Device for occluding an internal passageway

Abstract

The implantable device (100) is configured to withstand forces imparted by anatomical structures at the placement site. The implantable device includes an outer portion (110) and an inner portion (120). The outer portion is disposed between the inner portion and the wall of the anatomical placement site. The outer portion may enclose the inner portion. The outer portion may be a compliant balloon that is compressible in response to radially inward anatomical forces exerted thereon. The inner portion may include one or more portions (120a, 120b) configured to hold the implantable device in place at the placement site and to resist movement of the implantable device. The inner portion may be movable relative to the outer portion. The inner portion may include two or more portions that are movable relative to each other. A shaft (130) may extend through the device, for example, to facilitate inflation of the outer portion and / or positioning of the inner portion.

Description

Technical Field

[0001] The present disclosure generally relates to the field of devices, systems, and methods for occluding body lumens.

Background Art

[0002] For any of a variety of reasons, it may be desirable to occlude or block or embolize an internal body passage. For example, it may be desirable to prevent the passage of substances through the passage and divert the substances to pass through another lumen or passage, such as via a bypass or anastomosis. Certain types of procedures (known as gastric bypass procedures) involve forming an anastomosis between the stomach and a portion of the small intestine downstream of the pylorus, such as a portion of the jejunum. Such procedures are intended for the ingested food to bypass (and be absorbed in) a portion of the small intestine. Thus, another aspect of such procedures involves occluding the pylorus so that food does not enter the duodenum and instead reaches the jejunum through the bypass anastomosis, thereby reducing the metabolic disease being treated by such procedures.

[0003] A variety of occlusion devices for occluding the pylorus and the like are known in the art. However, some occlusion devices placed in dynamic environments such as the pylorus may exhibit wear and / or further fatigue after long-term use. For example, a pyloric occlusion device is subjected to a certain pressure approximately every 20 seconds when the stomach contracts with coordinated waves (gastric slow waves that start at the fundus of the stomach, propagate towards the pyloric antrum, and ultimately forcefully close the pyloric sphincter). Pyloric occlusion devices are generally placed in the most muscular region of the stomach and must be able to resist the regular muscle contractions applied there and prevent movement. Improvements in occlusion devices, systems, and methods would therefore be welcomed in the industry.

Summary of the Invention

[0004] This general description of the disclosure is provided to facilitate understanding and those skilled in the art will understand that each of the various aspects and features of the disclosure may be advantageously used, optionally separately or in other cases in combination with other aspects and features of the disclosure. In this general description, no limitation with respect to the scope of the claimed subject matter is intended by either inclusion or non-inclusion of elements, components, etc.

[0005] According to various principles of the disclosure, an implantable device configured to be delivered to and disposed at a placement site is an inner scaffold portion that is movable between a delivery configuration and an expanded placement configuration, and an outer portion formed separately from the inner portion and disposed over the inner portion, the outer portion being disposed between the body wall at the placement site and the inner portion of the implantable device when disposed.

[0006] In some embodiments, the inner portion has a first inner portion and a second inner portion. In some embodiments, the first inner portion and the second inner portion are movable relative to the outer portion and relative to each other. In some embodiments, the first inner portion and the second inner portion are movable away from each other in response to a force applied to the outer portion.

[0007] In some embodiments, the outer portion is a balloon that encloses the inner portion. In some embodiments, the ends of the balloon are tapered to guide the implantable device to the placement site. In some embodiments, the balloon includes an inflation valve that is separably connectable to an inflation lumen to enable inflation of the balloon and separation from the inflation lumen when the balloon is disposed.

[0008] In some embodiments, the inner portion has one or more ring-shaped retention members. In some embodiments, the inner portion has first and second toroidal retention members.

[0009] In some embodiments, the inner portion has one or more disk-shaped retaining members. In some embodiments, the implant device further includes a shaft that extends through the implant device. In some embodiments, the shaft extends axially within the implant device, and the inner portion has a first inner portion and a second inner portion that are movable relative to the shaft in response to a radially inward force applied to the implant device when the implant device is disposed at the placement site.

[0010] In some embodiments, the inner portion has one or more disk-shaped retaining members having a plurality of collars that are attached to the shaft and are movable relative to the shaft.

[0011] In some embodiments, the outer portion is expandable when the inner portion transitions from the delivery configuration to the placement configuration. According to various principles of the present disclosure, a method for forming an implant occlusion device includes attaching one or more retaining members onto a shaft, disposing a flexible cover portion over the retaining members and the shaft, and sealing the cover portion to the shaft at the proximal and distal ends to enclose the retaining members within the cover portion.

[0012] In some embodiments, the method further includes slidably attaching one or more retaining members onto the shaft. According to various principles of the present disclosure, a method for occluding a body passageway includes delivering an implant occlusion device to the body passageway, the implant occlusion device having an inner scaffold portion and an outer portion enclosing the inner portion; expanding the outer portion to engage the wall of the body passageway to dispose the implant occlusion device and occlude the body passageway; and transitioning the inner portion to an expanded placement configuration on both sides of the body passageway to fix the implant occlusion device relative to the body passageway and enable resistance to movement from the placement site.

[0013] In some embodiments, the method further includes placing an implantable occlusion device across the pylorus. In some embodiments, the outer portion is a compliant balloon, the inner portion includes first and second inner portions, and the method further includes placing the compliant balloon at the placement site, such that a radially inward force is applied to the compliant balloon by the placement site, compressing a section of the compliant balloon and causing the first and second inner portions to move axially away from each other.

[0014] In some embodiments, the outer portion is a balloon, and the method includes inflating the balloon using an inflation lumen when the balloon is delivered to the placement site, and removing the inflation lumen from the balloon to place the implantable occlusion device at the placement site.

[0015] These and other features and advantages of the present disclosure will be readily apparent from the following detailed description, and the scope of the claimed invention is set forth in the appended claims. The following disclosure is presented with respect to aspects or embodiments, but it should be recognized that individual aspects may be claimed separately or in combination with aspects and features of the embodiments or any other embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] 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 drawing of the drawings may be different. For example, a device may be enlarged so that details can be recognized, but is intended to be scaled in connection with, for example, fitting within a delivery catheter or the working channel of an endoscope. In each figure, identical or substantially 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 clarity and brevity, not all elements in all figures are labeled, nor are all elements of each embodiment shown, if an explanation is not necessary to enable one of ordinary skill in the art to understand the present disclosure.

[0017] The detailed description is better understood in conjunction with the accompanying drawings, in which like reference numerals represent like elements.

Figure 1

Figure 2A

Figure 2B

Figures 3A - 3C

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Figure 4B

[0018] The following detailed description should be read with reference to the drawings that illustrate exemplary embodiments. It should be understood that the present disclosure is not limited to the specific embodiments described, and thus can be modified. All devices, systems, and methods described herein are examples of devices and / or systems and / or methods implemented in accordance with one or more principles of the present disclosure. Each example of an embodiment is provided for illustrative purposes and is not the only way to implement these principles, but merely an example. Accordingly, references to elements, structures, or features in the drawings should be recognized as references to examples of embodiments of the present disclosure and should not be understood as limiting the present disclosure to the specific elements, structures, or features illustrated. Other examples of ways to implement the disclosed principles will occur to those skilled in the art upon reading the present disclosure. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the present disclosure without departing from the scope or spirit of the subject matter. For example, multiple features illustrated or described as part of one embodiment can be used with another embodiment to yield further embodiments. Accordingly, the subject matter is intended to embrace such modifications and variations that are within the scope of the appended claims and their equivalents.

[0019] It will be understood that the present disclosure is described in varying degrees of detail in this application. In certain instances, details that are not necessary for those of ordinary skill in the art to understand the present disclosure, or details that would make it difficult to recognize other details, may be omitted. The terms used herein are for the purpose of describing particular embodiments only 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 being generally understood by those of ordinary skill in the technical field to which the present disclosure pertains. 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.

[0020] As used herein, "proximal" refers to the direction towards or the position closest to the user (such as a medical professional, clinician, technician, operator, or physician, etc., and such terms are used interchangeably herein without intent to limit, including an automatic control system or other aspects) when using the device (e.g., when introducing the device into a patient or during implantation, placement, or delivery), and "distal" refers to the direction away from or the position farthest from the user closest to the delivery device when using the device (e.g., when introducing the device into a patient or during implantation, placement, or delivery). "Longitudinal" means the direction extending along the longer or larger dimension of an element. A "longitudinal axis" extends along the longitudinal extent of an element but is not necessarily straight and does not necessarily maintain a constant form if the element bends or flexes. "Center" means at least generally bisecting a central point and / or being generally equidistant from the periphery or boundary, and a "central axis" with respect to an opening means a line that at least generally bisects the central point of the opening, and when the opening includes, for example, a tubular element, channel, cavity, or hole, extends longitudinally along the length of the opening. As used herein, "channel" or "hole" is not limited to a circular cross-section. As used herein, a "free end" of an element is the end beyond which the element does not extend.

[0021] The present disclosure relates to devices, systems, and methods that can be placed in an anatomical site (which, for convenience in this specification, is referred to as a placement site, but is not intended to be limiting). The devices, systems, and methods of the present disclosure can be used to occlude a body passageway or body lumen. An example of such use is related to occluding the pylorus (e.g., related to creating a gastrojejunostomy). However, it should be understood that the present disclosure is not limited to such use (e.g., occlusion) and can have broader uses and / or configurations. Devices used to occlude a body passageway may be known by various terms that are used interchangeably herein, such as exclusion or occlusion devices. For convenience in this specification, reference is made to an implantable occlusion device, or simply an implantable device, but is not intended to be limiting. The placement of an implantable occlusion device may be performed within, across, or along an anatomical structure. It will be understood that terms such as "within," "across," "along," etc. may be used interchangeably herein without intending to be limiting. The anatomical structure can be a body passageway, body lumen, etc., and the present disclosure is not limited to use with a particular anatomical structure. For convenience and without intending to be limiting, reference may simply be made to a placement site in this specification.

[0022] According to various principles of the present disclosure, an implantable occlusion device is formed with an outer portion and an inner portion. The outer portion can be in the form of a cover portion that covers the inner portion. In some embodiments, the cover portion is formed of a flexible material such as a compliant material. In some embodiments, the cover portion is a sealed structure such as a balloon. The inner portion can be structured to hold the implantable occlusion device in a predetermined position relative to the anatomical structure. For example, the inner portion can be a scaffold type structure having a defined configuration / structure, as opposed to an element that can have a configuration determined by another element. More specifically, the inner portion can have a self-defined structure, as opposed to a flexible compliant element such as an outer portion having a structure or configuration defined by an underlying structure as the inner portion. Such an inner portion can be a scaffold, stent, frame, or the like, and such terms are not intended to be limiting and are used interchangeably herein.

[0023] Conventional stents may have a coating, but such a coating is formed on the stent (e.g., to protect body tissue from the stent, to prevent ingrowth of tissue, etc.) and generally is not separated from or separable from the stent. In contrast, the outer portion of an implantable occlusion device formed in accordance with various principles of the present disclosure can be a separate cover portion disposed over the stent and is disposed between the stent and the anatomical structure (e.g., a body passageway) along which the implantable occlusion device is disposed. Thus, the inner portion can move relative to the outer portion, whereby an implantable occlusion device formed in accordance with various principles of the present disclosure can provide greater flexibility with respect to positioning and placement than can be achieved by prior art devices. Further, the separately formed outer portion can have more structural effects than can be achieved by prior art stents, such as by providing more barriers (e.g., protective barriers) to the stent than are provided by coatings or other features of prior art stents.

[0024] In some embodiments, one or both of the inner and outer portions of the implantable occlusion device are movable from a delivery configuration to an deployed configuration. In the delivery configuration, the implantable occlusion device can be in a compact configuration, such as compressed, constrained, restrained (such terms are used interchangeably herein without intending to be limiting in their various grammatical forms). The compact configuration generally enables the delivery of the implantable occlusion device trans-luminally (i.e., through a body lumen, without the need for an incision) through the body. In the deployed configuration, the implantable occlusion device is expanded to engage the wall of the body lumen. For example, one or both of the inner and outer portions of the implantable occlusion device are expandable. The outer portion can be expanded by the expansion of the inner portion (such as in embodiments where the inner portion is self-expanding). Alternatively, if the outer portion surrounds and encloses the inner portion, an inflation lumen can be coupled to the outer portion to expand the outer portion. The inflation lumen can be removably coupled such that the implantable occlusion device can be deployed without the inflation lumen being coupled to the implantable occlusion device.

[0025] In some embodiments, the inner portion includes one or more retention members configured to fix or hold the implantable occlusion device relative to the deployment site. The retention members are structured to have sufficient strength to hold the inner portion in a predetermined position relative to the anatomical wall of the deployment site and to resist pull-out forces on the device (such as those induced by anatomical movements or processes such as peristalsis when disposed in the gastrointestinal tract). The inner portion can be flexible to conform to the shape of the deployment site where the implantable occlusion device is to be deployed. Nevertheless, the inner portion preferably provides sufficient resistance to movement and a sufficiently strong engagement with the body lumen to prevent the implantable occlusion device from moving relative to the deployment site when deployed.

[0026] As described above, the inner portion of the implantable occlusion device can be formed in various manners, such as forming a scaffold or a stent or a frame structure (e.g., as known in the art). In some embodiments, the scaffold is formed from one or more members / elements (such terms are used interchangeably herein without intending to limit) combined to form a rigid and / or semi-rigid structure. These members can be formed from one or more struts, wires, strands, filaments, ribbons, etc. (such terms are used interchangeably herein without intending to limit), and these struts, wires, strands, filaments, ribbons, etc. are braided, intertwined, woven, knitted, knotted, looped (e.g., bobbin-style), woven, knitted, wound, or in a similar manner to form an expandable and contractible scaffold configuration. Alternatively, the plurality of members forming the implantable medical device may be formed by cutting a structure (e.g., an optionally monolithic cylindrical tubular member) into an expandable configuration (e.g., a stent configuration having flanges at one or both ends) (e.g., by laser cutting), and such cutting forms a plurality of members such as a plurality of strut members.

[0027] The plurality of members forming the inner portion of the implantable occlusion device formed in accordance with various principles of the present disclosure can be formed from various non-limiting preferably biocompatible materials including, but not limited to, for example, metals, metal alloys, polymers, metal-polymer composites, ceramics, and combinations or sub-combinations thereof. For example, the filaments can be formed from various non-limiting preferably biocompatible metals such as, for example, stainless steel, nickel-titanium alloys (e.g., Nitinol), nickel-tungsten or tungsten alloys, cobalt-chromium alloys, cobalt-chromium-nickel-based alloys (e.g., Elgiloy®), nickel-copper alloys, nickel-cobalt alloys, nickel-iron alloys, nickel-chromium alloys, nickel-molybdenum alloys, nickel-chromium-molybdenum alloys, nickel-cobalt-chromium-molybdenum alloys, cobalt-chromium-molybdenum alloys, platinum enriched stainless steel, titanium, or equivalents (including combinations and sub-combinations thereof and other alloys).Additionally or alternatively, the plurality of members forming the implantable medical device can be formed from various non-limiting preferably biocompatible polymers such as polypropylene, polyester, polysulfone, nylon, silicone, polyurethane, polystyrene, polyethylene (PE) (including high-density PE and low-density PE), polyethylene terephthalate (PET), polyethylene naphthalate (PEN), polybutylene terephthalate (PBT), polytrimethylene terephthalate, polyether block amide (PEBA), polyether ether ketone (PEEK), polyether imide (PEI), poly(methyl methacrylate) (PMMA), polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM), polyether block ester, polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polyether-ester, ether or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers), polyamide, block polyamide / ether, polyimide (PI), ethylene vinyl alcohol, ethylene vinyl acetate copolymer (EVA), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide, perfluoro(propyl vinyl ether) (PFA), polyolefin, epoxy, poly(styrene-b-isobutylene-b-styrene), polycarbonate, ionomer, or the like (including mixtures, combinations, sub-combinations, and copolymers thereof). It should be understood that the plurality of members forming the implantable medical device can be formed from any of the above mixtures, composites, combinations, sub-combinations, copolymers, or co-structures. Providing an outer portion over an inner portion can allow for a wider selection of materials for forming the inner portion, such as materials having a lower level of biocompatibility.

[0028] The inner portion of the implantable occlusion device formed in accordance with various principles of the present disclosure can be a self-expanding device as known or previously known to those skilled in the art. For example, the inner portion can be formed from a shape memory or thermoformable material (e.g., nitinol or Elgiloy® or a shape memory polymer), whereby the inner portion can return from a folded delivery configuration to a preformed expanded configuration for positioning the implantable occlusion device upon advancement from a delivery sheath and / or withdrawal of the delivery sheath. Such a delivery sheath can be any suitable tubular elongate member as known to those skilled in the art for delivering a medical device, and the implantable occlusion device can be maintained in a delivery configuration within the member.

[0029] The outer portion can be configured to extend over the inner portion to isolate the inner portion from the body passageway (e.g., from direct contact with the body passageway). In some embodiments, the outer portion is a flexible and / or compliant / soft cover portion. The outer portion can be formed from any of a variety of biocompatible materials. For example, when implanted against a dynamic anatomical site (e.g., the pylorus that is constantly moving / being displaced in configuration), the outer portion can be formed from a compliant or semi-compliant material that allows it to move in response to the movement of the anatomical site where the implantable occlusion device is placed. In some embodiments, the outer portion has a variability in pliability (compliability) along its length and, in some cases, can have a higher pliability along a portion of the outer portion (e.g., can have a higher pliability at a location positioned within the pylorus than at locations positioned on either side of the pylorus). The outer portion can isolate the body passageway from any structural abnormalities, degradation, wear, etc. of the inner portion. Examples of materials that can be used to form the outer portion of an implantable occlusion device formed in accordance with various principles of the present disclosure include, but are not limited to, silicone, polytetrafluoroethylene (PTFE), various block copolymers (e.g., block copolymers composed of hard polyamide blocks and soft polyether blocks such as Pebax®), polyamides (e.g., Grilamid®, Vestamid®, etc.), polyurethane nylon elastomers, thermoplastic elastomers, and other polymeric materials. Such outer portions of implantable occlusion devices formed in accordance with various principles of the present disclosure can protect the body tissue at the placement site and / or the integrity of the inner portion of the device. For example, if a component of the inner portion deteriorates, the inner portion is not in direct contact with the tissue. Thus, any deterioration or other unexpected or unintended changes (other than intended changes such as expansion or flexion) to the inner portion do not affect the tissue at the placement site.As described above, the biocompatible material may be preferred for forming the inner portion of the implantable occlusion device formed according to various principles of the present disclosure. However, biocompatibility is not as important when the outer portion isolates the inner portion from contact with body tissue.

[0030] The outer portion can surround, enclose, or encapsulate the inner portion. For example, the other portion can be in the form of a balloon, and the inner portion is disposed within the balloon. For example, the implantable occlusion device can be disposed across a body passageway (e.g., the pylorus) to be occluded. The outer portion having the form of a balloon can be inflated to occlude the body passageway. The inner portion can be positioned within each end of the balloon and can include a retaining member configured to hold the implantable occlusion device at a generally predetermined position relative to the body passageway. The outer portion extends over the retaining member between the retaining member and the body tissue.

[0031] The implantable occlusion device formed according to various principles of the present disclosure can include a shaft extending through the implantable occlusion device. The shaft can facilitate the placement of the implantable occlusion device. For example, in embodiments where the outer portion encapsulates the inner portion, the shaft can facilitate the expansion of the outer portion for placement in the body passageway. In some embodiments, the shaft can be separable from an inflation lumen used to inflate the outer portion of the implantable occlusion device.

[0032] In some embodiments of an implantable occlusion device having a shaft that penetrates the implantable occlusion device, the inner portion may be axially movable relative to the outer portion, such as by sliding along the shaft. Such movement or adjustment of the position of the inner portion of the implantable occlusion device allows the implantable occlusion device to be adjusted to accommodate placement sites of various sizes (length / width / thickness). In some embodiments, the inner portion is in the form of a stent having a plurality of modified retaining members, such as a plurality of retaining members (e.g., flanges) of a known stent, but without a saddle member connecting the plurality of retaining members. In some embodiments, the inner portion is in the form of one or more, preferably two or more, ring-shaped or toroidal or disk-shaped retaining members. Such a plurality of retaining members may be spaced apart from each other within the outer portion of the implantable occlusion device and may be formed separately from each other.

[0033] In some embodiments, an implantable occlusion device formed in accordance with various principles of the present disclosure has an outer portion formed from a compliant material and an inner portion having a retaining member that is movable relative to the outer portion. The outer portion may completely enclose the inner portion (e.g., may be in the form of a balloon). In embodiments where the outer portion is a sealed structure such as a balloon, the force is substantially evenly distributed over the outer surface of the outer portion, thereby reducing stress concentration in a small area due to the contraction of the implantable occlusion device in response to an anatomical force or the like exerted on the implantable occlusion device. When disposed in a dynamic body passage such as the pylorus, the body passage exerts a force on the implantable occlusion device, causing the plurality of retaining members to move apart. The compliance of the outer portion enables the implantable occlusion device to conform to the body passage and occlude the flow of substances through the body passage. For example, the compliant outer portion is formed from a material that allows the compliant outer portion to "ride" on the waves of contraction (e.g., peristaltic motion) of the body wall at the placement site, thereby conforming with minimal resistance and not experiencing reduced stress or strain that would occur with a lower compliance material. Since the outer portion can be compressed with the contraction of the body wall at the placement site, the plurality of inner portions can move apart. For example, while fixing the implantable occlusion device relative to the body passage and resisting movement of the implantable occlusion device relative to the placement site, the inner portions can move or extend to both ends of the body passage. In embodiments having a plurality of separately formed retaining members (not coupled together with a saddle portion as in prior art stents), the outer portion holds the inner portion in a predetermined position relative to the placement site.

[0034] Various embodiments of devices, systems, and methods for placement at anatomical sites for, among other things, occluding an internal passageway, will be described with reference to the plurality of examples illustrated in the accompanying drawings. References to "one embodiment", "an embodiment", "some embodiments", "other embodiments", etc. in this specification indicate that one or more specific features, structures, concepts, and / or characteristics according to the principles of the present disclosure may be included in the embodiment. However, such references do not necessarily mean that all embodiments include the specific features, structures, concepts, and / or characteristics, or that a particular embodiment includes all features, structures, concepts, and / or characteristics. Some embodiments may include one or more such features, structures, concepts, and / or characteristics in various combinations thereof. One or more of the features, structures, concepts, and / or characteristics described with reference to one embodiment may be combined with one or more of the features, structures, concepts, and / or characteristics of any of the other embodiments provided herein. That is, any of the features, structures, concepts, and / or characteristics described herein may be mixed and adapted to form hybrid embodiments, and such hybrid embodiments are included within the scope of the present disclosure. Further, references to "one embodiment", "an embodiment", "some embodiments", "other embodiments", etc. at various places in this specification do not necessarily all refer to the same embodiment, and distinct or alternative embodiments do not necessarily exclude each other. Further, it should be understood that the various features, structures, concepts, and / or characteristics of the disclosed embodiments are independent and distinct from each other and may be used or exist individually or in various combinations with each other to form alternative embodiments that are considered part of the present disclosure. Accordingly, the present disclosure is not limited to only the embodiments specifically described herein, and it would be very cumbersome to describe all of the numerous possible combinations and sub-combinations of features, structures, concepts, and / or characteristics, and the examples of embodiments disclosed herein are not intended to limit the broader aspects of the present disclosure.The following description is merely illustrative of embodiments and is not intended to limit the broader aspects of the present disclosure.

[0035] In the drawings, common features are identified by common reference elements, and for the sake of brevity and convenience, the description of common features is generally not repeated without intent to limit. For clarity, not all components having the same reference number are numbered. Groups of similar elements may be indicated by numbers and letters. Generally, references to one or such elements or such elements as a group may be made by numbers only (without including letters associated with each similar element). In the following description, between various illustrated embodiments having reference numbers greater than 100, similar elements or components are generally incremented by only multiples of 100 and designated by the same reference number, and redundant descriptions are generally omitted for the sake of brevity. Further, a particular feature in one embodiment may be used across different embodiments and when appearing in different embodiments, is not necessarily individually labeled or described in detail.

[0036] Referring now to the drawings, an example of one embodiment of an implantable occlusion device 100 formed in accordance with various principles of the present disclosure is illustrated in FIG. 1 in an example of a gastric environment. Specifically, the implantable occlusion device 100 is illustrated as being disposed across the pylorus P, with the distal end 101 of the implantable occlusion device 100 positioned within the duodenum D and the proximal end 103 of the implantable occlusion device 100 positioned within the stomach S. In some embodiments, additional implantable devices such as an anastomosis device AD are implanted in the vicinity of the implantable occlusion device 100. For example, in an illustrated example of an embodiment, the anastomosis device AD creates an anastomosis between the stomach S and the jejunum J, and the implantable occlusion device 100 occludes the flow of gastric substances into the duodenum D. In such a configuration, gastric substances are directed from the stomach S through the anastomosis device AD to the jejunum J (rather than the duodenum D).

[0037] According to various principles of the present disclosure, an example of one embodiment of the implantable occlusion device 100 illustrated in FIG. 1 has an outer portion 110 and an inner portion 120 disposed within the outer portion 110. More specifically, in an illustrated example of one embodiment, the inner portion 120 includes two or more portions 120a, 120b that may be movable relative to each other and relative to the outer portion 110. For example, the inner portions 120a, 120b may move axially along the longitudinal axis LA of the implantable occlusion device 100 during natural movements of the implantable occlusion device 100, such as during peristaltic movement (e.g., disposed across the pylorus P). In an illustrated example of one embodiment, the outer portion 110 extends across the placement site with a portion 120a of the inner portion 120 distal to the pylorus P and a portion 120b of the inner portion 120 proximal to the pylorus P. The implantable occlusion device 100 may be closed on the implantable occlusion device 100, for example, by a radially inward force being exerted on the implantable occlusion device 100 by the pylorus P. The outer portion 110 may be compressed radially inward along a portion of the outer portion 110 between the inner portions 120a, 120b, and the inner portions 120a, 120b may be driven to move apart in response to the radially inward force exerted by the pylorus P. According to various principles of the present disclosure, the inner portions 120a, 120b are configured to fix the implantable occlusion device 100 relative to the placement site to resist movement of the implantable occlusion device 100 relative to the placement site.

[0038] An example of an embodiment of the implantable occlusion device 100 as shown in FIG. 1 is illustrated in FIGS. 2A and 2B. The implantable occlusion device 100 is shown in a substantially neutral configuration in FIG. 2A. In FIG. 2B, the implantable occlusion device 100 is shown in a state where a radially inward force (schematically indicated by the arrows shown) is applied to the intermediate section 105 (between the distal end 101 and the proximal end 103 of the implantable occlusion device 100) of the implantable occlusion device 100. As can be understood with reference to FIGS. 2A and 2B, the outer portion 110 has sufficient flexibility or softness to flex (bend) inward when a force is applied to the intermediate section 105 of the illustrated implantable occlusion device 100. Further, the inner portion 120 can be movable relative to the outer portion 110 such that when a force is applied to the intermediate section 105 of the implantable occlusion device 100, it is moved towards both ends 101, 103 of the implantable occlusion device 100. As can be understood with reference to FIGS. 1 and 2B, the inner portions 120a, 120b are advantageously positioned at both ends of the placement site (e.g., inside the stomach S upstream of the pylorus P and inside the duodenum D downstream of the pylorus P), seated against the anatomical structure, and can resist movement of the implantable occlusion device 100 relative to the placement site (such as in a manner known to those skilled in the art).

[0039] In one example of an embodiment illustrated in FIGS. 2A and 2B, the outer portion 110 is formed as a balloon, and the inner portion 120 is formed as two separate inner portions 120a, 120b that are movable relative to each other and relative to the outer portion 110 (e.g., slidable independently along the longitudinal axis LA of the implantable occlusion device 100). The inner portions 120a, 120b can be formed as ring-shaped or toroidal retaining members that are expandable from a delivery configuration to the illustrated deployed configuration. The delivery configuration of the implantable occlusion device 100 (including the outer portion 110 and the inner portion 120) is schematically shown in FIG. 3A, where the implantable occlusion device 100 is in a contracted configuration when first placed at the placement site. The implantable occlusion device 100 can be further contracted for storage within a delivery shaft 150 and delivery to the placement site. The delivery shaft 150 can enable transvascular navigation through the body, such as through the gastrointestinal system. In the deployed configuration as shown in FIGS. 2A and 2B, the inner portion 120 may expand the outer portion 110 (e.g., in the case where the inner portion 120 self-expands upon deployment from the delivery shaft 150), or may simply expand with the expansion of the outer portion 110 (e.g., the expansion of the outer portion 110 in the form of an inflatable balloon as will be described in more detail below with respect to FIGS. 3B and 3C). The outer surface of the inner portion 120 (e.g., defined by the outer diameter of the inner portions 120a, 120b) can contact the inside of the inner portion 120 and engage or seat against the body wall at the placement site via the outer portion 110. In some embodiments, the inner portion 120 supports the outer portion 110.

[0040] An example of one embodiment of the implantable occlusion device 100 illustrated in FIGS. 2A and 2B may include a shaft or mandrel 130 that extends substantially axially through the implantable occlusion device 100 along the longitudinal axis LA of the implantable occlusion device 100. In some embodiments, the outer portion 110 is formed as a balloon that covers and is coupled to the distal end 131 and the proximal end 133 of the mandrel 130. Thus, these ends of the outer portion 110 are sealed to the mandrel 130, and the outer portion 110 may be inflatable to expand the implantable occlusion device 100.

[0041] The distal end 131 of the mandrel 130 may form a guide tip 132 (optionally, together with the outer portion 110 formed thereon) to facilitate the guidance of the implantable occlusion device 100 to the placement site without the need for a guide wire. As can be understood, when the implantable occlusion device 100 is placed and retained at a predetermined position within the body passage and the outer portion 110 is inflated, the typical configuration of a balloon catheter having a catheter with an inflation lumen and a guide wire lumen coupled to the balloon may not be achievable. By forming the distal end 131 of the mandrel 130 as the guide tip 132, the implantable occlusion device 100 can be inserted and delivered without the assistance of a separate guide wire.

[0042] The proximal end 133 of the mandrel 130 can form an inflation port 134 for fluidly coupling with the inflation lumen 160, as shown in FIGS. 3A and 3B. When the implantable occlusion device 100 is deployed from the delivery shaft 150 (as shown, for example, in FIG. 3A), the outer portion 110 can be inflated via the inflation lumen 160, as shown in FIG. 3B. When the implantable occlusion device 100 is fully expanded such that it can be deployed (as schematically shown in FIG. 3B), the inflation lumen 160 is separated (detached) from the inflation port 134, as shown in FIG. 3C, and the implantable occlusion device 100 can be left in place at the deployment site. It is understood that the delivery shaft 150, the inflation lumen 160, and the inflation port 134 can be formed in any desired manner known to those skilled in the art to achieve inflation of an implantable deployable device that is expandable, such as an implantable balloon. For example, the mandrel 130 can include one or more inflation apertures 135 that are in fluid communication with the inflation port 134 and the inflation lumen 160. The inflation port 134 can be self-sealing such that when the inflation lumen 160 is separated from the inflation port 134, the inflation port 134 closes and holds an inflation medium (e.g., saline) within the inflated outer portion 110 of the implantable occlusion device 100.

[0043] It should be understood that other configurations of the implantable occlusion device having an outer portion and an inner portion are also within the scope of the present disclosure and the scope of the technical idea. For example, instead of having an inner portion with an overall shape of a plurality of tori or a plurality of rings, the implantable occlusion device 200 may have an inner portion 220 having one or more disk-shaped retaining members 220a, 220b. With such a configuration of the inner portions 220a, 220b, the inner portions 220a, 220b can extend more greatly in the radial direction from a hub 212 disposed substantially axially centered along a plurality of radially extending flanges 214 to the inside of the outer portion 210. By having the inner portion 220 extend more greatly in the radial direction in this way, the inner portion 220 can conform to (and conform to the outer portion 210) the anatomical structures on both sides of the body passage in which the outer portion 210 extends. For example, the outer portion 210 may conform to a part of the shape of the implantable occlusion device 200 with respect to the body passage, and the inner portion 220 can fix the implantable occlusion device 200 with respect to the placement site by conforming to a plurality of ends of the implantable occlusion device 200 with respect to the anatomical walls at both ends of the body passage in order to resist movement of the implantable occlusion device 200 with respect to the placement site. For example, as illustrated in FIG. 4B, the flange 214 of a particular retaining member 220a may be disposed within the duodenum D and may substantially conform to the duodenal side of the pylorus P. On the other hand, the flange of another retaining member 220b may be disposed within the stomach S and may substantially conform to the gastric side of the pylorus P. It should be understood that the flanges 214 need not be (as illustrated) symmetric. For example, one flange 214 may be configured to conform to the anatomical structure at one end of the placement site (e.g., the anatomical structure of the duodenum), and the other flange 214 may be configured to conform to the anatomical structure at the other end of the placement site (e.g., the anatomical structure of the stomach). As in the example of one embodiment illustrated in FIGS. 2A and 2B, the inner portions 220a, 220b are movable relative to each other and may, for example, be slidable independently along the longitudinal axis LA of the implantable occlusion device 200.

[0044] In embodiments where the mandrels 130, 230 extend through the implantable occlusion devices 100, 200, it should be understood that the inner portions 120, 220 may have radially inner sections that are either spaced from the mandrel 130 (as in the case of the inner portion 120 of the implantable occlusion device 100) or positioned generally closer to the mandrel 230 (as in the case of the inner portion 220 of the implantable occlusion device 200). For example, the inner portion 120 in the form of a torus as shown in FIGS. 2A and 2B may have an inner diameter that is larger than and spaced from the outer diameter of the mandrel 130 around which the inner portion 120 is disposed. In contrast, the inner portion 220 in the form of the retaining members 220a, 220b as shown in FIGS. 4A and 4B may have a collar portion or hub 212 that is positioned closer to the mandrel 230 (or at least closer to the mandrel 230 than the inner diameter of the inner portion 120 in FIGS. 2A and 2B). Nevertheless, it should be understood that the hub 212 may be disposed relative to the mandrel 230 so as to slide relative to the mandrel 230. The plurality of flanges 214 of the inner portion 220 as illustrated in FIGS. 3A and 3B may provide additional structural areas by which the inner portion 220 may secure the implantable occlusion device 200 to the placement site.

[0045] Although the various embodiments of the present disclosure have been described with specific reference to medical devices and systems and procedures for treating the gastrointestinal system, it should be understood that such medical devices and methods may be used to treat tissues such as the abdominal cavity, digestive system, urinary tract, genital tract, respiratory system, cardiovascular system, circulatory system, and the like. It should be understood that the various aspects of the disclosure described above can be applied to other passageways within the body to reduce flow through or otherwise affect other passageways within the body.

[0046] Various additional advantages of the various aspects, features, components, and structures of the embedded devices and / or systems as described above, as well as various aspects of their use and / or manufacture, will be understood by those skilled in the art in addition to those described above.

[0047] 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. Although the devices and methods of the present disclosure have been described with respect to preferred embodiments, it will be apparent to those skilled in the art that variations can be applied to the devices and / or methods, and the steps or order of steps of the methods, without departing from the concepts, teachings, and scope of the present disclosure. All such similar substitutions and modifications that are apparent to those skilled in the art are considered to be within the spirit, scope, and concept of the present disclosure as defined by the appended claims.

[0048] The above description has been presented for purposes of illustration and description as having a wide range of applications, and is not intended to limit the present disclosure to the forms disclosed herein. It should be understood that various additional, changes, and substitutions can be made to the embodiments disclosed herein without departing from the concepts, spirit, and scope of the present disclosure. In particular, it is apparent to those skilled in the art that the principles of the present disclosure can be embodied in other forms, structures, arrangements, ratios, and using other elements, materials, and components without departing from its concepts, spirit, scope, or features. For example, various features of the present disclosure can be grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the present disclosure. However, it should be understood that the various features of a given aspect, embodiment, or configuration of the present disclosure can be combined in alternative aspects, embodiments, or configurations. Although the present disclosure is presented from the perspective of embodiments, it should be understood that not all of the various distinct features of the subject matter need to be present to achieve at least some of the desired characteristics and / or advantages of the subject matter or such individual features. Those skilled in the art can understand that the present disclosure can be used with many variations of structures, mechanisms, ratios, materials, components, and other aspects that are particularly adapted to specific environments and operating requirements without departing from the principles or ideas or scope of the present disclosure. For example, elements shown as being integrally formed may be constructed from multiple parts, or elements shown as multiple parts may be integrally formed, the operation of an element may be reversed or changed in other ways, and the size or dimensions of an element may be changed. Similarly, although operations or actions or procedures have been described in a particular order, this should not be understood as requiring such a particular order to achieve the desired result, nor should it be understood that all operations or actions or procedures should be performed. Also, other implementations are within the scope of the appended claims. In some cases, the operations recited in the claims can be performed in a different order and still achieve the desired result.Accordingly, the embodiments disclosed in this specification should be considered exemplary in all respects and not restrictive, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the foregoing description or specific embodiments or configurations described or illustrated herein. In view of the foregoing, the individual features of any embodiment can be used and can be claimed separately or in combination with the features of that or any other embodiment, and the scope of the subject matter is indicated by the appended claims and is not limited to the foregoing description.

[0049] In the foregoing description and in the following claims, the following may be understood. As used herein, the phrases "at least one", "one or more", and "and / or" are open-ended expressions that are used both conjunctively and disjunctively. Terms such as "a", "the", "first", "second", etc. do not exclude a plurality. For example, "an" entity, as used herein, refers to one or more of that entity. Thus, the terms "a", "one or more", and "at least one" may be used interchangeably herein. The term "or" as used in this specification and the appended claims is generally used in the sense of "and / or" unless otherwise clearly indicated to the contrary for the content thereof. The conjunction "and" as used herein includes each of the structures, components, features, or equivalents so combined, unless the context clearly indicates otherwise, and the conjunction "or" includes one or the other of the structures, components, features, or equivalents so combined, alone and in any combination and number, unless the context clearly indicates otherwise. All references to direction (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used only for identification purposes to assist the reader's understanding of the present disclosure and / or to distinguish the regions of the associated elements from each other, and do not particularly limit the associated elements with respect to the position, orientation, or use of the present disclosure. References to connection (e.g., attached, coupled, connected, engaged, and joined) should be construed broadly and may include intermediate members between sets of elements and relative movement between elements unless otherwise indicated. Thus, references to connection do not necessarily imply that two elements are directly connected and in a fixed relationship to each other. References to identification (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.

[0050] The following claims are incorporated by reference into the forms for carrying out the present invention, and each claim is independent as a separate embodiment of the present disclosure. In the claims, the terms "comprising," "having," "including," and "containing" do not exclude the presence of other elements, components, features, groups, regions, integers, steps, operations, etc. Also, individual features may be included in different claims, but these features can, in some cases, be advantageously combined, and being included in different claims does not imply that a combination of the features is not feasible and / or not advantageous. Also, references to the singular do not exclude the plural. The reference signs in the claims are provided merely as examples for clarification and should in no way be construed as limiting the claims.

Claims

1. An implantable device configured to be delivered to and disposed at a placement site, comprising: an inner scaffold portion movable between a delivery configuration and an expanded placement configuration; and an outer portion formed separately from and disposed over the inner portion, the outer portion being disposed between the body wall at the placement site and the inner portion of the implantable device when disposed.

2. The implantable device according to claim 1, wherein the inner portion includes a first inner portion and a second inner portion.

3. The implantable device according to claim 2, wherein the first inner portion and the second inner portion are movable relative to and with respect to each other.

4. The implantable device according to claim 2 or 3, wherein the first inner portion and the second inner portion are movable away from each other in response to a force applied to the outer portion.

5. The implantable device according to any one of claims 1 to 4, wherein the outer portion is a balloon enclosing the inner portion.

6. The implantable device according to claim 5, wherein an end of the balloon is tapered to guide the implantable device to the placement site.

7. The implantable device according to claim 5 or 6, wherein the balloon includes an inflation valve detachably couplable to an inflation lumen to enable inflation of the balloon and separation from the inflation lumen when the balloon is disposed.

8. The implantable device according to any one of claims 1 to 7, wherein the inner portion includes one or more ring-shaped retaining members.

9. The implantable device according to any one of claims 1 to 8, wherein the inner portion includes first and second toroidal retaining members.

10. The implantable device according to any one of claims 1 to 7, wherein the inner portion includes one or more disk-shaped retaining members.

11. The implantable device according to any one of claims 1 to 10, further comprising a shaft extending through the implantable device.

12. The implantable device according to claim 11, wherein the shaft extends axially within the implantable device, and the inner portion includes a first inner portion and a second inner portion movable relative to the shaft.

13. The implantable device according to any one of claims 1 to 12, wherein the outer portion is expandable when the inner portion transitions from the delivery configuration to the deployment configuration.

14. A method of forming an implantable occlusion device, comprising: attaching one or more retention members onto a shaft; positioning a flexible cover portion over the retention members and the shaft; and sealing the cover portion to the shaft at a proximal end and a distal end to enclose the retention members within the cover portion.

15. The method of claim 14, further comprising slidably attaching the one or more retention members onto the shaft.

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