Apparatus, system, and method for implantable medical devices

Abstract

Disclosed is an implantable medical device system having at least two implantable medical devices coupled together by a connector while implanted in a common anatomical region. The connector allows the implantable medical devices to be secured in place relative to one another at their respective deployment sites. Additionally, the connector may function as a safety device by allowing one implantable medical device to move upon migration of another implantable medical device. For example, if migration of an implantable medical device causes a structural change in the common anatomical region, such a change may be generally reversible upon migration of the other implantable medical device as a result of the implantable medical devices being coupled via the connector.

Description

[Technical Field]

[0001] The present disclosure relates generally to the field of implantable medical devices. More specifically, the present disclosure relates to devices, systems, and methods for addressing forces that may cause migration of an implantable device. Even more specifically, the present disclosure relates to devices, systems, and methods for preventing migration of an implantable medical device and / or providing a safety mechanism during migration of an implantable medical device. [Background technology]

[0002] Various implantable medical devices are known that extend across anatomical structures for various purposes. For example, various stents can be used to hold tissues in apposition and / or to affect (e.g., establish or occlude) a connection (e.g., fluid communication) between anatomical structures, such as organs, cavities, lumen, passageways, etc. In some instances, it is desirable to create a semi-permanent or permanent anastomosis with an implantable medical device to allow fluid flow or drainage from one anatomical structure to another. Additionally or alternatively, in some instances, it is desirable to occlude or partially occlude a bodily passageway with an implantable medical device. In various procedures, lumen-apposing stents can be used to form anastomoses between anatomical structures and / or to affect the flow of matter through a bodily passageway. For example, in gastrointestinal (GI) procedures such as bypass surgery, lumen-apposing stents are used to create a gastrojejunostomy between the stomach and jejunum to facilitate the flow of food particles, liquids, chyme, etc. (generally, "gastric material") from the stomach to the lower GI tract. Additionally, such procedures generally involve bypassing the pylorus and duodenum (e.g., the first approximately 1.5 meters of the small intestine, where most food, fat, and nutrients are digested) by deploying another device across the pylorus and occluding flow therethrough. Thus, gastric material is blocked or prevented from passing into (and being digested in) the duodenum and redirected to the anastomosis between the stomach and jejunum, bypassing the duodenum. Such endoscopic bypass procedures are considered less invasive than traditional Roux-en-Y surgical bypass procedures and may be reversible. The first implantable medical device may help maintain the patency of the anastomosis. Therefore, it may be desirable for at least the first stent to remain securely in place until removal is desired or medically indicated. Furthermore, it may be desirable to maintain a second implantable medical device in place to maintain the redirected flow of gastric material to the jejunum rather than the duodenum. Additionally, if the first implantable medical device is removed and the anastomosis is closed, it may be important to provide an alternate route for gastric material to pass through the pylorus or the like into the intestine.Thus, there is a continuing need for improvements in implantable medical devices, systems, and methods to maintain them in place and / or address any displacement thereof. Summary of the Invention

[0003] This Summary is provided to introduce a selection of concepts in a simplified form that are described in more detail below in the Detailed Description. This Summary is not necessarily intended to identify key features or essential features of the claimed subject matter, nor is it intended to 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 described in this Summary or not, can be advantageously used separately in some instances and in combination with other aspects and features of the disclosure in other instances. No limitation on the scope of the claimed subject matter is intended by either the inclusion or non-inclusion of elements, components, etc. in this Summary.

[0004] According to various principles of the present disclosure, a system for forming a gastric bypass in a patient includes a first implantable medical device configured to form an anastomosis between the patient's stomach and a portion of the jejunum, a second implantable medical device configured to occlude the patient's pylorus, and a connector coupling the first implantable medical device and the second implantable medical device.

[0005] In some aspects, the connector has a configuration that differs from the configurations of the first implantable medical device and the second implantable medical device. In some embodiments, the connector is elongated and has a length that can extend from the first implantable medical device when implanted to create an anastomosis between the stomach and the jejunum, and can extend from the second implantable medical device when implanted across the pylorus.

[0006] In some embodiments, the first implantable medical device is a stent configured to maintain patency of the anastomosis, the stent comprising: a saddle region configured to extend through a portion of the stomach wall and the jejunum wall; a proximal retention member extending radially outward from the proximal end of the saddle region and configured to seat within the stomach and prevent distal migration of the first implantable medical device away from the stomach; and a distal retention member extending radially outward from the distal end of the saddle region and configured to seat within the jejunum and prevent proximal migration of the first implantable medical device into the stomach. In some embodiments, the second implantable medical device comprises a saddle region configured to occlude the flow of matter therethrough; a proximal retention member extending radially outward from the proximal end of the saddle region and configured to seat within the stomach and prevent the second implantable medical device from migrating distally away from the stomach; and a distal retention member extending radially outward from the distal end of the saddle region and configured to seat within the patient's duodenum and prevent the second implantable medical device from migrating proximally into the stomach.

[0007] In some embodiments, the connector is an elongate element that couples the first implantable medical device and the second implantable medical device, hi some embodiments, the connector is coupled to a proximal retention member of at least one of the first implantable medical device and the second implantable medical device.

[0008] In some embodiments, the connector includes an elongated portion having a first end and a second end, and a connector bar coupled to one of the first end or the second end of the elongated portion and movable between a first position extending along the elongated portion and a second position across the elongated portion, wherein when in the first position, the connector bar is extendable through a portion of a wall of one of the first implantable medical device or the second implantable medical device and is movable to the second position to hold one of the first end or the second end of the elongated portion coupled to the portion of the wall of the one of the first implantable medical device or the second implantable medical device.

[0009] In some embodiments, one of the first implantable medical device or the second implantable medical device has at least one double-walled retaining member having an inner wall adjacent the saddle region and an outer wall spaced from the inner wall, defining a space between the inner and outer walls, and the connector bar is extendable within the space between the inner and outer walls of the double-walled retaining member and movable to a second position so as to be retained within the space.

[0010] In some embodiments, the connector is formed separately from the first implantable medical device and the second implantable medical device. In some embodiments, the first implantable medical device secures the second implantable medical device via the connector to prevent it from migrating distally from the stomach, and the second implantable medical device secures the first implantable medical device via the connector to prevent it from migrating distally from the stomach.

[0011] In some embodiments, the first implantable medical device displaces the second implantable medical device as it moves from the anastomosis to open the pylorus to allow gastric material to pass. In accordance with various principles of the present disclosure, a system is provided for maintaining a pair of implantable medical devices in position relative to respective deployment sites of the pair of implantable medical devices. The system includes a first implantable medical device, a second implantable medical device, and a connector coupling the first and second implantable medical devices. In some aspects, the deployment site is in an anatomical environment that tends to separate the first and second implantable medical devices from each other, and each implantable medical device holds the other implantable medical device in position via the connector.

[0012] In some embodiments, the connector has a configuration that differs from the configurations of the first implantable medical device and the second implantable medical device. In some embodiments, the connector is elongated and has a length sufficient to extend between the first implantable medical device and the second implantable medical device when the first implantable medical device and the second implantable medical device are coupled together without exerting force on either the first implantable medical device or the second implantable medical device.

[0013] In some embodiments, the connector is formed separately from the first implantable medical device and the second implantable medical device. In some embodiments, the connector includes an elongated portion having a first end and a second end, and a connector bar coupled to one of the first end or the second end of the elongated portion and movable between a first position extending along the elongated portion and a second position across the elongated portion, wherein when in the first position, the connector bar is extendable through a portion of a wall of one of the first implantable medical device or the second implantable medical device and is movable to the second position to hold one of the first end or the second end of the elongated portion coupled to the portion of the wall of the one of the first implantable medical device or the second implantable medical device.

[0014] In accordance with various principles of the present disclosure, a method for forming a gastric bypass includes implanting a first implantable medical device across an apposed portion of the stomach wall and a portion of the jejunum to form an anastomosis between the stomach and the jejunum, implanting a second implantable medical device in the pylorus to at least partially obstruct the pylorus, and connecting the first and second implantable medical devices with an elongated connector.

[0015] In some embodiments, the method further comprises implanting a first implantable medical device on a first date and implanting a second implantable medical device on a second date that is different from the first date. In some embodiments, the step of coupling the first implantable medical device and the second implantable medical device with the elongate connector occurs after implantation of the first implantable medical device and the second implantable medical device.

[0016] In some embodiments, the method further includes securing a second implantable medical device via the connector and the first implantable medical device to prevent it from migrating distally from the stomach, and securing the first implantable medical device via the connector and the first implantable medical device to prevent it from migrating distally from the stomach.

[0017] In some embodiments, the method further includes coupling a connector between the first implantable medical device and the second implantable medical device such that when the first implantable medical device moves from the anastomosis, the second implantable medical device is displaced to open the pylorus and allow gastric material to pass through.

[0018] These and other features and advantages of the present disclosure will become readily apparent from the following detailed description, and the scope of the claimed invention is set forth in the appended claims. While the following disclosure is presented in terms of aspects or embodiments, it should be understood that each aspect may be claimed separately or in combination with aspects and features of that or any other embodiment.

[0019] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The accompanying drawings are provided for illustrative purposes only, and the dimensions, positions, order, and relative sizes reflected in the drawing figures may be changed. For example, devices may be enlarged so that details are discernible, but are intended to be reduced in size with respect to fitting within, for example, a delivery catheter or working channel of an endoscope. For purposes of clarity and conciseness, not every element is labeled in every figure, and not every element of each embodiment is shown unless illustration is necessary to enable those skilled in the art to understand the disclosure.

[0020] The detailed description will be better understood in conjunction with the accompanying drawings, in which like reference characters represent like elements, as follows: [Brief explanation of the drawings]

[0021] [Figure 1] 1 is a perspective view of an embodiment of an implantable medical device system formed in accordance with various aspects of the present disclosure and shown above a schematic representation of a gastrointestinal environment. [Figure 2] 1 is a perspective view of an example embodiment of a connector of an implantable medical device system formed in accordance with various principles of the present disclosure. [Figure 3] 3 is a perspective view of a portion of a connector such as that shown in FIG. 2 engaged with an example embodiment of an implantable medical device that may be used in a system such as that shown in FIG. 1. DETAILED DESCRIPTION OF THE INVENTION

[0022] The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. It should be understood that the disclosure is not limited to the particular embodiments described and, as such, may vary. All devices, systems, and methods discussed 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 embodiment is provided for illustrative purposes and is merely an example, not the only way, to implement these principles. Thus, references to elements or structures or features in the drawings should be recognized as references to example embodiments of the present disclosure and should not be understood as limiting the disclosure to the particular elements, structures, or features shown. 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 variations can be made in the present disclosure without departing from the scope or spirit of the present subject matter. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield still further embodiments. Accordingly, the present subject matter is intended to cover such modifications and variations as come within the scope of the appended claims and their equivalents.

[0023] It will be understood that the present disclosure is described in various levels of detail in this application. In some instances, details that are not necessary for those skilled in the art to understand the present disclosure or that would make other details difficult to understand may be omitted. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, technical terms used herein should be understood as commonly understood by one of ordinary skill in the art to which the present disclosure belongs. All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure.

[0024] As used herein, "proximal" refers to a direction or location closest to a user (e.g., a medical professional or clinician or technician or operator or physician, such terms are used interchangeably herein without limitation and include an automated controller system or otherwise) and / or closest to a delivery device, such as when using the device (e.g., when introducing the device into a patient or during implantation, positioning, or delivery), and "distal" refers to a direction or location furthest from a user and / or closest to a delivery device, such as when using the device (e.g., when introducing the device into a patient or during implantation, positioning, or delivery). "Longitudinal" means extending along the longer or greater dimension of an element. A "longitudinal axis" extends along the longitudinal extent of an element, but is not necessarily straight, and does not necessarily maintain a fixed configuration when the element flexes or bends, and "axial" refers generally along the longitudinal axis. However, it will be understood that references to axial or longitudinal movement with respect to the above-described systems or elements thereof need not be strictly limited to axial and / or longitudinal movement along the longitudinal or central axis of the referenced elements. "Center" means at least approximately bisecting the center point and / or being approximately equidistant from the periphery or boundary, and "central axis," with respect to an opening, means a line at least approximately bisecting the center point of the opening and extending longitudinally along the length of the opening when the opening comprises, for example, a tubular element, strut, channel, cavity, or hole. As used herein, "lumen" or "channel" or "hole" or "passage" is not limited to a circular cross-section. As used herein, a "free end" of an element is a terminus beyond which such element does not extend. It will be understood that terms such as at, on, adjacent to, or along can be used interchangeably herein without limitation, unless otherwise stated, and are intended to indicate generally relative spatial relationships, rather than precisely defined locations.Finally, a reference to "at" a location or site is intended to include at such location or site and / or near such location or site (e.g., along, adjacent to, etc.).

[0025] Various medical procedures involve the deployment of two or more implantable medical devices within an anatomical region, such as a common anatomical region. It will be understood that reference to a common anatomical region can include a common organ, cavity, body passageway, etc., as well as adjacent organs, cavities, body passageways, etc. An implantable medical device may be subjected to various biological forces, such as internal (e.g., peristalsis, blood flow, other fluid flow, etc.) or external (e.g., external body movements affecting internal organs) movements. It is generally desirable to maintain the position of an implantable medical device at the site where it is deployed. It will be understood that terms such as deployed, implanted, and anchored may be referred to interchangeably and without limitation herein, including their various grammatical forms. For example, reference may be made interchangeably to a deployment site, an implantation site, etc., without limitation. Two or more implantable medical devices implanted in an anatomical region may be subjected to the same force, for example, in generally the same direction relative to the anatomical region. For example, implantable medical devices may be subjected to similar forces that move the implantable medical devices out of the anatomical region in which they are deployed. Such movement may also cause the devices to move away from one another.

[0026] According to various principles of the present disclosure, two or more implantable medical devices are implanted in a common anatomical region, spaced apart from one another but coupled to one another. More specifically, in some embodiments, the implantable medical devices are separately formed and / or implanted independently, and the connection between them is achieved by a structure, such as a connector, that is separate or distinguishable from the implantable medical devices. For example, one or more of the implantable medical devices may be a therapeutic device having a structure that interacts with the anatomical region, and the connector may simply serve to connect the implantable medical devices without affecting the anatomical region. More specifically, the implantable medical devices may be medical devices having a structure that facilitates a particular therapeutic process or treatment or procedure (such terms and other terms are used interchangeably herein without limitation), and the connector may be a simple elongated element configured to connect the implantable medical devices together. In some embodiments, the connector may be an elongated element that is structurally distinct from the implantable medical devices. The connector may be a tether, wire, suture, cord, band, etc., without limitation other than its ability to maintain a connection between implantable medical devices.

[0027] In some embodiments, separately formed connectors (e.g., not integrally formed sections or portions of any of the implantable medical devices) may be used to couple the implantable medical devices together in accordance with various principles of the present disclosure. For example, separately formed connectors may be engaged with the implantable medical devices to couple the implantable medical devices together. However, given the different structures and functions of the implantable medical devices and connectors, in some embodiments, the connectors may be formed as an extension of (e.g., integrally formed with) at least one of the implantable medical devices, but have a unique configuration (e.g., elongated) that is distinct and / or different from the general shape and configuration of the implantable medical devices. It will be understood that, in accordance with various principles of the present disclosure, the implantable medical devices may be connected after at least one of the implantable medical devices has been implanted, after all of the implantable medical devices have been implanted, or may be coupled to one or more of the implantable medical devices prior to deployment.

[0028] In some instances, forces from a common anatomical region in which the implantable medical devices are implanted may tend to dislodge one or both of the implantable medical devices. An implantable medical device system including two or more implantable medical devices and a connector provides an anti-migration and / or safety system for the implantable medical devices. For simplicity and without limitation, the following reference will be made to two implantable medical devices. An implantable medical device system formed according to various principles of the present disclosure includes implantable medical devices implanted in a common anatomical region and connected to one another by a connector, where one of the implantable medical devices can secure the other of the implantable medical devices against forces tending to dislodge the other of the implantable medical devices from its deployment site. In such use, one of the implantable medical devices may be implanted in a position and / or formed in a manner that promotes stronger retention relative to the implantation site than can be achieved by the other of the implantable medical devices. Additionally or alternatively, the other of the implantable medical devices may be implanted in a position that is more prone to allowing its migration. Of course, it will be understood that the tendency to move may simply be situational, such as based on the nature of a particular force that impacts one of the implantable medical devices more strongly than another.

[0029] Additionally or alternatively, movement of one of the implantable medical devices may necessitate displacement of the other of the implantable medical devices, thereby moving one of the implantable medical devices in a manner that safely releases the other. For example, one of the implantable medical devices can move in a direction relative to the anatomical region, pulling the other of the implantable medical devices with it. More specifically, the implantable medical devices may be implanted in a common anatomical region, and one of the implantable medical devices can move out of the anatomical region, first pulling the other of the implantable medical devices into the anatomical region (thus moving in the opposite direction relative to the anatomical region from that in which one of the implantable medical devices moves), and then exiting the anatomical region together with one of the implantable medical devices. As a result, movement of a first implantable medical device of an implantable medical device system formed according to various principles of the present disclosure may cause eventual movement and removal of the entire system. Such a configuration may be useful when movement of one of the implantable medical devices of a system formed according to various principles of the present disclosure moves without also moving the other implantable medical devices. For example, in some uses, movement of one of the implantable medical devices may cause a structural change relative to or along a common anatomical region in which the implantable medical device system is implanted. Such a change may be reversible (by the implantable medical device causing the structural change) to also move the other implantable medical devices of the system, such as via connectors between the implantable medical devices.

[0030] In some embodiments, one of the implantable medical devices of an implantable medical device system formed according to various principles of the present disclosure may be structured to maintain patency of an exit passageway from a common anatomical region in which the implantable medical device system is implanted. Another of the implantable medical devices of an implantable medical device system formed according to various principles of the present disclosure may be structured to occlude an alternative passageway from the common anatomical region. In such a configuration of the implantable medical device system, upon displacement of the implantable medical device from the anastomosis, it may be desirable to also displace the occluding implantable medical device. Specifically, if the implantable medical device that maintains patency of the only exit passageway from the common anatomical region displaces and closes such passageway, it may be desirable to remove the occluding implantable medical device from occluding the other exit passageways from the common anatomical region. In such embodiments, connectors between such implantable medical devices allow displacement of the implantable medical device from the anastomosis, resulting in displacement of the implantable medical device from occlusion of the other exit passageways. Thus, the implantable medical device system may be considered to form a safety feature / system.

[0031] Various embodiments of implantable medical devices and systems, and related methods of use thereof, will now be described with reference to examples shown in the accompanying drawings. References herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., indicate that one or more particular features, structures, concepts, and / or characteristics in accordance with the principles of the present disclosure may be included in connection with the embodiments. However, such references do not necessarily imply that all embodiments include the particular feature, structure, concept, and / or characteristic, or that the embodiments include all features, structures, concepts, and / or characteristics. Some embodiments may include one or more such features, structures, concepts, and / or characteristics in various combinations thereof. It should be understood that one or more of the features, structures, concepts, and / or characteristics described with reference to one embodiment may be combined with one or more of the features, structures, concepts, and / or characteristics of any of the other embodiments provided herein. That is, any of the features, structures, concepts, and / or characteristics described herein can be mixed and matched to create mixed embodiments, and such mixed embodiments are within the scope of the present disclosure. Furthermore, references in various places herein to “one embodiment,” “an embodiment,” “some embodiments,” “other embodiments,” etc., do not necessarily all refer to the same embodiment, and separate or alternative embodiments do not necessarily mutually exclude other embodiments. Furthermore, it is to be understood that various features, structures, concepts, and / or properties of the disclosed embodiments are independent and distinct from one another and may be used or exist individually or in various combinations with one another to create alternative embodiments that are considered part of the present disclosure. Accordingly, the present disclosure is not limited to only the embodiments specifically set forth herein. It would be extremely tedious to describe all of the many possible combinations and subcombinations of features, structures, concepts, and / or properties, and the example embodiments disclosed herein are not intended to limit the broader aspects of the present disclosure. The following description is merely illustrative of examples of embodiments and is not intended to limit the broader aspects of the present disclosure.

[0032] Referring now to the drawings, an implantable medical device system 1000 formed in accordance with various principles of the present disclosure is shown in FIG. 1 implanted in a schematic example of an embodiment of a common anatomical region. Specifically, the implantable medical device system 1000 is shown in a gastric system with a first implantable medical device 100 implanted to create an anastomosis A between the stomach S and the jejunum J, a second implantable medical device 200 implanted across the pylorus P (between the stomach S and the duodenum D), and a connector 300 coupling the first and second implantable medical devices 100 and 200 together. In some embodiments, the connector 300 has a length sufficient to extend between the first and second implantable medical devices 100 and 200 without exerting any force of its own as a result of merely connecting the implantable medical devices 100, 200 and / or under normal use of the implantable medical device system 1000. In other words, the connector 300 can have a length such that the connector 300 exerts a force on one of the implantable medical devices 100, 200 through movement of the other of the implantable medical devices 100, 200, rather than as a result of the connector 300 being shorter than the distance between the implantable medical devices 100, 200. In some embodiments, the connector 300 is at least as long as the distance between the implantable medical devices 100, 200 when the implantable medical devices 100, 200 are implanted (as shown in FIG. 1 ). In some embodiments, the length of the connector 300 is such that the connector 300 does not exert a force on either of the implantable medical devices 100, 200 when the implantable medical device system 1000 is deployed and no movement force is being applied to the implantable medical devices 100, 200. In such an embodiment, when a moving force is applied to one of the implantable medical devices 100, 200, such as affecting the position of the implantable medical devices 100, 200, the connector 300 applies a force that resists the moving force to maintain the deployed position of the implantable medical devices 100, 200.

[0033] More specifically, the first implantable medical device 100 and the second implantable medical device 200 each have a proximal end 101, 201 deployed within a common anatomical region (in this case, within the stomach S) and a distal end 103, 203 extending away from the common anatomical region. In the example embodiment shown in FIG. 1 , the distal ends 103, 203 are positioned within adjacent anatomical regions (in this case, the jejunum J and duodenum D, respectively). As can be appreciated, the implantable medical devices 100, 200 each include a saddle region 110, 210 that extends the implantable medical device 100, 200 from one anatomical region to another. For example, in the illustrated example embodiment of the first implantable medical device 100, the saddle region 110 extends across the apposed walls of the stomach S and the jejunum J. Additionally, in the illustrated example of the second implantable medical device 200 embodiment, the saddle region 210 extends across the pylorus P between the stomach S and the duodenum D.

[0034] In some embodiments, such as those illustrated herein, each of the implantable medical devices 100, 200 includes a proximal retention member 120, 220, respectively, configured to hold the implantable medical device 100, 200 in a fixed position relative to a common anatomical region in which the implantable medical devices 100, 200 are deployed. More specifically, the proximal retention member 120, 220 can be sized, shaped, configured, and / or dimensioned to resist forces on the implantable medical device 100, 200 that may cause the implantable medical device 100, 200 to move from its respective deployment site. Even more specifically, the proximal retention member 120, 220 of the implantable medical device 100, 200 may be configured to resist movement of the implantable medical device 100, 200 away from the anatomical structure in which the proximal retention member 120, 220 is located (the stomach S in the illustrated example). 1 , one or both of the implantable medical devices 100, 200 may have a proximal retention member 120, 220 extending radially outward from its respective saddle region 110, 210 to seat against the proximal tissue wall surrounding the passageway through which the respective saddle region 110, 210 of the implantable medical device 100, 200 extends. Typically, the proximal retention member 120, 220 resists distal movement of the respective implantable medical device 100, 200.

[0035] Optionally, the implantable medical devices 100, 200 each include a distal retention member 130, 230, respectively, configured to hold the implantable medical device 100, 200 in place relative to the site at which the implantable medical device 100, 200 is deployed. More specifically, the distal retention members 130, 230 can be sized, shaped, configured, and / or dimensioned to resist forces on the implantable medical device 100, 200 that may cause the implantable medical device 100, 200 to move from its respective deployment site. Even more specifically, the distal retention members 130, 230 of the implantable medical devices 100, 200 may be configured to resist movement of the implantable medical device 100, 200 away from the anatomical structure in which the distal retention members 130, 230 are located (in the illustrated example, the jejunum J and duodenum D, respectively). 1 , one or both of the implantable medical devices 100, 200 may have a distal retention member 130, 230 extending radially outward from its respective saddle region 110, 210 to seat against the distal tissue wall surrounding the passageway through which the respective saddle region 110, 210 of the implantable medical device 100, 200 extends. Typically, the distal retention member 130, 230 resists proximal movement of the respective implantable medical device 100, 200.

[0036] In view of the above, it will be appreciated that in the example embodiment shown in FIG. 1 , implantable medical devices 100, 200 are each configured for implantation relative to an anatomical region and to resist migration relative to such anatomical region. In accordance with various principles of the present disclosure, connector 300 is coupled to implantable medical devices 100, 200, such that implantable medical devices 100, 200 and connector 300 together comprise implantable medical device system 1000 that resists migration from its deployment site. In the example embodiment shown in FIG. 1 , the deployment site for implantable medical device system 1000 is within a common anatomical structure, such as the stomach S. However, the deployment site may also be a common anatomical region that includes adjacent anatomical structures, and implantable medical device system 1000 extends through one or more anatomical structures. For example, a first implantable medical device 100 may be deployed in a first anatomical structure and a second implantable medical device 200 may be deployed in a second anatomical structure, with the connector 300 extending therebetween (either or both of the first and second anatomical structures, or through another anatomical structure, such as a lumen or passageway between the first and second anatomical structures). The implantable medical device system 1000 utilizes its components to resist migration by utilizing anti-migration features of one of the implantable medical devices 100, 200 to secure the other of the implantable medical devices 100, 200. For example, if one of the implantable medical devices 100, 200 has a greater tendency or likelihood of migration than the other of the implantable medical devices 100, 200 (e.g., due to differences in its structure and / or being subjected to greater migration-inducing forces and / or differences in the nature of its implantation site compared to the implantation site of the other of the implantable medical devices 100, 200), the one of the implantable medical devices 100, 200 can act as an anchor for the other of the implantable medical devices 100, 200 via the connector 300. More specifically, if one of the implantable medical devices 100, 200 has a tendency to migrate from a common anatomical region in which the implantable medical devices 100, 200 are implanted, such one of the implantable medical devices 100, 200 may also have a tendency to migrate away from the other of the implantable medical devices 100, 200.Once the other of the implantable medical devices 100, 200 is securely implanted in its particular deployment site, the other of the implantable medical devices 100, 200 can hold the other of the implantable medical devices 100, 200 in place to prevent migration via the connector 300. Additionally or alternatively, if the other of the implantable medical devices 100, 200 is also subjected to a force that would move the other of the implantable medical devices 100, 200 away from the common anatomical region in which the implantable medical device system 1000 is implanted, and thus away from the one of the implantable medical devices 100, 200, both of the implantable medical devices 100, 200 can exert a securing force on each other or resist migration of the implantable medical devices 100, 200 coupled via the connector 300. Thus, by using a connector 300 according to various principles of the present disclosure with two or more implantable medical devices, an anti-migration implantable medical device system 1000 is formed. The connector 300 can be particularly useful in preventing one of the implantable medical devices 100, 200 from moving away from the other of the implantable medical devices 100, 200.

[0037] It will be understood that the connector 300 of the implantable medical device system 1000 may be coupled to any of various sections or portions of the implantable medical device 100, 200. For example, the connector 300 may be coupled to one of the retention members 120, 130, 220, 230 and / or to one of the saddle regions 110, 210 of the implantable medical device 100, 200. Additionally, a free end of the connector 300 or another portion of the connector 300 may engage the implantable medical device 100, 200 to couple the connector 300 to the implantable medical device 100, 200 in any of a variety of ways. For example, the connector 300 may be tied, looped, welded, glued, sewn, knotted, woven, or otherwise coupled to the implantable medical device 100, 200. It will be understood that terms such as coupled, connected, engaged, interengaged, and other grammatical forms thereof may be used interchangeably herein without any limitation. It will further be understood that the connector 300 may be coupled to the implantable medical devices 100, 200 in a manner selected to counteract certain movement forces expected to affect the implantable medical device system 1000.

[0038] The connector 300 may be any generally elongated structure capable of coupling the implantable medical devices 100, 200 together, such as by spacing them apart, and maintaining the implantable medical devices 100, 200 coupled together. The connector 300 may be formed from a wire, suture, filament, thread, elastic, semi-elastic, or inelastic polymer tether, band, or the like. Preferably, the connector 300 is formed from a biocompatible material and is capable of withstanding various anatomical forces and / or environments (including chemical forces, such as from gastric fluids). Examples of materials that may be used to form the connector 300 include, but are not limited to, silicone, polyethylene terephthalate (PET), various non-absorbable suture materials (smooth or rough, elastic or inelastic, etc.), and the like.

[0039] In some embodiments, the ends of the connector 300 are enlarged or otherwise adjustable relative to a portion of the implantable medical device 100, 200 that is engaged therewith. Such enlarged or adjustable ends may facilitate coupling of the connector 300 to the implantable medical device 100, 200 and resist separation therefrom. For example, one or both ends of the connector 300 may be engageable with one or both portions of the implantable medical device 100, 200 to couple the connector 300 to the implantable medical device 100, 200. The ends of the connector 300 may be shaped, shaped, configured, etc. to enable coupling of the connector 300 with the implantable medical device 100, 200 such that the connector 300 and the implantable medical device 100, 200 are not inadvertently separated. For example, the end of connector 300 may be enlarged or otherwise formed, shaped, configured, etc. to pass through the wall of implantable medical device 100, 200 and resist returning out of the wall of implantable medical device 100, 200. In some embodiments, the enlarged end is in the form of a knot, crimp, weld, etc.

[0040] In some embodiments, ends of connector 300 are selectively movable to configurations that maintain such ends in fixed positions relative to implantable medical devices 100, 200. For example, in the example embodiment of connector 300 shown in FIG. 2, one or both ends 301, 303 of connector 300 are coupled to catch bars 310, 320, respectively. Catch bars 310, 320 may be movable (e.g., toggle) between a position generally aligned with elongated portion 302 of connector 300 between its ends 301, 303 and a catch position generally transverse (e.g., perpendicular) to elongated portion 302 of connector 300 (as shown in FIG. 2). Thus, either catch bar 310, 320 can pass through a wall of a portion of the implantable medical device 100, 200, such as when the catch bar 310, 320 is generally aligned with the elongated portion 302 of the connector 300, and then be moved into a catch position to resist movement out of engagement with the implantable medical device 100, 200. It will be understood that the end 301, 303 of the connector 300 can be coupled to the catch bar 310, 320 along the free end of the connector 300 (the terminus of the elongated portion 302 of the connector 300), such as against (e.g., abutting) a surface of the catch bar 310, 320. Alternatively, ends 301, 303 of connector 300 may pass through and be secured within openings in the walls of generally tubular catch bars 310, 320 (e.g., along intermediate portions 315, 325 of catch bars 310, 320, respectively, between either of their ends 311, 313, 321, 323). For example, free ends 307, 309 of connector 300 may extend outward from ends 311, 321 of catch bars 310, 320 and be enlarged to resist withdrawal therefrom, as shown in FIG. 2. Additionally or alternatively, ends 301, 303 of connector 300 may be coupled within the lumens of generally tubular catch bars 310, 320, such as with adhesives, welding, friction or interference fits, etc.

[0041] One or both of the implantable medical devices 100, 200 of the implantable medical device system 1000 formed according to various principles of the present disclosure can be formed in a variety of ways. In some embodiments, the implantable medical devices 100, 200 are scaffolding or stent structures that are expandable from a collapsed or contracted delivery configuration (e.g., facilitating intraluminal delivery through a body passageway to a deployment site without requiring open surgery for device delivery) to an expanded deployed configuration (as illustrated in FIG. 1 ). In some embodiments, one or both of the implantable medical devices 100, 200 are formed from one or more members / elements (such terms are used interchangeably herein, without any limitation) that combine to form a rigid and / or semi-rigid structure. In some embodiments, the walls of the implantable medical devices have gaps, apertures, openings, gaps, etc. therethrough. Application of a coating material to, covering, over, etc. (such terms are used interchangeably herein without any limitation) at least a portion of the wall of the device may fill such gaps, apertures, openings, crevices, etc., inhibit or prevent the flow or leakage of material therethrough, and / or inhibit tissue ingrowth therein. The members forming the device (e.g., the wall of the device) may be formed from one or more struts, wires, strands, filaments, etc., and such terms are used interchangeably herein without any limitation. For convenience, and without any limitation, reference will be made to filaments that may be braided, interengaged, entangled, interwoven, knitted, knotted, looped (e.g., bobbin-style), interwoven, woven, wound, etc. to form a scaffold configuration that may be expandable and / or contractible. The filaments forming the implantable medical devices of the implantable medical device system 1000 of the present disclosure may be formed from a variety of non-limiting, preferably biocompatible, materials, such as, but not limited to, metals, metal alloys, polymers, metal-polymer composites, ceramics, and combinations or subcombinations thereof.For example, the filaments forming the implantable medical device may be made from a variety of non-limiting, preferably biocompatible materials, including, but not limited to, polypropylene, polyester, polysulfone, nylon, silicone, polyurethane, polystyrene, polyethylene (PE) (including high 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), polyoxymethylene (POM), polyisoprene (PP ... The polymeric polymer may be formed from polyether block esters, polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polyether-esters, ether or ester-based copolymers such as butylene / poly(alkylene ether) phthalates and / or other polyester elastomers, polyamides, block polyamide / ethers, polyimides (PI), ethylene vinyl alcohol, ethylene vinyl acetate copolymers (EVA), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide, perfluoro(propyl vinyl ether) (PFA), polyolefins, epoxies, poly(styrene-b-isobutylene-b-styrene), polycarbonates, ionomers, and the like, as well as mixtures, combinations, subcombinations, and copolymers thereof.Additionally or alternatively, the components forming the implantable medical device may be formed from a variety of non-limiting, preferably biocompatible metals, including, but not limited to, stainless steel, nickel-titanium alloys such as Nitinol, nickel-tungsten or tungsten alloys, cobalt-chromium alloys, cobalt-chromium-nickel based alloys such as Elgiloy®, nickel-copper alloys, nickel-cobalt alloys, nickel-iron alloys, nickel-chromium alloys, nickel-molybdenum alloys, nickel-chromium-molybdenum alloys, nickel-cobalt-chromium-molybdenum alloys, cobalt-chromium-molybdenum alloys, platinum-strengthened stainless steel, titanium, etc. Additionally or alternatively, the components forming the implantable medical device of the implantable medical device system 1000 of the present disclosure may be formed from a variety of non-limiting, preferably biocompatible natural materials, including, but not limited to, feline or bovine intestine, natural fibers such as silk or cotton, etc., and combinations and subcombinations thereof. It will be understood that the members forming the implantable medical devices of the implantable medical device system 1000 of the present disclosure may be formed from any blends, composites, combinations, subcombinations, copolymers, or co-constructs of the above. Alternatively or additionally, the members forming the implantable medical device may be formed by cutting (e.g., by laser cutting) a tubular structure (e.g., optionally a monolithic cylindrical tubular member) into an expandable configuration, the cutting forming members such as strut members. The implantable medical devices of the implantable medical device system 1000 of the present disclosure may be self-expanding devices as known or previously known to those skilled in the art. For example, the implantable medical device may be formed from a shape memory or thermoformable material (e.g., Nitinol or Elgiloy® or a shape memory polymer) such that the implantable medical device returns from a collapsed configuration to a preformed expanded configuration upon advancement from and / or withdrawal of a delivery sheath (any acceptable tubular elongated member as known to those skilled in the art for delivery of medical devices) that maintains the implantable medical device in the delivery configuration therein.

[0042] In view of the above, at least a portion of the implantable medical devices 100, 200 of the implantable medical device system 1000 formed according to various principles of the present disclosure may have a gap or opening through which an end of the connector 300 can be inserted to couple with the implantable medical device 100, 200. Thus, the end of the connector 300 of the implantable medical device system 1000 may penetrate a portion of the wall of the implantable medical device 100, 200 and then be joined or otherwise attached to the wall of the implantable medical device 100, 200, as described above, or the end of the connector 300 may be enlarged to thereby inhibit or prevent withdrawal from the implantable medical device 100, 200. 2 can be inserted through a portion of the implantable medical device 100, 200 (e.g., through an opening in a wall thereof) with the catch bars 310, 320 generally aligned with the elongated portion 302 of the connector 300. Once the catch bars 310, 320 pass through a portion of the implantable medical device 100, 200 (e.g., a portion of a wall), the catch bars 310, 320 transition to a position generally transverse to the elongated portion 302 of the connector 300, generally locking the end of the connector 300 in place relative to the implantable medical device 100, 200.

[0043] In some embodiments, such as shown in FIG. 3 , the implantable medical device 100 has at least one retention member 120, 130 formed as a double-walled retention member 120, 130. More specifically, in the example embodiment shown in FIG. 3 , the proximal retention member 120 includes an inner wall 122 (closer to the saddle region 110) and an outer wall 124 generally spaced from the inner wall 122. A peripheral wall 126 may extend between the inner wall 122 and the outer wall 124 to maintain a space 125 between the walls 122, 124 of the proximal retention member 120. The distal retention member 130 similarly includes an inner wall 132 (closer to the saddle region 110), an outer wall 134 (generally spaced from the inner wall 132), and an optional peripheral wall 136 extending between the inner wall 132 and the outer wall 134, with a space 135 between the walls 132, 134. As can be seen with reference to FIG. 3 , catch bar 310 coupled to end 301 of elongated portion 302 of connector 300 may extend into space 125 within proximal retention member 120 and be oriented to resist removal from space 125. Catch bar 310 may pass through outer wall 124 at a location generally along elongated portion 302 of connector 300 and then transition to a position transverse to elongated portion 302, as shown. Catch bar 310 may similarly be positioned and retained within space 135 between walls 132, 134 of distal retention member 130. The other catch bar 320 of connector 300 (shown in FIG. 2 ) may be positioned and retained relative to a second implantable medical device 200 in a similar manner. For example, the proximal retention member 220 of the second implantable medical device 200 may have an inner wall 224 and an outer wall 226 spaced apart from each other (optionally by a peripheral wall or lip 228) to define a space 225 into which the other catch bar 320 of the connector 300 can be inserted and retained to connect the implantable medical devices 100, 200.

[0044] It will be understood that the present disclosure encompasses other configurations of the connector 300 and / or its engagement with the implantable medical devices 100, 200 to form an implantable medical device system 1000 in accordance with various principles of the present disclosure, and FIG. 3 illustrates only one example embodiment. For example, the connector 300 may be formed integrally with (as a part of and extension of) one or both of the implantable medical devices 100, 200. In some embodiments, one or more of the retention members 120, 130, 220, 230 include an extension, such as an axial extension, referred to herein as a lip. For example, one or both of the proximal retention members 120, 220 of the implantable medical devices 100, 200 may include a lip 128, 228, respectively, as shown in FIG. 1 . In some embodiments, the connector 300 is engaged with one or both of the implantable medical devices 100, 200 via its lip 128, 228. Optionally, at least the distal retention member 130 of the first implantable medical device 100 may also include a lip 138 (shown in FIG. 3 ) to which the connector 300 may be engaged. In some embodiments, the filament forming the implantable medical device 100, 200 and its lip 128, 228 may extend beyond the overall structure of the implantable medical device 100, 200 to form an elongated connector 300 according to various principles of the present disclosure. The implantable medical devices 100, 200 may be formed separately, with the connector 300 being integrally formed with one of the implantable medical devices 100, 200 and extending to and coupled to the other of the implantable medical devices 100, 200 to form an implantable medical device system 1000 according to various principles of the present disclosure. The connector 300 may be an extension of the filament forming one or both of the implantable medical devices 100, 200. Additionally or alternatively, the connector 300 may be a separate elongate element that is incorporated into a portion of the implantable medical device 100, 200 (e.g., a portion of a wall thereof) and bonded thereto by welding, adhesive, crimping, etc. For example, the connector may be bonded to the implantable medical device 100, 200 during application of a coating to the implantable medical device 100, 200 or during formation of a liner in the implantable medical device 100, 200.

[0045] An implantable medical device system 1000 formed according to various principles of the present disclosure may be deployed in any of a variety of ways. For example, as will be understood by one of ordinary skill in the art, the method of deploying an implantable medical device system 1000 formed according to various principles of the present disclosure may be influenced by the common anatomical region in which the implantable medical device systems 1000 are deployed. In some embodiments, both implantable medical devices 100, 200 are implanted simultaneously, while in other embodiments, the implantable medical devices 100, 200 are implanted sequentially, optionally at different times. For example, in the exemplary embodiment of the environment shown in FIG. 1 , a first implantable medical device 100 may be deployed across the juxtaposed tissues of the stomach S and the jejunum J to form an anastomosis A therebetween. The second implantable medical device 200 does not have to be implanted at the same time as the first implantable medical device 100 to allow tissue growth between the stomach S and the jejunum J to form a natural (tissue) anastomosis A (between the stomach S and the jejunum J after a gastrojejunostomy has been performed). In some examples, the second implantable medical device 200 may be implanted several days (e.g., 10-14 days) after the first implantable medical device 100 is implanted, such as to ensure that the anastomosis has been formed and / or that the first implantable medical device 100 has not become dislodged.

[0046] The connector 300 of the implantable medical device system 1000 formed according to various principles of the present disclosure may be deployed and coupled to the implantable medical devices 100, 200 in any of a variety of ways, which may be affected by the manner in which the implantable medical devices 100, 200 are deployed. For example, if the implantable medical devices 100, 200 are implanted simultaneously, the connector 300 may be deployed along with the implantable medical devices 100, 200 and coupled to one or both of the implantable medical devices 100, 200, or may be deployed separately from the implantable medical devices 100, 200 and then engaged to the implantable medical devices 100, 200 to couple them together. If the implantable medical devices 100, 200 are deployed separately, the connector 300 may be delivered separately from or along with either of the implantable medical devices 100, 200. If delivered separately, the connector 300 may be engaged with the implantable medical device 100, 200 upon delivery to the deployment site. Alternatively, the connector 300 may be delivered already engaged with either of the implantable medical devices 100, 200. If delivered with a first-deployed implantable medical device 100, 200, the connector 300 is positioned so as to be accessible during deployment of the second-deployed implantable medical device 100, 200. When delivered together with (engaged to) a second-deployed implantable medical device 100, 200, or delivered separately and then engaged with it at the deployment site, the connector 300 may extend from the second-deployed implantable medical device 100, 200 (e.g., after deployment of the second-deployed implantable medical device 100, 200) and engage with the other of the implantable medical devices 100, 200 to couple the implantable medical devices 100, 200 together.

[0047] In accordance with various principles of the present disclosure, implantable medical devices 100, 200 may each be configured for one or more medical procedures, therapies, etc. For example, the implantable medical devices may be used for one or more of the following procedures, therapies, etc.: forming an anastomosis, occluding a bodily passageway, passing or facilitating the passage of material through an anatomical wall, draining fluids, maintaining the patency of a bodily passageway or anastomosis, etc. It will be appreciated that references to occlusion herein should be understood to encompass partial occlusion. In contrast, connector 300 is configured simply to connect implantable medical devices 100, 200 and does not otherwise affect the procedure, therapies, etc. affected by implantable medical devices 100, 200.

[0048] In the example embodiment shown in FIG. 1 , the first implantable medical device 100 is configured as a stent having a passageway 105 extending therethrough to create a passageway (anastomosis A) between the patient's stomach S and jejunum J (gastrojejunostomy). Accordingly, the first implantable medical device 100 can be considered to have a scaffolding structure configured to maintain patency of the anastomosis A. In contrast, in the example embodiment shown in FIG. 1 , the second implantable medical device 200 is configured as a pylorus obstruction device having an obstructed, partially obstructed, or no passageway. The implantable medical device 200 is positioned within the patient's pylorus P relative to the anastomosis A formed by the first implantable medical device 100 to create a gastrojejunal bypass between the stomach S and the jejunum J. More specifically, the second implantable medical device 200 is configured to obstruct the passage of stomach contents into the duodenum D (by partially or completely obstructing the pylorus P), thereby redirecting the stomach contents to the anastomosis A and the jejunum J. The connector 300 of the implantable medical device system 1000, formed according to various principles of the present disclosure, has a different structural configuration than either of the implantable medical devices 100, 200 of the implantable medical device system 1000 and simply connects the implantable medical devices 100, 200. Both implantable medical devices 100, 200 are configured to resist migration from the stomach S (which may generally be considered distal migration). Generally, the distal retention member 130 and connector 300 of the first implantable medical device 100 can help prevent distal migration of the second implantable medical device 200 (in this case, into the duodenum D). For example, the inner wall 132 of the distal retention member 130 can secure the first implantable medical device 100 against the apposed tissue walls of the stomach S and jejunum J, holding the first implantable medical device 100 in place relative thereto. Similarly, the distal retention member 230 of the second implantable medical device 200 can help prevent distal migration of the first implantable medical device 100 (in this case, into the jejunum J).For example, similar to the first implantable medical device 100, the inner wall 232 of the distal retention member 230 of the second implantable medical device 200 can secure the second implantable medical device 200 in place relative to its deployment site, and can also secure the first implantable medical device 100 against distal movement via the connector 300. Similar to the distal retention member 130 of the first implantable medical device 100, the distal retention member 230 of the second implantable medical device 200 can include an outer wall 234 generally spaced apart from the inner wall 232, with a circumferential wall 236 extending therebetween (in this case, optionally contacting tissue of the duodenum D, in contrast to the circumferential wall 136 of the distal retention member 130 of the first implantable medical device 100).

[0049] 1 , connection of the first implantable medical device 100 with the second implantable medical device 200 may also create a safety mechanism for gastrojejunal bypass, facilitated by the illustrated example embodiment of the implantable medical device system 1000. More specifically, when connection of the implantable medical devices 100, 200 via the connector 300 causes the first implantable medical device 100 to move from its deployment site, thus closing anastomosis A, the first implantable medical device 100 also moves (proximally) the second implantable medical device 200 from its deployment site within the pylorus P. Thus, although anastomosis A between the stomach S and the jejunum J may be closed, gastric material is no longer prevented from exiting the stomach S via the pylorus P because the displaced second implantable medical device 200 no longer obstructs the pylorus P.

[0050] It will be understood that the implantable medical devices 100, 200 used in the implantable medical device system 1000 formed according to various principles of the present disclosure may have other configurations, as would be readily understood by one skilled in the art. Various anti-migration features, as known to those skilled in the art, may be provided to resist migration (e.g., secure) of each implantable medical device 100, 200 relative to its deployment site.

[0051] Although embodiments of the present disclosure may be described with specific reference to medical devices, systems, and procedures for treating the gastrointestinal system, it should be understood that such medical devices and methods may be used to treat tissues of the abdominal cavity, digestive system, urinary tract, reproductive tract, respiratory system, cardiovascular system, circulatory system, etc.

[0052] In addition to those described above, various additional advantages of the various aspects, features, components, and structures of the implantable medical device system as described above may be appreciated by those skilled in the art. All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the devices and methods of the present disclosure have been described in terms of preferred embodiments, it will be apparent to those skilled in the art that modifications can be applied to the devices and / or methods, and to the steps or sequence of steps of the methods described herein, without departing from the concept, spirit, and scope of the present disclosure. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope, and concept of the present disclosure as defined by the appended claims.

[0053] The foregoing discussion has broad applicability and has been presented for purposes of illustration and explanation, and is not intended to limit the disclosure to the form disclosed herein. It will be understood that various additions, modifications, and substitutions may be made to the embodiments disclosed herein without departing from the concept, spirit, and scope of the present disclosure. In particular, it will be apparent to those skilled in the art that the principles of the present disclosure may be embodied in other forms, structures, arrangements, proportions, and with other elements, materials, and components without departing from the concept, spirit, scope, or characteristics thereof. For example, various features of the present disclosure are grouped into one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that various features of certain aspects, embodiments, or configurations of the present disclosure may be combined in alternative aspects, embodiments, or configurations. While the present disclosure is presented in terms of embodiments, it should be understood that various individual features of the present subject matter need not all be present to achieve at least some of the desired properties and / or advantages of the present subject matter or such individual features. Those skilled in the art will understand that the present disclosure may be used with modifications, or numerous modifications, of the structure, arrangement, proportions, materials, components, and other aspects used in the practice of the present disclosure that are particularly adapted to particular environments and operating requirements without departing from the principles, spirit, or scope of the present disclosure. For example, elements shown as integrally formed may be constructed from multiple pieces, or elements shown as multiple pieces may be integrally formed, operations of elements may be reversed or otherwise altered, and sizes or dimensions of elements may be changed. Similarly, although operations or actions or procedures are described in a particular order, this should not be construed as requiring such a specific order to achieve desired results, or that all operations or actions or procedures should be performed. Furthermore, other implementations are within the scope of the following claims. In some cases, actions recited in the claims can be performed in a different order and still achieve desirable results.Accordingly, the embodiments disclosed herein are to be considered in all respects as illustrative and not restrictive, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the foregoing description or the specific embodiments or configurations described or illustrated herein. In view of the above, individual features of any embodiment can be used and claimed separately or in combination with features of that 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 in the claims that follow, it will be understood that the terms "at least one," "one or more," and "and / or," as used herein, are open-ended expressions that are both conjunctive and disjunctive in operation. Terms such as "a," "an," "the," "first," and "second" do not exclude a plurality. For example, the terms "a" or "an" entity, as used herein, refer to one or more of that entity. Thus, the terms "a" (or "an"), "one or more," and "at least one" can be used interchangeably herein. As used in this specification and the appended claims, the word "or" is generally used in its sense to include "and / or," unless expressly indicated otherwise. As used herein, the conjunction "and" includes each of the structures, components, features, etc. so coupled, unless the context clearly dictates otherwise, and the conjunction "or" includes one or the other of the structures, components, features, etc. so coupled, alone as well as in any combination and number, unless the context clearly dictates otherwise. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or the like) are used solely for identification purposes to aid the reader's understanding of this disclosure and / or serve to distinguish regions of related elements from one another and do not limit the related elements, particularly with respect to position, orientation, or use of this disclosure. References to connections (e.g., attached, coupled, connected, engaged, and joined) should be construed broadly and, unless otherwise indicated, can include intermediate members between and relative movement between a collection of elements. Thus, connective references do not necessarily imply that two elements are directly connected and in a fixed relationship to one another. Distinguishing 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 into this Detailed Description by this reference, with each claim standing on its own as a separate embodiment of this disclosure. In the claims, the terms "comprise," "comprising," "include," and "including" do not exclude the presence of other elements, components, features, groups, regions, integers, steps, operations, etc. Also, although individual features may be included in different claims, these may in some cases be advantageously combined, and their inclusion in different claims does not imply that a combination of features is not feasible and / or advantageous. Moreover, a reference to the singular does not exclude a plurality. Reference signs in the claims are provided merely as a clarifying example and should not be construed as limiting the scope of the claims in any way.

Claims

1. 1. A system for creating a gastric bypass in a patient, the system comprising: a first implantable medical device configured to form an anastomosis between the patient's stomach and a portion of the jejunum; a second implantable medical device configured to occlude the patient's pylorus; and a connector coupling the first implantable medical device and the second implantable medical device.

2. The system of claim 1 , wherein the connector has a configuration that is different from the configurations of the first implantable medical device and the second implantable medical device.

3. 3. The system of claim 1, wherein the connector is elongated and has a length that can extend from the first implantable medical device when implanted to create an anastomosis between the stomach and the jejunum, and can extend from the second implantable medical device when implanted across the pylorus.

4. the first implantable medical device is a stent configured to maintain patency of an anastomosis, the stent comprising: a saddle region configured to extend through a portion of the stomach wall and the jejunum wall; a proximal retention member extending radially outward from a proximal end of the saddle region and configured to seat within the stomach to prevent distal migration of the first implantable medical device away from the stomach; and a distal retention member extending radially outward from a distal end of the saddle region and configured to seat within the jejunum to prevent proximal migration of the first implantable medical device into the stomach; the second implantable medical device comprising: a saddle region configured to occlude the flow of matter therethrough; a proximal retention member extending radially outward from a proximal end of the saddle region and configured to seat within the stomach to prevent distal migration of the second implantable medical device away from the stomach; and a distal retention member extending radially outward from a distal end of the saddle region and configured to seat within the patient's duodenum to prevent proximal migration of the second implantable medical device into the stomach; The system of any one of claims 1 to 3, wherein the connector is an elongated element that couples the first implantable medical device and the second implantable medical device.

5. The system of claim 4 , wherein the connector is coupled to a proximal retention member of at least one of the first implantable medical device and the second implantable medical device.

6. 6. The system of claim 1, wherein the connector comprises: an elongated portion having a first end and a second end; and a connector bar coupled to one of the first end or the second end of the elongated portion and movable between a first position extending along the elongated portion and a second position across the elongated portion, wherein when in the first position, the connector bar is extendable through a portion of a wall of one of the first implantable medical device or the second implantable medical device and is movable to the second position to hold one of the first end or the second end of the elongated portion coupled to the portion of the wall of the one of the first implantable medical device or the second implantable medical device.

7. one of the first implantable medical device or the second implantable medical device has at least one double-walled retaining member comprising an inner wall adjacent the saddle region and an outer wall spaced from the inner wall, the outer wall defining a space between the inner wall and the outer wall; 7. The system of claim 6, wherein the connector bar is extendable into the space between the inner wall and the outer wall of the double-walled retaining member and movable to the second position so as to be retained within the space.

8. The system of any one of claims 1 to 7, wherein the connector is formed separately from the first implantable medical device and the second implantable medical device.

9. securing the second implantable medical device via the connector to prevent the first implantable medical device from migrating distally from the stomach; The system of any one of claims 1 to 8, wherein the second implantable medical device secures the first implantable medical device via the connector to prevent it from migrating distally from the stomach.

10. 10. The system of claim 1, wherein the first implantable medical device displaces the second implantable medical device as it moves from the anastomosis to open the pylorus to allow gastric material to pass.

11. 1. A system for maintaining a pair of implantable medical devices in position relative to respective deployment sites of the pair of implantable medical devices, the system comprising: a first implantable medical device; a second implantable medical device; a connector that couples the first implantable medical device to the second implantable medical device; the deployment site is in an anatomical environment that tends to separate the first and second implantable medical devices from one another; The system wherein each of the implantable medical devices holds the other of the implantable medical devices in place via the connector.

12. The system of claim 11 , wherein the connector has a configuration that is different from the configurations of the first implantable medical device and the second implantable medical device.

13. 13. The system of claim 11 or 12, wherein the connector is elongated and has a length sufficient to extend between the first implantable medical device and the second implantable medical device without exerting force on either the first implantable medical device or the second implantable medical device when the first implantable medical device and the second implantable medical device are coupled together.

14. The system of any one of claims 11 to 13, wherein the connector is formed separately from the first implantable medical device and the second implantable medical device.

15. 15. The system of claim 11, wherein the connector comprises: an elongated portion having a first end and a second end; and a connector bar coupled to one of the first end or the second end of the elongated portion and movable between a first position extending along the elongated portion and a second position across the elongated portion, wherein when in the first position, the connector bar is extendable through a portion of a wall of one of the first or second implantable medical device and is movable to the second position to hold one of the first or second ends of the elongated portion coupled to the portion of the wall of the one of the first or second implantable medical device.

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