Stent for forming anastomosis and medical tool including the same stent

Abstract

To provide a stent for forming an anastomosis in the digestive tract.SOLUTION: A stent includes a stent body having a restrained form. The stent body has an expanded form provided with a base end of the body expanded to form a base end side flange, an end of the body expanded to form an end side flange, and a cylindrical region extending between the base end side flange and the end side flange. At least the cylindrical region of the stent is attached with a cover, and the cylindrical region with the cover has a passable internal passage configured to make it possible to flow through the cylindrical region with the cover. The base end side flange and the end side flange are configured to arrange adjacent layers of body tissues without damaging the body tissues between them side by side. The base end side flange and the end side flange are provided with a roll-up type wall which rolls up toward the passable internal passage of the stent respectively.SELECTED DRAWING: Figure 15B

Description

[Technical field]

[0001] The present disclosure relates generally to medical methods and devices, and more particularly to methods and devices for forming anastomoses between body tissues and organs. [Background technology]

[0002] The present disclosure relates generally to medical methods and devices, and more particularly to methods and devices for creating an anastomosis. Some medical procedures require the formation of an anastomosis between adjacent body lumens. For example, some procedures may be performed by entering the gastrointestinal (GI) tract through a first organ or structure, such as the esophagus, stomach, duodenum, small intestine, large intestine, or peritoneal cavity, and delivering an anchor or stent to adjacent portions of adjacent organs and luminal or tissue structures, such as the GI tract, bile duct, pancreatic duct, gallbladder, pancreas, cysts, pseudocysts, abscesses, etc. Such methods and devices may be used for access between portions of the urinary tract, such as the bladder and ureters, ducts of the pulmonary system, such as the trachea and bronchi, and biliary tract, such as the bile duct and gallbladder, as well as for vascular applications.

[0003] Stents are commonly used to facilitate opening of closed body vessels for access, drainage or other purposes. Tissue anchors are used to secure adjacent tissues or organs. Interluminal tissue anchors with a central lumen are used to facilitate fluid communication between adjacent ducts, organs or lumens. In many cases, precise placement of the tissue anchor or stent is essential, especially when the tissue anchor or stent has distinct anchoring elements at its proximal and / or distal ends and the device is used to secure adjacent lumens.

[0004] Placing a stent or other tissue anchor between adjacent body lumens, organs, or other structures typically requires penetrating both the wall of the first body lumen to which access is provided and the wall of the second body lumen to which the procedure is targeted. When initially creating such an access penetration, there is a significant risk of leakage from either or both of the access and target body lumens into the surrounding space, such as, but not limited to, the peritoneal cavity. In some procedures, such as those involving bariatric, transgastric, or transduodenal access to the bile duct, loss of fluid into the surrounding tissue and body lumen can pose a significant risk to the patient. The risk can be exacerbated when it is necessary not only to penetrate the lumen wall, usually with a needle, to achieve the initial access, but also to subsequently enlarge or expand the initial penetration.

[0005] Gastric bypass surgery has become more common in recent years along with laparoscopic surgery. One type of gastric bypass surgery is the Roux-en-Y (RNY) gastric bypass. In weight loss bypass surgery, fluid leakage from the surgical anastomosis site is a concern among physicians. With a procedure such as the Roux-en-Y gastric bypass, the physician is required to surgically create and affix two such anastomoses, one at the fundus pouch to the jejunum and one at the ileum to the duodenum. Figures 1A-1C show an example of an RNY procedure. The procedure involves incising a portion of the stomach 1 to create a stomach / fundus pouch 5 at an incision line 4. The hole created in the stomach is sealed with staples 7. The intestine is incised at the incision line 4 between the duodenum 2 and the jejunum 3. As a result, food will bypass the sealed portion 6 of the stomach. The stomach or fundus pouch 5 is then connected to the jejunum 3. The duodenum 2 is then attached to the ileum / jejunum 4, forming an anastomosis 9 downstream of the anastomosis 8 between the gastric pouch and the jejunum. After the RNY procedure, food flows down the esophagus into the gastric pouch, which has a smaller volume than the patient's previous stomach. Food bypasses the previous volume of the stomach. In the method of claim 28, the gallbladder 10a encounters food in the jejunum instead of mixing with the food in the bypassed portion of the patient's stomach. FIG. 1C shows digestive fluids flowing from the gallbladder 10a through the cystic duct and common hepatic duct into the duodenum 2. FIG. 1C also shows digestive fluids flowing from the pancreas 10b through the pancreatic duct into the duodenum 2.

[0006] The RNY procedure is believed to be effective because the new stomach (pouch) is small and cannot accommodate the same volume of food as the patient's old stomach. If the patient eats too much, they will vomit. It is possible to enlarge the new pouch, but it is difficult. It is also theorized that the procedure may change the patient's satiety response / pattern. For example, it is possible that the presence of food and digestive fluids in the jejunum may signal the body that the patient is full. The RNY procedure also reduces the retention time that food is with the digestive fluids, as the fluids no longer mix with the food in the stomach, but in the jejunum downstream of the pouch. Reducing the retention time between food and digestive fluids may also have an effect on the adsorption of calories and nutrients.

[0007] It is important to create a tight anastomosis between the gastric pouch and the jejunum, as well as between the duodenum and the jejunum. Patient recovery time is typically around 5 days for RNY surgery. Leaks can cause serious complications for patients after surgery. Leaks occur in about 20% of patients. If there is a leak at any of the anastomotic sites, hospitalization is much longer, averaging around 25 days. In current RNY, staples are typically used to seal the bypassed stomach area, create the fundus pouch, and create the anastomosis. However, the stapling process can be lengthy using laparoscopic techniques, and the diameter of the anastomosis created by stapling varies between patients and physicians.

[0008] Other complications may occur, such as stricture formation at the anastomosis site. Strictures can cause thick walls to form at the anastomosis site, shortening the inner diameter of the passageway. The shortened diameter can restrict the flow of food through the anastomosis.

[0009] Colectomy is another procedure that involves the creation of an anastomosis with the intestine. A segment of the intestine can be removed and the cut ends of the intestine are connected by an anastomosis as shown in FIG. 2A. The anastomosis can be created by stapling the cut ends of the intestine together (FIGS. 2A-2C). Endolinear connectors can also be attached and used to connect the cut ends of the intestine. Typically, endolinear connectors have a short diameter and can limit the flow of non-fluid materials through the anastomosis. Summary of the Invention [Problem to be solved by the invention]

[0010] It would be desirable to provide improved protocols and access tools for creating an anastomosis while minimizing the risk of leakage. A faster method for creating an anastomosis is also desired. [Means for solving the problem]

[0011] The present invention relates to improved stents for creating anastomoses in the digestive tract, laparoscopic and endoscopic tools for delivering the stents, and methods of creating anastomoses using the stents and tools described herein.

[0012] A stent is disclosed herein. In some embodiments, the stent comprises a stent body formed of a woven filament braid having a constrained configuration, the stent body having an expanded configuration with a proximal end of the body expanded to a proximal flange, a distal end of the body expanded to a distal flange, and a cylindrical region between the proximal and distal flanges. At least the cylindrical region of the stent is covered. The covered cylindrical region has a navigable internal passageway configured to allow fluids, digested food, and partially digested food to flow therethrough. The proximal and distal flanges are configured to allow fluids, digested food, and partially digested food to flow therethrough. The proximal and distal flanges are configured to atraumatically engage body tissue between the proximal and distal flanges, and the proximal and distal flanges each have a pull-out force greater than about 2.94 N. The stent is also configured to be retrievable from the expanded configuration by a catheter device.

[0013] In any of the embodiments disclosed herein, the stent can include a proximal flange plug configured to prevent food from lodging in the interior area of ​​the proximal flange, and a distal flange plug configured to prevent food from lodging in the interior area of ​​the distal flange. In any of the embodiments disclosed herein, the stent includes an inner diameter of the proximal flange plug, and the inner diameter of the distal flange plug is about the same as the inner diameter of the cylindrical region. In any of the embodiments disclosed herein, the stent has a proximal flange including a double-walled flange and a distal flange including a double-walled flange.

[0014] In any of the embodiments disclosed herein, the stent has proximal and distal flanges each comprising five or more inflection points.In any of the embodiments disclosed herein, the stent has proximal and distal flanges each comprising six or more inflection points.

[0015] In any of the embodiments disclosed herein, the stent has a proximal flange with a curled wall that curls toward the accessible internal passageway of the stent, and a distal flange with a curled wall that curls toward the accessible internal passageway of the stent.

[0016] In any of the embodiments disclosed herein, the stent has a proximal flange with a rolled-up wall that rolls toward the outside of a covered cylindrical region, and a distal flange with a rolled-up wall that rolls toward the outside of a covered cylindrical region.

[0017] In any of the embodiments disclosed herein, the stent comprises a proximal flange configured to bend over a covered cylindrical region and a distal flange configured to bend over a covered cylindrical region. In any of the embodiments disclosed herein, the stent comprises a proximal flange further comprising a curved surface adjacent a proximal end of the proximal flange configured to atraumatically engage body tissue, and a distal flange further comprising a curved surface adjacent a distal end of the distal flange configured to atraumatically engage body tissue.

[0018] In any of the embodiments disclosed herein, the stent has a proximal flange with an inner diameter larger than the diameter of the covered cylindrical region, and a distal flange with an inner diameter larger than the diameter of the covered cylindrical region.

[0019] In any of the embodiments disclosed herein, the entire stent body is covered. In any of the embodiments disclosed herein, the stent is a self-expanding stent.

[0020] A self-expanding anastomotic stent is disclosed herein. In any of the embodiments disclosed herein, the self-expanding stent comprises a flexible body having an unexpanded configuration and an expanded configuration, the expanded configuration comprising a proximal end of the body expanded to a proximal flange, a distal end of the body expanded to a distal flange, and a cylindrical region between the proximal and distal flanges. At least the cylindrical region is covered. The covered cylindrical region has a navigable internal passageway configured to allow fluids, digested food, and partially digested food to flow therethrough. The proximal and distal flanges each protrude away from the internal passageway of the cylindrical region to allow fluids, digested food, and partially digested food to flow therethrough. The stent is further configured to be retrievable from the expanded configuration within the patient's body after formation of the anastomosis.

[0021] In any of the embodiments disclosed herein, the proximal and distal flanges are configured to atraumatically engage body tissue, and the proximal and distal flanges each have a pull-out force of greater than about 2.94 N.

[0022] In any of the embodiments disclosed herein, the proximal and distal flanges each comprise five or more inflection points. In any of the embodiments disclosed herein, the proximal and distal flanges each comprise six or more inflection points.

[0023] In any of the embodiments disclosed herein, the proximal flange has a rolled wall that rolls toward the outside of the covered cylindrical region, and the distal flange has a rolled wall that rolls toward the outside of the covered cylindrical region.

[0024] In any of the embodiments disclosed herein, the proximal flange is configured to bend over a covered cylindrical area, and the proximal flange is configured to bend over a covered cylindrical area.

[0025] In any of the embodiments disclosed herein, the proximal flange further comprises a curved surface adjacent a proximal end of the proximal flange configured to atraumatically engage body tissue, and the distal flange further comprises a curved surface adjacent a distal end of the distal flange configured to atraumatically engage body tissue.

[0026] Disclosed herein is a medical device configured for laparoscopic use, which may include a handle, a shaft engaged to the handle, a self-expanding stent, and a stent retainer configured to hold the self-expanding stent in a constrained state, the stent retainer comprising a material that restrains the self-expanding stent, is configured to hold the stent in a constrained state, is configured to open to allow the stent to expand, and is configured to be removable after stent deployment.

[0027] In any of the embodiments disclosed herein, the medical device can include an articulation element configured to change an orientation of the stent retainer relative to the shaft from a first orientation along an axial plane defined by the shaft to a second orientation in the axial plane defined by the shaft.

[0028] In any of the embodiments disclosed herein, the stent retainer is configured to selectively release the first end of the stent and the second end of the stent. In any of the embodiments disclosed herein, the medical device can include a first pull wire assembly configured to controllably release a first end of the stent by opening a flexible material, and a second pull wire assembly configured to controllably release material restraining a second end of the stent by opening the flexible material.

[0029] In any of the embodiments disclosed herein, the stent retainer and the self-expanding stent are part of a removable cartridge assembly. In any of the embodiments disclosed herein, the medical device can include a sharpened tip configured to penetrate body tissue.

[0030] Disclosed herein is a method of forming an anastomosis, which may include endoscopically accessing a patient's stomach with an endoscope and a catheter device carrying a stent, making an incision in the stomach wall, advancing the endoscope and catheter device through the incision in the stomach wall, advancing the endoscope to a location in the peritoneal cavity adjacent a target location in the intestinal tract, advancing the catheter device through the wall of the intestinal tract, placing a first end of a stent in the intestinal tract, and placing a second end of the stent in the stomach to form a pathway between the stomach and the intestinal tract.

[0031] In any of the embodiments disclosed herein, the target location within the intestinal tract is the jejunum or ileum. In any of the embodiments disclosed herein, the target location within the intestinal tract is the duodenum.

[0032] In any of the embodiments disclosed herein, the stomach is a fundus pouch formed during a gastric bypass procedure. In any of the embodiments disclosed herein, the method includes forming the fundus pouch as part of the gastric bypass procedure prior to endoscopically accessing the GI tract with a catheter device. In any of the embodiments disclosed herein, the method includes, after deploying the first end of the stent, retracting the catheter device and the first end of the stent proximally to engage the first end of the stent with a wall of the intestine and moving the intestine into apposition with the wall of the fundus pouch.

[0033] In any of the embodiments disclosed herein, the stent is a self-expanding stent having a first double-walled flange structure at a first end and a second double-walled flange structure at a second end.

[0034] In any of the embodiments disclosed herein, penetrating the ileum or jejunum wall further comprises activating an energized portion of the catheter device adjacent the tip, contacting the jejunum or ileum wall with the energized tip, and advancing the energized tip through the jejunum or ileum wall.

[0035] In any of the embodiments disclosed herein, deploying the stent includes removing the sheath restraining the stent and allowing the stent to self-expand. In any of the embodiments disclosed herein, after placing the first end of the stent in the jejunum or ileum, further comprising pausing retraction of the sheath after placing the first end of the stent in the jejunum or ileum and confirming placement of the first end within the jejunum or ileum.In any of the embodiments disclosed herein, after confirming placement of the first end of the stent within the jejunum or ileum, continuing retraction of the sheath to place a second end of the stent within the stomach.

[0036] In any of the embodiments disclosed herein, the method further comprises removing the stent after formation of the anastomosis. In any of the embodiments disclosed herein, the method further comprises laparoscopically accessing the peritoneal cavity prior to endoscopically accessing the patient's fundus pouch with the catheter device carrying the stent; creating a laparoscopic environment in the peritoneal cavity; and introducing a hand instrument into the peritoneal cavity. In any of the embodiments disclosed herein, the method further comprises guiding a tip of the catheter device into the peritoneal cavity using a hand instrument, and guiding a tip of the catheter device through the peritoneal cavity to a target location outside the jejunum using a hand instrument. In any of the embodiments disclosed herein, the method further comprises holding the jejunum adjacent to the target location in the jejunum with a second hand instrument in the peritoneal cavity prior to penetrating the jejunum wall. In any of the embodiments disclosed herein, the method further comprises visualizing the fundus pouch, the tip of the catheter device, and the target location in the jejunum from the peritoneum using laparoscopic guidance.

[0037] In any of the embodiments disclosed herein, after forming the fundus pouch, the method further comprises suturing a portion of the fundus pouch to a portion of the jejunum or ileum adjacent to the target location in the jejunum or ileum.

[0038] In any of the embodiments disclosed herein, advancing the catheter device through a wall of the intestine further comprises advancing a grasping device from a port of the endoscope, grasping the intestine adjacent the target location with the grasping device, and advancing the catheter device through the wall of the intestine while grasping the intestine with the grasping device.

[0039] A method of forming an anastomosis is disclosed. The method may include endoscopically accessing a patient's stomach with a catheter device carrying a stent, delivering a position marker visible under ultrasound guidance to a target location in the intestine, ultrasonically locating the position marker of the target location in the intestine relative to the catheter device carrying the stent, advancing the catheter device to penetrate the stomach wall and the intestinal wall, placing a first end of the stent in the intestine, and placing a second end of the stent in the stomach to form a pathway between the stomach and the intestine. In some embodiments, the target location in the intestine is the jejunum or ileum.

[0040] Disclosed herein are methods of forming an anastomosis that can include placing a stent in the passage between a fundus pouch and the intestine formed during a gastric bypass procedure. In any of the embodiments disclosed herein, the method further comprises forming a fundus pouch during a gastric bypass procedure and connecting the fundus pouch to the intestine to form a passage between the fundus pouch and the intestine.

[0041] In any of the embodiments disclosed herein, the method further comprises removing the stent after formation of the anastomosis. In any of the embodiments disclosed herein, deploying the stent further comprises deploying a first end of the stent within the intestinal lumen and deploying a second end of the stent within the fundus pouch.

[0042] Disclosed herein is a method of forming an anastomosis, comprising accessing a patient's peritoneal cavity with a laparoscopic device comprising a stent having a first end and a second end, penetrating a wall of a fundic pouch with the laparoscopic device, placing the first end of the stent within the fundic pouch, penetrating a wall of the jejunum with the laparoscopic device, and placing the second end of the stent within the jejunum to form a pathway between the fundic pouch and the jejunum.

[0043] In any of the embodiments disclosed herein, the method further comprises forming a fundus pouch as part of a gastric bypass procedure prior to accessing the patient's peritoneal cavity with a laparoscopic device.

[0044] In any of the embodiments disclosed herein, after the first end of the stent is deployed, pulling traction on the laparoscopic device to engage a first flange of the first end of the stent with the wall of the fundus pouch.

[0045] In any of the embodiments disclosed herein, the stent is a self-expanding stent with a first double-walled flange structure at a first end and a second double-walled flange structure at a second end.

[0046] In any of the embodiments disclosed herein, deploying the stent comprises removing a restraint from the stent and allowing the stent to self-expand. In any of the embodiments disclosed herein, removing the restraint comprises removing the sheath. In any of the embodiments disclosed herein, removing the restraint comprises removing the material restraining the stent.

[0047] In any of the embodiments disclosed herein, the method further comprises endoscopically removing the stent after formation of the anastomosis. In any of the embodiments disclosed herein, the method further includes rotating an orientation of a stent holder holding the stent relative to the shaft of the laparoscopic device from a first orientation along an axial plane defined by the shaft to a second orientation relative to an axial plane defined by the shaft after reaching the peritoneal cavity and prior to penetrating the wall of the fundus pouch.

[0048] Disclosed herein is a method of forming an anastomosis in a patient's digestive tract, comprising: accessing a patient's peritoneal cavity with a laparoscopic device carrying an anastomosis device, penetrating a first intestinal wall adjacent a first closed end of the intestine with a surgical device in the peritoneal cavity, positioning a first end of the anastomosis device at the penetration in the first intestinal wall, placing the first end of the anastomosis device in a first internal volume of the intestine adjacent the penetration in the first intestinal wall, penetrating a second intestinal wall adjacent a second closed end of the intestine with a surgical device in the peritoneal cavity, positioning a second end of the anastomosis device at the penetration in the second intestinal wall; and placing the second end of the anastomosis device in the second internal volume of the intestine adjacent the penetration in the second intestinal wall, thereby forming a pathway between the first internal volume of the intestine and the second internal volume of the intestine.

[0049] In any of the embodiments disclosed herein, the first closed end of the intestine is a first closed portion of the colon and the second closed end of the intestine is a second closed portion of the colon. In any of the embodiments disclosed herein, the anastomosis device is a stent. In any of the embodiments disclosed herein, placing the first end of the stent further comprises pulling a traction portion on a double-wall flange structure of the stent after placing the first end of the stent in the first interior space of the intestine to engage the first end of the stent with the first intestinal wall and move the first intestinal wall proximate to the penetration of the second intestinal wall.

[0050] In any of the embodiments disclosed herein, the anastomosis device comprises two separate parts, a first end comprising a first part comprising a first tissue engaging structure and a first electromagnetic coupling structure, and a second end comprising a second part comprising a second tissue engaging structure and a second electromagnetic coupling structure. In any of the embodiments disclosed herein, the method further comprises magnetically connecting the first electromagnetic coupling structure to the second electromagnetic coupling structure.

[0051] In any of the embodiments disclosed herein, the method further comprises endoscopically removing the anastomosis device after formation of the anastomosis. Disclosed herein is a method of forming an anastomosis in the digestive tract of a patient, the method including accessing a first portion of the intestine with a catheter device carrying a stent, penetrating a wall of the first portion of the intestine adjacent a first closed end of the intestine with the catheter device, penetrating a wall of a second portion of the intestine adjacent a second closed end of the intestine with the catheter device, placing a first end of the stent into engagement with the wall of the second portion of the intestine, and placing a second end of the stent into engagement with the wall of the first portion of the intestine, thereby forming a pathway between the first portion of the intestine and the second portion of the intestine.

[0052] In any of the embodiments disclosed herein, the first portion of the intestinal tract is a first portion of the colon and the second portion of the intestinal tract is a second portion of the colon. In any of the embodiments disclosed herein, accessing the first portion of the intestinal tract with the catheter device further comprises accessing the peritoneal cavity with the catheter device, forming a penetration in the first portion of the intestinal tract, and advancing the catheter into the interior space of the first portion of the intestinal tract.

[0053] In any of the embodiments disclosed herein, the first end of the stent has a double-wall flange structure and the second end of the stent has a double-wall flange structure, and the method further comprises pulling a traction portion on the double-wall flange structure of the first end of the stent to engage the first end of the stent with a wall of the second portion of the intestine, and pulling the second portion of the intestine into apposition with the wall of the first portion of the intestine.

[0054] In any of the embodiments disclosed herein, penetrating the wall of the first portion of the intestine and penetrating the wall of the second portion of the intestine includes applying electrical energy to a tip of a catheter device and contacting the wall of the first portion of the intestine and the wall of the second portion of the intestine with the electrically energized tip.

[0055] In any of the embodiments disclosed herein, the method further comprises using a laparoscopic tool to guide the catheter device prior to penetrating the wall of the second portion of the intestinal tract.

[0056] In any of the embodiments disclosed herein, the method further comprises removing the anastomosis device after formation of the anastomosis. Effect of the Invention

[0057] Thus, according to the present invention, an improved stent for forming an anastomosis in the digestive tract is provided. [Brief description of the drawings]

[0058] [Figure 1A] FIG. 1 shows an illustrated example of gastric bypass surgery. [Figure 1B] FIG. 1 shows an illustrated example of gastric bypass surgery. [Figure 1C] FIG. 1 shows an illustrated example of gastric bypass surgery. [Figure 2A] FIG. 1 shows an illustrated example of a colectomy surgery. [Figure 2B] FIG. 1 shows an illustrated example of a colectomy surgery. [Figure 2C] FIG. 1 shows an illustrated example of a colectomy surgery. [Figure 3A] 1 illustrates a catheter device according to some embodiments. [Figure 3B] 1 illustrates a catheter device according to some embodiments. [Figure 3C] 1 illustrates a catheter device according to some embodiments. [Figure 3D]1 illustrates a catheter device according to some embodiments. [Figure 4A] 1A-1C are diagrams illustrating a process of deploying a stent according to some embodiments. [Figure 4B] 1A-1C are diagrams illustrating a process of deploying a stent according to some embodiments. [Figure 4C] 1A-1C are diagrams illustrating a process of deploying a stent according to some embodiments. [Figure 5A] 1A-1D are diagrams illustrating a laparoscopic surgical device for placing a stent, according to some embodiments. [Figure 5B] 1A-1D are diagrams illustrating a laparoscopic surgical device for placing a stent, according to some embodiments. [Figure 5C] 1A-1D are diagrams illustrating a laparoscopic surgical device for placing a stent, according to some embodiments. [Figure 6] 1 illustrates a laparoscopic surgical device according to some embodiments. [Figure 7A] 1 illustrates a laparoscopic surgery device according to some embodiments. [Figure 7B] 1 illustrates a laparoscopic surgery device according to some embodiments. [Figure 8A] 1 illustrates a laparoscopic surgical device according to some embodiments. [Figure 8B] 1 illustrates a laparoscopic surgical device according to some embodiments. [Figure 9A] 1 illustrates a laparoscopic surgery device according to some embodiments. [Figure 9B] 1 illustrates a laparoscopic surgical device according to some embodiments. [Figure 9C] 1 illustrates a laparoscopic surgery device according to some embodiments. [Figure 9D] 1 illustrates a laparoscopic surgical device according to some embodiments. [Figure 9E] 1 illustrates a laparoscopic surgery device according to some embodiments. [Figure 10] 1 illustrates a laparoscopic surgical device according to some embodiments. [Figure 11A] 1 illustrates a laparoscopic surgical device according to some embodiments. [Figure 11B] 1 illustrates a laparoscopic surgical device according to some embodiments. [Figure 11C] 1 illustrates a laparoscopic surgical device according to some embodiments. [Figure 11D] 1 illustrates a laparoscopic surgical device according to some embodiments. [Figure 12A] 1A-1D illustrate various aspects of an embodiment of a stent cartridge device, according to some embodiments. [Figure 12B] 1A-1D illustrate various aspects of an embodiment of a stent cartridge device, according to some embodiments. [Figure 12C] 1A-1D illustrate various aspects of an embodiment of a stent cartridge device, according to some embodiments. [Figure 12D] 1A-1D illustrate various aspects of an embodiment of a stent cartridge device, according to some embodiments. [Figure 12E] 1A-1D illustrate various aspects of an embodiment of a stent cartridge device, according to some embodiments. [Figure 12F] 1A-1D illustrate various aspects of an embodiment of a stent cartridge device, according to some embodiments. [Figure 13A] 1 illustrates a laparoscopic surgical device according to some embodiments. [Figure 13B] 1 illustrates a laparoscopic surgical device according to some embodiments. [Figure 13C] 1 illustrates a laparoscopic surgical device according to some embodiments. [Figure 14] 1 illustrates a portion of a device with a fiber optic illumination system according to some embodiments. [Figure 15A] 1A-1D are diagrams illustrating cross sections of stents according to some embodiments. [Figure 15B] 1A-1D are diagrams illustrating cross sections of stents according to some embodiments. [Figure 15C]1A-1D are diagrams illustrating cross sections of stents according to some embodiments. [Figure 15D] 1A-1D are diagrams illustrating cross sections of stents according to some embodiments. [Figure 15E] 1A-1D are diagrams illustrating cross sections of stents according to some embodiments. [Figure 15F] 1A-1D are diagrams illustrating cross sections of stents according to some embodiments. [Figure 15G] 1A-1D are diagrams illustrating cross sections of stents according to some embodiments. [Figure 16A] 1A-1D are diagrams illustrating cross sections of stents according to some embodiments. [Figure 16B] 1A-1D are diagrams illustrating cross sections of stents according to some embodiments. [Figure 16C] 1A-1D are diagrams illustrating cross sections of stents according to some embodiments. [Figure 16D] 1A-1D are diagrams illustrating cross sections of stents according to some embodiments. [Figure 16E] 1A-1D are diagrams illustrating cross sections of stents according to some embodiments. [Figure 16F] 1A-1D are diagrams illustrating cross sections of stents according to some embodiments. [Figure 16G] 1A-1D are diagrams illustrating cross sections of stents according to some embodiments. [Figure 16H] 1A-1D are diagrams illustrating cross sections of stents according to some embodiments. [Figure 16I] 1A-1D are diagrams illustrating cross sections of stents according to some embodiments. [Figure 16J] 1A-1D are diagrams illustrating cross sections of stents according to some embodiments. [Figure 17A] 1 illustrates a stent according to some embodiments. [Figure 17B] 1 illustrates a stent according to some embodiments. [Figure 17C] 1 illustrates a stent according to some embodiments. [Figure 18A] 1A-1D are diagrams illustrating cross sections of stents according to some embodiments. [Figure 18B]1A-1D are diagrams illustrating cross sections of stents according to some embodiments. [Figure 18C] 1A-1D are diagrams illustrating cross sections of stents according to some embodiments. [Figure 18D] 1A-1D are diagrams illustrating cross sections of stents according to some embodiments. [Figure 19A] 1 illustrates a stent with a two-part structure according to some embodiments. [Figure 19B] 1A-1C illustrate a method of implanting a stent having a two-part structure according to some embodiments. [Figure 19C] 1A-1C illustrate a method of implanting a stent having a two-part structure according to some embodiments. [Figure 19D] 1A-1C illustrate a method of implanting a stent having a two-part structure according to some embodiments. [Figure 20A] 1A-1C are diagrams illustrating a method of placing a stent between the stomach and a portion of the intestinal tract according to some embodiments. [Figure 20B] 1A-1C are diagrams illustrating a method of placing a stent between the stomach and a portion of the intestinal tract according to some embodiments. [Figure 20C] 1A-1C are diagrams illustrating a method of placing a stent between the stomach and a portion of the intestinal tract according to some embodiments. [Figure 21A] 1A-1C are diagrams illustrating a method of placing a stent between the stomach and a portion of the intestinal tract using ultrasound guidance according to some embodiments. [Figure 21B] 1A-1C are diagrams illustrating a method of placing a stent between the stomach and a portion of the intestinal tract using ultrasound guidance according to some embodiments. [Figure 21C] 1A-1C are diagrams illustrating a method of placing a stent between the stomach and a portion of the intestinal tract using ultrasound guidance according to some embodiments. [Figure 21D] 1A-1C are diagrams illustrating a method of placing a stent between the stomach and a portion of the intestinal tract using ultrasound guidance according to some embodiments. [Figure 22A] 1A-1C are diagrams illustrating a method of placing a stent between the stomach and a portion of the intestinal tract using an endoscopic catheter and laparoscopic tools according to some embodiments. [Figure 22B] 1A-1C are diagrams illustrating a method of placing a stent between the stomach and a portion of the intestinal tract using an endoscopic catheter and laparoscopic tools according to some embodiments. [Figure 22C] 1A-1C are diagrams illustrating a method of placing a stent between the stomach and a portion of the intestinal tract using an endoscopic catheter and laparoscopic tools according to some embodiments. [Figure 22D] 1A-1C are diagrams illustrating a method of placing a stent between the stomach and a portion of the intestinal tract using an endoscopic catheter and laparoscopic tools according to some embodiments. [Figure 23A] 1A-1C illustrate a method of placing anastomotic stents between the fundus pouch and the jejunum and between the duodenum and ileum after a gastric bypass procedure according to some embodiments. [Figure 23B] 1A-1C illustrate a method of placing anastomotic stents between the fundus pouch and the jejunum and between the duodenum and ileum after a gastric bypass procedure according to some embodiments. [Figure 23C] 1A-1C illustrate a method of placing anastomotic stents between the fundus pouch and the jejunum and between the duodenum and ileum after a gastric bypass procedure according to some embodiments. [Figure 23D] 1A-1C illustrate a method of placing anastomotic stents between the fundus pouch and the jejunum and between the duodenum and ileum after a gastric bypass procedure according to some embodiments. [Figure 23E] 1A-1C illustrate a method of placing anastomotic stents between the fundus pouch and the jejunum and between the duodenum and ileum after a gastric bypass procedure according to some embodiments. [Figure 23F] 1A-1C illustrate a method of placing anastomotic stents between the fundus pouch and the jejunum and between the duodenum and ileum after a gastric bypass procedure according to some embodiments. [Figure 23G] 1A-1C illustrate a method of placing anastomotic stents between the fundus pouch and the jejunum and between the duodenum and ileum after a gastric bypass procedure according to some embodiments. [Figure 24A] 11A-11C illustrate a method of placing a stent between a fundus pouch and a portion of the intestine according to some embodiments. [Figure 24B]11A-11C illustrate a method of placing a stent between a fundus pouch and a portion of the intestine according to some embodiments. [Figure 24C] 11A-11C illustrate a method of placing a stent between a fundus pouch and a portion of the intestine according to some embodiments. [Figure 25A] 11A-11C are diagrams illustrating a method of placing a stent between a fundus pouch and a portion of the intestine using ultrasound guidance according to some embodiments. [Figure 25B] 11A-11C are diagrams illustrating a method of placing a stent between a fundus pouch and a portion of the intestine using ultrasound guidance according to some embodiments. [Figure 25C] 11A-11C are diagrams illustrating a method of placing a stent between a fundus pouch and a portion of the intestine using ultrasound guidance according to some embodiments. [Figure 25D] 11A-11C are diagrams illustrating a method of placing a stent between a fundus pouch and a portion of the intestine using ultrasound guidance according to some embodiments. [Figure 26A] 14A-14C illustrate a method of placing a stent between a fundus pouch and a portion of the intestine using an endoscopic catheter and laparoscopic tools according to some embodiments. [Figure 26B] 14A-14C illustrate a method of placing a stent between a fundus pouch and a portion of the intestine using an endoscopic catheter and laparoscopic tools according to some embodiments. [Figure 26C] 14A-14C illustrate a method of placing a stent between a fundus pouch and a portion of the intestine using an endoscopic catheter and laparoscopic tools according to some embodiments. [Figure 26D] 14A-14C illustrate a method of placing a stent between a fundus pouch and a portion of the intestine using an endoscopic catheter and laparoscopic tools according to some embodiments. [Figure 27A] 1A-1C are diagrams illustrating a method of forming an anastomosis between two sealed portions of an intestine according to some embodiments. [Figure 27B] 1A-1C are diagrams illustrating a method of forming an anastomosis between two sealed portions of an intestine according to some embodiments. [Figure 27C] 1A-1C are diagrams illustrating a method of forming an anastomosis between two sealed portions of an intestine according to some embodiments. [Figure 27D] 1A-1C are diagrams illustrating a method of forming an anastomosis between two sealed portions of an intestine according to some embodiments. [Figure 27E] 1A-1C are diagrams illustrating a method of forming an anastomosis between two sealed portions of an intestine according to some embodiments. [Figure 28A] 1A-1C illustrate a laparoscopic method for placing a stent between the stomach and a portion of the intestinal tract according to some embodiments. [Figure 28B] 1A-1C illustrate a laparoscopic method for placing a stent between the stomach and a portion of the intestinal tract according to some embodiments. [Figure 28C] 1A-1C illustrate a laparoscopic method for placing a stent between the stomach and a portion of the intestinal tract according to some embodiments. [Figure 28D] 1A-1C illustrate a laparoscopic method for placing a stent between the stomach and a portion of the intestinal tract according to some embodiments. [Figure 28E] 1A-1C illustrate a laparoscopic method for placing a stent between the stomach and a portion of the intestinal tract according to some embodiments. [Figure 28F] 1A-1C illustrate a laparoscopic method for placing a stent between the stomach and a portion of the intestinal tract according to some embodiments. [Figure 28G] 1A-1C illustrate a laparoscopic method for placing a stent between the stomach and a portion of the intestinal tract according to some embodiments. [Figure 29A] 14A-14C illustrate a laparoscopic method for placing a stent between a fundus pouch and a portion of the intestine according to some embodiments. [Figure 29B] 14A-14C illustrate a laparoscopic method for placing a stent between a fundus pouch and a portion of the intestine according to some embodiments. [Figure 29C] 14A-14C illustrate a laparoscopic method for placing a stent between a fundus pouch and a portion of the intestine according to some embodiments. [Figure 29D] 14A-14C illustrate a laparoscopic method for placing a stent between a fundus pouch and a portion of the intestine according to some embodiments. [Figure 29E] 14A-14C illustrate a laparoscopic method for placing a stent between a fundus pouch and a portion of the intestine according to some embodiments. [Figure 29F] 14A-14C illustrate a laparoscopic method for placing a stent between a fundus pouch and a portion of the intestine according to some embodiments. [Figure 29G] 14A-14C illustrate a laparoscopic method for placing a stent between a fundus pouch and a portion of the intestine according to some embodiments. [Figure 30A] 1A-1C illustrate a laparoscopic method for placing a stent between two sealed sections of the intestine according to some embodiments. [Figure 30B] 1A-1C illustrate a laparoscopic method for placing a stent between two sealed sections of the intestine according to some embodiments. [Figure 30C] 1A-1C illustrate a laparoscopic method for placing a stent between two sealed sections of the intestine according to some embodiments. [Figure 30D] 1A-1C illustrate a laparoscopic method for placing a stent between two sealed sections of the intestine according to some embodiments. [Figure 30E] 1A-1C illustrate a laparoscopic method for placing a stent between two sealed sections of the intestine according to some embodiments. [Figure 30F] 1A-1C illustrate a laparoscopic method for placing a stent between two sealed sections of the intestine according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0059] Methods and devices for forming anastomoses are disclosed herein. The devices and methods disclosed herein can be used to form multiple anastomoses. Tissue anchors and stents can be used to form anastomoses. Anastomoses can be created using endoscopes, catheters, laparoscopic surgical instruments, laparoscopes, general surgical devices, or a combination of one or more of these devices. The stents disclosed herein can be delivered using a catheter-based system. In some embodiments, the stents disclosed herein can be delivered using a laparoscopic device. In some embodiments, the stents disclosed herein can be delivered using a rigid catheter-less system. In some embodiments, the stents can be delivered using a combination of catheters and laparoscopic tools, e.g., the stent can be placed using a catheter device and navigation and visualization assistance can be provided by laparoscopic tools.

[0060] Disclosed herein are improved access tools, improved stent designs for forming a consistent leak-free anastomosis with a known size that does not impede food flow, and methods for placing the stent endoscopically and laparoscopically. The devices and methods disclosed herein are useful for forming a consistent leak-free anastomosis between body lumens. The ability to form a leak-free anastomosis with a consistent size of fluid path is a convenient alternative for applications where the surgeon or physician has previously connected two tissues using manual methods with staples and sutures, such as in gastric bypass surgery. The stents disclosed herein can be placed in anastomoses formed between the fundus pouch and the jejunum and from the duodenum to the ileum to promote the formation of a healthy anastomosis, further reducing the risk of leakage of material into the peritoneal cavity. Stents can also be used to form a pathway between the stomach or fundus pouch and a portion of the intestine, such as the jejunum.

[0061] The benefits also apply to procedures for creating an anastomosis between any two sections of intestine, such as the closed ends in a colectomy procedure. Prior art methods typically create a stapled or sutured connection that creates a small diameter stricture that can reduce the flow of material through the intestine. The stents disclosed herein can be used to create an anastomosis between two closed sections of intestine that has improved capacity for material flow through the anastomosis compared to conventional colectomy techniques.

[0062] Although forming anastomoses between adjacent body lumens of the gastrointestinal tract, such as between the stomach and a portion of the intestine and between two portions of the intestine, the methods and devices may be used herein for forming any surgical anastomosis.

[0063] In a Roux-en-Y procedure, the stents disclosed herein can be used at two surgical anastomoses, one from the fundus pouch of the stomach to the intestine (e.g., the jejunum), and also between two portions of the intestine, such as the junction from the duodenum to the ileum. More broadly, the stents can be used to join any segment of the GI tract. In some embodiments, the stents and tissue anchors can be used in any type of surgical anastomosis between tissue planes.

[0064] The tissue anchors and stents disclosed herein can be delivered using a catheter-based delivery system in some embodiments. Catheter-based devices and methods for placing stents are disclosed in commonly owned U.S. Patent No. 8,357,193 and U.S. Patent Publication No. 2013-0310833. A natural orifice may be used to reach the target location, or a catheter may be introduced through the peritoneal cavity into and into the intestine. In another example, a catheter can be introduced into any body lumen relevant to the NOTES procedure, such as the bile duct, gallbladder, etc. The catheter-based delivery system can be attached to an endoscope or other similar navigation device. The catheter device can be used with laparoscopic tools to improve visualization and positioning of the device.

[0065] A needle can be used to initially reach the target area and then a guidewire for a catheter to reach the target area. In some cases, a catheter device may be used to reach the target location directly without a guidewire or needle. The use of a catheter device without a guidewire may be referred to as free access. The catheter may also be guided by laparoscopic tools as described herein.

[0066] 3A-3D illustrate a catheter device 11 according to some embodiments for placing a stent between body lumens. The catheter device 11 of FIG. 3A includes a control handle 12 having a body 14 with a first slide actuator 15 with a knob 16 and a lock 20. A second slide actuator 18 with a lock 22, a range lock mechanism 24, an electrical plug 23, a catheter body 26, a sheath 27, a shaft 28, a stent friction material 30, a distal tapered tip 32, and a stent or other tissue anchor 34 (FIG. 3BA). FIG. 3B is a close-up of the end of the device 11 including the distal tapered tip 32.

[0067] The distal tapered tip 32 comprises a distal tip base 33. The sheath 27 can contact the distal tapered tip and engage with the outer diameter of the distal tip base 33. The sheath 27 can radially restrain the stent 34 and prevent it from expanding. The distal tapered tip 32 can comprise a conductive portion with a cutting element 35. The cutting element 35 shown has a concentric design with respect to the guidewire lumen 39. A conductive protrusion 36 extends from the cutting element 35 towards the outer diameter of the distal tip 32. The protrusion 36 shown fits into a recessed portion 41 (FIG. 3D) of the distal tip 32. In some embodiments, the conductive cutting element is optional. For example, the catheter can comprise a blunt tip or a conical tip without a conductive cutting element in any of the ways described herein.

[0068] The conductive areas of the tip, such as the cutting element 35 and protrusions 36, may be configured to cut, heat, and / or cauterize tissue of a patient. Electrical energy is provided to energize the conductive areas of the tip. Electrical energy, such as radio frequency (RF) energy and radio frequency (HF) energy, may be provided to the conductive portions of the tip. The electrical energy may be provided through an electrical plug 23. The handle includes an electrical control for controlling the electrical energy provided to the tip.

[0069] The cutting element 35 and the projections 36 shown can be made from a biocompatible conductive medical material, such as stainless steel. A different conductive material, such as copper, can be used to provide electrical energy to the cutting element 35 and projections 36. The projections 36 can be connected to wires 38 at connections 37. The wires 38 are in electrical contact with the electrical plug 23. The electrical plug 23 provides electrical energy to the cutting element 35 and projections 36 through the wires 38. The distal tip 32 is made from an insulating material to insulate the cutting element 35 and projections 36 from the surrounding device structure.

[0070] 3C-3D show close-up views of the distal tip 32. FIG. 3C is a side view showing the protrusion 36 entering the distal tip 32 just short of the outer diameter of the distal tip 32. FIG. 3D is a top view of the distal tip 32 showing the protrusion 36 entering the recessed portion 41 of the distal tip 32. The distal tip shown in FIGS. 3C-3D can produce a tissue cutting pattern in a central cutting region with two linear cuts that radiate from the central region or annular portion. The protrusion 36 in FIGS. 3A-3C enters the recessed portion 41 of the distal tip 32 before the distal tip 32 reaches its maximum diameter. In some embodiments, the protrusion may be covered adjacent the outer diameter so that the exposed portion of the protrusion does not reach the maximum outer diameter of the distal tip 32. The slit made in the tissue by the protrusion 36 is slightly shorter than the diameter of the tip. Some force may be applied to push the distal tip through the slit in the tissue made by the energized tip. The elasticity of the tissue can accommodate the slightly larger diameter of the distal tip and catheter. This tight fit can prevent leakage of biological material from the body lumen.

[0071] The tip design disclosed herein allows for high current densities that may facilitate faster tissue dissection and reduced trauma to surrounding tissue areas than conventional blunt cone tips with welded electrical connections such as those manufactured by Cook Medical Inc. The Cook Medical manufactured tip delivers power throughout the blunt tip. This tip requires a relatively large amount of power and flows a lower current density. A lower current density takes longer to dissect tissue, which can result in excessive heating that may result in damage to the surrounding tissue areas and the surrounding catheter portion. The blunt tip may also cause tissue tearing increasing the chance of leakage of biological material.

[0072] 4A-4C show schematic diagrams of stent delivery to form an anastomosis between two body lumens. Once catheter 11 has successfully entered second body lumen L2, distal flange 43 of stent 34 may be deployed by partially retracting sheath 27 as shown in FIG. 4A. Distal flange 43 may then be drawn proximally toward the wall of T2 to appose the body lumen walls during the remainder of the deployment procedure as shown in FIG. 4B. Flange 43 may be deployed by further retracting the sheath. After tension is applied using distal flange 43, sheath 27 is further retracted to deploy proximal end 46 of stent 34 and fully deploy stent 34, such that proximal flange 47 engages the luminal surface of first tissue layer T1 as shown in FIG. 4C. After the stent is deployed, the catheter with all components may be removed by detaching the handle from the endoscope and withdrawing the entire construct. A central passageway or opening through the stent provides fluid communication between body lumens L1 and L2. Stent 34 in the figure has optional outer cuffs or lips 45 on either end of the stent. The optional cuffs or lips 45 can be configured to improve the flow of food and partially digested food. Any of the stents described herein can be deployed using the methods illustrated in Figures 4A-4C and 20-30.

[0073] The stents described herein can also be deployed using common surgical devices, such as laparoscopic delivery devices. The devices can be used in any laparoscopic procedure in which anastomoses are created. The systems described herein can be used to create a wide variety of anastomoses between a wide variety of body lumens using laparoscopic techniques.

[0074] There are hundreds of thousands of surgical anastomoses performed by physicians each year; however, there is no method for standardizing this anastomosis. The disclosed surgical anastomosis device would allow physicians to standardize patient management and prevent extended hospital stays due to anastomotic leaks and retreatment due to anastomotic stenosis. Currently, there are no known devices for delivering such treatments using laparoscopic tools. Disclosed herein is a laparoscopic delivery system that allows physicians to deliver anastomosis devices such as stents.

[0075] The laparoscopic delivery system comprises a number of components that allow for controlled delivery of the distal and / or proximal ends of the stent and the cylindrical "saddle" portion of the stent. The laparoscopic delivery system can include a handle, a shaft, an actuation mechanism for deploying an anastomosis device (e.g., a stent), and an anastomosis device, as shown in the embodiment illustrated in Figures 5A-5C. The shaft can be rigid. The actuation mechanism can be configured to selectively deploy the first and second ends of the anastomosis device. The anastomosis device can be held in a compressed configuration using a sheath, tubing, or other physical restraint to radially compress the anastomosis device. Examples of radial restraints include perforated tubing, heat shrink tubing, biodegradable tubing, wires, hooks, or other removable or adjustable radial restraints. The radial restraints are configured to be removed through a laparoscope entry port. The delivery device can rotate or move the stent retainer relative to the shaft of the delivery device to position the stent relative to the target location, as shown in Figure 5A.

[0076] The anastomotic device can be deployed by removing radial compression to allow expansion of the anastomotic device as shown in Figures 5B, 5C, and 8B. Opposite ends of the anastomotic device can be deployed separately and sequentially.

[0077] An actuation mechanism can be used to remove radial compression from the stent. Examples of actuation mechanisms include a movable sheath, wires, hooks, or other structures to translate axial movement along the shaft of the laparoscopic delivery device into lateral movement along the axial length of the stent. An actuation mechanism can be used to retract the sheath or remove the structure that radially compresses the stent.

[0078] 5A-5C illustrate a laparoscopic device 50 for deploying a stent 34 according to some embodiments. The laparoscopic device 50 includes a handle 51, a shaft 52, and a stent holder 54. The shaft 52 can grip the stent 35 with a removable clamp 53. The device 50 can include articulation points 56 for changing the orientation of the stent 34 and the stent holder 54 relative to the axis of the shaft 51. Further details of the stent holder 54 and the stent actuation mechanism are illustrated in FIG. 5B. The stent holder 54 includes a heat shrink or other removable tubing. Each end of the stent 34 is in radial compression by the heat shrink tubing. The heat shrink tubing can be connected to an actuation mechanism such as a pull wire 55 shown in FIG. 5B. The pull wire 55 can be pulled to remove or rupture the perforated heat shrink tubing 54, thereby deploying the ends of the stent 34 as shown in FIG. 5C. Each wire can be connected to either the distal or proximal end of the radial restraint of the stent 34. The wires can deploy either the distal or proximal ends of the stent independently, or can be used to actuate both segments simultaneously.

[0079] Removal of the stent radial restraint can be accomplished using a variety of structures. Figure 6 illustrates a laparoscopic device according to some embodiments. Figure 6 illustrates a portion of a delivery device that uses a wheel or pulley 58 adjacent to the delivery shaft 52 near where it connects to the stent retainer. The wheel can translate axial motion along the delivery shaft 52 into axial motion along the axis of the stent retainer 54. A pull wire 55 can be pulled from the handle 51 of the device, which translates into motion along the axis of the stent 34 to cut and remove the radial restraint. The pull wire 55 can be inside or outside the radial restraint.

[0080] 7A-7B illustrate a laparoscopic device 70 according to some embodiments. FIG. 7A illustrates an additional arrangement between the radial restraint and a pull wire or cord 71. The pull wire 71 can contact the radial restraint along the inner wall of the radial restraint and can be folded back along the outside of the wall of the radial restraint. Pulling the wire or cord can sever the radial restraint, allowing the stent to expand. The radial restraint can also optionally include perforations 73 to facilitate severing the restraint along the perforations 73. FIG. 7B illustrates another example of a cord / wire arrangement. It is contemplated that one or more wires 74, 75 can be embedded longitudinally on either side of the perforations 73 in the radial restraint.

[0081] 8A-8B show another example of the use of a pull wire 82 to deploy an end of a stent 34 from a laparoscopic device 80, according to some embodiments. The radial restraint 81 in the figure is a perforated heat shrink material. The pull wire 82 is shown on the inside of the heat shrink material 81 and on the outer surface of the heat shrink material 81. The pull wire can be pulled toward the center of the stent to split the heat shrink material and deploy the end of the stent as shown in FIG. 8B. The pull wire 82 can be secured or affixed to a clamp of the device 80 at a connection point 83.

[0082] 9A-9E illustrate a laparoscopic device and a stent cartridge for use therewith, according to some embodiments. The stent cartridge 90 is shown in FIG. 9A and includes a stent 34, a first section 91 of heat shrink tubing holding a first end of the stent, a second section 93 of heat shrink tubing holding a second end of the stent, a first pull wire 92 running along the first section 91 of heat shrink tubing and the stent for deploying the first end of the stent, and a second pull wire 94 running along the second section 93 of heat shrink tubing and the stent for deploying the second end of the stent. The removable cartridge 90 may be held in place using a clamp or other releasable securing mechanism. FIGS. 9B-9E illustrate a handle 95 and shaft 96 of a laparoscopic device with a clamp 97 that can be removably engaged with the stent cartridge 90. The handle 95, shaft 96, and camp 97 of the laparoscopic device are reusable. The stent cartridge 90 is replaceable for each surgical procedure. The handle of the laparoscope is equipped with a clamp 97 for holding the stent cartridge 90, with an articulation point 98 for rotating the orientation of the stent cartridge. FIG. 9D illustrates the clamp 97 with two semicircular movable parts that can be opened and closed to engage the stent cartridge 90. This delivery system further allows for independent actuation of both the distal and proximal sections 91, 93 of the shrink tubing covering the distal and proximal sections of the stent 34. The articulation point 98 allows the physician some additional movement within the patient's body if necessary during positioning or deployment of the stent 34. In this embodiment, either the proximal or proximal segment can be independently deployed by pulling either the pull wire 92 or 94 as selected by the physician.

[0083] FIG. 10 illustrates a laparoscopic device according to some embodiments. The stent cartridge 100 can be used with the laparoscopic system disclosed herein. FIG. 10 also illustrates another embodiment of a radial restraint for a stent. The stent 34 can be radially restrained toward the tube 101 with tension applied using wires, strings, or hooks 102 to secure the ends of the stent 34 to the tube 101. The radial restraint can be removed to deploy the stent ends, allowing the stent to expand to the expanded configuration 103. The device shown in FIG. 10 can be used with a laparoscopic type device. The device can reach the target organ through the peritoneal cavity and secure the stent cartridge 100 using clamps 103 and shaft 104. The clamps 103 can be used to remove the wires, strings, or hooks 102 to deploy the stent. The clamps 103 include a release mechanism to release the grip on the stent after the stent is deployed. After placement of the stent, the tube 101 and stent 34 are released from the delivery device. The 101 tube is within the interior space of the stent 34. The tube 101 can then be removed endoscopically. When the stent is placed between the fundus pouch and the intestine, the tube 101 can be retrieved through either the fundus pouch or the intestine. The tube 101 can be malleable to facilitate movement through tight passageways yet rigid enough to hold the stent in place. In some embodiments, the tube 101 can be biodegradable.

[0084] Another embodiment of a laparoscopic tool 110 for placing a stent is illustrated in Figures 11A-11C. The stent can be incorporated into a stent section 116 at the end of a laparoscopic device 110 as illustrated in Figures 11A-11C. The device 110 includes an articulation point 112 for changing the orientation of the stent section relative to the shaft 111 of the device 110. The delivery device includes a nosecone 115. The nosecone 115 can be used to enter the body. The nosecone 115 can be movable relative to the delivery shaft 111. The device 110 includes two sheath sections 113, 114 configured to hold the stent in a constrained configuration. The proximal section 113 or section can cover the proximal portion of the stent. A separate distal section 114 of the sheath can constrain the distal portion of the stent. The proximal section 113 of the sheath and the distal section 114 of the sheath can be moved relative to each other. The device 110 can move the proximal 113 and distal 114 portions of the restrainer / sheath separately to deploy the stent, as shown in FIG. 11C. The distal 114 portion of the sheath can be moved distally to allow the distal portion of the stent to expand. Similarly, the proximal 113 portion of the sheath can be moved proximally to allow the proximal portion of the stent to expand. The device 110 can be introduced laparoscopically into the peritoneal cavity and then enter a body lumen, such as a portion of the intestine. The stent can then be deployed after the device 110 has advanced through the body lumen to a target location (optionally entering additional body lumens).

[0085] The sheath can be deployed in a variety of ways. In some embodiments, the nosecone can hold the sheath and stent in place and move distally / forward to pull the proximal portion of the stent away from the proximal restraint. In some embodiments, the proximal portion of the stent can be deployed using a push rod type arrangement where the proximal end of the stent is pushed distally to deploy the proximal flange. In some embodiments, the nosecone can be pushed distally while holding the stent in place to remove the distal sheath to deploy the distal end of the sheath. In some embodiments, an expandable structure can be used to selectively hold the stent or sheath in place. In one embodiment, the distal segment deploys using a push rod type actuation mechanism to move the nosecone and sheath, while the proximal segment deploys using a tension type mechanism to pull the sheath proximally to deploy the proximal stent flange. In one embodiment, the stent can be wrapped with a removable material to hold the stent in a radially constrained deployment. The stent can be deployed by removal of the wrapping. In one embodiment, the stent can be anchored in a radially constrained configuration. The anchoring can be removed to deploy the stent to an expanded configuration.

[0086] FIG. 11D illustrates another embodiment delivery device 117 with pull wires 118a, 118b configured to remove portions 119a, 119b of the radial restraint, respectively. The radial restraint may be a sheath or removable tubing. The sheath may comprise one or more pieces. A proximal portion 119a of the sheath may cover a proximal portion of the stent. The proximal portion of the stent may be deployed using a proximal pull wire 118a to move or remove the proximal sheath 119a, which restrains the proximal portion of the sheath. A separate distal portion 119b of the sheath may restrain a distal portion of the stent. The distal sheath 119b may be moved or removed separately using a distal pull wire 118b.

[0087] In some embodiments, the delivery system includes a laparoscopic instrument with a handle, a shaft, and a removable cartridge. The removable cartridge may include the distal tip of the delivery system and a pre-loaded anastomosis device. A physician can manipulate the system inside the patient to place the anastomosis device at a target location. The handle and shaft can be sterilized after a surgical procedure and used in a subsequent surgical procedure with a new cartridge having an anastomosis device, such as the stent cartridge described in Figures 5A-5C, 10, 12A-12F, and 13A-13C.

[0088] Further examples of stent cartridges and engagement structures are illustrated in Figures 12A-12F and 13A-13C. The engagement structures can be used to removably attach a reusable delivery device with a handle and shaft portion. Figures 12A-12F illustrate a portion of a delivery device including a stent cartridge with various mating structures. The ends of the stent cartridge can use mechanical means to mate with a delivery system using a laparoscopic handle. A cartridge 120 containing a stent 34 is illustrated in Figure 12A. The cartridge 120 can include a rigid inner member 124, a nosecone 121, an inner pocket for receiving the stent 34, a sheath 122 with mating structures 126, a stent engagement ring 123, and an inner mating structure 125 for engaging the rigid inner member with a rigid laparoscopic handle. The individual mating structures can be independently controlled by the laparoscopic handle. The mating portions of the sheath allow separate control of the outer sheath to move the sheath independently relative to the inner portion. The inner mating portion 125 allows control of the movement of the inner shaft 124 and the nosecone 121. The laparoscope handle can be actuated to pull back the sheath 122 and release the stent 34. FIG. 12A illustrates a cartridge 120 with a stent 34 held in place by a stent retention device 123 coupled around the outer sheath 122 and inner deployment shaft 124. Various mating structures are also illustrated in FIGS. 12B-12F. FIGS. 12B-C illustrate two different cross-sectional views of the end of the cartridge 120 with the inner mating portion 125. FIGS. 12D-E illustrate two different cross-sectional views of another embodiment of the end of the cartridge 120 with the inner mating portion 125 and the sheath engagement portion 126. FIG. 12F illustrates another embodiment of a mating structure.

[0089] FIG 13A illustrates a cartridge device 130 with mating structures 133, 134 for the outer sheath 131 and the inner anchoring shaft 136, respectively. FIG 13A illustrates the nosecone 132 pushed distally to reveal a portion of the stent section 134. FIG 13B is a close-up of the outer sheath mating structure 133 and the inner anchoring shaft mating structure 134. FIG 13C illustrates a close-up of the nosecone 132, the sheath 131, the inner anchoring shaft 136, and the stent section 135.

[0090] The delivery devices disclosed herein may include means for visualization of the device and stent. Examples of visualization include ultrasound, fluoroscopy, direct visualization, and other methods. Direct visualization may be facilitated by the use of light, such as a fiber optic assembly. FIG. 14 illustrates a distal portion 140 of the delivery device with fiber optic lights 141, 143. Fiber optic lights can aid visualization in laparoscopic surgical procedures. Fiber optic lights can aid in confirming device placement within a body lumen, such as the stomach, colon, or intestine. The device may include multiple fiber optic lights as illustrated in FIG. 14. The device illustrated in FIG. 14 includes a fiber optic light 141 at the tip of the device adjacent the nosecone 142. FIG. 14 also illustrates a fiber optic light 143 along the shaft of the delivery device adjacent the proximal side of the stent 34 / stent section. Fiber optic light sources may also be adjacent the ends of the stent sections to aid the surgeon in confirming stent placement during the surgical procedure. Different colored lights may be used to identify different locations on the device. The nosecone and other portions of the delivery device may be transparent. It is contemplated that the fiber optic light source is located adjacent to the transparent portion such that light is visible through the transparent portion. For example, the fiber optic light source may be located within the transparent nosecone and / or within the transparent portion of the delivery shaft.

[0091] Fluoroscopy may also be used to visualize the devices disclosed herein. An intraluminal connection port may be incorporated into the devices disclosed herein to allow for the introduction of fluidic diagnostic agents via a delivery system. For example, a Toue-Borst connector may be used. A fluorescent die may be introduced through the intraluminal connection port for fluoroscopy.

[0092] The devices disclosed herein can be used to create one or more anastomoses. For example, a catheter-based stent delivery device can be used with an endoscope to create an anastomosis, for example, between segments of the intestine. An endoscopic device can also be used to create an anastomosis between a portion of the intestine, such as the fundus pouch and the jejunum. A combination of a laparoscopic device and a catheter device, as described herein, can also be used to create a single anastomosis. For example, a catheter device can deploy a first half of a stent and a laparoscopic device can deploy a second half of the stent. The stent halves can then be joined to form an anastomosis, as shown in Figures 19A-19D.

[0093] The tip designs disclosed herein can be designed to minimize or prevent leakage from the opening cut in the passage of the target anatomical structure, taking into account the diameter of the device entering the anatomical structure. In some embodiments, the delivery device has a tip with a conical shape. In some embodiments, the delivery device has a tip with a shape other than a conical shape. In some embodiments, the tip of the delivery device can be blunt, rounded, or pointed. In some embodiments, the delivery device has a tip with a cauterizing mechanism, such as an energized tip. Energy can be provided to the tip of the device, such as radio frequency (RF), radio frequency (HF), or other types of energy. The energized tip of the device can then cut tissue to create a luminal access into the target anatomical structure. In some embodiments, the delivery device has a balloon or expansion member that allows the stent or tissue passage to expand.

[0094] In some embodiments, the delivery device has a balloon or expansion member that allows the stent or tissue passageway to widen before or after deployment of the stent. For example, a self-expanding stent may be deployed and then post-expanded using a balloon to facilitate self-expansion to achieve an expanded configuration faster than the time required for the stent to self-expand. In some embodiments, the devices disclosed herein may include an energized tip.

[0095] In some embodiments disclosed herein, a guidewire is used for navigation into the target anatomy. If a guidewire is used, the device may include a guidewire lumen and a hole in the tip for the wire to exit distally. The devices disclosed herein can follow the guidewire placed in the target anatomy. The guidewire can be placed in the target anatomy using a needle, such as a 19 gauge needle. The device can follow the guidewire until the tip reaches the target anatomy.

[0096] In some embodiments, the device can be used without a guidewire. In some embodiments, the devices disclosed herein can be flexible to facilitate passage through a body lumen, for example, the catheter-based devices disclosed herein can be flexible for use with an endoscope.

[0097] In some embodiments, the devices disclosed herein may be rigid or may include a rigid shaft. For example, laparoscopic devices may use a rigid shaft to facilitate access into the peritoneal cavity. In some embodiments, laparoscopic devices may include some flexibility.

[0098] In some embodiments, the devices disclosed herein can be used to place a stent to create an anastomosis between either the stomach, the small intestine (duodenum, jejunum, ileum) and large intestine (cecum, colon), the rectum, biliary structures, or the esophagus.

[0099] The stent or tissue anchor can be used to create an anastomosis in the GI tract. The stent can also reduce the anastomotic leakage rate and allow fluid, partially digested food, and food to pass through the stent compared to original surgical anastomosis alone. The stent can save time and prevent leakage over stapling and other surgical anastomosis methods. The stent can also be applied to colectomy processes where a stent is used to create an anastomosis between cut ends of the intestine. The stents disclosed herein can also be used with basic endoscopic tools, catheters, laparoscopes, and general surgical tools. Examples of methods and devices for placing stents are discussed herein.

[0100] Examples of stents and anchors for tissue are discussed in more detail below. Examples of stents and tissue anchors that can be deployed using the devices and methods disclosed herein are disclosed in commonly owned U.S. Patent Application Publication Nos. 2009 / 0281557 and 2013 / 0310833. Devices and methods for placing stents are also disclosed in commonly owned U.S. Patent Application Publication Nos. 8,357,193 and 2013 / 0310833. Additional devices and methods for placing stents and anchors are disclosed in U.S. Provisional Patent Application Nos. 61 / 648,544, filed May 17, 2012, and 61 / 727,629, filed November 16, 2012. The devices and methods disclosed in the above patent applications can be used with the concepts disclosed herein.

[0101] The stents disclosed herein can be configured to promote the flow of fluids, partially or completely digested food, and food through the internal passages of the stent. The flanges of the stent can be configured to reduce the likelihood of food becoming stagnant within the stent. The ends of the flanges can also be configured to reduce the likelihood of trapping food or partially digested food and to better receive and deliver food, for example, by angling the ends away from the interior space of the stent or by rolling the ends outward away from the interior space of the stent. In one embodiment, the stent ends can be configured to promote unidirectional material flow.

[0102] Other design considerations for the stents described herein include the manufacturability of the stent and the ability to load and deploy the stent using the devices disclosed herein.

[0103] The stent design also provides improved lateral strength and pull-out force over conventional stents. Pull-out force can be determined using two different tests: the stent pull-out force test and the implant anchor pull-pout test.

[0104] For the pull-out force test, the stent is tested in a fully expanded configuration. The stent is placed through a hole in the material sized to accommodate the expanded diameter of the cylindrical saddle region of the stent. The hole in the material may be approximately 10 mm or 15 mm depending on the size of the stent. The stent pull-out test measures the force required to deform the distal flange of a fully expanded stent and pull the expanded distal flange of the stent through the opening. In some embodiments, the stent pull-out force is greater than about 260 grams (about 2.55 N). In some embodiments, the stent pull-out force is greater than about 300 grams (about 2.94 N). In some embodiments, the stent pull-out force is greater than about 400 grams (about 3.92 N). In some embodiments, the stent pull-out force is greater than about 500 grams (about 4.9 N). In some embodiments, the stent pull-out force is greater than about 550 grams (about 5.39 N). In some embodiments, the stent pull-out force is greater than about 600 grams (about 5.88 N). In some embodiments, the stent pull-out force is greater than about 700 grams (about 6.86 N). In some embodiments, the stent pull-out force is greater than about 800 grams (about 7.84 N). In some embodiments, the stent pull-out force is greater than about 900 grams (about 8.82 N). In some embodiments, the stent pull-out force is greater than about 1000 grams (about 9.8 N).

[0105] For implant anchor testing, the distal flange is tested for strength while the proximal flange of the stent is held in a restrained configuration by a catheter device. The distal flange is placed on the opposite side of a rigid material having a hole sized to accommodate the shaft of the catheter. The catheter can be pulled with a force measured to deform the distal flange and pull it through the hole in the rigid material. In some embodiments, the stent has an implant anchor test strength of greater than about 1 N. In some embodiments, the stent has an implant anchor test strength of greater than about 2 N. In some embodiments, the stent has an implant anchor test strength of greater than about 3 N. In some embodiments, the stent has an implant anchor test strength of greater than about 4 N. In some embodiments, the stent has an implant anchor test strength of greater than about 5 N. In some embodiments, the stent has an implant anchor test strength of greater than about 6 N. In some embodiments, the stent has an implant anchor test strength of greater than about 7 N. In some embodiments, the stent has an implant anchor test strength of greater than about 8 N. In some embodiments, the stent has an implant anchor test strength of greater than about 9 N. In some embodiments, the stent has an implant anchor test strength of greater than about 10 N. In some embodiments, the stent has an implant anchor test strength of greater than about 15 N.

[0106] The stents disclosed herein further provide advantages over conventional rigid rivet-type anastomosis devices used in the GI tract because the stents firmly and atraumatically engage the tissue wall and do not form necrotic tissue. Reduced formation of necrotic tissue promotes faster formation of healthy anastomoses. The stents disclosed herein are also configured to be retrievable and removable after formation of the anastomosis.

[0107] Various examples of stent configurations and shapes that can be used with the devices disclosed herein are illustrated in Figures 15A-15G, 16A-16J, 17A-17C, and 18A-18D. The tissue anchor or stent can be made from a shape memory alloy such as Nitinol®. The stent can be self-expanding such that the stent expands from a constrained tubular configuration to an expanded configuration illustrated in Figures 15A-15G, 16A-16J, 17A-17C, and 18A-18D.

[0108] The stents disclosed herein may include a coating or membrane, such as a silicone coating, over the entire outer surface of the tissue anchor. The coating or membrane inhibits tissue ingrowth and minimizes fluid leakage when the stent is implanted. The reduced tissue ingrowth improves the removability of the stent after anastomosis formation. In contrast to intravascular stents, which are typically not designed to be dislodged or retrieved, the stents illustrated herein are collapsible and designed to be removable and retrieveable. The stents also do not include barbs or other sharp protrusions that are commonly used in intravascular stents to permanently secure the stent to the vessel.

[0109] Stent geometries may vary. For example, the shape of the ends or flanges may be optimized to improve the strength of the stent and provide a sufficient amount of linear force against each tissue plane while allowing smooth food flow through the internal opening of the complex structure. The shape of the ends may be described as "bell-shaped", consisting of multiple structural folds, having multiple inflection points, etc. An inflection point may be considered the location of the bend where a change in the direction of the bend occurs. Further ends may be rolled or may protrude against the tissue plane. An alternative design may be configured with an opening wider than the internal diameter of the device.

[0110] FIG. 15A illustrates a cross-section of an embodiment of a stent 150 with a cylindrical saddle region 151, a flange 152 with an end 153 configured to bend back toward the flange 154, and a flange 154 with an end 155 configured to bend back toward the flange 152. The flanges 152, 154 and ends 153, 155 are configured to hold the tissue walls T1, T2 in apposition. The distal portions of the flanges 152, 154 are curved to reduce trauma to the tissue walls. FIGS. 15B and 15C have a similar configuration to FIG. 15A, but with additionally rolled stent ends 153, 155. FIG. 15B shows ends 153, 155 rolled in a generally semicircular shape, while FIG. 15C has ends 153, 155 that form nearly a complete circle. The stent ends 153, 155 of FIGS. 15B-15C are able to engage tissue atraumatically with high strength due to the additional rolls at the distal end of the stent structure.

[0111] 15D-15G illustrate further cross-sectional views of the stent structure. FIG. 15D illustrates a stent 150 with flange structures 152, 154 protruding away from a cylindrical saddle region 151. The cylindrical saddle region 151 has a diameter D1, and the outer flange structures 152, 154 have a larger diameter D2. FIG. 15E illustrates a stent 150 with flange structures 152, 154 rolling outwardly and away from the interior space of the cylindrical saddle region 151. FIG. 15F illustrates flange structures 152, 154 protruding away from the cylindrical saddle region 151 and having rolled ends 153, 155. The rolled ends can provide additional lateral strength to the stent. FIG. 15G illustrates flange structures 152, 154 that protrude away from the interior space of the cylindrical saddle region 151 and further comprise a double-walled flange structure to increase the strength of the stent 150 and to further engage the tissue wall without trauma when implanted.

[0112] 16A-16J illustrate various partial cross-sectional views of flange configurations of a stent. Some flange designs may have spaces within each flange that may trap food or other matter passing through the stent. The flanges can be designed to minimize the chance of food or other matter becoming trapped within the interior spaces of the stent or stent flanges. The stent illustrated in FIGS. 16A-16I has a flange design designed to minimize food and partially digested food becoming trapped or stuck within the flange spaces.

[0113] FIG. 16A illustrates a partial cross-sectional view of a stent 160 with a flange structure 162 having multiple inflection points. The inflection points create radial bends in the three-dimensional stent structure. The wall of the flange 162 protrudes away from the cylindrical saddle region 161 (first inflection point), then bends back toward the center of the longitudinal path 164 of the stent 160 (two more inflection points), then bends back again away from the center of the longitudinal path 164 of the stent 160 (two more inflection points), and bends again at the stent end 163 (one more inflection point). Each bend can be considered an inflection point. The stent 160 illustrated in FIG. 16A has six inflection points. These inflection points can reinforce the stent flanges. The stent has an open end with a diameter larger than that of the cylindrical saddle region 161 to reduce the possibility of food becoming lodged within the stent and to promote the flow of food and partially digested food through the body of the stent. Additional inflection points can increase the lateral strength and pull-out force of the expanded stent.

[0114] Figure 16B illustrates a stent 160 with a flange structure 162 having seven inflection points. The structure is similar to the stent illustrated in Figure 16A, but the outer stent wall bends back toward the center of the longitudinal path 164 at the ends 163.

[0115] 16C illustrates a stent 160 with a flange configuration 162 that includes rolled stent ends 163. The rolled ends roll back toward a cylindrical saddle region 161 to form a circular cross section. The stent flange ends 163 are bent back toward themselves to prevent fluid flow directly to the ends of the stent. This stent configuration further reduces the likelihood of food becoming lodged in the interior space of the flanges 162.

[0116] FIG. 16D illustrates a stent 160 with flanges 162 that project away from a longitudinal path 164 of the saddle region 161 and ends 163 that roll outwardly past the outer location of the flanges 162.

[0117] 16E illustrates a stent 160 with flanges 162 that have five inflection points. The flanges 162 jut outwardly away from the center of a saddle region 161, then bend back toward a central passageway 164, and then bend again so that ends 163 jut out away from the longitudinal center 164 of the cylindrical saddle region 161.

[0118] FIG. 16F illustrates a stent 160 having flanges 162 protruding away from a cylindrical saddle region 161 and forming a rolled-up circular cross section with ends 163 rolled back toward the flange 162.

[0119] FIG. 16G is similar to FIG. 16F, but with the ends 163 of the stent wrapped in a shape that is more than a perfect circle at the ends 163 of the stent. 16H illustrates a stent flange 162 having multiple near right angle bends with convoluted ends 163 that roll away from a cylindrical central region 161. The right angles can increase the lateral strength and pull-out force of the stent.

[0120] 16I illustrates a flange having a sinusoidal exterior shape with rolled ends that roll away from a cylindrical saddle region. The wavy sinusoidal exterior shape can increase the lateral strength and pull-out force of the stent.

[0121] Figure 16J illustrates a stent cross section one with a flange having the structure illustrated in Figure 16A and a flange illustrated in Figure 161. The flange illustrated in Figure 16A has a wider opened and can be placed against the direction of fluid flow. The flange illustrated in Figure 161 has a narrower outer end and can be used as the opposite end where material exits the interior space of the stent.

[0122] 17A-17B are cross-sectional and external views, respectively, of a stent 170 according to some embodiments. The flange structure 171 first protrudes outwardly away from the stent body and then rolls back towards the interior space of a cylindrical saddle region 172 to form a semicircular flange configuration. The flange provides additional lateral strength and improved pull-out force while minimizing the chance of food or partially digested food becoming lodged within the interior space of the flange. FIG. 17C is an alternative configuration with a semicircular flange structure 171 that rolls back towards the cylindrical saddle region 172.

[0123] The stent structures shown in Figures 18A-18D can be referred to as double-walled flange structures. Figure 18A illustrates a stent 180 having a cylindrical saddle region 182 and a flange 181 with a relatively large open cylindrical region and a wide cuff or lip 183 at the flange structure 181. Figure 18B illustrates a stent 180 with a smaller inner diameter than Figure 18A but with a large double-walled flange 181 for atraumatic tissue engagement. Figure 18C illustrates a stent 180 with a diameter of the outer cuff or lip 183 larger than the diameter of the inner cylindrical saddle region.

[0124] FIG 18D illustrates an embodiment of a stent 180 similar to FIG 18C but with a separate plug 184 in the flange 181 to prevent food from becoming lodged in the flange space. The plug can be made of a material suitable for flowing or passing through the digestive tract after the stent is removed. In some embodiments, the flange can be made of a biodegradable or bioabsorbable material. This flange plug structure can be used with any of the stent structures disclosed herein.

[0125] In some embodiments, the stent ends are symmetrical. In some embodiments, the stent ends can have different end shapes. The shape of the stent ends can be selected based on the location of the body lumen and anastomosis as well as the desired physical properties. The stent can be designed to promote unidirectional flow since food or partially digested food should flow primarily in one direction. Unidirectional flow may also provide or require reinforcement of the leading stent flange (e.g., the proximal flange) that first contacts the flow of material. The proximal flange can be designed with a cross section that has a stronger pull-out force than the distal flange. The diameter of the opening of the proximal flange can have a wider design than the distal flange to minimize the chance of material getting stuck in the flange. The end of the proximal flange can also be designed to further reduce the chance of food or material getting stuck in the flange. For example, it is conceivable that the stent could have a cross section as illustrated in FIG. 16A for the proximal flange with wider flange ends and a flange design as illustrated in FIG. 16I for the distal flange, as illustrated in FIG. 16J.

[0126] The dimensions of the stent can be designed to provide the desired retention on the tissue wall along with the desired conduit for fluid flow. For example, the width and diameter of the flange can be optimized to provide the desired properties. A cuff or lip can be provided distal to the flange to provide reinforcement. The diameter and length of the cuff can also be optimized to modify the properties of the stent. The diameter of the cuff can be larger than the diameter of the cylindrical hollow portion. This can make it easier to reach the subsequent stent and reduce the chance of material getting stuck in the flange. The cuff or outer lip can also be shaped to minimize the chance of food or partially digested food getting stuck in the flange space. For example, the outer cuff or lip can have a wall that protrudes or rolls away from the interior space of the stent. The diameter and length of the cylindrical portion can be optimized depending on the thickness of the tissue wall and the desired stent location. The overall length of the stent can also be optimized depending on the specific application.

[0127] In some embodiments, the intraluminal diameter of the saddle region is about 8 mm to about 40 mm, hi some embodiments, the intraluminal length of the cylindrical saddle region is about 15 mm to about 25 mm. Examples of manufacturing techniques include using laser cutting, weaving, welding, etching, and wire forming. A membrane material such as silicone can be applied to the wire stent frame to prevent fluid passage through the stent wall. The membrane material can be applied by painting, brushing, spraying, dipping, or molding.

[0128] In some embodiments, any of the stents disclosed herein may comprise two halves. FIG. 19A illustrates two halves of a stent, each with a magnetic ring. FIG. 19A illustrates a first stent half 190 with a flexible flange 191 and a magnetic ring 192, and a second stent half 193 with a magnetic ring 194 and a flexible flange 195. The magnets may be configured to attract each other. Thus, each half may be separately deployed by a laparoscopic device 196 at a respective target location, for example, by deploying the flexible flange 191 by canceling the constraint on the flange, such as by advancing a nosecone 197, at a separate side of the target anastomotic tissue or lumen as shown in FIGS. 19B-19C. The laparoscopic device 196 may be removed through the hollow cylindrical region of the first stent half 190. Magnets 192, 194 could then be joined together such that flange 191 engages tissue wall T1 and flange 195 engages tissue wall T2 to form an anastomosis as illustrated in Figure 19D. Other types of connections could also be made with the two stent halves. For example, clips, rings, tabs, and other interlocking structures could be used.

[0129] 20A-20C illustrate a method of placing a stent between the stomach and a portion of the intestine according to some embodiments. The procedure illustrated in FIGs. 20A-20C may be referred to as the NOTES procedure. Although the NOTES procedure is relatively quick and easy, it does have a high risk of contamination of the peritoneal cavity because an endoscope and catheter device penetrate the stomach wall and enter the peritoneal cavity to find the target segment of the intestine.

[0130] The endoscope is advanced through the mouth and down the esophagus into the stomach. The endoscope may include multiple ports. For example, one port may include a catheter device carrying a stent, and a second port may include a gripping device and / or an incision making tool. After making an incision in the stomach wall, the endoscope 200 may be advanced through the wall of the stomach 201 as shown in FIG. 20A. The endoscope 200 is used to identify a target location in the intestine 203, such as a specific location in the jejunum. The gripping tool 202 is then used to attach and secure the intestine adjacent to the target location in the intestine 203 as shown in FIG. 20A. A cystotome or other suitable device may be advanced through the second port of the endoscope 200 to deliver a guidewire to the intestine 203. The cystotome may be exchanged over the guidewire for a catheter device 204. The catheter device 204 carrying the stent 34 may follow the guidewire to the intestine 203. The catheter device 204 may include a dilator, such as an energized tip, to enlarge the initial penetration into the intestinal tract 203. In some cases, the use of a guidewire is optional, and the energized tip of the catheter device is used to make the initial penetration in the stomach and intestinal tract. After reaching the intestinal tract 203, the catheter device 204 may place the distal flange of the stent 34 in the intestinal tract 203 by withdrawing or retracting the sheath constraining the distal flange of the stent 34, as shown in FIG. 20A. After expansion of the distal flange of the stent 34, the stent 34, the catheter device 203, and the endoscope 200 are withdrawn proximally to draw the intestinal tract 203 closer to the stomach 201, at which point the grasper 202 may be released and withdrawn, as shown in FIG. 20B. The proximal flange of the stent 34 may be placed in the stomach 201 by continuing to withdraw the sheath constraining the stent 34. After placement of the stent 34, a pathway is formed between the stomach 200 and the intestine 203 through the interior of the stent, as shown in FIG. 20C.The stent flanges are designed to allow food and partially digested food to flow through the interior space of the stent. Optionally, the stent may be balloon expanded after placement to more quickly form a fully expanded configuration. After placement of the stent, the endoscope is removed. The junction between the stomach and intestine is allowed to heal and form an anastomosis. After formation of the anastomosis, the stent can be removed endoscopically using a snare or other known techniques.

[0131] Current ultrasound endoscopes have one open lumen for passing tools. These ultrasound endoscopes do not have additional lumens for utilizing additional tools. These endoscopes with ultrasound capabilities with ultrasound guidance can also be used to find target areas of the intestine. Figures 21A-21C illustrate a method of placing a stent between the stomach and a portion of the intestine using ultrasound guidance according to some embodiments. The procedure illustrated in Figures 21A-21C can be called an EUS (endoscopic ultrasound) procedure. The EUS procedure provides a reduced risk of contamination of the peritoneal cavity compared to the NOTES procedure because it does not require a large incision in the stomach and its scope does not leave the stomach, and the target area of ​​the intestine can be found by ultrasound, which does not require much searching around compared to using an endoscope to explore the peritoneal cavity to find the target area of ​​the intestine.

[0132] An endoscope 210 equipped with ultrasound capabilities enters through the mouth and is advanced down the esophagus into the stomach 211. There are many ways to create an ultrasound target, for example, an injection catheter may be advanced through a port in the endoscope, through the pyloric valve, past the duodenum, and into the target location in the intestine 213. Once the injection catheter has been advanced to the target location in the intestine 213, a bolus of saline is injected. After injection of the saline, the injection catheter is removed. A needle 212 can then be advanced within the lumen of the endoscope. Ultrasound can be used to identify an area of ​​the intestine 213 that is filled with saline, as shown in FIG. 21A. Ultrasound guidance is used to advance the needle 212 to first puncture the stomach and intestinal walls to reach the intestine 213, and then advance a guidewire into the intestine. The catheter device 214 carrying the stent 34 can follow the guidewire to reach the target location in the intestine 213 as shown in FIG. 21B. Although needle access is recommended in this embodiment; in some embodiments, a catheter may be used to make an initial penetration into the stomach wall and intestine directly using an energized distal tip without a needle and guidewire. After reaching the intestine 213, the catheter device 214 can place the distal flange of the stent 34 in the intestine 213 by withdrawal or retraction of the sheath restraining the distal flange of the stent 34 as illustrated in FIG. 21B. The catheter device 214 can be retracted proximally to draw the intestine 213 into apposition to the stomach 211 as shown in FIG. 21C. The proximal flange of the stent 34 can then be placed in the stomach 211 by continuing to retract the sheath restraining the stent 34 as shown in FIG. 21D. After the stent 34 is placed, a pathway is created between the stomach 211 and the intestine 213 through the interior of the stent 34. The stent flanges are designed to allow food and partially digested food to flow through the interior space of the stent. Optionally, the stent may be balloon expanded after placement to more quickly form a fully expanded configuration. After placement of the stent, the endoscope is removed. The junction between the stomach and intestine is allowed to heal and form an anastomosis.After creation of the anastomosis, the stent can be removed endoscopically using a snare or other known techniques.

[0133] Laparoscopic tools can also be used to assist the catheter device in locating and reaching portions of the body such as the intestines and stomach, which reside in a cluttered state within the peritoneal cavity. The availability of laparoscopic graspers and cameras can improve the understanding and visualization of target anatomical structures within the peritoneal cavity, as well as the positioning of the target anatomical structures in the desired orientation and placement for the surgical procedure.

[0134] 22A-22D illustrate a method of placing a stent 34 between a stomach 221 and a portion of the intestine 223 using an endoscopic catheter 220 and laparoscopic tools 225, 226 according to some embodiments. Multiple laparoscopic ports can be used to assist the catheter device 224 in locating and entering the target location of the intestine 223. A laparoscopic environment is created within the peritoneum. In one embodiment, two tools and one camera can be used with a three laparoscopic port arrangement. The catheter device 224 (with or without an endoscope 220) enters through the mouth and advances down the esophagus to the stomach. The catheter device 224 can include a fiber optic light that can shine through the stomach wall for visualization within the peritoneal cavity by the camera, as described in FIG. 14. This light can facilitate identification of the location of the tip of the catheter before penetrating the stomach wall. The catheter tip can also be visualized by piercing the stomach wall 221 with the catheter and using a laparoscopic tool to see where the catheter is in contact with the stomach wall 221. The tip of the laparoscopic tool 225 can contact the location of the wall of the stomach 221 where the catheter 224 is in contact to create an incision that allows the catheter to advance through the stomach wall as shown in FIG. 22A. In another embodiment, the catheter 224 can have a tip that is energized to incise and penetrate the stomach wall 221. The laparoscopic tools 225, 226 can assist the catheter 224 in extending through the stomach wall 221. A laparoscopic camera can be used to identify the target area of ​​the intestine 223. After locating the target area of ​​the intestine, the laparoscopic tools 225, 226 can assist in holding the intestine 223 and positioning the tip of the catheter 224 adjacent to the outer wall of the intestine 223 as shown in FIG. 22A. The energized tip of the catheter device 224 may then be used to penetrate the wall of the intestine 223, and a laparoscopic tool 226 may be used to make an incision in the intestine 223, after which the catheter 224 may be advanced into the intestine 223 as shown in FIG. 22B.After reaching the intestine 223, the catheter device 224 can deploy the distal flange of the stent 34 in the intestine 223 by withdrawing or retracting the sheath that restrains the distal flange of the stent as illustrated in FIG. 22B. The catheter device 224 can be retracted proximally to draw the intestine 223 close to the penetration of the stomach 221 as shown in FIG. 22C. After drawing the intestine 223 close to the penetration of the stomach 221, the proximal flange of the stent 34 can be deployed in the stomach 221 by continuing to retract the sheath that restrains the stent 34. After the stent 34 is deployed, a fluid conduit is formed through the inside of the stent 34 between the stomach 221 and the intestine 223 as shown in FIG. 22D. The stent flange is designed to allow food and partially digested food to flow through the internal space of the stent. Optionally, the stent may be balloon expanded after deployment to more quickly form a fully expanded configuration. After placement of the stent, the endoscope is removed. The junction between the stomach and intestine is allowed to heal and form an anastomosis. After formation of the anastomosis, the stent can be removed endoscopically using a snare or other known techniques.

[0135] The above NOTES, EUS, laparoscopically assisted, and laparoscopic catheter access methods are illustrated as creating an anastomosis between the stomach and intestine. The methods and steps are equally applicable to creating an anastomosis using a fundic pouch created as part of a gastric bypass procedure. The use of the stent disclosed herein for an anastomosis between the gastric pouch and intestine creates a consistent size anastomosis and fluid conduit between the gastric pouch and intestine while greatly reducing the chance of leakage during the procedure. The procedure is quicker and less invasive than traditional gastric bypass procedures and is reproducible with reliable and consistent anastomosis creation.

[0136] 24A-24C illustrate a method of placing a stent between a fundic pouch 241 and a portion of the intestine according to some embodiments. The method illustrated in FIGS. 24A-24C is similar to the method illustrated in FIGS. 20A-20C, but instead of an anastomosis between the stomach and the intestine, an anastomosis is formed between the fundic pouch 241 and the intestine 243 formed during a gastric bypass procedure. An endoscope is advanced through the mouth and down the esophagus into the fundic pouch. The endoscope may include multiple ports. For example, one port may include a catheter device carrying a stent and a second port may include a grasping device and / or a tool for making an incision. After making an incision in the fundic pouch, the endoscope 240 is advanced through a penetration in the fundic pouch 241. The fundus pouch 241 is formed by stapling the stomach walls together to create a pouch 241 having a volume less than the entire stomach volume, thereby creating a diverted portion 245 of the stomach. FIG. 24A illustrates a gripping device 242 that holds the intestine 243 adjacent to a target location in the intestine 243 to facilitate access of a catheter 244 to the intestine 243. The catheter 243 may follow a guidewire placed after an initial access penetration made by a needle (as shown) or an energized tip of the catheter 244 may be used for initial penetration of the intestine 243. The distal end of the stent 34 is placed inside the intestine 243 as shown in FIG. 24A, after which the proximal traction portion of the catheter device 244 and the distal flange of the stent are retracted to draw the intestine 243 closer to the fundus pouch 241 as shown in FIG. 24B. The sheath of the catheter 244 is further retracted to place the proximal end of the stent 34. After placement of the proximal end of the stent 34, the endoscope 240 and catheter 244 are removed from the fundus pouch 241, leaving the expanded stent 34 in place to form a pathway between the fundus pouch 241 and the intestine 243, as shown in FIG. 24C.

[0137] 25A-25C illustrate a method of placing a stent between a fundus pouch and a portion of the intestine using ultrasound guidance according to some embodiments. The method illustrated in FIGS. 25A-25C is similar to the method illustrated in FIGS. 21A-21C, except that an anastomosis is formed between the fundus pouch and the intestine instead of between the stomach and the intestine. One difference between the methods illustrated in FIGS. 21A-21C is that an ultrasound marker (e.g., saline in the embodiment illustrated in FIGS. 21A-21C) is placed prior to forming the fundus pouch, since the fundus pouch is initially stapled closed and not in communication with the intestine. After formation of the fundus pouch 251, an ultrasound endoscope 250 carrying a catheter device 254 with a stent 34 is advanced through the mouth and esophagus into the fundus pouch 251. The diverted portion of the stomach is shown as 255. Ultrasound guidance is used to find the marker in the intestine 253 and advance the needle 252 which makes an initial penetration through the wall of the fundic pouch 251 and the wall of the intestine 253 as shown in FIGURE 25A. After the guidewire is placed through the needle, the needle may be removed. The catheter 254 may then follow the guidewire to the intestine 253. The distal flange of the stent 34 is deployed by removing the sheath of the catheter device 254 as shown in FIGURE 25B. A proximal traction member may be pulled on the distal flange of the stent 34 to draw the intestine 253 closer to the fundic pouch 251 as shown in FIGURE 25C. The catheter sheath is further retracted to deploy the proximal end of the stent 34. After placement of the proximal end of the stent 34, the endoscope 250 and catheter 254 are removed from the fundus pouch 251, leaving the expanded stent 34 in place and creating a pathway between the fundus pouch 251 and the intestine 253, as shown in FIG. 25D.

[0138] 26A-26D illustrate a method of placing a stent between a fundic pouch 261 and a portion of the intestine using an endoscopic catheter 260 and laparoscopic tools 265, 266 according to some embodiments. The method illustrated in FIGS. 26A-26D is similar to the method illustrated in FIGS. 22A-22D, but instead of an anastomosis between the stomach and the intestine, an anastomosis is formed between the fundic pouch 261 and the intestine 263. A catheter 264 is advanced to a desired location in the fundic pouch 261 and then penetrates the wall of the fundic pouch 261 with the assistance of the laparoscopic tools. The circumvented portion of the stomach is shown as 267. Laparoscopic graspers 265, 266 are used to position the tip of the catheter device 264 relative to the target location in the intestine 263 as shown in FIG. 26A. The catheter 264 is advanced to penetrate the wall of the intestine 263 using the energized tip of the catheter device 264, or a penetration is made using laparoscopic tools 255 or 256 and the sheath is then withdrawn to place the distal flange of the stent 34 inside the intestine 263 as shown in FIG. 26B. A proximal traction member is pulled over the distal flange of the stent 34 and the catheter 254 to draw the intestine 263 closer to the fundus pouch 261 as shown in FIG. 26C. The sheath can be further withdrawn to place the proximal flange of the stent 34 inside the fundus pouch 261, thereby forming a pathway between the fundus pouch 261 and the intestine 263 as shown in FIG. 26D. After placement of the stent 34, the catheter is removed from the fundus pouch 261.

[0139] The stents disclosed herein can also be used with conventional gastric bypass procedures. For example, the stents can be placed in any of the anastomoses formed during the gastric bypass procedure, such as the stomach-to-jejunum anastomosis and the duodenum-to-ileum anastomosis. The stents can be delivered endoscopically or laparoscopically (e.g., laparoscopic access to the intestine through the peritoneal cavity using a catheter device carrying the stent). The stents can improve the healing of the anastomoses formed during the gastric bypass procedure while reducing the risk of leakage. The stents also promote the formation of healthy anastomoses. Moreover, the stents can be quickly and easily deployed across the anastomoses formed between the stomach-to-jejunum and the duodenum-to-ileum.

[0140] 23A-23G illustrate a method of placing an anastomosis stent between a fundus pouch and a section of the intestine, such as the jejunum, and between two sections of the intestine, such as the duodenum and ileum, after a gastric bypass procedure according to some embodiments. Although described with respect to forming an anastomosis between the fundus pouch and the jejunum and between the duodenum and ileum, anastomoses can be formed between the fundus pouch and any portion of the intestine and between any two portions of the intestine. A conventional gastric bypass procedure is first performed to create anastomoses using staples and sutures between the gastric pouch and a portion of the intestine, such as the jejunum, and between two sections of the intestine, such as the duodenum and ileum. After the gastric bypass procedure, a suture or staple line 229 remains, as shown in FIG. 23A, which has a known possibility and risk of leakage. The anastomotic stents described herein can be placed at the anastomosis between the fundic pouch and the jejunum and between the duodenum and the ileum to reduce the chance of leakage at the anastomosis. Staple lines 229 are omitted in Figures 23B-23G at the junctions between the fundic pouch and the jejunum and between the duodenum and the ileum to facilitate illustration of the placement of the stent at these sites. The stent is placed adjacent to the staple or suture lines, rather than through or across the staple or suture lines. Figure 23B illustrates the advancement of the endoscope 230 through the fundic pouch 231 and the jejunum 233 to the anastomosis between the duodenum 234 and the ileum 235. The diverted stomach 236 is stapled adjacent to the fundic pouch 231. Stent 34 is placed from catheter 232 between duodenum 234 and ileum 235 as shown in Figures 23C-23DC. Endoscope 230 is retracted to the anastomosis between fundic pouch 231 and jejunum 233 as shown in Figure 2ED. The first catheter is removed and a second catheter is put in place. Stent 34 is placed between fundic pouch 231 and jejunum 233 using the second catheter as shown in Figures 23F-23G.

[0141] The stent can also be deployed using two devices as shown in Figures 19B-19D. The stent shown in two halves (Figure 19A) can be deployed using a separate device for each half. One end of the stent can be deployed as shown in Figures 19B-19C. After both halves are deployed, a magnetic ring or other connecting mechanism can be used to connect the two halves to form an anastomosis as shown in Figure 19D. The first part of the device can be deployed through the esophagus and the other part of the device can be inserted laparoscopically or through another natural orifice such as the rectum.

[0142] The sealed portion of the intestine is evident, for example, when performing a resection procedure. During such a resection procedure, standard surgical tools are used to make a double staple line and then cut between the staple lines, creating two ends of the intestine at the incision site. This can be performed, for example, at two locations in the intestine, leaving two sealed portions of the intestine that need to be joined by the surgeon removing the segment between the two cut lines. Methods of creating an anastomosis between two sealed portions of the intestine (e.g., colon and rectum) are disclosed herein. Figures 27A-27F and 30A-30F illustrate a method of creating an anastomosis between two sealed portions of the intestine.

[0143] 27A-27F illustrate a method of creating an anastomosis between two sealed portions of the intestine using a catheter to reach a portion of the intestine through the peritoneal cavity. Two sealed ends 282, 283 of the colon are created during a colon portion resection procedure as described above. A catheter 280 then enters the peritoneal cavity and enters the intestine at a target penetration 281 as shown in FIG. 27A. A laparoscopic tool 284, shown as a grasper, can be used to facilitate navigation of the catheter 280. The catheter 280 is advanced as shown in FIG. 28B to penetrate the colon at a penetration 285 adjacent to the first sealed end 282 of the colon. This penetration is not made through the stapled or sutured end. The catheter can use an energized tip to create the penetration 285. The catheter is then advanced to penetrate a second portion of the colon at penetration 286 using the grasper 284 used to position the colon as shown in FIG. 28C. The distal flange of the stent 34 is deployed by removing the sheath on the catheter. The stent 34 is deployed in the colon to engage the wall of the colon as shown in FIG. 28D. A proximal traction member is pulled over the catheter 280 and stent 34 to draw the colon closer to penetration 285, after which the proximal end of the stent 34 is deployed within the first segment of the colon as shown in FIG. 28E. The same procedure can be followed to utilize standard surgical tools for the formation of a fundic pouch to create an anastomosis between the fundic pouch and the intestine (e.g., without passing a staple line).

[0144] Laparoscopic tools can also be used to access the peritoneal cavity and place a stent to create an anastomosis between any portion of the gastrointestinal tract. Figures 28A-28G, 29A-29G, and 30A-30F illustrate a method of using a laparoscopic stent delivery device to place a stent between body lumens in the GI tract.

[0145] 28A-28G illustrate a laparoscopic method for placing a stent between the stomach and a portion of the intestine using the laparoscopic device 50 illustrated in FIGS. 5A-5C. A laparoscopic environment is created in the peritoneal cavity, and the laparoscopic device 50 enters the peritoneal cavity (FIG. 28A). The target body lumen, in this example the stomach 291 and the intestine 292, is located. A penetration 293 is created in the stomach 291 using endoscopic or laparoscopic tools. The orientation of the stent retainer of the device 50 is adjusted to facilitate positioning the end of the stent 34 inside the penetration 293 in the stomach 291 (FIG. 28B). The end of the stent 34 then enters the stomach 291 through the penetration 293 (FIG. 28C). The radial restraint, illustrated as a contractible wrapping tubing, is releasable using a ripcord-type mechanism. Removal of the contractile wrapping allows the stent 34 to assume an expanded configuration inside the stomach 291 as shown in FIG. 28D. A penetration 294 is made in the intestine 292 using endoscopic or laparoscopic tools. The other end of the stent 34 can then be placed inside the intestine 292 using a similar methodology as shown in FIGS. 28D-28F. FIGS. 28D-28E illustrate placement of the second end of the stent 34 through the penetration 294. The radial restraint is removed to allow the second flange of the stent 34 to deploy inside the intestine 292 (FIG. 28F). After the distal and proximal ends of the stent 34 are placed, the device 50 releases control over the stent 34. After the stent 34 is released by the device 50, the device 50 can be removed from the peritoneal cavity along with the cut radial restraint and the cord or pull wire used to cut the radial restraint.

[0146] 29A-29G illustrate a laparoscopic method for placing a stent between a fundic pouch and a portion of the intestine using the laparoscopic device 50 illustrated in FIGS. 5A-5C. FIGS. 29A-29G are similar to FIGS. 28A-28G, but create an anastomosis between the fundic pouch and the intestine instead of the stomach and intestine. A laparoscopic environment is created within the peritoneal cavity, and the laparoscopic device 50 enters the peritoneal cavity (FIG. 29A). The target body lumen, in this example the fundic pouch 301 and the intestine 302, is located. A penetration 303 is made in the fundic pouch 301 using endoscopic or laparoscopic tools. The orientation of the stent retainer of the device 50 is adjusted to facilitate positioning the end of the stent 34 inside the penetration 303 in the fundic pouch 301 (FIG. 29B). The end of the stent 34 then enters the stomach 301 through the penetration 303 (FIG. 29C). The radial restraint, illustrated as a shrinkable wrapping tubing, can be released using a ripcord-type mechanism. Removal of the shrinkable wrapping allows the stent 34 to assume an expanded configuration inside the fundus pouch 301 as shown in FIG. 29D. A penetration 304 is made in the intestine 302 using endoscopic or laparoscopic tools. The other end of the stent 34 can then be placed inside the intestine 302 using a similar methodology as shown in FIGS. 29D-29F. FIGS. 29D-29E illustrate the placement of the second end of the stent 34 through the penetration 304. The radial restraint is removed to allow the second flange of the stent 34 to unfold inside the intestine 302 (FIG. 29F). After the distal and proximal ends of stent 34 have been deployed, device 50 releases control over stent 34. After stent 34 has been released by device 50, device 50 may be removed from the peritoneal cavity along with the cut radial restraint and the cord or pullwire used to cut the radial restraint.

[0147] Figures 30A-30F illustrate a laparoscopic method for placing a stent between two sealed sections of a formable intestinal tract as described above, using the laparoscopic device 50 illustrated in Figures 5A-5C. A laparoscopic environment is created within the peritoneal cavity, and the laparoscopic device 50 enters the peritoneal cavity (Figure 30A). The cut and sealed ends 310 and 311 of the target body lumen, in this example the colon, are located. Using endoscopic or laparoscopic tools, a first penetration 312 is made adjacent to the first sealed end 310 of the colon, and a second penetration 313 is made adjacent to the second sealed end 311 of the colon. The penetrations 312, 313 are made through the wall of the colon, not through the stapled and sealed ends 310, 311. The orientation of the stent retainer of device 50 is adjusted to facilitate positioning the ends of stent 34 inside colon penetrations 312 and 313 (FIG. 30B). The end of stent 34 then enters the first end of the colon through penetration 312 (FIG. 30C). The radial restraint, illustrated as a contractible wrapping tubing, can be released using a ripcord-type mechanism. Removal of the contractible wrapping allows stent 34 to assume an expanded configuration inside the first end of the colon as shown in FIG. 30D. The other end of stent 34 can then be placed inside the second end of the colon using a similar methodology as shown in FIGS. 30D-30F. FIGS. 30D-30E illustrate the placement of the second end of stent 34 through penetration 313. The radial restraint is removed to allow the second flange of the stent 34 to deploy inside the second end of the colon (FIG. 28E). After the distal and proximal ends of the stent 34 are deployed, the device 50 releases control over the stent 34. After the stent 34 is released by the device 50, the device 50, along with the cut radial restraint and the cord or pull wire used to cut the radial restraint, is removed from the peritoneal cavity leaving only the stent 34 and allowing a pathway to be formed between the first end of the colon and the second end of the colon (FIG. 30F).

[0148] Although Figures 28-30 are illustrated using a laparoscopic device 50, any of the laparoscopic stent delivery devices disclosed herein can be used in these methods.

[0149] Although discussed in detail with respect to gastric bypass and colectomy procedures, the methods and devices can be used herein for the creation of any surgical anastomosis. The embodiments can be used to attach the ureter to a new portion of the bladder. The embodiments can also be used to create an anastomosis between the rectum and another body lumen. The embodiments can also be used to create an anastomosis between the esophagus and another body lumen. The embodiments can be applied to ERCP applications that require access to a guidewire through multiple tissue planes to reach the target anatomical structure. The embodiments are useful for applications and procedures such as transduodenal, transgastric, biliary, pancreatic pseudocyst, transhepatic, transcystic, transpancreatic, transintestinal, transbiliary, transesophageal, transbronchial, transgastric, jejunostomy, transcolonic, etc.

[0150] In some embodiments, the methods and devices can be used for peritoneal access and TIPS (transjugular intrahepatic portosystemic shunting). In some embodiments, the methods and devices can be used in applications and procedures such as for vascular access, arterial to vascular, pericardial access, and venous access with insufficient via transvalve access.

[0151] When a feature or element is referred to herein as being "on" another feature or element, the feature or element may be directly on the other feature or element, or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. Furthermore, when a feature or element is referred to as being "connected," "attached," or "coupled" to another feature or element, it will be understood that the feature or element may be directly connected, attached, or coupled to the other feature or element, or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated may be applicable to other embodiments. Moreover, as will be appreciated by those skilled in the art, a reference to a structure or feature being located "adjacent" to another feature may have a portion that overlaps or underlies the adjacent feature.

[0152] The terms used herein are intended to describe particular embodiments only and are not intended to limit the invention. For example, as used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. Furthermore, it will be understood that the terms "comprises" and "comprising," as used herein, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any combination of one or more of the associated listed items and may be abbreviated as " / ."

[0153] Spatially relative terms, such as "under," "below," "lower," "over," "upper," and the like, may be used herein to facilitate the description of the relationship of one element or feature to another element or feature as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass various orientations of the device during use or operation in addition to the orientation shown in the figures. For example, if a device in the figures were upside down, an element described as "under" or "beneath" another element or feature would be oriented "over" the other element or feature. Thus, the exemplary term "under" can encompass both an up and down orientation. The device may be oriented differently (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly," "downwardly," "vertical," "horizontal," and the like are used herein for descriptive purposes only, unless expressly indicated otherwise.

[0154] The terms "first" and "second" may be used herein to describe various features / elements, but these features / elements should not be limited by the above terms unless the context indicates otherwise. The above terms may be used to distinguish one feature / element from another feature / element. Thus, a first feature / element discussed below may be named a second feature / element, and similarly, a second feature / element discussed below may be named a first feature / element without departing from the teachings of the present invention.

[0155] As used herein in the specification and claims, including as used in the examples, and unless otherwise expressly indicated, all numbers may be read as if preceded by the word "about" or "approximately" (even if the term is not expressly indicated). The words "about" or "approximately" may be used when describing magnitudes and / or configurations to indicate that the stated value and / or configurations are within a reasonable expected range of values ​​and / or configurations. For example, a numerical value may have a value that is ±0.1% of the stated value (or range of values), ±1% of the stated value (or range of values), ±2% of the stated value (or range of values), ±5% of the stated value (or range of values), ±10% of the stated value (or range of values), etc. Any numerical ranges recited herein are intended to include all subranges subsumed within the range.

[0156] Although various illustrative embodiments have been described above, any of a number of modifications may be made to the various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which the steps of the various above-described methods are performed may often be changed in alternative embodiments, and one or more steps of the methods may be omitted altogether in other alternative embodiments. Optional features of the various device and system embodiments may be included in some embodiments and not in others. Thus, the foregoing description has been provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0157] The examples and illustrations contained herein are for purposes of illustration, not limitation, showing specific embodiments in which the subject matter may be practiced. As already mentioned, other embodiments may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. Such embodiments of the subject matter of the present invention may be individually or collectively referred to by the term "invention" merely for convenience, and without willfully limiting the scope of the present application to any single invention or inventive concept, even if more than one is actually disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement that is expected to achieve the same purpose may be substituted for the specific embodiment shown. The present disclosure is intended to cover all adaptations or modifications of the various embodiments. Combinations of the above embodiments, as well as other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

[0158] Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, it will be apparent that various alternatives, modifications and equivalents can be used, and that the above description should not be taken as limiting the scope of the invention which is defined in part by the appended claims.

[0159] The technical ideas that can be understood from the above-described embodiment will be described below as supplementary notes. [Appendix 1] 1. A stent comprising: a stent body formed of a woven filament braid having a constrained configuration, the stent body having an expanded configuration with a proximal end of the body expanded to define a proximal flange, a distal end of the body expanded to define a distal flange, and a cylindrical region extending between the proximal and distal flanges, at least the cylindrical region having a cover; the covered cylindrical region having an open interior passageway configured to permit flow therethrough; the proximal and distal flanges are configured to allow flow therethrough; A stent, wherein the base flange and the distal flange are configured to juxtapose adjacent layers of body tissue without damaging the body tissue between the base flange and the distal flange, the base flange having a rolled-up wall that rolls toward the accessible internal passage of the stent, and the distal flange having a rolled-up wall that rolls toward the accessible internal passage of the stent.

[0160] [Appendix 2] 1. A stent comprising: a stent body formed of a woven filament braid having a constrained configuration, the stent body having an expanded configuration with a proximal end of the body expanded to define a proximal flange, a distal end of the body expanded to define a distal flange, and a cylindrical region extending between the proximal and distal flanges, at least the cylindrical region having a cover; the covered cylindrical region having an open interior passageway configured to permit flow therethrough; the proximal and distal flanges are configured to allow flow therethrough; A stent, wherein the base flange and the distal flange are configured to juxtapose adjacent layers of body tissue without damaging the body tissue between the base flange and the distal flange, and the base flange is configured to bend to cover the covered cylindrical region, and the distal flange is configured to bend to cover the covered cylindrical region.

[0161] [Appendix 3] 3. The stent of claim 2, wherein the base flange has a convoluted wall that convolutes toward the accessible internal passage of the covered cylindrical region, and the distal flange has a convoluted wall that convolutes toward the accessible internal passage of the covered cylindrical region.

[0162] [Appendix 4] 4. The stent of any one of claims 1 to 3, wherein the base flange further comprises a curved surface adjacent a base end of the base flange configured to atraumatically engage body tissue, and the distal flange further comprises a curved surface adjacent a tip of the distal flange configured to atraumatically engage body tissue.

[0163] [Appendix 5] 3. The stent of claim 1 or claim 2, wherein the proximal flange has an inner diameter larger than a diameter of the covered cylindrical region and the distal flange has an inner diameter larger than a diameter of the covered cylindrical region.

[0164] [Appendix 6] 3. The stent of claim 1 or claim 2, wherein the stent is a self-expanding stent. [Appendix 7] A self-expanding stent, a flexible body having an unexpanded configuration and an expanded configuration, the expanded configuration comprising a proximal end of the body expanded to define a proximal flange, a distal end of the body expanded to define a distal flange, and a cylindrical region between the proximal and distal flanges, at least the cylindrical region having a cover; the covered cylindrical region having an open interior passageway configured to permit flow therethrough; the proximal and distal flanges each project away from the interior passage of the cylindrical region to permit flow therethrough; A stent, wherein the base flange and the distal flange are configured to appose adjacent layers of body tissue without damaging the body tissue between the base flange and the distal flange, and the base flange is configured to bend to cover the covered cylindrical region and the distal flange is configured to bend to cover the covered cylindrical region.

[0165] [Appendix 8] 8. The stent of claim 7, wherein the base flange has a convoluted wall that convolutes toward the accessible internal passage of the covered cylindrical region, and the distal flange has a convoluted wall that convolutes toward the accessible internal passage of the covered cylindrical region.

[0166] [Appendix 9] 9. The stent of claim 7 or claim 8, wherein the proximal flange further comprises a curved surface adjacent a proximal end of the proximal flange configured to atraumatically engage body tissue, and the distal flange further comprises a curved surface adjacent a distal end of the distal flange configured to atraumatically engage body tissue.

[0167] [Appendix 10] 8. The stent of claim 7, wherein the proximal flange has an inner diameter larger than a diameter of the covered cylindrical region, and the distal flange has an inner diameter larger than a diameter of the covered cylindrical region.

[0168] [Appendix 11] 8. The stent of claim 7, wherein the stent is a self-expanding stent. [Appendix 12] A medical device, handle, A shaft engaged with a handle; 1. A stent comprising: a stent body formed of a woven filament braid having a constrained configuration, the stent body having an expanded configuration with a proximal end of the body expanded to define a proximal flange, a distal end of the body expanded to define a distal flange, and a cylindrical region extending between the proximal and distal flanges, at least the cylindrical region having a cover; the covered cylindrical region having an open interior passageway configured to permit flow therethrough; the proximal and distal flanges are configured to allow flow therethrough; a stent, the proximal flange and the distal flange configured to appose adjacent layers of body tissue without trauma to the body tissue between the proximal flange and the distal flange; and a stent retainer configured to hold the stent in a constrained state; The stent retainer comprises a material that restrains the stent and is configured to hold the stent in a restrained state and is configured to release and expand the stent.

[0169] [Appendix 13] 13. The medical device of claim 12, wherein the stent retainer is configured to selectively release the distal and proximal flanges of the stent.

[0170] [Appendix 14] 13. The medical device of claim 12, further comprising a sharpened tip configured to penetrate body tissue.

[0171] [Appendix 15] 13. The medical device of claim 12, further comprising a conductive element at a distal end of the shaft configured to penetrate body tissue.

Claims

1. 1. A stent comprising: a stent body formed of a woven filament braid having a constrained configuration, the stent body having an expanded configuration with a proximal end of the body expanded to define a proximal flange, a distal end of the body expanded to define a distal flange, and a cylindrical region extending between the proximal and distal flanges, at least the cylindrical region having a cover; the covered cylindrical region having an open interior passageway configured to permit flow therethrough; the proximal and distal flanges are configured to allow flow therethrough; A stent, wherein the base flange and the distal flange are configured to juxtapose adjacent layers of body tissue without damaging the body tissue between the base flange and the distal flange, the base flange having a rolled-up wall that rolls toward the accessible internal passage of the stent, and the distal flange having a rolled-up wall that rolls toward the accessible internal passage of the stent.

2. 1. A stent comprising: a stent body formed of a woven filament braid having a constrained configuration, the stent body having an expanded configuration with a proximal end of the body expanded to define a proximal flange, a distal end of the body expanded to define a distal flange, and a cylindrical region extending between the proximal and distal flanges, at least the cylindrical region having a cover; the covered cylindrical region having an open interior passageway configured to permit flow therethrough; the proximal and distal flanges are configured to allow flow therethrough; A stent, wherein the base flange and the distal flange are configured to juxtapose adjacent layers of body tissue without damaging the body tissue between the base flange and the distal flange, and the base flange is configured to bend to cover the covered cylindrical region, and the distal flange is configured to bend to cover the covered cylindrical region.

3. The stent of claim 2, wherein the base flange has a rolled wall that rolls toward the accessible internal passage of the covered cylindrical region, and the distal flange has a rolled wall that rolls toward the accessible internal passage of the covered cylindrical region.

4. The stent of any one of claims 1 to 3, wherein the base flange further comprises a curved surface adjacent a base end of the base flange configured to atraumatically engage body tissue, and the distal flange further comprises a curved surface adjacent a tip of the distal flange configured to atraumatically engage body tissue.

5. 3. The stent of claim 1 or claim 2, wherein the proximal flange has an inner diameter greater than a diameter of the covered cylindrical region, and the distal flange has an inner diameter greater than a diameter of the covered cylindrical region.

6. The stent of claim 1 or claim 2, wherein the stent is a self-expanding stent.

7. A self-expanding stent, a flexible body having an unexpanded configuration and an expanded configuration, the expanded configuration comprising a proximal end of the body expanded to define a proximal flange, a distal end of the body expanded to define a distal flange, and a cylindrical region between the proximal and distal flanges, at least the cylindrical region having a cover; the covered cylindrical region having an open interior passageway configured to permit flow therethrough; the proximal and distal flanges each project away from the interior passage of the cylindrical region to permit flow therethrough; A stent, wherein the base flange and the distal flange are configured to appose adjacent layers of body tissue without damaging the body tissue between the base flange and the distal flange, and the base flange is configured to bend to cover the covered cylindrical region and the distal flange is configured to bend to cover the covered cylindrical region.

8. The stent of claim 7, wherein the base flange has a rolled wall that rolls toward the accessible internal passage of the covered cylindrical region, and the distal flange has a rolled wall that rolls toward the accessible internal passage of the covered cylindrical region.

9. 9. The stent of claim 7 or claim 8, wherein the base flange further comprises a curved surface adjacent a base end of the base flange configured to atraumatically engage body tissue, and the distal flange further comprises a curved surface adjacent a tip of the distal flange configured to atraumatically engage body tissue.

10. 8. The stent of claim 7, wherein the proximal flange has an inner diameter greater than a diameter of the covered cylindrical region and the distal flange has an inner diameter greater than a diameter of the covered cylindrical region.

11. The stent of claim 7 , wherein the stent is a self-expanding stent.

12. A medical device, handle, A shaft engaged with a handle; 1. A stent comprising: a stent body formed of a woven filament braid having a constrained configuration, the stent body having an expanded configuration with a proximal end of the body expanded to define a proximal flange, a distal end of the body expanded to define a distal flange, and a cylindrical region extending between the proximal and distal flanges, at least the cylindrical region having a cover; the covered cylindrical region having an open interior passageway configured to permit flow therethrough; the proximal and distal flanges are configured to allow flow therethrough; a stent, the proximal flange and the distal flange configured to appose adjacent layers of body tissue without trauma to the body tissue between the proximal flange and the distal flange; and a stent retainer configured to hold the stent in a constrained state; The stent retainer comprises a material that restrains the stent and is configured to hold the stent in a restrained state and is configured to release and expand the stent.

13. 13. The medical device of claim 12, wherein the stent retainer is configured to selectively release the distal and proximal flanges of the stent.

14. 13. The medical device of claim 12, further comprising a sharpened tip configured to penetrate body tissue.

15. The medical device of claim 12 , further comprising a conductive element at a distal end of the shaft configured to penetrate body tissue.

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