Apparatus, system, and method for juxtaposing and holding anatomical structures.

Abstract

Implantable medical devices such as stents have dynamic features that allow one or both ends of the implantable medical device to move relative to an intermediate section between them. The implantable medical device may be sized, formed, configured, and / or dimensions set to hold anatomical structures in juxtaposition. The dynamic section allows relative movement of the juxtaposed anatomical structures without causing movement of the ends of the implantable medical device fixed to the anatomical structures.

Description

Technical Field

[0001] The present disclosure generally relates to the field of implantable medical devices, systems, and methods. More particularly, the present disclosure relates to medical devices, systems, and methods for juxtaposing and holding anatomical structures.

Background Art

[0002] Various devices, such as stents, are extended into anatomical structures for various purposes. For example, various stents are known for establishing connections between anatomical structures. Some such connections are made simply to hold tissues juxtaposed, while others also establish fluid communication between anatomical structures such as organs, cavities, lumens, and passages. In some cases, it is desirable to create semi-permanent or permanent anastomoses that allow fluid flow or drainage from one anatomical structure to another. For example, in various gastrointestinal (GI) procedures (e.g., gastric bypass surgery), juxtaposed stents can be used to form anastomoses in the GI system, such as a gastrojejunal anastomosis between the stomach and the jejunum. A gastrojejunal anastomosis facilitates the flow of food particles, liquids, oatmeal, etc., from the stomach into the lower GI duct, 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 surgical bypass procedures and may be reversible. As can be understood, it is desirable that the anastomotic device be firmly retained in place until removal is desired or medically instructed. Generally, and more broadly, in various procedures or uses of implantable medical devices extending across anatomical structures, it may be desirable to keep the device in place for extended periods (e.g., days, weeks, months, or even 6-12 months or more). However, when placed across two different anatomical structures that can move relative to each other, the implantable medical device may become dislodged and move away from the deployment site due to movement of the anatomical structure to which the stent is placed and fixed. Therefore, there remains an ongoing need for improved anti-mis-migration features and / or configurations of implantable devices extending across juxtaposed, generally non-adhesive anatomical structures, as well as improvements to related systems and methods. [Overview of the project]

[0003] This summary is provided in a simplified form to introduce a selection of concepts that will be described in more detail in the following detailed description. 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. A person skilled in the art will understand that each of the various aspects and features of the disclosure may be used advantageously in some examples, separately or in other examples, in combination with other aspects and features of the disclosure, whether or not they are described in this summary. No limitation on the scope of the claimed subject matter is intended by the inclusion or exclusion of elements, components, etc., in this summary.

[0004] According to various principles of this disclosure, an implantable medical device is configured to hold a first anatomical structure and a second anatomical structure juxtaposed between a first end and a second end of the implantable medical device. The implantable medical device has an intermediate section defined between the first end and the second end of the implantable medical device and extending through the anatomical structure. In some embodiments, the first end of the implantable medical device is configured to be fixed to the first anatomical structure. In some embodiments, the second end of the implantable medical device is configured to be fixed to the second anatomical structure. In some embodiments, the intermediate section is sized, formed, configured, and / or dimensions such that it holds a first end of the implantable medical device fixed to the first anatomical structure and a second end of the implantable medical device fixed to the second anatomical structure juxtaposed. In some embodiments, the intermediate section includes a dynamic section configured to allow the first end of the implantable medical device to move relative to the second end of the implantable medical device.

[0005] A dynamic section can optionally have a coextensive extent, essentially identical to that of an intermediate section. In some embodiments, at least the first and second ends of the implantable medical device are formed of interconnected filaments, and the dynamic section of the intermediate section has a structure different from the structure of the interconnected filaments of the intermediate section.

[0006] The dynamic sections are optionally formed from substantially solid polymer walls. In some embodiments, the intermediate section includes a section formed of interconnected filaments, and the dynamic section includes a first dynamic section that connects a first end of the section of interconnected filaments of the intermediate section to a first end of an implantable medical device, and a second dynamic section that connects a second end of the section of interconnected filaments of the intermediate section to a second end of an implantable medical device.

[0007] In some embodiments, a first retaining member extends radially outward along a first end of the implantable medical device, and a second retaining member extends radially outward along a second end of the implantable medical device, and the first and second retaining members are formed from filaments interconnected in a first pattern, and at least a portion of the intermediate section is formed from filaments interconnected in a second pattern different from the first pattern. In some embodiments, the second pattern imparts a degree of flexibility to the intermediate section that is different from the flexibility imparted to the first and second retaining members by the first pattern. In some embodiments, the dynamic section includes a first dynamic section that connects a first end of a portion of the intermediate section formed from interconnected filaments to the first retaining member, and a second dynamic section that connects a second end of a portion of the intermediate section formed from interconnected filaments to the second retaining member.

[0008] In some embodiments, a lumen is defined through an implantable medical device to form an anastomosis between juxtaposed anatomical structures. Optionally, a dynamic section is reinforced to maintain the lumen through the implantable medical device in an open configuration.

[0009] Optionally, an intermediate section may contain two or more dynamic sections. In some embodiments, the implantable medical device is transitionable from a delivery configuration to an extended deployment configuration. In some embodiments, when the implantable medical device transitions to the deployment configuration, the first end of the implantable medical device extends to define a first retaining member that extends radially outward. Additionally or alternatively, when the implantable medical device transitions to the deployment configuration, the second end of the implantable medical device extends to define a second retaining member that extends radially outward. Additionally or alternatively, the first end of the intermediate section is coupled to the first retaining member. Additionally or alternatively, the second end of the intermediate section is coupled to the second retaining member.

[0010] In some embodiments, the intermediate section is sized, formed, configured, and / or dimensions such that it holds adjacent non-adhesive anatomical structures in juxtaposition.

[0011] According to various principles of this disclosure, an implantable medical device is configured to hold a first anatomical structure and a second anatomical structure in juxtaposition, and the implantable medical device has a first end and a second end with an intermediate section extending between them. The implantable medical device has a first retaining member which is sized, formed, configured and / or dimensioned to secure the first end of the implantable medical device to the first anatomical structure, a second retaining member which is sized, formed, configured and / or dimensioned to secure the second end of the implantable medical device to the first anatomical structure, and a dynamic section which is defined along the intermediate section and allows the intermediate section to move relative to the first retaining member and the second retaining member.

[0012] In some embodiments, the first and second retaining members are formed from interconnected filaments, and the dynamic section has a structure different from that of the interconnected filaments of the first and second retaining members.

[0013] According to various principles of this disclosure, a method for holding a patient's first anatomical structure juxtaposed with a patient's second anatomical structure includes fixing a first end of an implantable medical device to the first anatomical structure, extending an intermediate section of the implantable medical device across the first and second anatomical structures, fixing a second end of the implantable medical device to the second anatomical structure, and allowing a dynamic section of the implantable medical device to flex with respect to at least one of the retaining members. In some embodiments, the intermediate section is sized, formed, configured, and / or dimensions such that it holds the first and second anatomical structures juxtaposed together with the first end of the implantable medical device fixed to the first anatomical structure and the second end of the implantable medical device fixed to the second anatomical structure.

[0014] Optionally, a lumen is defined through an implantable medical device, and the method further comprises forming an anastomosis between a first anatomical structure and a second anatomical structure. In some embodiments, the first anatomical structure is the patient's jejunum and the second anatomical structure is the patient's stomach, and the method further comprises forming a gastrojejunal anastomosis.

[0015] In some embodiments, the method further includes delivering an implantable medical device transcatheterally through a patient in a delivery configuration; deploying a first end of the implantable medical device within a first anatomical structure, allowing the first end of the implantable medical device to expand, thereby forming a first retaining member fixed to the distal surface of the first anatomical structure; extending an intermediate section through the wall of the first anatomical structure and the wall of a second anatomical structure; deploying a second end of the implantable medical device within a second anatomical structure, allowing the second end of the implantable medical device to expand, thereby forming a second retaining member fixed to the proximal surface of the second anatomical structure.

[0016] These and other features and advantages of this disclosure will be readily apparent from the following detailed description, and the scope of the claimed invention is set forth in the attached claims. The following disclosure is presented with respect to aspects or embodiments, but it should be understood that each aspect may be claimed separately or in combination with the aspects and features of that embodiment or any other embodiment. [Brief explanation of the drawing]

[0017] Non-limiting embodiments of this disclosure are described by 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 dimensions, locations, order, and relative sizes reflected in the figures within the drawings may vary. 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's working channel. In each figure, elements that are identical, substantially identical, or equivalent may be denoted by the same reference numeral, and similar elements may be denoted by similar reference numerals differing by 100, with redundant descriptions omitted. For clarity and brevity, not all elements are labeled in every figure, and not all elements of each embodiment are shown where not illustration is necessary to enable those skilled in the art to understand this disclosure. The detailed descriptions will be better understood in conjunction with the accompanying drawings, where similar reference numerals represent similar elements, as follows. [Figure 1] Figure 1 is a perspective view of one embodiment of an implantable medical device, formed according to various aspects of this disclosure and positioned in a schematic diagram of the gastrointestinal environment. [Figure 2] Figure 2 is an elevation view of an example of one embodiment of an implantable medical device, formed according to various principles of the present disclosure and shown to extend across two different anatomical walls. [Figure 3] Figure 3 shows another example of an embodiment of an implantable medical device formed according to various principles of this disclosure. [Figure 4] Figure 4 shows another example of an embodiment of an implantable medical device formed according to various principles of this disclosure. [Modes for carrying out the invention]

[0018] The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. It should be understood that this disclosure is not limited to the specific embodiments described and is therefore subject to change. 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 this disclosure. Each example of an embodiment is provided for illustrative purposes and is merely an example, not the only way to implement these principles. Accordingly, references to elements, structures, or features in the drawings should be recognized as references to examples of embodiments of this disclosure and should not be understood as limiting this disclosure to specific elements, structures, or features illustrated. Other examples of ways of implementing the disclosed principles will be recalled by those skilled in the art who have read this disclosure. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in this disclosure without departing from the scope of the subject matter or the technical idea. For example, a feature illustrated or described as part of one embodiment can be used in conjunction with another embodiment to result in further embodiments. Therefore, this subject matter is intended to encompass such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0019] It will be understood that this disclosure is described in varying levels of detail in this application. In certain examples, details that are not necessary for a person skilled in the art to understand this disclosure, or that would make it difficult to recognize other details, may be omitted. The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit beyond the scope of the appended claims. Unless otherwise defined, the technical terms used herein should 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 are possible to manufacture and perform in light of this disclosure without undue experimentation.

[0020] As used herein, “proximal” means the direction or location closest to the user (such as a medical professional, clinician, technician, operator, or physician, and such terms are used interchangeably herein without intent to limit, including automated controller systems, etc.) and / or the direction or location closest to the delivery device when using the device (e.g., when introducing the device into a patient, or during implantation, placement, or delivery); “distal” means the direction or location furthest from the user and / or the direction or location closest to the delivery device when using the device (e.g., when introducing the device into a patient, or during implantation, placement, or delivery); “longitudinal” means extending along the longer or larger dimension of the element; “longitudinal axis” means extending along the longitudinal range of the element, but not necessarily linear, and not necessarily maintaining a fixed configuration if the element bends or curves; and “axial” generally means along the longitudinal axis. However, it will be understood that references to axial or longitudinal movement relating to the systems or elements described above do not need to be strictly limited to axial and / or longitudinal movement along the longitudinal axis or central axis of the element referred to. "Center" means at least roughly intersecting the center point and / or being roughly equidistant from the periphery or boundary, and "central axis" means, with respect to an opening, a line that at least roughly intersects the center point of the opening and extends longitudinally along the length of the opening if the opening includes, for example, a tubular element, column, channel, cavity, or hole. As used herein, "lumen," "channel," "bore," or "passage" are not limited to a circular cross-section. As used herein, the "free end" of an element is the end beyond which such an element does not extend. Terms such as at the end, on the end, adjacent to the end, or along the end may be used interchangeably herein without limitation unless otherwise stated, and it will be understood that they are intended to indicate general relative spatial relationships rather than precisely defined locations.Finally, references to a position or site “at” are intended to include at such position or site and / or in the vicinity of such position or site (e.g., along it, adjacent thereto, etc.).

[0021] Implantable medical devices formed in accordance with various principles of the present disclosure extend across adjacent or juxtaposed anatomical structures and are configured to be held in a fixed position relative thereto. According to various further principles of the present disclosure, such implantable medical devices are formed to hold anatomical structures juxtaposed relative to each other. Implantable medical devices formed in accordance with various principles of the present disclosure may be formed to establish a flow or access passage (e.g., anastomosis) between juxtaposed anatomical structures. The implantable medical device is configured and deployed to be fixed or otherwise held in a predetermined position relative to a deployment site, such as relative to the tissue wall of the deployment site. For example, implantable medical devices formed in accordance with various principles of the present disclosure are configured with one or more retention or anchor structures (alternatively, may be referred to as retention members or flanges). Additionally or alternatively, implantable medical devices formed in accordance with various principles of the present disclosure are designed to promote ingrowth of the accompanying tissue and improve resistance to migration. It will be understood that terms such as retention or fixation (and other grammatical forms thereof) may be used interchangeably herein with terms such as fix, attach, associate, couple, engage, implant, insert, hold, grip, secure, etc. (and their grammatical forms) without intent to limit. Further, note that references to anatomical sites, deployment sites, treatment sites, delivery sites, etc. may alternatively be made without intent to limit.

[0022] One challenge in deploying implantable medical devices across anatomical structures is that anatomical structures (especially if non-adhesive) are capable of moving relative to one another, and even after the implantable medical device has been deployed across such anatomical structures and held juxtaposed, it may remain capable of moving relative to one another, at least to some extent. Relative movement of anatomical structures may cause movement of the implantable medical device, potentially hindering its implantation (e.g., hindering inward tissue growth) and potentially causing it to detach / migrate from the deployment site. For example, an implantable medical device deployed across the stomach and part of the intestine (e.g., the jejunum), such as to form a gastrojejunal anastomosis ("GJ"), is subjected to a variety of forces that tend to cause movement of the implantable medical device. Because the intestine is typically motile, especially relative to the stomach, it may move not only laterally relative to the stomach but also away from it. Additionally or alternatively, the weight and gravity of the intestine may pull it away from the stomach, exerting an uplift force on the implantable medical device. Therefore, it is desirable to improve the retention of implantable medical devices against the deployment site (e.g., against the juxtaposed anatomical structure into which the implantable medical device is deployed). As mentioned above, various implantable medical devices can be designed to promote tissue internal growth in order to improve resistance to migration against the deployment site. However, such tissue internal growth does not occur immediately. Therefore, it is desirable to improve the retention of such implantable medical devices for at least a sufficient residence time to establish tissue internal growth against the deployment site.

[0023] Examples of embodiments of the implantable medical device disclosed herein have an elongated body with an end configured to secure the implantable medical device to its anatomical structure, and an intermediate section extending between the ends. In some embodiments, such as those described herein, a retention member (which may alternatively be referred to as a flange, anchor section, etc., without intending to limit) is defined / provided at an end of the implantable medical device and is configured to maintain the implantable medical device in a predetermined position relative to an anatomical structure juxtaposed and held by the implantable medical device. The intermediate section (which may alternatively be referred to as a saddle region) extends between the retention members and through an anatomical structure in which the implantable medical device is deployed. The retention members may have a diameter larger than the diameter of the intermediate section and may additionally be configured to hold the implantable medical device in a predetermined position relative to the deployment site.

[0024] According to various principles of this disclosure, at least a portion of the intermediate section includes one or more dynamic sections (which may also be referred to as parts, regions, etc.) configured such that lateral and / or radial forces move or act upon the intermediate section without affecting the retaining member. Thus, the lateral and / or radial forces are not transmitted to the retaining member. The juxtaposed anatomical structures to which the retaining member is fixed, and the retaining member, can therefore move and flex independently of each other (without the forces acting on the intermediate section affecting the fixed position of the retaining member relative to the juxtaposed anatomical structures), thereby enabling the formation of an anastomosis between them. For example, the dynamic sections of the intermediate section of an implantable medical device can flex and move continuously as the juxtaposed anatomical structures move relative to each other, thereby reducing the forces acting on individual retaining members and thus reducing the rate of movement of the implantable medical device. It will be understood that a singular reference to a dynamic section may be interpreted as including multiple dynamic sections. In some embodiments, the dynamic section has substantially the same extent as the intermediate section (for example, defined along substantially the entirety of the intermediate section). In some embodiments, the intermediate section may be considered to be the dynamic section itself.

[0025] According to various principles of this disclosure, the dynamic section allows for movement, bending, flexing, contraction, etc., relative to other sections of the implantable medical device when relative movement occurs in the juxtaposed anatomical structures into which the implantable medical device is deployed. The dynamic section may be formed and / or configured differently from other sections of the implantable medical device. In some embodiments, the dynamic section has different structural and / or material properties from the retaining member. For example, the dynamic section may be formed of different material or combination of materials from the material or combination of materials forming the other sections of the intermediate section and / or the retaining member, such as being distal or proximal to the dynamic section. Additionally or alternatively, the dynamic section may have a different structure from, or be formed differently from, the other sections of the intermediate section and / or the retaining member, such as being distal or proximal to the dynamic section. In some embodiments, at least a portion of the intermediate section of the implantable medical device, formed according to various principles of this disclosure, is coupled to a retaining member (e.g., an extension of the retaining member). In such embodiments, the ends of the dynamic sections of the intermediate section are coupled to a portion of the retaining member (for example, extending from the retaining member and optionally being part of the retaining member).

[0026] According to various further principles of this disclosure, implantable medical devices are configured to form an anastomosis between / over them of anatomical structures into which the implantable medical device is deployed. According to various principles of this disclosure, implantable medical devices may be configured not only to prevent their migration during the formation of the anastomosis, but also to maintain the necessary integrity of the implantable medical device in order to prevent leakage through / out of the anastomosis (e.g., leakage laterally rather than longitudinally from the ends of the device). For example, an implantable medical device formed according to various principles of this disclosure may form an anastomosis between the patient's stomach and jejunum and be configured and deployed to prevent leakage through the device into the peritoneum during the formation of the anastomosis. For example, a coating or liner or other impermeable or semi-impermeable material may extend along the implantable medical device (and optionally be bonded to the implantable medical device by coating or other means). More specifically, the coating or liner may extend on or within the wall forming the implantable medical device, be attached to the wall, be formed with the wall, or otherwise be associated with the wall. The coating may be applied uniformly along the entire length of the implantable medical device, or it may be applied unevenly, for example, with increasing thickness towards the proximal or distal end (e.g., forming a ridge), or it may cover only a portion of the implantable medical device (e.g., forming an opening, slit, slot, etc.).

[0027] An example of an embodiment of an implantable medical device formed according to various principles of this disclosure has a dynamic section separately formed along an intermediate section between the retaining members of the implantable medical device. Various features or properties of the dynamic section allow the anatomical structures held juxtaposed by the implantable medical device to move independently of each other, while allowing the retaining members of the implantable medical device to remain in place relative to the anatomical structures. For example, the dynamic section may be a flexible section (e.g., a flexible cylinder / tube) that absorbs or moves with forces acting on the intermediate section of the implantable medical device so as not to interfere with the retaining members of the implantable medical device. Thus, the dynamic section can facilitate the fixation of the implantable medical device, the formation of anastomoses, and / or the maintenance of a lumen extending longitudinally through the implantable medical device in an open configuration that allows material to pass through it.

[0028] Next, various embodiments of implantable medical devices, systems, and related methods will be described with reference to examples shown in the accompanying drawings. References in this specification to “one embodiment,” “a certain embodiment,” “several embodiments,” and “other embodiments” indicate that one or more specific features, structures, concepts, and / or properties according to the principles of this disclosure may be included in relation to an embodiment. However, such references do not necessarily mean that all embodiments include a particular feature, structure, concept, and / or property, or that one embodiment includes all of them. Some embodiments may include one or more such features, structures, concepts, and / or properties in various combinations thereof. It should be understood that one or more of the features, structures, concepts, and / or properties described with reference to one embodiment may be combined with one or more of the features, structures, concepts, and / or properties of any of the other embodiments provided herein. That is, any of the features, structures, concepts, and / or properties described herein can be mixed and adapted to create hybrid embodiments, and such hybrid embodiments are within the scope of this disclosure. Furthermore, references to “one embodiment,” “a certain embodiment,” “several embodiments,” and “other embodiments” in various parts of this specification do not necessarily all refer to the same embodiment, and distinct 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 and distinct from one another and may be used or exist individually or in various combinations with each other to produce alternative embodiments that are considered part of this disclosure. Therefore, because it would be extremely cumbersome to describe all of the numerous possible combinations and partial combinations of features, structures, concepts, and / or characteristics, 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 various dimensions provided herein are examples only, and those skilled in the art should understand that they can easily determine an appropriate range of standard deviation and acceptable variation therefrom that is included in this disclosure and any claims associated therewith. The following description is merely an example for illustrating embodiments and is not intended to limit broader aspects of this disclosure.

[0029] In the accompanying drawings, common features are identified by common reference elements, and for brevity and convenience, without intent to limit, descriptions of common features are generally not repeated. For clarity, not all components having the same reference number are numbered. Furthermore, groups of similar elements may be indicated by numbers and letters, and generally, a single element or such elements, or such elements as a group, can be referred to by numbers only (without including the letters associated with each similar element). In the following description, similar elements or components among the various illustrated embodiments having reference numbers greater than 100 are generally designated with the same reference number incremented by multiples of 100, and redundant descriptions are generally omitted for brevity. Furthermore, certain features in one embodiment may be used across different embodiments and are not necessarily individually labeled when appearing in different embodiments.

[0030] Referring here to the drawings, an example of an embodiment of an implantable medical device 100 formed according to various principles of this disclosure is shown in Figure 1 as holding a proximal anatomical structure PS and a distal anatomical structure DS juxtaposed with respect to each other. More specifically, an implantable medical device 100 that forms an anastomosis (e.g., a gastrojejunal anastomosis) between the stomach (as the proximal anatomical structure PS) and a portion of the small intestine (as the distal anatomical structure DS), such as the jejunum, is shown within the patient's gastrointestinal system. An additional device, such as an occlusion device OD, can be deployed against the pylorus to occlude it so that material from the stomach is directed towards the gastrojejunal anastomosis rather than passing through the pylorus. It will be understood that implantable medical devices formed according to various principles of this disclosure may be useful in procedures other than metabolic procedures, e.g., any other procedures or applications where the movement of the implantable medical device is a concern. The reference to gastrojejunal anastomosis is for illustrative purposes only and is not intended to limit the scope.

[0031] An example of an embodiment of the implantable medical device 100 shown in Figure 1 has a distal end 101 that extends into and is fixed to the distal anatomical structure DS, and a proximal end 103 that extends into and is fixed to the proximal anatomical structure PS. The implantable medical device 100 may be delivered by any of the various methods known to those skilled in the art, typically by first delivering the distal end 101 and then deploying the proximal end 103. For example, the implantable medical device 100 may be delivered in a compact (e.g., retracted, folded, etc.) delivery configuration that can pass through an elongated tubular element (e.g., endoscope, catheter, sheath, etc.) configured for transcatheter / intraluminal delivery (e.g., transcatheter as opposed to open surgical procedures) to the deployment site through the patient. For example, the implantable medical device may be delivered via a spontaneous opening transcatheter endoscopic surgery (NOTES) procedure, which is considered simpler and less invasive than open surgical procedures (e.g., Roux-en-Ye procedures). To deploy the implantable medical device 100 to a deployment site, the implantable medical device 100 can be advanced distally from an elongated tubular element and / or the elongated tubular element can be pulled proximal. Once deployed, the implantable medical device 100 can be expanded into a deployed configuration that substantially corresponds to the deployment site (for example, to engage with the deployment site and ensure secure implantation). The implantable medical device 100 may be self-expanding (i.e., expandable on its own from a delivery configuration to a deployed configuration, for example, by being formed at least partially from a shape memory material), or it may be expanded with the assistance of another device, such as a balloon. This disclosure is not limited to a method of delivering the implantable medical device 100, or a delivery device or system used for delivery.

[0032] The illustrated implantable medical device 100 is sized, formed, configured, and / or dimensions set to hold distal anatomical structures DS and proximal anatomical structures PS juxtaposed relative to each other. According to various principles of this disclosure, in embodiments in which the implantable medical device 100 holds anatomical structures juxtaposed, the length of the implantable medical device 100 between the distal end 101 and the proximal end 103 is determined based on the nature of the anatomical structures to be held juxtaposed by the implantable medical device 100 and various other properties. For example, the length of the implantable medical device 100 may be determined based on the thickness of the tissue walls of the anatomical structures to be held juxtaposed, how close the anatomical structures should be held relative to each other, etc. It will be understood that other properties of the implantable medical device 100 may also be selected based on the anatomical structures into which the implantable medical device 100 is deployed.

[0033] When used to hold anatomical structures side by side, an example embodiment of the implantable medical device 100 shown in Figure 1 includes a distal retaining member 110 along the distal end 101 of the implantable medical device 100 and a proximal retaining member 120 along the proximal end 103 of the implantable medical device 100, with an intermediate section 130 of the implantable medical device 100 defined between them. The retaining members 110, 120 are sized, formed, configured, and / or dimensions set to hold the implantable medical device 100 against the deployment site. More specifically, the size, shape, configuration, and / or dimensions of the retaining members 110, 120 may be selected to abut against the anatomical walls of the distal anatomical structure DS and the proximal anatomical structure PS, for example, the anatomical walls of the anatomical structures DS and PS (e.g., tissue walls extending radially outward from the body passage through which the intermediate section 130 of the implantable medical device 100 extends). Therefore, the retaining members 110, 120 are typically lateral to the intermediate section 130 of the implantable medical device (for example, along the longitudinal axis LA along which the implantable medical device 100 or at least most of its length generally extends). Typically, the retaining members 110, 120 are wider than the intermediate section 130 (radially across the longitudinal axis of the body passage) and resist movement of the implantable medical device 100 relative to the deployment site by holding the retaining members 110, 120 against any pull-out forces acting on the implantable medical device 100.

[0034] In the embodiment of the implantable medical device 100 shown in Figure 1, the retaining members 110 and 120 are located close to the ends of the intermediate section 130, spaced apart from each other, and hold anatomical structures DS and PS, such as non-adhesive anatomical structures, side by side. The anatomical structures DS and PS may be adjacent to each other, as opposed to spaced anatomical structures having another anatomical structure between them. The intermediate section 130 extends through the anatomical structures DS and PS, for example, through a body passage defined through them. The reference to a body passage will be understood to include naturally occurring passages as well as medically formed passages (for example, a passage formed using a medical instrument such as an incision instrument, such as between the stomach and jejunum, as shown in Figure 1) or others. Therefore, the entire length of the implantable medical device 100 from one end 101 to the other end 103 can be based on a longitudinal range that is desirable or necessary to hold non-adhesive anatomical structures DS and PS juxtaposed and to form an anastomosis between them (e.g., formed by tissue growth of the juxtaposed anatomical walls toward each other and toward the implantable medical device 100). The intermediate section 130 can be seen in Figure 1, but the intermediate section 130 extends through the juxtaposed walls of the anatomical structures DS and PS and beyond the walls (e.g., the non-juxtaposed surface DS as shown in Figure 1). D and PS P It will be understood that the size can be determined so that it is not visible (beyond the limit).

[0035] In the example of the implantable medical device 100 shown in Figure 1, the distal retaining member 110 has a tissue engagement surface 112t facing the wall of the distal anatomical structure DS, and the proximal retaining member 120 has a tissue engagement surface 122t facing the wall of the proximal anatomical structure PS. More specifically, the tissue engagement surface 112t of the distal retaining member 110 is the distal-facing surface DS of the wall of the distal anatomical structure DS. D The tissue engagement surface 122t of the proximal retaining member 120 engages with the surface PS facing the proximal direction of the wall of the proximal anatomical structure PS. PThe tissue engagement surfaces 112t and 122t of the holding members 110 and 120, or at least one or more portions thereof, engage with the anatomical structures DS and PS (and their distal surfaces DS). D and the proximal direction of the surface PS P The size, form, configuration, and / or dimensions are set so as to abut against the tissue engagement surface. The retaining members 110, 120 may be single-wall elements, and it will be understood that the tissue engagement surfaces 112t, 122t are faces of the respective retaining members 110, 120. Alternatively, at least one of the retaining members 110, 120 may be a double-wall retaining member. For example, in the embodiment shown in Figure 1, the illustrated double-wall distal retaining member 110 has a first wall 114t defining the tissue engagement surface 112t and a second wall 114o defining the outward-facing surface 112o of the distal retaining member 110 (facing away from the deployment site and the rest of the implantable medical device 100). The peripheral wall 114p extends between the first wall 114t and the second wall 114o of the distal retaining member 110 and defines the peripheral surface 112p of the distal retaining member 110 (extending between the tissue engagement surface 112t and the outward-facing surface 112o of the distal retaining member 110). Similarly, the double-walled proximal retaining member 120 shown in Figure 1 has a first wall 124t defining the tissue engagement surface 122t and a second wall 124o defining the outward-facing surface 122o of the proximal retaining member 120 (facing away from the deployment site and the rest of the implantable medical device 100), with the peripheral wall 124p extending between the first wall 124t and the second wall 124o and defining the peripheral surface 122p of the proximal retaining member 120. It will be understood that one of the retaining members 110, 120 may be formed as a double-wall retaining member, while the other may be formed as a single-wall retaining member.

[0036] As can be understood, if the anatomical structures into which an implantable medical device is deployed shift or move relative to each other and / or are not maintained parallel to each other, the walls of the anatomical structures may exert pull-out forces on the retaining members of the implantable medical device. Therefore, the intermediate section 130, formed according to various principles of this disclosure, is configured to move with the relative movement of the anatomical structures DS and PS into which the implantable medical device 100 is deployed. Such movement of the intermediate section 130 inhibits the transmission of such movement of the anatomical structures DS and PS to the retaining members 110, 120, thereby reducing the pull-out forces or other forces acting on the retaining members 110, 120 that could cause them to move away from their respective deployment sites. It will be understood that the ability of the intermediate section 130 to move with the relative movement of the anatomical structures DS and PS may be referred herein, additionally or alternatively, without intent to limit, as the ability to absorb, mitigate, dissipate, etc., the relative movement of the anatomical structures DS and PS.

[0037] In some embodiments, an implantable medical device 100 formed according to various principles of this disclosure has an intermediate section 130 having one or more features or properties distinct from the retaining members 110, 120. The distinct features or properties of the intermediate section 130 may extend along the entire length of the intermediate section 130, or may be limited to one or more sections / parts of the intermediate section 130. Such distinct features or properties may allow the intermediate section 130 to move without moving the retaining members 110, 120 due to the relative movement of the anatomical structure into which the implantable medical device 100 is deployed, and thus prevent the retaining members 110, 120 from falling out and / or moving. For convenience, and without intent to limit, one or more parts of the intermediate section 130 having features or properties distinct from those of the retaining members 110, 120 may be referred to as a dynamic section of the intermediate section 130. It will be understood that a reference to a dynamic section may refer to a single section or two or more sections of the intermediate section 130. Distinct features or properties may be differences in material properties and / or material composition and / or one or more structural properties. For example, the intermediate section 130 may be formed of a material that is more flexible than the material of the retaining members 110, 120. Alternatively, the intermediate section 130 and the retaining members 110, 120 may be formed of similar materials constructed to have different structural configurations that allow for different flexibility. Terms such as properties and features (and / or similar terms) may be used interchangeably herein without intent to limit (unless expressly indicated), and reference to one term shall not mean exclusion of the other term (unless expressly indicated). Similarly, terms such as distinct and different may be used interchangeably herein without intent to limit (unless expressly indicated), and reference to one term shall not mean exclusion of the other term.

[0038] Figure 2 shows an example of an embodiment of an implantable medical device 200 having an intermediate section 230 with a dynamic section configured to hold anatomical structures side by side and to move with the movement of the juxtaposed anatomical structures. The illustrated example of the embodiment has two retaining members 210, 220 with the intermediate section 230 between them. The retaining members 210 and 220 are shown as double-walled retaining members, each comprising distal tissue engagement surfaces 212t and 222t defined by their respective first walls 214t and 224t, outward-facing surfaces 212o and 222o defined by their respective second walls 214o and 224o, and circumferential surfaces 212p and 222p defined by their respective circumferential walls 214p and 224p (connecting their respective first walls 214t and 224t and second walls 214o and 224o). However, the distal tissue engagement surfaces 212t and 222t and the outward-facing surfaces 212o and 222o of the retaining members 210 and 220 may also be defined by the opposite side of a single wall of the retaining member 210 or 220, and the present disclosure is not limited in this respect. The intermediate section 230 has a dynamic section having properties / features separate from those of the retaining members 210, 220, allowing the movement of the juxtaposed non-adhesive anatomical structures DS and PS to affect the intermediate section 230 without affecting the retaining members 210, 220. For example, the retaining members 210, 220 are typically configured to be more resistant to bending than the dynamic section of the intermediate section 230, in order to hold the implantable medical device 200 in place relative to the deployment site. In contrast, at least the dynamic section of the intermediate section 230 is typically capable of bending, flexing, pivoting, or deforming in a manner that does not transmit force to the retaining members 210, 220, cause their deformation, or otherwise affect them.

[0039] In the embodiment shown in Figure 2, the retaining members 210, 220 are structurally separated, spaced apart from each other, and connected by a separate intermediate section 230, allowing the retaining members 210, 220 and the intermediate section 230 to have distinct / different properties / characteristics. The intermediate section 230 can be distinguished in various ways, such as being formed separately from the retaining members 210, 220, being processed to have properties different from those of the retaining members 210, 212, or being formed together with the retaining members 210, 220 (e.g., using a similar manufacturing process) but with modifications thereto (e.g., changes to its material).

[0040] The retaining members 210, 220 of an example embodiment of the implantable medical device 200 shown in Figure 2 may be formed from a plurality of strands that can be interconnected to form a self-supporting structure. It will be understood that terms such as strand may, without intent to limit, be used interchangeably with terms such as wire, filament, or ribbon. It will be further understood that terms such as interconnected, woven, interwoven, braided, twisted, entangled, knitted, looped (e.g., bobbin style), tied, reverse-wound, engaged with each other, or otherwise formed may, without intent to limit, be used interchangeably (optionally, in other grammatical forms) herein. Self-supporting structures may, without intent to limit, be referred to alternatively with terms such as stent, framework, scaffold, graft, etc. The filaments forming the retaining members 210, 220 may themselves be formed from metals such as stainless steel (preferably biocompatible) and / or alloys of nickel-titanium alloys (e.g., Nitinol), nickel-tungsten alloys or tungsten alloys, cobalt-chromium alloys, cobalt-chromium-nickel alloys (e.g., 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, platinum-enriched stainless steel, titanium, or similar materials, and may include combinations and partial combinations thereof, as well as other alloys.Additionally or alternatively, the filament may be made of polymer material (preferably biocompatible), such as polypropylene, polyester, nylon, polyethylene terephthalate (PET), polyether ether ketone (PEEK), poly(methyl methacrylate) (PMMA), polysulfone, polyurethane, polystyrene, polyethylene (PE) (including high-density and low-density PE), polyethylene naphthalate (PEN), polybutylene terephthalate (PBT), polytrimethylene terephthalate, polyether block amide (PEBA), polyetherimide (PEI), 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 copolymer (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers, polyamide, block polyamide / ether, polyimide). It may be formed from poly(PI), ethylene vinyl alcohol, ethylene vinyl acetate copolymer (EVA), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide), perfluoro(propyl vinyl ether) (PFA), polyolefin, epoxy, poly(styrene-b-isobutylene-b-styrene), polycarbonate, ionomer, or similar materials, and may include mixtures, combinations, partial combinations, and copolymers thereof. Additionally or alternatively, The filaments may be formed from bioabsorbable materials such as polyglycolic acid, lactic acid, poly(lactic acid-glycolic acid copolymer), caprolactone, polymers, polydioxanone, cat or bovine intestines, or similar materials, and / or natural fibers such as silk or cotton, or similar materials. The filaments may be formed from any mixture, composite, or co-construction of the above. Alternatively, the retaining members 210, 220 may be formed from laser-cut tubes, or joined elongated elements, or another self-supporting structure.In some embodiments, the material on which one or both of the retaining members 210, 220 are formed is a shape memory material or a thermoformable material.

[0041] In some embodiments, at least a portion of the wall of an implantable medical device formed according to various principles of this disclosure has gaps, holes, openings, voids, etc., through which it penetrates. The application of a coating material (such terms are used interchangeably herein without intent to limit) to or over at least a portion of an implantable medical device formed according to various principles of this disclosure can fill some or all of such gaps, holes, openings, voids, etc., thereby inhibiting or preventing the flow or leakage of material through them and / or inhibiting internal tissue growth therein. Additionally or alternatively, a liner may be provided along at least a portion of the implantable medical device. Such coatings or liners may be formed from any of a variety of polymer materials (preferably biocompatible and / or non-degradable upon exposure to bodily fluids such as bile), including silicone, rubber, polyethylene, PVDF, urethane, polyurethane, and other thermoplastic elastomers, and include mixtures, composites, combinations, partial combinations, copolymers, and / or co-constructs thereof.

[0042] The retaining members of the implantable medical device described above may be configured to resist various lateral and / or axial forces acting on the implantable medical device and the retaining members, while intermediate sections extending between the retaining members may be configured to flex, bend, pivot, or otherwise move with the movement of the anatomical structure, or to allow the movement of the anatomical structure. Such movement of the intermediate sections prevents the relative movement of the anatomical structure from being transmitted to the retaining members. For example, the pivoting of the walls of the anatomical structure relative to each other (movement such that the planes on which the walls of the anatomical structure are located intersect rather than are parallel to each other) will cause the intermediate sections to pivot, but will not cause a shift or other movement of the retaining members, or the transmission of excessive force to the retaining members. Thus, forces that could cause movement of the retaining members are suppressed or prevented from being transmitted to the retaining members.

[0043] To enable such movement, an intermediate section of an implantable medical device formed according to various principles of this disclosure may include a dynamic section, the dynamic section of which may be formed of a flexible material and / or a material formed to have a structure with greater flexibility than the end (e.g., retaining member) of the implantable medical device. Thus, the dynamic section of the intermediate section may have a different structure and / or material than the structure and / or material of the end / retaining member. For example, at least a portion of the intermediate section 230 of the implantable medical device 200 shown in Figure 2 includes a flexible cylinder, tube, sleeve, etc. (such terms and other grammatical forms are used interchangeably herein without intent to limit) that extends between the retaining members 210, 220 of the implantable medical device 200 and defines a dynamic section. The dynamic section in the example embodiment shown in Figure 2 may have substantially the same extent as the intermediate section 230 (i.e., substantially the entire length of the intermediate section 230 is formed to function as the dynamic section of the implantable medical device 100). The dynamic section of the implantable medical device 200 has features or characteristics that differ from the retaining members 210, 220 in one or more respects.

[0044] In an example of an embodiment of the implantable medical device 200 shown in Figure 2, the wall of the intermediate section 230 may be formed from a material that is more flexible than the material of the retaining members 210, 220. For example, the intermediate section 230 may be formed from a flexible material such as silicone, or other generally flexible and preferably biocompatible materials such as flexible polymer materials including but not limited to composite materials and / or copolymers thereof, such as polyethylene (PE), polyethylene terephthalate (PET), polypropylene (PP), nylon, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), ethylene fluoride propylene (FEP), polyurethane, polyvinyl chloride (PVC), polyether ether ketone (PEEK), polyether esters, polyamides and polyether block copolymers (e.g., PEBAX® elastomers), perfluoroalkoxy plastics (PFA), polyvinylidene fluoride (PVDF), thermoplastic resins and / or thermosetting resins, and composite materials and / or copolymers thereof. Such flexible materials can be used to form the walls of an implantable medical device 200 (e.g., at least a portion of the intermediate section 230) having desired flexibility, in contrast to structures configured to provide structural stability, such as the stent structure of the retaining members 210, 220 described above. In some embodiments, as described above, the retaining members 210, 220 may be formed from a combination of materials (e.g., the material forming the underlying stent structure, as described above, and a coating or liner having higher flexibility than the stent material), while the intermediate section 230 may simply be formed from a flexible material having higher flexibility than the stent material. That is, even if it is formed from the same material that forms the coating or liner of the retaining members 210, 220, the intermediate section 230 will lack the additional support structure present in the retaining members 210, 220. In some embodiments, the intermediate section 230 is formed from a substantially solid wall of flexible material (in contrast to, for example, a woven material that may have gaps along it).

[0045] In embodiments in which an implantable medical device is configured and deployed to form an anastomosis between juxtaposed anatomical structures, the intermediate section may be in the form of a generally cylindrical tube having a lumen defined through it. For example, in the embodiment of the implantable medical device 200 shown in Figure 2, the lumen 235 defined through the intermediate section 230, together with the lumens 215 and 225 defined through the retaining members 210 and 220 respectively, defines the lumen 205 through the implantable medical device 200, forming an anastomosis between the juxtaposed anatomical structures PS and DS. According to various principles of the present invention, the intermediate section 230 may be made of a flexible material while maintaining the lumen 235 through the intermediate section 230 in an open configuration. For example, reinforcing structures such as braided layers, circumferential or helical reinforcements, and / or ribbed or corrugated sections can be included within or along the walls of the intermediate section 230 to provide hoop strength, radial force, and / or other resistance to crushing and closure of the lumen 235 passing through the intermediate section 230. The retaining members 210, 220 are typically configured to maintain an open configuration for the lumens 215, 225 passing through them, thereby maintaining an open configuration for the lumen 205 passing through the implantable medical device 200 together with the intermediate section 230.

[0046] An intermediate section 230, formed separately from the retaining members 210, 220 of an implantable medical device 200 formed according to various principles of this disclosure, is nevertheless coupled to the retaining members 210, 220. The intermediate section 230 may be fixed to the retaining members 210, 220 so as to hold the retaining members 210, 220 in a predetermined position relative to the deployment site. Furthermore, the intermediate section 230 should be fixed to the retaining members 210, 220 so as not to detach from them during use in the patient's body. Thus, in any desired manner to maintain the connection thereto for the duration of the residence time or lifespan (i.e., “lifetime”) of the implantable medical device 200, the distal end 231 of the intermediate section 230 may be fixed to the distal retaining member 210, and the proximal end 233 of the intermediate section 230 may be fixed to the proximal retaining member 220. For example, the intermediate section 230 may be formed separately from the retaining members 210, 220 and then securely bonded to them. More specifically, the intermediate section 230 may be formed by dipping, painting, spraying, or otherwise coating and / or covering a mandrel, such as a Teflon®-coated mandrel, with a polymer material that forms the walls of the intermediate section 230. The polymer material is usually in a liquefied form during the formation of the intermediate section 230 (e.g., during application to the mandrel or mold or other element that forms the final shape of the finished intermediate section 230), allowing it to cool, cure, solidify, crosslink, or otherwise form the walls of the finished intermediate section 230. Each end of the intermediate section 230 thus formed can be fixed to the retaining members 210, 220 (e.g., by joining, bonding, stitching, weaving, attaching, etc.) by using a suitable glue, adhesive, resin, or other bonding technique. The material on which the intermediate section 230 is formed may be readily bondable to one or more materials forming the retaining members 210, 220.For example, if one or both of the retaining members 210, 220 have a coating or liner as described above, the material of the intermediate section 230 can be readily bonded with the material of such coating or liner on the retaining members 210, 220, especially if it is formed of the same material. The material forming the intermediate section 230 may be used to form the coating or liner provided to the retaining members 210, 220. Optionally, such material may be applied to the retaining members 210, 220 during the formation of the intermediate section 230, thereby bonding such sections of the implantable medical device 200. The intermediate section 230 can be formed according to various principles of this disclosure using various techniques available to those skilled in the art, and this disclosure is not limited in this respect.

[0047] In some embodiments, the retaining members 210, 220 are structurally configured to facilitate joining of the ends 231, 233 of the intermediate section 230 to the retaining members 210, 220. For example, the retaining members 210, 220 may include flanges, shoulders, or other structures formed to facilitate joining or securing the intermediate section 230 to them. In the example embodiment of the implantable medical device 200 shown in Figure 2, the retaining members 210, 220 have respective extensions 216, 226 extending toward the intermediate section 230 of the implantable medical device 200. More specifically, the distal retaining member 210 has an extension 216 extending toward the proximal retaining member 220 from the tissue engagement surface 212t of the distal retaining member 210. Similarly, the proximal retaining member 220 has an extension 226 extending toward the distal retaining member 210 from the tissue engagement surface 222t of the proximal retaining member 220. The extensions 216,226 are sized, formed, configured, and / or dimensioned to facilitate coupling with the ends 231,233 of the intermediate section 230. For example, one or both of the extensions 216,226 may be substantially cylindrical with a diameter selected so that the ends 231,233 of the intermediate section 230 can be fitted onto or inside the extensions 216,226 and then secured thereto. It will be understood that the joint between the intermediate section 230 and the retaining members 210,220 may be formed and / or have selected finish features or properties considering how the implantable medical device 200 will be used (e.g., based on the deployment site, tensile or pull-out forces expected to affect the implantable medical device 200, etc.). It should be noted that the extensions 216, 226 may be structurally similar to the extensions 118, 128, 218, 228 (extending away from the intermediate sections 130, 230) that extend outward from any of the retaining members 110, 120, 210, 220 in examples of embodiments of implantable medical devices 100, 200.Any or all of such extensions 116, 118, 216, 218, 216, 228 can facilitate the finishing of the woven material (e.g., providing easier access to the ends of the woven filaments to weld or otherwise treat the filaments to prevent fraying), the operation of the associated implantable medical devices 100, 200 (e.g., delivery and / or withdrawal), and so on.

[0048] Alternatively, the intermediate section of an implantable medical device formed according to various principles of this disclosure may be formed of woven or otherwise interwoven filaments rather than a layer of generally solid material (e.g., a silicone wall). The weave pattern and / or weave pitch or other structural properties of the intermediate section may be adjusted as desired or as necessary to achieve a certain degree of flexibility relative to the retaining members. Figure 3 shows an example embodiment of an implantable medical device 300 comprising retaining members 310, 320, in which at least a portion of the intermediate section 330 is formed of woven or interwoven material. The retaining members 310 and 320 are shown as double-wall retaining members in which the first walls 314t and 324t and the second walls 314o and 324o are connected by circumferential walls 314p and 324p, respectively, defining distal tissue engagement surfaces 312t and 322t, proximal tissue engagement surfaces 312t and 322t, and circumferential surfaces 312p and 322p, respectively. However, the retaining members 310 and 320 may simply be single-wall retaining members, and it should be noted that this disclosure is not limited thereto. Furthermore, outwardly extending portions 318 and 328 are optional. The woven portion 334 of the intermediate section 330 of the implantable medical device 300 may have similar or different flexibility (or resistance to bending) to the retaining members 310 and 320. In such embodiments, the dynamic section of the intermediate section 330 may be formed, provided, or at least reinforced by a flexible connecting region 336 that connects the distal end 337 of the woven portion 334 of the intermediate section 330 to the distal retaining member 310 and the proximal end 339 of the woven portion 334 of the intermediate section 330 to the proximal retaining member 320. The connecting region 336 is configured to be sufficiently flexible so that forces applied to the intermediate section 330 are absorbed or dissipated or otherwise transmitted to the retaining members 310, 320. In the example embodiment of the implantable medical device 300 shown in Figure 3, the connecting region 336 is or includes a suture 338. However, other configurations of the connecting region 336 are also included in the scope and spirit of this disclosure.Figure 4 shows, for example, an example embodiment of an implantable medical device 400 similar to the implantable medical device 300 in Figure 3, without sutures (as in the implantable medical device 300 in Figure 3) connecting the woven portion 434 of its intermediate section 430 to its respective retaining members 410, 420. Other features and elements of the implantable medical device 400 shown in Figure 4 are similar to those of the implantable medical device 300 shown in Figure 3, and are labeled with the same reference letters with 100 added to the numerical part, and for the sake of brevity, it will be understood that the description relating to the implantable medical device 300 is to be referred to without the intention of being limiting. In some embodiments, the distal end 331 and proximal end 333 of the intermediate section 330 are not directly connected to the retaining members 310, 320, thereby further distinguishing the characteristics or features of these sections of the implantable medical device 300 from one another.

[0049] In the example of the embodiment of the implantable medical device 300 shown in Figure 3, the intermediate section 330 includes a sleeve or liner 332, which may be similar to the intermediate section 230 of the implantable medical device 200 in Figure 2, or similar to other liners in the saddle region of a stent known to those skilled in the art. The liner 332 may extend along the entire length of the intermediate section 330, or it may extend to less than the entire length of the intermediate section 330. The liner 332 may extend at least along the ends 331, 333 of the intermediate section 330. The liner 332 may extend across the gap between the ends 337, 339 of the woven portion 334 of the intermediate section 330 and the retaining members 310, 320 of the implantable medical device 300, thereby connecting the intermediate section 330 to the retaining members 310, 320. Additionally or alternatively, the liner 332 may form one or more dynamic sections of the connection region 336 and / or the intermediate section 330 of the implantable medical device 300, or at least partially. In embodiments in which the liner 332 forms one or more dynamic sections of the intermediate section 330 of the implantable medical device 300, the liner 332 has sufficient flexibility to allow the aforementioned bending, pivoting, etc., of the intermediate section 330 without dislodging or otherwise affecting the retaining members 310, 320. The liner 332 can maintain axial flow through the implantable medical device 300 (and suppress lateral flow through the walls of the implantable medical device 300) by extending across gaps or discontinuities between the ends 337, 339 of the woven portion 334 of the intermediate section 330 and the retaining members 310, 320. Similar to the intermediate section 230 of the example embodiment of the implantable medical device 300 shown in Figure 2, the ends 331, 333 of the intermediate section 330 of the example embodiment of the implantable medical device 200 shown in Figure 3 may be coupled to extensions 316, 326 similar to the extensions 216, 226 described above. For brevity, the above description of the extensions 216, 226 of the example embodiment shown in Figure 2 is referred to as applicable to the extensions 316, 326 of the example embodiment shown in Figure 3.

[0050] In consideration of the foregoing, it should be understood that the various embodiments shown in the figures have several distinct and independent features, each of which, at least individually, has a specific advantage that is desirable but not essential for the implantable medical device of this disclosure. Therefore, not all of the various distinct features described herein are necessary to achieve at least some of the desired properties and / or advantages described herein. Only one of the various features may be present in an implantable medical device formed according to the various principles of this disclosure. Alternatively, one or more of the features described with reference to one embodiment may be combined with one or more of the features of any other embodiment provided herein. That is, any of the features described herein can be mixed and harmonized to create a hybrid design, and such hybrid design is within the scope of this disclosure. Furthermore, throughout this disclosure, reference numbers are used to indicate a comprehensive element or feature of the disclosed embodiment. The same reference number may be used to indicate an element or feature that is not identical in form, shape, structure, etc., but provides similar functionality or advantages. Additional reference codes (such as letters instead of numbers) may be used to distinguish similar elements or features from one another.

[0051] Embodiments of the present disclosure may be described herein with specific reference to medical devices and systems and procedures for treating the gastrointestinal system, but it should be understood that such medical devices, systems, and methods may be used to treat anatomical structures such as the abdominal cavity, digestive system, urinary tract, reproductive tract, respiratory system, cardiovascular system, and circulatory system. For example, the anatomical structures into which the implantable medical devices of the present disclosure are deployed may be organs, cysts, pseudocysts, muscles, lumens, channels, blood vessels, passages, anatomical walls, etc., which are separate or detached from each other and / or independent of each other, whether they are different parts of the same anatomical structure or different anatomical structures. It will be further understood that the present disclosure is not limited to use between specific anatomical structures and / or use for holding anatomical structures. For convenience, and without intent to limit, it may be mentioned to hold tissue walls side by side, but it should be understood that this is merely one example of the anatomical structures to which the principles of the present disclosure are applicable and their associations. Furthermore, for convenience and without intent to limit, non-adhesive anatomical structures will be referred to herein. In addition to those stated above, various further advantages of various embodiments, features, components, and structures of implantable medical devices as described herein will be understood by those skilled in the art.

[0052] It should be understood by those skilled in the art that this description is merely an example of exemplary embodiments and is not intended to limit broader aspects of the disclosure. All devices and methods described herein are examples of devices and / or methods implemented in accordance with one or more principles of the disclosure. These examples are merely examples and not the only ways of implementing these principles, and are not intended to limit broader aspects of the disclosure. Accordingly, references to elements, structures or features in the drawings should be recognized as references to examples of embodiments of the disclosure and should not be understood as limiting the disclosure to specific elements, structures or features illustrated. Other examples of ways of implementing the disclosed principles will be recalled by those skilled in the art who have read this disclosure. It will be apparent to those skilled in the art that variations may be applied to the disclosed devices, systems and / or methods and / or sequences of steps of methods described herein without departing from the concepts, spirit and scope of the disclosure. It will be understood that various features described in relation to one embodiment may typically be applied to another embodiment, whether expressly indicated or not. The various features described below may be used individually or in any combination thereof. Accordingly, the present invention is not limited to the embodiments specifically described herein, and all alternatives and modifications that are obvious to those skilled in the art are deemed to be within the spirit, scope, and concept of this disclosure as defined by the appended claims.

[0053] The foregoing description is broadly applicable and presented for illustrative and explanatory purposes, and is not intended to limit this disclosure to one or more 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, proportions, and using other elements, materials, and components without departing from the concepts, spirit, or scope or characteristics thereof. For example, various features of this disclosure are 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 with respect to embodiments, it should be understood that various distinct features of the subject matter do not all need to be present to achieve at least some of the desired characteristics and / or advantages of the subject matter or such individual features. Those skilled in the art will understand that this disclosure can be used with numerous modifications, or modifications to the structure, arrangement, proportions, materials, components, etc., 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, an element shown as being formed as a whole may consist of multiple parts, or an element shown as multiple parts may be formed as a whole, the operation of an element may be reversed or modified, and the size or dimensions of an element may be modified. Similarly, while an operation or action or procedure is described in a particular order, this should not be understood as requiring such a particular order to achieve a desired result, or as meaning that all operations or actions or procedures should be performed. In addition, other forms of implementation are within the scope of the following claims. In some cases, the operations described in the claims may be performed in a different order, and the desired result may still be achieved.Accordingly, the embodiments disclosed herein should be considered in all respects as illustrative and not limiting, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the foregoing description or any specific embodiment or configuration described or illustrated herein. In consideration of the foregoing, individual features of any embodiment may be used and may be claimed separately or in combination with features of that embodiment or any other embodiment, and the scope of the subject matter is indicated by the appended claims and is not limited to the foregoing description.

[0054] In the foregoing description and the following claims, it will be understood that: As used herein, the terms “at least one,” “one or more,” and “and / or” are open-ended expressions that function both conjunctively and disjunctly. Terms such as “a,” “an,” “the,” “first,” and “second” do not exclude plurals. For example, the term “a” or “an” entity, as used herein, refers to one or more of those entities. Thus, the terms “a” (or “an”), “one or more,” and “at least one” can be used interchangeably herein. As used herein and in the appended claims, the term “or” is generally used to include “and / or” unless the content clearly indicates otherwise. Where used herein, the conjunction "and" includes each of the structures, components, features, etc. that are thus connected, unless the context clearly indicates otherwise, and the conjunction "or" includes one or more of the structures, components, features, etc. that are thus connected, individually and in any combination and number, unless the context clearly indicates otherwise. All directional references (e.g., proximal, distal, top, bottom, upward, downward, left, right, lateral, longitudinal, front, rear, 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 serve to distinguish areas of related elements from one another, and do not limit the elements that are relevant in particular with respect to the location, orientation or use of this disclosure. References to connections (e.g., attached, joined, connected, engaged, and linked) should be interpreted broadly and, unless otherwise indicated, may include intermediate members between sets of elements and relative movement between elements. Therefore, references to connections do not necessarily imply that the two elements are directly connected and have a fixed relationship with one another.Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority, but are used to distinguish one feature from another.

[0055] The following claims are incorporated by reference into this detailed description, and each claim stands independently as a distinct embodiment of the present disclosure. In the claims, the terms “equipped,” “equipped,” “included,” and “included” do not exclude the existence of other elements, components, features, groups, areas, integers, steps, operations, etc. In addition, 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 not feasible and / or advantageous. In addition, singular references do not exclude plurals. Reference numerals in the claims are provided merely as examples for clarity and should never be construed as limiting the claims.

Claims

1. An implantable medical device for implantation into a first anatomical structure and a second anatomical structure, The first end and, The second end and An intermediate section defined between the first end and the second end, At least one dynamic section along at least a portion of the aforementioned intermediate section and Equipped with, The first end and the second end, together with the intermediate section extending through the first and second anatomical structures, are configured to hold the first and second anatomical structures side by side. The first end of the implantable medical device is configured to be fixed to the first anatomical structure, The second end of the implantable medical device is configured to be fixed to the second anatomical structure, The intermediate section is configured to hold the first anatomical structure and the second anatomical structure side by side, together with the first end of the implantable medical device fixed to the first anatomical structure and the second end of the implantable medical device fixed to the second anatomical structure. An implantable medical device wherein the at least one dynamic section is configured to allow the first end of the implantable medical device to move relative to the second end of the implantable medical device.

2. At least the first and second ends of the implantable medical device are formed of interconnected filaments, The implantable medical device according to claim 1, wherein the at least one dynamic section has a structure different from the structure of the interconnected filaments at the first end and the second end.

3. The implantable medical device according to claim 1 or 2, wherein the at least one dynamic section is formed of a substantially solid polymer wall.

4. The implantable medical device according to any one of claims 1 to 3, wherein the at least one dynamic section has substantially the same extent as the portion of the intermediate section that does not have the at least one dynamic section.

5. The aforementioned intermediate section includes sections formed by interconnected filaments, The implantable medical device according to any one of claims 2 to 4, wherein the at least one dynamic section includes a first dynamic section that connects a first end of the section of interconnected filaments of the intermediate section to the first end of the implantable medical device, and a second dynamic section that connects a second end of the section of interconnected filaments of the intermediate section to the second end of the implantable medical device.

6. The first retaining member extends radially outward along the first end of the implantable medical device, The second retaining member extends radially outward along the second end of the implantable medical device, The first retaining member and the second retaining member are formed from filaments interconnected in a first pattern. The implantable medical device according to any one of claims 1 to 5, wherein at least a portion of the intermediate section is formed from filaments interconnected in a second pattern different from the first pattern.

7. The implantable medical device according to claim 6, wherein the second pattern imparts to the intermediate section a degree of flexibility different from that imparted to the first retaining member and the second retaining member by the first pattern.

8. The implantable medical device according to claim 6 or 7, wherein the at least one dynamic section comprises a first dynamic section that connects a first end of the portion of the intermediate section formed from interconnected filaments to a first retaining member, and a second dynamic section that connects a second end of the portion of the intermediate section formed from interconnected filaments to a second retaining member.

9. An implantable medical device according to any one of claims 1 to 8, wherein a lumen is defined through the implantable medical device to form an anastomosis between juxtaposed anatomical structures.

10. The implantable medical device according to any one of claims 1 to 9, wherein the at least one dynamic section is reinforced to maintain the lumen through the implantable medical device in an open configuration.

11. The implantable medical device according to any one of claims 1 to 10, wherein the at least one intermediate section comprises two or more dynamic sections.

12. The implantable medical device is transitionable from a delivery configuration to an extended deployment configuration. The first end of the implantable medical device extends to define a first retaining member that extends radially outward when the implantable medical device transitions to the deployed configuration. The second end of the implantable medical device extends to define a second retaining member that extends radially outward when the implantable medical device transitions to the deployed configuration. The first end of the intermediate section is connected to the first retaining member. The implantable medical device according to any one of claims 1 to 11, wherein the second end of the intermediate section is coupled to the second retaining member.

13. The implantable medical device according to any one of claims 1 to 12, wherein the intermediate section is sized, formed, configured, and / or dimensions set to hold adjacent non-adhesive anatomical structures juxtaposed.

14. An implantable medical device configured to hold a first anatomical structure and a second anatomical structure side by side, wherein the implantable medical device has a first end and a second end, with an intermediate section extending between the first end and the second end, and the implantable medical device is A first retaining member, sized, formed, configured, and / or dimensioned to secure the first end of the implantable medical device to the first anatomical structure, A second retaining member, sized, formed, configured, and / or dimensioned to secure the second end of the implantable medical device to the first anatomical structure, A dynamic section defined along the intermediate section, which allows the intermediate section to move relative to the first retaining member and the second retaining member. An implantable medical device equipped with the following features.

15. The first retaining member and the second retaining member are formed from interconnected filaments, The implantable medical device according to claim 14, wherein the dynamic section has a structure different from the structure of the interconnected filaments of the first retaining member and the second retaining member.

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