withdrawing the parallel region from the tissue of interest. A method further comprising orienting the overtube with respect to the hollow body organ by aligning. (Item 281) 265. The method of item 265, wherein the step of engaging the parallel regions of the tissue comprises the step of fixing the tissue with the fixation assembly while engaging the fastener with the tissue.</p><p> (Gist of the invention) Various tools and methods for the treatment of obesity are described herein and are less traumatic and less invasive than currently available procedures. Various methods for the treatment of obesity and other gastric related diseases (eg, gastroesophageal reflux disease (GERD)) are disclosed. One method involves reducing the size of the gastric sac to limit caloric intake and provide a faster feeling of fullness. This method can be done by creating a small intestinal sac in the stomach. This procedure can be enhanced, if desired, by performing pylorus plasty prior to and / or in combination with pyloric sphincter reduction (ie, disabling the pyloric sphincter). This increases the rate at which the stomach is emptied, allowing the direct passage of sugar and fat into the intestine, thereby inducing damping. In addition, food in the stomach could also be made to bypass the proximal part of the intestine (ie, part of the duodenum and jejunum) by creating a gastric anastomosis, thereby bypassing the duodenum and jejunum. Causes malabsorption of sugars and fats, which are mostly absorbed in the portion. Sugars and fats that enter the intestine directly from the stomach, rather than passing through the pylorus and proximal duodenum and jejunum, "can cause dumping syndrome and diarrhea, which in turn causes enhanced behavioral alterations. Obtain, thereby preventing the patient from eating these types of high-calorie diets.</p><p> To form a modified sac, a marking device (eg, bougie) can be used at the beginning of the procedure to create a "roadmap" of pigment markers on the inner surface of the stomach from the pylorus to the esophagus. .. This may allow, for example, endoscopic visualization and provide the physician with a clear reference point for the placement of staples and fixed elements. A distal balloon, which is preferably attached to the inflatable tip at the distal end, can be inserted into the pylorus to stabilize the bougie during the procedure, and the proximal end of the tubing by the physician. Can be inflated from.</p><p> In reducing the size of the stomach, one variation is to grab the inner wall of the stomach, preferably through a transesophageal-advanced endoscope, and one to several individual fixations on the opposite inner wall. Includes placing elements and then putting these fixed elements together. The gastric sac is by a variety of other device variations that utilize other methods (eg, staping the opposing walls of the stomach together to form two separate lumens from within the internal surface of the stomach). Can be modified and / or made. Endoscopic stapling devices can be used to accomplish such tasks. Such endoscopic staplers preferably bring together two areas of tissue and then fasten elements (eg, staples, clips, tags, screws, etc.) to secure these two areas together. It can be applied to two areas of the organization.</p><p> In addition to the stapling and clipping devices applied by the endoscope, rotating and rotatable probes can also be used to form modified smaller lumens within the main lumen. Such probes can generally be inserted into the stomach by an endoscope and can engage a portion of the lining of the stomach, then rotate the engaged portion of the stomach wall around the probe itself. This wall can be combined with another part of the stomach wall. Such a rotating probe can be used to create a blind-ended sac in the main gastric cavity, or, along with other devices, into the pylorus of an existing smaller sac. Can be used to create. Once the rotation of the stomach wall is apposition, a row of fasteners or multiple fasteners (eg, staples, blind staples, clips, tags, adhesives, screws, etc.) can be used to maintain the stomach. In addition, other variations may include gastric volume reduction devices as part of the present invention. Such volume reduction devices can generally be inserted transesophageally into the stomach, for example by the use of an endoscope. This reduction device can be used to pull or engage a portion of the lining of the stomach; the pulled or engaged portion is then aggressive or a natural process (eg, compression necrosis). ) Can be finally removed either.</p><p> To assist in the overall effect, pylorus formation procedures can also be performed to facilitate the procedure. Pyloroplasty can be performed before (preferably) the gastric reduction procedure, in combination with this procedure, or after this procedure. The pylorus formation procedure typically disables the pyloric sphincter. In general, the pylorus-forming device can be passed endoscopically through the esophagus into the stomach, and preferably across a location within the pylorus or across the pylorus. The energy or stimulus is then preferably applied to the pylorus, disabling the pylorus.</p><p> In addition, additional anastomotic gastric bypass procedures can also be performed to further facilitate the procedure. This anastomotic procedure may preferably be performed before, in combination with, or after the gastric reduction and pylorus formation procedures (if performed). This procedure generally involves making a lateral anastomosis by endoscopy or laparoscope, preferably from the inside of the stomach and intestines, and from the inside of the gastrointestinal tract. This procedure can be similar to the Lou Y gastric bypass procedure, but with minimal trauma.</p><p> When utilizing any one of the gastric reduction tools described herein, treatment of hollow body organs may require the above tools to pass multiple times. Therefore, overtube assemblies can be used in combination with these tools to facilitate patient treatment. Achieving such a procedure may require the tool used to cross the esophagus multiple times. An overtube assembly preferably constructed from an overtube member is disclosed, which can be inserted into a hollow body organ (eg, stomach) through the patient's esophagus.</p><p> This overtube may preferably define a working lumen extending from the proximal end to the distal end of the overtube. At the distal end, at least one window and preferably two or more windows can be defined on opposite sides of each other. These windows are preferably defined in the form of slots near or at the distal end of the overtube. The length and width of these slots are preferably long enough to approach the desired length boundary or connecting line in the stomach. These slots are preferably positioned side by side with each other, while other variations are offset windows separated by splitting the walls within the overtube lumen, as well as offsets and alternatives positioned side by side with adjacent windows. It can include windows that are both things. At least most of the overall length or length of the overtube is preferably flexible enough to be inserted into the body and adapts to the curvature within the body. Alternatively, a portion of the length of the overtube can be made to have different flexible regions. This overtube also allows the overtube to be manipulated, either actively by a doctor or surgeon, or passively by an endoscopic device inserted into the overtube. It may have a flexible region with flexibility that allows it to be bent into any shape.</p><p> A separate device tube can be inserted into the lumen of the overtube and is preferably freely adjustable (ie, longitudinally and rotatable within the overtube). The drive tube itself is defined in which the endoscopic device can be inserted so as to extend beyond the distal ends of both the overtube and the drive tube to test and / or identify the tissue area of interest. Has a lumen. Fasteners can also preferably be located within the lumen of the overtube and distal to the drive tube. The proximal end of the fastener can be configured to engage the drive tube and can be formed into a variety of different shapes. For example, the fasteners can be in linear form (eg, spear, harpoon, rivet, etc.), stapled, or spiral or helical. The shape of the fastener is generally determined, among other things, by the desired approach structure and overtube configuration, as described in more detail below. The fastener is preferably configured to remain attached to the inner wall of the drive tube or overtube lumen until the fastener is deployed within the tissue area of interest. To deploy the fasteners throughout the tissue, the drive tube to which the fasteners are connected can be advanced distally through the overtube lumen, rotating the drive tube by a proximally actuated rotational force. As the drive tube rotates, the fastener advances into the tissue, tightening the tissue in a manner similar to a screw.</p><p> The overtube assembly may also have a fluid port that is in fluid communication with the overtube working cavity and also in fluid communication with the pump, which pump provides negative pressure to create decompression in the overtube cavity. Can be used for; any number of ports can be used. In addition, when used, the fluid port and any other fluid port can also be fluid connected to the positive pressure pump, either in parallel or alternately. In addition, the same pump can be used to provide both negative and positive pressure.</p><p> Upon use, the overtube assembly can be inserted into the patient, for example, orally, and can be advanced into the esophagus until the distal end enters the stomach. Once reaching the stomach, the distal end can be actively or passively positioned by the physician or surgeon until the device is positioned in the desired position. Preferably, the pump in fluid communication with the overtube lumen can then be activated to create decompression in the overtube to pull a portion of the identified tissue in the window. Once the tissue has adhered and pulled into the window, the fasteners can be advanced to the invaginated tissue to secure this tissue. If this procedure requires additional fasteners, the overtube device can be maintained in a position inside the stomach, while the drive tube can be pulled from this area to the location of additional fasteners. Alternatively, this drive tube can be retracted or held in its place, and the endoscopic device is removed from the lumen of the overtube and of other tools or devices through the overtube to this area. Can allow insertion.</p>

<p> According to the present invention, a technique for the treatment of obesity that is less traumatic and less invasive than currently available procedures, obesity and other gastric related diseases (eg, gastroesophageal reflux disease (GERD)). )) Techniques for treatment are provided.</p>

<figref num="1A">FIG. 1A shows an example of a modified stomach with a smaller sac created from the inner surface.</figref><figref num="1B">FIG. 1B shows a partial upper view of the cross section of FIG. 1A.</figref><figref num="2">Figure 2 shows variations for marking devices or bougie for making the inner surface of the stomach.</figref><figref num="3A">FIG. 3A shows a variation on the positioning of the marking device inserted into the stomach.</figref><figref num="3B">FIG. 3B shows a cross-sectional view of the stomach contracted around the marking device, derived from FIG. 3A.</figref><figref num="3C">FIG. 3C shows a cross-sectional view of the injected stomach with the obtained mark, derived from FIG. 3B.</figref><figref num="4A">FIG. 4A shows an interior view of the smaller curvature of the anchored stomach.</figref><figref num="4B">FIG. 4B shows a cross-sectional view derived from FIG. 4A with an anchor attached.</figref><figref num="5A">FIG. 5A shows a side view of the crimping variation for the fastening device.</figref><figref num="5B">FIG. 5B shows an upper view of several connected crimping devices from FIG. 5A.</figref><figref num="5C">FIG. 5C shows a side view of several connected crimping devices derived from FIG. 5A.</figref><figref num="6A">FIG. 6A shows a schematic diagram of a zip-tie or ratchet variation for a fastening device.</figref><figref num="6B">FIG. 6B shows an upper view of the device of FIG. 6A mounted on the stomach wall.</figref><figref num="6C">FIG. 6C shows an upper view of another double zip tie variation for the fastening device.</figref><figref num="6D">FIG. 6D shows an upper view of the stomach in FIG. 6B with fasteners tightened.</figref><figref num="6E">Figure 6E shows an upper view of another vertical zip tie variation for the fastening device.</figref><figref num="7A">FIG. 7A shows an upper view of an extendable double hook device attached to the stomach wall.</figref><figref num="7B">FIG. 7B shows an upper view of an extendable double hook device attached to the stomach wall.</figref><figref num="7C">FIG. 7C shows the device of FIG. 7A locked by the crimping variation.</figref><figref num="8A">FIG. 8A shows an upper view of the modified stomach maintained by retaining staples.</figref><figref num="8B">FIG. 8B shows an upper view of the modified stomach maintained by retaining staples.</figref><figref num="9A">FIG. 9A shows a isometric view of variations for the endoscopic stapling device.</figref><figref num="9B">FIG. 9B shows an isometric view of variations for the endoscopic stapling device.</figref><figref num="10">FIG. 10 shows an isometric view of variations for the box tape ring device.</figref><figref num="11A">FIG. 11A shows an assembly diagram of another stapling device variation.</figref><figref num="11B">FIG. 11B shows a side view of the device of FIG. 11A.</figref><figref num="12A">FIG. 12A shows an isometric view of the crescent variation of the stapling device.</figref><figref num="12B">FIG. 12B shows a side view of the device of FIG. 12A, showing the staple deployment.</figref><figref num="12C">FIG. 12C shows an internal side view of the device of FIG. 12A with a moving wedge that subsequently unfolds the staples.</figref><figref num="13">FIG. 13 shows an internal view of the stomach with an example of a stapling device arrangement.</figref><figref num="14">FIG. 14 shows an internal view of the stomach with an example of a modified stapling device that could be used for the treatment of GERD.</figref><figref num="15A">FIG. 15A shows an assembly diagram of variations for close-up devices.</figref><figref num="15B">FIG. 15B shows the process of invagination of the layers and clamps inside the stomach using the device of FIG. 15A.</figref><figref num="15C">FIG. 15C shows the process of invagrating the inner layer and tightening of the stomach using the device of FIG. 15A.</figref><figref num="15D">FIG. 15D shows the process of invagrating the inner layer and tightening of the stomach using the device of FIG. 15A.</figref><figref num="15E">FIG. 15E shows an assembly diagram of another variation of the device of FIG. 15A, where this clip can be replaced with a screw.</figref><figref num="15F">FIG. 15F illustrates the process of invagrating the internal layer and tightening of the stomach using the device of FIG. 15E.</figref><figref num="15G">Figure 15G shows the process of invagrating the inner layer and tightening of the stomach using the device of Figure 15E.</figref><figref num="15H">FIG. 15H shows the process of invagrating the inner layer and tightening of the stomach using the device of FIG. 15E.</figref><figref num="16A">FIG. 16A shows an example of a modified stomach made by a rotating device variation.</figref><figref num="16B">FIG. 16B shows an upper cross section of the stomach of FIG. 16A, where the modified lumen can be created by rotating the inner layer of the stomach on its own.</figref><figref num="16C">FIG. 16C shows an alternative upper cross-section of the stomach of FIG. 16A, where the modified lumen can be made by rotating the aligned portion of the inner layer of the stomach by itself.</figref><figref num="17A">FIG. 17A shows an isometric view of the vacuum tube variation.</figref><figref num="17B">FIG. 17B shows a cross-sectional view of the vacuum tube variation.</figref><figref num="18A">FIG. 18A shows an isometric view of the counter rotating vacuum tube variation.</figref><figref num="18B">FIG. 18B shows a cross-sectional view of a counter rotating vacuum tube variation.</figref><figref num="19A">FIG. 19A shows an isometric view of a vacuum tube variation with mounting points.</figref><figref num="19B">FIG. 19B shows a cross-sectional view of a vacuum tube variation having a mounting point.</figref><figref num="20A">FIG. 20A shows an isometric view of the split tube variation.</figref><figref num="20B">FIG. 20B shows a cross-sectional view of the split tube variation.</figref><figref num="21">FIG. 21 shows an example of the arrangement of rotatable device variations inside the stomach.</figref><figref num="22A">FIG. 22A shows a possible fabrication of a rotating lumen using the devices of FIGS. 19A and 19B.</figref><figref num="22B">FIG. 22B shows a possible fabrication of a rotating lumen using the devices of FIGS. 19A and 19B.</figref><figref num="23A">FIG. 23A shows a possible fabrication of a rotating lumen using the devices of FIGS. 20A and 20B.</figref><figref num="23B">FIG. 23B shows a possible fabrication of a rotating lumen using the devices of FIGS. 20A and 20B.</figref><figref num="23C">FIG. 23C shows a possible fabrication of a rotating lumen using the devices of FIGS. 20A and 20B.</figref><figref num="23D">FIG. 23D shows a possible fabrication of a rotating lumen using the devices of FIGS. 20A and 20B.</figref><figref num="24A">FIG. 24A shows a isometric view of variations for a dual rotatable tube device.</figref><figref num="24B">FIG. 24B shows an end view of the device of FIG. 24A.</figref><figref num="24C">FIG. 24C shows a cross-sectional view of the device of FIG. 24A.</figref><figref num="25A">FIG. 25A shows variations of the endoscopic vacuum device inside the stomach.</figref><figref num="25B">FIG. 25B shows an end view of a variation on a lumen fabrication from the internal surface of the stomach using the device of FIG. 25A.</figref><figref num="25C">FIG. 25C shows an end view of a variation on a lumen fabrication from the internal surface of the stomach using the device of FIG. 25A.</figref><figref num="26">FIG. 26 shows a isometric view of variations for gastric volume reduction devices.</figref><figref num="27A">FIG. 27A shows the device of FIG. 26 that is inserted into the stomach to pull out or tighten the lining tissue to reduce the volume of the stomach.</figref><figref num="27B">FIG. 27B shows the device of FIG. 26 that is inserted into the stomach to pull out or tighten the lining tissue to reduce the volume of the stomach.</figref><figref num="27C">FIG. 27C shows the device of FIG. 26 that is inserted into the stomach to pull out or tighten the lining tissue to reduce the volume of the stomach.</figref><figref num="27D">FIG. 27D shows the device of FIG. 26 that is inserted into the stomach to pull out or tighten the lining tissue to reduce the volume of the stomach.</figref><figref num="28">FIG. 28 shows another variation on a gastric volume reduction device that utilizes gripping and binding devices.</figref><figref num="29A">FIG. 29A shows an isometric view of a variation of the gastric volume reduction device that utilizes a tension roller to pull tissue between the rollers.</figref><figref num="29B">FIG. 29B shows an isometric view of a variation of the gastric volume reduction device that utilizes a tension roller to pull tissue between the rollers.</figref><figref num="29C">FIG. 29C shows another variation of the devices of FIGS. 29A and 29B with ratchet rollers.</figref><figref num="30">FIG. 30 shows a variation isometric view of a pylorus-forming device with an angioplasty balloon.</figref><figref num="31">FIG. 31 shows another variation of an isometric view of a pylorus-forming device with a stretchable probe.</figref><figref num="32A">Figure 32A shows a variation of the sphincter incision arm for use in the pylorus formation procedure.</figref><figref num="32B">Figure 32B shows a variation of the sphincter incision arm for use in the pylorus formation procedure.</figref><figref num="33">FIG. 33 shows a stomach with the distal portion of the smaller curved wall removed to show possible use for the device of FIG. 31.</figref><figref num="34A">FIG. 34A shows another variation of the pylorus-forming device with a combination of a cutting notch and a staple notch.</figref><figref num="34B">FIG. 34B shows the device of FIG. 34A with possible use in the stomach.</figref><figref num="35">FIG. 35 shows a typical and normal human gastrointestinal system.</figref><figref num="36">FIG. 36 shows an example of a gastrointestinal system modified by a preferred anastomotic procedure.</figref><figref num="37">FIG. 37 shows a isometric view of variations for the anastomotic placement device .</figref><figref num="38">FIG. 38 shows a cross-sectional view of an anastomotic assembly that fits a portion of the intestinal tract with a portion of the stomach.</figref><figref num="39">FIG. 39 shows a cross-sectional view of another anastomotic assembly that fits two different parts of the intestinal tract.</figref><figref num="40A">FIG. 40A shows an isometric view of an overtube assembly with a bendable distal region.</figref><figref num="40B">FIG. 40B shows a mandrel of any shape that can be inserted through or along this overtube assembly.</figref><figref num="41">FIG. 41 shows a variation of the distal assembly diagram for the distal end of the overtube assembly, showing fasteners and drive tubes placed inside the overtube.</figref><figref num="42A">FIG. 42A shows a detailed isometric view of the proximal assembly of the overtube.</figref><figref num="42B">FIG. 42B shows a cross-sectional side view of the assembly of FIG. 42A.</figref><figref num="43">FIG. 43 shows a schematic diagram of an example of an overtube assembly used in a patient.</figref><figref num="44">FIG. 44 shows an end cross section of an overtube for use within the gastric lumen.</figref><figref num="45">FIG. 45 shows a isometric view of the overtube inside the stomach, with the stomach and overtube walls partially removed for clarity.</figref><figref num="46A">FIG. 46A shows a isometric view of one variation of the distal end of the overtube.</figref><figref num="46B">FIG. 46B shows an end view of one variation of the distal end of the overtube.</figref><figref num="47A">FIG. 47A shows another variation of the distal end of the overtube with an offset window.</figref><figref num="47B">FIG. 47B shows an end view of another variation of the distal end of the overtube with an offset window.</figref><figref num="48A">FIG. 48A shows a isometric view of the overtube variation inside the stomach before tissue fixation.</figref><figref num="48B">FIG. 48B shows an isometric view of the overtube variation inside the stomach after tissue fixation.</figref><figref num="49A">FIG. 49A shows another variation of the distal end of the overtube with an alternative window.</figref><figref num="49B">FIG. 49B shows another variation of the distal end of the overtube with an alternative window.</figref><figref num="50A">FIG. 50A shows side views of the overtubes of FIGS. 49A and 49B.</figref><figref num="50B">FIG. 50B shows side views of the overtubes of FIGS. 49A and 49B.</figref><figref num="51">FIG. 51 shows a side sectional view of the overtube of FIGS. 49A and 49B.</figref>

Obesity has become an ever-increasing problem, and various treatment tools and methods that are less traumatic and less invasive than currently available procedures are described herein. As disclosed in more detail below, various methods for the treatment of obesity and other gastric related disorders are described. In general, the size of the gastric sac can be reduced to limit caloric intake and to give a feeling of fullness earlier. This can be achieved by creating smaller gastric sac in the stomach by various methods. This procedure is enhanced by performing pylorus plasty (ie, incapacitating the pyloric sphincter) before and / or in combination with reducing the size of this pouch, if necessary. obtain. In addition, food in the stomach is brought to the proximal part of the intestine (ie, the duodenum) by creating a gastric anastomosis, which causes malabsorption of sugars and fats, which are mostly absorbed in the bypass part of the duodenum and jejunum. And part of the jejunum) can also be bypassed. Sugars and fats that enter the intestine directly from the stomach, rather than passing through the pylorus and proximal duodenum and jejunum, can cause "dumping" syndrome and diarrhea. In addition, disabling this pylorus can also partially lead to dumping syndrome due to the rapid gastric emptying that can occur. This can then result in enhanced behavioral alterations, which can prevent patients from eating these types of high-calorie foods.

FIG. 1A shows an example of a modified stomach 10 that can be made by any one of the methods described below as part of the present invention. Larger curvature 12 and smaller curvature 14 are found in the modified stomach 10, as well as in the distal ends of the esophagus 16 and pylorus 18. As part of the invention, the stomach 10 can be divided along the junction 24 into a modified pouch 22 (which is preferably less than about 1 ounce in volume), and a main pouch 20. FIG. 1B shows a partial top view of the cross section of the main pouch 20 and the modified pouch 22 as viewed from the cut surface P of FIG. 1A. As will be appreciated, the modified lumen 26 is preferably formed by the junction 24 from the main lumen 28 by joining a portion of the stomach wall 30. During food intake, the modified pouch 22 receives food from the esophagus 16 and preferably passes directly through the modified lumen 26 towards the pylorus 18. The main pouch 20 remains intact and can function normally, but preferably finds little or no food. Acids and other fluids that can occur in the main lumen 28 can be expelled through a reduced outlet near the pylorus 18 and can pass through the digestive system normally.

(Marking tools and methods) As part of forming the modified pouch, a marking device, preferably at the beginning of this procedure, can be used to create a pigment marker "roadmap" on the inner surface of the stomach, from the pylorus to the esophagus. Once such pigment marks are placed, they can be visualized, for example, endoscopically, which gives the surgeon a clear reference point for the placement of staples or fixed elements. An example of such a marking device is shown in FIG. 2 as a marking device or bougie 40. The bougie 40 is preferably an elongated device made from the tubing member 44, which may have some defined channels within it. The tubing 44 can be made from any variety of biocompatible materials (eg, stainless steel, plastic, etc.) and preferably has a diameter and cross section similar to the cross section of the finished smaller modified pouch. A series of dye ports 46 can be defined along their length, through which the marking dye can be derived from the proximal end of the bougie 40. Preferably, any variety of biocompatible dyes that enhance visualization can be used (eg, methylene blue, thionin, acridine orange, acridine yellow, acriflavine, quinacrine, and derivatives thereof, brilliant green, gentian violet, crystal. Violet, triphenylmethane, bisnaphthalene, trypan blue, and trypan red). Any series of vacuum ports 48 may be present along their length and on either side of the dye port 46. The distal balloon 52, which can be inserted into the pylorus to stabilize the bougie 40 during this procedure, is preferably mounted by the surgeon on the inflatable tip 50 of the distal end 42 and tubing. Can be inflated from the proximal end of 44.

Figures 3A-3C show the bougie 40 during one usage. FIG. 3A shows the stomach 60 when the bougie 40 is inserted downward through the esophagus 62. If the bougie 40 is advanced downwards to the pylorus 76, the distal balloon 52 can be inflated via the inflatable tip 50, which secures the device. The bougie 40 may preferably be shaped to follow the smaller curvature 64 and / or approach the smaller curvature 64. The bougie 40 is also preferably rotated so that the dye port 46 faces away from the small curvature 64 and towards the larger curvature 66. The air and fluid contained within the stomach 60 can then be introduced endoscopically through vacuum port 48 or through the esophagus 62, preferably if they are contained within bougie 40. Is removed by either. FIG. 3B shows a cross section 3B-3B of FIG. 3A when the stomach 60 is contracted. Once contracted, the modified lumen 70 can be shaped around the bougie 40 and separate from the contracted main lumen 68. In this contracted state, the dye can be guided through the dye port 46, which leaves the dye marker 72 on the inner layer 74. Once this staining is performed, lumen 68 can be injected as shown in FIG. 3C, and bougie 40 can be removed. As understood in FIG. 3C, the dye marker 72 marks or depict the junction region, where the anchors or fasteners together form the inner layer 74 to form a modified lumen 74. Can be arranged to depict.

(How to use stomach reduction tools and fasteners) One variation that reduces the size of the stomach is to grip the inner wall of the stomach, preferably through an endoscope that is advanced through the esophagus, and place one to several fixed elements on the opposite inner wall. And then with regard to bringing these fixed elements together.

Some examples of different possible variations on fasteners are shown and listed below. These variations are not intended to be limiting, they are provided merely as exemplary examples.

FIG. 4A shows an internal view of the smaller curvature of the stomach 60, with the larger curved wall removed. As will be appreciated, the individual anchors 80 can be anchored to the inner surface along the joint 24, where the modified pouch 22 of FIG. 1 forms. Anchor 80 can be any biocompatible material (eg, stainless steel, polymer, etc.), which can be a variety of fasteners (eg, staples, ratchet wires, zip ties, clips, tags, eyelets, crimps, and screws. ) Can be formed. The anchor 80 can be placed by estimating the junction boundary, which is preferably placed along the dye marker 72, which is shown in FIG. 4B, cross section 4B-4B of FIG. 4A. As such, it can be formed by the methods and tools described above prior to placing the anchor 80. After the anchor 80 is secured, the suture 82 can be sewn through each of the anchors 80, preferably in a zigzag fashion, and then the suture 82 is sewn along the dye marker 72 on the opposing surface of the inner layer 74. Together they can be sewn tightly to form a modified lumen. Alternatively, the individual anchors 80 can be pre-mounted or pre-fixed by sutures 82, and the anchors 80 can be fixed to the inner layer 74 in this manner.

FIG. 5A shows a side view of variations of the crimp member 90 with respect to the fixed device. The crimp member 90 can preferably be made from a biocompatible material (eg, stainless steel, nitinol, etc.) and can be formed to have an elbow 92 extending to two opposing anchor ends 94. FIG. 5B shows a top view of a modified lumen 100 made from the main lumen 98 by any of the methods described herein. In this variation, some crimp members 90 may be connected or secured to the inner layer 96 by the anchor ends 94. When they are connected, each of the members 90 is preferably configured to combine adjacent crimp members 90, as well as zippers. FIG. 5B shows a member 90 assembled from the top to form a cavity 100, and FIG. 5C shows a diagram of 5C-5C of FIG. 5B, where each of the crimp members 90 is a zipper. Also shown in combination with those elbows 92.

FIG. 6A shows an isometric view of another variation of the fixed device in the ratchet wire or zip tie 110. This particular variation shows a distal tip or male end 112 and a corresponding proximal or female end 114 with a ratchet length 116 between these two ends. FIG. 6B shows a top view of the stomach wall 120 just before forming the modified lumen 124 from the main lumen 122. As will be appreciated, the male end 112 of the first zip tie 110'can be perforated through one side of the inner layer 118, and the second zip tie 110 "can be perforated through the opposite ends of the inner layer 118". It can be perforated so that the male end 112 of each zip tie preferably corresponds to the female end 114 of the other zip tie, then each zip tie 110', 110'to form this lumen 124. Can be sewn together and therefore tightened together, as shown in Figure 6D. A modified lumen 124 is formed by aligning a plurality of zip ties 110, preferably by any of the above methods.

An alternative zip tie device that can be used is an upright version of the zip tie 110. As shown in FIG. 6E, the first upright zip tie 134'and the second upright zip tie 134'can be used in place of the zip tie 110, and the lumen 124 is formed in much the same manner as above. A further alternative is shown in FIG. 6C, where the male zip tie 126 preferably has a double puncture male end with a catheter tube 128. In this variation, a vacuum device, or forceps, as described in detail below, can be used to sew parts of the stomach wall 120 together, preferably when the aligned stomach wall 120 is placed. A needle 130 passing through a double female zip tie 132 can be used to puncture the tissue 120 and lock into the catheter tube 128, then the needle 130 can be pulled back through the tissue 120. At the same time, the male end / catheter tube 128 is pulled back through the tissue 120 and pulled into the corresponding double female zip tie 132, then the locked zip tie 126 is pulled tightly against the female zip tie 132 and cut off. This procedure can be repeated for any number of zip ties, which can then be used to pull this inner layer together to form a smaller pouch, and also It can be used with the dye marking device 40 and the above procedure.

Further variations on individual anchor fasteners are shown in Figure 7A. This variation shows a gripping device 140 with a fixed tube 142 and an extendable member 146 that can extend from a distal opening 144. The stretchable member 146 can preferably be made from a biocompatible material (eg, a superelastic alloy or a shape memory alloy (eg, nitinol)), which, once extending away from the distal opening 144. It can be urged to drive away from the longitudinal axis defined by tube 142. If the member 146 is extended, the member can be extended by the hook 148 to grip the aligned portion of the inner layer 150. As mentioned above, the position held by the hook 148 can be defined by the marking device as described above and can be observed by the physician, for example, through an endoscope. Once the hook 148 grips the appropriate portion of the inner layer 150, the member 146 is pulled back through the distal opening 144, as shown in FIG. 7B, and the anchoring device (eg, crimp 152) is As shown in FIG. 7C, it can slide over the distal section of member 146 and maintain the position of hook 148 and side-by-side inner layer 150 to create the desired lumen.

(How to use gastric reduction tools and staple devices) With the exception of individual anchoring devices and tightening devices, this gastric sac can be modified and / or made by a variety of other device variations utilizing other methods. FIG. 8A shows an upper sectional view of FIG. 1B with the addition of staples 160 that maintain the joint 24. This figure shows, for example, how a stapler applied by an endoscope can be used to maintain and hold a junction 24 to form a modified lumen 26. FIG. 8B shows an enlarged view of the joint 24 and staple 160 applied from inside the lumen 26.

Such tasks can be accomplished using an endoscopic staple device to staple the opposing sides of the stomach together and form two separate lumens from within the internal surface of the stomach. Such an endoscopic stapler preferably combines two regions of tissue together and then applies a tightening element (eg, staples, clips, tags, etc.) to the two regions of tissue to these. Areas can be fixed together. These staple devices may optionally incorporate the use of a marking device or bougie 40 as a guide to vacuum placement and / or a preliminary step of staples to form the desired modified lumen. To do. Tightening elements (eg staples) are preferably made from biocompatible materials such as stainless steel, titanium, polymers, sutures, nitinol, or any other similar metal and alloy, and any conventional Can be either in the shape of (eg, C-shaped staples and U-shaped staples) or any other shape desired herein. Two areas of tissue can be glued to this staple device by a variety of bonding methods (eg, teeth, spines, hooks, vacuum, or any combination thereof). In adhesive devices that utilize vacuum to hold aligned areas of tissue together, such devices can be tubular or cane-like members, preferably spaced around the perimeter of the tube or cane. It has at least two windows that can be vacated. These windows can be separated by arcs in the range of about 20 ° to 180 ° around the longitudinal axis defined by the length of this tube or cane, and preferably arcs in the range of about 90 ° to 180 °. It is divided by.

Some examples of different possible variations on this staple device are shown and discussed below. These variations are not intended to be limiting, they are provided merely as exemplary examples.

FIG. 9A shows a variation of the endoscopic staple device in the isometric view of the anvil staple device 170. The staple unit 172 attached to the distal end of the tube 174 is shown. The staple inclusion body 176 (where the staples are mounted) and the vacuum port 178 (which is shown in another form with a staple slot 180, through which the staples can be placed) are staple units 172. Is inside. FIG. 9B shows a reverse isometric view of the device of FIG. 9A. As will be appreciated, the staple unit 172 may have a partition wall 184 that can be inserted into the partition wall slot 186, which partition wall is preferably intermediate between the sides of the staple inclusion body 176, and the staple inclusion body. The interior of the 176 can be separated into two separate chambers. Septum 184 may provide several functions, one of which allows selective activation of opposite sides of vacuum port 178 of unit 172 if tissue is selectively glued to the device. It can be. Other functions of partition 184 are discussed below.

Upon operation, the staple unit 172 can be inserted into the stomach through the esophagus, and the first part of the inner layer is a single staple inclusion body 176 via a vacuum created in vacuum port 178. Can be stapled to the sides. This vacuum can be created in the staple unit 172 via the tube 174 and can be invoked from the proximal end of the tube 174 from outside the patient's body. Once the first portion of this inner layer is glued to one side of the staple inclusion body 176, the opposing set of vacuum ports 178 can be activated and the unit 172 is the opposite second of the inner layer. It can be used to pull the first part relative to the part, which can then be glued to the device, so that the first and second parts are preferably together. This operation preferably forms the modified lumen 26 of FIGS. 8A and 8B. If this tissue is held against the unit 172, the septum 184 can be pulled out of the septum slot 186, for example by forceps introduced via an endoscope or integrated actuator, and within the staple inclusion body 176. Can form a single chamber. The removal of the septum 184 can then bring the first and second parts of the tissue into contact together. The side surface 188 of the partition wall 184 can incorporate a cut surface, a friction surface, a knurled surface, a heated surface, a frozen surface, a chemically damaged surface, or some other damaged surface into the tissue. Such a surface 188 can damage the inner layers in contact with each other as the partition wall 184 is removed if the surface 188 slides too far. This injury, once stapled or anchored together, can provide a stronger healing response and more constitutive fixation between the injured tissue.

After removing the septum 184, the staples loaded into the staple inclusions 176 are heated through the staple slots 180 to secure this tissue. When the staples are heated, the anvil 182 can be used as an anvil to secure the staples to the tissue, resulting in a modified lumen 26 as shown in FIG. 8B. The length of the staple device 170 can be made according to the desired joint length and size of the patient's stomach. This particular variation can be withdrawn from this region after the staple procedure by first extruding the staple device 170 past the resulting staple line.

FIG. 10 shows an isometric view of another variation of the box staple fastening device 190. A staple fastening unit 192 is shown in which it is mounted in fluid communication with the vacuum tube 193. The stapled device 190 can be inserted and operated in the same manner as the device 170 described above. The staple fastening unit 192 may have a vacuum port 194 that is selectively initiated on either side of the bulkhead 196 as described above. The tips of the staples 198 are shown partially positioned for illustrative purposes, but are preferably not positioned until the bulkhead 196 is first retracted in the indicated direction. The partition 196 can also be configured to damage the contact tissue as the partition 196 is withdrawn in the same manner as described above. The staple fastening device 190 can be easily applied and removed after the staple 198 has been placed.

FIG. 11A shows a set isometric view of another variation of the staple fastening device 200. This variation 200 shows a curved tube 202 that may have a cavity 204 house staple 206 and acts as a combination of vacuum slot and staple slot 216. The tube 202 can be molded in a variety of fashions, but is shown here as a C-shaped tube or a U-shaped tube, with channels 1 210'and 2 channels for adhering two side-by-side parts of the tissue. The 210'' is preferably separated by a removable bulkhead 212. With this variation 200, the tissue can be glued in channels 210', 210'' through vacuum / staple slots 216, and once placed, the staples 206 are placed and the bulkhead 212 is the use of curved wedges 218. Is removed at the same time. During operation, the curved wedge 218 can be pulled back into the cavity 204 from the distal end to the proximal end of the tube 202, for example by a pull wire attached to the wedge 218. When the wedge 218 is advanced proximally, the wedge 218 preferably pushes the central axis 208 of the staple 206 against the contact edge 214 of the bulkhead 212. As the wedge 218 is advanced further proximally, then the urging end) 220 rotates the curved edge of the staple 206 around the central axis 208 and places it through slot 216. While the staples 206 are placed, the notch 222, preferably located at the distal end of the wedge 218, can engage the contact edge 214 and begin sliding the bulkhead 212 simultaneously towards the proximal end of the tube 202. .. FIG. 11B shows a side view of the staple fastening device 200 of FIG. 11A. As you can see, the curved wedge 218 is preferably in contact with the bulkhead 212 through the notch 222, and at the same time pushes the propulsion staple 206 in place. This figure shows a single staple 206 for illustrative purposes only, and any plurality of staples 206 may actually be used, depending on the desired result.

FIG. 12A shows an isometric view of yet another variation of the staple fastening device 230. This variation omits the removable bulkhead. The curved tube 232 is preferably curved with this variation of the crescent-shaped contact channel 234. As shown, within the contact channel 234, many vacuum ports 236 and staple slots 238 can be defined in different patterns. A possible W-shaped staple 240, preferably having a central axis 242 at the midpoint of the staple 240, is shown outside the tube 232 in a possible direction for insertion into the staple slot 238 for illustrative purposes. FIG. 12B shows a cross section 12B-12B from FIG. 12A. As you can see, tube 232 is translating tube 244 (preferably through tube 232) and transport wedge (translating). wedge) 246 (preferably placed sliding into lumen 244). Wedge 246 can be transported by pull wire 248, as seen in FIGS. 12B and 12C (side view of the interior of tube 232). The pull wire 248, which can be made of any high-strength material (eg, stainless steel, nitinol, nylon, polymer, etc.), can be manipulated by the practitioner from outside the patient's body, from the proximal end of tube 232. Similar to device 200 in FIGS. 11A and 11B, once the vacuum port 236 gains the backing of adjacent internal tissue, the transport wedge 246 can be advanced proximally. The advancing wedge 246 may allow staples 240 to be placed continuously through staple slots 238 as shown to retain tissue and form the desired lumen.

An example of the arrangement for any of the above stapled devices is shown in FIG. As shown, the stomach 250, with the wall partially cut off, is seen with a stapled device 252 inserted therein. The stapled device 252 is shown only as an example of insertion and may include any device described herein. The device 252 (preferably orally advanced to the stomach 250 through the esophagus 256) is preferably located at the distal end of the delivery / vacuum tube 254. Once inserted, the device 252 can be placed with the help of a smaller curvature 258 of the stomach 250. Vacuum / staple port 260 (which can be any of the shapes described herein) is also indicated. In a preferred variation, the staple fastening device 252 may be configured to result in a staple line or junction with a smaller degree of curvature starting at the heart notch 264 and descending towards the pylorus 262. Thus, device 252 may have a length and vacuum / staple port 260 configured such that the distal end of device 252 points towards the pylorus 262.

FIG. 14 shows a stapled device 270 with a slightly different configuration for the treatment of other gastrointestinal disorders (eg, gastroesophageal reflux disease (GERD) as described above). The stomach 250 of FIG. 13 is shown, but apart from the treatment of GERD, the stapled device 270 has the device 270 and the vacuum / staple port 272 straight or smaller, as described above. It can be slightly modified to sway (rather than towards them) from Curve 258 and Staple 262. Thus, the vacuum / staple port 272 preferably results in a staple line or junction starting at the cardiac notch 264 and then swaying from the lesser degree of curvature 258 and pylorus 262. Device 270 can be any device described and manipulated herein (apart from shimmering modifications). Similarly, any device described herein can be used for the treatment of GERD by simply bending the device to produce staggered staples. Alternatively, a single non-swaying staple wire may also be sufficient to treat GERD. This staple wire can act as a Heimlich valve, which preferably closes depending on the pressure exerted from the larger or major lumen. In addition, a smaller amount of modified lumen in the esophagus 256 and in-line may provide a smaller amount of acid available for esophageal reflux.

An isometric view of a variation of the single channel vacuum device is shown in FIG. 15A on the proximity device 280. Tube 282 is preferably a tubular device that can be inserted into the stomach through the patient's esophagus. Tube 284 can pass through tube 282 from the proximal end to the distal end of tube 282. At the distal end, two or more windows or slots 286 are preferably defined facing each other, as shown. The length and width of slot 286 can be varied, and preferably long enough to approach the desired length of the border or junction of the modified lumen; similarly, the width is preferably of the stomach. It is wide enough to fit at least two layers of internal lining. A proximity clip 288 with at least two penetrating ends 290 is shown, and from either the proximal or distal end of the tube 282, preferably fills the lumen 284 before inserting the device 280 into the patient. Can be done. Clip 288 is preferably constructed of a biocompatible material as described above. The biodegradable plug 292 can be placed at the distal end of tube 282 prior to insertion into the patient, and is preferably a biocompatible biodegradable material (eg, biodegradable polymer (eg, polyactide, eg, polyactide,). It is composed of polyglycolides and their copolymers)). Alternatively, the plug 292 may be constructed of a non-biodegradable material and may simply be passed after this procedure. The plug 292 may assist in maintaining a vacuum seal through slot 286 during the proximity procedure, as described below.

FIG. 15B shows the end view of tube 282 in operation from cross section 15B-15B from FIG. 15A. As shown, the opposite portion of the medial lining 294 of the stomach can be withdrawn into the lumen 284 through the opposite slot 286 by creating a vacuum within the lumen 284. Proximity clips 288 can be propelled distally through tube 282 so that each end 290 can be pulled out through the corresponding slot 286 and / or penetrated through the lining 294 in the lumen 284. If the lining 294 is in close proximity within the lumen 284, the biodegradable plug 292 can be recessed within the lining 294. Thus, as shown in FIG. 15D, if the clip 288 and the end 290 are placed over the lining 294, the tube 282 can be pulled out of this area, but the clip 288 is preferably through the distal end of the tube 282. Slide to hold the adjacent inner lining 294 in that position by the end 290. Upon removal of tubing 282, plug 292 can slide outward from the distal end of tubing 282 and is maintained within the newly formed lumen, either disintegrating over time or passing through the patient's system. ..

FIG. 15E shows the device of FIG. 15A, in which in this variation the clip 288 can be replaced by a screw 289, which is preferably in the form of a spiral or coil with a tapered width or diameter. The first few turns or coils of this screw 289 may have the same or similar diameter as the remaining tapered coils; this may allow the through-end 291 to engage the inner 294. And also, the screw 289 may allow it to be advanced in the desired direction through the tissue. The screw 289 preferably maintains a direction parallel to the tube 282 during delivery to the tissue (ie, the longitudinal axis defined by the thread 289 is preferably parallel to the longitudinal axis defined by the tube 282. Or almost parallel). In addition, the outer diameter of the first few turns or coils is preferably the same as or slightly smaller than the inner diameter of tube 282. This further allows the screw 289 to be advanced through the lumen 284 in the proper direction before engaging with the inner 294.

As described above for the devices of FIGS. 15A-15D, the opposite portion of the medial lining 294 of the stomach passes through the opposite slot 286 by creating a vacuum within the lumen 284, as shown in FIG. 15F. Can be pulled out. The screw 289 can then be advanced through the lumen 284 and rotated in the direction of the arrow indicated until the through end 291 engages the indented lining 294. The penetration end 291 is preferably sharp needle-like, allowing penetration through a multi-layer lining 294. As the screw 289 is further rotated, it can be further advanced distally through the rest of the indented lining 294. The tapered diameter and decreasing width can also begin to be closer to the opposite edge of the lining 294 towards each other, as shown in FIG. 15G. Finally, as shown in FIG. 15H, further advancement of the screw 289 may preferably pull out the opposite surfaces and bring them into contact with each other. Tube 282 can then be removed as described above. Although the fixation of one screw 289 is described, a plurality of screws 289 can be fastened one after another to form a continuous fixing line.

The screw 289 can be made of a bioabsorbable or biocompatible material (eg, polymer or superelastic alloy) as described herein, and a barb or whiskers raised along its length. It can be formed integrally with the filament, and once the screw 289 engages within the lining 294, it helps prevent the screw from backtracking. Examples of spiral suture needles or screws that can be used in this variation are shown and described in US Pat. No. 5,330,503 to Yoon et al., Which is incorporated herein by reference in its entirety. Another example of a spiral fastener or screw and applicator that may be used in this variation or another variation is US Pat. No. 5,582,616 to Bolduc et al., Which is also hereby incorporated by reference in its entirety. ) Shown and described. Other examples of spiral fasteners or screws and applicators are all U.S. Pat. Nos. 5,810,882; 5,824,008; and U.S. Pat. No. 5,964,772 to Bolduc et al. Incorporated as).

(How to use gastric reduction tools and rotatable devices) With the exception of stap-fastening devices and clip devices applied by endoscopes, rotating and rotatable probes can also be used to form modified smaller lumens within the main lumen. In this way, the probe can generally be inserted into the stomach endoscopically and can engage with a portion of the medial lining of the stomach, and then wrap the engaged portion of the stomach wall around the probe itself. Rotate to equate the wall with another position on the stomach wall. Such a rotating probe can be used to create a closed-end pouch within the major gastric lumen, or, when using other devices, to create a smaller pouch that exits the pylorus. Can be done. Once the stomach wall is properly wrapped, a line of fasteners or multiple fasteners (eg, staples, blind staples, clips, tags, glue, etc.) can be used to maintain the stomach. The tube itself can preferably be made of any of a variety of biocompatible materials (eg, stainless steel, nickel, platinum, etc.) that are strong enough to be loaded with twists.

An example of a stomach modified by such a rotating probe or device is shown in FIG. 16A. The major sac 300 appears to be a modified sac 302 formed along a lesser degree of curvature of the stomach and depicted by the junction 304. This example shows a modified sac 302 extending from the esophagus 306 and ending at a sac opening 308 proximal to the pylorus 310. The sac opening 308 can also be made to terminate at the pylorus 310.

FIG. 16B shows a top view from cross section 16B-16B from FIG. 16A of one variation in producing a modified sac 302 having a modified lumen 314 from a major sac 300 having a major lumen 312. Here, the junction 304 can be formed by wrapping the stomach around itself. FIG. 16C shows an alternative top view from section 16B-16B from FIG. 16A. Here, the modified sac 302'with the modified lumen 314' can be formed from the major sac 300'with the major lumen 312'. In this particular variation, the junction 304'is formed by taking the side-by-side side of the inner gastric lining near the lower degree of curvature and bringing them close together to form a modified lumen 314'. Can be done.

Some examples of possible variations in the rotating probe or device are shown and described below. These variations are not intended to be limiting and are provided merely as exemplary examples.

FIG. 17A shows a vacuum tube 320 that may have an elongated tubular body. The tube 320 can be inserted into the patient's stomach through the esophagus, for example, via an endoscope. Therefore, the distal end 322 is preferably rounded or gently tapered so as to be non-traumatic to the patient. The opening or window 324 is defined in the wall of the tube 320 near the distal end 322, and as seen in FIG. 17B, the opening 324 preferably communicates with the lumen 326 which can pass through the tube 320. There is. The geometry of the opening 324 is preferably large enough to accommodate the invagination of tissue from the inner gastric lining due to the vacuum created within the lumen 326 and opening 324. This vacuum can be activated by the practitioner from the proximal end of the tube 320 from the outside of the patient. As described in more detail below, once the tissue has been invaginated into the window 324, a fastener member can be inserted and placed to secure the inner gastric lining, thereby the whole. Reduce the volume of. As shown in FIG. 17B, which is cross section 17B-17B from FIG. 17A, the tube 320 preferably has a diameter and cross section that can approximate the final geometry of the newly created lumen in the stomach.

Figure 18A shows counter-rotating tube) Shows an isometric view of another variation on 330. The counter-rotating tube 330 may have a gently tapered distal end 332, the opening 334 being defined in the wall of the tube near the distal end 332. Preferably, an additional internal tube 336 is included within the tube 330. This internal tube 336 may be geometrically similar to tube 330, but preferably has a diameter small enough to allow free rotation around the longitudinal axis shared by both tubes 330 and 336. The internal tube 336 also has an internal opening 338, which internal opening 338 may allow communication between the lumen 340 and the openings 334 and 338. As mentioned above, the vacuum can arise from the proximal end of the tube 330 and draws tissue from the inner gastric lining through the lumen 340 to the openings 334 and 338 (if they are aligned). As shown in FIG. 18B, which is a cross section 18B-18B from FIG. 18A, once the tissue is invaginated into the openings 334, 338, the internal tube 336 makes the tissue its structure. Can be rotated to effectively tighten and hold firmly in the field. The addition of tightening action in addition to vacuum can aid in tissue retention, thereby assisting the rotation of both tube 330 and internal tube 336 in forming the modified lumen. Both tubes 330 and 336 can be manipulated and rotated from the proximal end of the patient's outer tube.

FIG. 19A shows an isometric view of another variation of the barb tube 350. The tube 350 may be similar to the vacuum tube 330 described above. The distal end 352 is preferably tapered, and the opening 354 can be defined at the wall of the tube 350 near the distal end 352. In addition, at least one (preferably some) bond points 356 (eg, teeth, barbs, or hooks) can be defined along at least one single edge around the opening 354. The coupling point 356 is preferably defined along the leading edge of the opening 354 for the rotation of the tube 350. FIG. 19B, a cross section 19B-19B from FIG. 19A, preferably shows an opening 354 communicating with the lumen 358 and a connection point 356 in the preferred direction.

Figure 20A shows a split tube (split). tube) Shows an isometric view of yet another variation on 360. The split tube 360 can be formed from at least two splittable halves (eg, first half 364 and second half 366), which can be connected together longitudinally along the split 370. When the first half 364 and the second half 366 are connected together, the split tube 360 preferably forms a tapered distal end 362. The split tube 360 may also define a lumen 372 that can pass through the split tube 360. This variation may also have at least one (preferably several) coupling points 368 for each of the first half 364 and the second half 366. As shown in this figure, the first half 364 may preferably have a row of coupling points 368 aligned along a portion of the split 370, and the second half 366 may likewise be the first. It may have a row of coupling points 368 that are parallel to a row of coupling points arranged half 364 and preferably mirroring. The connection point 368 can be any type of connection point described above, and the number and location of the connection points 368 can depend on the desired length of the resulting connection formed as the stomach rotates. FIG. 20B, which is cross section 20B-20B from FIG. 20A, shows an example of the parallel relationship between the split 370 and the coupling point 368.

FIG. 21 shows an example of a probe device that can rotate during insertion into the stomach 380. As you can see, the tube 384 can be inserted into the stomach 380, preferably by endoscopy, via the esophagus 382. Tube 384 can be any of the above devices, and is generally shown as an example of how such a device can be inserted into an organ (eg, stomach 380). Once the tube 384 is inserted, it can engage the inner portion of the stomach 380, preferably along a lesser degree of curvature 386. This engagement can be achieved by any of the methods described herein, such as a coupling point that partially penetrates the gastric lining, a vacuum that adheres to a portion of the lining, and the like. Once engaged, the tube 384 can then be rotated to wrap the engaged portion of the stomach wall around the probe itself, equating that wall with another portion of the stomach wall.

FIG. 22A shows variations in partial cross-sections 22 / 23-22 / 23 from FIG. 21, along with tubes 350 from FIGS. 19A and 19B during preferred operation. As shown, the inner lining 390 is via the vacuum created in the opening 354 through the lumen 358 and / or through the coupling point 356 which can partially penetrate the lining 390, as described above. , Can be attached to tube 350. The position for the tube 350 to adhere can also be determined or assisted by the use of the marking device 40 as described above. Once the desired position of the inner lining 390 is established, the tube 350 can be rotated around its longitudinal axis by at least about 180 ° (preferably at least about 360 °) according to the arrows shown. As also shown in FIG. 16B, the lining 390 is preferably rotated until the adhered portion contacts the second portion of the lining 390, resulting in the modified lumen 314 of FIG. 22B. Once the modified lumen 314 is formed, the fastener can be released or placed at position 392 through the opening 354 or via a separate endoscopic staple fastening device to secure the modified lumen 314. And maintain. Fasteners may include any fasteners (eg, staples) as described herein. Once the modified lumen 314 has been fixed, the tube 350 can then be removed. FIG. 16B shows the newly created modified sac 302, along with the modified lumen 314, and as you can see, the medial lining 390 also forms the medial surface defining the modified lumen 314.

23A-23D show another variation in partial cross-section 22 / 23-22 / 23 from FIG. 21, along with the split tube 360 from FIGS. 20A and 20B. The split tube 360 can either be inserted individually into the stomach as separate halves 364, 366, or inserted into the stomach as a whole tube and then split in the stomach. Once separated, the first half 364 and the second half 366 can be engaged to the inner lining 390 by a coupling point 368 at a short distance from each other. The separation distance can be determined by the desired obtained size of the lumen. Alternatively, the separation distance may be determined or assisted by the use of the marking device 40 as described above.

As shown in FIG. 23A, once the first half 364 and the second half 366 engage the inner lining 390, then each free end 394 of the halves 364, 366 is in the direction of the arrow as shown. Can be rotated into. The free ends 394 can be configured to simply touch or interlock with each other and rotate around a hinge or central axis. As the first half 364 and the second half 366 continue to rotate, FIGS. 23B and 23C show the progression of cavitation so that the junction 368 is drawn around and towards each other. Finally, in FIG. 23D, the split tube 360 is preferably reformed, so that the modified lumen 314'can be formed as also shown in FIG. 16C, then preferably through the junction 304'. It can be fixed or maintained by fasteners that can be placed (eg, staples).

Further variations in the rotating device are shown in the isometric view of the dual tube device 400 shown in FIG. 24A. The double tube 400 may have at least two elongated members (first member 402 and second member 404) which can be rotationally attached to the control device 406 and parallel to each other. Members 402, 404 can preferably rotate in opposition, and preferably rotate by rotation control device 408, which is located in control device 406. The first member 402 may have a first distal end 410 that is slightly off the longitudinal axis of the first member 402 by a first tilt 412. The first opening 414 is also preferably defined in the wall of the first member 402, proximal to the first distal end 410. The second member 404 may preferably resemble the first member 402 and may have a second distal end 416 slightly separated from the longitudinal axis of the second member 404 by a second tilt 418. Near the second distal end 416, the second opening 420 may be defined in the wall of the second member 404.

FIG. 24B shows a terminal view of 24B-24B from FIG. 24A. The distal ends 410, 416 preferably appear to be parallel and contrasting images to each other. Also, the preferred counter-rotational action can be seen by the arrow in the direction. FIG. 24C shows a cross section 24C-24C from FIG. 24A. As shown, the relationship between the first and second openings (414, 420, respectively) and the first and second cavities (422, 424, respectively) can be seen in this figure. The cavities 422, 424 preferably pass through members 402, 404, respectively, and communicate with openings 414, 420, respectively. A vacuum can be created from the control device 406 through the cavities 422, 424 into openings 414, 420, respectively. During operation, members 402, 404 can be inserted into the patient's stomach through the esophagus. A vacuum is then created in the first and second openings 414, 420 and can be engaged with a portion of the medial lining of the stomach. Once engaged, the modified sac can be made from the inner lining in much the same manner as described in FIGS. 23A-23D (that the individual opposed rotating members 402, 404 do not form a split tube). except). The vacuum application and counter-rotation operations can preferably be controlled through a control device 406 located outside the patient's body.

FIG. 25A shows yet another variation of the indicated vacuum device 432 inserted into the stomach 430. The vacuum device 432 can be an endoscopic device that is inserted into the stomach 430 through the esophagus 434. The device 432 may have a vacuum member 438 and at least two grip members 440, preferably located on either side of the vacuum member 438. Once the device 432 is introduced into the stomach 430, the vacuum member 438 is towards the desired region of the medial lining 442, as seen in FIG. 25B, which is a cross-sectional view of the device 432 attached to the medial lining 442 of the stomach. Directed to. The desired region of the inner lining 442 may be arranged along a larger degree of curvature 436 or along a lesser degree of curvature 444, depending on the desired result. In that position, a vacuum can be created at member 438, preferably attracting a portion of the inner lining 442 between the grip members 440. If the lining 442 is attached to the vacuum member 438, the grip member 440 can be used to tighten and grip the attracted portion of the lining 442. Device 432 can then be rotated in the direction of the arrow shown in FIG. 25C to form a modified lumen. The grip member 440 can then be fixed in place, released from device 432, and left as a graft. Alternatively, the lining 442 may be fastened to maintain the created lumen by any method described herein, and the grip member 440, along with the rest of the device 432, is removed from the stomach 430. obtain.

(Stomach reduction tools and methods using volume reduction devices) Apart from the use of rotating and rotatable probes, gastric volume reduction devices can also be used as part of the present invention. Such volume reduction devices can generally be inserted into the stomach through the esophagus, for example, through the use of an endoscope. A reduction device can be used to pull or engage a portion of the medial lining of the stomach; then the pulled or engaged portion, either actively or by a natural process. Can eventually be removed.

Some examples of different possible modifications of the gastric volume reduction device are shown and described below. These modifications are not intended to be limiting and are provided merely as exemplary examples.

FIG. 26 shows an isometric view of the modification of the gastric volume reduction device of the concentric tube device 450. The device 450 may have an inner tube 452 that defines the lumen 454, which preferably passes through the entire inner tube 452. The pusher sleeve 456 may be placed concentrically with the inner tube 452 so that the pusher sleeve 456 can slide freely along the inner tube 452. The pusher sleeve 456 is also preferably located on the inner tube 452 so that the distal end of the inner tube 452 opens so that the ring 458 can rotate or be stretched over the distal end. .. The ring 458 is preferably made of an elastic material, which allows the ring 458 to elastically tighten the inner tube 452.

During use, FIG. 27A shows a diagram of a concentric tube device 450 within the stomach 460, preferably inserted through the esophagus 462. The distal end of the device 450 (particularly the inner tube 452) can be brought to a position near the location of the inner surface 464, where tissue can preferably be removed. As shown in FIG. 27B, once the device 450 is in place, decompression can be activated within the lumen 454. Decompression can then draw a portion of the drawn inner layer tissue 466 into the lumen 454, as shown in the cross section of the device 450. While the inner layer tissue 466 is retained within the lumen 454, the pusher sleeve 456 can be pushed or urged distally along the inner tube 452. If the pusher sleeve 456 advances, as shown in Figure 27C, the ring 458 is far away along the inner tube 452 until it is completely separated from the distal end of the inner tube 452 and pushed over a portion of the inner layer tissue 466. The elastic ring 458 can be pushed or pushed to the position. The device 450 can then be removed from the stomach 460 after stopping decompression, thereby leaving the inner layer tissue 466 with the elastic ring 458. As shown in FIG. 27D, pressure necrosis then allows the inner layer tissue 466 and ring 458 to pass normally through the rest of the patient's body, simply away from the rest of the inner surface 464. The action of pulling up and removing part of the inner surface 464 can effectively reduce the overall volume of the stomach 460, thereby reducing the volume available for food intake. Thus, this procedure can be repeated several times, either continuously or simultaneously, until the total volume of the stomach 460 is reduced to the desired volume based on the desired result.

FIG. 28 shows another modification of the gastric volume reduction device. As shown, the endoscope 474 (preferably having a grasping device 476 (eg, biopsy forceps)) can be inserted into the stomach 472. A ligator (eg, a ring stapler, a tie, etc.) (either as part of the endoscope 474 or as a ligation device 478 introduced separately) is also preferably introduced into the stomach 472. Will be done. The forceps 476 and the ligating device 478 can be used in combination with each other, for example, by grasping the tissue 480 from which the forceps 476 are removed and then the ligating device 478 tying or ligating the tissue 480. Forceps 476 can then be used to cut out and remove the tissue 480 to be removed on the tie 482 and reduce the overall gastric volume. Examples of available jaw structures are shown and described in US Pat. No. 5,749,893 of Vidal et al., The entire of which is incorporated herein by reference. Alternatively, the ligated and removed tissue 480 may remain attached to the stomach 470 and is spontaneously removed by pressure necrosis. Some incisions can be made to reduce the volume of the stomach, for example from stomach 472 (indicated by the dashed line) to the final reduced stomach 470.

FIG. 29A shows another modification with a tow roller 490. The device may have at least two rigid rollers 492, which are preferably elongated and are connected to each other, preferably at both ends, by, for example, an elastic member 494. The connection of rollers 492 can create channels 496 between them, through which tissue can be withdrawn. FIG. 29B shows roller 492, a portion of the medial gastric surface 498 is pulled out through channel 496 by a grasping device (eg, forceps 500). On the other hand, the roller 492 can be held in the stomach, for example, by holding forceps 502, which can be used to hold the roller 492 against the medial surface 498. The elastic member 494 together sandwiches the roller 492, thereby creating a region of pressure necrosis within the internal surface 498 to be removed. Also, if the inner surface 498 is pulled up through the channel 496, the roller 492 may include a ratchet device inside to prevent the surface 498 from rewinding through the channel 496. Once the desired amount of surface 498 has been withdrawn, it can either be cut out or can be naturally removed by necrosis. FIG. 29C shows an alternative modification with a ratcheted roller 504. The ratcheted roller 504 can be operated in the same manner as described for the roller 492, but preferably has a traction surface to increase traction between the tissue and the roller 504. The torque device 506 can be used with a ratcheted roller 504, which is endoscopically introduced into the stomach and can engage one of the rollers 504 to rotate the roller 504. In addition, either the roller 492 or the ratcheted roller 504 can be used to simply collect gastric surface tissue to allow tightening (eg, suturing, stapling, etc.).

(Pylorus formation tools and methods) Creating a gastric sac in the stomach can be achieved by the various methods described above. To aid in the overall effect for the treatment of obesity, pylorus formation procedures can also be performed to improve the treatment. Pylorus formation can be performed before (preferably) the gastric reduction procedure, with or following the gastric reduction procedure. The pylorus formation procedure typically causes pyloric sphincter insufficiency. However, for procedures for GERD using the above devices and methods, the pylorus formation procedure described herein may be omitted. Traditional pylorus procedures can typically be performed surgically or through the use of standard angioplasty balloons (eg, in the 7 mm range). However, more aggressive procedures may be required to permanently defeat a relatively healthy and normal pylorus.

To perform this in general, the pylorus-forming device can be endoscopically passed through the esophagus to the stomach, preferably at the location of the pylorus or across the pylorus. The energy of the stimulus is then preferably applied to the pylorus, causing the pylorus to fail. Energy can be in the form of, for example, heat, electricity, chemicals, RF, etc., or a combination thereof. Examples of chemical energy stimulation may include alcohol and sotrodecol. The stimulus can be in the form of, for example, dilation, amputation, excision, virus, or a combination thereof. Examples of viral or chemical stimuli can be, for example, toxins such as botulinum toxin type A virus (Botox). An example of how to use Botox is described in US Pat. No. 5,437,291 to Pasricha et al., Which is incorporated herein by reference in its entirety. Due to the incomplete pylorus, the gastric contents can be flushed directly into the proximal duodenum with minimal resistance. In addition, some of the pylorus-forming procedures may be selected or designed to last only for a specific time period (eg, a week or months). For example, the effect of a simple dilation or injection of Botox can be designed to insufficiency of the pylorus for only a few months, which can be the desired time for the patient to obtain the desired results of this procedure. ..

Some examples of different possible modifications of the pylorus-forming device are shown and described below. These modifications are not intended to be limiting and are provided merely as exemplary examples.

FIG. 30 shows an isometric view of one modification of the expansion device of balloon device 510 that may have an angioplasty balloon 512 located near or at the distal end of catheter 514. The angioplasty balloon 512 can be used alone to simply dilate the pylorus. Alternatively, the external balloon surface 516 may have at least one, preferably several stimulating members 518, around the surface 516. The stimulating member 518 is shown in the figure as a cutting blade or wire, or these may include electrodes, cold distribution probes or members, chemical dispersion probes, and the like. Alternatively, the balloon 512 can be an expansion wire basket co-located with the stimulating member 518.

FIG. 31 shows an isometric view of another modification of probe 520. Device 520 may have a catheter or delivery member 524 (eg, probe 526), which may extend from the distal end 522. Three probes 526 are shown in the figure, but at least one and up to several probes of various thicknesses and lengths can be used. The probe 526 may be contractible so that it can be retracted into the distal end 522 and then stretched when treating the pylorus, for example during delivery through the esophagus or stomach. The probe 526 may be electrically connected to a voltage or power source located outside the patient's body to deliver electrical, RF, or thermal energy to the pylorus. Alternatively, they can be configured like needles to deliver chemical or biological stimuli to defeat the pylorus. For example, probe 526 is used to inject chemicals (eg, alcohol, sotrodecol) or other excision chemicals, or biological stimuli (eg, Botox virus or other inactivating virus) into the phylum. Can be used. Such stimuli can be retained within the distal end 522, delivery catheter 524, or they can be delivered from the proximal end of catheter 524 and injected into probe 526.

Other modifications that can be used for the pylorus procedure are shown in Figures 32A and 32B. FIG. 32A shows a sphincter resection arm 530 with a distal end 532. The arm 530 can be bent as shown and the cutting member 534 can be pulled along the arm 530 between the distal end 532 and the proximal position of the distal end 532. Another modification is shown in FIG. 32B, where the delivery member 536 may have a bow support member 538 to support the cutting member 540. The modifications shown in FIGS. 32A and 32B are delivered through the esophagus, through the stomach and to the pylorus via a catheter or endoscope, in which either the cutting member 534 or 540 is the tissue or pylorus of the pylorus. It can be used to cut or saw the tissue around the pylorus to make the pylorus incomplete. These specific modifications of the sphincter resection shown in Figures 32A and 32B can be manufactured by Medi-Globe Corporation, located in Tempe, AZ.

FIG. 33 shows the stomach 550, with the distal portion of the lesser curvature wall removed for clarity. Device 520 may be delivered through the esophagus 522 to a location proximal to pylorus 558 (eg, first position 554). If the probes 526 are retracted during delivery, they can be extended as shown. The distal end 522 of the device 520 can be advanced to, for example, a second position 556, so that the probe 526 can penetrate the pylorus 558 to deliver the stimulus.

FIG. 34A shows another modified isometric view with the combination device 560. The device 560 may have a housing 562 at the distal end of the delivery catheter or endoscope 564. Housing 562 defines a notch 566 that can be oriented perpendicular to the longitudinal axis defined by endoscope 564. The notch 566 preferably has a shape large enough to accommodate a portion of the pylorus 558, and the housing 562 is tapered at its distal end to the pylorus 558 during the procedure. Allows easy insertion of. At the notch 566, there can be a cutting blade 568, and on either side of the blade 568 there can be fasteners 570 (eg, individual anchors, staples, etc.). In operation, FIG. 34B shows housing 562 and endoscope 564 delivered through the esophagus 552. The wall of the stomach 550 is partially amputated for clarity. The housing 562 can be inserted into the pylorus 558, then the notch 566 is preferably aligned such that part of the pylorus sphincter is within the notch 566. Alternatively, the pyloric tissue can also be pulled into the notch 566 via decompression or gripping members. Once the pyloric tissue is within the notch 566, the cutting blade 568 can act across the notch 566 and cut a portion of the pyloric tissue. The fastener 570 can then be deployed on either side of the incision 572 to attach the incised tissue. The number of incisions 572 can vary depending on the desired degree of pyloric insufficiency. Alternatively, the inflatable balloon can be attached to the back of the notch 566 and inflated to push the housing 562 in place with the pylorus 558, and inject tissue into the notch 566.

(Anastomosis tools and methods) In addition to the tools and methods described above for gastric reduction and pylorus procedures, additional anastomotic gastric bypass procedures can also be performed to further enhance the procedure. The anastomotic procedure can preferably be performed before, at the same time, or after the gastric reduction and pylorus procedure (if all performed). For the treatment of GERD using the above devices and methods, the anastomotic procedure described herein may be omitted. This procedure generally involves making an interlateral anastomosis endoscopically or laparoscopically, preferably from the stomach and intestines, and from the gastrointestinal tract. This procedure can be similar to the Lou Y Gastric Bypass (RYGB) procedure, but with minimal trauma. This procedure can also effectively bypass food from the stomach, pass through the proximal portion of the intestine, and preferably be delivered directly to the lower part of the intestine. This bypassed portion can be considered a malabsorption region.

A typical human normal gastrointestinal system is shown in Figure 35 for comparison. The stomach 580 is shown, with the pylorus 582 near the gallbladder 584 and connected to the proximal portion of the duodenum 586. The distal portion of the duodenum 586 is connected to the proximal portion of the jejunum 588, and the distal portion of the jejunum is connected to the proximal portion of the ileum 590. The ileum 590 is then connected to the ascending colon 592, which follows the transverse colon (removed for clarity), then the descending colon 594, and finally the rectum 596.

The gastrointestinal system that can be modified by the preferred anastomotic procedure is shown in Figure 36. Stomach 600 is indicated by this modification as being modified by making a modified sac 602, which can be made by any of the above methods and tools. The esophagus 603 is preferably connected to the proximal end of the sac 602. As mentioned above, the distal end of the sac 602 can be directly connected to the pylorus 604 or can be a blind end sac, with the pylorus 604 connected to the proximal end of the duodenum 606. The first anastomosis 608 can preferably be made from either the distal duodenum 606 or the proximal jejunum 610 between the modified sac 602 and part of the gastrointestinal tract. The first anastomosis 608 can be located in the range of about 20-50 cm from the pylorus 604. The second anastomosis 614 can preferably be made between a portion of the duodenum 606 and a portion of the ileum 612. The second anastomosis 614 can be located in the range of about 15-55 cm from the pylorus 604, or about 150-200 cm below the pylorus 604 along the length of the small intestine. This procedure allows the excretion of secretions produced by the stomach 600 to pass through the pylorus 604, and bile and keems secretions from the pancreas and gallbladder 618 pass through the bile duct 620 and partially duodenal 606. It may be possible to pass directly through the distal ileum 616 and out of the body through the second anastomosis 614. The bypassed stomach 600, pylorus 604, and proximal duodenum 606 can act as malabsorbent areas. This is because sugars and fats that can be normally mostly absorbed in this area can be passed through the distal duodenum 606 or the proximal jejunum 610.

During the anastomotic procedure, both the first anastomosis 608 and the second anastomosis 614 can be made first, respectively. The duodenum 606 can then be closed between the two anastomoses 608, 614. The pylorus 604 can then be closed or remain open, depending on the desired results and the procedures and tools performed, depending on the length and size of the resulting modified stomach 602. Finally, the modified sac 602 can be made after the anastomotic procedure. Alternatively, the modified sac 602 can also be made prior to the anastomotic procedure, depending on the desired results and the procedures and tools performed. If the modified sac 602 is first made, the anastomotic procedure can be reversed to produce essentially the same result.

The conventional RYGB procedure is typically performed through a 6-8 inch incision that extends from the end of the sternum just above the navel. However, the above procedure can be performed endoscopically or laparoscopically as a whole. FIG. 37 shows an isometric view of the assembly that can be used to accomplish some of the procedures. The deployment device 630 may preferably have an anastomotic assembly 632 connected by an operable length 634 to operate the handle 636. The assembly 632 may be operable during insertion, preferably across the esophagus, through the stomach, by an operating grip 638 that may be placed on the operating handle 636. Control by the physician or surgeon of the operating handle 636 can be facilitated by the handle 640.

The anastomotic assembly 632 may preferably have a stapler housing 644 configured to fit in close contact with the distal element 646 by magnetic forceps, the use of this magnetic forceps as described below. The distal element 646 may preferably be tapered or rounded on one side and have a coring anvil 648 on the opposite side. The coring anvil 648 is tapered or rounded and can fit snugly against a pair of coring 650s, preferably near or centered on the stapler housing 644. The stapler housing 644 also houses several staples loaded into staple slot 652, which can be arranged circumferentially around a pair of coring pairs 650 and close to length 634 by staple trigger 642. Can be operated from the staple.

FIG. 38 shows a cross-sectional view of the anastomotic assembly 632 fitted with the distal element 646 in the first anastomosis 608 between the modified sac 602 and the jejunum 610. The walls of the modified sac 602 and jejunum 610 have been removed for clarity. In making the first anastomosis 608, the distal element 646 can first be placed within the appropriate portion of the jejunum 610. This can be done by passing the distal element 646 orally through the esophagus, stomach, and then the duodenum. The distal element 646 is preferably magnetized, either by making the distal element 646 from a natural ferrous material or by artificially magnetizing the distal material thereof. To. Due to the magnetization, the distal element 646 can be pushed through the body to a location within the duodenum, for example, by a magnetic rod or a magnetic pickup, which can be manipulated from outside the patient's body.

During or after placement of the distal element 646, the stapler housing 644 (which can be attached to an operable length 634) can be introduced into the stomach 602 through the esophagus, and the stomach wall at the desired site of the first anastomosis 608. It can be placed along the 660. Once both stapler housings 644 and distal elements 646 are in place, they can preferably be coupled together by magnetic force and an incentive between the two. In addition, the two can be aligned either by an alignment groove (not shown) or by fitting the coring of the coring anvil 648 to pair 650. When mating occurs, a portion of the stomach wall 660 and intestinal wall 662 is preferably retained or maintained between the stapler housing 644 and the distal element 646. To enhance the fit, fasteners can be deployed from the stapler housing 644 through the staple slot 652, preferably through both the stomach wall 660 and the intestinal wall 662, to the distal element 646, if desired. FIG. 38 shows staples 667 deployed as fasteners, which are mechanical fasteners of any type as described above, as well as, for example, grommet swages, snaplock fits, staples, screws, clips, and May include rubbing fits.

Once the fitting is achieved, the device can be juxtaposed to maintain the position of the stomach wall 660 and intestinal wall 662 for about a week. This can result in pressure necrosis of the tissue between the stapler housing 644 and the distal element 646, preferably fusing the serosal layer of the intestine, at which point the assembly can fall and pass, preferably. , The first anastomosis 608 can be left behind. Alternatively, the coring device 664, which may be slidably included within the stapler housing 644, proceeds through the center of the stapler housing 644, and both the stomach wall 660 and the intestinal wall 662 can first make an anastomosis 608. The remaining assembly can then be left to cause pressure necrosis and tissue fusion, as described above. Another alternative could be to use the stapler 644 and the distal element 646 as a mechanism for the conventional end-to-end anastomosis (EEA) stapler. In this case, once they are aligned, the rods can travel through the center of the assembly, preferably locking the distal element 646 to the intestinal wall 662. The rod can preferably be pulled back by pulling the distal stapler segment into the stapler housing 644. This action causes the staples to fire, and the circumferential blade cuts through the center of the staple ring, thereby creating an anastomosis.

To make the second anastomosis 614, an approach similar to making the first anastomosis 608 can be taken. An example of another magnetic anastomosis device, which can be used in this procedure, is set forth in US Pat. No. 5,690,656 of Cope et al., Which is incorporated herein by reference in its entirety. And it is described. FIG. 39 shows a portion of the duodenum 606 parallel to a portion of the ileum 612 and a portion of the distal ileum 616, with a portion of the intestinal wall removed for clarity. In this modification, the proximal element 670 can be used, preferably the element that is magnetically paired with the distal element 646. The distal element 646 can first be pushed to the desired position (preferably the ileum 612) by, for example, a magnetic rod or magnetic pickup, which magnetic rod or magnetic pickup is outside the patient's body in the same manner as described above. Can be manipulated from. During or after placement of the distal element 646, the proximal element 670 can also be delivered or pushed in the desired position in the same manner. Once both elements 646, 670 are in place, they are preferably paired together by magnetic force. This pairing can be augmented with fasteners (eg, staples 667) to hold both elements 646, 670 in place, if desired. The intestinal wall between can be punctured, as described above, but can simply cause pressure necrosis between elements 646, 670, resulting in fusion of the serosal layers of the intestine, at this point, Elements 646, 670 fall and pass, preferably leaving a second anastomosis 614 behind.

(Stomach reduction tool overtube system) When using one of the above gastric reduction tools (eg, FIGS. 7A, 9A-14, 26, 30-32B, and 34A), the treatment of hollow body organs is performed multiple times with the tool used. May be needed. Therefore, to facilitate patient treatment, overtube assemblies can be used with those tools. FIG. 40A shows an isometric view of the overtube assembly 680, which can be used to provide minimal discomfort and efficient treatment to the patient. The overtube assembly 680 is preferably composed of an overtube member 682, which can be inserted through the patient's esophagus into a hollow body organ (eg, stomach). The working lumen 684 can be defined through an overtube 682 from the proximal end 698 of the overtube module 692 to the distal end 696 of the overtube 682. At the distal end 696, at least one window 700, and preferably two or more windows 700, are preferably defined oppositely to each other in this modification, as shown. The window 700 is preferably defined in the shape of a slot near or at the distal end 696 of the overtube 682. The length and width of slot 700 can vary and is preferably long enough to approach the desired length of the boundary or junction, as discussed below. The stomach is composed of at least three layers, including the inner mucosal layer (mucosa), the outer muscularis mucosae (muscularis mucosae), and the outer serosa layer (serosal membrane). The width of the window 700 is preferably wide enough to accommodate at least two layers of the medial gastric lining, more preferably all layers of the stomach. An exemplary width of the window 700 can range from about 0.320 cm (0.125 inches) to 0.950 cm (0.375 inches), and about 0.635 cm (0.250 inches) to 15. It can be in the range of any length of 25 cm (6 inches). Overtube assembly 680, including the modifications described herein, can be used to perform a variety of procedures, along with the various tools and methods described above.

Some aspects of the invention are reached after experiments with gastric tissue and the challenge of reliably obtaining and immobilizing such tissue. In particular, the assembly 680 is desired to be contiguously adjacent to the tissue, and as a result, as described herein, the assembly 680 is an outer layer, or a fibrous layer of the stomach wall, when the fastener is delivered. Continuously reach (eg, mucosa and serosa). The present invention may assist this by obtaining tissue, thus allowing these fibrous layers to intersect or overlap within the working lumen 684 and be anchored together. Once these fibrous layers are properly secured, they adhere, fuse or scratch to affect the desired fasteners. Preferably, the tissue remains lined up, eg, twice, for 2-4 weeks to act on healing, but tissue fusion can occur immediately after 5-10 days of the procedure. Complications (eg, gastric erosion, ulcers, and damage to the fixed wall) if the tissue folds are inconsistently fixed, or if the fasteners only penetrate fibrous tissue (eg, mucosa). Can occur.

Preferably, at least most of the overall length or device length of the overtube 682 is flexible enough to be inserted into the body through, for example, the esophagus and at least partially fits the curvature of the body. For example, the overtube 682 can range in length from about 40 cm (15.75 inches) to 100 cm (39.40 inches), and preferably about 80 cm (31.50 inches). The overall diameter of the overtube 682 can range from about 5 mm (0.20 inches) to 30 mm (1.18 inches), and preferably from about 15 mm (0.60 inches) to 17 mm (0.70 inches). Alternatively, the length of the overtube 682 may be sufficiently flexible, but the flexion area 694 near the distal end 696, which may be more flexible than the rest of the overtube 682. Prescribe. The flexion region 694 can be flexible, so that it is optional, either actively by the doctor or surgeon or passively by the endoscope inserted into the overtube 682. Can be manipulated or bent into the shape of. Examples of tubular structures (actively manipulable and selectively rigid) can be found, among others, in US Pat. Nos. 5,624,381 (Kieturakis) and 4,790,290 (Allred, III et al.). ..

If passively operable, the overtube 682 can be made from any variety of biocompatible materials. This is a structure sufficient for the device to still allow bending (eg, thermosetting or thermoreversible materials (eg PTFE, FEP, polyurethane, PVC, silicone, nylon, pellethane, etc.)). )I will provide a. Alternatively, the overtube 682 can be performed to have a flexed or arched shape near or at the distal end 696. When introduced into a patient, a straightened mandrel 702 or an endoscopic device can be placed in the flexion area 694 to maintain a straightened shape, as shown in Figure 40B. If the overtube 682 is preferably placed within the patient, the straightened 702 can be pulled out of the device, transforming the overtube 682 into its preformed shape. Another alternative is that the overtube 682 remains passively manipulable and has its formed insertable mandrel in the curved shape 704, as also seen in FIG. 40B. In this case, the overtube 682 can be inserted in its straightened shape, and the curved mandrel 704 is inserted through the overtube 682, in forced and straightened shapes, through the overtube 682. .. When the curved mandrel 704 reaches the distal end 696, the mandrel 704 can be curved into a preformed shape and the overtube 682 can be deformed using the mandrel 704. In this case, the mandrel 704 is preferably made from a shape memory alloy (eg, a nickel-titanium alloy such as Nitinol). In either case, the mandrel can be inserted within the internal working channel of the overtube 682 or along the defined external channel along the outer surface of the overtube 682.

The overtube 682 can also be made to have a proximal portion that is relatively stiffer than the flexion region 694 or the distal end 696. Also, the overtube 682 may have a wall thickness that depends on the type of material used for the structure sufficient to maintain the structural rigidity of the device during use. For example, wall thickness can be used in the range of about 0.80 mm (0.032 inch) to 6.35 mm (0.250 inch).

Preferably, a separate drive tube 688 is inserted into the lumen 684 of the overtube 682 through the overtube module 692. Preferably, the drive tube 688 is a tubular member having an outer diameter smaller than the inner diameter of the overtube 682. The drive tube 688 can be made of the same or similar material as the overtube 682, or any other material described above. Preferably, the tube 682 and tube are freely adjustable within the overtube 682 (ie, freely movable in the longitudinal direction and / or rotationally within the overtube 682). There is a sufficient gap between the 688. The drive tube 688 is made to have a defined lumen through the tube 688 from the proximally located insertion port 686 to the distal end of the tube 688. To protect the drive tube 688 from being totally pushed through the overtube 682, the drive tube stop 690 can be localized to the proximal end of the tube 688. The stop 690 can be any protrusion (eg, a disc of extended diameter), which contacts the overtube module 692 to prevent further advancement of the drive tube 688 within the overtube 682. The stop 690 can be made from a material similar to tube 688, or from a biocompatible metal material (eg, stainless steel, platinum, etc.) and can be attached to drive tube 688.

A detailed assembly view of the distal end 696 of the overtube assembly 680 is shown in FIG. 41 with the drive tube 682 partially stripped for clarity. As shown, the overtube 682 may have a drive tube 688 that is inserted into the lumen 684 and extends towards the distal end of the overtube 682. The endoscope 710 (preferably equipped with any conventional endoscope device having optical visual capability (eg, through fiber optics)) is at the proximal end through insertion port 686 to the drive tube 688. Can be inserted. The endoscope 710 is distal through both the overtube 682 and the drive tube 688 to extend beyond the distal end 696 of the overtube 682 to test and / or identify the tissue area of interest. You can proceed to.

Preferably, the fastener 714 is also placed near the distal end 696 of the overtube 682 or within the lumen 684 within the distal end 696. Preferably, the fastener 714 is located distal to the drive tube 688 and may be configured to have a proximal end 716 for engagement of the drive tube 688 with the fastener engagement area 712. Since the fastener 714 travels distally, it may be further configured to have a taber-like distal end 718 to penetrate the tissue. As shown, the fastener 714 can be configured in a spiral or helical shape with at least two rotations, and the endoscope 710 can pass through it unobstructed. Can be configured to form a sufficiently large inner diameter. During the advancement of the overtube 682 into the body, or during testing with the endoscope 710, the fastener 714 may be maintained within the lumen 684 by temporary attachment of the device to the inner wall of the lumen 684. .. However, preferably, the fastener 714 can be attached to the area 712 via the proximal end 716 until the fastener 714 is deployed within the tissue. Proximal end 716 is a conventional mechanical engagement (eg, friction fit or anti-movement located within region 712), or an electrically actuated coupling or connection (eg, electrically-erodable) coupling. ) Can be temporarily connected to the area 712.

Once the fastener 714 is deployed to the tissue, the drive tube 688 with the fastener 714 to be connected can travel distally through the lumen 684, and then the drive tube 688 is actuated proximally. It can be rotated via a rotational force. The rotational force can be moved either manually or by automation using a motorized assembly (not shown). The drive tube 688 rotates around the long axis of the drive tube, and the fastener 714 also rotates and advances to the tissue area of interest while fixing the tissue in a screw-like manner.

The fastener 714 (preferably in the form of a helix and a spiral) can have a tapering width or diameter, if desired. The first few rotations or coil of fastener 714 may have the same or smaller diameter as the remaining tapered coil; this may allow the distal penetrating end 718 to engage the tissue, And also it may allow the fastener 714 to be advanced in the desired direction through the tissue. Preferably, the fastener 714 remains parallel to the overtube 682 while being delivered to the tissue (ie, the longitudinal direction defined by the fastener 714 is preferably the longitudinal axis defined by the overtube 682. In the direction, parallel or close to parallel). In addition, the first few rotations or the outer diameter of the coil can be the same diameter or slightly shorter, the inner diameter of the overtube 682. This may further allow the fastener 714 to be advanced through the lumen 684 in the proper direction before engaging with tissue.

The fastener 714 is made from a bioabsorbable or biocompatible material (eg, such as the polymers or hyperelastic alloys or metals described herein (eg, stainless steel, platinum, titanium, etc.)). Obtained, and once engaged with tissue, it can be integrally formed with spines or whisker-like filaments protruding along its length to help prevent the fastener 714 from retreating. The fastener 714 can be the same fastener as or similar to the screw 289 above. This can also resemble the spiral suture needle or fastener shown and described in US Pat. No. 5,330,503 to Yoon, which is incorporated above.

FIG. 42A shows a detailed isometric view of the proximal assembly of the overtube assembly 680 with the endoscope 710 inserted into insertion port 686. The shaft of the endoscope 710 appears to be almost completely inserted into the assembly 680 through the insertion port 686 located at the drive tube stop 690 to the endoscope handle 720. Endoscope 710 can be selectively advanced and retracted into assembly 680 by a physician or surgeon, or fully retracted from insertion port 686 during procedures to allow insertion of other tools or devices. obtain.

The fluid port 722 also appears to extend from the overtube module 692, which fluid port 722 may be included as part of the overtube assembly 680. The fluid port 722 is in fluid communication with the working lumen 684 defined in the overtube 682 and may be fluid contacted through, for example, a hose to a pump capable of decompressing the cavity 684 to provide negative pressure. .. A single fluid port 722 is shown, but any number of ports can be used. If multiple ports are utilized, each port may be fluidly connected to the same pump or different pumps. In addition, the fluid port 722 and any other fluid port can also be fluidly connected to a positive pressure pump, either in parallel or as an alternative, when used. Alternatively, the same pump can be used to provide both negative and positive pressures. Positive pressure pumps also deliver fluid through fluid port 722 into lumen 684 for delivery of gases such as therapeutic agents, saline, or nitrogen, especially for blowing into areas within the body. Can be used to provide the proper pressure to do so.

Any number of markers 744 can be placed on the overtube assembly 680 (eg, on the overtube module 692, as shown in FIG. 42A). The marker 744 can be placed on the module 692 corresponding to the perimeter position of the window 700 and can therefore be used as a guide for aligning the window 700 with the patient. The overtube 682 can be manipulated and rotated from outside the body to align the marker 744 (eg, align it with the patient's nose) with a marker placed on the patient. In this manner, the window 700 of the overtube 682 can be preferably positioned to the patient through external manipulation without the need to align the window 700 by direct visualization within the patient.

The drive tube 688 can be selectively advanced and regressed in connection with the overtube 682 and also in connection with the endoscope 710, so that it is a fluid-tight. The seal) is preferably maintained between the overtube module 692 and the drive tube 688. This fluid adhesion seal is preferably sustained to maintain pressure (positive or negative pressure) in the lumen 684 through fluid port 722, and more specifically in FIG. 42B (assembly of FIG. 42A). As seen in (showing the cross-sectional profile of), it is maintained in the connecting tube 728, which is created between the outer surface of the drive tube 688 and the inner surface of the overtube 682. This can be achieved by any number of conventional sealing methods. For example, the overtube module 692 can be gasketed to the outer surface of the drive tube 688 to maintain a seal between the two, as also seen in FIG. 42B. Alternatively, other types of seals may be utilized, such as, for example, seal gels, ferrofluidic seals, and the like. In addition to maintaining a fluid adhesion seal, the guard 724 can also be provided in the assembly 680 to provide structural strength to the tissue area into which the assembly 680 is inserted, and can also be pinched or pinched. Protects the overtube 682 from being crushed. For example, if the assembly 680 is inserted orally into the patient's esophagus, the guard 724 can be inserted into the patient's oral cavity and used as a biting guard to prevent the patient from biting through the overtube 682. The guard 724 also ensures a smooth path for the overtube 682 through the patient's oral cavity.

FIG. 43 shows a schematic diagram of an example of assembly 680 used within patient 730. As shown, assembly 680 can be inserted orally through the mouth 732 of patient 730 and advances within the esophagus 734 until the distal end 696 progresses beyond the esophagogastric junction 738 to the stomach 736. Can be Once in the stomach 736, the distal end 696 can be actively or passively positioned by the physician or surgeon around the flexible region 694 until the device is positioned in the desired location. The pump 742, which is in fluid communication with the connecting tube 728 in the overtube 682, preferably via the fluid tube 740, is then over to pull in the portion of tissue identified within the window 700. It can be activated to produce decompression in tube 682. A decompression force of about 15-20 inches-Hg can be utilized, but the amount of decompression pressure can vary depending on the size of the window 700 and the amount of tissue drawn into the overtube 682. As mentioned above, the pump 742 can also be used as a positive pressure pump, which in turn passes through the tube 740 and overtube 682 for therapeutic agent, fluid or It can be used to deliver a gas.

FIG. 44 shows an end cross-sectional view of the overtube 682 in the gastric lumen 764 of the stomach 736 once decompression has occurred in the working lumen 684. As shown, the overtube 682 can be positioned adjacent with respect to the smaller curvature 750 of the stomach 736; the overtube 682 is alternative, depending on the desired treatment and effect on the patient. , The larger curvature 760 or may be positioned closer to any location between them. For example, the overtube 682 is preferably positioned closer to the smaller curvature 750 before approaching the wall of the gastric tissue, so that the modified lumen is the pyloric sphincter of the esophagus 734 to the stomach 736. It can be made by an overtube assembly 680 that leads directly to. Alternatively, the overtube 682 may be positioned closer to the larger curvature 760 for the treatment of GERD. As found, the overtube 682 may require an inner layer of the stomach, and several layers of gastric tissue, creating folds 762 within the outer surface of the stomach 736, which may indicate where the stomach 736 has invaded. That is, the mucosal layer 754, the muscle layer 756 and the serosal layer 758) can be retracted into the lumen 684 through the window 700. Not all layers of the stomach 736 need to be invaginated, but at least two layers (more preferably all layers) are preferably retracted, resulting in the proper tissue to approach the wall of the stomach 736 684. Is in the lumen 684. The invaginated tissue 752 is drawn into the lumen 684, so that the fastener (as further described below) grabs both or some areas of the invaginated tissue 752 and the tissue. The decompression is preferably maintained until it can approach or maintain the tissue.

FIG. 45 shows a schematic representation of the overtube 682 in the stomach 736, with the stomach and overtube partially removed for clarity. As shown, the overtube 682 can be inserted as described above. Once positioned as desired within the gastric cavity 764, decompression can occur within the working cavity 684 within the overtube 682, and tissue 752, as shown, through the window 700. It can be invaginated into the cavity 684. Once the invaginated tissue 752 is properly drawn into the overtube 682, any number of flexible endoscopic stapling devices, as described herein, can be used to remove the aspirated tissue. Can be used to keep together.

Alternatively, the fastener 714 can travel distally while rotating the fastener using a drive tube 688, which is shown to be retracted. As the fastener 714 rotates, its sharp distal tip 718 alternates into and around the invaginated tissue 752 until the fastener 714 is fully advanced into the tissue 752. Can bend in a helical or spiral pattern. The fastener 714 can be configured inwardly biased so that once the fastener 714 is placed within the tissue 752, the coil of the fastener 714 tilts inward, resulting in a reduction in the diameter of the fastener 714. And then the stopper 714 stretches. A single clasp 714 can be used to join the appositional walls of tissue 752 within the stomach 736, in which case the clasp 714 is preferably an elongated clasp long enough to bind the tissue. Is. Alternatively, a plurality of fasteners 714 may be fastened together to form a continuous fixing line. In this case the overtube 682 can be advanced to a distal position within the stomach 736, and a portion of this tissue wall can be tightened as described above. The overtube 682 can then be pulled proximally within the gastric cavity 764 and repositioned.

While maintaining the position of the overtube 682 within the gastric cavity 764, the drive tube 688 can be pulled from the overtube cavity 684, and another fastener 714 can be inserted into the overtube 682, and tissue. It can be advanced distally to tighten another part of the wall. This process can be repeated as needed until the desired length or position of the tissue is tightened. Alternative configurations for drive tubes may include clamping devices to hold close tissues together while tightening the tissues together, as described in more detail below.

The biodegradable plug (eg, plug 292 above) can be placed in the distal end of the overtube 682, if desired, in a manner similar to the above, and preferably prior to insertion into the patient. Is made from biocompatible biodegradable materials (eg, biodegradable polymers (eg, polylactides, polyglycolides and copolymers thereof)). Alternatively, the plug may be made from a non-biodegradable material and may simply pass after this procedure. This plug may assist in maintaining the decompression seal through the window 700 during the tightening procedure.

Figures 46A and 46B show detailed isometric and end views of one variation of the distal end 696 of the overtube 682. As shown in FIG. 46A, the window 700 may also be slotted, as described above. FIG. 46B shows an end view, in which the inlaid tissue 752 projects into the lumen 684. The aligned portion of the tissue 752 can be pulled out into the overtube 682 by vacuum until some of the tissue 752 contact each other in the contact area 770.

Another variation that constitutes the distal end of the overtube is shown in FIGS. 47A and 47B. As shown in FIG. 47A, the isometric view of the offset variation 780 of the overtube is aligned as defined near or at the distal end along the length of the overtube 780, as described above. Can have windows 782, 782'. However, the working lumen within the overtube 780 may have a separation wall 786 formed within the overtube, which extends diametrically and has two separate lumens 784, 784'. To form. The separation wall 786 is preferably formed within the distal end portion of the overtube 780 and can be the same length as windows 782, 782'. Alternatively, the wall 786 may extend over the entire length of the overtube 780. The separated cavities 784 and 784'lead to windows 782 and 782', respectively. As shown in FIG. 47B, the side-by-side walls of tissues 788, 788'can be drawn into the respective cavities 784, 784' until they overlap each other between the separation barriers 786. To tighten and / or bring the side-by-side walls of tissue 788, 788'close, an endoscope or flexible fastener device can be used to tighten tissue to each other. Alternatively, the longitudinally formed channel 789 can be optionally defined within the wall 786 near where the separation wall 786 joins the wall of the overtube 780. Fasteners formed in a helix or spiral as described above can then be used in this variation as well. This variation 780 may or may not use a separate endoscope placed within the working lumen.

FIG. 48A shows an isometric view of the overtube 780 inserted into the gastric cavity 764 (both walls of the stomach 736 and overtube 780 are partially omitted for clarity). As shown, inlaid and overlapping gastric linings 788, 788'can be found within the first and second cavities 784, 784' (separation barrier 786 omitted for clarity only). Will be). The overlapping tissues 788, 788'are maintained relative to each other so that the fastener assembly 806 can be advanced within the overtube 780 where nearby tissues will be placed. The fastener assembly 806 can be any one of the fastener devices or endoscope stapling assemblies as described above. The example shown comprises a shaft 808 with a clasp anvil 810 swivelly coupled around a pivot 812. Fastener assembly 806 can be operated from its proximal end to clamp tissue 788, 788'between anvil 810 and fastener 814. As mentioned above, the fastener 814 may be in the form of a clasp, rivet or other mechanical fastener as described herein, which may be housed within the shaft 808. To secure the tissues to each other, the fastener assembly 806 can be clamped onto the overlapping tissues 788, 788', creating a fixation zone or fixation area 816. FIG. 48B shows tissue 788, 788'and fastener assembly 806, which are joined together over a fixed area 816, and this fastener assembly 806 is removed from the overtube 780. ing.

Figures 49A-50B show another variation for constructing the distal end of the overtube. FIG. 49A shows an isometric view of the overtube 790 with several alternating windows. On the aligned flanks of the overtube 790, the first channel 792 and the second channel 792'can be defined to extend longitudinally along the distal end of the overtube 790. Along the first channel 792, a large number of windows 794 are preferably evenly spaced from each other, with the first channel 792 extending throughout. On the side-by-side side, the second channel 792'can also define a large number of windows 794' evenly spaced from each other. Windows 794 and 794'are similarly shaped, but in an overlapping fashion, alternating in side-by-side windows to allow tissue to be drawn into lumen 796. FIG. 49B shows an isometric view of the overtube 790 from FIG. 49A with half the walls omitted for clarity. FIG. 50A shows a side view of the overtube 790 and the first channel 792, while FIG. 50B shows a side view of the overtube 790 and the other side of the second channel 792'. The number of windows on either channel 792 or 792'is not intended to be limited, but any number of alternating windows may be incorporated into the overtube 790 due to the desired application and result.

FIG. 51 shows a cross-sectional side view of the overtube 790 of FIGS. 49A-50B showing the fit into the tissue. As shown, the inlaid tissue 800, 800'can be pulled into the lumen 796 by the first and second windows 794, 794', respectively. Once pulled inward, the overlapping tissues 800, 800'can be fastened to each other using a drive tube and a spiral fastener 714 as described above. Alternatively, and as shown, fastener 802, each preferably having a tapered or sharp distal tip 804, is a tissue 800 fitted from the proximal end of the overtube 790 to tighten them together. , 800'can be driven distally to each adjacent region. Once tightened, the overtube 790 can then be removed from the area by simply retracting the overtube 790, but successfully handles the tissue tightened through the first and second channels 792, 792'. Two fasteners 802 are shown, but many fasteners can be used due to the desired result. In addition, once the fastener is placed in the tissue, barbs or whiskers-like filaments are formed along its length to prevent the fastener from retracting or moving from the tissue. Can protrude, and can engage with tissue.

The application of the devices and methods of use discussed above is not limited to the area of the body and may include a number of additional treatment applications. Other treatment sites may include an area or area of the body around the body of the organism. Modifications of the above assemblies and methods for carrying out the present invention, as well as variations of aspects of the invention apparent to those skilled in the art, are intended to be within the claims.

Preferred embodiments of the present invention are as follows.

(1) A method for forming a sac from the inside of an organ, and the following: The step of openly adhering the first region of the interior to the tissue adhesive member; The step of moving the first region inside the tissue through the tissue adhesive member; The step of openly adhering the internal second region to the tissue adhesive member so that the first region is located proximal to the second region; The step of fixing the first region to the second region to form the sac. Including, methods. (2) The method of embodiment 1, wherein the first and second regions are created in at least two openable adhesive regions defined in the tissue adhesive member by vacuum. A method of openly adhering to the tissue adhesive member. (3) The method according to embodiment 1, wherein the first region is positioned adjacent to the second region. (4) The method according to the first embodiment, wherein the first region is parallel to the second region. (5) The method according to the first embodiment, in which the second region of the inner surface is openly bonded to the tissue adhesive member so that the first region is positioned proximal to the second region. A method comprising removing a partition wall arranged in the tissue adhesive member such that the first region is in contact with a second region. (6) The method of embodiment 5, comprising the step of inducing a healing response in the first or second region while removing the septum. (7) The method according to embodiment 5, further comprising excising the first region or the second region while removing the partition wall. (8) The method according to embodiment 7, wherein the step of excising the first region or the second region is selected from the group consisting of cutting, knurling, heating, freezing and chemical ablation. A method, including a method. (9) The method according to the first embodiment, in which the step of fixing the first region to the second region slides a wedge arranged in an internal channel defined by the tissue adhesive member. A method of further including the step of causing the wedge to advance the mechanical fastener so as to tighten the first region to the second region. (10) The method of embodiment 9, wherein the mechanical fastener is selected from the group consisting of C-shaped staples, U-shaped staples, clips and tags. (11) The method according to the first embodiment, wherein the first region and the second region are released from the tissue adhesive member. (12) The method according to embodiment 1, wherein the organ includes a stomach. (13) The adhesive member is inserted into the stomach endoscopically through the passage of the esophagus before the first region of the interior is openly adhered to the tissue adhesive member, embodiment 12. The method described in. (14) The method of embodiment 1, wherein the step of fixing the first region to the second region defines a boundary between the lumen and the rest of the organ. (15) The method according to embodiment 14, wherein the boundary is a straight line. (16) The method of embodiment 14, wherein the boundary is adjacent to a curved surface of the organ. (17) The method of embodiment 14, wherein the boundaries are adjustable. (18) The method of embodiment 14, wherein the boundary projects with respect to the rest of the organ. (19) The step of fixing the first region to the second region to form the lumen propels the fastener through an internal channel defined in the tissue adhesive member to the first region. The method according to embodiment 1, comprising the step of fixing the second region together. (20) 19. The method of embodiment 19, wherein the fastener has a gradually tapered spiral shape with a penetrating end. (21) The step of propelling the fastener through the internal channel places the fastener around a longitudinal axis defined by the fastener so that the first region and the second region are tightened together. 19. The method of embodiment 19, comprising the step of rotating. (22) Modified gastric sac, below: The outer and inner surfaces that define the main lumen, as well as the gastric sac with a proximal gastric sac opening proximal to the main lumen; A gastric sac having proximal and distal ends, as well as an internal surface between these ends, the ends of which are formed from the rotated portion of the internal surface of the gastric sac, resulting in the said. The gastric lumen defines a volume separate from the main lumen, which is the gastric sac that maintains contact with the esophagus. (23) The modified gastric sac according to embodiment 22, further comprising a plurality of fasteners attached to the gastric lumen and the interface defined by the gastric sac. (24) The modified gastric sac according to embodiment 23, wherein the fastener comprises a biocompatible mechanical fastener selected from the group consisting of staples, tags, clips, sutures, screws, and adhesives. .. (25) The modified gastric sac according to embodiment 22, wherein the gastric lumen is straight. (26) The modified gastric sac according to claim 22, wherein the gastric lumen is tapered, and as a result, the distal end is larger than the proximal end. (27) The modified gastric sac according to claim 22, wherein the gastric lumen is tapered, and as a result, the proximal end is larger than the distal end. (28) An embodiment in which the proximal gastric lumen defines a proximal gastric lumen opening, and the proximal gastric lumen and the proximal gastric lumen opening are coaxially positioned. 22 Modified gastric sac.