Implantable medical device including a migration-preventing structure for forming an anastomosis site

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] Various 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 these connections are made simply to place tissues side by side, while others establish fluid communication between anatomical structures such as organs, body cavities, lumens, and passages. In some cases, it is desirable to create a semi-permanent or permanent anastomosis that allows fluid flow or drainage from one anatomical structure to another. For example, in various gastrointestinal (GI) surgeries (e.g., gastric bypass surgery), lumen apposing stents may be used to form anastomoses in the digestive system, such as gastrojejunal anastomosis between the stomach and the jejunum. Gastrojejunal anastomosis makes it easier for food particles, liquids, and oatmeal to flow from the stomach to the lower digestive tract, bypassing the pylorus and duodenum (e.g., the first approximately 1.5 m of the small intestine where most food, fats, and nutrients are digested). Such procedures are considered less invasive than conventional Roux-en-Y bypass surgery and may be reversible. It is desirable that the anastomotic device remain firmly in place until removal is desired or medically instructed. Generally, in various surgeries and applications of stents extending between anatomical structures, such as when forming anastomoses, it may be desirable to leave the stent in place for extended periods (e.g., days, weeks, months, or even 6 to 12 months or more). Therefore, there is a continuous need for devices, systems, and methods with more robust anti-migration structures related to this. [Overview of the Initiative]

[0003] This summary is provided to introduce a selection of concepts in a simplified form, which will be further elaborated upon in the detailed description below. This summary is not intended to necessarily identify any major or essential features of the claimed subject matter, nor is it intended to be 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 disclosure, whether or not they are described in this summary, may be advantageously used separately in some cases, or in other cases in combination with other aspects and features of the disclosure. The inclusion or exclusion of elements, components, etc., in this summary is not intended to limit the scope of the claimed subject matter.

[0004] According to various principles of this disclosure, an implantable medical device includes an elongated body having a proximal and distal end, the elongated body defining a lumen extending therein; a proximal retaining member along the proximal end of the elongated body; a distal retaining member along the distal end of the elongated body; a saddle region defined between the proximal and distal retaining members; and at least one anti-movement structure extending outward from the outer surface of the elongated body. In some embodiments, at least the saddle region has a coated wall formed of a material that prevents the passage of fluid, and the at least one anti-movement structure is uncoated to promote the growth of surrounding tissue.

[0005] In some embodiments, the at least one anti-movement structure is in a semi-closed or closed form relative to the elongated body. In some embodiments, the at least one anti-movement structure includes at least one retaining portion that extends laterally with respect to the axis of the moving force affecting the implanted medical device.

[0006] In some embodiments, the lumen of the elongated 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-movement structure extends laterally from at least one of the proximal retaining member or the distal retaining member and extends toward 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-movement structure extends laterally from at least one of the proximal retaining member or the distal retaining member and extends toward 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 fix the implantable medical device to the proximal tissue wall, the distal retaining member is configured to fix the implantable medical device to the distal tissue wall, and the at least one anti-movement structure is configured to be embedded in either the proximal tissue wall or the distal tissue wall.

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

[0010] In some embodiments, the implantable medical device is transitionable between an elongated delivery configuration and a shortened deployment configuration, the proximal and distal retaining members being defined when the implantable medical device transitions to the deployment configuration and a portion of the elongated body extends radially outward, and in the shortened configuration, the length of the saddle region and the configuration of the proximal and distal retaining members are selected so that the tissue extending across the elongated body is pulled together and the at least one anti-movement 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 a woven filament, and the at least one anti-movement structure is formed from one extension of the woven filament.

[0012] In some embodiments, the at least one anti-movement structure is formed separately from and coupled to the proximal retaining member or at least one of the distal retaining members. According to various principles of this disclosure, an implantable medical device comprises an elongated body having a proximal and distal end, defining a lumen extending therein; and at least one anti-migration structure extending outward from the outer surface of the elongated body. In some embodiments, the elongated body is formed from a plurality of filaments forming a wall of the elongated body with gaps, at least a portion of the wall of the elongated body is coated to prevent fluid from passing through and to resist tissue infiltration, and the at least one anti-migration structure is uncoated to promote tissue infiltration around it.

[0013] In some embodiments, the at least one anti-movement structure is in a semi-closed or closed form relative to the elongated body. In some embodiments, the at least one anti-movement structure includes at least one retaining portion extending laterally with respect to the axis in the direction in which the moving force affecting the implanted 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 elongated body, a distal retaining member extending radially outward along the distal end of the elongated body, and a saddle region defined between the proximal retaining member and the distal retaining member, wherein the at least one anti-movement structure extends from at least one of the retaining members toward the saddle region.

[0015] According to various principles of this disclosure, a method for forming an anastomosis includes extending an implantable medical device across a proximal and distal tissue wall; extending the proximal end of the implantable medical device radially outward relative to a saddle region extending through the tissue wall to form a proximal retaining member fixed to the proximal side of the proximal tissue wall; and extending the distal end of the implantable medical device radially outward relative to the saddle region to form a distal retaining member fixed to the distal side of the distal tissue wall. In some embodiments, the saddle region has a tubular wall defining a lumen, the wall being coated with a material that prevents the passage of fluid, 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 or distal tissue wall, thereby promoting tissue infiltration into the at least one anti-migration structure.

[0016] In some embodiments, the method further includes ensuring that the at least one anti-movement structure is embedded in at least one of the proximal tissue wall or the distal tissue wall. In some embodiments, the method further includes deploying an implantable medical device such that the proximal retaining member and the distal retaining member draw the proximal and distal tissue walls together to facilitate the formation of an anastomosis between them.

[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 or distal retaining members toward the respective proximal or distal tissue wall, thereby promoting tissue infiltration into the at least one uncoated anti-migration structure.

[0018] In some embodiments, the method further includes positioning the 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 infiltration 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 infiltration into the at least one distal uncoated anti-migration structure.

[0019] According to various principles of this disclosure, a method is disclosed for forming an implantable medical device defining a lumen with at least one anti-migration structure. 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 the flow of fluid through the walls; and forming an anti-migration structure that promotes the growth of surrounding tissue by extending uncoated filaments outward from the outer surface of the implantable medical device in at least a partially closed shape.

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

[0021] In some embodiments, the method further includes completely coating the wall of the implantable medical device without coating the anti-movement structure. In some embodiments, the method further includes extending the uncoated filament from a portion of the expandable wall of the implantable medical device into a retaining member having a diameter larger than the 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 be readily apparent from the following detailed description. The scope of the present invention is presented in the appended claims. The following disclosure is presented in terms of aspects or embodiments, but it should be understood that each aspect may be claimed separately or in combination with the aspects and features of its embodiment or other embodiments. [Brief explanation of the drawing]

[0023] Non-limiting embodiments of this disclosure are described by reference to the accompanying drawings, which are schematic and not intended to be drawn to any particular scale. The accompanying drawings are provided for illustrative purposes only, and dimensions, locations, order, and relative sizes reflected in the figures within the drawings may differ. For example, devices may be enlarged to allow for the identification of details, but are intended to be reduced to fit within, for example, a delivery catheter or an endoscope working channel. For clarity and brevity, not all elements are referenced in all figures, nor are all elements of each embodiment shown where illustration is not necessary for a person skilled in the art to understand this disclosure.

[0024] A more detailed explanation can be better understood by referring to the attached diagram. In the diagram, the same reference letter represents the same element. [Figure 1] The diagram shows a perspective view of an embodiment of an implantable medical device formed according to various aspects of this disclosure and positioned within a schematic diagram of the gastrointestinal environment. [Figure 2]A front view of an implantable medical device formed in accordance with various principles of the present disclosure is shown. [Figure 3] A front view of an embodiment of an implantable medical device formed in accordance with various aspects of the present disclosure and disposed across a schematic view of opposing tissue walls is shown. [Figure 4] A front view of an embodiment of an implantable medical device similar to FIG. 3 is shown, where the tissue walls form an anastomosis. **DETAILED DESCRIPTION**

[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 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. Therefore, 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 understood 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 this disclosure. Indeed, it will be apparent to those skilled in the art that various modifications and changes can be made to 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 within the scope of the appended claims and their equivalents.

[0026] It will be understood that this disclosure is described in various levels of detail. In some cases, details that are not necessary for a person skilled in the art to understand this disclosure, or details that would make it difficult to recognize other details, have been omitted. The terms used herein are for the sole purpose of describing specific embodiments and are not intended to limit the scope beyond the appended claims. Unless otherwise defined, the technical terms used herein shall be understood as commonly understood by a person skilled in the art to which this disclosure belongs. All devices and / or methods disclosed and claimed herein can be made and carried out without undue experimentation by reference to this disclosure.

[0027] In this specification, “proximal” means the direction or location closest to the user (such as a medical professional, clinician, technician, operator, or physician; these terms are used interchangeably in this specification without intent to limit them, including automated controller systems, etc.) and / or the delivery device when the device is used (e.g., when the device is introduced into a patient, or when it is implanted, positioned, or delivered); and “distal” means the direction or location furthest from the user and / or the delivery device when the device is used (e.g., when the device is introduced into a patient, or when it is implanted, positioned, or delivered). “Longitudinal” means extending along the longer or larger dimension of the element. The “longitudinal axis” extends along the longitudinal direction of the 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 the center point and / or being approximately equidistant from the outer edge or boundary; "central axis" means, with respect to an opening, a line that extends longitudinally along the length of the opening and at least approximately bisecting the center point of the opening, if the opening includes, for example, a tubular element, a column, a channel, a cavity, or a bore. As used herein, "channel," "bore," "lumen," or "passage" are not limited to a circular cross-section. In this specification, the "free end" of an element is the end of the element that does not extend further. Finally, any reference to a place or part "of / at" is intended to include the tissue in the vicinity of such place or part (e.g., along it, adjacent to it, etc.).

[0028] According to various principles of this disclosure, implantable medical devices are formed to extend across adjacent or neighboring anatomical structures. It will be understood that, for the purposes of this disclosure, such implantable medical devices may be referred to as scaffolds, grafts, stents, etc., without limitation. According to various further principles of this disclosure, such implantable medical devices are formed to hold multiple anatomical structures adjacent to each other. More specifically, such stents may be formed to establish flow or access passages between neighboring anatomical structures. Anatomical structures include lumens, channels, blood vessels, passages, body cavities, organs, cysts, pseudocysts, etc., and this disclosure is not necessarily limited to use between specific anatomical structures. For convenience and without limitation, the holding of neighboring tissue walls may be mentioned, but it will be understood that this is merely one example of the anatomical structures to which the principles of this disclosure are applicable and their relevance.

[0029] One example of the use of implantable medical devices formed according to the various principles of this disclosure is the formation of an anastomosis between a patient's stomach and a portion of the patient's small intestine, such as the jejunum (also known as gastrojejunal anastomosis). For convenience and without intent to limit, the foregoing descriptions of devices, systems, and methods are made in reference to the formation of a gastrojejunal anastomosis, but this disclosure should be understood not to be limited to such uses or applications. Furthermore, although this disclosure refers to applications to the digestive system, it will be understood that the principles of this disclosure can also be applied to other systems or structures of the patient's body, as will be understood by those skilled in the art.

[0030] Implantable medical devices formed according to various principles of this disclosure include an elongated body that can transition from a delivery configuration to a deployed configuration. In the delivery configuration, the elongated body is generally compact and / or compressed so that it can be delivered transcatheterally within the patient's body without requiring open surgery. For example, an implantable medical device may be delivered by transluminal endoscopic surgery (NOTES) with a natural opening, which is considered simpler and less invasive than open surgery (such as Roux-en-Y procedure). Thus, in the delivery configuration, the implantable medical device may be compressed and / or extended, or otherwise configured, to fit within a generally tubular delivery device (e.g., an endoscope, catheter, shaft, etc.) that can be delivered transluminally within the patient's body. Once the implantable medical device is delivered to a desired anatomical site (also referred to herein as, but not limited to, the treatment site, deployment site, delivery site, etc.), the implantable medical device can transition to a deployed configuration. In the deployed configuration, the implantable medical device may be in a generally expanded configuration. In the deployed configuration, the implantable medical device may define a saddle region having a first end and a second end, and one or more retaining members (also referred to herein as flanges) at or along each end. Unless otherwise specified, terms such as "at," "on," "adjacent to," and "along" the ends may be used interchangeably herein without limitation and should be understood as indicating a generally relative spatial relationship rather than a strictly limited location. The retaining members are sized, shaped, constructed, and / or dimensional to hold the implantable medical device relative to the deployed site. More specifically, the size, shape, constructed, and / or dimensional of the retaining members may be selected to be tangent to a body wall extending radially outward from the internal passage where the saddle region of the implantable medical device is located. Thus, the retaining members are oriented laterally to the saddle region of the implantable medical device and typically extend substantially perpendicular to the saddle region. Typically, the retaining member is wider than the saddle area (in the radial direction lateral to the longitudinal axis of the body passage).When we refer to bodily passages, it should be understood that this includes not only naturally occurring passages (such as the pylorus) but also medically constructed passages (for example, passages created using medical devices between the stomach and jejunum).

[0031] In some aspects of this disclosure, a saddle region defines a lumen through which a substance (e.g., a fluid) can pass from one anatomical structure through the lumen of the saddle region to another anatomical structure. A retaining member of the implantable medical device holds the implantable medical device in place relative to the two anatomical structures. In addition, or alternatively, the retaining member holds adjacent tissues of the anatomical structures in which the implantable medical device is placed. According to various principles of this disclosure, the implantable medical device, including the saddle region and retaining member, is partially or completely coated with a material that prevents substances from passing through walls, such as the walls of the saddle region. Such coatings typically inhibit tissue infiltration into the walls of the implantable medical device. However, tissue infiltration may help to inhibit the movement of the device relative to the implantation site.

[0032] According to various principles of this disclosure, an uncoated anti-migration structure extends from the elongated body of an implantable medical device to promote the growth of internal or surrounding tissue. In some embodiments, the anti-migration structure extends from at least one (and optionally both) of the retaining members of the implantable medical device. In some embodiments, the anti-migration structure extends laterally with respect to the retaining member, for example substantially perpendicular to the retaining member, and into the tissue to which the retaining member is attached. The anti-migration structure may be closed or at least partially closed, such as U-shaped or loop-shaped. The anti-migration structure may be formed with at least a retaining portion that extends laterally with respect to the direction of the force causing movement relative 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 retaining member, and its retaining portion extends substantially along the plane of the retaining member (e.g., in a plane substantially parallel to the plane of the retaining member). Therefore, tissue infiltration along the retaining portion of the anti-movement structure holds the implanted medical device in place with respect to the anatomical structure from which tissue extends and grows around the anti-movement structure. It will be understood that even if the original portion of the implanted medical device from which the anti-movement structure extends (e.g., the retaining member) is not coated, the shape or configuration of the anti-movement structure that extends away from the outer surface of the implanted medical device and / or provides a lateral retaining portion relative to the main direction in which movement is expected promotes tissue infiltration into the implanted medical device.

[0033] In some embodiments, the anti-movement structure is positioned at the outermost edge of the retaining member. In such a position, the anti-movement structure utilizes the maximum surface area of ​​the retaining member attached to the tissue to exert a retaining force on the adjacent tissue and prevent stent migration. In some embodiments, the anti-movement structure is configured to protrude into or penetrate the tissue to increase the retaining or gripping force on the tissue, such as by being embedded in the tissue. Tissue infiltration in this region promotes further fixation of the deployment site of the implantable medical device to the tissue. Anti-movement structures formed according to the various principles of this disclosure provide sufficient retaining force at the gastrojejunal anastomosis to withstand forces caused by peristalsis and turbulence caused by the digestion of food bolus. As a result, implantable medical devices formed according to the various principles of this disclosure have a longer duration of implantation than conventional implantable medical devices.

[0034] In some embodiments, implantable medical devices and their anti-misalignment structures, formed according to various principles of the present disclosure, may be sized, shaped, constructed, dimensional, positioned, and / or oriented to facilitate the formation of natural anastomoses 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 retaining members) and / or the structure of the retaining members or their tissue-facing surfaces (e.g., increasing inclination toward the saddle region as the retaining members extend radially away from the saddle region) may be selected to hold the adjacent tissue walls in an adjacent position by applying pressure to them, further promoting the formation of anastomoses between them.

[0035] Various embodiments of immobilization prevention structures for embedded devices, systems, and methods, in accordance with the various principles of this disclosure, are described below with reference to examples shown in the accompanying drawings. References in this specification such as “one embodiment,” “embodiment,” “several embodiments,” and “other embodiments” indicate that one or more specific features, structures, concepts, and / or characteristics in accordance with the principles of this disclosure may be included in relation to that embodiment. However, such references do not necessarily mean that all embodiments include that particular feature, structure, concept, and / or characteristic, or that one embodiment includes all of those features, structures, concepts, and / or characteristics. Some embodiments may include one or more such features, structures, concepts, and / or characteristics in various combinations. It should be understood that one or more features, structures, concepts, and / or characteristics described with reference to one embodiment can be combined with one or more features, structures, concepts, and / or characteristics of any other embodiment provided herein. That is, hybrid embodiments can be created by combining any of the features, structures, concepts, and / or characteristics described herein, and such hybrid embodiments are within the scope of this disclosure. Furthermore, references to “one embodiment,” “embodiment,” “several embodiments,” and “other embodiments” in various parts of this specification do not necessarily all refer to the same embodiment, and separate or alternative embodiments are not necessarily mutually exclusive with other embodiments. Moreover, it should be understood that the various features, structures, concepts, and / or characteristics of the disclosed embodiments are independent of each other and may be used or presented individually or in various combinations to create alternative embodiments that are considered part of this disclosure. Therefore, because describing all the numerous possible combinations and subcombinations of features, structures, concepts, and / or characteristics would be too cumbersome, this disclosure is not limited to the embodiments specifically described herein, and the examples of embodiments disclosed herein are not intended to limit broader aspects of this disclosure. The following description is merely an illustrative example of embodiments and is not intended to limit broader aspects of this disclosure.

[0036] Figure 1 shows an implantable medical device 100 configured to pass through a passage within the body and / or extend between a first anatomical structure and a second anatomical structure (e.g., between tissue walls), according to various principles of this disclosure. In an example of the illustrated embodiment, the implantable medical device 100 is shown to extend into the digestive system, traversing 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 jejunum J in close contact and align, thereby allowing tissue to grow along the adjacent tissues and the openings therein, establishing a long-term and / or permanent flow or access passage between them. For convenience and without intent to limit, the terms “anastomosis” and “flow channel” are used herein, but the application of the principles of this disclosure is not necessarily limited in this way. In the illustrated embodiment, an additional implantable medical device 1000 can be deployed across the pylorus P, for example, to occlude the pylorus P, thereby redirecting the flow of material 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 can also be applied to such implantable medical devices 1000. As stated above, the present disclosure is not limited to such anatomical structures or the illustrated digestive environment or such use. For example, the implantable medical device 1000 could be, but not limited to, a drainage device, a support device (e.g., a support wall of a body lumen or passage), an occlusion device (e.g., a pyloric occlusion device), etc.

[0037] An example of an embodiment of the implantable medical device 100 shown in Figure 1 includes an elongated body 110 having a proximal end 111 and a distal end 113. The elongated body 110 of the implantable medical device 100 may have a tubular structure overall, with a lumen 115 extending through it, such as between its proximal end 111 and distal end 113. The elongated body 110 may extend along the entire length of the implantable medical device 100 (for example, the proximal end 111 and distal end 113 of the elongated body 110 may have substantially the same extent as the proximal end 101 and distal end 103 of the implantable medical device 100, respectively), or it may extend along the entire length or only a portion of the length of the implantable medical device 100, but the disclosure is not limited in this respect.

[0038] The implantable medical device 100 is typically transitionable 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 transluminal delivery to an anatomical site (e.g., delivery via a naturally occurring passage within the body). In the deployment configuration, the size, shape, configuration, and / or dimensions of the implantable medical device 100 can be determined to realize various structures or forms for various purposes, such as facilitating the positioning of the implantable medical device 100 to the treatment site, fixation to the treatment site, formation of a passage through the anatomical site, and support of tissue and / or tissue walls. For example, in the delivery configuration, a long body 110 may have an elongated length (along its longitudinal axis LA) and / or a reduced diameter (usually lateral to the longitudinal axis LA) compared to the deployment configuration. In some embodiments, the elongated body 110 may be considered to be in a constrained, unexpanded, retracted, restrained, or folded configuration when in a delivery configuration (not shown, but readily apparent to those skilled in the art). In an unfolded configuration, the elongated body 110 may have a configuration that is generally shortened and / or radially expanded compared to, for example, the delivery configuration. In some embodiments, the elongated body 110 may be considered to be in an unconstrained, expanded, unretracted, restrained, or neutral configuration when in an unfolded configuration.

[0039] According to various principles of this disclosure, the implantable medical device 100 includes a proximal retaining member 120 along the proximal end 101 of the implantable medical device 100 and a distal retaining member 130 along the distal end 103 of the implantable medical device 100. Although one retaining member is formed along each end of the implantable medical device 100, it will be understood that multiple retaining members may be provided at either end or both ends of the implantable medical device 100. In some embodiments, the proximal end 111 of the elongated body 110 extends radially to form the proximal retaining member 120, and the distal end 113 of the elongated body 110 extends radially to form the distal retaining member 130, defining a saddle region 140 extending between them. In the deployed configuration of the implantable medical device 100, the saddle region 140 typically has a diameter larger than the diameter of the elongated body 110 in the delivery configuration. The retaining members 120 and 130 typically have a diameter larger than the diameter of the saddle region 140. The diameters of the retaining members 120 and 130 may be the same 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 retaining members 120 and 130 may be sized, shaped, constructed, and / or sized such that they fix the implantable medical device 100 to a tissue wall (for example, extending radially outward from the internal passage through 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 retaining members 120 and 130 may be angled toward the saddle region 140 or include a portion or surface that protrudes toward the saddle region 140 to apply pressure to the tissue wall in which the retaining members 120 and 130 are positioned. The retaining members 120 and 130 may be formed as single-walled or double-walled structures. For example, if the retaining members 120, 130 are formed by the extension of the proximal and / or distal portions of the wall of the implantable medical device 100 / long body 110, such extended wall can extend radially outward and then radially inward to form the double-walled retaining members 120, 130.The retaining members 120 and 130 do not need to be limited to a portion of the end of the elongated body 110, but can additionally or alternatively be considered as extensions of the elongated body 110 at the end of the implantable medical device 100, and it will be understood that the disclosure is not limited to this.

[0040] In some embodiments (such as the example shown in Figure 1), it is advantageous for at least a portion of the implantable medical device 100 to be coated with a material that maintains the flow of material (such as fluid) through a defined lumen 115 that penetrates the elongated body 110 without crossing at least a portion of the walls of the elongated body 110. For example, in embodiments in which the implantable medical device 100 forms a flow path, it may be desirable to restrict the flow of material through the lumen 115 from the proximal end 101 to the distal end 103 of the implantable medical device 100 without leakage from the lumen 115 (e.g., through the walls of the implantable medical device 100). In some embodiments, the coating is applied to at least a portion or all of the saddle region 140 of the implantable medical device 100 to maintain the flow of material through the saddle region 140 without passing through the walls of the saddle region 140. In some embodiments, the coating is also applied to additional portions of the implantable medical device 100, such as at least a portion or all of one or both of the retaining members 120, 130. It will be understood that the retaining members 120, 130 may include defined lumens 125, 135 inside each other (such as extensions of a defined lumen 115 within the elongated body 110), and the retaining members 120, 130 may be coated with a material that maintains the flow of substance (such as a fluid) through their lumens 125, 135 (not the walls of the retaining members 120, 130) and through the lumen 115 to the elongated body 110. The coating may also give the implantable medical device 100 some degree of structural stability or rigidity.

[0041] The implantable medical device 100 (the entire implantable medical device 100 or a part thereof) can be coated by various methods such as painting, dipping, spraying, clamping, heat shrinking, and electrospinning. The coating can be applied to at least a portion of the outer surface of the wall of the implantable medical device 100, or to the inner surface only, or to both the outer and inner surfaces. The coating may be, but is not limited to, known or previously known biocompatible materials that can prevent fluids from passing through, including, 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, and polynaphthalene. This includes polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyetherimide, polyphenylene sulfide (PPS), polyphenylene oxide (PPO), perfluoro(propyl vinyl ether) (PFA), polyparaphenylene terephthalamide, polybutylene terephthalate (PBT), polyoxymethylene (POM), polyether block esters, 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 also includes copolymers and / or combinations thereof.

[0042] Expandable implantable medical devices can be formed in various ways, such as forming 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 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 formed by braiding, interlocking, entanglement, weaving, braiding, knotting, looping (e.g., bobbinette style), weaving, knitting, wrapping, etc., to form an expandable and contractible scaffold structure. For convenience and without limitation, we will refer to the woven filaments that form the wall of the implantable medical device 100. The filaments forming the implantable medical device can be formed from a variety of biocompatible materials, which are, for example, but preferably, metals, metal alloys, polymers, metal-polymer composites, ceramics, and combinations or subcombinations thereof.For example, the filaments forming an implantable medical device can be formed from a variety of biocompatible polymers, which are, for example, but not limited to, 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), polyetherimide (PEI), poly(methyl methacrylate) (PMMA), polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxy These include simethylene (POM), polyether block esters, polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polyether esters, ether or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers, polyamides, block polyamides / ethers, polyimides (PI), ethylene vinyl alcohol, ethylene vinyl acetate copolymer (EVA), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide, perfluoro(propyl vinyl ether) (PFA), polyolefins, epoxy, poly(styrene-b-isobutylene-b-styrene), polycarbonates, ionomers, etc., and also include mixtures, combinations, subcombinations, and copolymers thereof.In addition, or alternatively, the components forming the implantable medical device may be formed from a variety of biocompatible alloys, which include, but are 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, and other alloys thereof, as well as combinations and subcombinations thereof. In addition, or alternatively, the components forming the implantable medical device may be formed from a variety of biocompatible natural materials, which include, but are not limited to, cat or cow intestines; natural fibers such as silk or cotton, and combinations and subcombinations thereof. It will be understood that the components forming an implantable medical device may be formed from mixtures, composites, combinations, subcombinations, copolymers, or co-components of any of the above. Alternatively, the components forming an implantable medical device may be formed by cutting (e.g., laser cutting) a tubular structure (e.g., optionally a monolithic cylindrical tubular member) into an expandable configuration, the cutting of which components such as strut members are formed. The implantable medical device may be a self-expanding device as known or previously known to those skilled in the art. For example, the implantable medical device may be formed from a shape memory material or thermoformable material (e.g., Nitinol or Elgiloy® or a shape memory polymer), so that when the implantable medical device is advanced from a delivery sheath (any acceptable tubular elongated member known to those skilled in the art for the delivery of a medical device) and / or when the delivery sheath that holds the implantable medical device in the delivery configuration is withdrawn, it returns from a shrunk configuration to a pre-formed expanded configuration.

[0043] In some embodiments of implantable medical devices formed according to various principles of this disclosure, the walls of the implantable medical devices, such as those formed as woven or knitted elements, may have gaps, holes, openings, or voids. Applying a coating material thereto fills these gaps, holes, openings, or voids in the walls of the implantable medical device, thereby inhibiting or preventing the flow or leakage of material through them. In some embodiments, the coating may encapsulate the components forming the walls of the implantable medical device 100. For example, elements forming the walls of an example embodiment of an implantable medical device 100 formed according to various principles of this disclosure may be embedded in the coating material so as to be completely covered by the coating material.

[0044] While coatings for implantable medical devices formed according to the various principles of this disclosure offer various advantages, it will be understood that such coatings may be lubricating, slippery, or otherwise resistant to maintaining the desired position of the implantable medical device 100 relative to the body tissue into which it is deployed. According to the various principles of this disclosure, one or more anti-movement structures 150 extend along or from any part of the implantable medical device 100, and the position of such anti-movement structures 150 may facilitate holding (e.g., fixing) the implantable medical device 100 in place and preventing it from moving away from the deployment site. As will be described in more detail below, in this specification, anti-movement structures 150 are described as extending, 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 to such terms) are used interchangeably in this specification and are not intended to be limiting. The size, shape, configuration, dimensions, position, and arrangement of the anti-movement structure 150 can be determined in various ways to increase resistance to movement of the implanted medical device 100 from the implantation site, as will be understood by those skilled in the art, considering the following points. Typically, the anti-movement structure 150 is provided along the outer surface of the implanted medical device 100 facing the tissue, so that the anti-movement structure 150 interacts with the tissue to hold the implanted medical device 100 against the tissue and resist movement from there.

[0045] In some embodiments, the anti-migration structure 150 is uncoated or lacks a coating, such as that provided on other parts of the implantable medical device 100 (particularly along the saddle region 140). According to various principles of this disclosure, the uncoated anti-migration structure 150 is provided along one or more parts or regions of the implantable medical device 100 that face the tissue of the deployment site. Because the anti-migration structure 150 is uncoated, tissue infiltration around the anti-migration structure 150 may occur, and may even be promoted, thereby holding the implantable medical device 100 in place relative to the deployment site.

[0046] In some embodiments, at least one of the anti-movement structures 150 includes a oriented retaining portion 152 positioned to withstand forces affecting the implanted medical device 100. For example, the retaining portion 152 may extend laterally with respect to the direction in which the implanted medical device 100 may move, and / or laterally with respect to the primary direction of forces that may affect the implanted medical device 100. In the examples of embodiments shown in Figures 1, 2, 3A, and 3B, the anti-movement structure 150 is U-shaped or loop-shaped, or formed as a closed or semi-closed shape, and tissue grows around and inside such a shape to resist the moving forces acting on the implanted medical device 100 (e.g., forces arising from normal bodily movements or functions such as peristalsis, or forces arising from the passage of material through an anastomosis formed by and maintained along the implanted medical device 100). In the embodiments shown in Figures 1, 2, 3A, and 3B, one or more anti-movement structures 150 include at least one retaining portion 152 that extends laterally with respect to the direction in which the implanted medical device 100 may move and / or laterally with respect to the main direction of forces that may affect the implanted medical device 100. For example, the retaining portion 152 may be part of a U-shaped anti-movement structure 150 and extend laterally with respect to / or coupled to the legs of the U-shaped anti-movement structure 150 (e.g., portions substantially parallel to each other) (the legs extend toward and engage with the retaining members 120, 130 of the implanted medical device 100). In the embodiment shown in Figure 1, the implanted medical device 100 typically experiences the greatest force along its longitudinal axis LA (within the anatomical site in which it is deployed). Therefore, as can be seen by referring to the examples of embodiments of the implantable medical device 100 shown in Figures 2, 3A, and 3B, the retaining portion 152 extends generally laterally with respect to the longitudinal axis LA of the implantable medical device 100. Thus, as tissue grows around the retaining 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 place relative to the tissue at the deployment site.

[0047] According to various principles of this 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 parts of the implantable medical device 100. The anti-movement structures 150 may be spaced apart from one another along a region or section of the implantable medical device 100 (for example, along one of the retaining members 120, 130). For an implantable medical device 100 formed according to various principles of this disclosure, it will be understood that various configurations and / or locations of the anti-movement structures 150 are within the scope and spirit of this 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 in close proximity to each other (for example, in a zigzag pattern), 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 embodiments shown in Figures 1, 2, 3A, and 3B, one or more anti-movement structures 150 extend from at least one of the retaining members 120 and 130. Optionally, one or more anti-movement structures 150 are provided on both the proximal retaining member 120 and the distal retaining member 130. By providing at least one anti-movement structure 150 on both retaining members 120 and 130, the anti-movement effect of the anti-movement structures 150 can be enhanced by resisting distal and proximal forces acting on the implantable medical device 100. The anti-movement structures 150 can be arranged in a zigzag pattern, spaced apart from each other or close together, at various positions along the retaining members 120 and 130, at various positions around the retaining members 120 and 130, or at various positions along the surfaces of the retaining members 120 and 130.

[0049] As shown in Figures 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 retaining members 120, 130. As referred to herein, the radially extending walls 122, 132 are walls forming the retaining members 120, 130 which are generally perpendicular to the longitudinal axis LA of the implantable medical device 100. The radially extending walls 122, 132 of the retaining members 120, 130 are also typically perpendicular to a saddle region 140 which extends generally along the longitudinal axis LA of the implantable medical device 100. Such a configuration is advantageous when deploying the implantable medical device 100 to an anatomical site where internal forces exert influence on the implantable medical device 100 along its longitudinal axis LA. For example, if the implantable medical device 100 defines a flow path through it (e.g., through a lumen 115 defined within the implantable medical device 100), the forces that could cause movement of the implantable medical device 100 are typically greatest along its longitudinal axis LA. Therefore, the radially outward-extending walls of the retaining members 120, 130 are oriented perpendicular to the longitudinal axis LA of the implantable medical device 100, thus increasing the surface area for resisting axial forces acting on the implantable medical device 100. The radially outward-extending walls of the retaining members 120, 130 can fix the implantable medical device 100 to a tissue wall extending (e.g., radially outward) from the passage through which the implantable medical device 100 is deployed, and / or to the tissue wall through which the retaining members 120, 130 are deployed. In some embodiments, the anti-movement structure 150 is positioned along the radially outermost edges of the retaining members 120, 130. Such a position of the anti-movement structure 150 may be advantageous for maintaining the maximum surface area of ​​the radially extending walls 122, 132 of the retaining members 120, 130 pressed against the tissue. However, other locations are also within the scope and intent of this disclosure.

[0050] The anti-movement structure 150 can enable a compact configuration when the implanted medical device 100 is in a delivery configuration by extending generally toward, along, parallel to, or generally flat with respect to the wall of the implanted medical device 100. However, in the deployed configuration of the implanted 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 implanted medical device 100 from which the anti-movement structure 150 extends. For example, the anti-movement structure 150 can extend from the wall of the implanted medical device 100 in a direction transverse to that wall. For example, in the embodiment shown in Figure 2, the anti-movement structure 150 extends generally laterally from the radially extending walls 122 and 132 of the holding members 120 and 130, respectively, along the side of the holding members 120 and 130 facing the saddle region 140. Therefore, the anti-movement structure 150 extends from the retaining members 120, 130 toward the saddle region 140. The anti-movement structure 150 can extend toward the saddle region 140 at an angle of approximately 45° to approximately 135° relative to the walls 122, 132 of the retaining members 120, 130. In other words, the anti-movement structure 150 may be perpendicular to the walls 122, 132 of the retaining members 120, 130, or it may be inclined from perpendicular to approximately 45°. If it is inclined relative to the walls 122, 132 of the retaining members 120, 130 (i.e., not perpendicular), the anti-movement structure 150 may be inclined toward the saddle region 140 or inclined toward the saddle region 140. The angle at which the anti-movement structure 150 extends relative to the retaining members 120 and 130 can be changed in either direction (medially or lateral) based on (but not limited to) the magnitude of the pressure to be applied to the stomach wall, and / or the general characteristics of the deployment site, and / or whether it is desired to promote tissue infiltration away from the saddle region 140 (usually outward) or closer to the saddle region 140 (usually inward).

[0051] In some embodiments, the anti-movement structure 150 may be configured to extend into the wall of the anatomical tissue into which the implantable medical device 100 is deployed. It will be understood herein that terms such as penetration, fixation, interlocking, implantation, and other grammatical forms thereof may be used interchangeably without intent to limit them. As shown in Figure 3A, an example of an embodiment of the implantable medical device 100 extends between the proximal tissue wall PTW and the 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, with the proximal retaining member 120 positioned on the proximal side of the proximal tissue wall PTW and the distal retaining member 130 positioned on the distal side of the distal tissue wall DTW. In the illustrated example of the embodiment, the anti-movement structure 150 extends laterally from the retaining members 120, 130 toward the saddle region 140 of the implantable medical device 100. The length of the elongated main body 110, particularly its saddle region 140, may be selected to allow the retaining members 120 and 130 to apply pressure to the tissue walls PTW and DTW, holding them adjacent to each other. Such pressure embeds the anti-movement structure 150 into the tissue walls PTW and DTW, further enhancing the anti-movement properties of the anti-movement structure 150. When the tissue walls PTW and DTW are held adjacent to each other, the tissue may grow along the saddle region 140 of the implantable medical device 100, forming an anatomical / tissue anastomosis (as opposed to an artificial anastomosis formed by the implantable medical device 100), as shown in Figure 3B. In some cases, particularly when the pressure applied by the retaining members 120 and 130 (optionally reinforced by the anti-movement structure 150) is applied to the adjacent tissues, causing them to fuse, the growth of tissue along the saddle region 140 may be promoted.

[0052] It will be understood that the anti-movement structure 150 can be formed in a variety of ways according to the various principles of this disclosure. The anti-movement structure 150 may be formed as a wire, filament, thread, tether, rope, band, or other element that provides sufficient resistance to forces affecting the implanted medical device 100 and the anti-movement structure 150. The anti-movement structure 150 may be formed separately from the implanted medical device 100 and be coupled (directly or indirectly) to the implanted medical device 100 by welding, soldering, weaving, bonding (e.g., gluing), mechanical deformation (e.g., knotting, looping, crimping, interference fit or friction fit), or other methods known to those skilled in the art. In addition, or instead, the anti-movement structure 150 may be an integral extension of the wall of the implanted medical device 100. For example, in some embodiments, one or more elements forming the implantable medical device 100 (e.g., woven or interwoven filaments) can be extended or pulled out from the rest of the implantable medical device 100 to form an anti-movement structure 150. More specifically, the lips 124, 134 may extend axially from the retaining members 120, 130 away from the saddle region 140 and may be provided with sufficient additional material to pull the filaments (or other members) of the implantable medical device 100 to form the anti-movement structure 150 from there. The method for forming the anti-movement structure 150 is selected to enhance the anti-movement force achieved by the anti-movement structure 150. For example, the method for forming the anti-movement structure 150 may be selected to facilitate the formation of the retaining portion 152 as described above.

[0053] Considering 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, etc. For example, a catheter-based stent delivery device can be used in conjunction with an endoscope to form one anastomosis between, for example, two parts of the intestine. An anastomosis can be formed between the fundic sac and a part of the intestine, such as the small intestine, using an endoscope-based device. A single anastomosis can also be formed using a combination of a laparoscope-based device and a catheter device as described herein. 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 a first body lumen) that establishes access and a second tissue wall (e.g., the wall of an organ or a second body lumen) that is the target of the surgery. For example, a passage can be formed between adjacent tissues (e.g., by cutting) by introducing an instrument into the anatomical site where the anastomosis will be performed. The tissue at the site of deployment may be pretreated in various ways, such as scraping (e.g., using a hook knife, high-temperature biopsy forceps, or high-temperature snare), ablation, drug treatment, or argon plasma coagulation (APC), to promote, accelerate, and / or increase cell growth as a result of the healing response. The induced tissue growth may promote the infiltration of the above tissue into the anti-migration structure of the implantable medical device to be placed at the treatment site. Subsequently, a delivery device (e.g., a tubular elongated member) is guided to the anatomical site where the implantable medical device is implanted. The distal end of the delivery device can be extended 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 to the distal tissue wall. The delivery device can then be further retracted to expose the portion of the implantable medical device closer to the distal end. The proximal end of the implantable medical device can expand to form a proximal retaining member that secures the implantable medical device to the proximal tissue wall.

[0054] This disclosure is not limited to any particular form or configuration of an implantable medical device or a system or method used in conjunction with such a device, and it will be understood that the principles of this disclosure are applicable to various configurations of implantable medical devices, systems, and methods known to those skilled in the art. It will be understood that various aspects of the above disclosure are applicable to other implantable medical devices, systems, and / or methods, such as devices placed elsewhere in the body (whether or not there are fluid channels at such locations or whether fluid channels need to be created).

[0055] While embodiments of this disclosure may be described in detail in relation to medical devices, systems, and procedures for forming anastomoses, it will be understood that the principles of this disclosure can also be applied to devices such as implantable medical device 1000 for forming gastric outlet obstruction (e.g., pyloric P obstruction) as shown in Figure 1. Furthermore, while embodiments of this disclosure are described in detail in relation to medical devices, systems, and procedures for treating the digestive system, it should be understood that such medical devices and methods can be used in conjunction with implantable medical devices used in the abdominal cavity, digestive system, biliary system, urinary tract, reproductive system, respiratory system, cardiovascular system, circulatory system, etc.

[0056] Those skilled in the art will be able to understand, in addition to what has been described above, various embodiments, features, components, and various further advantages of the above-described anti-movement structures.

[0057] The foregoing description is broadly applicable and is presented for illustrative and explanatory purposes only, and is not intended to limit this disclosure to the forms disclosed herein. It will be understood that various additions, modifications, and substitutions can be made to the embodiments disclosed herein without departing from the concepts, spirit, and scope of this disclosure. In particular, it will be apparent to those skilled in the art that the principles of this disclosure can be embodied in other forms, structures, arrangements, and proportions with other elements, materials, and components without departing from the concepts, spirit, scope, or characteristics thereof. For example, various features of this disclosure can be grouped into one or more aspects, embodiments, or configurations for the purpose of streamlining this disclosure. However, it should be understood that various features of a particular aspect, embodiment, or configuration of this disclosure can be combined in alternative aspects, embodiments, or configurations. Although this disclosure is presented in terms of embodiments, it should be understood that not all of the various individual features of the subject matter of the invention are necessary to achieve the desired characteristics and / or advantages of the subject matter of the invention or at least some of the individual features of such features. Those skilled in the art will understand that this disclosure can be used with many modifications or changes to the structures, arrangements, proportions, materials, components, and other elements used in the implementation of this disclosure, without departing from the principles, spirit, or scope of this disclosure, to be particularly suited to specific environmental and operating requirements. For example, elements shown to be formed as a single unit may consist of multiple parts, elements shown as multiple parts may be formed as a single unit, the operation of elements may be reversed or modified, and the size or dimensions of elements may be modified. Similarly, where operations, actions, or procedures are described in a particular order, it does not mean that such a particular order is necessary, or that all operations, actions, or procedures must be performed, to obtain the desired result. Furthermore, other implementations are also within the scope of the following claims. In some cases, the operations described in the claims may be performed in a different order to obtain the desired result.Accordingly, the embodiments disclosed herein should be considered in all respects to be illustrative and not limiting, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to any particular embodiment or configuration described or illustrated herein. In consideration of the foregoing, individual features of any embodiment may be used or claimed separately or in combination with features of that embodiment or other embodiments, and the scope of the subject matter is indicated by the appended claims and is not limited to the foregoing.

[0058] From the foregoing description and the following claims, it will be understood that: The terms “at least one,” “one or more,” and “and / or” as used herein are open-ended expressions that function as both conjunctions and separators. Terms such as “one,” “it,” “first,” and “second” do not preclude the plural form. For example, the word “one” as used herein refers to one or more of its entities. Thus, the terms “one,” “one or more,” and “at least one” are interchangeable within this specification. All directional references (e.g., proximal, distal, top, bottom, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, up, down, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or similar) are used solely for identification purposes to aid the reader’s understanding of this disclosure and / or to distinguish areas of related elements from one another, and do not limit the related elements in particular with respect to the location, orientation, or use of this disclosure. References of connection (e.g., attached, joined, connected, engaged, joined) should be interpreted broadly and, unless otherwise specified, may include intermediate members between sets of elements or relative movement between elements. Therefore, references of connection do not necessarily mean that two elements are directly connected and have a fixed relationship with one another. References of identification (e.g., primary, secondary, first, second, third, fourth, etc.) do not imply importance or priority, but are used to distinguish one feature from another.

[0059] The following claims are incorporated by this reference into this detailed description, and each claim exists independently as a separate embodiment of the present disclosure. In the claims, the term “includes” does not preclude the presence of other elements, components, features, areas, integers, steps, operations, etc. Furthermore, individual features may be included in different claims, but they may be advantageously combined, and inclusion in different claims does not mean that the combination of features is unfeasible and / or unfavorable. Furthermore, singular references do not preclude plural references. Reference numerals in the claims are provided merely as illustrative examples and are not to be construed as limiting the scope of the claims.

Claims

1. It is an implantable medical device, A long body having a proximal end and a distal end, the long body defining a lumen extending therein; A proximal retaining member along the proximal end of the elongated main body; A distal holding member along the distal end of the elongated main body; A saddle region defined between the proximal holding member and the distal holding member; and The long body includes at least one anti-movement structure extending outward from its outer surface, At least the saddle region has walls coated with a material that prevents the passage of fluid, The aforementioned at least one anti-movement structure is not coated in order to promote endoproliferation of surrounding tissue. An implantable medical device in which the at least one anti-movement structure is in a semi-closed or closed form relative to the elongated main body.

2. The implantable medical device according to claim 1, wherein the at least one anti-movement structure includes at least one holding portion extending laterally with respect to the axis of a moving force affecting the implantable medical device.

3. The implantable medical device according to claim 2, wherein the lumen of the elongated main body extends through the saddle region, and the retaining portion extends laterally with respect to the longitudinal axis of the saddle region.

4. The implantable medical device according to claim 3, wherein the at least one movement prevention structure extends laterally from at least one of the proximal holding member or the distal holding member and extends toward the saddle region.

5. The proximal holding member and the distal holding member extend radially outward from the saddle region. The implantable medical device according to claim 1, wherein the at least one movement prevention structure extends laterally from at least one of the proximal holding member or the distal holding member and extends toward the saddle region.

6. The implantable medical device according to claim 5, wherein the saddle region is configured to extend between a proximal tissue wall and a distal tissue wall, the proximal retaining member is configured to fix the implantable medical device to the proximal tissue wall, the distal retaining member is configured to fix the implantable medical device to the distal tissue wall, and the at least one anti-movement structure is configured to be embedded in either the proximal tissue wall or the distal tissue wall.

7. The implantable medical device according to claim 6, wherein the at least one anti-movement structure includes at least one anti-movement structure extending from the proximal holding member toward the saddle region and at least one anti-movement structure extending from the distal holding member toward the saddle region.

8. The implantable medical device is transitionable between a long delivery configuration and a shortened deployment 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 main body extends radially outward. The implantable medical device according to claim 1, wherein in the deployed configuration, the length of the saddle region and the configuration of the proximal retaining member and the distal retaining member are selected so as to pull together the tissue extending across the elongated body and the at least one anti-movement structure is fixed to the tissue.

9. The implantable medical device according to claim 1, wherein at least one of the proximal retaining member or the distal retaining member is formed from woven filaments, and the at least one anti-movement structure is formed from one extension of the woven filaments.

10. The implantable medical device according to claim 1, wherein the at least one movement prevention structure is formed separately from and coupled to at least one of the proximal holding member or the distal holding member.

11. It is an implantable medical device, A long body having a proximal end and a distal end, the long body defining a lumen extending therein; and The long body includes at least one anti-movement structure extending outward from its outer surface, The aforementioned elongated body is formed from a plurality of filaments that form the walls of the elongated body with gaps between them. At least a portion of the wall of the elongated body is coated to prevent fluid from passing through and to resist tissue infiltration. The aforementioned at least one anti-movement structure is not coated to promote endografting of surrounding tissue, An implantable medical device in which the at least one anti-movement structure is in a semi-closed or closed form relative to the elongated main body.

12. The implantable medical device according to claim 11, wherein the at least one anti-movement structure includes at least one holding portion extending laterally with respect to an axis in the direction in which a moving force affecting the implantable medical device is applied.

13. The implantable medical device further includes a proximal retaining member extending radially outward along the proximal end of the elongated body, a distal retaining member extending radially outward along the distal end of the elongated body, and a saddle region defined between the proximal retaining member and the distal retaining member. The implantable medical device according to claim 11, wherein the at least one movement prevention structure extends toward the saddle region from at least one of the proximal holding member or the distal holding member.

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