Devices, systems and methods for occluding anatomical passageways - Patents.com

Abstract

The occlusion device has a lumen formed therethrough and a saddle portion that is narrower than the saddle portions of conventional occlusion devices or stents, and an occlusion element is provided over a portion of the saddle portion to allow for occlusion of material flow through the saddle portion. The narrowed saddle portion may have an inner diameter of 6 mm or less. The occlusion element may be formed of a material that occludes a portion of the lumen of the occlusion device that extends through the saddle portion and / or inhibits the portion of the saddle portion from expanding to occlude material flow through the lumen. The remaining portion of the saddle portion and / or an inner-facing surface of at least one retention member that extends outwardly along an end of the saddle portion may be configured to promote tissue ingrowth, such as by remaining uncoated.

Description

[Technical field]

[0001] The present disclosure relates generally to the field of implantable devices, systems, and methods, and more particularly, to the field of implantable devices, systems, and methods for occluding anatomical passageways. [Background technology]

[0002] Various medical procedures involve obstructing the flow of material through a body passageway. For example, methods of treating various medical conditions, such as obesity, diabetes, or duodenal ulcers, involve bypassing or restricting the flow of material through the duodenum. Common bariatric procedures include sleeve gastrectomy, Roux-en-Y gastric bypass, and gastric banding, and are either obstructive (as in gastric banding and sleeve gastrectomy), anti-resorptive (as in Roux-en-Y), or both. All of these procedures are highly invasive and can be associated with serious complications. Newer, less invasive procedures, which involve less trauma and a lower risk of complications, include the creation of an anastomosis, such as between the stomach and jejunum (gastrojejunostomy, or GJ for short), and the creation of a pylorus atresia by endoscopic procedures (e.g., endoscopic ultrasound, or EUS for short), such as the NOTES (natural orifice transluminal endoscopic surgery) procedure. In cases where treatment requires complete bypass of the duodenum, obstruction of the pylorus (e.g., total obstruction) may be recommended. An obstruction device, such as a duodenal expulsion device, may be placed in the pyloric sphincter to block or block the passage of material (fluid, chyme, etc.) from the stomach through the pylorus to the duodenum. Various challenges to preventing migration of a placed obstruction device include the natural movement of the body (e.g., digestive system) and the continuous flow of material against the obstruction device. Peristaltic movement of the pylorus to pass material through the pylorus (e.g., distally toward the small intestine), counter-peristalsis through the pylorus, which is usually less frequent (proximally toward the stomach), and the natural tendency of the pylorus to expel material within the pylorus present unique challenges to the placement and retention of a pylorus obstruction device. Back pressure from the large and small intestines through the duodenum may also cause device migration. Thus, improved devices, systems, and methods for obstructing the flow of material in the body while also resisting migration of the obstruction device relative to the site where the obstruction device is placed are desired. Summary of the Invention

[0003] This summary of the disclosure is provided to aid in understanding, and those skilled in the art will appreciate that each of the various aspects and features of the disclosure may be advantageously used separately in some cases, or in other cases in combination with other aspects and features of the disclosure. No limitations on the scope of the claimed subject matter, either by inclusion or non-inclusion of elements, components, etc., are intended in this summary.

[0004] In accordance with various principles of the present disclosure, an occlusion device having a first end, a second end, and an intermediate region between the first and second ends and forming a lumen therethrough includes a first retention member extending radially outwardly along the first end of the occlusion device, a second retention member extending radially outwardly along the second end of the occlusion device, a saddle along the intermediate region of the occlusion device, and an occlusion element disposed along at least a portion of the saddle for occluding the flow of material through the lumen, the occlusion element being formed from a coating material.

[0005] In some embodiments, at least one of the viscosity, percent solids, thickness, durometer, or flexibility of the coating material is selected to allow the coating material to occlude at least a portion of the lumen through the occlusion device. In some embodiments, the coating material spans a portion of the lumen to define an inner diameter of less than 2 mm through a portion of the lumen. In some embodiments, the coating material extends along the saddle by approximately 2-3 mm. In some embodiments, the coating material is limited to a central region of the saddle, with a peripheral region of the saddle being uncoated to promote tissue ingrowth.

[0006] In some embodiments, at least one of the viscosity, solids percentage, thickness, durometer, or flexibility of the coating material is selected to enable the coating material to inhibit at least a portion of the saddle from expanding to occlude the flow of material through the lumen formed through the occlusion device.

[0007] In some embodiments, an outer diameter of at least one of the first retention member or the second retention member is at least about 10 times greater than an outer diameter of the saddle portion. In some embodiments, the first retention member and the second retention member have a saddle-facing surface configured to promote tissue ingrowth.

[0008] In accordance with various principles of the present disclosure, a method of occluding a lumen of an occlusion device includes narrowing an intermediate region of a tubular element to form a saddle; forming a first retention member along a first end of the tubular element having an outer diameter larger than an outer diameter of the saddle; forming a second retention member along a second end of the tubular element having an outer diameter larger than an outer diameter of the saddle; and applying a coating material to a portion of the region of the saddle to occlude a portion of the lumen of the occlusion device extending through that portion.

[0009] In some embodiments, the method further comprises constraining a portion of the saddle such that the diameter of the lumen within the constrained portion of the saddle is 6 mm or less. In some embodiments, applying the coating includes applying a coating material having at least one of a viscosity, solids percentage, thickness, durometer, or flexibility that allows the coating material to occlude at least a portion of a lumen through the occlusion device and / or inhibit the coated portion of the saddle from expanding to occlude the flow of material through the lumen formed through the occlusion device.

[0010] In some aspects, the method further includes leaving a portion of the saddle and surfaces of the first retention member and second retention member facing the saddle to promote tissue ingrowth uncoated.

[0011] In accordance with various principles of the present disclosure, an occlusion device having a first end, a second end, and an intermediate region between the first and second ends and forming a lumen therethrough includes a first retention member extending radially outwardly along the first end of the occlusion device, a second retention member extending radially outwardly along the second end of the occlusion device, a saddle along the intermediate region of the occlusion device, and an occlusion element disposed along at least a portion of the saddle to occlude the flow of material through the lumen, wherein at least a portion of the lumen extending through the saddle has a diameter of less than about 6 mm.

[0012] In some embodiments, the obstruction element is formed from a coating material applied to the saddle. In some embodiments, the obstruction element is disposed around an outer portion of the saddle to limit expansion of the saddle. In some embodiments, the obstruction element extends within a portion of the lumen extending through the saddle to form a plug within the portion of the lumen extending through the saddle. In some embodiments, the coating material is limited to a central region of the saddle, and a peripheral region of the saddle is uncoated to promote tissue ingrowth. In some embodiments, the surfaces of the first and second retention members facing the saddle are uncoated to promote tissue ingrowth.

[0013] In some embodiments, an outer diameter of at least one of the first retention member or the second retention member is at least about 10 times greater than an outer diameter of the saddle portion. In some embodiments, the diameter of at least a portion of the lumen extending through the saddle is about 2 mm.

[0014] In accordance with various principles of the present disclosure, a method of occluding a passageway within a body includes placing within the body passage an occlusion device forming a lumen therethrough and having a saddle-shaped region, the occlusion device having a first retention member extending outwardly along a first end of the occlusion device and a second retention member extending outwardly along a second end of the occlusion device, wherein an occlusion element is provided along a portion of the saddle to occlude a portion of the lumen of the occlusion device, and a remaining portion of the saddle not occluded by the occlusion element is uncoated to promote tissue ingrowth.

[0015] In some aspects, the occlusion element is a coating that occludes a portion of the lumen of the occlusion device in the portion of the saddle where the occlusion element is located. In some variations, the obstruction element prevents expansion of the portion of the saddle where the obstruction element is located.

[0016] In some aspects, the surfaces of the first retention member and the second retention member configured to seat against tissue are configured to promote tissue ingrowth. In some embodiments, at least that portion of the saddle where the obstructing element is located has an inner diameter of 6 mm or less.

[0017] Implementations of devices formed according to various principles of the present disclosure may include one or more of the following features, separately and independently, or in any suitable combination: The device may include an occlusion element configured to occlude and / or prevent expansion of a portion of the lumen of the occlusion device within the portion of the saddle where the occlusion element is located. At least that portion of the saddle where the occlusion element is located may have an inner diameter of 6 mm or less. The occlusion element may extend within a portion of the lumen that extends through the saddle. The occlusion element may be disposed around an outer portion of the saddle to limit expansion of the saddle. The occlusion element may be formed from a coating material applied to the saddle. The coating material may extend over a portion of the lumen to define an inner diameter of less than 2 mm through a portion of the lumen. The coating material may extend along the saddle by approximately 2-3 mm. The coating material may be limited to a central region of the saddle, and a peripheral region of the saddle may be uncoated to promote tissue ingrowth. At least one of the viscosity, solids percentage, thickness, durometer, or flexibility of the coating material may be selected to allow the coating material to occlude at least a portion of the lumen through the occlusion device. At least one of the viscosity, solids percentage, thickness, durometer, or flexibility of the coating material may be selected to allow the coating material to restrain at least a portion of the saddle from expanding to occlude the flow of material through the lumen formed through the occlusion device. An outer diameter of at least one of the first retention member or the second retention member may be at least about 10 times greater than an outer diameter of the saddle. The first retention member and the second retention member may have a saddle-facing surface configured to promote tissue ingrowth. The saddle-facing surfaces of the first retention member and the second retention member may be configured to promote tissue ingrowth. A diameter of at least a portion of the lumen extending through the saddle may be about 2 mm. The device may be formed by constraining a portion of the saddle such that the diameter of the lumen within the constrained portion of the saddle is 6 mm or less.The device may be formed by applying a coating material having at least one of a viscosity, percent solids, thickness, durometer, or flexibility to allow the coating material to occlude at least a portion of a lumen through the occlusion device and / or inhibit the coated portion of the saddle from expanding to occlude the flow of material through the lumen formed through the occlusion device. A portion of the saddle and / or surfaces of the first and second retention members facing the saddle and configured to seat against tissue may be configured to promote tissue ingrowth.

[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 will be set forth in the appended claims. Although the following disclosure is presented in terms of aspects or embodiments, it should be recognized that each aspect may be claimed separately or in combination with aspects and features of that embodiment or any other embodiment. [Brief description of the drawings]

[0019] [Figure 1] FIG. 1 is a perspective view illustrating one embodiment of an occlusion device formed in accordance with various aspects of the present disclosure and positioned in a schematic representation of a gastrointestinal environment. [Diagram 2] 1 is a front view of an example embodiment of an occlusion device formed in accordance with various principles of the present disclosure. [Diagram 3] 1 is a front view of another example embodiment of an occlusion device formed in accordance with various principles of the present disclosure. [Figure 4] 1 is a front view of another example embodiment of an occlusion device formed in accordance with various principles of the present disclosure. [Diagram 5] 1 is a schematic front view of another example embodiment of an occlusion device formed in accordance with various principles of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] 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 to scale. The accompanying drawings are provided for illustrative purposes only, and the dimensions, positions, order, and relative sizes reflected in each of the drawings may vary. For example, the devices may be enlarged so that details can be appreciated, but are intended to be scaled in relation to fitting, for example, into a delivery catheter or working channel of an endoscope. In each of the drawings, identical or nearly identical or equivalent elements are generally represented by the same reference numerals, and similar elements shown are generally designated by different similar reference numerals incremented by 100, and redundant descriptions are omitted. For the sake of clarity and conciseness, not every element is labeled in every drawing, nor every element of every embodiment is shown, unless explanation is necessary to enable a person skilled in the art to understand the present disclosure.

[0021] The detailed description is better understood in conjunction with the accompanying drawings, in which like reference numerals represent like elements and in which: 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 and may therefore vary. All devices and systems as well as 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 of an embodiment is provided for illustration 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 disclosure and should not be understood as limiting the disclosure to the particular elements, structures or features shown. Other examples of ways of implementing 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. It is therefore intended that the present subject matter encompass such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0022] It will be understood that the present disclosure is described in this application with varying degrees of detail. In certain instances, details that are not necessary for a person skilled in the art to understand the present disclosure or that make it difficult for the person skilled in the art to appreciate other details may be omitted. The terms used herein are only for the purpose of describing certain embodiments and are 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 those skilled 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.

[0023] As used herein, "proximal" refers to a direction or location closest to a user (healthcare professional or clinician or technician or operator or physician, etc. (these terms are used interchangeably herein without any limitation and include automated controller systems, etc.) and / or closest to a delivery device when, etc., the device is used (e.g., when, etc., the device is introduced 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 when, etc., the device is used (e.g., when, etc., the device is introduced into a patient or during implantation, positioning, or delivery). "Longitudinal" means extending along the longer or greater dimension of an element. "Center" means at least approximately bisecting through a center point and / or approximately equidistant from a perimeter or boundary, and "central axis" means, with respect to an opening, a line at least approximately bisecting through a center point of the opening and extending longitudinally along the length of the opening, where the opening comprises, for example, a tubular element, channel, cavity, or bore. As used herein, a passage or lumen is not limited to a circular cross section. As used herein, a "free end" of an element is an end beyond which such element does not extend.

[0024] In accordance with various principles of the present disclosure, the implantable device is configured to occlude (herein understood to include completely or substantially completely or even partially occlude, unless otherwise indicated) the flow of material through an anatomical placement site. As used herein, the placement site of the device is the site or location where the device is placed, positioned, implanted, expanded, attached, etc. (such terms are used interchangeably herein, without any limitation intended) within the body, and may also be the intended treatment site or treatment location of the device when placed and used. The placement site may be a passageway or lumen within the body, such terms are used interchangeably herein, without any limitation intended, and the broad principles of the present disclosure are applicable to various shapes and sizes of passageways, lumens, cavities, etc. within the body, or other anatomical structures. The passageway within the body may extend between anatomical structures (e.g., body cavities or organs adjacent to the passageway within the body) that generally have a larger diameter than the passageway within the body.

[0025] An occlusion device formed according to various principles of the present disclosure may be positioned with the saddle region of the occlusion device extending across, through, or into the body passage (such terms are used interchangeably herein, without any limitation). The body passage may have an entrance and an exit, and the implantable device may include a retention member (which may alternatively be referred to as a flange) that seats against an anatomical structure (e.g., a body wall) along or adjacent the entrance and / or exit of the body passage as an anti-migration structure configured to resist migration of the implantable device from a placement site (e.g., relative to the body passage). It is understood that terms such as resist, prevent, and prevent (and other grammatical forms) may be used interchangeably herein, without any limitation. The retention member may extend radially outward along either end of the intermediate region (where the saddle is located). It should be understood that terms such as along, at, on, or adjacent to an end may be used interchangeably herein without any intended limitation, unless otherwise stated, and are intended to indicate a general relative spatial relationship, not a strictly defined location. The retention member is configured to engage one or more anatomical structures at the placement site to inhibit migration of the occlusion device relative to the placement site. For example, the retention member may be in the form of a lateral extension or flange that is wider than the mid-region of the device and wider than the body passageway in which the mid-region of the device is placed. The retention member is wider (radially across the longitudinal axis of the body passageway) than the saddle and is configured to seat against an internal body wall that extends radially outward from the body passageway.

[0026] In some embodiments, at least one of the retention members is configured to resist movement of the implantable device relative to the placement site. In some embodiments, the first retention member and the second retention member are similarly shaped, such as having curved surfaces oriented to resist movement of the retention members, although such shapes may not have identical dimensions (i.e., the shapes may have different relative dimensions, scales, or proportions). For example, the first retention member and the second retention member may be substantial replicas of one another (optionally with different relative proportions) oriented in generally the same direction. Alternatively, in some embodiments, the first retention member and the second retention member may be mirror images (bilaterally symmetrical) (e.g., similar shapes oriented in generally opposite directions, optionally with different relative proportions). In some embodiments, the first retention member and the second retention member are generally not identical or symmetrical. For example, the first retention member and the second retention member may have different shapes, dimensions, relative proportions, etc. In some embodiments, a coating is applied to a portion of at least one of the retention members to enhance and / or reduce the flexibility of the retention member to increase its pull-out strength. In some embodiments, at least a portion of the surface of at least one of the retention members that contacts tissue at the deployment site is configured to promote tissue ingrowth thereto (e.g., is not coated with a material that may inhibit tissue ingrowth). It should be understood that the coating may be applied to an outwardly facing side surface of the retention member that faces away from the saddle and does not contact tissue, while at least a portion of the inwardly facing side surface of the retention member that contacts tissue is configured to promote tissue ingrowth thereto. In some embodiments, at least one of the retention members is formed with a double wall (two walls adjacent and in contact or spaced apart from each other), each wall forming a side of the retention member. The wall of the double-walled retaining member closer to the saddle (generally contacting tissue at the deployment site) may be considered the inside of the retaining member, and the wall of the double-walled retaining member further from the saddle (generally not contacting tissue) may be referred to herein as the outside of the retaining member. In some embodiments, two or more retaining members extend along one or both ends of the occlusion device.

[0027] In some embodiments, the first and second retention members are not generally identical or symmetrical. For example, the first and second retention members may have different shapes, sizes, relative proportions, etc. In some embodiments, the occlusion device placed across the pylorus may have an enlarged stomach retention member (e.g., having a larger diameter than the duodenal retention member) to resist distal migration from the stomach into the duodenum. In some embodiments, the occlusion device placed across the pylorus may have an elongated duodenal retention member that extends further from the saddle region than the stomach retention member and extends into the duodenum to enhance retention therein.

[0028] In certain aspects of the present disclosure, the implantable device may be specifically configured to occlude the flow of material through an anatomical structure. Terms such as occlude, block, prevent, inhibit, hinder, reduce, retard, etc. (and various conjugations thereof) may be used interchangeably herein to indicate, without limitation, a reduction in the flow of material by more than 50% up to 100%, including about 1% increments therebetween. In some placement sites, total occlusion may not be feasible due to various flow patterns through the passageway or other anatomical features of the body passageway. For example, in embodiments where the occlusion device is configured to be placed across the pylorus, a significant amount of fluid flow pressure may be imposed on the stomach side of the device and / or a significant amount of back pressure may be imposed on the duodenal side of the device. Thus, a small enough lumen may remain through the occlusion device to allow the passage of gas or low viscosity fluids without creating excess pressure on the occlusion device that may displace it.

[0029] In accordance with various principles of the present disclosure, an occlusion element configured to occlude at least a portion of the lumen formed through the occlusion device is disposed at least in a portion of the mid-region of the occlusion device so as to block or prevent the flow of material through the lumen. The occlusion element may be a separately formed element applied to the saddle (e.g., within the lumen through the saddle and / or covering at least a portion of the exterior of the saddle) or may be a further modification of the saddle (e.g., a crimp). For convenience, and without any intent to be limiting, occlusion elements are referred to herein as occlusion elements separately formed and applied to the exterior of and / or within the occlusion device, as well as to further modifications of the saddle beyond narrowing of the mid-region to distinguish the saddle from retention members at the ends of the occlusion device.

[0030] In some embodiments, the occlusion element is a coating that is applied to at least a portion of the saddle of the occlusion device to form a plugging material. In some embodiments, the viscosity and / or solids percentage of the coating material is selected to provide the desired occlusion. Additionally or alternatively, the thickness of the coating material applied to at least a portion of the saddle region provides the desired occlusion. In some embodiments, the properties of the coating material (e.g., expandability, thickness, etc.) inhibit the expansion of the saddle region of the occlusion device and inhibit or prevent the flow of solid or semi-solid materials through the occlusion device. In some embodiments, the coating material forms a plug that occludes the passage through the occlusion device at least along a portion of the intermediate region of the occlusion device. Additionally or alternatively, the coating material may form a constraint against the saddle that limits the expansion of the saddle region of the expandable occlusion device to occlude the passage of materials through the lumen of the occlusion device. In some embodiments, the occlusion device is braided, woven, interwoven, knitted, wound, twisted, looped (e.g., bobbinette style), knotted, or the like (such terms are used interchangeably herein without any limitation), or formed from laser cut tubes (which in some cases may be considered to form a plurality of struts), or otherwise formed from a plurality of filaments or the like formed to allow for such transitional ability. It is understood that the term filament is used for convenience and may be used interchangeably herein without any limitation with terms such as wire or strand or fiber or strut. Such formation of the device wall may leave a plurality of openings therethrough, such as between the filaments. It is understood that the term opening is used for convenience and may be used interchangeably herein without any limitation with terms such as space or gap. A coating may be applied to the device to extend through gaps in the device wall and prevent the flow of material through such gaps, forming an occlusion element.Such coatings may be similar to coatings known in the art for use with occlusion devices to occlude flow through the walls of the device and / or inhibit tissue ingrowth into or against the walls of the occlusion device, It is understood that such coatings will generally have a lower viscosity and / or a lower percentage of solids and / or be applied in smaller amounts than materials used to occlude the flow of matter through the lumen of the occlusion device, such as by forming a plug therein, and / or in accordance with various principles of the present disclosure.

[0031] In some embodiments, additional structure may be provided along at least a portion of the saddle region of the occlusion device to enhance occlusion of material through the lumen of the occlusion device, such as a crimp (e.g., modification or addition of a constriction element around the area of ​​the saddle), or additional occlusion elements (e.g., dowels, pins, bars, mandrels, etc.) may be inserted into the lumen of the occlusion device. Such additional structure may occlude at least a portion of the narrowed intermediate region of the occlusion device.

[0032] To facilitate endoscopic or transluminal (or otherwise, without the need for open surgery) delivery and deployment and optional removal, devices formed according to various principles of the present disclosure may be configured to transition or move between a collapsed or compact delivery configuration and an expanded deployed configuration. The devices may be formed from biocompatible materials (e.g., metals or polymers or alloys), such as shape memory or heat formable materials (e.g., nickel-titanium alloys such as Nitinol or cobalt-chromium-nickel-molybdenum alloys such as Elgiloy®), which may be advantageously used to enable expansion of the device to a desired deployed configuration.

[0033] Various embodiments of occlusion devices according to the principles of the present disclosure will now be described with reference to examples illustrated in the accompanying drawings. References herein to "one embodiment," "an embodiment," "several embodiments," "other embodiments," etc. indicate that one or more particular features, structures, and / or characteristics according to the principles of the present disclosure may be included in association with the embodiments. However, such references do not necessarily mean that all embodiments include the particular feature, structure, and / or characteristic, or that the embodiments include all features, structures, and / or characteristics. Some embodiments may include one or more such features, structures, and / or characteristics in various combinations thereof. Furthermore, references in various places herein to "one embodiment," "an embodiment," "several embodiments," "other embodiments," etc. do not necessarily all refer to the same embodiment, nor are they necessarily separate or alternative embodiments mutually exclusive with other embodiments. It should be understood that when a particular feature, structure, and / or characteristic is described in association with one embodiment, such feature, structure, and / or characteristic may also be used in association with other embodiments, whether or not expressly described, unless expressly stated to the contrary. Furthermore, it is to be understood that such features, structures, and / or characteristics may be used or presented alone or in various combinations with each other to create alternative embodiments that are considered part of this disclosure, since it would be too cumbersome to describe all of the many possible combinations and subcombinations of features, structures, and / or characteristics. Furthermore, various features, structures, and / or characteristics are described that may be exhibited by some embodiments but not by other embodiments. Similarly, various features, structures, and / or characteristics or requirements are described that may be features, structures, and / or characteristics or requirements of some embodiments but may not be features, structures, and / or characteristics or requirements of other embodiments. Thus, the disclosure is not limited to only the embodiments specifically described herein, and the example embodiments disclosed herein are not intended to limit the broad aspects of the disclosure.

[0034] It will be understood that common features in various drawings are identified by common reference elements, and for brevity and convenience, without any intention of limitation, the description of the common features will not be repeated throughout. For clarity, not all components having the same reference numbers are numbered. In the following description, it will be understood that similar elements or components among various illustrated embodiments having reference numbers greater than 100 will be generally designated by the same reference numbers incremented by multiples of 100, and redundant descriptions will generally be omitted for brevity. Furthermore, a particular feature in one embodiment may be used across different embodiments, and when appearing in different embodiments, it will not necessarily be individually labeled or described in detail, but reference will be made to the previous description of the similar components.

[0035] Referring now to the drawings, for convenience and without any intent to be limiting, an example of an implantable device 100 formed in accordance with various principles of the present disclosure is illustrated in FIG. 1. The illustrated occlusion device 100 has a proximal end 101, a distal end 103, and an intermediate region 105 between the proximal end 101 and the distal end 103. A proximal retention member 110 is provided along the proximal end 101 of the occlusion device 100, a distal retention member 120 is provided along the distal end 103 of the occlusion device 100, and a saddle portion 130 extends along the intermediate region 105 between the proximal end 101 and the distal end 103. The saddle portion 130 may be configured to be disposed through a passageway within a body. Retention members 110, 120 are wider than saddle portion 130 and are positioned against respective body walls surrounding (e.g., extending outwardly from) respective entrances and exits of the body passageway to prevent migration of occlusion device 100 relative to the body passageway (distal / proximal or downstream / upstream relative to the direction of normal flow of matter through the body passageway). In the illustrated example embodiment, saddle portion 130 is positioned within pylorus P, proximal retention member 110 is positioned within stomach S (such as relative to the antrum) and configured to prevent distal migration of occlusion device 100 into duodenum D, and distal retention member 120 is positioned within duodenum D and configured to prevent proximal migration of occlusion device 100 into stomach S.

[0036] 2, the occlusion device 200 has a first (e.g., proximal) retention member 214 along its first (e.g., proximal) end 201, a second (e.g., distal) retention member 216 along its second (e.g., distal) end 203, and a saddle 230 along its intermediate region, such that the diameter of the lumen 207 of the occlusion device in such portion of the saddle 230 may be minimized to a near zero (e.g., completely closed) state to occlude the lumen 207 through the occlusion device 200. It should be understood that it may be desirable to allow a small amount of material, such as gas or liquid, to pass through the lumen 207 so that pressure on the occlusion device 200 (e.g., back pressure from the duodenum D or pressure from gastric material in the stomach S) does not dislodge or cause the occlusion device 200 to move. For example, the narrowest portion of lumen 207 through occlusion device 200 may have a diameter of about 0-2 mm, e.g., 1-1.5 mm, including 0.01 mm increments therebetween. It should be understood that the inner diameter of saddle 230 is generally not equal to zero, such that some movement of liquid or gas through saddle 230 and into the duodenum is acceptable.

[0037] The illustrated occlusion device 200 may be formed from a plurality of filaments, e.g., braided to form a tubular element. The material of the tubular element (e.g., the material of the filaments braided or woven to form the tubular element) may be a shape memory material, such as, but not limited to, a nickel-titanium alloy (e.g., Nitinol) or a cobalt-chromium-nickel-molybdenum alloy (e.g., Elgiloy®). The configuration of the occlusion device 200 may be set by shaping the tubular element, such as by compressing or constraining or shrinking or clamping or otherwise narrowing the middle region 205 (e.g., with a form also known as a mid-form) to form a saddle 230, and optionally by expanding the end regions to form the retention members 210, 220. In accordance with various principles of the present disclosure, the ends of the tubular element from which the occlusion device is formed may be held (e.g., locked against sliding or rotation) while a tool is used to form the shape of the occlusion device. Thus, as can be appreciated, by forming an occlusion device in which at least a portion of the saddle is formed narrower than the saddle of a conventional occlusion device, it is possible to form the occlusion device using tools similar to those currently used to form occlusion devices having saddles, without further manipulation (e.g., twisting) of the tubular elements to narrow the saddle. The material of the occlusion device 200 so formed may be treated (e.g., heated) to set the formed tubular elements to a desired shape, in a manner known to those skilled in the art, the details of which known methods do not form part of this disclosure.

[0038] In accordance with various principles of the present disclosure, at least a portion of intermediate region 205 of occlusion device 200 is further narrowed by application of occlusion element 240 thereto to reduce the portion of lumen 207 of the occlusion device extending through such portion of saddle portion 230, thereby occluding the flow of material through such narrowed portion of saddle portion 230 and lumen 207.

[0039] In some embodiments, the portion of lumen 207 extending through the further narrowed portion of saddle 230 is further narrowed or occluded by application of a coating material thereto to form occlusion element 240. The occlusion element 240 formed by the coating material may block or otherwise obstruct a portion of lumen 207 within the narrowed portion of saddle 230. Additionally or alternatively, the coating material may resist expansion of saddle 230 (e.g., enhance its inherent resistance to expansion), thereby restricting the passage of material through saddle 230. The coating material may be formed from biocompatible polymeric materials (e.g., silicone, urethane, polyurethane, urethane polyether block amide (PEBA), polyethylene, polyethylene terephthalate (PET), polyvinylidene difluoride (PVDF), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyester, polypropylene, polynaphthalene, Chronoflex®, C-Flex® thermoplastic elastomers, Krator® SEBS and SBS polymers), or similar biocompatible polymer blends and / or copolymers thereof and / or combinations thereof.

[0040] The coating material may be applied to increase the bulk of the coating to the extent that the coating occludes the saddle 230 by plugging it and / or by preventing the expansion of the saddle 230. For example, the thickness of the coating on the walls of the saddle 230 may be at least about 100 μm, and may even be about 500 μm thick (including 1 μm increments therebetween). In some embodiments, about 0.1 g of coating material may be applied to coat a prior art occlusion device (e.g., to prevent the passage of material through its walls), whereas up to about 0.3 g or even up to about 0.4 g of coating material may be applied to the occlusion device 200 to form an occlusion element 240 according to various principles of the present disclosure. In some embodiments, one or more material properties of the coating enable the coating to form an occlusion element 240 (e.g., a plug or other form of obstruction) rather than simply a coating (e.g., simply a covering layer). More specifically, in contrast to typical coating materials used on prior art stents (e.g., to inhibit tissue ingrowth and / or prevent passage of material through the walls of the stent and / or to provide structural rigidity / reduce flexibility and / or provide some degree of lubricity to facilitate movement relative to tissue or prevent tissue ablation), one or more properties of the coating material contribute to the occlusion formed by narrowing of the intermediate region 205 of the occlusion device 200. In some embodiments, the coating material has a higher viscosity than prior art coatings used for such purposes as described above, such that instead of simply coating the walls of the occlusion device 200, the coating material may form a mass (e.g., a plug) within the portion of the occlusion device's lumen 207 within the saddle 230 to occlude the saddle 230. The added viscosity may enable the coating to form an occlusion element 240 in or around the saddle 230 to limit the expansion of the saddle 230 and thereby block or prevent the passage of material therethrough.Additionally or alternatively, in some embodiments, because the coating material is a higher solids material (has a higher solids percentage) than prior art coating materials, the coating material of the present disclosure may form a mass within the portion of the occlusion device lumen 207 within the saddle 230, occluding the saddle 230 and / or forming a restraining element for the saddle 230, limiting the expansion of the saddle 230 and inhibiting or preventing the passage of matter therethrough. Additionally or alternatively, in some embodiments, the coating material may be applied to have a thickness sufficient to provide occlusion of at least a portion of the lumen 207 extending through the saddle 230 and / or limit the expansion of the saddle 230, thereby inhibiting or preventing the passage of matter therethrough. For example, while typical coatings for inhibiting tissue ingrowth, increasing lubricity, etc. may have thicknesses greater than about 45-55 μm, coatings forming occlusion element 240 according to various principles of the present disclosure may have thicknesses of about 100 μm or more, and even about 500 μm (including 1 μm increments therebetween). Additionally or alternatively, in some embodiments, the coating material may have a durometer sufficient to cause occlusion of saddle 230 and / or limit (resist) the expansion of saddle 230, thereby preventing or inhibiting the passage of material therethrough. For example, increasing the durometer may affect the percentage solids of the material, with a higher percentage solids resulting in less flow of the material during curing and a thicker coating layer being applied. Additionally or alternatively, in some embodiments, the flexibility and / or elasticity of the coating material may be selected to provide occlusion of at least a portion of lumen 207 extending through saddle 230 and / or to limit expansion of saddle 230, thereby inhibiting or preventing the passage of material therethrough. For example, saddle 230 may be coated to prevent lumen expansion of more than about 2-5 mm and / or to not allow an increase in the outer diameter of the saddle of more than 75%.It should be understood that one or more such properties, and / or other properties not enumerated herein, of the coating material may contribute to the ability of the coating material to occlude (e.g., form a plug) and / or restrain the saddle 230, either by being integrated into the saddle 230 or simply by forming around the periphery of the saddle 230 to resist expansion of the saddle 230. As discussed above, in some embodiments, it may be desirable to leave a lumen having a small diameter (e.g., 0.1-0.6 mm). In such embodiments, before the coating is applied to a portion of the saddle 230, a very thin mandrel or guidewire may be inserted through the lumen 207 of the occlusion device 200 to leave a minimal inner diameter through a portion of the saddle 230 as described above.

[0041] In some embodiments, further narrowing of the saddle 230 with the coating material may achieve the desired occlusion without other mechanical deformation of the saddle 230, such as twisting it, or other manipulation of the saddle 230. Generally, the occlusion device 200 is constrained or otherwise deployed in a reduced diameter configuration to allow for transluminal delivery through the body (e.g., for transcatheter delivery without invasive open surgery). Once the occlusion device 200 is deployed, it may transition from a delivery configuration (contracted, folded, reduced diameter, etc.) to a deployed (expanded) configuration, with the occluding portion of the saddle 230 generally remaining in the occluded configuration. For example, upon deployment of the occlusion device 200, the coated portion of the saddle 230 may not transition to a configuration significantly different from its delivery configuration. For example, the inner diameter of the saddle 230 may expand by no more than about 2-5 mm and / or the outer diameter of the saddle 230 does not increase by more than about 75%.

[0042] In accordance with various principles of the present disclosure, the inner diameter of the portion of lumen 207 within the more narrowed portion of saddle 230 (formed to be narrower than the typical saddles of prior art occlusion devices) may be 6 mm or less, preferably about 5 mm or less, or even as small as about 2 mm, or as small as about 1.5 mm, or even as small as about 1 mm ± 0.2 mm (these dimensions include about 0.1 mm increments therebetween). The outer diameter of such portion of saddle 230 may be about 7 mm or less, preferably about 6 mm or less, or even as small as about 2 mm, or as small as about 2 mm ± 0.2 mm (these dimensions include about 0.1 mm increments therebetween). The diameter of the filament (e.g., wire) forming occlusion device 200 may be about 0.005 inches (0.127 mm), or even up to about 0.010 inches (0.254 mm). It should be understood that, as described herein, the "occlusion" of a portion of lumen 207 through saddle 230 need not be a complete occlusion, but may allow the passage of fluids (gas and / or liquid) that may induce sufficient pressure on occlusion device 200 to cause displacement of occlusion device 200 or otherwise dislodge occlusion device 200 from its placement site, such as by allowing a lumen having a minimum diameter to extend through occlusion device 200 as described above. For example, occlusion element 240 formed by a coating material may leave a portion of lumen 207 through saddle 230 having an inner diameter of less than about 2 mm but greater than 0 (including about 0.1 mm increments therebetween).

[0043] The coating materials used in accordance with various principles of the present disclosure to form the occlusion element 240 generally inhibit tissue ingrowth into underlying structures. It should be understood that the coating material forming the occlusion element 240 need not be applied along the entire length of the saddle 230 along the longitudinal axis LA of the occlusion device 200, and that in the absence of such coating material, at least some tissue ingrowth is permitted (and possibly encouraged) along the length of the saddle 230. It is believed that tissue ingrowth into the occlusion device 200 enhances the retention of the occlusion device 200 to the body passageway in which it is placed, reducing and potentially preventing migration of the occlusion device 200 from its placement site. The coating material may be limited to be applied only a few millimeters along the length of the saddle 230. For example, in some embodiments, the saddle 230 of the occlusion device 200 configured to be positioned across the pylorus P may be sized to correspond to an average length of the pylorus P of about 17 mm in length. In accordance with various principles of the present disclosure, the coating material may be applied only about 2-3 mm along the length of the saddle 230. In some embodiments, the coating material is limited to a generally central location along the length of the saddle 230.

[0044] To further enhance the benefit of tissue ingrowth to the occlusion device 200, the inwardly facing sides 212, 222 of each of the retention members 210, 220 are configured to promote tissue ingrowth (e.g., uncoated). In the example embodiment of the occlusion device 200 shown in FIG. 2, the retention members 210, 220 are double-walled retention members, with the inwardly facing sides 212, 222 of the retention members 210, 220 being the inner walls of the double-walled retention members 210, 220 and the outwardly facing sides 214, 224 of the retention members 210, 220 being the outer walls of the double-walled retention members 210, 220. The retention members 210, 220 are generally positioned against tissue surrounding the entrance / exit of the passageway in which the occlusion device 200 is positioned (e.g., against the stomach S and duodenum D) and may have a diameter significantly larger than the diameter of the saddle portion 230 to increase the surface area that the occlusion device 200 contacts with the tissue. For example, the outer diameter of one or both of the retention members 210, 220 may be at least about 10 times larger than the outer diameter of the saddle 230, and may be up to about 20 times larger than the outer diameter of the saddle 230 (including all multiples therebetween). Such an increase in surface area of ​​the sides of the retention members 210, 220 that contact tissue at the deployment site not only increases the pull-out strength (resistance to migration relative to the deployment site) of the retention members 210, 220, but also provides a larger surface area for tissue ingrowth to increase the effectiveness of tissue ingrowth in preventing migration of the occlusion device 200. In some embodiments, the outer diameter of the retention members 210, 220 is at least about 30 mm or more, and may be about 50 mm or more (including about 0.5 mm increments therebetween). Retention members 210, 220 may be formed from tubular elements, such as braided tubular elements, that form occlusion device 200 as a result of contracting intermediate region 205 to form saddle 230 and / or by expanding end regions of the tubular elements (e.g., by inserting washers into the end regions) to form retention members 210, 220. In some embodiments, end rings are used to form extensions or lips 216, 226 that extend axially from retention members 210, 220 in a direction away from saddle 230.

[0045] In some embodiments, a coating may be applied to portions of the occlusion device 200 that do not contact tissue to provide structural rigidity for anti-migration purposes, as is known in the art. The coating may comprise any suitable biocompatible material known or previously known in the art for such purposes, such as polymeric materials (e.g., silicone, urethane, polyurethane, urethane polyether block amide (PEBA), polyethylene terephthalate (PET), polyvinylidene difluoride (PVDF), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyester, polypropylene, polynaphthalene, Chronoflex®, C-Flex® thermoplastic elastomers, Krator® SEBS and SBS polymers), or similar biocompatible polymer blends and / or copolymers thereof and / or combinations thereof. The coating may be applied to at least a portion of the outer surfaces 214, 224 of the retention members 210, 220 and / or to the welds (along the ends 201, 203 of the occlusion device 200 which may be welded if the occlusion device 200 is formed from a braided or woven material) or lips 216, 226 (axial extensions of the occlusion device 200 which extend outwardly from the outward facing sides of the retention members 210, 220 in a direction away from the saddle portion 230).

[0046] In some embodiments, the occlusion device may be configured to have a more gradual transition from the narrow saddle to the wider retention members as illustrated in FIG. 2. For example, in the example embodiment of the occlusion device 300 illustrated in FIG. 3, the diameter of the saddle 330 transitions to the wider retention members 310, 320 with a gradual increase in the outer diameter of the saddle 330. For example, the diameter of the saddle 330 may transition to the wider retention members 310, 320 at a slope of about 35-40°. The transition region T as illustrated in FIG. 3 may be configured to allow the saddle 330 to better conform to the contours of the anatomy of the deployment site to increase the contact of the saddle 330 with tissue and / or increase the surface area of ​​the saddle 330, thereby improving tissue ingrowth in an uncoated saddle 330. To reduce fatigue of the material forming the occlusion device 300, a forming tool having rounded surfaces may be used to form the saddle 330 as illustrated in FIG. 3. In some embodiments, occlusion element 340, such as occlusion element 240 of occlusion device 200 described above and illustrated in FIG. 2, is disposed within central region C and does not extend into transition region T. In some embodiments, central region C may have a short length relative to transition region T, which may be characterized by a greater increase in outer diameter per millimeter than the change in outer diameter along central region C. For example, in some embodiments, transition region T may have a length of about 16-18 mm ± 1 mm (and including 0.05 mm increments therebetween) and central region C may have a length of about 4-8 mm ± 1 mm (and including 0.05 mm increments therebetween). In some embodiments, transition region T is maintained uncoated.

[0047] As discussed above, the occlusion element may be formed in various manners to achieve a desired occlusion through at least the narrowed portion of the saddle of an occlusion device formed according to various principles of the present disclosure. FIG. 4 illustrates an example of a crimp-type occlusion element 440 that covers the saddle 430 of an illustrated example of an embodiment of an occlusion device 400. The occlusion element 440 may be a swaged formation or a separately formed clamp or band that is applied to cover the outside of the saddle 430. The occlusion element 440 is formed to prevent the expansion of the saddle 430 to block the passage of material through at least that portion of the lumen 407 of the occlusion device that extends through the saddle 430. FIG. 5 illustrates an example of a separately formed occlusion element 540, such as a dowel, pin, bar, rod, mandrel, etc., in the saddle 530 of an illustrated example of an embodiment of an occlusion device 500 to block the flow of material through the saddle 530. Occlusion elements such as those illustrated in Figures 4 and 5, as well as occlusion elements 240, 340 illustrated in Figures 2 and 3 and described above, allow the occlusion device to have an uncoated saddle that promotes tissue ingrowth in the occlusion device while also occluding the flow of material through the occlusion device.

[0048] Considering that occlusion devices formed according to various principles of the present disclosure have a narrower saddle with a lumen that is substantially occluded or close to occluded along at least a portion thereof (e.g., a central region), a typical delivery system may need to be modified. For example, various implantable devices having a through lumen (e.g., stents and conventional occlusion devices) may be delivered via a flexible tubular elongate member of a delivery / placement system (which may in turn be guided through a delivery sheath and / or an endoscope and / or a delivery catheter). A guidewire may first be transluminally inserted into the body to guide the delivery / placement device to the placement site and place the implantable device at a desired location at the placement site. The lumen of the implantable device and the flexible tubular elongate member through which the implantable device is delivered may be threaded over the guidewire to be guided by the guidewire. Occlusion devices formed according to various principles of the present disclosure may not have a lumen large enough to allow the flexible tubular elongate member to be inserted into the occlusion device (at least not in the occluded portion). Thus, an occlusion device formed according to various principles of the present disclosure may be inserted directly over a guidewire to be guided to a desired location at a deployment site. A pusher known to those skilled in the art may be used to push the occlusion device out of a delivery sheath within which it is delivered transluminally through the body to a deployment site. It should be understood that various aspects of the above disclosure may be applied to other passageways within the body to reduce flow through such passageways. Although embodiments of the present disclosure have been described with specific reference to medical devices and systems and procedures for treating the digestive 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, and the like.

[0049] The above description has broad applicability and is presented for purposes of illustration and description, and is not intended to limit the disclosure to the form or forms disclosed herein. It should 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 disclosure. In particular, it will be apparent to those skilled in the art that the principles of the disclosure may be provided in other forms, structures, arrangements, ratios, and with other elements, materials, and components without departing from the concept, spirit, or scope, or characteristics thereof. For example, various features of the disclosure are grouped together in one or more aspects, embodiments, or forms for the purpose of streamlining the disclosure. However, it should be understood that various features of some aspects, embodiments, or forms of the disclosure may be combined with alternative aspects, embodiments, or forms. Although the disclosure is presented with respect to embodiments, it should be recognized that such individual features need not be present to achieve at least some of the desired properties and / or benefits of the subject matter or various separate features of the subject matter. Those skilled in the art will recognize that the present disclosure may be used with many modifications, or with modifications of structure, arrangement, size, materials, components, or otherwise used in the practice of the present disclosure that are specifically adapted to particular environments and operating conditions, without departing from the principles or spirit or scope of the disclosure. For example, elements shown as integrally formed may be composed of multiple parts, or elements shown as multiple parts may be integrally formed, operations of elements may be reversed or otherwise changed, and sizes or dimensions of elements may be changed. Similarly, although operations or acts or procedures are described in a particular order, this should not be construed as requiring such a particular order, or that all operations or acts or procedures are performed to achieve a desired result. Additionally, other implementations are within the scope of the following claims. In some cases, the acts recited in the claims may be performed in a different order and still achieve a desired result.The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the claimed subject matter being indicated by the appended claims and not limited to the foregoing description or the specific embodiments or arrangements described or illustrated herein. In view of the above, the individual features of any embodiment may be used and claimed separately or in combination with the features of that embodiment or any other embodiment, the scope of the subject matter being indicated by the appended claims and not limited to the foregoing description.

[0050] In the foregoing description and in the claims that follow, it is recognized that: As used herein, the terms "at least one," "one or more," and "and / or" are open-ended expressions that are both conjunctive and disjunctive in operation. The terms "a," "an," "the," "first," "second," etc. do not preclude a plurality. For example, as used herein, the term "a" or "an" entity refers to one or more of that entity. As such, the terms "a" (or "an"), "one or more," and "at least one" may be used interchangeably herein. All directional designations (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, upward, downward, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used for identification purposes only to aid the reader in understanding this disclosure and / or serve to distinguish regions of related elements from one another and are not intended to limit the related elements with respect to position, orientation, or use, particularly in this disclosure. Connection designations (e.g., attached, coupled, connected, and joined) are to be interpreted broadly and may include intermediate members and relative movement of elements between a group of elements unless otherwise indicated. As such, connection designations do not necessarily imply that two elements are directly and in fixed relationship to one another. Identification designations (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority and are used to distinguish one feature from another.

[0051] The following claims are hereby incorporated by reference into this detailed description, with each claim standing on its own 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 in some cases be advantageously combined, and their inclusion in different claims does not imply that the combination of features is not feasible and / or advantageous. In addition, 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 interpreted as limiting the scope of the claims in any way.

Claims

1. 1. An occlusion device having a first end, a second end, and an intermediate region between the first end and the second end and defining a lumen therethrough, a first retention member extending radially outward along the first end of the occlusion device; a second retention member extending radially outwardly along the second end of the occlusion device; a saddle along the intermediate region of the occlusion device; an obstruction element disposed along at least a portion of the saddle to obstruct the flow of material through the lumen; An occlusion device, wherein the occlusion element is formed from a coating material.

2. 10. The occlusion device of claim 1, wherein at least one of the viscosity, solids percentage, thickness, durometer, or flexibility of the coating material is selected to enable the coating material to occlude at least a portion of the lumen through the occlusion device.

3. 3. The occlusion device of claim 1, wherein the coating material spans a portion of the lumen to define an inner diameter of less than 2 mm through the portion of the lumen.

4. 4. The occlusion device of claim 1, wherein the coating material is limited to a central region of the saddle, and a peripheral region of the saddle is uncoated to promote tissue ingrowth.

5. 5. The occlusion device of claim 1, wherein at least one of the viscosity, solids percentage, thickness, durometer, or flexibility of the coating material is selected to enable the coating material to inhibit at least a portion of the saddle portion from expanding to occlude the flow of material through a lumen formed through the occlusion device.

6. 6. The occlusion device of claim 1, wherein an outer diameter of at least one of the first retention member or the second retention member is at least about 10 times greater than an outer diameter of the saddle portion.

7. 7. The occlusion device of claim 1, wherein the first retention member and the second retention member have a surface facing the saddle configured to promote tissue ingrowth.

8. 1. A method of occluding a lumen of an occlusion device, comprising: narrowing an intermediate region of the tubular element to form a saddle; forming a first retention member along a first end of the tubular element having an outer diameter greater than an outer diameter of the saddle portion; forming a second retention member along a second end of the tubular element having an outer diameter greater than the outer diameter of the saddle portion; and applying a coating material to a portion of the saddle region to occlude a portion of the lumen of the occlusion device extending through the portion.

9. 10. The method of claim 9, further comprising constraining a portion of the saddle such that the diameter of the lumen within the constrained portion of the saddle is 6 mm or less.

10. 10. The method of any one of claims 8-9, wherein applying the coating material further comprises applying a coating material with at least one of a viscosity, solids percentage, thickness, durometer, or flexibility that allows the coating material to occlude at least a portion of the lumen through the occlusion device and / or inhibit a coated portion of the saddle from expanding to occlude the flow of material through the lumen formed through the occlusion device.

11. 11. The method of claim 8, further comprising leaving intact a portion of the saddle and surfaces of the first and second retention members facing the saddle configured to promote tissue ingrowth.

12. 1. An occlusion device having a first end, a second end, and an intermediate region between the first end and the second end and defining a lumen therethrough, a first retention member extending radially outward along the first end of the occlusion device; a second retention member extending radially outwardly along the second end of the occlusion device; a saddle along the intermediate region of the occlusion device; an obstruction element disposed along at least a portion of the saddle to obstruct the flow of material through the lumen; An occlusion device, wherein the diameter of at least a portion of the lumen extending through the saddle is less than about 6 mm.

13. The occlusion device of claim 12 , wherein the occlusion element is a coating of material applied to the saddle.

14. 14. The occlusion device of any one of claims 12-13, wherein an outer diameter of at least one of the first retention member or the second retention member is at least about 10 times greater than an outer diameter of the saddle portion.

15. 15. The occlusion device of any one of claims 12 to 14, wherein the diameter of at least a portion of the lumen extending through the saddle is about 2 mm.

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