Anti-movement structure of a device, system, and method for forming an anastomosis

Abstract

An implantable medical device has at least a portion of a wall coated to prevent fluid from passing therethrough and one or more uncoated anti-migration structures that promote growth of surrounding tissue. The anti-migration structures are in a partially closed shape or a fully closed shape and form a lateral retaining portion relative to a direction in which a migration force normally affects the implantable medical device at an anatomical site where the implantable medical device is disposed.

Description

Technical Field

[0001] The present disclosure generally relates to the field of implantable medical devices. In particular, the present disclosure relates to medical devices, systems, and methods that extend across anatomical structures, such as those for establishing connections and / or fluid communication between anatomical structures. More specifically, the present disclosure relates to anti-displacement structures for devices, systems, and methods for establishing connections and / or fluid communication between anatomical structures.

Background Art

[0002] A variety of devices, such as stents, are known for extending between anatomical structures for various purposes. For example, various stents are known for establishing connections between anatomical structures. Some of such connections are made simply to place adjacent tissues, while others establish fluid communication between anatomical structures such as organs, body cavities, lumens, passages, etc. In some cases, it may be desirable to create a semi-permanent or permanent anastomosis that allows for the flow or drainage of fluid from one anatomical structure to another. For example, in various gastrointestinal (GI) surgeries (e.g., gastric bypass surgery), a lumen apposing stent may be used to form an anastomosis in the digestive system, such as a gastrojejunostomy between the stomach and the jejunum. The gastrojejunostomy allows food particles, liquids, chyme, etc. to flow more easily from the stomach, bypassing the pylorus and duodenum, to the lower digestive tract (e.g., the first approximately 1.5 m of the small intestine where most food, fats, and nutrients are digested). Such surgeries are considered to be less invasive than traditional Roux-en-Y bypass surgery and may be reversible. As understood, it is desirable for the anastomosis device to remain firmly in place at a predetermined position until removal is desired or medically indicated. Generally, in various surgeries and applications of stents that extend between anatomical structures, such as when forming an anastomosis, it may be desirable to leave the stent in place for an extended period of time (e.g., days, weeks, months, or even 6 months to 12 months or more). Accordingly, there is a continuing need for devices, systems, and methods with stronger anti-migration structures related thereto. SUMMARY OF THE INVENTION

[0003] This summary is provided to introduce, in simplified form, a selection of concepts that are further described in detail below. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter. Those skilled in the art will understand that each of the various aspects and features of the present disclosure, whether or not described in this summary, may be advantageously used separately or in combination with other aspects and features of the present disclosure in some cases. It is not intended that the scope of the claimed subject matter be limited by whether elements, components, etc. are included or not included in this summary.

[0004] According to various principles of the present disclosure, an implantable medical device includes an elongate body having a proximal end and a distal end, the elongate body defining a lumen extending therethrough; a proximal retention member along the proximal end of the elongate body; a distal retention member along the distal end of the elongate body; a saddle region defined between the proximal retention member and the distal retention member; and at least one anti-migration structure extending outwardly from an outer surface of the elongate body. In some aspects, at least the saddle region has a wall coated with a material that prevents fluid passage, and the at least one anti-migration structure is uncoated to promote ingrowth of surrounding tissue therearound.

[0005] In some embodiments, the at least one anti-migration structure is in the form of a semi-closed shape or a closed shape with respect to the elongate body. In some embodiments, the at least one anti-migration structure includes at least one retention portion extending transverse to an axis of a migration force affecting the implantable medical device.

[0006] In some embodiments, the lumen of the elongate body extends through the saddle region, and the retaining portion extends laterally with respect to the longitudinal axis of the saddle region. In some embodiments, the at least one anti-displacement structure extends laterally from at least one of the proximal retaining member or the distal retaining member and extends in a direction towards the saddle region.

[0007] In some embodiments, the proximal retaining member and the distal retaining member extend radially outward from the saddle region, and the at least one anti-displacement structure extends laterally from at least one of the proximal retaining member or the distal retaining member and extends in a direction towards the saddle region.

[0008] In some embodiments, the saddle region is configured to extend between a proximal tissue wall and a distal tissue wall, the proximal retaining member is configured to secure an implantable medical device to the proximal tissue wall, the distal retaining member is configured to secure an implantable medical device to the distal tissue wall, and the at least one anti-displacement structure is configured to be embedded in one of the proximal tissue wall or the distal tissue wall.

[0009] In some embodiments, the at least one anti-displacement structure includes at least one anti-displacement structure extending from the proximal retaining member towards the saddle region and at least one anti-displacement structure extending from the distal retaining member towards the saddle region.

[0010] In some embodiments, the implantable medical device is movable between an elongate delivery configuration and a shortened deployed configuration, the proximal retaining member and the distal retaining member are defined when the implantable medical device transitions to the deployed configuration and a portion of the elongate body extends radially outward, and in the shortened configuration, the length of the saddle region and the configuration of the proximal retaining member and the distal retaining member are selected to draw together the tissue overlying the elongate body such that the at least one anti-displacement structure is secured to the tissue.

[0011] In some embodiments, at least one of the proximal retaining member or the distal retaining member is formed from woven filaments, and the at least one anti - migration structure is formed from an extension of one of the woven filaments.

[0012] In some embodiments, the at least one anti - migration structure is formed separately from and coupled to at least one of the proximal retaining member or the distal retaining member. According to various principles of the present disclosure, an implantable medical device includes an elongate body having a proximal end and a distal end, the elongate body defining a lumen extending therethrough; and at least one anti - migration structure extending outwardly from an outer surface of the elongate body. In some aspects, the elongate body is formed from a plurality of filaments forming the wall of the elongate body with a gap, at least a portion of the wall of the elongate body being coated to prevent fluid from passing through and to resist ingrowth of tissue, and the at least one anti - migration structure not being coated to promote ingrowth of surrounding tissue.

[0013] In some embodiments, the at least one anti - migration structure is in the form of a semi - closed shape or a closed shape with respect to the elongate body. In some embodiments, the at least one anti - migration structure includes at least one retaining portion extending laterally with respect to an axis in the direction in which a migration force affecting the implantable medical device is applied.

[0014] In some embodiments, the implantable medical device further includes a proximal retaining member extending radially outward along the proximal end of the elongate body, a distal retaining member extending radially outward along the distal end of the elongate body, and a saddle region defined between the proximal retaining member and the distal retaining member, and the at least one anti - migration structure extends from at least one of the retaining members toward the saddle region.

[0015] According to various principles of the present disclosure, a method of forming an anastomosis includes extending an implantable medical device across a proximal tissue wall and a distal tissue wall; forming a proximal retention member fixed to the proximal side of the proximal tissue wall by radially expanding a proximal end of the implantable medical device radially outwardly relative to a saddle region extending through the tissue wall; and forming a distal retention member fixed to the distal side of the distal tissue wall by radially expanding a distal end of the implantable medical device radially outwardly relative to the saddle region. In some embodiments, the saddle region has a tubular wall defining a lumen, the wall being coated with a material that prevents fluid passage, and the method further includes positioning the implantable medical device such that at least one uncoated anti-migration structure extends toward at least one of the proximal tissue wall or the distal tissue wall to facilitate ingrowth of tissue into the at least one anti-migration structure.

[0016] In some embodiments, the method further includes causing the at least one anti-migration structure to be embedded in at least one of the proximal tissue wall or the distal tissue wall. In some embodiments, the method further includes deploying the implantable medical device such that the proximal retention member and the distal retention member draw the proximal tissue wall and the distal tissue wall together to facilitate formation of an anastomosis therebetween.

[0017] In some embodiments, the method further includes positioning the implantable medical device such that at least one uncoated anti-migration structure extends from at least one of the proximal retention member or the distal retention member toward the respective proximal tissue wall or distal tissue wall to facilitate ingrowth of tissue into the at least one uncoated anti-migration structure.

[0018] In some embodiments, the method further includes positioning an implantable medical device such that at least one proximal uncoated anti-migration structure extends laterally from the proximal retaining member to the proximal tissue wall to facilitate tissue ingrowth into the at least one proximal uncoated anti-migration structure, and at least one distal uncoated anti-migration structure extends laterally from the distal retaining member toward the distal tissue wall to facilitate tissue ingrowth into the at least one distal uncoated anti-migration structure.

[0019] According to various principles of the present disclosure, a method of forming an implantable medical device defining a lumen with at least one anti-migration structure is disclosed. In some embodiments, the method includes coating the walls of the implantable medical device, defining a lumen through the implantable medical device with a material that prevents fluid flow through the walls; and forming an anti-migration structure that promotes tissue ingrowth therearound by extending an uncoated filament outwardly from the outer surface of the implantable medical device in at least a partially closed shape.

[0020] In some embodiments, the method further includes forming an uncoated retaining portion of the anti-migration structure by extending at least a portion of the uncoated filament laterally with respect to the longitudinal axis of the implantable medical device.

[0021] In some embodiments, the method further includes completely coating the walls of the implantable medical device without coating the anti-migration structure. In some embodiments, the method further includes extending an uncoated filament from a portion of the expandable wall of the implantable medical device into a retention member having a diameter larger than an adjacent saddle region of the implantable medical device. In some embodiments, the method further includes extending the uncoated filament toward the saddle region.

[0022] These and other features and advantages of the present disclosure will become readily apparent from the following detailed description. The scope of the invention is set forth in the appended claims. The following disclosure is presented from the perspective of aspects or embodiments, but it should be understood that individual aspects can be claimed separately or in combination with aspects and features of that or other embodiments.

Brief Description of the Drawings

[0023] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The accompanying drawings are provided for illustrative purposes only, and the dimensions, positions, orders, and relative sizes reflected in the figures within the drawings may vary. For example, a device may be enlarged so that details can be discerned, but is intended to be reduced, for example, to fit within a delivery catheter or the working channel of an endoscope. For purposes of clarity and brevity, not all elements are labeled in all figures, nor are all elements of each embodiment shown where illustration is not necessary for one of ordinary skill in the art to understand the present disclosure.

[0024] The detailed description is better understood when considered in conjunction with the accompanying drawings. In the drawings, the same reference characters represent the same elements.

Figure 1

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Mode for Carrying Out the Invention

[0025] Detailed Description The following detailed description should be read with reference to the drawings that illustrate exemplary embodiments. It should be understood that the present disclosure is not limited to the specific embodiments described and can vary. All of the devices, systems, and methods described herein are examples of devices and / or systems and / or methods implemented in accordance with one or more principles of the present disclosure. Each example of an embodiment is provided for illustrative purposes and is not the only way to implement these principles, but merely an example. Thus, references to elements or structures or features in the drawings should be understood as references to examples of embodiments of the present disclosure and should not be construed as limiting the present disclosure to the specific elements, structures, or features illustrated. Other examples of ways to implement the disclosed principles will occur to those skilled in the art upon reading the present disclosure. Indeed, it will be apparent to those skilled in the art that various modifications and changes can be made in the present disclosure without departing from the scope or spirit of the subject matter of the present invention. Accordingly, the subject matter of the present invention is intended to embrace modifications and changes that fall within the scope of the appended claims and their equivalents.

[0026] It will be understood that the present disclosure has been described in various levels of detail in the present application. In some cases, details that are not necessary for those skilled in the art to understand the present disclosure, or details that make it difficult to recognize other details, may be omitted. The terms used herein are for the purpose of describing particular embodiments only and are not intended to limit beyond the scope of the appended claims. Unless otherwise defined, technical terms used herein are to be understood as being commonly understood by those skilled in the art to which the present disclosure pertains. All devices and / or methods disclosed and claimed herein can be made and implemented without undue experimentation with reference to the present disclosure.

[0027] As used herein, "proximal" refers to the direction or location that is closest to the user (such as a medical professional, clinician, technician, operator, or physician, which terms are used interchangeably herein without limitation and include, for example, an automated control system) and / or closest to the delivery device when the device is in use (e.g., when introducing the device into a patient or implanting, positioning, or delivering it). "Distal" refers to the direction or location that is farthest from the user and / or closest to the delivery device when the device is in use (e.g., when introducing the device into a patient or implanting, positioning, or delivering it). "Longitudinal" means extending along the longer or greater dimension of an element. A "longitudinal axis" extends along the longitudinal direction of an element, but is not necessarily straight and does not necessarily maintain a fixed configuration when the element is bent or curved. "Center" means at least approximately bisecting a central point and / or being approximately equidistant from an outer edge or boundary. A "central axis" with respect to an opening means a line that extends longitudinally along the length of the opening and at least approximately bisects the central point of the opening when the opening includes, for example, a tubular element, strut, channel, cavity, or bore. As used herein, "channel" or "bore" or "lumen" or "passageway" is not limited to a circular cross-section. As used herein, the "free end" of an element is the end at which the element does not extend any further. Finally, a reference to a location or site "of / at" is intended to include tissue in the vicinity (e.g., along it, adjacent, etc.) of such location or site.

[0028] According to various principles of the present disclosure, an implantable medical device is formed to extend across adjacent or juxtaposed anatomical structures. It will be understood that, herein, such implantable medical devices may be referred to, without intending to be limiting, as scaffolds, grafts, stents, etc. According to various further principles of the present disclosure, such implantable medical devices are formed to hold multiple anatomical structures juxtaposed. More specifically, such a stent may be formed to establish a flow or access passage between juxtaposed anatomical structures. Anatomical structures include lumens, channels, blood vessels, passages, body cavities, organs, cysts, pseudocysts, etc., and the present disclosure is not necessarily limited to use between specific anatomical structures. For convenience and without intending to be limiting, reference may be made to holding tissue walls juxtaposed, but it is understood that this is merely an example of anatomical structures to which the principles of the present disclosure are applicable and their relevance thereto.

[0029] An example of the use of an implantable medical device formed in accordance with various principles of the present disclosure is to form an anastomosis (also called a gastrojejunostomy) between a patient's stomach and a portion of the patient's small intestine, such as the jejunum. For convenience and without intending to be limiting, the foregoing description of devices, systems, and methods has been made with reference to the formation of a gastrojejunal anastomosis, but it should be understood that the present disclosure is not limited to only such use or application. Further, although the present disclosure refers to applications to the digestive system, it will be understood that the principles of the present disclosure are applicable to other systems or structures of the patient's body, as will be understood by those skilled in the art.

[0030] Implanted medical devices formed in accordance with various principles of the present disclosure include an elongate body that is movable from a delivery configuration to a deployed configuration. In the delivery configuration, the elongate body is generally compact and / or compressed so that it can be delivered into a patient's body via a catheter without the need for an open surgery. For example, the implanted medical device can be delivered by natural orifice transluminal endoscopic surgery (NOTES), which is considered to be easier and less invasive than open surgery (such as laparotomy). Thus, in the delivery configuration, the implanted medical device can be compressed and / or elongated or otherwise configured to fit within a generally tubular delivery device (e.g., an endoscope, catheter, shaft, etc.) that can be delivered into the patient's body through the lumen. When the implanted medical device is delivered to a desired anatomical site (also referred to herein as a treatment site, deployment site, delivery site, etc., but not limited thereto), the implanted medical device can transition to the deployed configuration. In the deployed configuration, the implanted medical device can be in a generally expanded configuration. In the deployed configuration, the implanted medical device can define a saddle region having a first end and a second end, and one or more retention members (also referred to herein as flanges) at or along each end thereof. Terms such as "at" an end, "on" an end, "adjacent to" an end, "along" an end, etc. may be used interchangeably herein without intent to limit, unless otherwise specified, and are intended to indicate a generally relative spatial relationship rather than a precisely defined position. The retention members are sized, shaped, configured, and / or dimensioned to hold the implanted medical device relative to the deployment site. More specifically, the size, shape, configuration, and / or dimensions of the retention members can be selected such that the saddle region of the implanted medical device contacts a body wall that extends radially outward from the body passageway in which the saddle region is disposed. Thus, the retention members are lateral to the saddle region of the implanted medical device and typically extend substantially perpendicular to the saddle region. Usually, the retention members are wider (radially transverse to the longitudinal axis of the body passageway) than the saddle region.When referring to a body passageway, it will be understood that this includes not only naturally occurring passageways (e.g., the pylorus), but also medically created passageways (e.g., passageways created using medical instruments between the stomach and the jejunum, etc.).

[0031] In some aspects of the present disclosure, the saddle region defines a lumen therethrough that enables a substance (e.g., a fluid) to pass from one anatomical structure through the lumen of the saddle region to another anatomical structure. The retention member of the implantable medical device holds the implantable medical device in a predetermined position with respect to two anatomical structures. Additionally, or alternatively, the retention member holds adjacent the tissue of the anatomical structure in which the implantable medical device is disposed. According to various principles of the present disclosure, the implantable medical device including the saddle region and the retention member is partially or completely coated with a material that prevents a substance from passing through a wall such as a wall of the saddle region. Such a coating typically inhibits ingrowth of tissue into the wall of the implantable medical device. However, ingrowth of tissue may serve to inhibit movement of the device relative to the implantation site.

[0032] According to various principles of the present disclosure, an anti - migration structure that is not coated to promote ingrowth of tissue inside or around it extends from the elongated body of an implantable medical device. In some embodiments, the anti - migration structure extends from at least one (and optionally both) of the retention members of the implantable medical device. In some embodiments, the anti - migration structure extends laterally with respect to the retention member, for example, substantially perpendicular to the retention member, and extends into the tissue to which the retention member is attached. The anti - migration structure can be in a closed shape or at least a partially closed shape, such as a U - shape or a loop - shape. The anti - migration structure includes at least a retention portion that extends laterally with respect to the direction of the force that causes movement with respect to the implantable medical device and / or laterally with respect to the longitudinal axis of the implantable medical device (e.g., the direction in which the lumen defined by the saddle region extends). In some embodiments, the anti - migration structure extends from the retention member, and the retention portion extends generally along the plane of the retention member (e.g., within a plane generally parallel to the plane of the retention member). Thus, due to the ingrowth of tissue along the retention portion of the anti - migration structure, the implantable medical device is held in place with respect to the anatomical structure in which tissue grows and extends around the anti - migration structure. Even if the original portion (e.g., the retention member) from which the anti - migration structure extends of the implantable medical device is not coated, the shape or configuration of the anti - migration structure, which provides a retention portion that extends away from the outer surface of the implantable medical device and / or is lateral to the main direction in which movement is expected, promotes ingrowth of tissue with respect to the implantable medical device.

[0033] In some embodiments, the anti - migration structure is disposed at the outermost edge of the retention member. At such a position, the anti - migration structure utilizes the maximum surface area of the retention member attached to the tissue to exert a holding force on the adjacent tissue and prevent the movement of the stent. In some embodiments, the anti - migration structure is configured to protrude into or penetrate the tissue, such as by being embedded in the tissue, to enhance the holding or gripping force on the tissue. The ingrowth of tissue in this region promotes further fixation of the implantable medical device at the deployment site to the tissue. The anti - migration structure formed according to various principles of the present disclosure provides sufficient holding force to the gastrojejunal anastomosis to withstand forces caused by peristaltic movement or turbulent flow caused by the digestion of food boluses. As a result, the implantable medical device formed according to various principles of the present disclosure has a longer indwelling period than conventional implantable medical devices.

[0034] In some aspects, the implantable medical device and its anti - migration structure formed according to various principles of the present disclosure can be sized, shaped, configured, dimensioned, positioned, and / or oriented to promote the formation of a natural anastomosis between adjacent anatomical structures by promoting tissue growth between adjacent tissue walls. More specifically, the overall dimensions of the implantable medical device (e.g., the length of the saddle region and / or the distance between retention members) and / or the structure of the surface of the retention member or the surface facing the tissue (such as an increasing slope towards the saddle region as the retention member extends radially away from the saddle region) can be selected to apply pressure to the adjacent tissue walls to hold the tissue walls adjacent to each other and further promote the formation of an anastomosis therebetween.

[0035] Various embodiments of the anti-movement structure of an embedded device, system, and method according to various principles of the present disclosure will be described below with reference to the examples shown in the accompanying drawings. References in this specification to "one embodiment", "an embodiment", "some embodiments", "other embodiments", etc. indicate that one or more specific features, structures, concepts, and / or characteristics according to the principles of the present disclosure may be included in that embodiment. However, such references do not necessarily mean that all embodiments include that specific feature, structure, concept, and / or characteristic, or that one embodiment includes all features, structures, concepts, and / or characteristics. Some embodiments may include one or more of such features, structures, concepts, and / or characteristics in various combinations. It should be understood that one or more of the features, structures, concepts, and / or characteristics described with reference to one embodiment can be combined with one or more of the features, structures, concepts, and / or characteristics of any of the other embodiments provided herein. That is, any combination of the features, structures, concepts, and / or characteristics described herein can be used to create a hybrid embodiment, and such hybrid embodiments are within the scope of the present disclosure. Further, references in this specification to "one embodiment", "an embodiment", "some embodiments", "other embodiments", etc. at various places do not necessarily all refer to the same embodiment, and distinct embodiments or alternative embodiments are not necessarily mutually exclusive of other embodiments. Further, it should also be understood that the various features, structures, concepts, and / or characteristics of the disclosed embodiments are separated independently of each other and can be used or presented individually or in various combinations with each other to create alternative embodiments that are considered part of the present disclosure. Therefore, since it is too cumbersome to describe all possible combinations and sub-combinations of features, structures, concepts, and / or characteristics, the present disclosure is not limited to only the embodiments specifically described herein, and the examples of embodiments disclosed herein are not intended to limit the broader aspects of the present disclosure. The following description is only an exemplary example of an embodiment and is not intended to limit the broader aspects of the present disclosure.

[0036] In accordance with various principles of the present disclosure, an implantable medical device 100 is shown in FIG. 1 configured to pass through a passageway within the body and / or extend between a first anatomical structure and a second anatomical structure (e.g., between tissue walls). In an example of the illustrated embodiment, the implantable medical device 100 is shown extending within the digestive system across openings formed in the patient's stomach S and jejunum J. The implantable medical device 100 is configured to hold the walls of the stomach S and the jejunum J in close contact and alignment, allowing tissue to grow along the adjacent tissues and the openings therein, and enabling the establishment of a long-term and / or permanent flow or access passage therebetween. For convenience and without intention of limitation, reference is made herein to "anastomosis" and "flow path", but the application of the principles of the present disclosure need not necessarily be so limited. In an example of the illustrated embodiment, an additional implantable medical device 1000 can be deployed across the pylorus P, e.g., to occlude the pylorus P, redirecting the flow of substances from the stomach S through the implantable medical device 100 to the jejunum J. It will be understood that the principles of the present disclosure are also applicable to such implantable medical devices 1000. As described above, the present disclosure need not be limited to such anatomical structures, or the illustrated digestive environment, or even such uses. For example, the implantable medical device 100 can be, but is not limited to, a drainage device, a support device (e.g., a support wall for a body lumen or passageway), an occlusion device (e.g., a pyloric occlusion device), etc.

[0037] An example of an embodiment of the implantable medical device 100 shown in FIG. 1 includes an elongate body 110 having a proximal end 111 and a distal end 113. The elongate body 110 of the implantable medical device 100 may generally have a tubular configuration with a lumen 115 extending therethrough, such as between its proximal end 111 and distal end 113. The elongate body 110 may extend over the entire length of the implantable medical device 100 (e.g., the proximal end 111 and distal end 113 of the elongate body 110 may have substantially the same spread as the proximal end 101 and distal end 103 of the implantable medical device 100, respectively), or may extend only over the entire length or a portion of the length of the implantable medical device 100, but the present disclosure is not limited in this regard.

[0038] The implantable medical device 100 is typically movable between a delivery configuration and a deployment configuration. In the delivery configuration, the size, shape, configuration, and / or dimensions of the implantable medical device 100 facilitate trans-luminal delivery to an anatomical site (e.g., delivery through a naturally occurring passageway in the body). In the deployment configuration, the implantable medical device 100 may be sized, shaped, configured, and / or dimensioned to achieve various structures or forms for various purposes, such as facilitating positioning of the implantable medical device 100 relative to a treatment site, fixation relative to the treatment site, formation of a passageway through an anatomical site, support of tissue and / or tissue walls, etc. For example, when in the delivery configuration, the elongate body 110 may have an extended length (along its longitudinal axis LA) and / or a reduced diameter (usually transverse to the longitudinal axis LA) relative to the deployment configuration. In some embodiments, the elongate body 110 may be considered to be in a constrained, unexpanded, contracted, restrained, folded, etc. configuration when in the delivery configuration (not shown, but readily understood by those skilled in the art). In the deployment configuration, the elongate body 110 may have a generally shortened and / or radially expanded configuration, for example, compared to the delivery configuration. In some embodiments, the elongate body 110 may be considered to be in an unconstrained, expanded, unshrunk, unrestrained, neutral, etc. configuration when in the deployment configuration.

[0039] According to various principles of the present disclosure, the implantable medical device 100 includes a proximal retention member 120 along the proximal end 101 of the implantable medical device 100 and a distal retention member 130 along the distal end 103 of the implantable medical device 100. Although one retention member is formed along each end of the implantable medical device 100, it will be understood that a plurality of retention members may be provided at either or both ends of the implantable medical device 100. In some embodiments, the proximal end 111 of the elongate body 110 radially expands to form the proximal retention member 120, and the distal end 113 of the elongate body 110 radially expands to form the distal retention member 130, defining a saddle region 140 extending therebetween. In the deployed configuration of the implantable medical device 100, the saddle region 140 typically has a diameter greater than the diameter of the elongate body 110 in the delivery configuration. The retention members 120, 130 typically have respective diameters greater than the diameter of the saddle region 140. The diameters of the retention members 120, 130 may be the same as or different from each other, depending on the intended use of the implantable medical device 100, as will be understood by those skilled in the art. The retention members 120, 130 are sized, shaped, configured, and / or dimensioned to fix the implantable medical device 100 against the tissue wall (e.g., extending radially outward from the body passageway in which the saddle region 140 of the implantable medical device 100 extends) and prevent the implantable medical device 100 from moving relative to the deployment site. In some embodiments, at least a portion of one or both of the retention members 120, 130 is angled toward the saddle region 140, or includes a portion or surface that projects toward the saddle region 140 to apply pressure against the tissue wall in which the retention members 120, 130 are disposed. The retention members 120, 130 may be formed as a single-wall structure or a double-wall structure. For example, if the retention members 120, 130 are formed by expansion of the proximal and / or distal portions of the wall of the implantable medical device 100 / elongate body 110, such expanded walls can extend radially outward and then return radially inward to form the double-wall retention members 120, 130.The holding members 120 and 130 do not necessarily have to be limited to a part of the end of the elongated body 110, and additionally or alternatively, they can be regarded as extensions of the elongated body 110 at the end of the implantable medical device 100, and it will be understood that the present disclosure is not limited in this regard.

[0040] In some embodiments (such as the example shown in FIG. 1), at least a part of the implantable medical device 100 is advantageously coated with a material that maintains the flow of a substance (such as a fluid) through the lumen 115 defined through the elongated body 110 without crossing at least a part of the wall of the elongated body 110. For example, in an embodiment where the implantable medical device 100 forms a flow path, it may be desirable to restrict the flow of the substance through the lumen 115 from the proximal end 101 to the distal end 103 of the implantable medical device 100 without leaking from the lumen 115 (e.g., through the wall of the implantable medical device 100). In some embodiments, the coating is applied to at least a part or the whole of the saddle region 140 of the implantable medical device 100 to maintain the flow of the substance through the saddle region 140 without passing through the wall of the saddle region 140. In some embodiments, the coating is also applied to additional parts of the implantable medical device 100, such as at least a part or all of one or both of the holding members 120 and 130. The holding members 120 and 130 can include their respective internally defined lumens 125 and 135 (such as extensions of the lumen 115 defined within the elongated body 110), and it will be understood that the holding members 120 and 130 can be coated with a material that maintains the flow of a substance (such as a fluid) flowing through the elongated body 110 through their lumens 125 and 135 (rather than through the walls of the holding members 120 and 130) and through the lumen 115. The coating can also give the implantable medical device 100 a certain degree of structural stability or rigidity.

[0041] The implantable medical device 100 (the whole or a part of the implantable medical device 100) can be coated by various methods such as painting, dipping, spraying, sandwiching, heat shrinkage, electrospinning, etc. The coating can be applied to only the outer surface, or only the inner surface, or both the outer and inner surfaces of at least a part of the wall of the implantable medical device 100. The coating can be made of a known or previously known biocompatible material that can prevent fluid from passing through, including but not limited to silicone, styrene isoprene butadiene (SIBS), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), urethane, polyurethane, polyvinylidene chloride (PVC), polyether block amide (PEBA), polyimide, polyethylene, polyethylene terephthalate (PET), polysulfone, nylon, polytrimethylene terephthalate, polyvinylidene fluoride (PVDF), polyester, polyether ester, polypropylene, polyolefin, polystyrene, polynaphthalene, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyether imide, polyphenylene sulfide (PPS), polyphenylene oxide (PPO), perfluoro(propyl vinyl ether) (PFA), polyparaphenylene terephthalamide, polybutylene terephthalate (PBT), polyoxymethylene (POM), polyether block ester, poly(styrene-butadiene-styrene) (SBS), styrene-ethylene-butylene-styrene (SEBS), poly(styrene-b-isobutylene-b-styrene), ethylene vinyl alcohol, ethylene vinyl acetate copolymer (EVA), polycarbonate, ionomer, thermoplastic elastomer (TPE), epoxy, etc., and their copolymers and / or combinations are also included.

[0042] Expandable implantable medical devices can be formed in a variety of ways, such as to form a scaffold or stent structure. In some embodiments, the implantable medical device is formed from one or more members / elements (these terms are used interchangeably herein without intention of limitation) that are combined to form a rigid and / or semi-rigid structure. The members are formed from one or more struts, wires, strands, filaments, etc., which are braided, interlaced, intertwined, woven, knitted, tied, looped (e.g., bobbinet style), woven, knitted, wound, etc. to form an expandable and contractible scaffold configuration. For convenience and without intention of limitation, reference is made to filaments woven to form the wall of the implantable medical device 100. The filaments forming the implantable medical device can be formed from a variety of materials, preferably biocompatible, such materials being, for example, but not limited to, metals, metal alloys, polymers, metal-polymer composites, ceramics, and combinations or sub-combinations thereof.For example, filaments for forming implantable medical devices can be formed from various biocompatible polymers, which are preferably, but not limited to, for example, polypropylene, polyester, polysulfone, nylon, silicone, polyurethane, polystyrene, polyethylene (PE) (including high-density and low-density PE), polyethylene terephthalate (PET), polyethylene naphthalate (PEN), polybutylene terephthalate (PBT), polytrimethylene terephthalate, polyether block amide (PEBA), polyether ether ketone (PEEK), polyether imide (PEI), poly(methyl methacrylate) (PMMA), polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM), polyether block ester, polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polyether ester, ether- or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers, polyamide, block polyamide / ether, polyimide (PI), ethylene vinyl alcohol, ethylene vinyl acetate copolymer (EVA), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide, perfluoro(propyl vinyl ether) (PFA), polyolefin, epoxy, poly(styrene-b-isobutylene-b-styrene), polycarbonate, ionomer, etc., and mixtures, combinations, sub-combinations, and copolymers thereof are also included.In addition to, or alternatively to, the member forming the implantable medical device can preferably be formed from various biocompatible alloys, which can include, for example but not limited to, stainless steel, nickel-titanium alloys such as nitinol, nickel-tungsten or tungsten alloys, cobalt-chromium alloys, cobalt-chromium-nickel-based alloys such as Elgiloy®, nickel-copper alloys, nickel-cobalt alloys, nickel-iron alloys, nickel-chromium alloys, nickel-molybdenum alloys, nickel-chromium-molybdenum alloys, nickel-cobalt-chromium-molybdenum alloys, cobalt-chromium-molybdenum alloys, stainless steel with increased platinum concentration, titanium, etc., as well as combinations and sub-combinations thereof, and other alloys thereof. In addition to, or alternatively to, the member forming the implantable medical device can preferably be formed from various biocompatible natural materials, which can include, for example but not limited to, cat or bovine intestine, etc.; natural fibers such as silk or cotton, etc., and combinations and sub-combinations thereof. It will be understood that the member forming the implantable medical device can be formed from a mixture, composite, combination, sub-combination, copolymer, or co-constituent of any of the above. Alternatively, the member forming the implantable medical device may be formed by cutting (e.g., laser cutting) a tubular structure (e.g., an optionally monolithic cylindrical tubular member) into an expandable configuration, whereby members such as strut members are formed by the cutting. The implantable medical device may be a self-expanding device as known to those skilled in the art or heretofore known. For example, the implantable medical device may be formed from a shape memory material or a thermoformable material (e.g., nitinol or Elgiloy® or a shape memory polymer), whereby the implantable medical device returns from a contracted configuration to a pre-formed expanded configuration when advanced from a delivery sheath (any acceptable tubular elongate member known to those skilled in the art for delivering the medical device) and / or when the delivery sheath maintaining the implantable medical device in a delivery configuration is withdrawn.

[0043] In some embodiments of an implantable medical device formed in accordance with various principles of the present disclosure, the walls of the implantable medical device, such as those formed as braided or woven elements, have gaps, holes, openings, interstices, and the like. Applying a coating material thereto can fill the gaps, holes, openings, interstices, etc. in the walls of the implantable medical device, suppressing or preventing the flow or leakage of substances therethrough. In some embodiments, the coating may encapsulate the members forming the walls of the implantable medical device 100. For example, the elements forming the walls of an example embodiment of the implantable medical device 100 formed in accordance with various principles of the present disclosure may be embedded in the coating material so as to be completely covered by the coating material.

[0044] The coatings of implantable medical devices formed in accordance with various principles of the present disclosure provide various advantages, but it will be understood that such coatings may be lubricious, slippery, or may resist maintaining the desired position of the implantable medical device 100 relative to the body tissue in which the implantable medical device 100 is deployed. According to various principles of the present disclosure, one or more anti-migration structures 150 extend along or from any portion of the implantable medical device 100, and depending on the location of such anti-migration structures 150, it may be facilitated to hold (e.g., fix) the implantable medical device 100 in a predetermined position to prevent movement from the deployment site. As will be described in more detail below, herein, the anti-migration structure 150 is described as being extended, formed, or provided on, along, or around the implantable medical device 100, and it will be understood that such descriptive terms (and other grammatical forms including reasonable alternatives of such terms) are used interchangeably herein and are not intended to be limiting. The anti-migration structure 150 can be sized, shaped, configured, dimensioned, positioned, arranged, etc. in various ways to increase the resistance to movement of the implantable medical device 100 from the implantation site, which will be understandable to those skilled in the art considering the following points. Generally, the anti-migration structure 150 is provided along the outer surface of the implantable medical device 100 facing the tissue, so that the anti-migration structure 150 interacts with the tissue to hold the implantable medical device 100 against the tissue and resist movement therefrom.

[0045] In some embodiments, the anti - migration structure 150 is not coated or is not provided with a coating such as that provided on other portions of the implantable medical device 100 (particularly along the saddle region 140). According to various principles of the present disclosure, the uncoated anti - migration structure 150 is provided along one or more portions or regions of the implantable medical device 100 that face the tissue at the deployment site. Since there is no coating on the anti - migration structure 150, in - growth of tissue around the anti - migration structure 150 can occur and even be promoted, as a result of which the implantable medical device 100 is held in a predetermined position relative to the deployment site.

[0046] In some embodiments, at least one of the anti - migration structures 150 is arranged and oriented to withstand forces that affect the implantable medical device 100 and includes an oriented retention portion 152. For example, the retention portion 152 may extend laterally with respect to a direction in which the implantable medical device 100 may move and / or laterally with respect to a main direction of a force that may affect the implantable medical device 100. In the examples of the embodiments shown in FIGS. 1, 2, 3A, and 3B, the anti - migration structure 150 is U - shaped or loop - shaped, or formed in a closed or semi - closed shape, and as tissue grows around and within such a shape, it resists the migration forces applied to the implantable medical device 100 (e.g., forces resulting from normal body movements or functions such as peristaltic motion, or forces resulting from the passage of substances through anastomoses formed and maintained along the implantable medical device 100). In the examples of the embodiments shown in FIGS. 1, 2, 3A, and 3B, one or more anti - migration structures 150 include at least one retention portion 152 that extends laterally with respect to a direction in which the implantable medical device 100 may move and / or laterally with respect to a main direction of a force that may affect the implantable medical device 100. For example, the retention portion 152 can be a part of the U - shaped anti - migration structure 150 and can extend laterally with respect to and / or be coupled to the legs of the U - shaped anti - migration structure 150 (the legs extend toward and engage the retention members 120, 130 of the implantable medical device 100). In the example of the embodiment shown in FIG. 1, the implantable medical device 100 typically receives the greatest forces along its longitudinal axis LA (within the anatomical site where it is deployed). Thus, as can be understood by referring to the examples of the embodiments of the implantable medical device 100 shown in FIGS. 2, 3A, and 3B, the retention portion 152 extends generally laterally with respect to the longitudinal axis LA of the implantable medical device 100. Thus, as tissue grows around the retention portion 152 of the anti - migration structure 150, the anti - migration structure 150, and thus the implantable medical device 100, becomes more securely held in a predetermined position with respect to the tissue at the deployment site.

[0047] According to various principles of the present disclosure, one or more, for example two or more, three or more, or four or more anti-movement structures 150 may extend from a portion of the implantable medical device 100 and / or from different portions of the implantable medical device 100. The anti-movement structures 150 may be spaced apart from each other along a region or section of the implantable medical device 100 (e.g., along one of the holding members 120, 130). Regarding the implantable medical device 100 formed according to various principles of the present disclosure, various configurations and / or positions of the anti-movement structures 150 are understood to be within the scope and spirit of the present disclosure, as will be described in more detail below with reference to examples of embodiments. For example, the number of anti-movement structures 150 may be increased or decreased, one or more anti-movement structures 150 may be arranged close to each other (e.g., in a zigzag pattern close to each other), the position of the anti-movement structures 150 may be changed, the shape of the anti-movement structures 150 may be changed, the relative ratio of the anti-movement structures 150 and the implantable medical device 100 may be changed, and the dimensions of the anti-movement structures 150 may be changed.

[0048] In the example of the embodiment shown in FIGS. 1, 2, 3A, and 3B, one or more anti-movement structures 150 extend from at least one of the holding members 120, 130. Optionally, one or more anti-movement structures 150 are provided on both the proximal holding member 120 and the distal holding member 130. By providing at least one anti-movement structure 150 on both holding members 120, 130, the anti-movement effect of the anti-movement structure 150 can be enhanced by resisting the distal and proximal forces applied to the implantable medical device 100. The anti-movement structures 150 can be arranged spaced apart from each other or in a zigzag pattern close to each other at various positions along the holding members 120, 130, at various positions along the periphery of the holding members 120, 130, or at various positions along the surface of the holding members 120, 130.

[0049] As shown in FIGS. 1, 2, 3A, and 3B, in some embodiments, one or more anti - movement structures 150 extend from radially extending walls 122, 132 of at least one of the holding members 120, 130. As referred to herein, the radially extending walls 122, 132 are walls that form the holding members 120, 130 that are generally transverse to the longitudinal axis LA of the implantable medical device 100. The radially extending walls 122, 132 of the holding members 120, 130 are also generally transverse to the saddle region 140 that generally extends along the longitudinal axis LA of the implantable medical device 100. Such a configuration is advantageous when deploying the implantable medical device 100 in an anatomical site where forces in the body affect the implantable medical device 100 along its longitudinal axis LA. For example, when the implantable medical device 100 defines a flow path through which (e.g., through the lumen 115 defined within the implantable medical device 100) fluid flows, the forces that can cause movement of the implantable medical device 100 are typically greatest along its longitudinal axis LA. Thus, since the walls extending radially outward of the holding members 120, 130 are transverse to the longitudinal axis LA of the implantable medical device 100, the surface area for resisting the axial forces applied to the implantable medical device 100 is increased. The walls extending radially outward of the holding members 120, 130 can fix the implantable medical device 100 against tissue walls that extend (e.g., radially outward) from the passageway in which the implantable medical device 100 is deployed and / or against the tissue walls in which the holding members 120, 130 are deployed. In some embodiments, the anti - movement structure 150 is disposed along the radially outermost edges of the holding members 120, 130. Such a position of the anti - movement structure 150 can be advantageous for maintaining the maximum surface area of the radially extending walls 122, 132 of the holding members 120, 130 that are pressed against the tissue. However, other locations are also within the scope and spirit of the present disclosure.

[0050] The anti - movement structure 150 can enable a compact configuration by extending generally toward, along, parallel to, or generally flat against the wall of the implantable medical device 100 when the implantable medical device 100 is in the delivery configuration. However, in the deployment configuration of the implantable medical device 100, the anti - movement structure 150 can extend at various angles (i.e., angles greater than 0 degrees and less than 180 degrees) with respect to the wall of the implantable medical device 100 from which the anti - movement structure 150 extends. For example, the anti - movement structure 150 can extend in a direction transverse to the wall of the implantable medical device 100. For example, in the example of the embodiment shown in FIG. 2, the anti - movement structure 150 extends generally laterally from the radially extending walls 122, 132 of the holding members 120, 130 along the side facing the saddle region 140 of the holding members 120, 130. Thus, the anti - movement structure 150 extends from the holding members 120, 130 toward the saddle region 140. The anti - movement structure 150 can extend toward the saddle region 140 at an angle from about 45° to about 135° with respect to the walls 122, 132 of the holding members 120, 130. In other words, the anti - movement structure 150 may be perpendicular to the walls 122, 132 of the holding members 120, 130, or may be inclined from perpendicular by up to about 45°. When inclined with respect to the walls 122, 132 of the holding members 120, 130 (i.e., not perpendicular), the anti - movement structure 150 may be inclined toward the saddle region 140 or may be inclined away from the saddle region 140. The angle at which the anti - movement structure 150 extends with respect to the holding members 120, 130 can be varied in either direction (inward or outward) based on, but not limited to, the magnitude of the pressure desired to be applied to the stomach wall, and / or the general characteristics of the deployment site, and / or whether it is desired to promote ingrowth of tissue away from (usually outward) or toward (usually inward) the saddle region 140.

[0051] In some embodiments, the anti - migration structure 150 may be configured to extend into the wall of the anatomical tissue in which the implantable medical device 100 is deployed. It will be understood that terms such as penetration, fixation, engagement, embedding, and other grammatical forms thereof may be used interchangeably without intention of limitation. As shown in FIG. 3A, an example of an embodiment of the implantable medical device 100 extends between a proximal tissue wall PTW and a distal tissue wall DTW. Specifically, the elongated body 110 of the implantable medical device 100 extends from the proximal side of the proximal tissue wall PTW to the distal side of the distal tissue wall DTW, the proximal retention member 120 is disposed on the proximal side of the proximal tissue wall PTW, and the distal retention member 130 is disposed on the distal side of the distal tissue wall DTW. In the example of the illustrated embodiment, the anti - migration structure 150 extends laterally from the retention members 120, 130 towards the saddle region 140 of the implantable medical device 100. The length of the elongated body 110, particularly the length of its saddle region 140, may be selected such that the retention members 120, 130 apply pressure to the tissue walls PTW and DTW and hold the tissue walls PTW and DTW adjacent to each other. Such pressure causes the anti - migration structure 150 to be embedded in the tissue walls PTW and DTW, further enhancing the anti - migration property of the anti - migration structure 150. When the tissue walls PTW and DTW are held adjacent to each other, the tissue grows along the saddle region 140 of the implantable medical device 100 and can form an anatomical / tissue anastomosis (as opposed to an artificial anastomosis as formed by the implantable medical device 100), as shown in FIG. 3B. In some cases, particularly when the pressure applied by the retention members 120, 130 (optionally enhanced by the anti - migration structure 150) is applied to the adjacent tissues and the adjacent tissues fuse, etc., growth of the tissue along the saddle region 140 may be promoted.

[0052] It will be understood that the anti - migration structure 150 can be formed in various ways in accordance with the various principles of the present disclosure. The anti - migration structure 150 may be formed as a wire, filament, thread, tether, rope, band, or other element that provides sufficient resistance to the forces affecting the implantable medical device 100 and the anti - migration structure 150. The anti - migration structure 150 may be formed separately from the implantable medical device 100 and (directly or indirectly) coupled to the implantable medical device 100 by welding, soldering, weaving, adhesion (e.g., gluing), mechanical deformation (e.g., tying, loop - forming, crimping, press - fitting or friction - fitting, etc.), or other methods known to those skilled in the art. Additionally, or alternatively, the anti - migration structure 150 may be an integral extension of the wall of the implantable medical device 100. For example, in some embodiments, one or more of the elements forming the implantable medical device 100 (e.g., woven or interwoven filaments) can be extended or drawn out from the remainder of the implantable medical device 100 to form the anti - migration structure 150. More specifically, the lips 124, 134 can axially extend from the holding members 120, 130 in a direction away from the saddle region 140 and be provided with sufficient additional material to pull on the filaments (or other members) of the implantable medical device 100 to form the anti - migration structure 150 therefrom. The method of forming the anti - migration structure 150 is selected to enhance the anti - migration force achieved by the anti - migration structure 150. For example, the method of forming the anti - migration structure 150 can be selected to facilitate the formation of the holding portion 152 as described above.

[0053] In view of the above description, it will be understood that the devices, systems, and methods disclosed herein can be used to form one or more anastomoses and can be used with basic endoscopic tools, catheters, laparoscopes, general surgical tools, and the like. For example, by using a catheter-based stent delivery device in combination with an endoscope, one anastomosis can be formed, for example, between two portions of the intestine. By using an endoscope-based device, an anastomosis can be formed between the fundic sac and a portion of the intestine such as the small intestine. Using a combination of the laparoscopic-based device and the catheter device described herein, a single anastomosis can also be formed. When deploying a stent or other tissue anchor between adjacent body lumens, organs, or other structures, it is usually necessary to penetrate both a first tissue wall (e.g., the wall of an organ or the first body lumen) to establish access and a second tissue wall (e.g., the wall of an organ or the second body lumen) that is the subject of the surgery. For example, by introducing an instrument into the anatomical site where the anastomosis is to be performed, a passage (e.g., an incision) can be formed between adjacent tissues. The tissue at the deployment site can be pretreated in various ways, such as by abrasion (e.g., using a hook knife, a hot biopsy forceps, a hot snare), ablation, drug treatment, argon plasma coagulation (APC), etc., to promote, accelerate, and / or increase cell growth as a result of the healing response. The induced tissue growth can promote the ingrowth of the above tissue into the anti-migration structure of the implantable medical device disposed at the treatment site. Thereafter, a delivery device (e.g., a tubular elongate member) is guided to the anatomical site where the implantable medical device is to be implanted. The distal end can be extended from the delivery device and / or the delivery device can be retracted to deploy the distal end of the device. In some embodiments, the distal end expands to form a retaining member that secures the implantable medical device against the distal tissue wall. Next, the delivery device can be further retracted to expose a portion of the implantable medical device near the distal end of the implantable medical device. The proximal end of the implantable medical device can expand to form a proximal retaining member that secures the implantable medical device against the proximal tissue wall.

[0054] The present disclosure is not limited to a particular form or configuration of an implantable medical device, or a system or method used therewith. It will be understood that the principles of the present disclosure are applicable to various configurations of implantable medical devices, systems, and methods as are known to those of skill in the art. It will be understood that the various aspects of the disclosure above are applicable to other implantable medical devices, systems, and / or methods, such as devices placed at other locations within the body (regardless of the presence or need to create a flow path at such locations).

[0055] Embodiments of the present disclosure may be described specifically in connection with medical devices, systems, and procedures for forming anastomoses, but it will be understood that the principles of the present disclosure are also applicable to devices such as the implantable medical device 1000 for forming a gastric outlet obstruction (e.g., obstruction of the pylorus P) as shown in FIG. 1. Further, embodiments of the present disclosure have been described with specific reference to medical devices, systems, and procedures for treating the digestive system, but it should be understood that such medical devices and methods can be used with implantable medical devices used in the abdominal cavity, digestive system, biliary system, urinary tract, genital system, respiratory system, cardiovascular system, circulatory system, etc.

[0056] Those of skill in the art will be able to understand various additional advantages of the various aspects, features, components, and structures of the anti-migration structure as described above, in addition to those described above.

[0057] The foregoing description is applicable in a wide range and is presented for purposes of illustration and explanation and is not intended to limit the present disclosure to the forms disclosed herein. It will be understood that various additions, changes, and substitutions can be made to the embodiments disclosed herein without departing from the concepts, spirit, and scope of the present disclosure. In particular, it will be apparent to those skilled in the art that the principles of the present disclosure can be embodied in other forms, structures, arrangements, ratios, together with other elements, materials, and components, without departing from its concepts, spirit, scope, or characteristics. For example, various features of the present disclosure are grouped into one or more aspects, embodiments, or configurations for the purpose of streamlining the present disclosure. However, it should be understood that the various features of a particular aspect, embodiment, or configuration of the present disclosure can be combined in alternative aspects, embodiments, or configurations. Although the present disclosure is presented from the perspective of embodiments, it should be understood that not all of the various individual features of the subject matter of the present invention need to be present to achieve the desired characteristics and / or advantages of the subject matter of the present invention or at least some of such individual features. A person skilled in the art will understand that the present disclosure can be used with many modifications or changes to the structures, arrangements, ratios, materials, components, and others used in the implementation of the present disclosure that are particularly adapted to specific environments and operating requirements without departing from the principles, spirit, or scope of the present disclosure. For example, elements shown as being integrally formed may be composed of a plurality of parts, elements shown as a plurality of parts may be integrally formed, the operation of an element may be reversed or changed, and the size or dimensions of an element may be changed. Similarly, even when operations, actions, or procedures are described in a particular order, such a particular order is not necessary in the sense that it is required to obtain a desired result or that all operations, actions, or procedures need to be performed. Further, other implementations are within the scope of the following claims. In some cases, the operations recited in the claims can be performed in a different order and still obtain a desired result.Accordingly, the embodiments disclosed herein are to be considered in all respects as illustrative and not restrictive, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the specific embodiments or configurations described in the foregoing description or illustrated herein. In view of the foregoing, the individual features of any embodiment can be used or claimed separately or in combination with the features of that or other embodiments, and the scope of the subject matter is indicated by the appended claims and is not limited to the foregoing description.

[0058] In the foregoing description and the following claims, the following will be understood. The phrases “at least one,” “one or more,” and “and / or” as used herein are open-ended expressions having both the function of a conjunction and a disjunction. Terms such as “one,” “the,” “first,” “second,” etc. do not exclude a plural number. For example, the term “one” as used herein refers to one or more of that entity. Thus, the terms “one,” “one or more,” and “at least one” can be used interchangeably herein. All directional references (e.g., proximal, distal, superior, inferior, above, below, left, right, lateral, longitudinal, front, back, top, bottom, up, down, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or the like) are used for identification purposes only to assist the reader's understanding of the present disclosure and / or to distinguish the regions of related elements from one another and are not intended to limit the related elements with respect to the position, orientation, or use of the present disclosure. Connecting references (e.g., attached, coupled, connected, engaged, joined) are to be construed broadly and can include intermediate members between assemblies of elements and relative movement between elements unless expressly stated otherwise. Thus, a connecting reference does not necessarily mean that two elements are directly connected and in a fixed relationship to one another. Identifying references (e.g., primary, secondary, first, second, third, fourth, etc.) do not imply importance or priority and are used to distinguish one feature from another.

[0059] The following claims are hereby incorporated by reference into this detailed description, and each claim exists independently as an individual embodiment of the present disclosure. In the claims, the term "comprising" does not exclude the presence of other elements, components, features, regions, integers, steps, operations, etc. Further, individual features may be included in different claims, and these may be advantageously combined, and being included in different claims does not mean that combinations of the features are not feasible and / or not advantageous. Further, references to singular forms do not exclude plural forms. The reference signs in the claims are provided merely as examples for explanation and are not to be construed as limiting the scope of the claims.

Claims

**Claim 1** An implantable medical device, comprising an elongate body having a proximal end and a distal end, the elongate body defining a lumen extending therethrough; a proximal retention member along the proximal end of the elongate body; a distal retention member along the distal end of the elongate body; a saddle region defined between the proximal retention member and the distal retention member; and at least one anti - migration structure extending outwardly from an outer surface of the elongate body, wherein at least the saddle region has a wall coated with a material that prevents fluid passage, and the at least one anti - migration structure is uncoated to promote in - growth of surrounding tissue. An implantable medical device. **Claim 2** The implantable medical device according to claim 1, wherein the at least one anti - migration structure is in the form of a semi - closed shape or a closed shape with respect to the elongate body. **Claim 3** The implantable medical device according to claim 1 or 2, wherein the at least one anti - migration structure includes at least one retention portion extending laterally with respect to an axis of a migration force affecting the implantable medical device. **Claim 4** The implantable medical device according to any one of claims 1 to 3, wherein the lumen of the elongate body extends through the saddle region, and the retention portion extends laterally with respect to a longitudinal axis of the saddle region. **Claim 5** The implantable medical device according to any one of claims 1 to 4, wherein the at least one anti - migration structure extends laterally from at least one of the proximal retention member or the distal retention member and extends in a direction towards the saddle region. **Claim 6** The proximal retention member and the distal retention member extend radially outward from the saddle region, The implantable medical device according to any one of claims 1 to 5, wherein the at least one anti - migration structure extends laterally from at least one of the proximal retention member or the distal retention member and extends in a direction towards the saddle region. **Claim 7** The saddle region is configured to extend between a proximal tissue wall and a distal tissue wall, the proximal retaining member is configured to secure the implantable medical device to the proximal tissue wall, the distal retaining member is configured to secure the implantable medical device to the distal tissue wall, and the at least one anti-migration structure is configured to be embedded in one of the proximal tissue wall or the distal tissue wall. The implantable medical device according to any one of claims 1 to 6.

8. The at least one anti-migration structure includes at least one anti-migration structure extending from the proximal retaining member toward the saddle region and at least one anti-migration structure extending from the distal retaining member toward the saddle region. The implantable medical device according to any one of claims 1 to 7.

9. The implantable medical device is movable between an elongated delivery configuration and a shortened deployed configuration, The proximal retaining member and the distal retaining member are defined when the implantable medical device transitions to the deployed configuration and a portion of the elongated body extends radially outward. In the shortened configuration, the length of the saddle region and the configuration of the proximal retaining member and the distal retaining member are selected to draw together the tissue across the elongated body so that the at least one anti-migration structure is secured to the tissue. The implantable medical device according to any one of claims 1 to 8.

10. At least one of the proximal retaining member or the distal retaining member is formed from woven filaments, and the at least one anti-migration structure is formed from an extension of one of the woven filaments. The implantable medical device according to any one of claims 1 to 9.

11. The at least one anti-migration structure is formed separately from and coupled to at least one of the proximal retaining member or the distal retaining member. The implantable medical device according to any one of claims 1 to 10.

12. An implantable medical device, An elongated body having a proximal end and a distal end, the elongated body defining a lumen extending therethrough; and At least one anti-migration structure extending outward from an outer surface of the elongated body, The elongated body is formed from a plurality of filaments that form the wall of the elongated body with gaps, At least a part of the wall of the elongate body is coated to prevent fluid from passing through and to resist ingrowth of tissue. The at least one anti-migration structure is an implantable medical device that is not coated to promote ingrowth of the surrounding tissue. **Claim 13** The implantable medical device according to claim 12, wherein the at least one anti-migration structure is in a semi-closed or closed shape with respect to the elongate body. **Claim 14** The implantable medical device according to claim 12 or 13, wherein the at least one anti-migration structure includes at least one holding portion extending laterally with respect to an axis in a direction in which a migration force affecting the implantable medical device is applied. **Claim 15** The implantable medical device further includes a proximal holding member extending radially outward along the proximal end of the elongate body, a distal holding member extending radially outward along the distal end of the elongate body, and a saddle region defined between the proximal holding member and the distal holding member. The implantable medical device according to any one of claims 12 to 14, wherein the at least one anti-migration structure extends from at least one of the holding members toward the saddle region.

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