System and method for creating a permanent drainage fistula

Abstract

The present invention provides a medical device for forming an opening channel or access passage between body tubular lumens. [Solution] The present invention relates to a device that uses an elongated body, a proximal holding portion, and a distal holding portion to bring the muscle layers of a first body lumen and a second body lumen into contact and to form a long-term or permanent opening or access channel between them. The medical device comprises an elongated body that forms a lumen and includes a proximal portion, a distal portion, a certain length, and a certain diameter, wherein the elongated body 310 may have an elongated tubular form (e.g., a restrained form, an unexpanded form, or a transport form) and a retracted form (e.g., an unrestrained form, an expanded form, or an unfolded form) in which the proximal portion 312 expands radially into the proximal holding portion 314 and the distal holding portion 322 expands radially into the distal holding portion 324, with a cylindrical saddle portion 328 extending between them.

Description

Technical Field

[0001] The present invention relates to the field of medical devices and to communicating a plurality of body lumens. More particularly, the present invention relates to devices and methods for forming a permanent opening flow path or access passage between body lumens.

Background Art

[0002] In various situations and conditions, it may be desirable to construct access to a plurality of body lumens to communicate one with the other. Various medical devices (e.g., drainage stents) can form an opening flow path or access flow path between body lumens. These medical devices generally are not suitable for long-term use and often are removed from the patient's body within a few weeks or months after placement. When the medical device is removed, rapid cell regeneration of the mucosal layer of each body lumen may essentially close or seal the opening (e.g., fistula or anastomosis). Such self-sealing ability may be advantageous in certain situations, but in various medical situations, after removing the anastomosis device from the patient's body, it is necessary to maintain a long-term or permanent opening between the body lumens.

[0003] For example, when the flow of bile from the gallbladder to the common bile duct (CBD) is blocked, bile accumulates in the gallbladder, which can cause jaundice in the short term and pose a life threat in the long term. To relieve the symptoms of acute cholecystitis by draining bile and gallstones from the gallbladder to the duodenum, commercially available drainage devices (e.g., Axios®, Boston Scientific) are placed. Since such drainage devices are not permanently implanted, the standard treatment for chronic cholecystitis is removal of the gallbladder. Approximately 800,000 gallbladder removal surgeries are performed annually in the United States alone.

[0004] Favorable medical outcomes can be achieved with the apparatus and methods of the present invention. For example, by placing the tissue walls of a first body lumen and a second body lumen in direct contact and fusing the opposing muscle layers, a long-term or permanent open flow passage or open access passage can be formed that prevents or significantly inhibits closure or sealing. [Overview of the Initiative]

[0005] In a first embodiment, the present invention relates to a medical device comprising a slender body that forms a lumen and has a proximal portion, a distal portion, a certain length, and a certain diameter. The slender body may have a slender tubular shape and a retracted shape comprising a proximal retaining portion formed by the expansion of the proximal portion, a distal retaining portion formed by the expansion of the distal portion, and a cylindrical saddle portion defined between the proximal retaining portion and the distal retaining portion. A plurality of proximal tissue engagement elements are arranged distal to the proximal retaining portion along the outer surface of the cylindrical saddle portion, and a plurality of distal tissue engagement elements are arranged proximal to the distal retaining portion along the outer surface of the cylindrical saddle portion. The first end of each proximal tissue engagement element is attached to the outer surface of the cylindrical saddle portion, and the second end of each proximal tissue engagement element extends toward the distal retaining portion without being attached. The first end of each distal tissue engagement element is attached to the outer surface of the cylindrical saddle portion, and the second end of each distal tissue engagement element extends toward the proximal retaining portion without being attached. The unattached second end of each proximal tissue engagement element can be raised and lowered around the outer surface of the cylindrical saddle portion. The unattached second end of each distal tissue engagement element can be raised and lowered around the outer surface of the cylindrical saddle portion. The unattached second end of each proximal tissue engagement element is configured to penetrate the tissue wall of the first body lumen. The unattached second end of the distal tissue engagement element is configured to penetrate the tissue wall of the second body lumen. When the elongated body is in an elongated tubular form, the multiple proximal and distal tissue engagement elements can lie flat relative to the outer surface of the elongated body. The surface of the proximal retaining portion is configured to contact the inner surface of the tissue wall of the first body lumen, and the surface of the distal retaining portion is configured to contact the inner surface of the tissue wall of the second body lumen. The tissue walls of the first and second body lumen are positioned between the proximal and distal retaining portions along a cylindrical saddle portion. A portion of the tissue wall of the first body lumen, to which multiple proximal tissue engagement elements are engaged, curves toward the distal retaining portion along the cylindrical saddle portion, and a portion of the tissue wall of the second body lumen, to which multiple distal tissue engagement elements are engaged, curves toward the proximal retaining portion along the cylindrical saddle portion, and the tissue layers of the tissue wall of the first body lumen (e.g., muscular layer) may be positioned in contact with the tissue layers of the second tissue wall (e.g., muscular layer).

[0006] In another embodiment, the present invention relates to a medical device comprising a tubular body that forms a lumen and has a proximal portion, a distal portion, a fixed length, and a fixed diameter. The tubular body comprises a tubular shape and a retracted shape consisting of a proximal holding portion formed by the expansion of the proximal portion, a distal holding portion formed by the expansion of the distal portion, and a cylindrical saddle portion defined between the proximal and distal holding portions. A first magnet is disposed in the proximal holding portion, and a second magnet is disposed in the distal holding portion. The proximal and distal holding portions are biased toward each other by the attractive force between the first and second magnets. The surface of the proximal holding portion is configured to be in contact with the inner surface of the tissue wall of the first body lumen, and the surface of the distal holding portion is configured to be in contact with the inner surface of the tissue wall of the second body lumen. The tissue walls of the first and second body lumens are juxtaposed between the proximal and distal retaining portions along the cylindrical saddle portion. The surface of the proximal retaining portion may cause tissue necrosis within the tissue wall of the first body lumen, and the surface of the distal retaining portion may cause tissue necrosis within the tissue wall of the second body lumen. Tissue necrosis within the tissue walls of the first and second body lumens may expose and arrange the adjacent layers of healthy tissue (e.g., muscular layer) of the first and second body lumens.

[0007] In another embodiment, the present invention relates to a medical device comprising a slender body that forms a lumen and has a proximal portion, a distal portion, a certain length, and a certain diameter. The slender body comprises a slender tubular shape and a contracted shape consisting of a proximal holding portion formed by the expansion of the proximal portion, a distal holding portion formed by the expansion of the distal portion, and a cylindrical saddle portion defined between the proximal and distal holding portions. A filament is passed through a portion of the slender member and can be compressed at its proximal and distal ends toward each other. For example, a first end of the filament is attached to the proximal end of the medical device at a first portion, and a second end of the filament extends from the proximal end of the medical device at a second portion without being attached, and the portion of the filament between the first and second ends can form a loop extending along the cylindrical saddle portion between the proximal and distal holding portions. By pulling the second end of the filament in the proximal direction, the proximal and distal retaining portions are biased toward each other. The medical device may further include a locking member attached to an elongated body adjacent to the second portion. The locking member is configured to fix a portion of the filament. The surface of the proximal retaining portion is configured to contact the inner surface of the tissue wall of the first body lumen, and the surface of the distal retaining portion is configured to contact the inner surface of the tissue wall of the second body lumen. The tissue walls of the first and second body lumen may be juxtaposed between the proximal and distal retaining portions along a cylindrical saddle portion. The surface of the proximal retaining portion may cause tissue necrosis within the tissue wall of the first body lumen, and the surface of the distal retaining portion may cause tissue necrosis within the tissue wall of the second body lumen. Tissue necrosis within the tissue walls of the first and second body lumens may expose and arrange the adjacent layers of healthy tissue (e.g., muscle layer) in the first and second body lumens.

[0008] In another embodiment, the present invention relates to a medical device comprising a luminous body having a proximal portion, a distal portion, a certain length, and a certain diameter. The luminous body may comprise a tubular shape and a retracted shape comprising a proximal holding portion formed by the expansion of the proximal portion, a distal holding portion formed by the expansion of the distal portion, and a cylindrical saddle portion defined between the proximal and distal holding portions. The medical device may be heated in the presence of energy such as MRI energy to induce tissue necrosis in the tissue walls of a first body lumen and a second body lumen. Tissue necrosis in the tissue walls of the first and second body lumen may expose and arrange layers of healthy tissue (e.g., muscle layer) of the first and second body lumen that are in contact with each other.

[0009] In another embodiment, the present invention relates to a medical device comprising a first flexible member having an inner surface, an outer surface, and a first opening extending between them, and a second flexible member having an inner surface, an outer surface, and a second opening between them. A plurality of tabs extend from the surface of the second flexible member, and a plurality of recesses are formed inside the inner surface of the first flexible member. Each recess of the first flexible member is configured to receive a corresponding tab of the second flexible member, and the first and second openings can form a combined opening. The inner surfaces of the first flexible member and the second flexible member are spaced apart when the plurality of tabs are received in the plurality of recesses. The plurality of tabs are configured to penetrate the tissue walls of the first and second body lumens. The plurality of tabs are configured to extend through the opening between the first and second body lumens.

[0010] Non-limiting embodiments of this specification are described with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. In the drawings, identical or substantially identical components described are indicated by a single reference numeral. For clarity, not all components are labeled in all drawings, and not all components of each embodiment are shown where the illustration is not necessary for a person skilled in the art to understand the invention. [Brief explanation of the drawing]

[0011] [Figure 1] A perspective view showing a medical device according to one embodiment of the present invention. [Figure 2A] A diagram illustrating an exemplary step of placing a medical device between a first body lumen and a second body lumen according to one embodiment of the present invention. [Figure 2B] A diagram illustrating an exemplary step of placing a medical device between a first body lumen and a second body lumen according to one embodiment of the present invention. [Figure 2C] A diagram illustrating an exemplary step of placing a medical device between a first body lumen and a second body lumen according to one embodiment of the present invention. [Figure 2D] A diagram illustrating an exemplary step of placing a medical device between a first body lumen and a second body lumen according to one embodiment of the present invention. [Figure 2E] A diagram illustrating an exemplary step of placing a medical device between a first body lumen and a second body lumen according to one embodiment of the present invention. [Figure 2F] A diagram illustrating an exemplary step of placing a medical device between a first body lumen and a second body lumen according to one embodiment of the present invention. [Figure 3A] A perspective view showing a medical device positioned between a first body lumen and a second body lumen, according to one embodiment of the present invention. [Figure 3B] A perspective view showing a medical device positioned between a first body lumen and a second body lumen, according to one embodiment of the present invention. [Figure 4A] A diagram illustrating an exemplary process for arranging magnets inside the proximal and distal holding sections of a medical device according to one embodiment of the present invention. [Figure 4B] A diagram illustrating an exemplary process for arranging magnets inside the proximal and distal holding sections of a medical device according to one embodiment of the present invention. [Figure 4C] A diagram illustrating an exemplary process for arranging magnets inside the proximal and distal holding sections of a medical device according to one embodiment of the present invention. [Figure 4D] A diagram illustrating an exemplary process for arranging magnets inside the proximal and distal holding sections of a medical device according to one embodiment of the present invention. [Figure 5A] A diagram showing an exemplary process for arranging magnets inside the proximal holding part and the distal holding part of a medical device, according to an embodiment of the present invention. [Figure 5B] A diagram showing an exemplary process for arranging magnets inside the proximal holding part and the distal holding part of a medical device, according to an embodiment of the present invention. [Figure 5C] A diagram showing an exemplary process for arranging magnets inside the proximal holding part and the distal holding part of a medical device, according to an embodiment of the present invention. [Figure 5D] A diagram showing an exemplary process for arranging magnets inside the proximal holding part and the distal holding part of a medical device, according to an embodiment of the present invention. [Figure 6A] A perspective view showing a medical device arranged between a first body lumen and a second body lumen, according to an embodiment of the present invention. [Figure 6B] A perspective view showing a medical device arranged between a first body lumen and a second body lumen, according to an embodiment of the present invention. [Figure 7A] A perspective view showing a medical device arranged between a first body lumen and a second body lumen, according to an embodiment of the present invention. [Figure 7B] A perspective view showing a medical device arranged between a first body lumen and a second body lumen, according to an embodiment of the present invention. [Figure 8] A diagram showing calculations and equations related to the heating of an implantable medical device induced by electromagnetic waves (radiofrequency), according to an embodiment of the present invention. [Figure 9A] A perspective view showing a medical device arranged between a first body lumen and a second body lumen, according to an embodiment of the present invention. [Figure 9B] A perspective view showing a medical device arranged between a first body lumen and a second body lumen, according to an embodiment of the present invention. [Figure 9C] A perspective view showing a medical device arranged between a first body lumen and a second body lumen, according to an embodiment of the present invention.

Mode for Carrying Out the Invention

[0012] The present invention is not limited to the specific embodiments described. The terms used in this specification are for the purpose of describing specific embodiments and are not intended to limit beyond the scope of the appended claims. Unless otherwise defined, all technical terms used in this specification have the same meaning as commonly understood by those of ordinary skill in the technical field to which the invention pertains.

[0013] Embodiments of the present invention will be described with respect to medical devices (e.g., stents) and systems for gallbladder drainage. However, the devices can be used for various medical applications (e.g., external gallbladder drain conversion, small intestine - small intestine anastomosis, gastrojejunostomy, gastroduodenostomy, gastroileostomy) to form or maintain temporary or permanent opening channels or drainage passages from or between various internal organs, body lumens, tubes, blood vessels, fistulas, cysts, spaces (e.g., dermis, stomach, duodenum, jejunum, small intestine, gallbladder, kidney, pancreas, gallbladder / pancreas branch, bladder, urethra, abscess, walled-off pancreatic necrosis (WOPN), bile duct). The devices can be inserted using different approaches such as different access sites and percutaneous, endoscopic, laparoscopic, or combinations thereof. The medical devices described herein are self-expanding, but in other embodiments, the medical devices can be expanded by other means such as balloon catheters. Furthermore, such medical devices are not limited to drainage and can facilitate access to organs, blood vessels, and body lumens for other purposes such as transporting or bypassing fluid or solid substances from one site to another, forming passages, removing obstructions, non-invasively or minimally invasively manipulating tissues inside organs, or introducing drugs through opening channels.

[0014] As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural unless explicitly stated otherwise. “Comprise,” “comprising,” “include,” and “including,” as used herein, identify the presence of a particular feature, area, process, element, or component, but it should be understood that this does not exclude the presence or addition of one or more other features, areas, integers, processes, operations, elements, components, or groups thereof.

[0015] As used herein, the term “distal” refers to the end of the device furthest from the medical device when the device is introduced into the patient’s body, and the term “proximal” refers to the end of the device closest to the medical practitioner when the device is inserted into the patient’s body.

[0016] In one embodiment, the present invention relates to a medical device (e.g., a self-expanding drainage stent) that extends between a first body lumen and a second body lumen, aligning with the muscle layers of each body lumen to form a long-term or permanent opening channel or opening access passage. Referring to Figure 1, in one embodiment, the medical device 100 of the present invention includes an elongated body 110 that forms a lumen and has a proximal portion, a distal portion, a certain length, and a certain diameter. The elongated body 110 has an elongated tubular form (not shown in the figure, for example, a restrained form, an unexpanded form, or a transport form) and a retracted form (e.g., an unrestrained form, an expanded form, or a deployed form) in which the proximal portion 112 expands radially within a proximal holding portion 114 and the distal portion 122 expands radially within a distal holding portion 124, with a cylindrical saddle portion 128 extending and maintained between them. The diameter of the cylindrical saddle portion 128 may be larger than the diameter of the elongated body 110 in its elongated tubular form. The proximal and distal retaining portions 114 and 124 extend perpendicular to the circumferential direction of the elongated body 110, forming flat surfaces 114a and 124a, respectively. In some embodiments, the angle of the elongated body with respect to the circumferential direction may be a different angle, or may vary along the retaining portion that forms a curved portion. Multiple proximal tissue engagement elements 132 are arranged along the outer surface of the cylindrical saddle portion 128 at the distal portion of the proximal retaining portion 114, and multiple distal tissue engagement elements 142 are arranged along the outer surface of the cylindrical saddle portion 128 at the proximal portion of the distal retaining portion 124. The first end 134 of each proximal tissue engagement element 132 is attached to the outer surface of the cylindrical saddle portion 128, and the second end 136 of each proximal tissue engagement element 134 is not attached (it is a free end) and extends toward the distal retaining portion 124. The first end 144 of each distal tissue engagement element 142 is attached to the outer surface of the cylindrical saddle portion 128, and the second end 146 of each distal tissue engagement element 142 is not attached (it is a free end) and extends toward the proximal retaining portion 114. In the elongated tubular form, the proximal and distal tissue engagement elements 132, 142 are arranged along the outer surface of the elongated body (for example, lying flat along the outer surface).When the elongated body transitions to its contracted form, the proximal and distal tissue engaging elements 132 and 142 are biased outward and extend upward along the outer surface of the cylindrical saddle portion 128 (for example, approximately parallel to or at an acute angle to the long axis of the cylindrical saddle portion).

[0017] In some embodiments, the first ends 134,144 of either or both of the first tissue engagement elements and the second tissue engagement elements 132,142 can be fixed to the outer surface of the cylindrical saddle portion 128 using a suitable glue, adhesive, resin, or other bonding technique well known in the art. Additionally or alternatively, the proximal and distal tissue engagement elements 132,142 are formed as extensions or projections of filaments (woven, knitted, or braided) that constitute the elongated body 110. Any one of the second ends 136,146 of the proximal and distal tissue engagement elements 132,142 is configured to be acuminate or pointed, or to penetrate the respective tissue walls of the first or second body lumen, as described below. Additionally, any one of the proximal tissue engagement elements and distal engagement elements 132, 142 may further comprise one or more receptacles, hooks, fingers, teeth, etc., configured to fix the tissue engagement element within the tissue wall of the first or second body lumen, respectively.

[0018] In Figure 1, the proximal and distal tissue engagement elements 132 and 142 are shown to be arranged at equal intervals on the outer surface of the cylindrical saddle portion 128, directly in contact with the proximal and distal retaining portions 114 and 124, respectively. However, in some embodiments, the proximal and distal tissue engagement elements 132 and 142 may have various shapes, dimensions, numbers, orientations, patterns, and spacings along the cylindrical saddle portion. Additionally or alternatively, in some embodiments, the tissue engagement elements are not limited to the cylindrical saddle portion but may be arranged on or along the proximal and distal retaining portions, such as on a surface facing flat tissue.

[0019] In one embodiment, when the medical device 100 according to the present invention transitions from an elongated tubular form to a retracted form, the proximal tissue engagement element and distal tissue engagement elements 132, 142 reorient a portion of the first and second body lumens, respectively, so that the muscular layers of the first and second body lumens are in contact with the outer surface of the cylindrical saddle portion 128 and positioned within the patient's body. Referring to Figures 2A to 2F, for illustrative purposes, during use, the medical device 100 of the present application is positioned in an elongated tubular form within the lumen of the tissue penetration element 10. The pointed distal end 12 of the tissue penetration element 10 can be advanced to penetrate the tissue wall 191 of the first body lumen 190 (e.g., stomach or duodenum) and the tissue wall 196 of the second body lumen 195 (e.g., gallbladder).

[0020] In some embodiments, the tissue-penetrating element 10 is advanced along a guidewire 16 that has been advanced through a first and second body lumen, with the distal end of the guidewire positioned in the second body lumen. Alternatively, in the above method, a separate instrument having a pointed distal end may be inserted into the second body lumen along the passage to form a passage. When the guidewire is used to guide the separate instrument, the guidewire is left in place and the separate instrument is removed along the guidewire. The medical device in the various embodiments described above, which is loaded into a transport catheter, is inserted along the guidewire and positioned according to the steps outlined above.

[0021] Referring to Figure 2A, the distal portion 122 of the medical device 100 is then advanced distally beyond the lumen of the tissue penetration element 10, for example, so that the distal portion 142 of the distal tissue engagement element is positioned, and so that it is released from constraint within the lumen of the tissue penetration element 10. Referring to Figure 2B, the tissue penetration element 10 is then retracted proximal so that at least some of the distal tissue engagement elements 142 engage (e.g., puncture or penetrate) a portion of the tissue wall 196 of the second body lumen 195 adjacent to the opening formed by the sharp distal end 12. As the tissue penetration element 10 is further retracted proximal, the portion of the tissue wall 196 of the second body lumen 195 is reoriented and curved toward, for example, the tissue wall 191 of the first body lumen 190.

[0022] Referring to Figure 2C, the distal portion 122 of the medical device 100 is then further advanced distally beyond the lumen of the tissue penetration element 10 so that the distal retaining portion 124 is positioned entirely within the second body lumen 195 and the flat surface 124a is positioned in contact with the inner surface of the tissue wall 196. Referring further to Figure 2C, once the distal retaining portion 124 and a portion of the cylindrical saddle portion 128 are positioned from inside the tissue penetration element 10, the portion of the tissue wall 196 of the second body lumen 195, with which the distal tissue engagement element 142 is engaged, is further reoriented to face the tissue wall 191 of the first body lumen 190. Referring to Figures 2D and 2E, the tissue penetration element 10 is then further retracted proximally into the first body lumen 190, and the proximal portion 112 of the medical device 100 is advanced distally beyond the lumen of the tissue penetration element 10 so that, for example, it is released from its constraints within the lumen of the tissue penetration element 10 and positioned in contact with a portion of the tissue wall of the first body lumen 190 adjacent to the opening formed by the sharp distal end 12, so that the proximal tissue engagement element 132 is deployed. Referring to Figure 2F, the proximal portion 112 of the medical device 100 is then further advanced distally beyond the lumen of the tissue penetration element 10 so that the proximal holding portion 114 is positioned entirely within the first body lumen 190 and the flat surface 114a is positioned in contact with the inner surface of the tissue wall 191. In one embodiment, the proximal retaining portion 114 and the other portion of the cylindrical saddle portion 128 are deployed from within the tissue penetrating element 10, and a portion of the tissue wall 191 of the first body lumen 190, which is engaged by one or more proximal tissue engaging elements 132, is reoriented to face the tissue wall 196 of the second body lumen 195, which has been previously reoriented, and the muscle layers 194, 199 of the first and second body lumen 190, 195 are positioned in contact along the cylindrical saddle portion 128.

[0023] In some embodiments, the proximal and distal engagement elements 132, 142 are sufficiently flexible or deformable to allow the medical device 100 to be removed from the patient's body without causing substantial trauma to the respective tissue layers. Additionally or alternatively, any one or all of the proximal and distal engagement elements are formed from a biodegradable or bioerosive material configured to dissolve after the muscle layers 194, 199 have fused, thereby making the medical device easier to remove from the patient's body.

[0024] In one embodiment, the medical device 200 of the present invention is positioned inside the patient's body so that the proximal and distal holding portions cause selective and localized tissue necrosis of a first and second body lumen, exposing adjacent portions of the muscle layer of each body lumen along the outer surface of the cylindrical saddle portion. Referring to Figures 3A-3B, in one embodiment, the medical device 200 of the present invention includes an elongated body 210 having a proximal portion 212 and a distal portion 222, and having a certain length and a certain diameter, forming a lumen. The elongated body 210 has an elongated tubular shape (e.g., restrained shape, unexpanded shape, or transported shape, not shown) and a retracted shape (e.g., unrestrained shape, expanded shape, or deployed shape) in which the proximal portion 212 expands radially into the proximal holding portion 214 and the distal portion 222 expands radially into the distal holding portion 224, leaving a cylindrical saddle portion 228 in between. The diameter of the cylindrical saddle portion 228 may be larger than the diameter of the elongated body 210 in the elongated tubular form. The proximal and distal holding portions 214 and 224 extend perpendicular to the circumferential direction of the elongated body 210, forming flat surfaces 214a and 224a, respectively. The first magnet 150 may be placed in the proximal holding portion 214, and the second magnet 152 may be placed in the distal holding portion 224. The first magnet and the second magnets 150 and 152 are placed in the first and second holding portions 214 and 224, respectively, and the polarity of each magnet provides an attractive force between them along the entire circumference of the cylindrical saddle portion 228 (for example, 360 degrees). As will be explained in detail below, the medical device 200 is positioned between the first and second body lumens 190 and 195, with the flat surface 214a of the proximal holding portion 214 contacting and pushing the tissue wall 191 of the first body lumen 190, and the flat surface 224a of the distal holding portion 224 contacting and pushing the tissue wall 196 of the second body lumen 195, and positioned in contact with the body lumens along the cylindrical saddle portion 228 (Figure 3A). In one embodiment, the attractive force between the first and second magnets 150 and 152 pulls the proximal and distal holding portions 214 and 224 towards each other, shortening the cylindrical saddle portion 228 and exerting a constant and consistent force between the flat surfaces 214a and 224a and the inner surfaces of each tissue wall 191 and 196. In addition, the outer surfaces of each tissue wall can be compressed relative to each other between the proximal and distal retaining portions 214 and 224.Constant and consistent pressure applied to the inner and outer surfaces of each tissue wall 191,196 can cause selective and localized necrosis at specific depths in each tissue layer. For example, the depth of necrosis in the first and second tissue walls 191,196 is limited to the mucosal layers 193,198 in order to selectively expose, contact, and position the free ends of the muscular layers 194,199 along the cylindrical saddle portion 228.

[0025] In one embodiment, the medical device 200 is positioned between the first and second body lumens according to the illustrative steps outlined in Figures 2A-2F, except that the tissue walls 191, 196 of the first and second body lumens 190, 195 are positioned in contact along the cylindrical saddle portion 128, for example, each tissue wall is not reoriented by the proximal and distal tissue engagement elements. Referring to Figures 4A-4D, in one embodiment, the first and second magnets 150, 152 each comprise a series of magnets 150a-f, 152a-f loaded on a transport wire 154. With the medical device 200 properly positioned between the first and second body lumens 190, 195, the transport device 156 (e.g., an endoscope) is advanced through the lumen of the medical device 200 into the second body lumen 195. The delivery wire 154, loaded with a series of magnetic fragments 152a-f, is advanced through the transport device 156 into the second body lumen 195. Next, the transport device 156 is pulled proximally into the medical device 200 (Figure 4A), and the proximal and distal ends of the transport wire 154 are pulled proximally, exposing the magnetic fragments 152a-f to, for example, the outside of the transport device 156, which are then snapped or positioned at predetermined locations on the open inner surface of the distal holding section 224 (Figures 4B-4C). With the magnetic fragments 152a-f positioned within the distal holding section 224, the transport wire 154 can be removed from the medical device 200 by releasing one end of the transport wire 154 and pulling the other end proximally. By repeating this process, the magnetic fragments 150a-f can be positioned within the proximal holding section 214 (Figure 4D). With the magnetic fragments 150a-f and 152a-f fully deployed within the proximal and distal retaining portions 214 and 224, selective tissue necrosis of the mucosal layers 193 and 198 and fusion of the muscular layers 194 and 199 can proceed as described above. Referring to Figures 5A-5D, in one embodiment, the first and second magnets 150 and 152 may each include flexible magnets configured to transition between a constrained form (e.g., linear) and an unconstrained form (e.g., nonlinear or circular).With the medical device 200 properly positioned between the first and second body lumens 190 and 195, the transport device 156 (e.g., an endoscope) is advanced through the lumen of the medical device 200 into the second body lumen 195 (Figure 5A). As the flexible magnet 152 is advanced through the transport device 156 into the second body lumen, the magnet 152 transitions to an unrestrained form (Figure 5B). A medical device 158 (e.g., a gripping device) may be passed through the endoscope to grasp the flexible magnet 152 and pull it into the medical device. The flexible magnet 152 deforms as it enters the lumen of the medical device and expands (e.g., snaps) into the distal holding section 224 when the medical device is pulled proximal (Figure 5C). By repeating this process, the flexible magnet 150 can be positioned in the proximal holding section 214 (Figure 5D). With the flexible magnets 150 and 152 fully deployed within the proximal and distal holding portions 214 and 224, selective tissue necrosis of the mucosal layers 193 and 198, and fusion of the muscular layers 194 and 199 can proceed as described above.

[0026] In various embodiments, one or more magnets are positioned in the proximal and distal retaining sections, or adjacent to each other (e.g., side by side), to promote selective tissue necrosis of the mucosal layer or fusion of the muscular layer. In other embodiments, magnets may be used in the retaining sections of these and other devices to assist in maintaining adjacent tissue layers in a juxtaposed position for drainage, without necessarily causing necrosis or fusion.

[0027] Referring to Figures 6A to 6B, in one embodiment, the medical device 300 of the present disclosure comprises an elongated body that forms a lumen and includes a proximal portion, a distal portion, a certain length, and a certain diameter. The elongated body 310 may have an elongated tubular form (e.g., a restrained form, an unexpanded form, or a transport form, not shown) and a retracted form (e.g., an unrestrained form, an expanded form, or an unfolded form) in which the proximal portion 312 expands radially into the proximal holding portion 314 and the distal holding portion 322 expands radially into the distal holding portion 324, with a cylindrical saddle portion 328 extending between them. The diameter of the cylindrical saddle portion 328 may be larger than the diameter of the elongated body 310 in the elongated tubular form. The proximal and distal retaining portions 314 and 324 extend perpendicular to the circumferential direction of the elongated body 310, forming their respective flat surfaces 314a and 324a. The filament 160 (e.g., suture thread, thread, nitinol wire, medical-grade nylon, etc.) is passed through a portion of the elongated body (e.g., through the woven, knitted, or braided filament forming the elongated body), and the first end 162 of the filament 160 is attached to the proximal end of the medical device 300 at the first portion (e.g., proximal to the proximal retaining portion 314), while the second end 164 of the filament 160 is not attached and extends proximal beyond the proximal end of the medical device 300 at the second portion, which is different from the first portion. For example, the first and second portions may be substantially opposite each other on the medical device (e.g., 180 degrees apart). The portion of the filament 160 between the first end and the second ends 162, 164 may form a loop extending along the cylindrical saddle portion 328 between the proximal and distal retaining portions 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 knots, glues, adhesives, resins or other bonding techniques well known in the art.In various embodiments, the filament 160 is configured to slide through a woven, knitted, or braided filament forming an elongated body, and while the medical device is immobilized in its retracted configuration (for example, while positioned between a first and second body lumen), the second end 164 of the filament 160 can be retracted proximal, thereby biasing the proximal and distal retaining portions 314, 324 toward each other and shortening the cylindrical saddle portion 328. A locking member 166 (e.g., a cleat, tie-off, etc.) may be attached to the medical device adjacent to the second portion. Additionally or alternatively, the locking member may be integrally formed from a portion of the filament forming the elongated body 310. The locking member 166 is configured to securely receive or engage a portion of the filament 160 (e.g., a loop, winding, etc.) after the second end 164 of the filament 160 has retracted proximally, and maintains the proximal and distal holding portions 314, 324 in their compressed (e.g., further shortened) form.

[0028] In various embodiments, when the filament 160 is retracted proximal and “tied off” to the locking member 166, it can form a desired amount of pressure on the tissue walls 191,196 of the first and second body lumens 190,195, as described below. The proximal and distal retaining portions 314,324 (and the pressure exerted on the respective tissue walls) can be adjusted as needed by fixing different portions of the filament 160 to the locking member 166. For example, additional force can be applied between the respective tissue walls by releasing (e.g., untying) the filament 160 from the locking member and pulling the second end 164 further proximal to re-secure 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 and sliding the second end 164 distally to re-secure the filament 160 to the locking member 166. Alternatively, as a first step in removing the medical device 300 from the patient's body, the filament 160 is released from the locking member 166, and the free end 164 is made slidable distally without being fixed again to the locking member 166.

[0029] In one embodiment, the medical device 300 is positioned between the first and second body lumens according to the illustrative steps schematically shown in Figures 2A to 2F, except that the tissue walls 191 and 196 of the first and second body lumens 190 and 195 are positioned in contact along the cylindrical saddle portion 328, for example, the respective tissue walls are not reoriented by the proximal tissue engagement element and the distal tissue engagement element. With the medical device properly positioned between the first and second body lumens 190 and 195, the flat surface 314a of the proximal retaining portion 314 can contact and press against the tissue wall 191 of the first body lumen 190, and the flat surface 324a of the distal retaining portion 324 can contact and press against the tissue wall 196 of the second body lumen 195, thereby positioning the body lumens in contact along the cylindrical saddle portion 328 (Figure 6A). Next, the second end 164 of the filament 160 is pulled proximal (for example, using a suitable gripping member) and fixed to the locking member 166 in order to bias the proximal and distal retaining portions 314, 324 toward each other, thereby applying constant and consistent pressure between the flat surfaces 314a, 324a and the inner surfaces of each tissue wall 191, 196. In addition, the outer surfaces of each tissue wall can be compressed relative to each other between the proximal and distal retaining portions 314, 324. The constant and consistent pressure applied to the outer and inner surfaces of each tissue wall 191, 196 can cause selective and localized necrosis at a specific depth in each tissue layer. For example, the depth of necrosis of the first tissue wall 191 and the second tissue wall 196 can be limited to the mucosal layers 193, 198 in order to selectively expose and position the free ends of the muscular layers 194, 199 along the cylindrical saddle portion 328 (Figure 6B).

[0030] In one embodiment, the medical device 400 of the present invention can construct a long-term or permanent opening or access channel without reorienting (e.g., Figures 1-2F) or compressing (e.g., Figures 3A-6B) the tissue walls 191, 196 of the first and second body lumens 190, 195 along a cylindrical saddle portion. Referring to Figures 7A-7B, in one embodiment, the medical device 400 of this specification comprises an elongated body forming a lumen and having a proximal portion, a distal portion, a certain length, and a certain diameter. The elongated body 410 may have an elongated tubular shape (for example, a restrained shape, an unexpanded shape, or a transport shape, not shown), and a contracted shape (for example, an unrestrained shape, an expanded shape, or an unfolded shape) in which the proximal part 412 expands radially into the proximal holding part 414 and the distal part 422 expands into the distal holding part 424, leaving a cylindrical saddle part 428 extending between them. The diameter of the cylindrical saddle part 428 may be larger than the diameter of the elongated body 410 in the elongated tubular shape. The proximal and distal holding parts 414 and 424 extend perpendicular to the circumferential direction of the elongated body 410, forming flat surfaces 414a and 424a, respectively. The medical device 400 is positioned between the first and second body lumens according to the process outlined in Figures 2A to 2F above, except that the tissue walls 191 and 196 of the first and second body lumens 190 and 195 are positioned in contact along the cylindrical saddle portion 428, for example, each tissue wall is not reoriented by the proximal tissue engagement element and the distal tissue engagement element. With the medical device properly positioned between the first and second body lumens 190 and 195, the flat surface 414a of the proximal retaining portion 414 contacts and presses against the tissue wall 191 of the first body lumen 190, and the flat surface 424a of the distal retaining portion 424 contacts and presses against the tissue wall 196 of the second body lumen 195, thereby positioning the body lumens in contact along the cylindrical saddle portion 428 (Figure 7A).

[0031] In one embodiment, the medical device 400 may include a certain amount of iron material (e.g., a membrane or coating, or formed within woven, knitted, or braided filaments of a long body) to induce local vibrations of the medical device 400 by exposing the patient to an appropriate amount of magnetic field. By forming vibrations of an appropriate frequency within the medical device, for example by exposing the medical device to a magnetic field generated by a standard MRI machine, the medical device may be heated to an appropriate temperature to selectively kill cells in the mucosal layers 193,198 of the first and second body lumens 190,195. In addition to selectively killing cells in the mucosal layers 193,198 and placing them in direct contact with the underlying muscle layers 194,199 of the first and second body lumens 190,195, the heat radiated from the medical device 400 can also cauterize the exposed tissue surface and promote fusion of the muscle layers (Figure 7B).

[0032] Referring to the calculation results for CEM43 (Cumulative Effective Minutes at 43°C) at 43°C in Figure 8, electromagnetic induction heating of an implanted medical device can cause cell death if the surrounding tissue is exposed to high temperatures (e.g., above body temperature, 37°C) for an extended period. For example, in one embodiment, cell death may occur after exposure to a medical device heated to 45.7°C (e.g., 8.7°C above body temperature) for 1 minute, or after exposure to a medical device heated to 42.0°C (e.g., 5.0°C above body temperature) for 160 minutes. Figures 7A-7B show thermally induced opening or access channels that can be achieved by using a medical device 400 that does not include tissue engagement elements, magnets, or sliding filaments, but in various embodiments, one or all of the medical devices 100, 200, 300 herein may include an MRI-induced heating step to further promote cell death constituting the mucosal layer and to bring the adjacent muscle layers of the first and second body lumens into contact. Similarly, in various embodiments, any one of the medical devices 100, 200, 300, 400 of this specification may comprise any combination of the elements disclosed herein (e.g., tissue engagement elements, magnets, or sliding filaments, iron materials).

[0033] The elongated bodies of any medical devices 100, 200, 300, 400 shown in Figures 1-7B may be formed from woven, knitted, or braided filaments (e.g., nitinol wire). The proximal, distal, and cylindrical saddle portions may further have membranes or coatings on their inner and outer surfaces to form a continuous opening internal passage configured for the flow or access of (e.g., bodily fluids, substances, etc.) through the interior. The coatings may include a variety of non-degradable and biocompatible polymer materials, such as silicone, rubber, polyethylene, PVDF, Chronoflex®, and thermoplastic elastomers, to accommodate the elongated tubular and retracted forms of the medical devices. Additionally or alternatively, the woven, knitted, or braided filaments in any one of the various embodiments may further include metallic or polymeric filaments, which may be single filaments woven on themselves or multifilaments woven together. Additionally or alternatively, in one embodiment, the opening inner passage may further comprise one or more valves (e.g., duckbill valves, slit valves) that can transition between a closed and an open configuration to block or prevent the flow of fluid passing through the interior until the patient or healthcare worker determines that the valve should be opened (e.g., by inserting a drainage tube). These valves may be located at any point along the opening inner passage of the elongated body. Examples of such valves are disclosed in U.S. Patent Application No. 2012 / 0226243, the contents of which are incorporated herein by reference in their entirety. Such valves may consist of a variety of suitable biocompatible and non-degradable materials, such as any polymer described herein, and may be used in conjunction with any one of the various embodiments described or considered to be within the scope of the present invention.

[0034] Any one first and second retaining part of the medical devices 100, 200, 300, and 400 shown in Figures 1-7B can have various configurations, and one or more retaining parts extend radially at an angle that is not necessarily perpendicular to the elongated body or a surface that is not necessarily flat. For example, one or both of the proximal and distal retaining parts may extend outward toward the end of the elongated body and backward toward the center of the elongated body, or their direction may be changed in some combination of the two. Additionally or alternatively, one or both of the proximal and distal retaining parts may have an outer diameter d1 that is larger than the outer diameter d2 of the cylindrical saddle part. For example, the outer diameter d1 may be about 75% to 100% larger than the outer diameter d2 of the cylindrical saddle part. For the purpose of showing non-limiting examples, the outer diameter d1 may be about 7.0 mm to about 30 mm, and the outer diameter d2 may be about 3.0 mm to about 15.0 mm. In various embodiments, the dimensions (e.g., diameter) of the opening formed between the first and second body lumens can be increased or decreased by expanding or decreasing the dimensions (e.g., width) of the proximal and distal retaining portions (e.g., increasing or decreasing the surface area of ​​the tissue layer compressed between the proximal and distal retaining portions). Additionally or alternatively, the length of the elongated body in the contracted form may be at least 40% shorter than the length of the elongated body in the elongated tubular form.

[0035] In some embodiments, any one of the medical devices 100, 200, 300, or 400 of the present application may remain in a predetermined location within the patient's body for a sufficient amount of time to join or fuse (e.g., grow together) the muscle layers 194, 199, at which point the medical device may be removed from the patient's body, leaving a long-term or permanent opening, drainage, or access passage between the first and second body lumens 190, 195. For example, the medical device 100, 200, 300, or 400 may remain in the body for several days to several weeks to form the required level of tissue necrosis between the proximal and distal retention portions. The necrotic tissue may eventually slough off, leaving a permanent opening formed by the fused muscle layers.

[0036] In various embodiments, any one of the medical devices 100, 200, 300, 400 of the present invention may further include, to further promote the selective death of cells in the mucosal layers of the first and second body lumens, at least one chemical (e.g., silver nitrate) or antiproliferative agent embedded in or within the coating of the medical device, for example, a coating of the cylindrical saddle portion or the flat surfaces of the proximal and distal retaining portions. Additionally or alternatively, when the medical device of the present invention is removed from the patient's body, surgical glue, cryosurgery, or cryoablation treatment may be performed on the inside of the diameter of the opening between the first and second body lumens to seal the fused muscle layer and prevent mucosal cells from growing internally.

[0037] In one embodiment, as described herein, the opening formed between the first and second body lumens may be maintained by replacing the medical device used to form the opening with a permanent implant (e.g., a grommet) configured to physically prevent closure or resealing. Referring to Figures 9A-9B, the medical device 500 of the present application comprises an interlockable first flexible member and a second flexible member 172,182. For example, the first flexible member and the second flexible member 172,182 may be formed of a suitable polymer material (e.g., silicone, rubber) configured to be deformed, curved, folded, rolled, compressed, or otherwise deformed (e.g., within a transport sheath) for transport into the first or second body lumen and to return to their original non-deformed form when released from constraint within each body lumen. The first flexible member 172 comprises an outer surface 174, a substantially flat or planar inner surface 176, an outer edge 175 having a first circumferential surface, and an inner edge 177 having a second circumferential surface smaller than the first circumferential surface, the inner edge 177 forming a first opening 178 extending between the outer surface and the inner surfaces 174, 176. Multiple 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 comprises an outer surface 184, a substantially flat or planar inner surface 186, an outer edge 185 having a first circumferential surface, and an inner edge 187 having a second circumferential surface smaller than the first circumferential surface, the inner edge 187 forming a second opening 188 extending between the outer surface and the inner surfaces 184, 186. Multiple tabs 199a, 199b (for example, two or more) may extend from the inner surface 186 along the outer edge 185 of the second flexible member 182. A cylinder 181 having the same extent as 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 is configured to receive the corresponding tabs 199a, 199b of the second flexible member 182, for example, by interlocking or snap-fitting, and the first and second openings 178, 188 are aligned to form a continuous opening lumen formed by the cylinder 181, and the inner surfaces 176, 186 of the first and second flexible members 172, 182 are spaced apart by a predetermined distance.

[0038] Referring to Figure 9B, in use and for illustrative purposes, the medical device 500 of the present invention may be positioned in a previously formed opening between the first and second body lumens 190, 195 by loading the first flexible member 172 and the second flexible member 182 into the lumen of the transport tube in a folded or compressed form (not shown). The transport tube is advanced through the opening between the first and second body lumens 190, 195, and the distal end of the transport tube is positioned in the second body lumen 195. Next, the second flexible member 182 is advanced distally beyond the lumen of the transport tube, and the second flexible member 182 transitions to an unrestrained form within the second body lumen 195. A separate medical device (not shown) is advanced through the lumen of the transport tube or along the outer surface of the transport tube to grasp the second flexible member 182 and position the multiple tabs 199a, 199b in contact with the tissue wall 196 of the second body lumen 195, so that the second opening 188 aligns with the opening between the first body lumen and the second body lumen 190, 195. The medical device is then pulled proximal with sufficient force so that the tabs 199a, 199b of the second flexible member 182 extend through the tissue walls 191, 196 of the first body lumen and the second body lumen 190, 195, and the cylinder 181 extends through the opening between the first body lumen and the second body lumen 190, 195. The transport tube is then pulled proximal, and the distal end of the transport tube is positioned within the first body lumen 190. Next, the first flexible member 172 is advanced distally beyond the lumen of the transport tube, and the first flexible member 172 transitions to an unrestrained configuration within the first body lumen 190. While the medical device maintains pressure on the second flexible member 182, the first flexible member 172 is positioned in contact with the tissue wall 191 of the first body lumen 190, with the first opening 178 aligned with the opening between the first body lumen and the second body lumen 190, 195, and the recesses 189a, 189b of the inner surface 174 of the first flexible member 172 aligned with the tabs 199a, 199b of the second flexible member 182 extending into the first body lumen 190, and the cylinder 181 extending through the opening between the first body lumen and the second body lumen 190, 195.In one embodiment, the distal end of the transport tube may be used to position the first flexible member 172 in contact with the tissue wall 191 of the first body lumen 190. Alternatively, a second medical device (not shown) may be positioned within the first body lumen 190 to grasp the first flexible member 172 and align the recesses 189a and 189b with the respective ends of the tabs 199a and 199b. Next, the first flexible member 172 and the second flexible member 182 are advanced toward each other, and tabs 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 182, so that the first opening 178 and the second opening 188 of the first and second flexible members 172, 176 can be aligned with the opening between the first and second body lumens. 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 lumens to be maintained in an uncompressed state (e.g., without causing tissue necrosis) while the medical device is implanted in the patient's body. Figures 9A to 9B show how two tabs 199a and 199b and two corresponding recesses 189a and 189b are arranged on opposite sides of the ends of the flexible members 172 and 182, but in various embodiments, any number of tabs and recesses may be arranged in various patterns, orientations, and configurations.

[0039] Referring to Figure 9C, in order to minimize trauma to the tissue layers of the first and second body lumens, in one embodiment, the medical device 500 of the present invention further comprises interlockable first and second flexible members 172, 182 as described above. A cylinder 181 having the same width as the second opening 188 may extend from the inner surface 186 of the second flexible member 182. The free end of the cylinder is provided with a series of tabs (or a single continuous tab, or annular tab) configured to extend through the opening between the first body lumen and the second body lumen and to engage in an interlocking or snap-fit ​​manner with a corresponding recess 173 (e.g., an annular groove) surrounding the first opening 178 of the first flexible member 172, so that the first and second openings 178,188 align to form a continuous opening lumen formed by the cylinder 181, and the inner surfaces 176,186 of the first and second flexible members 172,182 are spaced apart by a predetermined distance.

[0040] Additionally, in various embodiments, the first flexible member and the second flexible members 172,182 are not limited to being located within the first and second body tubules. For example, the first flexible member may be located within the second body tubule to receive the tab of the second flexible member located within the first body tubule.

[0041] All apparatuses and methods described herein and in the claims can be achieved and implemented without excessive experimentation in light of the present invention. While the apparatuses and methods according to the present invention are described in preferred embodiments, those skilled in the art will understand that the apparatuses, methods, processes, and sequences of processes described herein can be modified without departing from the spirit and scope of the invention. Such alternative or modified forms that are obvious to those skilled in the art will be considered not to depart from the spirit, scope, and concept of the invention as defined by the appended claims.

Claims

1. A tubular elongated body having a lumen and comprising a proximal portion, a distal portion, a length, and a diameter, having a transport configuration and a deployment configuration contracted in the longitudinal direction, wherein in the deployment configuration, the elongated body has a proximal holding portion formed by the proximal portion expanding radially, a distal holding portion formed by the distal portion expanding radially, and a cylindrical saddle portion defined between the proximal holding portion and the distal holding portion, A plurality of proximal tissue engaging elements are arranged along the outer surface of the cylindrical saddle portion toward the distal side of the proximal retaining portion and have free ends extending toward the distal retaining portion, A plurality of distal tissue engaging elements are arranged along the outer surface of the cylindrical saddle portion on the proximal side of the distal holding portion and have free ends extending toward the proximal holding portion, A medical device equipped with the following features.

2. The medical device according to claim 1, wherein the first end of the proximal tissue engagement element is attached to the outer surface of the cylindrical saddle portion, and the free end of the proximal tissue engagement element extends toward the distal holding portion without being attached to the outer surface of the cylindrical saddle portion.

3. The medical device according to claim 2, wherein the first end of the distal tissue engagement element is attached to the outer surface of the cylindrical saddle portion, and the free end of the distal tissue engagement element extends toward the proximal holding portion without being attached to the outer surface of the cylindrical saddle portion.

4. The medical device according to claim 3, wherein the free ends of the proximal tissue engagement element and the distal tissue engagement element extend radially outward from the outer circumferential surface of the cylindrical saddle portion.

5. The medical device according to claim 3 or 4, wherein the free end of the proximal tissue engagement element is configured to penetrate the tissue wall of a first body lumen, and the free end of the distal tissue engagement element is configured to penetrate the tissue wall of a second body lumen.

6. The medical device according to any one of claims 1 to 5, wherein the surface of the proximal retaining portion is configured to be in contact with the inner surface of the tissue wall of the first body lumen, and the surface of the distal retaining portion is configured to be in contact with the inner surface of the tissue wall of the second body lumen.

7. The medical device according to claim 6, wherein a portion of the tissue wall of the first body lumen, engaged with the plurality of proximal tissue engaging elements, is curved toward the distal holding portion along the cylindrical saddle portion, a portion of the tissue wall of the second body lumen, engaged with the plurality of distal tissue engaging elements, is curved toward the proximal holding portion along the cylindrical saddle portion, and the muscle layer of the tissue wall of the first body lumen is positioned in contact with the muscle layer of the tissue wall of the second body lumen.

8. The medical device according to any one of claims 5 to 7, wherein the tissue walls of the first body lumen and the second body lumen are arranged along the cylindrical saddle portion between the proximal retaining portion and the distal retaining portion.

9. The medical device according to any one of claims 1 to 7, wherein at least one of the proximal holding portion and the distal holding portion extends perpendicularly to the outer circumferential surface of the cylindrical saddle portion.

10. The medical device according to any one of claims 1 to 7, 9, wherein the first magnet is disposed within the proximal holding portion and the second magnet is disposed within the distal holding portion.

11. A medical device according to any one of claims 1 to 7, 9, or 10, further comprising a coating.

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