Device for occluding body access

Abstract

An implantable device (100) is configured to withstand a force applied thereto by an anatomical structure in a deployed position. The implantable device includes an outer portion (110) and an inner portion (120). The outer portion is positioned between the inner portion and a wall of the anatomical deployment location. The outer portion may surround the inner portion. The outer portion may be a compliant balloon that may be compressed in response to a radially inward anatomical force applied thereon. The interior may include one or more portions (120a, 120b) configured to hold the implantable device in the deployed position and resist migration of the implantable device. The inner portion may move with respect to the outer portion. The interior may include one or more portions that may move relative to each other. A shaft (130) may extend through the device, such as to facilitate inflation of the exterior and / or positioning of the interior.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 394,425, filed on August 2, 2023, the entire disclosure of which is incorporated herein by reference for all purposes. Technical Field

[0002] The present invention relates generally to the field of devices, systems and methods for occluding body lumens. Background Art

[0003] For any of a variety of reasons, it may be desirable to occlude or block or plug a body passage. For example, it may be desirable to prevent material from passing through a passage and divert the material to pass through another cavity or passage, such as via a bypass or anastomosis. One type of surgery (called gastric bypass surgery) involves creating an anastomosis between the stomach and a portion of the small intestine downstream of the pylorus, such as a portion of the jejunum. This surgery is intended to cause ingested food to bypass a portion of the small intestine (and be absorbed therein). Therefore, another aspect of this surgery involves occluding the pylorus so that food does not enter the duodenum, but instead passes through the bypass anastomosis and enters the jejunum to reduce the metabolic diseases treated by this surgery.

[0004] Various occlusive devices, such as those for occluding the pylorus, are known in the art. However, some occlusive devices positioned in dynamic environments, such as the pylorus, may show wear and / or even fatigue after prolonged use. For example, a pyloric occlusive device is subjected to constant pressure during digestion as the stomach contracts (approximately once every 20 seconds) in a coordinated wave (gastric slow waves start from the fundus, propagate toward the antrum, and eventually slam the pyloric sphincter shut). Pyloric occlusive devices are typically positioned in the most muscular area of ​​the stomach and must be able to resist regular muscle contractions applied thereto while also resisting migration. Therefore, improvements to occlusive devices, systems, and methods would be welcomed by the industry. Summary of the invention

[0005] The Summary of the Invention is given to aid understanding, and those skilled in the art will appreciate that the various aspects and features of the invention may be advantageously used alone in some cases, or in combination with other aspects and features of the invention in other cases. The inclusion or exclusion of elements, components, etc. in the Summary of the Invention is not intended to limit the scope of the claimed subject matter.

[0006] According to various principles of the present invention, an implantable device configured to be delivered to and deployed at a deployment location includes an inner stent portion that is convertible between a delivery configuration and an expanded deployment configuration; and an outer portion that is formed separately from the inner portion and positioned on the inner portion so that, when deployed, the outer portion is positioned between a body wall at the deployment location and the interior of the implantable device.

[0007] In some embodiments, the interior has a first interior and a second interior. In some embodiments, the first interior and the second interior are movable relative to the exterior and relative to each other. In some embodiments, the first interior and the second interior are movable away from each other in response to a force applied to the exterior.

[0008] In some embodiments, the outer portion is a balloon surrounding the inner portion. In some embodiments, the end of the balloon is tapered to guide the implantable device to a deployment position. In some embodiments, the balloon includes an inflation valve detachably coupled to the inflation chamber to allow inflation of the balloon and separation from the inflation chamber when the balloon is deployed.

[0009] In some embodiments, the interior has one or more annular retaining members. In some embodiments, the interior has first and second annular retaining members.

[0010] In some embodiments, the interior has one or more disc-shaped retaining members.

[0011] In some embodiments, the implantable device further comprises a shaft extending through the implantable device. In some embodiments, the shaft extends axially within the implantable device and has a first interior and a second interior that are movable relative to the shaft in response to a radially inward force applied to the implantable device when the implantable device is deployed in the deployed position.

[0012] In some embodiments, the interior has one or more disc-shaped retaining members having a collar mounted on the shaft and movable relative to the shaft.

[0013] In some embodiments, the outer portion can expand when the inner portion is transformed from the transport configuration to the deployed configuration.

[0014] According to various principles of the present invention, a method of forming an implantable occlusive device includes mounting one or more retaining members on a shaft; positioning a compliant cover portion over the retaining members and the shaft; and sealing the cover portion relative to the shaft at proximal and distal ends to enclose the retaining members therein.

[0015] In some embodiments, the method further comprises slidably mounting one or more retaining members on the shaft.

[0016] According to various principles of the present invention, a method for occluding a body passage includes delivering an implantable occluding device to a body passage, the implantable occluding device having an inner stent portion and an outer portion surrounding the inner portion; expanding the outer portion to engage a wall of the body passage to deploy the implantable occluding device and occlude the body passage; and allowing the inner portion to transition to an expanded deployed configuration on either side of the body passage to anchor the implantable occluding device relative to the body passage to resist migration from a deployed position.

[0017] In some embodiments, the method further comprises deploying an implantable occlusive device through the pylorus.

[0018] In some embodiments, the outer portion is a compliant balloon and the inner portion includes first and second inner portions, and the method further includes deploying the compliant balloon in a deployment position, which applies a radially inward force to the compliant balloon to compress segments of the compliant balloon and move the first and second inner portions axially apart from each other.

[0019] In some embodiments, the outer portion is a balloon, and the method further comprises inflating the balloon with the inflation lumen when the balloon is delivered to the deployment site, and removing the inflation lumen from the balloon to deploy the implantable occlusive device at the deployment site.

[0020] These and other features and advantages of the present invention will become apparent from the following detailed description, and the scope of the invention claimed for protection is set forth in the appended claims. Although the following disclosure is presented in terms of various aspects or embodiments, it should be understood that individual aspects may be claimed individually or in combination with various aspects and features of this or any other embodiment. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Non-limiting embodiments of the present invention are described by way of example with reference to the accompanying drawings which are schematic and not intended to be drawn to scale. The accompanying drawings are provided for illustration purposes only, and the dimensions, positions, orders, and relative sizes reflected in the drawings in the accompanying drawings may vary. For example, the device may be enlarged so that the details are discernible, but is intended to be reduced with respect to, for example, being assembled in a delivery catheter or working channel of an endoscope. In the accompanying drawings, identical or nearly identical or equivalent elements are generally represented by the same reference characters, and similar elements are generally named with similar reference numerals that differ in increments of 100, with redundant descriptions omitted. For clarity and simplicity, not every element is indicated in each figure, and not every element of each embodiment shown is necessary to allow a person of ordinary skill in the art to understand the present invention.

[0022] The detailed description will be better understood in conjunction with the accompanying drawings, wherein like reference characters represent like elements, as described below:

[0023] Figure 1 A perspective view of one embodiment of an implantable device formed in accordance with various aspects of the present invention and positioned in a schematic diagram of a gastrointestinal environment is shown;

[0024] Figure 2A A perspective view showing an example of an embodiment of an implantable occlusive device formed according to various principles of the present invention;

[0025] Figure 2B Shows such as Figure 2A A front view of an example of an embodiment of an implantable occlusive device in which a force is applied to a middle section thereof;

[0026] FIG. 3A to FIG. 3C illustrates various stages of an example of a manner of inflating components of an implantable occlusive device formed according to various principles of the present invention;

[0027] Figure 4A An elevation view showing another example of an embodiment of an implantable occlusive device formed according to various principles of the present invention;

[0028] Figure 4B A schematic diagram of an environment in which an implantable occlusive device may be implanted is shown, for example Figure 3A A front view of an example of an embodiment of an implantable occlusive device in FIG. DETAILED DESCRIPTION

[0029] The following detailed description should be read with reference to the accompanying drawings, which depict illustrative embodiments. It should be understood that the present invention is not limited to the specific embodiments described and may therefore vary. All devices and systems and methods discussed herein are examples of devices and / or systems and / or methods implemented according to one or more principles of the present invention. Each example of an implementation is provided in an explanatory manner and is not the only way to implement these principles, but is merely an example. Therefore, references to elements or structures or features in the accompanying drawings must be understood as references to examples of implementations of the present invention and should not be understood as limiting the present invention to the specific elements, structures or features shown. Other examples of ways to implement the disclosed principles will occur to those of ordinary skill in the art when reading the present invention. In fact, it will be apparent to those of ordinary skill in the art that various modifications and variations can be made in the present invention without departing from the scope or spirit of the present subject matter. For example, features illustrated and described as part of one embodiment can be used together with another embodiment to produce a further embodiment. Therefore, the present subject matter is intended to cover such modifications and variations within the scope of the appended claims and their equivalents.

[0030] It should be understood that the present invention is explained in various levels of detail in this application. In some cases, details that are unnecessary for a person of ordinary skill in the art to understand the present invention or that make other details difficult to perceive may have been omitted. The terms used in this article are only used to describe specific embodiments and are not intended to be limited beyond the scope of the appended claims. Unless otherwise specified, the technical terms used herein are to be understood as commonly understood by a person of ordinary skill in the art to which the present invention belongs. According to the present invention, all devices and / or methods disclosed and claimed herein can be manufactured and performed without excessive experimentation.

[0031] As used herein, "proximal" means closest to a user (a medical professional or clinician or technician or operator or physician, etc., such terms are used interchangeably herein and are not intended to be limiting, and include automated controller systems or others), etc., such as when the device is used (e.g., when the device is introduced into a patient, or during implantation, positioning or delivery), and / or the direction or position closest to a delivery device, and "distal" means farthest from a user, such as when the device is used (e.g., when the device is introduced into a patient, or during implantation, positioning or delivery), and / or the direction or position closest to a delivery device. "Longitudinal" means extending along the longer or larger dimension of an element. "Longitudinal axis" extends along the longitudinal extent of an element, but is not necessarily straight, and does not necessarily maintain a fixed configuration if the element flexes or bends. "Center" means at least generally bisecting a center point and / or being generally equidistant from a perimeter or border, and "central axis" means a line at least generally bisecting a center point of an opening relative to an opening, which extends longitudinally along the length of the opening when the opening comprises, for example, a tubular element, a passage, a cavity or a hole. As used herein, a "channel" or "hole" is not limited to a circular cross-section. As used herein, a "free end" of an element is a terminal end beyond which such element does not extend.

[0032] The present invention relates to devices, systems and methods that can be positioned at an anatomical site (which, for convenience and without limitation, is referred to herein as a deployment site). The devices, systems and methods of the present invention can be used to occlude a body passage or cavity. An example of such a use is related to occluding the pylorus (e.g., related to creating a gastrojejunal anastomosis). However, it should be understood that the present invention is not limited to such uses (e.g., occlusion) and can have a wider range of uses and / or configurations. Devices for occluding body passages may be known by various terms, which can be used interchangeably herein, such as exclusion or blocking devices. For convenience and without limitation, reference is made herein to implantable occluding devices or simply implantable devices. Implantable occluding devices can be deployed at an anatomical structure or through or along an anatomical structure. It should be understood that terms such as at, through, along, etc. can be used interchangeably herein and are not intended to be limiting. The anatomical structure can be a body passage, a cavity, etc., and the present invention is not limited to use with a specific anatomical structure. For convenience and without limitation, reference is simply made to the deployment site in this article.

[0033] According to various principles of the present invention, an implantable occlusive device is formed with an exterior and an interior. The exterior can take the form of a cover portion on the interior. In some embodiments, the cover portion is formed by a flexible material, such as a compliant material. In some embodiments, the cover portion is a closed structure, such as a balloon. The interior can be configured to be relevant to the anatomical structure to keep the implantable occlusive device in place. For example, the interior can be a stent-type structure with a defined morphology / structure, which is contrary to an element that may have a morphology determined by another element. More particularly, the interior can have a customized structure, which is contrary to an exterior with a flexible compliant element, such as having a structure or morphology defined by an underlying structure such as the interior. This interior can be a skeleton, a stent, a framework, etc., and this term is used interchangeably herein and is not intended to be limiting.

[0034] Although previous stents may have coatings, such coatings are formed on the stent (e.g., to protect body tissue from the influence of the stent, to prevent tissue ingrowth, etc.) and are generally not or cannot be separated from the stent. On the contrary, the outside of the implantable occlusive device formed according to the various principles of the present invention can be a separate cover portion positioned on the stent to be positioned between the anatomical structure (e.g., body passage) and the stent, along which the implantable occlusive device is to be deployed. Therefore, the inside can be moved relative to the outside, which can provide an implantable occlusive device formed according to the various principles of the present invention, which has a greater degree of flexibility in positioning and deployment than that achieved by prior art devices. In addition, the separately formed outside may have a greater structural impact than that achieved by prior art stents, such as by providing a larger barrier (e.g., a protective barrier) to the stent than provided by the coating or other features of the prior art stents.

[0035] In some embodiments, one or both of the interior and exterior of the implantable occluding device can be converted from a delivery configuration to a deployment configuration. In the delivery configuration, the implantable occluding device can be in a compact configuration, such as a compressed, constrained, restricted, etc. configuration (such terms in various grammatical forms thereof can be used interchangeably herein without limitation). The compact configuration generally allows the implantable occluding device to be delivered through the body via the cavity (i.e., through a body passage without the need for open surgery). In the deployment configuration, the implantable occluding device expands, such as to engage the wall of a body passage. For example, one or both of the interior and exterior of the implantable occluding device are expandable. The exterior can be expanded by the expansion of the interior (such as, in an embodiment where the interior is self-expanding). Alternatively, if the exterior encapsulates and surrounds the interior, the inflation cavity can be connected to the exterior to expand the exterior. The inflation cavity can be removably connected to allow the implantable occluding device to be deployed without the inflation cavity being connected to the implantable occluding device.

[0036] In some embodiments, the interior includes one or more retaining members configured to anchor or otherwise retain the implantable occluding device relative to the deployment position. The retaining member can be constructed to have sufficient strength to retain the interior in a suitable position relative to the anatomical wall of the deployment position, and to resist the pull-out force on the device (such as, induced by anatomical movement or process, such as peristalsis, if deployed in the gastrointestinal tract). The interior can be flexible, such as in a shape that conforms to the deployment position, and the implantable occluding device is deployed at the deployment position. Nevertheless, the interior preferably provides sufficient resistance to movement and a sufficiently strong engagement with the body passage to prevent the implantable occluding device from moving relative to the deployment position after deployment.

[0037] As described above, the interior of the implantable occlusive device can be formed in various ways (e.g., as known in the art), such as to form a skeleton or stent or framework structure. In some embodiments, the stent is formed by one or more components / elements (such terms are used interchangeably herein and are not intended to be limited) that are combined to form a rigid and / or semi-rigid structure. The component can be formed by one or more pillars, wires, strands, filaments, bands, etc. (such terms are used interchangeably herein and are not intended to be limited), which are braided, interlocked, entangled, interwoven, knitted, knotted, looped (e.g., bobbin-like), woven, woven, wound, etc. to form an expandable and retractable stent morphology. Alternatively, the component forming the implantable medical device can be formed by cutting (e.g., laser cutting) the structure (e.g., optionally a cylindrical tubular member that is an integral part) into an expandable morphology (e.g., a stent morphology with a flange on one or both ends), and the incision forms a component, such as a pillar component.

[0038] The components forming the interior of the implantable medical device formed according to the various principles of the present invention can be formed of various non-limiting preferably biocompatible materials, such as but not limited to metals, metal alloys, polymers, metal-polymer composites, ceramics, and combinations or sub-combinations thereof. For example, the filaments can be formed of various non-limiting preferably biocompatible metals, such as but not limited to stainless steel, nickel-titanium alloys such as nitinol, nickel-tungsten or tungsten alloys, cobalt-chromium alloys, cobalt-chromium-nickel-based alloys such as tungsten, and the like. Nickel copper alloy, nickel cobalt alloy, nickel iron alloy, nickel chromium alloy, nickel molybdenum alloy, nickel chromium molybdenum alloy, nickel cobalt chromium molybdenum alloy, cobalt chromium molybdenum alloy, platinum-rich stainless steel, titanium, etc., including combinations and sub-combinations thereof and other alloys. Additionally or alternatively, the components forming the implantable medical device can be formed of various non-limiting preferred biocompatible polymers, such as but not limited to, polypropylene, polyester, polysulfone, nylon, silicone, polyurethane, polystyrene, polyethylene (PE) (including high density and low density PE), polyethylene terephthalate (PET), polyethylene naphthalate (PEN), polybutylene terephthalate (PBT), polytrimethylene terephthalate, polyether block amide (PEBA), polyether ether ketone (PEEK), polyetherimide (PEI), poly(methyl methacrylate) (PMMA), polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene Polypropylene (FEP), polyoxymethylene (POM), polyether block ester, polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polyether ester, ether or ester-based copolymer (e.g., butylene phthalate / poly (alkylene ether) ester and / or other polyester elastomers), polyamide, block polyamide / ether, polyimide (PI), ethylene vinyl alcohol, ethylene-vinyl acetate copolymer (EVA), polyphenylene sulfide (PPS), polyphenylene ether (PPO), polyparaphenylene terephthalamide, perfluoro (propyl vinyl ether) (PFA), polyolefins, epoxy resins, poly (styrene-b-isobutylene-b-styrene), polycarbonate, ionomers, etc., including mixtures, combinations, sub-combinations and copolymers thereof. It should be understood that the components forming the implantable medical device can be formed from a mixture, composite, combination, sub-combination, copolymer or co-construction of any of the above. Providing the exterior on the interior can allow for a wider selection of materials for forming the interior, such as materials with a lower level of biocompatibility.

[0039] The interior of an implantable occlusive device formed according to various principles of the present invention can be a self-expanding device, such as those known or heretofore known to those of ordinary skill in the art. For example, the interior can be made of a shape memory or thermoformable material (e.g., nitinol or The delivery sheath may be formed of a material such as a polyimide or a shape memory polymer such that the interior returns from a collapsed delivery configuration to a preformed expanded configuration when the delivery sheath is advanced from the delivery sheath and / or when the delivery sheath is withdrawn to deploy the implantable occlusive device. Such a delivery sheath may be any acceptable tubular elongated member, such as those known to those of ordinary skill in the art for delivering medical devices, and which may retain the implantable occlusive device therein in a delivery configuration.

[0040] The exterior can be configured to extend over the interior, such as to isolate the interior from a body passage (e.g., to avoid direct contact with the body passage). In some embodiments, the exterior is a flexible and / or compliant / compliant cover portion. The exterior can be formed by any of a variety of biocompatible materials. For example, if implanted in relation to a dynamic anatomical site (e.g., a pylorus that is constantly moving / converting its form), the exterior can be formed by a compliant or semi-compliant material that is convenient for moving in response to the movement of the anatomical site relative to the position of the implantable occlusive device being deployed. In some embodiments, the exterior has a compliance that varies along its length, and in some cases, may have greater compliance along a portion thereof (e.g., a position to be positioned in the pylorus has greater compliance than a position to be positioned on either side of the pylorus). The exterior can isolate the body passage from any structural abnormalities, degradation, wear, etc. of the interior. Examples of materials that may be used to form the exterior of an implantable occlusive device formed according to various principles of the present invention include polymeric materials such as, but not limited to, silicone, polytetrafluoroethylene (PTFE), various block copolymers (e.g., block copolymers composed of rigid polyamide blocks and soft polyether blocks, such as ), polyamides (e.g. The exterior of the implantable occlusive device formed according to the various principles of the present invention can protect the integrity of the body tissue and / or the interior of the device at the deployment location. For example, if the internal components degrade, the interior will not be in direct contact with the tissue. Therefore, any degradation or other unexpected or unexpected changes in the interior (changes other than expected changes, such as expansion or flexure) will not affect the tissue at the deployment location. As described above, although biocompatible materials may be more suitable for forming the interior of the implantable occlusive device formed according to the various principles of the present invention, if the exterior isolates the interior to prevent it from contacting the body tissue, less attention is paid to biocompatibility.

[0041] The exterior can enclose or surround or encapsulate the interior. For example, the other portion can take the form of a balloon in which the interior is positioned. For example, the implantable occluding device can be deployed through a body passage (e.g., pylorus) to be occluded. The exterior in the form of a balloon can be inflated to occlude the body passage. The interior can include a retaining member positionable within each end of the balloon and configured to hold the implantable occluding device approximately in a suitable position relative to the body passage. The exterior extends over the retaining member between the retaining member and the body tissue.

[0042] The implantable occlusive device formed according to various principles of the present invention may include a shaft extending therethrough. The shaft may facilitate deployment of the implantable occlusive device. For example, in embodiments where the exterior surrounds the interior, the shaft may facilitate expansion of the exterior to be deployed through a body passage. In some embodiments, the shaft may be separated from an inflation chamber for inflating the exterior of the implantable occlusive device.

[0043] In some embodiments where the implantable occluding device has an axis passing therethrough, the interior can be axially movable relative to the exterior, such as by sliding along the axis. This movement or adjustability of the position of the interior of the implantable occluding device allows the adjustability of the implantable occluding device to adapt to deployment positions with different sizes (length / width / thickness). In some embodiments, the interior adopts a form of a support with a modified retaining member, such as a retaining member (e.g., flange) of a known stent, but without a saddle-shaped member connecting the retaining member. In some embodiments, the interior adopts one or more, and preferably two or more annular or annular or disc-shaped retaining members. Such retaining members can be spaced apart from each other in the exterior of the implantable occluding device, and can be formed separately from each other.

[0044] In some embodiments, the implantable occlusive device formed according to various principles of the present invention has an outer portion formed of a compliant material, and an inner portion having a retaining member that can move relative to the outer portion. The outer portion can completely surround the inner portion (e.g., it can take the form of a balloon). In an embodiment where the outer portion is a closed structure, such as a balloon, the force can be substantially evenly distributed on the outer surface of the outer portion, thereby reducing the stress concentration in a small area caused by the contraction of the implantable occlusive device, such as in response to the anatomical force applied thereto. When placed through a dynamic body passage, such as the pylorus, the body passage can exert a force on the implantable occlusive device, which can cause the retaining member to separate. The compliance of the outer portion allows the implantable occlusive device to conform to the body passage and the flow of the occlusive material through the body passage. For example, the compliant outer portion can be formed by a material that allows the compliant outer portion to "ride" the contraction wave (e.g., peristalsis) of the body wall at the deployment position, thereby conforming to the minimum resistance, and therefore not subject to stress or strain that may otherwise weaken the less compliant material. Since the outer portion may be compressed with the contraction of the body wall at the deployment position, the inner portion may separate. For example, the inner portion can translate or extend to either end of the body passageway while anchoring the implantable occlusive device relative to the body passageway to resist migration of the implantable occlusive device relative to the deployed position. In embodiments having a separately formed retaining member (not coupled to the saddle portion as in prior art stents), the outer portion holds the inner portion in position relative to the deployed position.

[0045] Various embodiments of devices, systems and methods for deployment at anatomical locations, such as for occluding body passages, will now be described with reference to the examples shown in the accompanying drawings. References to "one embodiment", "embodiments", "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 invention may be included together with the embodiment. However, such references do not necessarily mean that all embodiments include specific features, structures, concepts and / or characteristics, or that one 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. It should be understood that one or more of the features, structures, concepts and / or characteristics described with reference to one embodiment may be combined with one or more of the features, structures, concepts and / or characteristics of any of the other embodiments provided herein. That is, any of the features, structures, concepts and / or characteristics described herein may be mixed and matched to create a hybrid embodiment, and such a hybrid embodiment is within the scope of the present invention. In addition, references to "one embodiment", "embodiments", "some embodiments", "other embodiments", etc. in various places in the specification do not necessarily all refer to the same embodiment, nor are they necessarily separate or alternative embodiments that are mutually exclusive with other embodiments. It should also be understood that the various features, structures, concepts and / or characteristics of the disclosed embodiments are independent and separate from each other and can be used or presented individually or in various combinations with each other to create alternative embodiments that are considered to be part of the present invention. Therefore, the present invention is not limited to the embodiments specifically described herein, because it would be too cumbersome to describe all 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 invention. The following description is merely an illustrative example of an embodiment and is not intended to limit the broader aspects of the present invention.

[0046] In the accompanying drawings, it should be understood that common features are identified by common reference elements, and for the sake of brevity and convenience and not intended to be limiting, the description of common features is usually not repeated. For the sake of clarity, not all parts with the same reference numerals are numbered. In addition, a group of similar elements can be indicated by numbers and letters, and usually only a number can be used to refer to an element or such an element or such an element as a group (excluding letters associated with each similar element). It should be understood that in the following description, similar elements or parts with reference numerals greater than 100 in various illustrated embodiments are generally marked with the same reference numerals increased by multiples of 100, and for the sake of brevity, redundant descriptions are usually omitted. In addition, some features in one embodiment can be used across different embodiments, and do not need to be individually marked when appearing in different embodiments.

[0047] Turning now to the accompanying drawings, Figure 1 1 shows an example of an embodiment of an implantable occlusive device 100 formed according to various principles of the present invention in an example of a gastric environment. Specifically, the implantable occlusive device 100 is shown deployed across the pylorus P, wherein the distal end 101 of the implantable occlusive device 100 is positioned within the duodenum D, and the proximal end 103 of the implantable occlusive device 100 is positioned within the stomach S. In some embodiments, an additional implantable device, such as an anastomotic device AD, is implanted in the vicinity of the implantable occlusive device 100. For example, in the example of the embodiment shown, the anastomotic device AD ​​creates an anastomosis between the stomach S and the jejunum J, and the implantable occlusive device 100 occludes the flow of gastric material into the duodenum D. Using this arrangement, gastric material is redirected from the stomach S to the jejunum J (rather than the duodenum D) via the anastomotic device AD.

[0048] According to various principles of the present invention, Figure 1 The example of an embodiment of the implantable occlusive device 100 shown has an outer portion 110 and an inner portion 120 positioned within the outer portion 110. More specifically, in the example of the embodiment shown, the inner portion 120 includes two or more portions 120a, 120b that can move relative to each other and relative to the outer portion 110. For example, during natural movement of the implantable occlusive device 100, such as during peristalsis (when deployed, for example, through the pylorus P), the inner portions 120a, 120b can be axially translated along the longitudinal axis LA of the implantable occlusive device 100. In the example of the embodiment shown, the outer portion 110 extends through the deployed position, wherein one portion 120a of the inner portion 120 is located distally of the pylorus P, and one portion 120b of the inner portion 120 is located proximally of the pylorus P. The pylorus P can be closed onto the implantable occlusive device 100, such as by exerting a radially inward force on the implantable occlusive device 100. The outer portion 110 can be compressed radially inwardly along a portion thereof between the inner portions 120a, 120b, and the inner portions 120a, 120b can be driven apart in response to a radially inward force applied by the pylorus P. In accordance with various principles of the present invention, the inner portions 120a, 120b are configured to anchor the implantable occlusive device 100 relative to the deployed position to resist migration of the implantable occlusive device 100 relative to the deployed position.

[0049] exist Figure 2A and Figure 2B An implantable occlusive device 100, such as Figure 1 An example of an embodiment is shown. The implantable occlusive device 100 is Figure 2A In the generally neutral form. Figure 2B, the implantable occlusive device 100 is shown with a radially inward force (schematically shown by the arrows) applied to the middle section 105 of the implantable occlusive device 100 (between the distal end 101 and the proximal end 103 of the implantable occlusive device 100). Figure 2A and Figure 2B It can be appreciated that the outer portion 110 is sufficiently flexible or compliant to bend inwardly when a force is applied to the middle section 105 of the implantable occlusive device 100 as shown. In addition, the inner portion 120 can move relative to the outer portion 110 to move toward either end 101, 103 of the implantable occlusive device 100 when a force is applied to the middle section 105 of the implantable occlusive device 100. As can be seen in FIG. Figure 1 and Figure 2B It is understood that the inner portions 120a, 120b can be advantageously positioned at the ends of the deployment location (e.g., in the stomach S upstream of the pylorus P, and in the duodenum D downstream of the pylorus P) and seated against the anatomical structure to resist migration of the implantable occlusive device 100 relative to the deployment location (such as, in a manner known to those of ordinary skill in the art).

[0050] exist Figure 2A and Figure 2B In the example of the embodiment shown in , the outer portion 110 is formed as a balloon, and the inner portion 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., independently slidable along the longitudinal axis LA of the implantable occlusive device 100). The inner portions 120a, 120b can be formed as an annular or doughnut-shaped retaining member that can be expanded from a delivery configuration to a deployment configuration as shown. Figure 3A Schematically illustrates a delivery configuration of an implantable occlusive device 100 (including an outer portion 110 and an inner portion 120), wherein the implantable occlusive device 100 is in a collapsed configuration, such as initially deployed at a deployment location. The implantable occlusive device 100 may be further collapsed for delivery to a deployment location within a delivery shaft 150. The delivery shaft 150 may be capable of transluminal navigation through the body, such as through the gastrointestinal system. In the deployed configuration, such as Figure 2A and Figure 2B As shown in FIG. 1 , the inner portion 120 may cause the outer portion 110 to expand (such as if the inner portion 120 self-expands when deployed from the delivery shaft 150), or may simply expand with the expansion of the outer portion 110 (e.g., inflation of the outer portion 110 in the form of an inflatable balloon, as described below with respect to FIG. Figure 3B and Figure 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 interior of the inner portion 120 and engage or seat against the body wall at the deployment location via the outer portion 110. In some embodiments, the inner portion 120 supports the outer portion 110.

[0051] Figure 2A and Figure 2B The example of an embodiment of the implantable occlusive device 100 shown in FIG may include a shaft or mandrel 130 extending axially therethrough generally along the longitudinal axis LA of the implantable occlusive device 100. In some embodiments, the outer portion 110 is formed as a balloon formed on and coupled to the distal end 131 and the proximal end 133 of the mandrel 130. Thus, the ends of the outer portion 110 are sealed to the mandrel 130, and the outer portion 110 may be inflatable to expand the implantable occlusive device 100.

[0052] The distal end 131 of the mandrel 130 can form a guide tip 132 (optionally with the outer portion 110 formed thereon) to facilitate guiding the implantable occlusive device 100 to a deployment location without the need for a guide wire. As can be appreciated, if the implantable occlusive device 100 is to be deployed and retained in a proper position within a body passageway, and the outer portion 110 is to be inflated, the typical form of a balloon catheter in which the catheter has an inflation lumen and a guide wire lumen coupled to the balloon may not be feasible. Forming the distal end 131 of the mandrel 130 as a guide tip 132 allows the implantable occlusive device 100 to be inserted and delivered without the aid of a separate guide wire.

[0053] The proximal end 133 of the mandrel 130 may define an inflation port 134 for fluidly coupling with the inflation lumen 160, such as Figure 3A and Figure 3B Once the implantable occlusive device 100 is deployed from the delivery shaft 150 (e.g., Figure 3A As shown), the outer portion 110 can be inflated via the inflation chamber 160, as shown in FIG. Figure 3B Once the implantable occlusive device 100 has been sufficiently expanded for deployment ( Figure 3B ), the inflation chamber 160 can be separated from the inflation port 134, such as Figure 3C As shown, the delivery shaft 150, the inflation lumen 160, and the inflation port 134 can be formed in any desired manner known to those of ordinary skill in the art to achieve inflation of an expandable, implantable, deployable device, such as an implantable balloon. For example, the mandrel 130 can include one or more inflation holes 135 that are in fluid communication with the inflation port 134 and the inflation lumen 160. The inflation port 134 can be self-sealing so that once the inflation lumen 160 is separated from it, the inflation port 134 will close to keep the inflation medium (e.g., saline) within the inflated outer portion 110 of the implantable occlusive device 100.

[0054] It should be understood that other forms of implantable occlusive devices with an exterior and interior are within the scope and spirit of the present invention. For example, the implantable occlusive device 200 can have an interior 220 having one or more disc-shaped retaining members 220a, 220b, rather than having an interior that is roughly shaped as a ring or annulus. This configuration of the interior 220a, 220b allows the interior 220a, 220b to extend along the radially extending flange 214 from the hub 212 positioned approximately axially in the center to a greater radial range of the interior of the exterior 210. This increased radial range of the interior 220 allows the interior 220 to conform to the anatomical structures on either side of the body passage through which the exterior 210 extends (and the exterior 210 conforms to the body passage). For example, the outer portion 210 can conform a portion of the shape of the implantable occlusive device 200 to a body passage, and the inner portion 220 can conform an end of the implantable occlusive device 200 to an anatomical wall at either end of the body passage to anchor the implantable occlusive device 200 to a deployed location to resist migration of the implantable occlusive device 200 to a deployed location. Figure 4B As shown, the flange 214 of one retaining member 220a can be positioned in the duodenum D and can generally conform to the duodenal side of the pylorus P, while the flange of the other retaining member 220b can be positioned in the stomach S and can generally conform to the gastric side of the pylorus P. It should be understood that the flanges 214 do not need to be symmetrical (as shown). For example, one flange 214 can be configured to conform to the anatomical structure at one end of the deployed position (e.g., the anatomical structure of the duodenum), and the other flange 214 can be configured to conform to the anatomical structure at the other end of the deployed position (e.g., the gastric anatomy). As shown in Figure 2A and Figure 2B In the example of the embodiment shown, the inner portions 220a, 220b can move relative to each other, such as can slide independently along the longitudinal axis LA of the implantable occlusive device 200.

[0055] It should be appreciated that in embodiments where the mandrel 130, 230 extends through the implantable occlusive device 100, 200, the inner portion 120, 220 may have a radially inwardly positioned segment that is spaced apart from the mandrel 130 (as in the case of the inner portion 120 of the implantable occlusive device 100), or that is generally positioned more closely relative to the mandrel 230 (as in the case of the inner portion 220 of the implantable occlusive device 200). For example, Figure 2A and Figure 2B As shown, the inner portion 120 in the form of a ring may have an inner diameter that is larger than and spaced apart from the outer diameter of the mandrel 130 about which the inner portion 120 is mounted. Figure 4A and Figure 4BThe inner portion 220 in the form of retaining members 220a, 220b shown in FIG. 1 may have a collar portion or hub 212 positioned more closely relative to the spindle 230 (or at least more closely relative to the spindle 130 than the spindle 130). Figure 2A and Figure 2B It should be understood that the hub 212 may nevertheless be positioned relative to the spindle 230 so as to slide relative thereto. Figure 3A and Figure 3B The flange 214 of the illustrated inner portion 220 can provide additional structural area upon which the inner portion 220 can anchor the implantable occlusive device 200 relative to the deployed position.

[0056] Although embodiments of the present invention may be described with particular reference to medical devices and systems and procedures for treating the gastrointestinal system, it should be understood that such medical devices and methods may also be used to treat tissues of the abdominal cavity, digestive system, urinary tract, reproductive tract, respiratory system, cardiovascular system, circulatory system, etc. It should be understood that various aspects of the above invention may be applied to other passageways in the body to reduce flow through the passageway or in other situations.

[0057] In addition to those discussed above, one of ordinary skill in the art may appreciate various further benefits of various aspects, features, components and structures of implantable devices and / or systems such as described above, and various aspects of their use and / or manufacture.

[0058] According to the present invention, all devices and / or methods disclosed and claimed herein can be made and performed without undue experimentation. Although the devices and methods of the present invention have been described in view of preferred embodiments, it is obvious to those skilled in the art that changes can be applied to the devices and / or methods and the steps or step sequences of the methods described herein without departing from the concept, spirit and scope of the present invention. For those skilled in the art, all such similar substitutions and modifications are considered to be within the spirit, scope and concept of the present invention as defined by the appended claims.

[0059] The above discussion has wide applicability and has been proposed for the purpose of illustration and description, and is not intended to limit the present invention to the form disclosed herein. It should be understood that various supplements, modifications and replacements can be made to the embodiments disclosed herein without departing from the concept, spirit and scope of the present invention. In particular, for those skilled in the art, the principles of the present invention can be embodied in other forms, structures, arrangements, proportions and with other elements, materials and components without departing from its concept, spirit or scope or characteristics. For example, in order to simplify the present invention, the various features of the present invention are combined together in one or more aspects, embodiments or forms. However, it should be understood that the various features of certain aspects, embodiments or forms of the present invention can be combined in alternative aspects, embodiments or forms. Although the present invention is proposed in the form of an embodiment, it should be understood that the various individual features of the present subject do not need to exist in full in order to achieve at least some of the desired characteristics and / or benefits of the present subject or such individual features. Those skilled in the art will understand that the present invention can be used in the case of many modifications or changes to the structures, arrangements, proportions, materials, components and others used in the practice of the present invention, which are particularly suitable for specific environments and operating requirements without departing from the principles or spirit or scope of the present invention. For example, an element shown as being integrally formed may be composed of multiple parts or elements shown as multiple parts that may be integrally formed, the operation of the element may be reversed or otherwise changed, and the size or dimensions of the element may vary. Similarly, although the operation or action or procedure is described in a particular order, this should not be understood as requiring such a particular order, or that all operations or actions or procedures must be performed to achieve the desired result. Additionally, other embodiments are also within the scope of the following claims. In some cases, the actions described in the claims may be performed in a different order and still achieve the desired result. Therefore, the embodiments disclosed at present should be shown as illustrative and not restrictive in all respects, and the scope of the subject matter claimed is indicated by the attached claims, and is not limited to the previous description or specific embodiments or arrangements described or shown herein. In view of the above, the individual features of any embodiment can be used and can be claimed alone or in combination with the features of the embodiment or any other embodiment, and the scope of the subject matter is indicated by the attached claims, and is not limited to the previous description.

[0060] In the description above and the claims below, the following will be understood. As used herein, the phrases "at least one", "one or more", and "and / or" are open expressions that are both conjunctions and non-conjunctions in operation. The terms "one", "an", "the", "first", "second", etc. do not exclude a plurality. For example, the term "one" or "one" entity as used herein refers to one or more of the entities. Therefore, the terms "one" (or "one"), "one or more", and "at least one" are used interchangeably herein. As used in this specification and the appended claims, the term "or" is generally adopted in the sense of including "and / or", unless the content clearly indicates otherwise. As used herein, the conjunction "and" includes each of the structures, components, features, etc. so connected, unless the context clearly indicates otherwise, and the conjunction "or" includes one or other of the structures, components, features, etc. so connected individually and in any combination and quantity, unless the context clearly indicates otherwise. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or the like) are used only for identification purposes to help the reader understand the present invention, and / or to distinguish the regions of associated elements from each other, and do not limit the associated elements, particularly the position, orientation, or use of the present invention. Unless otherwise indicated, connection references (e.g., attachment, connection, connection, engagement, and combination) are to be interpreted broadly and may include intermediate members between a collection of elements and relative movement between elements. In this regard, connection references do not necessarily imply that two elements are directly connected and in a fixed relationship to each other. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority, but are used to distinguish one feature from another.

[0061] The following claims are hereby incorporated into the Detailed Description by such reference, with each claim standing independently as a separate embodiment of the invention. In the claims, the terms "comprise", "include", "includes" and "comprising" do not exclude the presence of other elements, parts, features, groups, regions, integers, steps, operations, etc. Additionally, although individual features may be included in different claims, these features may be advantageously combined, and inclusion in different claims does not mean that a combination of features is not feasible and / or advantageous. In addition, singular references do not exclude the plural. Reference symbols in the claims are provided merely as examples of clarification and should not be construed as limiting the scope of the claims in any way.

Claims

1. An implantable device configured to be delivered to and deployed at a deployment site, the implantable device comprising: an inner stent portion convertible between a delivery configuration and an expanded deployed configuration; as well as An outer portion is formed separately from the inner portion and positioned on the inner portion such that, when deployed, the outer portion is positioned between a body wall at the deployed location and the inner portion of the implantable device.

2. The implantable device according to claim 1, wherein: The interior includes a first interior and a second interior.

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

4. An implantable device according to any one of claims 2 to 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. An implantable device according to any one of claims 1 to 4, wherein: The outer portion is a balloon surrounding the inner portion.

6. The implantable device according to claim 5, wherein: The end of the balloon is tapered to guide the implantable device to a deployment site.

7. An implantable device according to any one of claims 5 to 6, wherein: The balloon includes an inflation valve detachably coupled to an inflation lumen to allow inflation of the balloon and detachment from the inflation lumen when the balloon is deployed.

8. An implantable device according to any one of claims 1 to 7, wherein: The inner portion includes one or more annular retaining members.

9. An implantable device according to any one of claims 1 to 8, wherein: The interior portion includes first and second annular retaining members.

10. The implantable device according to any one of claims 1 to 7, wherein: The interior includes one or more disc-shaped retaining members.

11. The implantable device of 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 interior portion includes a first interior portion and a second interior portion movable relative to the shaft.

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

14. A method of forming an implantable occlusive device, the method comprising: mounting one or more retaining members on the shaft; positioning a compliant cover portion over the retaining member and the shaft; as well as The cover portion is sealed relative to the shaft at the proximal and distal ends to enclose the retaining member therein.

15. The method of claim 14, further comprising slidably mounting the one or more retaining members on the shaft.

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