DEVICES, SYSTEMS AND METHODS FOR PYLORIC OBSTRUCTION AND / OR DUODENAL EXCLUSION - Patent application

Abstract

An implantable device having an expandable element, e.g., a balloon, exerting a radially outward anti-migration force to hold the implantable device in place. The implantable device and occlusion device may be an occlusion device that is inserted through a body passageway. The implantable device may include a first member and a second member expandable within a lumen of the first member to exert an anti-migration force on the first member. The first member may be an expandable stent coated to resist tissue ingrowth and the second member may be an expandable balloon configured to exert an anti-migration force on the expandable stent.

Description

[Technical field]

[0001] The present disclosure relates to implantable medical devices and associated systems and methods for reducing and / or obstructing the passage of matter through body passageways or lumens. More specifically, the present disclosure relates to devices, systems and methods for reducing and / or obstructing the passage of matter through body passageways or lumens in the gastrointestinal tract, such as the pylorus. [Background technology]

[0002] Various devices, systems, and methods exist for obstructing or impeding bodily passageways. For example, in the gastrointestinal (GI) specialty, various devices have been designed to obstruct or impede or reduce flow through lumens of the GI system, such as the pylorus valve (pylorus). Methods for treating medical conditions such as obesity, diabetes, and duodenal ulcers include bypassing the duodenum and restricting the flow of material by obstructing the pylorus with an obstructing device, with the goal of inhibiting or preventing the passage of material (such as fluids or chyme) from the stomach through the duodenum and into the duodenum. Various challenges to preventing migration of a placed obstructing device are presented by the natural movement of the body (e.g., the GI system) and the constant flow of material against the obstructing device. The peristaltic action of the pylorus, which passes material (e.g., distally into the small intestine), the generally less frequent counterperistalsis through the pylorus (e.g., proximally into the small intestine), and the natural tendency of the pylorus to expel material present particular challenges for placement and retention of a pyloric occlusion device. Moreover, it is desirable to not only resist migration, but also to enable removal of the occlusion device without damaging tissue at the site of placement.

[0003] Thus, there remains a need for improvements in occlusion devices, such as pyloric plugs, that provide a desired amount of occlusion while resisting migration and, optionally, allowing for reversibility of the occlusion. Summary of the Invention

[0004] This summary of the disclosure is provided to aid in understanding, and those skilled in the art will recognize that each of the various aspects and features of the disclosure may be used to advantage in isolation in some instances, or may be used in combination with other aspects or features in other instances. No limitation as to the scope of the claimed subject matter is intended by the inclusion or exclusion of any element, component, etc. in this summary.

[0005] In accordance with various principles of the present disclosure, the implantable device includes a tissue contact member configured to resist tissue ingrowth and an anti-migration member formed separately from the tissue contact member and configured to hold the tissue contact member in place against tissue at the deployment site.

[0006] In some embodiments, the tissue contact member is coated with a material that resists tissue ingrowth. In some embodiments, at least one of the tissue contact member or the anti-migration member is expandable from a compact delivery configuration to an expanded deployed configuration. In some embodiments, the tissue contact member has a lumen defined therethrough, and the anti-migration member is expandable within the lumen defined therethrough to exert an anti-migration force on the tissue contact member to hold the tissue contact member in place against tissue at the deployment site. In some embodiments, the tissue contact member is an expandable stent, and the anti-migration member is an expandable balloon. In some embodiments, at least one of the tissue contact member or the anti-migration member includes at least one retention member extending radially outward from at least one of the tissue contact member or the anti-migration member. In some embodiments, the at least one retention member extends radially outward from an end of the anti-migration member.

[0007] In some embodiments, the tissue contacting member has a proximal end configured to seat on the stomach, a distal end configured to seat on the duodenum, and a saddle region extending between the proximal and distal ends and configured to seat on the pylorus, the anti-migration member has a proximal end, a distal end, and a saddle region, the proximal end of the anti-migration member has a proximal retention member extending radially therefrom and configured to seat on the stomach, the distal end of the anti-migration member has a distal retention member extending radially therefrom and configured to seat on the duodenum, the saddle region of the anti-migration member extends between the proximal and distal ends and is configured to extend through the saddle region of the tissue contacting member, In some embodiments, the distal retention member is curved to correspond to the curvature of the duodenum against which the distal retention member seats. In some embodiments, at least one of the tissue contacting member or the anti-migration member includes at least one retaining member extending radially outward from at least one of the tissue contacting member or the anti-migration member, hi some embodiments, the at least one retaining member extends radially outward from an end of the anti-migration member.

[0008] In accordance with various principles of the present disclosure, an occlusion device configured to occlude a body passageway includes a first member, the first member defining a lumen therethrough and configured to extend through the body passageway, and a second member formed separately from the first member and extending through the lumen of the first member. In some embodiments, the first member is coated to prevent tissue ingrowth in the first member, and the second member exerts a radially outward anti-migration force on the first member to hold the first member in position relative to the body passageway.

[0009] In some embodiments, the second member occludes the flow of matter through a lumen defined through the first member. In some embodiments, at least one of the first or second members includes at least one retention member extending radially outward from at least one of the first or second members. In some embodiments, the at least one retention member extends radially outward from an end of the second member and has a diameter greater than a diameter of a lumen through the first member and is configured to resist movement through the first member. In some embodiments, the diameter of the at least one retention member extending radially outward from an end of the second member is greater than a diameter of a body passage through which the first member extends and is configured to resist movement of the first and second members through the body passage.

[0010] In some embodiments, the first member is an expandable stent and the second member is an expandable balloon. In accordance with various principles of the present disclosure, a method of occluding the flow of matter through a body passage includes delivering a first member of an occlusion device through the body passage, the first member having a lumen extending therethrough and covered with a coating that prevents tissue ingrowth in the first member, delivering a second member of the occlusion device through the lumen of the first member, and expanding the second member to hold the first member in place within the body passage.

[0011] In some embodiments, the method includes extending a saddle region of the first member through the pylorus and expanding a second member within a lumen defined through the first member to retain the first member within the pylorus. In some embodiments, the method includes expanding at least one end of the second member to have a diameter greater than a diameter of the lumen defined through the first member and to resist movement of the second member relative to the first member. In some embodiments, the method includes expanding at least one end of the second member to have a diameter greater than a diameter of the body passageway and to resist movement of the second member relative to the body passageway.

[0012] In some embodiments, the second component is delivered after delivery of the first component. These and other features and advantages of the present disclosure will become apparent from the following detailed description, the scope of the claimed invention being set forth in the appended claims. Although the following disclosure is presented in terms of aspects or embodiments, it will be understood that each aspect may be claimed separately or in combination with aspects or features of that embodiment or other embodiments. [Brief description of the drawings]

[0013] Non-limiting embodiments of the present disclosure are illustratively described with reference to the accompanying drawings, which are conceptual 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 figures of the drawings may vary. For example, devices may be enlarged so that details are discernible, but are intended to be reduced in size, for example, with respect to fitting within a delivery catheter or working channel of an endoscope. In the figures, identical or nearly identical or equivalent elements are generally represented by the same reference numerals, and similar elements are generally indicated by similar reference numerals that differ in increments of 100, and redundant descriptions are omitted. For clarity and simplicity, not all elements are attached to every figure, and not all elements of each embodiment are shown unless the illustration is necessary for a person skilled in the art to understand the present disclosure.

[0014] The detailed description will be better understood in conjunction with the accompanying drawings, in which: Like reference numerals refer to like elements as follows: [Figure 1] FIG. 1 shows a schematic diagram of a portion of a gastrointestinal system including an obstruction device, as formed in accordance with various principles of the present disclosure, positioned across the pylorus. [Diagram 2] FIG. 2 illustrates an example embodiment of an occlusion device formed in accordance with various principles of the present disclosure. [Diagram 3] FIG. 3 illustrates another example embodiment of an occlusion device formed in accordance with various principles of the present disclosure. [Figure 4] FIG. 4 illustrates another example embodiment of an occlusion device formed in accordance with various principles of the present disclosure. [Diagram 5] FIG. 5 illustrates another example embodiment of an occlusion device formed in accordance with various principles of the present disclosure. [Figure 6] FIG. 6 illustrates another example embodiment of an occlusion device formed in accordance with various principles of the present disclosure. [Figure 7] FIG. 7 shows a schematic diagram of a portion of the gastrointestinal system in which an obstruction device such as that shown in FIG. 6 has been placed. [Figure 8] FIG. 8 shows a schematic diagram of a portion of the gastrointestinal system in which an anti-migration member of an occlusion device (without a tissue engaging member) has been placed, as shown in FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] The following detailed description should be read with reference to the drawings showing exemplary embodiments. It should be understood that the disclosure is not limited to the specific embodiments described, as such may vary. All devices, systems, and methods described herein are examples of devices and / or systems and / or methods implemented according to one or more principles of the 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 understood as references to example embodiments of the disclosure, and should not be understood as limiting the disclosure to the specific elements, structures, or features shown. Other examples of ways of implementing the disclosed principles will occur to those of skill in the art upon reading this disclosure. Indeed, it will be apparent to those of skill in the art that various modifications and variations can be made in the present disclosure without departing from the scope or spirit of the subject matter of the present patent invention. For example, features illustrated or described as part of one embodiment can be used in other embodiments to yield still further embodiments. It is therefore intended that the subject matter cover such modifications and variations as fall within the scope of the appended claims and their equivalents.

[0016] It will be understood that the present disclosure is described in this application at various levels of detail. In some instances, details that are not necessary to understand the present disclosure and that would obscure other details to one of ordinary skill in the art may be omitted. The terms used herein are intended to specifically describe the present embodiments only and are not intended to be limiting beyond the scope of the appended claims. Unless otherwise specified, technical terms used herein should be understood as commonly understood by one of ordinary skill in the art to which the present disclosure pertains. All of the devices and / or methods disclosed and claimed herein may be made and performed without undue perjury in light of the present disclosure.

[0017] 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, etc., which terms are used interchangeably herein without limitation and include an automated control system or other method) and / or closest to a delivery device, e.g., during use of the device (e.g., during introduction or implantation, positioning, delivery of the device to a patient), and "distal" refers to a direction or location furthest from a user and / or closest to a delivery device, e.g., during use of the device (e.g., during introduction or implantation, positioning, delivery of the device to a patient). "Longitudinal" means extending along the longer or greater dimension of an element. "Central" means at least approximately bisecting the center point and / or approximately equidistant from the periphery or boundary, and "central axis" means, for an opening, when the opening comprises, e.g., a tubular element, channel, cavity, or hole, a line that at least approximately bisects the center point of the opening and extends longitudinally along the length of the opening.

[0018] Various implantable devices are preferably configured to be securely implanted in the body to resist migration from the implanted site, but may be configured to be removable when desired or medically indicated. Examples of such implantable devices include implantable devices configured for insertion into a body passageway to occlude the flow of material through the body passageway. The terms body passageway and lumen may be used interchangeably herein without any limiting intent, and it will be understood that the broad principles of the present disclosure are applicable to various shapes and sizes of body passageways and lumens. Such devices may be referred to as devices that occlude, exclude, obstruct, impede, etc., and such terms (and other grammatical forms of such terms) may be used interchangeably herein without any limiting intent. The site or location within the human body where the device is inserted, positioned, deployed, implanted, expanded, positioned (such terms and other grammatical forms of such terms may be used interchangeably without any limiting intent) may be referred to herein as a treatment site or a positioning site or an implantation site, without any limiting intent. It will be understood that a deployment site may be generally understood to be the intended treatment site or the location of the device once deployed and in use. It will further be understood that reference may be made to the deployment of the device such as at, through, across, at, into, etc., the deployment site, and such terms will be used interchangeably herein without any limiting intent.

[0019] One example of an obstruction device is a pylorus obstruction device. Duodenal or pylorus exclusion as an endoscopic alternative to gastric bypass is still a relatively new concept and various challenges are still being discovered. Two such challenges are removability of the device (e.g., upon replacement or upon completion of treatment) and prevention of migration (e.g., as may occur due to natural movement, peristaltic action, pressure of material obstructed by the device). Obstruction devices formed in accordance with various principles of the present disclosure have one or more members sized, shaped, configured, dimensioned, etc. to address at least these challenges.

[0020] To address removability, at least the tissue engaging members of the implantable occlusion device that contact the tissue at the treatment site are formed and configured in accordance with various principles of the present disclosure to be easily removable (e.g., without adversely affecting or damaging the tissue at the treatment site). For example, the tissue engaging members of such occlusion devices may be configured to resist tissue ingrowth in the tissue engaging members. For example, the tissue engaging members may be coated or covered, e.g., along the areas that contact the tissue at the treatment site, with materials known in the art to inhibit or prevent tissue ingrowth into the device. Various known sheaths or coatings, e.g., biocompatible, polymeric, selectively lubricious coatings, and conventionally known coatings, may be applied to selected areas of the tissue engaging members of the occlusion device to contribute to the mechanics of the device, e.g., to add structural stability and / or inhibit tissue ingrowth. In some embodiments, the sheath or coating material may be selected to increase the pull-out force of the occlusion device during treatment, e.g., by virtue of the viscosity of the material and / or the ultimate durometer of the material. In one aspect, the tissue engaging members of the occlusion device are in the form of an expandable stent that may have interstitial spaces, and the coating covers the stent to inhibit or prevent tissue ingrowth onto or into the stent, e.g., into the interstitial spaces of the stent. It will be understood that other configurations and configurations of implantable occlusion devices and / or members of occlusion devices that resist tissue ingrowth are within the scope and spirit of the present disclosure. It will be understood that such an approach to removability eliminates the need for tissue ingrowth promoting treatments (e.g., pre-treatments), such as, for example, resection.

[0021] As can be appreciated by those skilled in the art, a challenge presented by facilitating removability of an implantable device, such as an occlusion device, is the risk of migration. Current data suggests that tissue ingrowth is important to prevent migration of an implantable device. For example, the use of bare, uncoated stents and ablation of the treatment site (e.g., in the region of the pylorus) prior to device placement have been found to be highly effective in reducing implantable device migration. Implantable devices that allow for easy removal, for example, by providing a coating that partially or completely covers the device to inhibit or prevent tissue ingrowth, will therefore generally be susceptible to migration without further modification of the device.

[0022] To address migration prevention of implantable devices that allow for removal in accordance with various principles of the present disclosure, the migration prevention member is operatively associated with the tissue engaging member to hold or urge the tissue engaging member in place relative to the placement site. For example, the migration prevention member operatively engages the tissue engaging member to hold the tissue engaging member against tissue at the placement site. In some embodiments, the migration prevention member is separate (formed separately) from the tissue engaging member. In some embodiments, the migration prevention member is deployed separate from (e.g., after) the tissue engaging member is deployed. In some embodiments, the migration prevention member is expandable relative to the tissue engaging member. In some embodiments, the migration prevention member is an inflatable balloon, such as an inflatable molded balloon. The balloon may be formed from a compliant or non-compliant material. In some embodiments, the balloon may be molded into a configuration that further promotes occlusion of the body passageway and / or prevention of migration in addition to urging the tissue engaging member into place. Any desired fluid, such as air or saline, may be used to inflate the balloon. Additionally or alternatively, hydrogel beads or other materials may be used in expanding the balloon to increase the balloon's pull-out force. In some embodiments, the anti-migration member may be easily removable (e.g., by deflation, such as by puncturing and otherwise releasing fluid from within the anti-migration member in the form of a balloon), such that a separate tissue engaging member is not required.

[0023] In some embodiments, the implantable device is configured to be placed in a body passageway to occlude the body passageway, and the tissue engaging member may have a lumen therethrough. The migration preventing member may be inserted into the lumen of the tissue engaging member. In some embodiments, the migration preventing member is expanded in the lumen of the tissue engaging member to hold the tissue engaging member in place against a wall of the body passageway in which the implantable device is positioned. For example, in some embodiments, the expansion of the migration preventing member creates a radial expansion force that urges the tissue engaging member into place against the body passageway. The migration preventing member located in the lumen of the tissue engaging member may function to close / occlude the body passageway by occluding the tissue engaging member located in the body passageway.

[0024] The tissue engaging member may include at least one retention member extending radially outward from the tissue engaging member and configured to hold the tissue engaging member in place relative to the deployment site. For example, the retention member may extend radially outward from (which should be understood to include at or near) one or both ends of the tissue engaging member that have a diameter greater than a medial saddle region of the tissue engaging member. The retention member is sized, shaped, configured, and / or dimensioned to seat (e.g., anchor) against tissue at the deployment site of the occlusion device. For example, when the saddle region of the occlusion device is positioned through a body passageway, the retention member may be a radially expanding member configured to seat against tissue surrounding the body passageway where the implantable device is positioned to hold the tissue engaging member in place relative to the body passageway (e.g., prevent the tissue engaging member from moving from its position within the body passageway).

[0025] Additionally or alternatively, the migration preventing member may include at least one retention member extending radially outward from (which should be understood to include at or near) one or both ends of the migration preventing member. The retention member of the migration preventing member may be sized, shaped, configured, or dimensioned to resist migration of the migration preventing member relative to a body passageway in which the tissue engaging member and / or occlusion device is positioned. For example, the retention member of the migration preventing member extending through a lumen defined through a mid-saddle region of the tissue engaging member may have a diameter larger than the diameter of the lumen of the tissue engaging member to resist migration through the lumen of the tissue engaging member. The retention member of the migration preventing member may be sized, configured, or dimensioned to seat (e.g., anchor) against tissue surrounding a body passageway in which the implantable device is positioned such that the migration preventing member is held in place. Optionally, the retaining member of the migration preventing member may also seat the retaining member of the tissue engaging member in place (e.g., with the retaining member of the tissue engaging member being between the retaining member of the migration preventing member and the tissue surrounding the body passageway) and such retaining member may function to increase the pull-out force of the tissue engaging member and / or the migration preventing member to prevent migration of the implantable device.

[0026] Various embodiments of occlusion devices and methods formed in accordance with various principles of the present disclosure will now be described in detail with reference to examples illustrated in the accompanying drawings. References herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," and the like indicate that one or more particular features, structures, and / or characteristics according to the present disclosure may be included in connection with the embodiment. However, such references do not necessarily mean that all embodiments include the particular feature, structure, and / or characteristic, or that one embodiment includes all features, structures, and / or characteristics. Some embodiments may include one or more of such features, structures, and / or characteristics in various embodiments, in various combinations thereof. Furthermore, references in various places herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," and the like are not necessarily all referring to the same embodiment, and are not necessarily mutually exclusive of other embodiments, whether independent or alternative. It should be understood that when a particular feature, structure, and / or characteristic is described in connection with one embodiment, such feature, structure, and / or characteristic may also be used with respect to other embodiments, unless expressly stated to the contrary. It should be further understood that such features, structures, and / or characteristics may be presented or used alone or in combination with one another to create alternative embodiments that are considered part of this disclosure, as it would be cumbersome to describe in detail all of the many possible combinations and subcombinations of features, structures, and / or characteristics. Additionally, various features, structures, and / or characteristics are described that may be exhibited by some embodiments and not by others. Similarly, various features, structures, and / or characteristics or requirements are described in detail that may be a feature, structure, and / or characteristic or requirement in some embodiments and may not be a feature, structure, and / or characteristic or requirement in other embodiments. Thus, the disclosure is not limited to only the embodiments described herein, and the example embodiments disclosed herein are not intended to limit the broad aspects of the disclosure.

[0027] It will be understood that in the drawings, common features are identified by common reference numbers, and for brevity and convenience, and without any intention of limitation, descriptions of common features are not repeated throughout. For clarity, not all components having the same reference numbers are numbered. In the detailed description that follows, similar elements and components in the various illustrated embodiments are indicated throughout with the same reference numbers incremented by a multiple of 100, and redundant descriptions are omitted throughout for brevity. Furthermore, certain features in one embodiment may be used across different embodiments and will not necessarily be individually labeled when they appear in other embodiments.

[0028] 1, an example embodiment of an implantable device, such as occlusion device 100, configured in accordance with various principles of the present disclosure to allow for removability and resistance to migration is illustrated. The occlusion device 100 is positioned across the pylorus P, with a distal end 101 positioned in the duodenum D and a proximal end 103 positioned in the stomach S (with a saddle region 116 between the distal end 101 and the proximal end 103 positioned at the pylorus P). Such an arrangement is one example, and it will be understood that the various principles of the present disclosure may be applied to other types of implantable devices positioned at other body locations with respect to different anatomical structures.

[0029] In accordance with various principles of the present disclosure, the occlusion device 100 includes a tissue engaging member 110 and an anti-migration member 120. The tissue engaging member 110 is a removable member that generally contacts tissue at the treatment site (in this example, the pylorus P) and is configured to be treated or removed, such as to inhibit tissue in-growth against the tissue engaging member 110. The anti-migration member 120 is operatively associated with the tissue engaging member 110 to hold the tissue engaging member 110 in position relative to the treatment site. For example, in the illustrated embodiment, the tissue engaging member 110 is configured to be disposed within a body passageway and has a lumen 115 (e.g., defined by a saddle region 116) extending therethrough. The anti-migration member 120 is positioned within the lumen of the tissue engaging member 110 and urges the tissue engaging member 110 into position between the anti-migration member 120 and the treatment site. The tissue engaging member 110 is typically deployed before (e.g., sequentially) the migration preventing member 120 is deployed, or the members 110 and 120 may be deployed together (e.g., simultaneously, with the migration preventing member 120 positioned within the lumen 115 defined by the saddle region 116 of the tissue engaging member 110). It will be understood that other configurations and embodiments are within the scope and spirit of the present disclosure.

[0030] The tissue engaging members 110, 210, 310, 410, 510, 610 of the occlusion devices 100, 200, 300, 400, 500, 600 formed according to various principles of the present disclosure may be in the form of a stent, as shown in Figures 1-7. The stent may be formed of a biocompatible metal, polymer, or combination thereof. The stent may be configured to transition between a delivery configuration (e.g., collapsed, constrained, unexpanded, etc.) configured to facilitate delivery through a body passageway (e.g., extending transluminally through a delivery catheter to a deployment site) and a deployment configuration (e.g., expanded) configured to facilitate deployment at a deployment site, such as by contacting the walls of a body passageway in which the stent is placed. The stent may be self-expanding or may be expanded with the aid of another device (e.g., an expandable balloon). Examples of stents include, without limitation, stents having one or more support members combined and / or arranged to form a rigid and / or semi-rigid stent structure. In some embodiments, the occlusion device is formed from one or more wires or filaments that are braided, wrapped, intertwined, interwoven, woven, knitted, looped (e.g., bobbinette style), knotted, etc., to form a scaffold structure. Alternatively, the stent may be a unitary structure formed from a cylindrical tubular member, such as a single cylindrical laser cut tubular member, with the remainder of the tubular member forming the scaffold member. The support members of a self-expanding stent may be formed from a thermoformable material or a shape memory material, such as Nitinol or Elgiloy, whereby the stent returns from a collapsed configuration to a preformed expanded configuration. Openings may be defined between adjacent support members or filaments of the stent. It will be understood that the term opening is used herein for convenience and may be used interchangeably, without limitation, as space or gap or gap space, etc.

[0031] In accordance with various principles of the present disclosure, the tissue engaging members 110, 210, 310, 410, 510, 610 of the occlusion devices 100, 200, 300, 400, 500, 600 are configured to facilitate removability from a treatment site. For example, the tissue engaging members 110, 210, 310, 410, 510, 610 may be covered with a covering or coating that inhibits or prevents tissue ingrowth (e.g., into openings in the walls of the tissue engaging members) and may facilitate removal of the occlusion devices 100, 200, 300, 400, 500, 600 if desired or medically indicated. For example, a coating may be applied to at least a portion of the tissue engaging member 110, 210, 310, 410, 510, 610 to inhibit or prevent tissue ingrowth into the tissue engaging member 110, 210, 310, 410, 510, 610 (e.g., tissue ingrowth into the tissue engaging member 110, 210, 310, 410, 510, 610, interstices or openings in the tissue engaging member, or into the walls of the tissue engaging member). The coating may be formed from any suitable biocompatible, and optionally lubricious, material known to those of skill in the art or known in the art. For example, the coating may be formed from a polymeric material such as silicone, polyurethane, polyvinylidene fluoride (PVDF), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyester, polypropylene, polyethylene, polynaphthalene, Chronoflex, and the like, and / or copolymers thereof, and / or combinations thereof.

[0032] In accordance with various principles of the present disclosure, to inhibit undesired migration, tissue engagement members 110, 210, 310, 410, 510, 610 of occlusion devices 100, 200, 300, 400, 500, 600 configured to extend through a body passageway may be sized, shaped, configured and / or dimensioned to resist migration away from the body passageway. For example, tissue engagement member 110, 210, 310, 410, 510, 610 includes a distal retention member 112, 212, 312, 412, 512, 612 configured to seat against tissue surrounding a distal opening of the body passageway (in the example shown in Figures 1 and 7, the duodenum D), and a proximal retention member 114, 214, 314, 414, 514, 614 configured to seat against tissue surrounding a proximal opening of the body passageway (in the example shown in Figures 1 and 7, the stomach S), with a saddle region 116, 216, 316, 416, 516, 616 extending therebetween that extends through the body passageway (in the example shown in Figures 1 and 7, the pylorus P). In some embodiments, one or both of the retaining members 112, 212, 312, 412, 512, 612, 114, 214, 314, 414, 514, 614 are double-walled retaining members, with the double walls of each retaining member adjacent to each other (as referred to herein, adjacent and in contact with each other, or spaced apart from each other).

[0033] The retention members 112, 212, 312, 412, 512, 612, 114, 214, 314, 414, 514, 614 may be sized, shaped, configured, and / or dimensioned to inhibit or prevent unintentional migration of the tissue engaging members 110, 210, 310, 410, 510, 610 out of the body passageway (e.g., distally into the duodenum D or proximally into the stomach S). ​​For example, in the example embodiment of the occlusion device 200 shown in FIG. 2, at least the distal retention member 212 of the example embodiment of the tissue engaging member 210 has a concave surface (e.g., an inner wall of the double-walled retention member 212) that faces the body passageway. Such a profile resists proximal migration in the direction of the body passageway and increases the pull-out force of the distal retention member 212. The distal retention member 312 of the example embodiment of the tissue engaging member 310 of the example embodiment of the occlusion device 300 in Figure 3 is shown with a similar recess facing the body passageway. It will be understood that the proximal retention members 214, 314 of the tissue engaging members 210, 310 of the occlusion devices 200, 300 in Figures 2 and 3, respectively, may have a similar recess facing the body passageway to resist distal movement in the direction of the body passageway. Various variations in the size, shape, dimensions, and configuration of one or both walls of the distal retention member 112, 212, 312, 412, 512, 612 and / or the proximal retention member 114, 214, 314, 414, 514, 614 to enhance the anti-migration characteristics of the tissue engagement member 110, 210, 310, 410, 510, 610 and / or increase the pull-out force of the retention member 112, 212, 312, 412, 512, 612, 114, 214, 314, 414, 514, 614 are within the scope and spirit of the present disclosure and include, without limitation, those shown and described in U.S. Patent Application Publication No. 2022 / 0346997, filed April 28, 2022, and published November 3, 2022.

[0034] As discussed above, to further inhibit unwanted migration of an occlusion device 100, 200, 300, 400, 500, 600 formed according to various principles of the present disclosure, the migration prevention members 120, 220, 320, 420, 520, 620 are operatively associated with the tissue engaging members 110, 210, 310, 410, 510, 610 to hold the tissue engaging members 110, 210, 310, 410, 510, 610 in a predetermined position relative to a deployment site. In the example shown in Figures 1-7, the migration prevention members 120, 220, 320, 420, 520, 620 are configured to hold the tissue engaging members 110, 210, 310, 410, 510, 610 within a body passageway (e.g., the duodenum D shown in Figures 1 and 7). More specifically, the saddle regions 116, 216, 316, 416, 516, 616 of the tissue engagement members 110, 210, 310, 410, 510, 610 define lumens 115, 215, 315, 415, 515, 615 therethrough through which the anti-migration members 120, 220, 320, 420, 520, 620, respectively, may extend. Similar to the tissue engagement members 110, 210, 310, 410, 510, 610, each associated migration prevention member 120, 220, 320, 420, 520, 620 may be configured to transition between a delivery configuration (e.g., collapsed, constrained, unexpanded, etc.) in which the migration prevention member 120, 220, 320, 420, 520, 620 is configured to facilitate delivery through a body passageway (e.g., extending transluminally through a delivery catheter to a deployment site) and an arrangement in which the migration prevention member 120, 220, 320, 420, 520, 620 is expanded to engage a deployment site. In some embodiments, if the tissue engaging member 110 is not self-expanding, an expandable anti-migration member 120, 220, 320, 420, 520, 620 may be used to expand the tissue engaging member 110, 210, 310, 410, 510, 610.

[0035] The migration prevention members 120, 220, 320, 420, 520, 620 are configured to be positioned within the lumens 115, 215, 315, 415, 515, 615 of their associated respective tissue engaging members 110, 210, 310, 410, 510, 610 to exert a force on the tissue engaging member 110, 210, 310, 410, 510, 610 as an anti-migration force that inhibits or prevents migration of the tissue engaging member 110, 210, 310, 410, 510, 610 from the deployment site (e.g., out of the body passageway where it is already deployed). Such forces may be referred to interchangeably herein, without limitation, as anti-migration forces or retention forces or holding forces or retention forces. In embodiments where the anti-migration member 120, 220, 320, 420, 520, 620 is expandable within the lumen 115, 215, 315, 415, 515, 615 of the associated tissue engaging member 110, 210, 310, 410, 510, 610, respectively, the anti-migration force may be controlled and selected by a medical professional by controlling or selecting the amount the anti-migration member 120, 220, 320, 420, 520, 620 is expanded to achieve a desired degree of retention without exerting an excessive amount of force that may produce undesirable results. In some embodiments, the anti-migration member 120, 220, 320, 420, 520, 620 may be configured to only exert up to a preselected maximum expansion force. In some embodiments, the anti-migration member 120, 220, 320, 420, 520, 620 may be an inflatable balloon formed from a compliant or non-compliant material. A medical professional controls or selects the volume or pressure of fluid delivered to the inflatable anti-migration member 120, 220, 320, 420, 520, 620, thereby controlling or selecting the anti-migration force exerted by the anti-migration member 120, 220, 320, 420, 520, 620 on its associated respective tissue engaging member 110, 210, 310, 410, 510, 610. If the inflatable anti-migration member 120, 220, 320, 420, 520, 620 is a balloon formed from a non-compliant material, the balloon may be sized, shaped, configured and / or dimensioned to exert only up to a preselected maximum expansive force.

[0036] 2, the radially outward force of the migration preventing members 220 of the occlusion device 200 may be sufficient against the tissue engaging member 210 (e.g., within the lumen 215 of the saddle region 216) to hold the migration preventing members 220 in place relative to the tissue engaging member 210. However, in addition to inhibiting or preventing migration of the tissue engaging members, in some embodiments, the migration preventing members may include features configured to inhibit or prevent migration of the migration preventing members themselves relative to the associated tissue engaging members and / or deployment site. The various example migration preventing members 320, 420, 520, 620 of each example embodiment of the occlusion devices 300, 400, 500, 600 shown in FIGS. 3, 4, 5, and 6, respectively, are configured to inhibit or prevent migration relative to the associated tissue engaging members 310, 410, 510, 610, and / or deployment site. For example, at least one end of the anti-migration member may be enlarged to resist migration out of the lumen of the saddle region of the tissue engaging member and / or out of the body passageway in which the occlusion device is positioned.

[0037] In the example embodiment of the occlusion device 300 shown in Figure 3, the migration preventing member 320 may be configured to inhibit or prevent migration of the migration preventing member 320 relative to the tissue engaging member 310. More specifically, the migration preventing member 320 of the occlusion device 300 shown in Figure 3 has a distal retention member 322 extending from a distal end 321 of the migration preventing member 320 and a proximal retention member 324 extending from a proximal end 323 of the migration preventing member 320. The diameter of the retention members 322, 324 (in a direction transverse to the longitudinal axis LA of the occlusion device 300) is greater than the diameter of the lumen 315 (in a direction transverse to the longitudinal axis LA of the occlusion device 300) through the saddle region 316 of the tissue engaging member 310 of the occlusion device 300, thereby inhibiting or preventing the migration preventing member 320 from sliding through the lumen 315 and from migrating relative to the tissue engaging member 310. The anti-migration member 320 may be an expandable balloon formed from a non-compliant material that is pre-formed such that the anti-migration member 320 expands into a "dogbone" shape, as shown in Figure 3. However, other configurations are within the scope and spirit of the present disclosure and the specific shape is not limited to a dogbone.

[0038] In addition to being configured to inhibit or prevent migration relative to a tissue engaging member, migration preventing members formed according to various principles of the present disclosure may be configured to inhibit or prevent migration relative to a deployment site. For example, a migration preventing member of an occlusion device deployed across a body passageway may be configured with migration preventing features that inhibit or prevent migration of the migration preventing member relative to the body passageway. In some embodiments, the migration preventing member may include a retention member, such as an enlarged member, at one or both ends that is sized, shaped, configured, or dimensioned to seat (e.g., anchor) against tissue surrounding the body passageway in which the implantable device is located to hold the migration preventing member in place relative to the body passageway.

[0039] Example embodiments of occlusion devices 400, 500, 700 having anti-migration members with at least one retention member that is sized, shaped, configured or dimensioned not only to retain the anti-migration member against the tissue engaging member, but also to retain the anti-migration member in a predetermined position relative to the deployment site are shown in Figures 4, 5, 6 and 7.

[0040] In the example embodiment of the occlusion device 400 shown in Figure 4, the migration preventing member 420 has a proximal retention member 424 that is sized, shaped, configured, and / or dimensioned to inhibit or prevent migration out of the lumen 415 defined through the saddle region 416 of the tissue engaging member 410 (in which the migration preventing member 420 is disposed) and to inhibit or prevent migration from the deployment site. For example, in the example embodiment shown in Figure 4, the proximal retention member 424 (in a direction transverse to the longitudinal axis LA of the occlusion device 400) may be enlarged to have a diameter larger than the diameter of the lumen 415 defined through the saddle region 416 of the tissue engaging member 410 of the occlusion device 400 and larger than the diameter of the body passage in which the saddle region 416 is configured to be disposed, and may be configured to resist migration through the lumen 415 and the body passage. The illustrated configuration may be suitable for placement of the occlusion device 400 across the pylorus P as in Figure 1, where the proximal retention member 424 has a diameter wider than that of the pylorus P to be positioned within the stomach S and resist distal migration through the pylorus P into the duodenum D. The distal retention member 422 may be smaller than the proximal retention member 424, as shown in Figure 4, or may be the same size as or larger than the proximal retention member 424, generally depending on the characteristics of the deployment site. As will be appreciated, the proximal retention member 424 may urge the proximal retention member 414 of the tissue engaging member 410 into position relative to the deployment site, again inhibiting or preventing migration of the tissue engaging member 410 in such an embodiment.

[0041] In the example embodiment of the occlusion device 500 shown in Figure 5, both the distal retention member 522 and the proximal retention member 524 of the migration preventing member 520 are configured to inhibit or prevent migration through the lumen 515 defined through the saddle region 516 of the tissue engaging member 510 (in which the migration preventing member 520 is disposed) and also to inhibit or prevent migration from the deployment site. For example, in the example embodiment illustrated in Figure 5, both the distal retention member 522 and the proximal retention member 524 may be enlarged to have a diameter (in a direction transverse to the longitudinal axis LA of the occlusion device 500) larger than the diameter of the lumen 515 defined through the saddle region 516 of the tissue engaging member 510 of the occlusion device 500 and larger than the body passageway in which the saddle region 516 is configured to be disposed, and may be configured to resist migration through the lumen 515 and the body passageway. 1 , with the proximal retention member 524 positioned in the stomach S and the distal retention member 522 positioned in the duodenum D, both having a diameter wider than the diameter of the pylorus P to resist migration of the anti-migration member 520 through the pylorus P distally or proximally into the duodenum D or stomach S. As will be appreciated, the proximal retention member 524 of the anti-migration member 520 may urge the proximal retention member 514 of the tissue engaging member 510 into position relative to the deployment site, and the distal retention member 522 may also urge the distal retention member 512 of the tissue engaging member 510 into position relative to the deployment site, again inhibiting or preventing migration of the tissue engaging member 510.

[0042] In accordance with various principles of the present disclosure, at least one retention member of the occlusion device is sized, shaped, configured, and / or dimensioned to correspond to the anatomical structure in which such retention member is seated. For example, in the example embodiment of the occlusion device 600 shown in FIG. 6, the distal retention member 622 of the anti-migration member 620 is sized, shaped, configured, and / or dimensioned to correspond to the anatomical contour of the duodenum D, as shown in FIG. 7. More specifically, the distal retention member 622 is curved or bent, e.g., to correspond to the typical bending of the duodenum D at the distal opening of the pylorus P toward the duodenum D, and may not otherwise extend completely along the longitudinal axis LA of the occlusion device 600. Similar to the proximal retention member of the above-described embodiments, the proximal retention member 624 is sized, shaped, configured, and / or dimensioned to correspond to the anatomical contour of the stomach S.

[0043] In some embodiments, the anti-migration member 620 of the occlusion device 600 shown in Figures 6 and 7 may be sized, shaped, configured, and / or dimensioned to be self-retained within an anatomical structure, such as the pylorus P (and stomach S and duodenum D), without the tissue engaging member 610 as shown in Figure 8. The anti-migration member 620 (with or without the tissue engaging member 610) may be an expandable element, such as a balloon, that expands to a predetermined size, shape, and / or configuration to conform to at least a portion of the anatomical structure at the deployment site and form at least one retention member large enough to anchor the anti-migration member in place. 8, the anti-migration member 620 has a distal retention member 622 sized, shaped, configured, and / or dimensioned to substantially conform to the shape of the duodenum D in which the distal retention member 622 is placed, and a saddle region 626 sized, shaped, configured, and / or dimensioned to extend across the pylorus P. The extended and curved configuration of the distal retention member 622 may enhance retention of the distal retention member 622 within the duodenum D. The proximal retention member 624 may be enlarged to resist distal migration from the stomach S towards the duodenum D, as in the occlusion devices previously described. The anti-migration member 620 may be formed from a semi-conformable material that is formed or shaped to determine the final size, shape, configuration, and / or dimensions to which the anti-migration member 620 expands. The saddle region 226 may be sized, shaped, configured, and / or dimensioned to engage the wall of the anatomical structure in which it is located (e.g., the pylorus P) with sufficient force to resist movement of the anti-migration member 620 relative to the anatomical structure. In the case of the pylorus P (or other anatomical structure that may not have a constant or fixed shape and / or diameter), the saddle region 226 may be sized, shaped, configured, and / or dimensioned to exert an anti-migration force against the pylorus P, but if formed from a semi-compliant material, may allow some compression in response to contraction of the pylorus P (or a decrease in diameter or other transition of other anatomical structures).

[0044] As discussed above, the migration preventing members 120, 220, 320, 420, 520, 620 formed according to various principles of the present disclosure may be balloons formed from compliant or non-compliant materials that are preformed (e.g., molded) into a shape configured to resist or prevent migration through the body passageway in which the migration preventing member 120, 220, 320, 420, 520, 620 is disposed. Such migration preventing members 120, 220, 320, 420, 520, 620 may occlude the passage of matter through the lumen 115, 215, 315, 415, 515, 615 of the tissue engaging member 110, 210, 310, 410, 510, 610 in which the migration preventing member 120, 220, 320, 420, 520, 620 is disposed. In this manner, the anti-migration members 120, 220, 320, 420, 520, 620 may be considered the occlusion members of the occlusion devices 100, 200, 300, 400, 500, 600. It will be appreciated that the anti-migration members 120, 220, 320, 420, 520, 620 may be used independent of the separate tissue engaging members 110, 210, 310, 410, 510, 610, thereby functioning as both a tissue engaging member of the occlusion devices 100, 200, 300, 400, 500, 600 and as an anchoring member for the anti-migration members. In such embodiments of the occlusion devices, the retaining members as well as an intermediate saddle region extending between the proximal and distal ends of the anti-migration members may function as both the anti-migration members as well as the tissue engaging members of the occlusion members.

[0045] To remove the occlusion device 100, 200, 300, 400, 500, 600, e.g., after a defined period in situ, the expandable members of the occlusion device are contracted (e.g., deflated, compressed) for removal, preferably in a transluminal or otherwise non-invasive manner (e.g., via a catheter or other means known or heretofore developed in the art). In embodiments in which the tissue engaging members 110, 210, 310, 410, 510, 610 are stents, such stents collapse or otherwise return (according to various manners known in the art) to a compact configuration for transluminal removal from the body. For example, a removal element 130 as shown in FIG. 1 may be operatively associated with the tissue engaging member 110 to facilitate the transition of the tissue engaging member 110 to the compact configuration in a manner known in the art. The removal element 130 is desirably large enough to be easily grasped by a device inserted in a minimally invasive manner, such as endoscopically or transluminally, and to be pulled to return the tissue engagement member 110 from the expanded configuration to a collapsed delivery configuration suitable for removal in a minimally invasive manner, such as endoscopically or transluminally. In embodiments in which the migration prevention member 120, 220, 320, 420, 520, 620 is a balloon, the migration prevention member is deflated (according to various manners known in the art) for transluminal removal from the body. For example, the fill fluid within the balloon is released from the balloon so that the balloon returns to a fully unexpanded configuration for removal from the body. In some embodiments, the balloon includes an inflation valve, which is actuated (e.g., by being removed, opened, broken, or disengaged) to release fluid from within the balloon. Additionally or alternatively, the integrity of the balloon is disrupted, such as by being punctured, to release the fluid within the balloon. A needle, such as an FNA (fine needle aspiration), may be used to aspirate fluid or evacuate gas from the balloon, either through the wall of the balloon or through an inflation valve used to inflate the balloon. The uninflated or deflated balloon may be grasped or otherwise retrieved and removed in any desired manner known in the art or heretofore developed.

[0046] It will be appreciated that various aspects of the present disclosure may be applied to occlusion devices configured for placement in other passageways within the body to reduce flow through such passageways, and further, it will be appreciated that various aspects of the present disclosure may be applied to placement sites other than body passageways.

[0047] The various configurations and features of the embodiments described herein and illustrated in the drawings have several separate and independent advantages that may be desirable or otherwise inconsequential to the occlusion device of the present disclosure. Thus, the various configurations and features described herein need not all be present to achieve at least some of the desired properties and / or advantages described herein. Furthermore, the various features described herein may be used alone or in any combination. It will be understood that various features described with respect to one embodiment may be applied to other embodiments, whether or not explicitly implied. Thus, it should be understood that 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 described herein. That is, any of the features described herein may be mixed and matched to create hybrid designs, and such hybrid designs are within the scope of the present disclosure. Thus, the present invention is not limited to only the embodiments specifically described herein. The foregoing descriptions are only illustrative examples of embodiments and are not intended to limit the broad aspects of the present disclosure.

[0048] The foregoing description has broad applicability and is presented for purposes of illustration and description, and is not intended to be limited to the configurations described 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, configurations, arrangements, ratios, and with other elements, materials, and components without departing from the concept, spirit, scope, or characteristics of the present disclosure. For example, various features of the present disclosure are grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the present disclosure. However, it should be understood that features of certain aspects, embodiments, or configurations of the present disclosure may be combined in alternative aspects, embodiments, or configurations. Although the present disclosure is presented in terms of embodiments, it will be understood that various separate 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 of such independent features. Those skilled in the art will appreciate that the present disclosure may be used with many modifications or changes in configuration, arrangement, proportion, materials, and components used in the practice of the disclosure that are specifically adapted to a particular environment and operational requirements without departing from the principles, spirit, or scope of the disclosure. For example, elements shown as integrally formed may be comprised of multiple parts, or elements shown as multiple parts may be integrally formed, the operation of elements may be reversed or otherwise changed, and the size or dimensions of elements may be changed. Similarly, although operations or acts or steps are described in a particular order, such a particular order should not be construed as necessary to achieve desired results, or that all of the operations or acts or steps must be performed. Additionally, other embodiments are within the scope of the following claims. In some cases, the operations recited in the claims can be performed in a different order and still achieve desirable results.The presently disclosed embodiments should therefore be considered in all respects as illustrative and not restrictive, and the scope of the claimed subject matter is set forth in the appended claims, and is not limited to the foregoing description or to the specific embodiments or arrangements described or illustrated herein. In accordance with the above concept, the individual features of any embodiment may be used and claimed separately or in combination with features of that embodiment or other embodiments, and the scope of the subject matter is set forth in the appended claims, and is not limited to the foregoing description.

[0049] In the foregoing description and in the claims that follow, it will be understood that: The terms "at least one," "one or more," and / or, as used herein, are open-ended expressions that are both conjunctive and disjunctive in operation. Terms such as "one," "the," "first," "second," and the like, do not exclude a plurality. For example, the term "one" entity as used herein refers to one or more entities. Thus, the terms "one," "one or more," and "at least one" may be used interchangeably herein. 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 in the reader's understanding of this disclosure and / or serve to distinguish regions of associated elements from one another and do not limit the location, orientation, or use of the specifically associated elements in the present disclosure.

[0050] Connection references (e.g., attached, coupled, connected, and joined) should be interpreted broadly and may include intermediate members between groups of elements and relative movement between the elements, unless otherwise indicated. For example, connection references do not necessarily imply that two elements are directly connected and in a fixed relationship to each other. 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.

[0051] The following claims are incorporated into this detailed description by this reference, with each claim standing as a separate embodiment of the present disclosure. In the claims, the term "comprises / comprising" does not exclude the presence of other elements, components, features, regions, integers, steps, operations, etc. In addition, although individual features may be included in different claims, they may be advantageously combined, and their inclusion in different claims does not imply that a combination of features is not feasible and / or advantageous. Moreover, singular references do not exclude a plurality. Reference signs in the claims are provided merely for illustrative purposes and should not be construed as limiting the scope of the claims in any way.

Claims

1. a tissue contact member configured to resist tissue ingrowth; an anti-migration member formed separately from the tissue contact member and configured to hold the tissue contact member in place against tissue at a deployment site. Implantable devices.

2. the tissue contact member is coated with a material that resists tissue ingrowth; 10. The implantable device of claim 1.

3. At least one of the tissue contact member or the migration prevention member is expandable from a compact delivery configuration to an expanded deployed configuration.

3. An implantable device according to claim 1 or 2.

4. the tissue contact member has a lumen defined therethrough; the anti-migration member is expandable within the lumen defined through the tissue contact member to exert an anti-migration force on the tissue contact member to hold the tissue contact member in place against tissue at the deployment site. An implantable device according to any one of claims 1 to 3.

5. the tissue contact member is an expandable stent; The migration prevention member is an expandable balloon. An implantable device according to any one of claims 1 to 4.

6. at least one of the tissue contacting member or the anti-migration member includes at least one retaining member extending radially outward from at least one of the tissue contacting member or the anti-migration member. An implantable device according to any one of claims 1 to 3.

7. the at least one retaining member extends radially outward from an end of the anti-movement member; 7. The implantable device of claim 6.

8. the tissue contact member having a proximal end configured to seat in the stomach, a distal end configured to seat in the duodenum, and a saddle region extending between the proximal and distal ends and configured to seat in the pylorus; the anti-migration member having a proximal end, a distal end and a saddle region; a proximal end of the anti-migration member having a proximal retention member extending radially therefrom and configured to seat on a stomach; a distal end of the anti-migration member having a distal retention member extending radially therefrom and configured to seat in the duodenum; a saddle region of the anti-migration member configured to extend between the proximal end and the distal end and to extend through the saddle region of the tissue contact member. An implantable device according to any one of claims 1 to 4.

9. the distal retention member curves to correspond to the curvature of the duodenum in which the distal retention member sits; 9. The implantable device of claim 8.

10. 1. An occlusion device for occluding a body passageway, comprising: a first member defining a lumen therethrough and configured to extend through the body passage; a second member formed separately from the first member and extending through a lumen of the first member; the first member is coated to prevent tissue ingrowth therein; the second member exerts a radially outward anti-migration force on the first member to hold the first member in position relative to the body passageway. Occlusion device.

11. the second member occludes the flow of material through the lumen defined through the first member.

11. The occlusion device of claim 10.

12. At least one of the first member or the second member includes at least one retention member extending radially outward from at least one of the first member or the second member. An occlusion device according to claim 10 or 11.

13. the at least one retention member extends radially outward from an end of the second member, has a diameter greater than a diameter of the lumen through the first member, and is configured to resist movement through the first member.

13. The occlusion device of claim 12.

14. a diameter of the at least one retention member extending radially outward from an end of the second member is greater than a diameter of the body passageway through which the first member extends and is configured to resist movement of the first and second members through the body passageway. An occlusion device according to claim 12 or 13.

15. the first member being an expandable stent; the second member being an expandable balloon; An occlusion device according to any one of claims 10 to 14.

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