Systems and methods for creating permanent drainage fistulas

Abstract

This invention generally relates to the field of medical devices and the establishment of fluid communication between body cavities. In particular, this invention relates to apparatus and methods for placing the muscle layers of first and second body cavities in contact to establish a long-term or permanent open flow or access pathway therebetween.

Description

[0001] This application is a divisional application of Chinese application filed on June 19, 2018, with application number 201880041110.9 and entitled "System and method for creating a permanent drainage fistula".

[0002] Cross-reference to related applications

[0003] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 62 / 522,348, filed June 20, 2017, pursuant to 35 USC §119, the entire contents of which are incorporated herein by reference for all purposes. Technical Field

[0004] This invention generally relates to the field of medical devices and the establishment of fluid communication between body cavities. In particular, this invention relates to apparatus and methods for establishing permanent, open flow or access pathways between body cavities. Background Technology

[0005] In various situations and conditions, it is desirable to establish access pathways to body cavities to create fluid communication between them. Various medical devices (e.g., drainage stents) can establish open flow or access pathways between body cavities. These devices are generally not recommended for long-term use and are typically removed from the patient within weeks or months of placement. Once the medical device has been removed, the rapidly replenishing cells of the mucosal layer of each body cavity can inherently close or seal the opening (e.g., fistulas, anastomoses, etc.). While this self-sealing ability can be advantageous in some cases, various medical conditions require maintaining long-term or permanent openings between body cavities after the anastomotic device has been removed from the patient.

[0006] For example, obstruction of bile flow from the gallbladder to the common bile duct (CBD) can lead to bile buildup within the gallbladder, causing jaundice in the short term and potentially life-threatening consequences in the long term. Commercially available drainage devices can be placed (e.g., the Axios from Boston Scientific Corporation). TM A stent is used to relieve acute cholecystitis by draining bile and / or gallstones from the gallbladder into the duodenum. Because these drainage devices are not recommended for permanent implantation, the standard of care for chronic cholecystitis is cholecystectomy. Approximately 800,000 cholecystectomies are performed annually in the United States alone.

[0007] Various advantageous medical outcomes can be achieved by the apparatus and / or method of the present invention, such as placing the tissue walls of the first and second body cavities in direct contact such that the juxtaposed muscle layers fuse together to form a long-term or permanent open flow or access pathway that prevents or significantly inhibits closure or sealing. Summary of the Invention

[0008] In one aspect, the present invention relates to a medical device comprising an elongated body forming a cavity and including a proximal portion, a distal portion, a length, and a diameter. The elongated body may include an elongated tubular shape and a shortened shape, wherein in the shortened shape, the proximal portion may expand into a proximal retaining member, and the distal portion may expand into a distal retaining member, thereby leaving a cylindrical saddle-shaped region therebetween. A plurality of proximal tissue engagement elements may be disposed distal to the proximal retaining member along the outer surface of the cylindrical saddle-shaped region, and a plurality of distal tissue engagement elements may be disposed proximal to the distal retaining member along the outer surface of the cylindrical saddle-shaped region. A first end of each proximal tissue engagement element may be attached to the outer surface of the cylindrical saddle-shaped region, and a second end of each proximal tissue engagement element may be unattached and extend toward the distal retaining member. A first end of each distal tissue engagement element may be attached to the outer surface of the cylindrical saddle-shaped region, and a second end of each distal tissue engagement element may be unattached and extend toward the proximal retaining member. The unattached second end of each proximal tissue-attaching element may be raised around the outer surface of the cylindrical saddle-shaped region. The unattached second end of each distal tissue-attaching element may be raised around the outer surface of the cylindrical saddle-shaped region. The unattached second end of each proximal tissue-attaching element may be configured to penetrate the tissue wall of the first body cavity. The unattached second end of each distal tissue-attaching element may be configured to penetrate the tissue wall of the second body cavity. In an elongated tubular configuration, a plurality of proximal and / or distal tissue-attaching elements may lie flat against the outer surface of the elongated body. The surface of the proximal retaining member may be configured to contact the inner surface of the tissue wall of the first body cavity, and the surface of the distal retaining member may be configured to contact the inner surface of the tissue wall of the second body cavity. The tissue walls of the first and second body cavities may be arranged side-by-side along the cylindrical saddle-shaped region between the proximal and distal retaining members. A portion of the tissue wall of a first body cavity joined by multiple proximal tissue engagement elements may be deflected toward a distal retaining member along a cylindrical saddle-shaped region, and a portion of the tissue wall of a second body cavity joined by multiple distal tissue engagement elements may be deflected toward a proximal retaining member along a cylindrical saddle-shaped region, thereby positioning the tissue layer (e.g., muscle layer) of the tissue wall of the first body cavity in contact with the tissue layer (e.g., muscle layer) of the tissue wall of the second body cavity.

[0009] In another aspect, the present invention relates to a medical device comprising an elongated body forming a cavity and including a proximal portion, a distal portion, a length, and a diameter. The elongated body may include an elongated tubular shape and a shortened shape, wherein in the shortened shape, the proximal portion may expand into a proximal retaining member, and the distal portion may expand into a distal retaining member, thereby leaving a cylindrical saddle-shaped region therebetween. A first magnet may be disposed within the proximal retaining member, and a second magnet may be disposed within the distal retaining member. An attractive force between the first and second magnets may push the proximal and distal retaining members toward each other. The surface of the proximal retaining member may be configured to contact the inner surface of the tissue wall of a first body cavity, and the surface of the distal retaining member may be configured to contact the inner surface of the tissue wall of a second body cavity. The tissue walls of the first and second body cavities may be juxtaposed along the cylindrical saddle-shaped region between the proximal and distal retaining members. The surface of the proximal retaining member may cause necrosis within the tissue wall of the first body cavity, and the surface of the distal retaining member may cause necrosis within the tissue wall of the second body cavity. Necrosis within the tissue walls of the first and second body cavities may expose healthy tissue layers (e.g., muscle layers) of the first and second body cavities and place them in contact with each other.

[0010] In another aspect, the present invention relates to a medical device comprising an elongated body forming a cavity and including a proximal portion, a distal portion, a length, and a diameter. The elongated body may include an elongated tubular form and a shortened form, wherein in the shortened form, the proximal portion may expand into a proximal retaining member, and the distal portion may expand into a distal retaining member, thereby leaving a cylindrical saddle-shaped region therebetween. A filament may pass through a portion of the elongated body to achieve compression of the proximal and distal ends toward each other. For example, a first end of the filament may be attached to the proximal end of the medical device at a first position, a second end of the filament may be unattached at a second position and extend from the proximal end of the medical device, and a portion of the filament between the first and second ends may form a loop extending along the cylindrical saddle-shaped region between the proximal and distal retaining members. Retracting the second end of the filament proximally may push the proximal and distal retaining members toward each other. The medical device may also include a locking member attached to the elongated body adjacent to the second position. The locking member may be configured to secure a portion of the filament. The surface of the proximal retaining member can be configured to contact the inner surface of the tissue wall of the first body cavity, and the surface of the distal retaining member can be configured to contact the inner surface of the tissue wall of the second body cavity. The tissue walls of the first and second body cavities can be arranged side-by-side between the proximal and distal retaining members along a cylindrical saddle-shaped region. The surface of the proximal retaining member may cause necrosis within the tissue wall of the first body cavity, and the surface of the distal retaining member may cause necrosis within the tissue wall of the second body cavity. Necrosis within the tissue walls of the first and second body cavities may expose healthy tissue layers (e.g., muscle layers) of the first and second body cavities and place them in contact with each other.

[0011] In another aspect, the present invention relates to a medical device comprising an elongated body forming a cavity and including a proximal portion, a distal portion, a length, and a diameter. The elongated body may include an elongated tubular shape and a shortened shape, wherein in the shortened shape, the proximal portion may expand into a proximal retaining member, and the distal portion may expand into a distal retaining member, thereby leaving a cylindrical saddle-shaped region therebetween. The medical device may become heated in the presence of energy, including MRI energy, and cause necrosis within the tissue walls of the first and second body cavities. Necrosis within the tissue walls of the first and second body cavities may expose healthy tissue layers (e.g., muscle layers) of the first and second body cavities and place them in contact with each other.

[0012] In another aspect, the present invention relates to a medical device comprising a first flexible member and a second flexible member, the first flexible member including an inner surface, an outer surface, and a first opening extending therebetween, and the second flexible member including an inner surface, an outer surface, and a second opening extending therebetween. A plurality of lugs may extend from the inner surface of the second flexible member, and a plurality of recesses may be formed within the inner surface of the first flexible member. Each recess of the first flexible member may be configured to receive a corresponding lug of the second flexible member such that the first and second openings may be aligned to form a combined opening. When the plurality of lugs can be received within the plurality of recesses, the inner surfaces of the first and second flexible members may be separated by a distance. The plurality of lugs may be configured to penetrate the tissue walls of first and second body cavities. The plurality of lugs may be configured to extend through the opening between the tissue walls of the first and second body cavities. Attached Figure Description

[0013] Non-limiting embodiments of the invention are described by way of example with reference to the illustrative and not scaled-down drawings. In the drawings, each identical or substantially identical component shown is generally represented by a single number. For clarity, not every component is labeled in every figure, and not every component of each embodiment shown is necessary for those skilled in the art to understand the invention. In the drawings:

[0014] Figure 1 A perspective view of a medical device according to an embodiment of the present invention is provided.

[0015] Figures 2A to 2F An exemplary step for placing a medical device between a first body cavity and a second body cavity is shown according to an embodiment of the present invention.

[0016] Figures 3A to 3B A perspective view of a medical device disposed between first and second body cavities according to an embodiment of the present invention is provided.

[0017] Figures 4A to 4DExemplary steps for placing a magnet within the proximal and distal retaining members of a medical device, according to an embodiment of the present invention, are shown.

[0018] Figures 5A to 5D Exemplary steps for placing a magnet within the proximal and distal retaining members of a medical device, according to an embodiment of the present invention, are shown.

[0019] Figures 6A to 6B A perspective view of a medical device disposed between first and second body cavities according to an embodiment of the present invention is provided.

[0020] Figures 7A to 7B A perspective view of a medical device disposed between first and second body cavities according to an embodiment of the present invention is provided.

[0021] Figure 8 Calculations and equations for radio frequency induction heating for implantable medical devices according to an embodiment of the present invention are provided.

[0022] Figures 9A to 9C A perspective view of a medical device disposed between first and second body cavities according to an embodiment of the present invention is provided. Detailed Implementation

[0023] This invention is not limited to the specific embodiments described. The terminology used herein is for describing specific embodiments only and is not intended to be limiting beyond the scope of the appended claims. Unless otherwise specified, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0024] Although embodiments of the invention have been described with specific reference to medical devices (e.g., stents, etc.) and systems for gallbladder drainage, it should be understood that such medical devices can be used in a variety of medical procedures (e.g., external biliary drainage conversion, enteroenterostomy, gastrojejunostomy, gastroduodenostomy, and gastroileostomy, etc.) to establish and / or maintain temporary or permanent open flow or drainage pathways originating from or between various body organs, cavities, ducts, blood vessels, fistulas, cysts, and spaces (e.g., dermis, stomach, duodenum, jejunum, small intestine, gallbladder, kidney, pancreas, biliary / pancreatic tree, bladder, ureter, abscess, encapsulated pancreatic necrosis (WOPN), bile ducts, etc.). The device can be inserted through various access points and methods, e.g., percutaneously, endoscopically, laparoscopically, or some combination thereof. The medical devices disclosed herein are self-expanding, but in other embodiments, the medical devices can be dilated in other ways, including, for example, by balloon catheters. Furthermore, this medical device is not limited to drainage, but can be easily accessed into organs, blood vessels, or body cavities for other purposes, such as creating pathways to transfer or detour fluid or solid from one location to another, removing obstructions, and / or delivering treatments, including non-invasive or minimally invasive manipulation of tissue within organs and / or introduction of pharmacological agents via open flow pathways.

[0025] As used herein, the singular forms “a,” “an,” and “the” are intended to also include the plural forms unless the context clearly indicates otherwise. It will also be understood that, when used herein, the terms “comprising” and / or “including” or “containing” and / or “including” indicate the presence of the stated feature, region, step, element, and / or component, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and / or groups.

[0026] As used herein, the term "distal" refers to the end furthest from the medical professional when the device is inserted into the patient, while the term "proximal" refers to the end closest to the medical professional when the device is inserted into the patient.

[0027] In one embodiment, the present invention relates to a medical device (e.g., a self-expanding drainage stent, etc.) configured to extend between first and second body cavities and align with the corresponding muscle layers of each cavity to establish a long-term or permanent open flow or access pathway therebetween. Reference Figure 1In one embodiment, the medical device 100 of the present invention may include an elongated body 110 forming a cavity and including a proximal portion, a distal portion, a length, and a diameter. The elongated body 110 may include an elongated tubular form (e.g., a constrained, unexpanded, or delivery form; not shown) and a shortened form (e.g., an unconstrained, expanded, or deployed form), wherein the proximal portion 112 radially expands into a proximal retaining member 114, and the distal portion 122 radially expands into a distal retaining member 124, thereby leaving a cylindrical saddle-shaped region 128 therebetween. The diameter of the cylindrical saddle-shaped region 128 may be larger than the diameter of the elongated body 110 in the elongated tubular form. The proximal and distal retaining members 114, 124 may extend perpendicular to the circumference of the elongated body 110 to define corresponding flat surfaces 114a, 124a. In various embodiments, the angle of the retaining member relative to the circumference of the elongated body may present other degrees or may vary along the retaining member to create inflection points within the retaining member. A plurality of proximal tissue engagement elements 132 may be disposed at a position distal to the proximal retaining member 114 along the outer surface of the cylindrical saddle region 128, and a plurality of distal tissue engagement elements 142 may be disposed at a position proximal to the distal retaining member 124 along the outer surface of the cylindrical saddle region 128. A first end 134 of each of the proximal tissue engagement elements 132 may be attached to the outer surface of the cylindrical saddle region 128, and a second end 136 of each of the proximal tissue engagement elements 134 may be unattached (e.g., free) and extend toward the distal retaining member 124. A first end 144 of each of the distal tissue engagement elements 142 may be attached to the outer surface of the cylindrical saddle region 128, and a second end 146 of each of the distal tissue engagement elements 142 may be unattached (e.g., free) and extend toward the proximal retaining member 114. In the elongated tubular morphology, proximal and distal tissue junction elements 132, 142 may be disposed along the outer surface of the elongated body (e.g., against it). When the elongated body is moved to the shortened morphology, the proximal and distal tissue junction elements 132, 142 may be deflected outward to extend along and above the outer surface of the cylindrical saddle-shaped region 128 (e.g., substantially parallel to the longitudinal axis of the cylindrical saddle-shaped region, or at an acute angle relative to it).

[0028] In various embodiments, the first ends 134, 144 of any one or both of the first and second tissue-engaging elements 132, 142 may be attached to the outer surface of the cylindrical saddle-shaped region 128 using suitable glue, adhesive, resin, or other bonding techniques (as commonly known in the art). Additionally or alternatively, the proximal and / or distal tissue-engaging elements 132, 142 may be formed as extensions or protrusions of woven, knitted, or braided filaments including elongated bodies 110. Any of the second ends 136, 146 of the proximal and distal tissue-engaging elements 132, 142 may be sharpened, pointed, or otherwise configured to pierce the tissue wall of the respective first or second body cavity, as discussed below. Furthermore, any of the proximal and distal tissue-engaging elements 132, 142 may also include one or more barbs, hooks, fingers, and / or teeth, configured to secure the tissue-engaging element within the tissue wall of the respective first or second body cavity.

[0029] although Figure 1 The proximal and distal tissue engagement elements 132, 142 are depicted as being uniformly spaced around the outer circumference of the cylindrical saddle region 128 and adjacent to the respective proximal and distal retaining members 114, 124. However, in various embodiments, the proximal and / or distal tissue engagement elements 132, 142 may include various shapes, sizes, numbers, orientations, patterns, and / or spacing along the cylindrical saddle region. Additionally or alternatively, in various embodiments, the tissue engagement elements are not limited to the cylindrical saddle region but may be positioned on or along the proximal and / or distal retaining members, including flat, tissue-facing surfaces.

[0030] In one embodiment, the medical device 100 of the present invention can be positioned within a patient's body such that the proximal and distal tissue-jointing elements 132, 142 reorient portions of the respective first and second body cavities as the medical device moves from an elongated tubular form to a shortened form, so as to place the muscle layers of the first and second body cavities in contact along the outer surface of the cylindrical saddle-shaped region 128. Reference Figures 2A to 2F In use and as an example, the medical device 100 of the present invention can be disposed in the cavity of the tissue penetrating element 10 in an elongated tubular form. The sharp distal end 12 of the tissue penetrating element 10 can be advanced through the tissue wall 191 of a first body cavity 190 (e.g., stomach or duodenum) and through the tissue wall 196 of a second body cavity 195 (e.g., gallbladder).

[0031] In various embodiments, the tissue-penetrating element 10 can be advanced over a guidewire 16 that has been previously advanced through the first and second body cavities, such that the distal end of the guidewire is positioned within the second body cavity. Alternatively, in the methods described above, a separate instrument with a sharp distal tip can be advanced along a path over and into the second body cavity to create a path. The guidewire is placed in place, or, if it is used to guide a separate instrument, left in place, and the separate instrument is withdrawn along the guidewire. A medical device according to the various embodiments described above, mounted on a delivery catheter, can be inserted over the guidewire and subsequently deployed according to the steps described above.

[0032] refer to Figure 2A The distal portion 122 of the medical device 100 can then be advanced distally beyond the cavity of the tissue-penetrating element 10, allowing the distal tissue-attaching element 142 to be deployed, for example, removed from constraints within the cavity of the tissue-penetrating element 10. (See reference...) Figure 2B The tissue-penetrating element 10 can then retract proximally such that at least some of the engagements (e.g., punctures or penetrations) of the distal tissue engagement elements 142 are adjacent to a portion of the tissue wall 196 of the second body cavity 195, which is formed by the sharp distal end 12. As the tissue-penetrating element 10 retracts further proximally, a portion of the tissue wall 196 of the second body cavity 195 may be reoriented, for example, deflected or rotated toward the tissue wall 191 of the first body cavity 190.

[0033] refer to Figure 2C The distal portion 122 of the medical device 100 can then be further advanced distally beyond the cavity of the tissue-penetrating element 10, such that the distal retaining member 124 is fully deployed within the second body cavity 195 and the flat surface 124a is positioned to contact the inner surface of the tissue wall 196. Still referring to... Figure 2C When the distal retaining member 124 and a portion of the cylindrical saddle-shaped region 128 are deployed from within the tissue-penetrating element 10, this portion of the tissue wall 196 of the second body cavity 195, engaged by the distal tissue-engaging element 142, can be further reoriented to face the tissue wall 191 of the first body cavity 190. (See reference...) Figure 2D and Figure 2E The tissue-penetrating element 10 can then be further retracted proximally into the first body cavity 190, and the proximal portion 112 of the medical device 100 is advanced distally beyond the cavity of the tissue-penetrating element 10, such that the proximal tissue-attaching element 132 is deployed, for example, by removing constraints from the cavity of the tissue-penetrating element 10, and positioned to contact a portion of the tissue wall 191 of the first body cavity 190 adjacent to the opening formed by the sharp distal end 12. (See reference...) Figure 2FThe proximal portion 112 of the medical device 100 can then be further advanced distally beyond the cavity of the tissue-penetrating element 10, such that the proximal retaining member 114 is fully deployed within the first body cavity 190 and the flat surface 114a is positioned to contact the inner surface of the tissue wall 191. In one embodiment, as the proximal retaining member 114 and the remaining portion of the cylindrical saddle region 128 are deployed from within the tissue-penetrating element 10, this portion of the tissue wall 191 of the first body cavity 195, engaged by one or more of the proximal tissue engaging elements 132, can be reoriented to face the previously reoriented tissue wall 196 of the second body cavity 195, thereby positioning the corresponding muscle layers 194, 199 of the first and second body cavities 190, 195 in contact with the cylindrical saddle region 128.

[0034] In various embodiments, the proximal and distal tissue bonding elements 132, 142 may be sufficiently flexible or deformable to allow the medical device 100 to be removed from the patient without causing substantial trauma to the respective tissue layers. Alternatively or additionally, any one or all of the proximal and distal tissue bonding elements may be made of a biodegradable or bioresolvable material configured to dissolve after fusion with the muscle layers 194, 199, thereby allowing for easier removal of the medical device from the patient.

[0035] In one embodiment, the medical device 200 of the present invention can be positioned within a patient's body such that the proximal and distal retaining members cause selective and localized tissue necrosis in the first and second body cavities to expose adjacent portions of the muscle layer of each body cavity along the outer surface of the cylindrical saddle-shaped region. Reference Figures 3A to 3BIn one embodiment, the medical device 200 of the present invention may include an elongated body 210 forming a cavity and including a proximal portion 212, a distal portion 222, a length, and a diameter. The elongated body 210 may include an elongated tubular form (e.g., a constrained, unexpanded, or delivery form; not shown) and a shortened form (e.g., an unconstrained, expanded, or deployed form), wherein the proximal portion 212 radially expands into a proximal retaining member 214, and the distal portion 222 radially expands into a distal retaining member 224, thereby leaving a cylindrical saddle-shaped region 228 extending therebetween. The diameter of the cylindrical saddle-shaped region 228 may be larger than the diameter of the elongated body 210 in the elongated tubular form. The proximal and distal retaining members 214, 224 may extend perpendicular to the circumference of the elongated body 210 to define corresponding flat surfaces 214a, 224a. A first magnet 150 may be disposed within a proximal retaining member 214, and a second magnet 152 may be disposed within a distal retaining member 224. The first and second magnets 150 and 152 may be disposed within respective first and second retaining members 214 and 224 such that the poles of each magnet provide attraction therebetween around the entire circumference (e.g., 360 degrees) of the cylindrical saddle-shaped region 228. As discussed in more detail below, the medical device 200 may be disposed between first and second body cavities 190 and 195 such that the flat surface 214a of the proximal retaining member 214 contacts and presses against the tissue wall 191 of the first body cavity 190, and the flat surface 224a of the distal retaining member 224 contacts and presses against the tissue wall 196 of the second body cavity 195, to position the body cavities in contact along the cylindrical saddle-shaped region 228. Figure 3A In one embodiment, the attraction between the first and second magnets 150, 152 can push the proximal and distal retaining members 214, 224 toward each other, thereby shortening the cylindrical saddle region 228 and providing constant and consistent pressure between the flat surfaces 214a, 224a and the respective inner surfaces of each tissue wall 191, 196. Additionally, the outer surfaces of each tissue wall can also be compressed abutted against each other between the proximal and distal retaining members 214, 224. The constant and consistent pressure applied to the inner and outer surfaces of each tissue wall 191, 196 may result in selective and localized necrosis at specific depths in each tissue layer. For example, the necrosis depth of the first and second tissue walls 191, 196 may be limited to the mucosal layers 193, 198 to selectively expose and contact the free ends of the muscle layers 194, 199 along the cylindrical saddle region 228.

[0036] In one embodiment, the medical device 200 can be configured to follow the procedures discussed above. Figures 2A to 2FThe exemplary steps outlined herein are used to position the tissue walls 191, 196 of the first and second body cavities 190, 195 between them, except that the tissue walls 191, 196 of the first and second body cavities are positioned in contact along a cylindrical saddle-shaped region 228, for example, the respective tissue walls are not reoriented by proximal and distal tissue junction elements. Reference Figures 4A to 4D In one embodiment, each of the first and second magnets 150, 152 may include a series of magnetic segments 150a-f, 152a-f loaded onto a delivery wire 154. With the medical device 200 properly positioned between the first and second body cavities 190, 195, a delivery device 156 (e.g., an endoscope, etc.) can be advanced through the cavity of the medical device 200 into the second body cavity 195. The delivery wire 154, loaded with a series of magnetic segments 152a-f, can be advanced through the delivery device 156 into the second body cavity 195. The delivery device 156 can then be retracted proximally. Figure 4A The delivery wire 154 is retracted proximally into the medical device 200, such that, for example, exposed magnetic segments 152a-f disposed outside the delivery device 156 are successively snapped or dropped into suitable positions within the open inner circumference of the distal retaining member 224. Figures 4B to 4C With the magnet segments 152a-f positioned within the distal holding member 224, one end of the delivery wire 154 can be released while the other end is retracted proximally to remove the delivery wire 154 from the medical device 200. This process can be repeated to place the magnet segments 150a-f within the proximal holding member 214. Figure 4D With magnet segments 150a-f and 152a-f fully deployed within the proximal and distal retaining members 214 and 224, selective tissue necrosis of the mucosal layers 193 and 198 and fusion of the muscle layers 194 and 199 may occur, as discussed above. (Reference) Figures 5A to 5D In one embodiment, each of the first and second magnets 150, 152 may include a flexible magnet configured to move between a constrained (e.g., linear) shape and an unconstrained (e.g., non-linear or circular) shape. With the medical device 200 properly positioned between the first and second body cavities 190, 195, a delivery device 156 (e.g., an endoscope) can be advanced through the cavities of the medical device 200 into the second body cavity 195. Figure 5A The flexible magnet 152 can be pushed through the conveying device 156 into the second cavity, causing the magnet 152 to move into an unconstrained shape. Figure 5BA medical instrument 158 ​​(e.g., a gripper, etc.) can be passed through an endoscope to grasp and pull the flexible magnet 152 into the medical device. The flexible magnet 152 can deform as it enters the cavity of the medical device and expand (e.g., snap) into the distal retaining member 224 as the medical instrument retracts proximally. Figure 5C This process can be repeated to place the flexible magnet 150 within the proximal retaining member 214. Figure 5D With the flexible magnets 150 and 152 fully deployed within the proximal and distal retaining members 214 and 224, selective tissue necrosis of the mucosal layers 193 and 198 and fusion of the muscle layers 194 and 199 may occur, as discussed above.

[0037] In various embodiments, one or more magnets may be positioned on or near (e.g., beside) the proximal and / or distal retaining members to facilitate selective tissue necrosis of the mucosal layer and fusion of the muscle layer. In other embodiments, magnets may be used in the retaining members of these and other devices to help hold adjacent tissue layers juxtaposed for drainage, without necessarily inducing necrosis and fusion.

[0038] refer to Figures 6A to 6BIn one embodiment, the medical device 300 of the present invention may include an elongated body forming a cavity and including a proximal portion, a distal portion, a length, and a diameter. The elongated body 310 may include an elongated tubular form (e.g., a constrained, unexpanded, or delivery form; not shown) and a shortened form (e.g., an unconstrained, expanded, or deployed form), wherein the proximal portion 312 radially expands into a proximal retaining member 314, and the distal portion 322 radially expands into a distal retaining member 324, thereby leaving a cylindrical saddle-shaped region 328 extending therebetween. The diameter of the cylindrical saddle-shaped region 328 may be larger than the diameter of the elongated body 310 in the elongated tubular form. The proximal and distal retaining members 314, 324 may extend perpendicular to the circumference of the elongated body 310 to define corresponding flat surfaces 314a, 324a. A filament 160 (e.g., suture, thread, nitinol, medical-grade nylon, etc.) may pass through a portion of an elongated body (e.g., through woven, knitted, or braided filaments forming the elongated body) such that a first end 162 of the filament 160 is attached to the proximal end of the medical device 300 at a first location (e.g., proximal to the proximal retaining member 314), and a second end 164 of the filament 160 is unattached at a second location different from the first location and extends proximally beyond the proximal end of the medical device 300. For example, the first and second locations may be on substantially opposite sides of the medical device (e.g., separated by 180 degrees). A portion of the filament 160 between the first end 162 and the second end 164 may form a loop extending along a cylindrical saddle-shaped region 328 between the proximal and distal retaining members 314, 324. In various embodiments, the first end 162 of the filament 160 may be attached to the proximal end of the medical device using suitable knotting, glue, adhesive, resin, or other bonding techniques (as commonly known in the art). In various embodiments, the filament 160 can be configured to slide through woven, knitted, or braided filaments forming the elongated body, such that the second end 164 of the elongated 160 is retracted proximally while securing the medical device (e.g., positioned between the first and second body cavities) in a shortened configuration by pushing the proximal and distal retaining members 314, 324 toward each other, thereby shortening the cylindrical saddle-shaped region 328. A locking member 166 (e.g., a stud, strap, etc.) can be attached to the medical device adjacent to the second location. Alternatively or additionally, the locking member can be integrally formed from a portion of the filament forming the elongated body 310. The locking member 166 can be configured to securely receive / engage a portion of the filament 160 (e.g., a loop, winding, etc.) after the second end 164 of the filament 160 has been retracted proximally, thereby holding the proximal and distal retaining members 314, 324 in a compressed (e.g., further shortened) configuration.

[0039] In various embodiments, the filament 160 can be retracted proximally and “knotted” to the locking member 166 to establish the required amount of pressure to the tissue walls 191, 196 of the first and second body cavities 190, 195, as discussed below. By securing different portions of the filament 160 to the locking member 166, the distance between the proximal and distal retaining members 314, 324 (and the pressure applied to the respective tissue walls) can be adjusted as needed. For example, additional force can be applied between the respective tissue walls by releasing (e.g., untying) the filament 160 from the locking member 166, further retracting the second end 164 proximally, and re-secured the filament 160 to the locking member 166. Similarly, the force applied between the respective tissue walls can be reduced by releasing the filament 160 from the locking member 166, allowing the second end 164 to slide distally, and re-secured the filament 160 to the locking member 166. Alternatively, the filament 160 can be released from the locking member 166, allowing the free end 164 to slide distally without being reattached to the locking member 166 as a first step in removing the medical device 300 from the patient.

[0040] In one embodiment, the medical device 300 can be configured to follow the procedures discussed above. Figures 2A to 2F The medical device is positioned between the first and second body cavities according to the exemplary steps outlined herein, except that the tissue walls 191, 196 of the first and second body cavities 190, 195 are positioned in contact with each other along a cylindrical saddle region 328. For example, the respective tissue walls are not reoriented by proximal and distal tissue engagement elements. When the medical device is correctly positioned between the first and second body cavities 190, 195, the flat surface 314a of the proximal retaining member 314 can contact and press against the tissue wall 191 of the first body cavity 190, and the flat surface 324a of the distal retaining member 324 can contact and press against the tissue wall 196 of the second body cavity 195 to position the body cavities in contact with each other along the cylindrical saddle region 328. Figure 6AThen, the second end 164 of the filament 160 can be retracted proximally (e.g., using a suitable gripping member, etc.) to push the proximal and distal retaining members 314, 324 toward each other and secure them to the locking member 166, thereby providing constant and uniform pressure between the flat surfaces 314a, 324a and the respective inner surface of each tissue wall. Additionally, the outer surface of each tissue wall can also be compressed against each other between the proximal and distal retaining members 314, 324. The constant and uniform pressure applied to the inner and outer surfaces of each tissue wall 191, 196 may result in selective and localized necrosis at a specific depth in each tissue layer. For example, the necrosis depth of the first and second tissue walls 191, 196 may be limited to the mucosal layers 193, 198 to selectively expose and place the free ends of the muscle layers 194, 199 in contact along the cylindrical saddle region 328. Figure 6B ).

[0041] In one embodiment, the medical device 400 of the present invention can establish a long-term or permanent open flow or access pathway without reorienting the tissue walls 191, 196 of the first and second body cavities 190, 195 along the cylindrical saddle region. Figures 1 to 2F ) or compression (e.g., Figures 3A to 6B ). refer to Figures 7A to 7B In one embodiment, the medical device 400 of the present invention may include an elongated body forming a cavity and including a proximal portion, a distal portion, a length, and a diameter. The elongated body 410 may include an elongated tubular form (e.g., a constrained, unexpanded, or delivery form; not shown) and a shortened form (e.g., an unconstrained, expanded, or deployed form), wherein the proximal portion 412 radially expands into a proximal retaining member 414, and the distal portion 422 radially expands into a distal retaining member 424, thereby leaving a cylindrical saddle-shaped region 428 extending therebetween. The diameter of the cylindrical saddle-shaped region 428 may be larger than the diameter of the elongated body 410 in the elongated tubular form. The proximal and distal retaining members 414, 424 may extend perpendicular to the circumference of the elongated body 410 to define corresponding flat surfaces 414a, 424a. The medical device 400 can be manufactured by following the principles discussed above. Figures 2A to 2FThe medical device is positioned between the first and second body cavities according to the exemplary steps outlined herein, except that the tissue walls 191, 196 of the first and second body cavities 190, 195 are positioned in contact with each other along a cylindrical saddle region 428. For example, the respective tissue walls are not reoriented by proximal and distal tissue engagement elements. When the medical device is correctly positioned between the first and second body cavities 190, 195, the flat surface 414a of the proximal retaining member 414 can contact and press against the tissue wall 191 of the first body cavity 190, and the flat surface 424a of the distal retaining member 424 can contact and press against the tissue wall 196 of the second body cavity 195 to position the body cavities in contact with each other along the cylindrical saddle region 428. Figure 7A ).

[0042] In one embodiment, the medical device 400 may include a quantity of ferrous material (e.g., formed in a thin film or coating and / or woven, knitted, or braided filaments within an elongated body) such that exposing a patient to a suitable magnetic field may cause localized vibration of the medical device 400. Establishing a suitable vibrational frequency within the medical device, for example by exposing the medical device to a magnetic field generated by a standard MRI machine, can heat the medical device to a suitable temperature to selectively kill cells of the mucosal layers 194, 198 of the first and second body cavities 190, 195. In addition to selectively killing cells of the mucosal layers 193, 198 and the muscle layers 194, 199 directly contacting the first and second body cavities 190, 195, the heat emanating from the medical device 400 can also cauterize exposed tissue surfaces to promote fusion of the muscle layers. Figure 7B ).

[0043] refer to Figure 8 The cumulative effective minutes (CEM 43) at 43°C indicates that radiofrequency-induced heating of the implanted medical device may lead to cell death when surrounding tissue is exposed to elevated temperatures (e.g., above 37°C; body temperature) over an extended period. For example, in one embodiment, cell death may occur one minute after exposing the medical device to a temperature of 45.7°C (e.g., 8.7°C above body temperature), or 160 minutes after exposing the medical device to a temperature of 42.0°C (e.g., 5.0°C above body temperature). Although Figures 7A to 7BA thermally induced open flow or access pathway is described using a medical device 400 that does not include tissue-attaching elements, magnets, or slidable filaments. However, in various embodiments, any or all of the medical devices 100, 200, and 300 disclosed herein may also include an MRI-induced heating step to further facilitate the necessary killing of cells, including mucosal layers, and to place adjacent muscle layers of first and second body cavities in contact. Similarly, in various embodiments, any of the medical devices 100, 200, 300, and 400 disclosed herein may include any combination of the elements disclosed herein (e.g., tissue-attaching elements, magnets or slidable filaments, ferrous materials, etc.).

[0044] Figures 1 to 7B The elongated body of any one of the medical devices 100, 200, 300, and 400 depicted may be made of woven, knitted, or braided filaments (e.g., nitinol wire, etc.). The proximal retaining member, distal retaining member, and / or cylindrical saddle region may also include a thin film or coating on its inner and / or outer surfaces to define a continuous, open internal passageway configured to allow flow and / or entry of (e.g., bodily fluids, materials, etc.) through it. The coating may comprise a variety of non-degradable and biocompatible polymeric materials (e.g., upon exposure to bodily fluids, such as bile), including, for example, silicone, rubber, polyethylene, PVDF, etc. Thermoplastic elastomers are used to conform the coating to medical devices in elongated tubular and shortened forms. Additionally or alternatively, the woven, knitted, or braided filaments in any of the various embodiments may be metal filaments or polymer filaments, and may also include single filaments spun themselves or multiple filaments woven together. Additionally or alternatively, in one embodiment, the open internal passage may also include one or more valves (e.g., duckbill valves, slit valves, etc.) movable between closed and open forms to block or prevent fluid flow through it until a patient or medical professional determines that the valve should be opened (e.g., by inserting a drainage tube). These valves may be positioned anywhere along the open internal passage of the elongated body. Examples of such valves are described in U.S. Patent Publication No. 2012 / 0226243, which is incorporated herein by reference in its entirety. Such valves may comprise a variety of suitable biocompatible and non-degradable materials, including any of the polymers discussed herein, and may be used with any of the various embodiments described or otherwise contemplated within the scope of the invention.

[0045] Figure 1-7BThe first and second retaining members of any one of the medical devices 100, 200, 300, and 400 depicted herein may include various forms such that one or more of the retaining members extend radially at an angle not necessarily perpendicular to the elongated body and / or their surfaces are not necessarily flat. For example, one or both of the proximal and distal retaining members may extend outward toward the end of the elongated body, return toward the central portion of the elongated body, or change direction in some combination of both. Additionally or alternatively, one or both of the proximal and distal retaining members may include an outer diameter d1 greater than the outer diameter d2 of the cylindrical saddle-shaped region. For example, the outer diameter d1 may be 75%-100% larger than the outer diameter d2 of the cylindrical saddle-shaped region. As a non-limiting example, the outer diameter d1 may be from about 7.0 mm to about 30 mm, and the outer diameter d2 may be from about 3.0 mm to about 15.0 mm. In various embodiments, the size (e.g., diameter) of the opening formed between the first and second body cavities can be increased or decreased by increasing or decreasing the size (e.g., width) of the proximal and distal retaining members (e.g., increasing or decreasing the surface area of ​​the tissue layer compressed between the proximal and distal retaining members). Additionally or alternatively, the length of the elongated body in the shortened form may be at least 40% shorter than the length of the elongated body in the elongated tubular form.

[0046] In various embodiments, any of the medical devices 100, 200, 300, 400 of the present invention can be held in a suitable location within the patient for a sufficient amount of time to allow the muscle layers 194, 195 to fuse or integrate (e.g., grow together), at which point the medical device can be removed from the patient to leave a long-term or permanent open flow, drainage, or access pathway between the first and second body cavities 190, 195. For example, the medical devices 100, 200, 300, 400 can be maintained in the body for several days to several weeks to establish the necessary level of tissue necrosis between the proximal and distal holding members. The necrotic tissue may eventually slough off, leaving a permanent opening defined by the fused muscle layers.

[0047] In various embodiments, any one of the medical devices 100, 200, 300, and 400 of the present invention may further include one or more chemicals (e.g., silver nitrate) or antiproliferative agents embedded in or within a coating of the medical device (including, for example, a cylindrical saddle-shaped region and / or flat surfaces of proximal and distal retaining members) to further promote selective killing of cells in the mucosal layers of the first and second body cavities. Additionally or alternatively, once the medical device of the present invention has been removed from the patient, surgical adhesive, cryotherapy, or cryoablation may be applied to the inner diameter of the opening between the first and second body cavities to seal the fused muscle layers and further prevent inward growth of mucosal cells.

[0048] In one embodiment, the opening created between the first and second body cavities, as described herein, can be maintained by replacing the medical device used to create the opening with a permanent implant (e.g., a clasp) configured to physically prevent (e.g., block) the opening from closing or resealing. Reference Figures 9A to 9B The medical device 500 of the present invention may include interlocking first and second flexible members 172, 182. For example, the first and second flexible members 172, 182 may be made of a suitable polymeric material (e.g., silicone, rubber, etc.) configured to deform, bend, fold, roll, compress, or otherwise deform (e.g., within a delivery sheath) for delivery into a first or second body cavity, and return to their original undeformed form once released from restraint within the respective body cavity. The first flexible member 172 may include an outer surface 174, a substantially flat or planar inner surface 176, an outer edge 175 having a first circumference, and an inner edge 177 having a second circumference smaller than the first circumference, wherein the inner edge 177 defines a first opening 178 extending between the outer and inner surfaces 174, 176. A plurality of recesses 189a, 189b (e.g., two or more) may be formed within the inner surface 176 along the outer edge 175 of the first flexible member 172. The second flexible member 182 may include an outer surface 184, a substantially flat or planar inner surface 186, an outer edge 185 having a first circumference, and an inner edge 187 having a second circumference smaller than the first circumference, wherein the inner edge 187 defines a second opening 188 extending between the outer and inner surfaces 184, 186. A plurality of lugs 199a, 199b (e.g., two or more) may extend from the inner surface 186 along the outer edge 185 of the second flexible member 182. A cylinder 181 extending co-existing with the second opening 188 may also extend from the inner surface 186 of the second flexible member 182. Each recess 189a, 189b of the first flexible member 172 may be configured, for example, to securely receive a corresponding lug 199a, 199b of the second flexible member 182 in an interlocking or snap-fit ​​manner, such that the first and second openings 178, 188 are aligned to form a continuous open cavity defined by the cylinder 181, and wherein the inner surfaces 176, 186 of the first and second flexible members 172, 182 are separated by a predetermined distance.

[0049] refer to Figure 9BIn use and by way of example, the medical device 500 of the present invention can be positioned within an opening previously formed between the first and second body cavities 190, 195 by loading the first and second flexible members 172, 182 in a folded or compressed form within the lumen of the delivery tube (not shown). The delivery tube can be advanced through the opening between the first and second body cavities 190, 195 such that the distal end of the delivery tube is positioned within the second body cavity 195. The second flexible member 182 can then be advanced distally beyond the lumen of the delivery tube such that the second flexible member 182 moves into an unconstrained form within the second body cavity 195. A separate medical device (not shown) can be advanced through the lumen of the delivery tube, or along the outer surface of the delivery tube, to grip the second flexible member 182 and position the plurality of lugs 199a, 199b in contact with the tissue wall 196 of the second body cavity 196 such that the second opening 188 is aligned with the opening between the first and second body cavities 190, 195. Then, the medical device can be retracted proximally with sufficient force, causing the lugs 199a and 199b of the second flexible member 182 to penetrate and extend through the tissue walls 191 and 196 of the first and second body cavities 190 and 195, and the cylinder 181 to extend through the opening between the first and second body cavities 190 and 195. Subsequently, the delivery tube can be retracted proximally, such that the distal end of the delivery tube is positioned within the first body cavity 190. Then, the first flexible member 172 can be advanced distally beyond the cavity of the delivery tube, such that the first flexible member 172 moves into an unconstrained shape within the first body cavity 190. While maintaining pressure on the second flexible member 182 using a medical device, the first flexible member 172 can be positioned to contact the tissue wall 191 of the first body cavity 190, such that the first opening 178 is aligned with the opening between the first and second body cavities 190, 195, the recesses 189a, 189b on the inner surface 174 of the first flexible member 172 are aligned with the lugs 199a, 199b of the second flexible member 182 extending into the first body cavity 190, and the cylinder 181 extends through the opening between the first and second body cavities 190, 195. In one embodiment, the distal end of the delivery tube can be used to position the first flexible member 172 to contact the tissue wall 191 of the first body cavity 190. Alternatively, a second medical device (not shown) can be positioned within the first body cavity 190 to grip the first flexible member 172 and align the recesses 189a, 189b with the corresponding ends of the lugs 199a, 199b. Then, the first and second flexible members 172, 182 can be advanced toward each other such that lugs 199a, 199b extending from the inner surface 186 of the second flexible member 182 engage with corresponding recesses 189a, 189b on the inner surface 176 of the second flexible member 172, thereby aligning the first and second openings 178, 188 of the first and second flexible members 172, 176 with the opening between the first and second body cavities.The predetermined distance between the inner surfaces 176, 186 of the first and second flexible members 172, 182 allows the tissue walls 191, 196 of the first and second body cavities to remain in an uncompressed state (e.g., a state that does not cause tissue necrosis) throughout the entire duration of the medical device being implanted in the patient. However. Figures 9A to 9B Two lugs 199a, 199b and two corresponding recesses 189a, 189b are depicted on opposite sides of the ends of their respective flexible members 172, 182, but in various embodiments, any number of lugs and recesses may be arranged in various patterns, orientations and / or shapes.

[0050] refer to Figure 9C To minimize damage to the tissue layers of the first and second body cavities, in one embodiment, the medical device 500 of the present invention may include interlocking first and second flexible members 172, 182, as discussed above. A cylinder 181 extending co-existing with a second opening 188 may extend from the inner surface 186 of the second flexible member 182. The free end of the cylinder may include a series of lugs (or a single continuous or circular lug) configured to extend through the opening between the first and second body cavities and engage, in an interlocking or snap-fit ​​manner, a corresponding recess 173 (e.g., a circular groove) surrounding the first opening 178 of the first flexible member 172, such that the first and second openings 178, 188 are aligned to form a continuous open cavity defined by the cylinder 181, and wherein the inner surfaces 176, 186 of the first and second flexible members 172, 182 are separated by a predetermined distance.

[0051] Furthermore, in various embodiments, the first and second flexible members 172, 182 are not limited to being disposed within the first and second body cavities. For example, the first flexible member may be disposed within the second body cavity to receive a lug of the second flexible member positioned within the first body cavity.

[0052] According to the present invention, all the apparatuses and / or methods disclosed and claimed herein can be manufactured and performed without requiring extensive experimentation. While the apparatuses and methods of the present invention have been described with reference to preferred embodiments, it will be apparent to those skilled in the art that variations can be made to the apparatuses and / or methods and to the steps or sequences of steps described herein without departing from the concept, spirit, and scope of the invention. All such similar substitutions and modifications that will be apparent to those skilled in the art are considered to be within the spirit, scope, and concept of the invention as defined by the appended claims.

Claims

1. A medical device comprising: An elongated body that forms a cavity and includes a proximal portion and a distal portion; The elongated body has an unexpanded form and an expanded form, wherein the proximal portion expands into a proximal retaining member and the distal portion expands into a distal retaining member, leaving a cylindrical saddle-shaped region between them. and A filament that passes through a portion of the elongated body, wherein the filament includes one end fixed to the elongated body and another free end, and wherein retracting the filament proximally pushes the proximal retaining member and the distal retaining member toward each other.

2. The medical device of claim 1, wherein the free end of the filament retracted proximally pushes the proximal retaining member and the distal retaining member toward each other.

3. The medical device of claim 1, wherein the surface of the proximal retaining member is configured to contact the inner surface of the tissue wall of the first body cavity, and the surface of the distal retaining member is configured to contact the inner surface of the tissue wall of the second body cavity.

4. The medical device according to claim 3, wherein, The surfaces of the proximal and distal retaining members are configured such that the tissue walls of the first and second body cavities are positioned along the cylindrical saddle region and between the proximal and distal retaining members.

5. The medical device of claim 4, wherein the proximal retaining member is configured to contact the inner surface of the tissue wall of the first body cavity at a flat surface of the proximal retaining member, wherein the distal retaining member is configured to contact the inner surface of the tissue wall of the second body cavity at a flat surface of the distal retaining member, or wherein both the proximal and distal retaining members are configured to contact the respective inner surfaces of the tissue walls of the first and second body cavities at flat surfaces of the proximal and distal retaining members.

6. The medical device of claim 4, wherein the proximal retaining member and the distal retaining member are configured to apply constant and consistent pressure to the tissue walls of the first body cavity and the second body cavity located therebetween.

7. The medical device of claim 1, wherein the fixed end of the filament is attached to the proximal portion of the elongated body at a first position, and the free end of the filament extends from the first position along the cylindrical saddle region to the proximal portion and returns along the cylindrical saddle region, terminating at a second position different from the first position at the distal portion of the elongated body.

8. The medical device of claim 1, further comprising a locking member attached to the elongated body adjacent to the free end of the filament.

9. The medical device according to claim 8, wherein, The locking member is configured to releasably secure or engage a portion of the free end of the filament, such that the distance and force between the proximal retaining member and the distal retaining member are adjustable.

10. The medical device of claim 1, wherein the fixed end of the filament is attached to the elongated body by knotting or adhesive.

11. The medical device of claim 1, wherein the fixed end of the filament is attached to the elongated body using adhesive.

12. The medical device of claim 1, wherein the fixed end of the filament is attached to the elongated body using resin bonding.

13. The medical device of claim 1, wherein the elongated body is formed of woven, knitted, or braided filaments.

14. The medical device of claim 13, wherein the filament is configured to slide through the woven, knitted, or braided filament.

15. The medical device of claim 1, wherein the proximal retaining member and the distal retaining member extend substantially perpendicularly from the longitudinal axis along the circumference of the cylindrical saddle region around the elongated body.

16. A medical device comprising: A slender tubular body that forms a cavity and includes a proximal portion and a distal portion; A filament, one end of which is fixed to the elongated tubular body; in: The elongated tubular body expands from its unconstrained, unexpanded state to its expanded state. When unconstrained, the proximal portion expands radially outward to form a proximal retaining member, and the distal portion expands radially outward to form a distal retaining member, leaving a cylindrical saddle-shaped region between them; and The unattached free end of the filament passes through the elongated tubular body from one end where the filament is fixed, and extends proximally beyond the proximal portion of the elongated tubular body. as well as When the elongated tubular body is in an expanded state, the filament is configured to push the expanded proximal retaining member and distal retaining member toward each other when the free end of the filament retracts proximally.

17. The medical device of claim 16, wherein the filament is fixed to the proximal portion of the elongated tubular body.

18. The medical device of claim 16 or 17, wherein the surface of the proximal retaining member is configured to contact the inner surface of the tissue wall of the first body cavity, and the surface of the distal retaining member is configured to contact the inner surface of the tissue wall of the second body cavity.

19. The medical device of claim 18, wherein the surfaces of the proximal retaining member and the distal retaining member are configured such that the tissue walls of the first body cavity and the second body cavity are positioned along the cylindrical saddle region and between the proximal retaining member and the distal retaining member.

20. The medical device of claim 18, wherein the proximal retaining member is configured to contact the inner surface of the tissue wall of the first body cavity at a flat surface of the proximal retaining member, wherein the distal retaining member is configured to contact the inner surface of the tissue wall of the second body cavity at a flat surface of the distal retaining member, or wherein both the proximal and distal retaining members are configured to contact the respective inner surfaces of the tissue walls of the first and second body cavities at flat surfaces of the proximal and distal retaining members.

21. The medical device of claim 20, wherein the proximal retaining member and the distal retaining member are configured to apply constant and uniform pressure to the tissue walls of the first and second body cavities juxtaposed therebetween.

22. The medical device of claim 21, wherein the constant and consistent pressure applied by the proximal retaining member and the distal retaining member results in selective and localized tissue necrosis at a specific depth in each tissue layer.

23. The medical device of claim 16 or 17, further comprising a locking member configured to engage a portion of the filament to maintain the compressed shape of the lateral retaining member and the distal retaining member.

24. The medical device of claim 23, wherein the locking member is configured to releasably secure or engage a portion of the free end of the filament such that the distance and force between the proximal retaining member and the distal retaining member are adjustable.

25. The medical device of claim 16 or 17, wherein the fixed end of the filament is attached to the elongated tubular body using a knot or adhesive.

26. The medical device of claim 16 or 17, wherein the fixed end of the filament is attached to the elongated tubular body using adhesive.

27. The medical device of claim 16 or 17, wherein the fixed end of the filament is attached to the elongated tubular body using resin bonding.

28. The medical device according to claim 16 or 17, wherein the elongated tubular body is formed from woven, knitted, or braided filaments.

29. The medical device of claim 28, wherein the filament is configured to slide through the woven, knitted, or braided filament.

30. The medical device of claim 16 or 17, wherein the lateral retaining member and the distal retaining member extend perpendicularly from the longitudinal axis along the cylindrical saddle region around the circumference of the elongated tubular body.

Images