Multi-Sharpness Split Top Soft Tissue Anchors

An occlusive implant may include an expandable framework configured to shift between a collapsed configuration and an expanded configuration, the expandable framework including a proximal end and a distal end. The expandable framework includes a plurality of anchor members extending radially outward from the expandable framework in the expanded configuration, each anchor member including a root portion fixedly attached to the expandable framework and extending distally to a trunk portion in the expanded configuration. At least a portion of the trunk portion extends radially outward relative to the root portion in the expanded configuration. At least one of the plurality of anchor members includes a plurality of branches extending radially outward from the trunk portion in the expanded configuration.

TECHNICAL FIELD

The disclosure relates generally to medical devices and more particularly to occlusive implants adapted for use in percutaneous medical procedures including implantation into the left atrial appendage (LAA) of a heart.

BACKGROUND

The left atrial appendage is a small organ attached to the left atrium of the heart. During normal heart function, as the left atrium constricts and forces blood into the left ventricle, the left atrial appendage constricts and forces blood into the left atrium. The ability of the left atrial appendage to contract assists with improved filling of the left ventricle, thereby playing a role in maintaining cardiac output. However, in patients suffering from atrial fibrillation, the left atrial appendage may not properly contract or empty, causing stagnant blood to pool within its interior, which can lead to the undesirable formation of thrombi within the left atrial appendage.

Thrombi forming in the left atrial appendage may break loose from this area and enter the blood stream. Thrombi that migrate through the blood vessels may eventually plug a smaller vessel downstream and thereby contribute to stroke or heart attack. Clinical studies have shown that the majority of blood clots in patients with atrial fibrillation originate in the left atrial appendage. As a treatment, medical devices have been developed which are deployed to close off the left atrial appendage. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and using medical devices.

SUMMARY

In one example, an occlusive implant may comprise an expandable framework configured to shift between a collapsed configuration and an expanded configuration, the expandable framework including a proximal end and a distal end. The expandable framework may include a plurality of anchor members extending radially outward from the expandable framework in the expanded configuration, each anchor member including a root portion fixedly attached to the expandable framework and extending distally to a trunk portion in the expanded configuration. At least a portion of the trunk portion may extend radially outward relative to the root portion in the expanded configuration. At least one of the plurality of anchor members may include a plurality of branches extending radially outward from the trunk portion in the expanded configuration.

In addition or alternatively to any example described herein, a tip portion of each branch of the plurality of branches extends proximally from a distalmost portion of its respective branch.

In addition or alternatively to any example described herein, the plurality of branches includes a first branch and a second branch.

In addition or alternatively to any example described herein, the first branch includes a rounded tip and the second branch includes a sharpened tip.

In addition or alternatively to any example described herein, the first branch extends proximally more than the second branch.

In addition or alternatively to any example described herein, the second branch extends radially outward a greater distance from a central longitudinal axis of the expandable framework than the first branch.

In addition or alternatively to any example described herein, the first branch includes a proximally facing first curved surface defined by a first radius and a first center and the second branch includes a proximally facing second curved surface defined by a second radius and a second center, wherein the second center is offset radially outward from the first center relative to a central longitudinal axis of the expandable framework.

In addition or alternatively to any example described herein, the plurality of branches further includes a third branch.

In addition or alternatively to any example described herein, at least one of the first branch, second branch, and third branch includes a rounded tip.

In addition or alternatively to any example described herein, each branch of the plurality of branches is configured to penetrate tissue.

In addition or alternatively to any example described herein, each branch of the plurality of branches is curved.

In addition or alternatively to any example described herein, each branch of the plurality of branches is curved in a radially outward direction from the trunk portion.

In addition or alternatively to any example described herein, each branch of the plurality of branches is curved in a proximal direction from the trunk portion.

In addition or alternatively to any example described herein, at least one branch of the plurality of branches has a concave cross-section facing toward the proximal end of the expandable framework.

In addition or alternatively to any example described herein, an occlusive implant system may comprise a sheath including an implant containment area proximate a distal end of the sheath; and an occlusive implant comprising an expandable framework configured to shift between a collapsed configuration and an expanded configuration, the expandable framework including a proximal end and a distal end. The expandable framework may include a plurality of anchor members extending radially outward from the expandable framework in the expanded configuration, each anchor member including a root portion fixedly attached to the expandable framework and extending distally to a trunk portion in the expanded configuration. At least a portion of the trunk portion may extend radially outward relative to the root portion in the expanded configuration. At least one of the plurality of anchor members may include a plurality of branches extending radially outward from the trunk portion in the expanded configuration. Recapturing the occlusive implant within the implant containment area after shifting to the expanded configuration may include advancing the distal end of the sheath distally into contact with the plurality of anchor members, wherein contact between the distal end of the sheath and at least one of the plurality of branches urges remaining branches of the plurality of branches away from contact with the sheath.

In addition or alternatively to any example described herein, each branch contacted by the distal end of the sheath includes a rounded tip and each remaining branch includes a sharpened tip.

In addition or alternatively to any example described herein, each sharpened tip is disposed distal of each rounded tip as measured parallel to a central longitudinal axis of the expandable framework.

In addition or alternatively to any example described herein, distal advancement of the sheath after contact between the distal end of the sheath and at least one of the plurality of branches deflects the at least one of the plurality of anchor members at the trunk portion.

In addition or alternatively to any example described herein, each branch of the plurality of branches has a concave cross-section facing toward the proximal end of the expandable framework in the expanded configuration.

In addition or alternatively to any example described herein, an occlusive implant system may comprise an expandable framework configured to shift between a collapsed configuration and an expanded configuration, the expandable framework including a proximal end and a distal end. The expandable framework may include a plurality of anchor members extending radially outward from the expandable framework in the expanded configuration, each anchor member including a root portion fixedly attached to the expandable framework and extending distally to a trunk portion in the expanded configuration. At least a portion of the trunk portion may curve radially outward relative to the root portion in the expanded configuration and is defined by a center. At least one of the plurality of anchor members may include a plurality of branches extending radially outward from the trunk portion in the expanded configuration. The plurality of branches may include a first branch having a first curve defined by first center in the expanded configuration and a second branch having a second curve defined by a second center in the expanded configuration. The first center and the center of the at least a portion of the trunk portion may be disposed a first radial distance from a central longitudinal axis of the expandable framework in the expanded configuration, and the second center may be disposed a second radial distance from the central longitudinal axis greater than the first radial distance in the expanded configuration.

The above summary of some embodiments, aspects, and/or examples is not intended to describe each embodiment or every implementation of the present disclosure. The figures and the detailed description more particularly exemplify aspects of these embodiments.

While aspects of the disclosure are amenable to various modifications and alternative forms, examples are shown in the drawings and described herein. It should be understood, however, that the intention is not to limit aspects of the disclosure to the particular embodiments described. On the contrary, the disclosure shall cover all modifications, equivalents, and alternatives falling within the spirit and scope thereof.

DETAILED DESCRIPTION

The following description should be read with reference to the drawings, which are not necessarily to scale, wherein like reference numerals indicate like elements throughout the several views. The detailed description and drawings are intended to illustrate but not limit the present disclosure. Those skilled in the art will recognize that the various elements described and/or shown may be arranged in various combinations and configurations without departing from the scope of the disclosure. The detailed description and drawings illustrate exemplary aspects of the disclosure. However, in the interest of clarity and ease of understanding, while every feature and/or element may not be shown in each drawing, the feature(s) and/or element(s) may be understood to be present regardless, unless otherwise specified.

The recitation of numerical ranges by endpoints includes all numbers within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

Relative terms such as “proximal”, “distal”, “advance”, “retract”, variants thereof, and the like, may be generally considered with respect to the positioning, direction, and/or operation of various elements relative to a user/operator/manipulator of the device, wherein “proximal” and “retract” indicate or refer to closer to or toward the user and “distal” and “advance” indicate or refer to farther from or away from the user. In some instances, the terms “proximal” and “distal” may be arbitrarily assigned in an effort to facilitate understanding of the disclosure, and such instances will be readily apparent to the skilled artisan. Other relative terms, such as “upstream”, “downstream”, “inflow”, and “outflow” refer to a direction of fluid flow within a lumen, such as a body lumen, a blood vessel, or within a device. Still other relative terms, such as “axial”, “circumferential”, “longitudinal”, “lateral”, “radial”, etc. and/or variants thereof generally refer to direction and/or orientation relative to a central longitudinal axis of the disclosed structure or device.

The term “extent” may be understood to mean the greatest measurement of a stated or identified dimension, unless the extent or dimension in question is preceded by or identified as a “minimum”, which may be understood to mean the smallest measurement of the stated or identified dimension. For example, “outer extent” may be understood to mean an outer dimension, “radial extent” may be understood to mean a radial dimension, “longitudinal extent” may be understood to mean a longitudinal dimension, etc. Each instance of an “extent” may be different (e.g., axial, longitudinal, lateral, radial, circumferential, etc.) and will be apparent to the skilled person from the context of the individual usage. Generally, an “extent” may be considered the greatest possible dimension measured according to the intended usage, while a “minimum extent” may be considered the smallest possible dimension measured according to the intended usage. In some instances, an “extent” may generally be measured orthogonally within a plane and/or cross-section, but may be, as will be apparent from the particular context, measured differently—such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), etc.

The terms “monolithic” and “unitary” shall generally refer to an element or elements made from or consisting of a single structure or base unit/element. A monolithic and/or unitary element shall exclude structure and/or features made by assembling or otherwise joining multiple discrete structures or elements together.

The left atrial appendage may be attached to and in fluid communication with a left atrium of a patient's heart. In some patients, the left atrial appendage may have a complex geometry and/or irregular surface area. Those of skill in the art will also recognize that the medical devices and methods disclosed herein may be adapted for various sizes and shapes of the left atrial appendage, as necessary. The left atrial appendage may include a generally longitudinal axis arranged along a depth of a main body of the left atrial appendage. The main body may include a wall and an ostium forming a proximal mouth. In some embodiments, a lateral extent of the ostium and/or the wall may be smaller or less than a depth of the main body along the longitudinal axis, or a depth of the main body may be greater than a lateral extent of the ostium and/or the wall. In some embodiments, the left atrial appendage may include a tail-like element associated with a distal portion of the main body, which element may protrude radially or laterally away from the main body.

The following figures illustrate selected components and/or arrangements of a left atrial appendage closure device, a left atrial appendage closure device system, and/or methods of using the left atrial appendage closure device and/or the left atrial appendage closure device system. It should be noted that in any given figure, some features may not be shown, or may be shown schematically, for simplicity. Additional details regarding some of the components of the implant and/or the system may be illustrated in other figures in greater detail. While discussed in the context of occluding the left atrial appendage, the left atrial appendage closure device and/or the left atrial appendage closure device system may also be used for other interventions and/or percutaneous medical procedures within a patient. Similarly, the devices and methods described herein with respect to percutaneous deployment may be used in other types of surgical procedures, as appropriate. For example, in some examples, the devices may be used in a non-percutaneous procedure. Devices and methods in accordance with the disclosure may also be adapted and configured for other uses within the anatomy.

The figures illustrate selected components and/or arrangements of an occlusive implant system10, shown schematically inFIGS.1-2for example. It should be noted that in any given figure, some features of the occlusive implant system10may not be shown, or may be shown schematically, for simplicity. Additional details regarding some of the components of the occlusive implant system10may be illustrated in other figures in greater detail. In some embodiments, the occlusive implant system10may include a delivery device that can be used for percutaneous delivery of an occlusive implant to an area of interest in the anatomy, such as a left atrial appendage. In some embodiments, the occlusive implant system10may include a delivery device that can be used for percutaneous delivery of a replacement heart valve implant (e.g., a replacement mitral valve, a replacement aortic valve, etc.) to an area of interest in the anatomy, such as a native heart valve. This, however, is not intended to be limiting as the occlusive implant system10and/or the delivery device may also be used for other interventions including valve repair, valvuloplasty, and the like, or other similar interventions.

The occlusive implant system10may include a sheath40having a lumen42extending from a proximal opening to a distal opening, a core wire30slidably disposed within the lumen42, and an occlusive implant100having an expandable framework110configure to shift between a collapsed configuration (e.g.,FIG.1), wherein the occlusive implant100is disposed within an implant containment area of the sheath40proximate a distal end of the sheath40and/or the distal opening in the collapsed configuration, and an expanded configuration (e.g.,FIG.2), wherein the occlusive implant100and/or the expandable framework110is configured to shift between the collapsed configuration and the expanded configuration when the occlusive implant100is disposed distal of the distal end of the sheath40and/or the distal opening, and/or when the occlusive implant100is distal of and/or outside of the implant containment area of the sheath40. The occlusive implant100may be disposed at and/or releasably connected to a distal portion of the core wire30. The core wire30may be slidably and/or rotatably disposed within the lumen42of the sheath40and/or the implant containment area of the sheath40. In some embodiments, a proximal end of the core wire30may extend proximally of a proximal end of the sheath40and/or the proximal opening of the lumen42for manual manipulation by a clinician or practitioner. In some embodiments, the example occlusive implant100may be removably attached, joined, or otherwise connected to the distal end of the core wire30. The core wire30may be configured to and/or may be capable of axially translating the occlusive implant100relative to the sheath40and/or the implant containment area of the sheath40. In one example, the core wire30may be advanced distally while the sheath40is held in a constant position. In another example, the core wire30may be advanced distally while the sheath40is retracted proximally. In yet another example, the core wire30may be held in a constant position while the sheath40is retracted proximally relative to the core wire30and/or the occlusive implant100. Other configurations are also contemplated. The sheath40and/or the core wire30may have a selected level of axial stiffness and/or pushability characteristics while also having a selected level of flexibility to permit navigation through the patient's vasculature.

Some suitable, but non-limiting, examples of materials for the occlusive implant system10, the core wire30, the sheath40, and/or the occlusive implant100, etc. are discussed below. It is contemplated that any exemplary occlusive implant and/or feature thereof disclosed herein may be used in accordance with and/or be associated with the example occlusive implant system10described above.

FIGS.3-4illustrate an example configuration of the occlusive implant100comprising the expandable framework110configured to shift axially and/or radially along a central longitudinal axis102between the collapsed configuration and the expanded configuration. The expandable framework110may comprise a plurality of interconnected struts112defining a plurality of cells. In some embodiments, the plurality of cells may be a plurality of closed cells. In some embodiments, the plurality of cells may be a plurality of open cells. In some embodiments, the plurality of cells may include a plurality of open cells and a plurality of closed cells in various combinations and/or arrangements. The expandable framework110may be compliant and substantially conform to and/or be in sealing engagement with the shape and/or geometry of an ostium and/or a lateral wall of a left atrial appendage in the expanded configuration. In some embodiments, the occlusive implant100may expand to a size, extent, or shape less than or different from a maximum unconstrained extent, as determined by the surrounding tissue, the ostium, and/or the lateral wall of the left atrial appendage. In some embodiments, reducing a thickness of various elements of the expandable framework110may increase the flexibility and compliance of the expandable framework110and/or the occlusive implant100, thereby permitting the expandable framework110and/or the occlusive implant100to conform to the tissue around it, rather than forcing the tissue to conform to the expandable framework110and/or the occlusive implant100.

The expandable framework110may include a proximal end114and a distal end116. In some embodiments, the expandable framework110may include a proximal hub118configured to releasably attach, join, couple, engage, or otherwise connect to a distal end of the core wire30. In some embodiments, the proximal hub118of the expandable framework110may include a threaded insert coupled thereto. In some embodiments, the threaded insert may be configured to and/or adapted to couple with, join to, mate with, or otherwise engage a threaded member disposed at the distal end of the core wire30. In some embodiments, the proximal hub118may include internal threads configured to rotatably and/or threadably engage an externally threaded distal end of the core wire30. Other means of releasably coupling and/or engaging the proximal hub118of the expandable framework110to the distal end of the core wire30are also contemplated. As noted herein, some features are not shown in every figure to improve clarity.

The expandable framework110and/or the plurality of interconnected struts112may be formed and/or cut from a tubular member. In some embodiments, the expandable framework110and/or the plurality of interconnected struts112may be integrally formed and/or cut from a unitary member. In some embodiments, the expandable framework110and/or the plurality of interconnected struts112may be integrally formed and/or cut from a unitary tubular member and subsequently formed and/or heat set to a desired shape in the expanded configuration. In some embodiments, the expandable framework110and/or the plurality of interconnected struts112may be integrally formed and/or cut from a unitary flat member or sheet, and then rolled or formed into a tubular structure and subsequently formed and/or heat set to the desired shape in the expanded configuration. Some exemplary means and/or methods of making and/or forming the expandable framework110and/or the plurality of interconnected struts112include laser cutting, machining, punching, stamping, electro discharge machining (EDM), chemical dissolution, etc. Other means and/or methods are also contemplated.

In some embodiments, the occlusive implant100and/or the expandable framework110may include a plurality of anchor members140projecting radially outward from the plurality of interconnected struts112in the expanded configuration. In some embodiments, each anchor member of the plurality of anchor members140may include a root portion142directly and/or fixedly attached to and/or at the expandable framework110and/or the plurality of interconnected struts112and extending distally to a trunk portion144in the expanded configuration. In some embodiments, the plurality of anchor members140may be configured to engage with the lateral wall of the left atrial appendage. Other configurations are also contemplated. Additionally details regarding the plurality of anchor members140is discussed below.

Returning toFIG.3, in some embodiments, the occlusive implant100may optionally include an occlusive element120connected to, disposed on, disposed over, disposed about, or covering at least a portion of the expandable framework110and/or the plurality of interconnected struts112. In some embodiments, the occlusive element120may be connected to, disposed on, disposed over, disposed about, or cover at least a portion of an outer (or outwardly-facing) surface of the expandable framework110and/or the plurality of interconnected struts112. In some embodiments, the occlusive element120may be attached to the proximal hub118and/or may be attached to the expandable framework110at the proximal hub118. In some embodiments, the occlusive element120may extend radially outward from and/or may extend distally from the proximal hub118. In some embodiments, the occlusive element120may be attached and/or secured to the expandable framework110at a plurality of discrete locations. In some embodiments, one of, some of, and/or all of the plurality of anchor members140may extend through an occlusive element120, where present.

In some embodiments, the occlusive element120may include a membrane, a fabric, a mesh, a tissue element, or another suitable construction. In some embodiments, the occlusive element120may be porous. In some embodiments, the occlusive element120may be non-porous. In some embodiments, the occlusive element120may be permeable to selected gases and/or fluids. In some embodiments, the occlusive element120may be substantially impermeable to selected gases and/or fluids, such as blood, water, etc. In some embodiments, the occlusive element120may be designed, sized, and/or configured to prevent thrombus and/or embolic material from passing out of the left atrial appendage into the left atrium and/or the patient's bloodstream. In some embodiments, the occlusive element120may be configured to promote endothelization after implantation, thereby effectively removing the target site (e.g., the left atrial appendage, etc.) from the patient's circulatory system. Some suitable, but non-limiting, examples of materials for the occlusive element120are discussed below.

FIGS.5-6illustrate an example embodiment of one of a plurality of anchor members240associated with the occlusive implant100. As will be understood, the discussion herein related to the plurality of anchor members240may be applied equally to and/or may be used in place of each of, some of, or one of the plurality of anchor members140shown inFIGS.3-4, as desired. References to the expandable framework110and/or elements thereof discussed herein, while not expressly shown, may be understood to be as shown and/or discussed in the context ofFIGS.3-4.

As discussed herein, the expandable framework110may include a plurality of anchor members240extending radially outward from the expandable framework110in the expanded configuration. In some embodiments, each anchor member of the plurality of anchor members240may include a root portion242directly and/or fixedly attached to and/or at the expandable framework110and/or the plurality of interconnected struts112and extending distally to a trunk portion244in the expanded configuration. In some embodiments, a proximal trunk portion may extend along and/or generally parallel to the expandable framework110in the expanded configuration. In some embodiments, the proximal trunk portion may extend distally from the root portion242and generally parallel to the central longitudinal axis102of the expandable framework110. In some embodiments, the proximal trunk portion may extend distally from the root portion242and radially inward toward the central longitudinal axis102in the expanded configuration. In some embodiments, the proximal trunk portion may extend distally from the root portion242and radially outward away from the central longitudinal axis102in the expanded configuration. In some embodiments, at least a portion of the trunk portion244extends radially outward of and/or relative to the root portion242in the expanded configuration. In some embodiments, a distal trunk portion may extend radially outward of and/or relative to the root portion242in the expanded configuration. In some embodiments, the distal trunk portion may include a bend extending radially outward from the proximal trunk portion such that at least a portion of the distal trunk portion extends radially outward of and/or relative to the root portion242in the expanded configuration.

In some embodiments, at least one of the plurality of anchor members240may include a plurality of branches250extending radially outward from the trunk portion244in the expanded configuration. In some embodiments, a tip portion of each branch of the plurality of branches250may extend proximally of and/or from a distalmost portion of its respective branch in the expanded configuration. In some embodiments, the plurality of branches250may include a first branch252and a second branch254. The plurality of branches250may be circumferentially and/or laterally offset from each other. For example, the first branch252may be circumferentially and/or laterally offset from the second branch254. In at least some embodiments, the second branch254is not axially and/or longitudinally aligned with the first branch252.

In some embodiments, the first branch252may include a rounded tip and the second branch254may include a sharpened tip. Other configurations are also contemplated. In some embodiments, each branch of the plurality of branches250may be configured to penetrate tissue in the expanded configuration. In some embodiments, only the sharpened tip of the second branch254may be configured to penetrate tissue in the expanded configuration.

In some embodiments, the first branch252may extend proximally more than the second branch254as measured parallel to the central longitudinal axis102of the expandable framework110in the expanded configuration. In some embodiments, the second branch254and/or the sharpened tip may be disposed distal of the first branch252and/or the rounded tip as measured parallel to the central longitudinal axis102of the expandable framework110in the expanded configuration.

In some embodiments, the second branch254may extend radially outward a greater distance from the central longitudinal axis102of the expandable framework110and/or the occlusive implant100(as measured along a radius in a plane normal to the central longitudinal axis102) than the first branch252in the expanded configuration.

In some embodiments, the first branch252of the plurality of branches250may be curved in the expanded configuration. In some embodiments, the second branch254of the plurality of branches250may be curved in the expanded configuration. In some embodiments, each branch of the plurality of branches250may be curved in the expanded configuration. In some embodiments, the first branch252of the plurality of branches250may be curved in a radially outward direction from the trunk portion244in the expanded configuration. In some embodiments, the second branch254of the plurality of branches250may be curved in the radially outward direction from the trunk portion244in the expanded configuration. In some embodiments, each branch of the plurality of branches250may be curved in the radially outward direction from the trunk portion244in the expanded configuration. In some embodiments, the first branch252of the plurality of branches250may be curved in a proximal direction from the trunk portion244in the expanded configuration. In some embodiments, the second branch254of the plurality of branches250may be curved in the proximal direction from the trunk portion244in the expanded configuration. In some embodiments, each branch of the plurality of branches250may be curved in the proximal direction from the trunk portion244in the expanded configuration.

In some embodiments, at least one branch of the plurality of branches250may have a concave cross-section facing toward the proximal end114of the expandable framework110in the expanded configuration. In some embodiments, the first branch252of the plurality of branches250may have a concave cross-section facing toward the proximal end114of the expandable framework110in the expanded configuration. In some embodiments, the second branch254of the plurality of branches250may have a concave cross-section facing toward the proximal end114of the expandable framework110in the expanded configuration. In some embodiments, each branch of the plurality of branches250may have a concave cross-section facing toward the proximal end114of the expandable framework110in the expanded configuration.

In some embodiments, the first branch252of the plurality of branches250may include a proximally facing first curved surface260defined by a first radius262and a first center264in the expanded configuration. In some embodiments, the second branch254of the plurality of branches250may include a proximally facing second curved surface270defined by a second radius272and a second center274in the expanded configuration. In some embodiments, the second center274may be offset radially outward from the first center264relative to the central longitudinal axis102of the expandable framework110in the expanded configuration.

In some embodiments, at least a portion of the trunk portion244curves radially outward relative to the root portion242in the expanded configuration and is defined by a center245. In some embodiments, the first center264of the first curved surface260of the first branch252and the center245of the at least a portion of the trunk portion244that curves radially outward relative to the root portion242are disposed a first radial distance266from the central longitudinal axis102of the expandable framework in the expanded configuration, and the second center274of the second curved surface270of the second branch254is disposed a second radial distance276from the central longitudinal axis102greater than the first radial distance266in the expanded configuration.

In some alternative embodiments, at least a portion of the first branch252and/or the second branch254extending radially outward from the at least a portion of the trunk portion244that curves radially outward relative to the root portion242may be substantially straight and/or may be devoid of a curve, a radius, and/or a defined center, as shown inFIG.6A. In some embodiments, at least a portion of the first branch252extending radially outward from the at least a portion of the trunk portion244that curves radially outward relative to the root portion242may be substantially straight and/or may be devoid of a curve, a radius, and/or a defined center. In some embodiments, at least a portion of the second branch254extending radially outward from the at least a portion of the trunk portion244that curves radially outward relative to the root portion242may be substantially straight and/or may be devoid of a curve, a radius, and/or a defined center. In some embodiments, at least a portion of both of the first branch252and the second branch254extending radially outward from the at least a portion of the trunk portion244that curves radially outward relative to the root portion242may be substantially straight and/or may be devoid of a curve, a radius, and/or a defined center. In some embodiments, a first portion of the first branch252may be curved and a second portion of the first branch252may be substantially straight. In some embodiments, a first portion of the second branch254may be curved and a second portion of the second branch254may be substantially straight. Other configurations are also contemplated.

FIGS.7-8illustrate an example embodiment of one of a plurality of anchor members340associated with the occlusive implant100. As will be understood, the discussion herein related to the plurality of anchor members340may be applied equally to and/or may be used in place of each of, some of, or one of the plurality of anchor members140shown inFIGS.3-4, as desired. References to the expandable framework110and/or elements thereof discussed herein, while not expressly shown, may be understood to be as shown and/or discussed in the context ofFIGS.3-4. As discussed herein, the expandable framework110may include a plurality of anchor members340extending radially outward from the expandable framework110in the expanded configuration. In some embodiments, each anchor member of the plurality of anchor members340may include a root portion342directly and/or fixedly attached to and/or at the expandable framework110and/or the plurality of interconnected struts112and extending distally to a trunk portion344in the expanded configuration. In some embodiments, a proximal trunk portion may extend along and/or generally parallel to the expandable framework110in the expanded configuration. In some embodiments, the proximal trunk portion may extend distally from the root portion342and generally parallel to the central longitudinal axis102of the expandable framework110. In some embodiments, the proximal trunk portion may extend distally from the root portion342and radially inward toward the central longitudinal axis102in the expanded configuration. In some embodiments, the proximal trunk portion may extend distally from the root portion342and radially outward away from the central longitudinal axis102in the expanded configuration. In some embodiments, at least a portion of the trunk portion344extends radially outward of and/or relative to the root portion342in the expanded configuration. In some embodiments, a distal trunk portion may extend radially outward of and/or relative to the root portion342in the expanded configuration. In some embodiments, the distal trunk portion may include a bend extending radially outward from the proximal trunk portion such that at least a portion of the distal trunk portion extends radially outward of and/or relative to the root portion342in the expanded configuration.

In some embodiments, at least one of the plurality of anchor members340may include a plurality of branches350extending radially outward from the trunk portion344in the expanded configuration. In some embodiments, a tip portion of each branch of the plurality of branches350may extend proximally of and/or from a distalmost portion of its respective branch in the expanded configuration. In some embodiments, the plurality of branches350may include a first branch352and a second branch354. In some embodiments, the plurality of branches350may further include a third branch356. The plurality of branches350may be circumferentially and/or laterally offset from each other. In some embodiments, the first branch352may be circumferentially and/or laterally offset from the second branch354and/or the third branch356. In some embodiments, the second branch354may be circumferentially and/or laterally offset from the first branch352and/or the third branch356. In some embodiments, the third branch356may be circumferentially and/or laterally offset from the first branch352and/or the second branch354.

In some embodiments, the second branch354may be circumferentially and/or laterally offset from the first branch352in a first circumferential direction (e.g., counterclockwise as viewed from the proximal end114toward the distal end116of the expandable framework110) and/or a first lateral direction. In some embodiments, the third branch356may be circumferentially and/or laterally offset from the first branch352and/or the second branch354in the first circumferential direction and/or the first lateral direction. In some embodiments, the second branch354may be disposed circumferentially between the first branch352and the third branch356.

In some embodiments, the first branch352is not axially and/or longitudinally aligned with the second branch354and/or the third branch356. In some embodiments, the second branch354is not axially and/or longitudinally aligned with the first branch352and/or the third branch356. In some embodiments, the third branch356is not axially and/or longitudinally aligned with the first branch352and/or the second branch354. Other configurations are also contemplated.

In some embodiments, at least one of the plurality of branches350may include a rounded tip. In some embodiments, at least one of the first branch352, the second branch354, and the third branch356may include a rounded tip. In some embodiments, other branches of the plurality of branches350may each include a sharpened tip. In some embodiments, the first branch352may include a rounded tip, the second branch354may include a sharpened tip, and the third branch356may include a sharpened tip. Other configurations are also contemplated. In some embodiments, each branch of the plurality of branches350may be configured to penetrate tissue in the expanded configuration. In some embodiments, only the sharpened tip of the second branch354and/or the third branch356may be configured to penetrate tissue in the expanded configuration.

In some embodiments, the first branch352may extend proximally more than the second branch354and/or the third branch356as measured parallel to the central longitudinal axis102of the expandable framework110in the expanded configuration. In some embodiments, the second branch354, the third branch356, and/or the sharpened tip(s) thereof may be disposed distal of the first branch352and/or the rounded tip as measured parallel to the central longitudinal axis102of the expandable framework110in the expanded configuration.

In some embodiments, the second branch354and/or the third branch356may extend radially outward a greater distance from the central longitudinal axis102of the expandable framework110and/or the occlusive implant100(as measured along a radius in a plane normal to the central longitudinal axis102) than the first branch352in the expanded configuration.

In some embodiments, the first branch352of the plurality of branches350may be curved in the expanded configuration. In some embodiments, the second branch354of the plurality of branches350may be curved in the expanded configuration. In some embodiments, the third branch356of the plurality of branches350may be curved in the expanded configuration. In some embodiments, each branch of the plurality of branches350may be curved in the expanded configuration. In some embodiments, the first branch352of the plurality of branches350may be curved in a radially outward direction from the trunk portion344in the expanded configuration. In some embodiments, the second branch354of the plurality of branches350may be curved in the radially outward direction from the trunk portion344in the expanded configuration. In some embodiments, the third branch356of the plurality of branches350may be curved in the radially outward direction from the trunk portion344in the expanded configuration. In some embodiments, each branch of the plurality of branches350may be curved in the radially outward direction from the trunk portion344in the expanded configuration. In some embodiments, the first branch352of the plurality of branches350may be curved in a proximal direction from the trunk portion344in the expanded configuration. In some embodiments, the second branch354of the plurality of branches350may be curved in the proximal direction from the trunk portion344in the expanded configuration. In some embodiments, the third branch356of the plurality of branches350may be curved in the proximal direction from the trunk portion344in the expanded configuration. In some embodiments, each branch of the plurality of branches350may be curved in the proximal direction from the trunk portion344in the expanded configuration.

In some embodiments, at least one branch of the plurality of branches350may have a concave cross-section facing toward the proximal end114of the expandable framework110in the expanded configuration. In some embodiments, the first branch352of the plurality of branches350may have a concave cross-section facing toward the proximal end114of the expandable framework110in the expanded configuration. In some embodiments, the second branch354of the plurality of branches350may have a concave cross-section facing toward the proximal end114of the expandable framework110in the expanded configuration. In some embodiments, the third branch356of the plurality of branches350may have a concave cross-section facing toward the proximal end114of the expandable framework110in the expanded configuration. In some embodiments, each branch of the plurality of branches350may have a concave cross-section facing toward the proximal end114of the expandable framework110in the expanded configuration.

In some embodiments, the first branch352of the plurality of branches350may include a proximally facing first curved surface360defined by a first radius362and a first center364in the expanded configuration. In some embodiments, the second branch354of the plurality of branches350may include a proximally facing second curved surface370defined by a second radius372and a second center374in the expanded configuration. In some embodiments, the third branch356of the plurality of branches350may include a proximally facing third curved surface380defined by a third radius382and a third center384in the expanded configuration. In some embodiments, the second center374may be offset radially outward from the first center364relative to the central longitudinal axis102of the expandable framework110in the expanded configuration. In some embodiments, the third center384may be offset radially outward from the first center364and/or the second center374relative to the central longitudinal axis102of the expandable framework110in the expanded configuration.

In some embodiments, at least a portion of the trunk portion344curves radially outward relative to the root portion342in the expanded configuration and is defined by a center345. In some embodiments, the first center364of the first curved surface360of the first branch352and the center345of the at least a portion of the trunk portion344that curves radially outward relative to the root portion342are disposed a first radial distance366from the central longitudinal axis102of the expandable framework in the expanded configuration, and the second center374of the second curved surface370of the second branch354is disposed a second radial distance376from the central longitudinal axis102greater than the first radial distance366in the expanded configuration. In some embodiments, the third center384of the third curved surface380of the third branch356is disposed a third radial distance386from the central longitudinal axis102greater than the first radial distance366and/or the second radial distance376in the expanded configuration.

In some alternative embodiments, at least a portion of the first branch352, the second branch354, and/or the third branch356extending radially outward from the at least a portion of the trunk portion344that curves radially outward relative to the root portion342may be substantially straight and/or may be devoid of a curve, a radius, and/or a defined center, similar to the alternative embodiment(s) shown inFIG.6A.

FIGS.9-10illustrate an example embodiment of one of a plurality of anchor members440associated with the occlusive implant100. As will be understood, the discussion herein related to the plurality of anchor members440may be applied equally to and/or may be used in place of each of, some of, or one of the plurality of anchor members140shown inFIGS.3-4, as desired. References to the expandable framework110and/or elements thereof discussed herein, while not expressly shown, may be understood to be as shown and/or discussed in the context ofFIGS.3-4.

As discussed herein, the expandable framework110may include a plurality of anchor members440extending radially outward from the expandable framework110in the expanded configuration. In some embodiments, each anchor member of the plurality of anchor members440may include a root portion442directly and/or fixedly attached to and/or at the expandable framework110and/or the plurality of interconnected struts112and extending distally to a trunk portion444in the expanded configuration. In some embodiments, a proximal trunk portion may extend along and/or generally parallel to the expandable framework110in the expanded configuration. In some embodiments, the proximal trunk portion may extend distally from the root portion442and generally parallel to the central longitudinal axis102of the expandable framework110. In some embodiments, the proximal trunk portion may extend distally from the root portion442and radially inward toward the central longitudinal axis102in the expanded configuration. In some embodiments, the proximal trunk portion may extend distally from the root portion442and radially outward away from the central longitudinal axis102in the expanded configuration. In some embodiments, at least a portion of the trunk portion444extends radially outward of and/or relative to the root portion442in the expanded configuration. In some embodiments, a distal trunk portion may extend radially outward of and/or relative to the root portion442in the expanded configuration. In some embodiments, the distal trunk portion may include a bend extending radially outward from the proximal trunk portion such that at least a portion of the distal trunk portion extends radially outward of and/or relative to the root portion442in the expanded configuration.

In some embodiments, at least one of the plurality of anchor members440may include a plurality of branches450extending radially outward from the trunk portion444in the expanded configuration. In some embodiments, a tip portion of each branch of the plurality of branches450may extend proximally of and/or from a distalmost portion of its respective branch in the expanded configuration. In some embodiments, the plurality of branches450may include a first branch452and a second branch454. In some embodiments, the plurality of branches450may further include a third branch456. The plurality of branches450may be circumferentially and/or laterally offset from each other. In some embodiments, the first branch452may be circumferentially and/or laterally offset from the second branch454and/or the third branch456. In some embodiments, the second branch454may be circumferentially and/or laterally offset from the first branch452and/or the third branch456. In some embodiments, the third branch456may be circumferentially and/or laterally offset from the first branch452and/or the second branch454.

In some embodiments, the second branch454may be circumferentially and/or laterally offset from the first branch452in a first circumferential direction (e.g., counterclockwise as viewed from the proximal end114toward the distal end116of the expandable framework110) and/or a first lateral direction. In some embodiments, the third branch456may be circumferentially and/or laterally offset from the first branch452and/or the second branch454in the first circumferential direction and/or the first lateral direction. In some embodiments, the second branch454may be disposed circumferentially between the first branch452and the third branch456.

In some embodiments, the first branch452is not axially and/or longitudinally aligned with the second branch454and/or the third branch456. In some embodiments, the second branch454is not axially and/or longitudinally aligned with the first branch452and/or the third branch456. In some embodiments, the third branch456is not axially and/or longitudinally aligned with the first branch452and/or the second branch454. Other configurations are also contemplated.

In some embodiments, at least one of the plurality of branches450may include a rounded tip. In some embodiments, at least one of the first branch452, the second branch454, and the third branch456may include a rounded tip. In some embodiments, other branches of the plurality of branches450may each include a sharpened tip. In some embodiments, the first branch452may include a rounded tip, the second branch454may include a sharpened tip, and the third branch456may include a rounded tip. Other configurations are also contemplated. In some embodiments, each branch of the plurality of branches450may be configured to penetrate tissue in the expanded configuration. In some embodiments, only the sharpened tip of the second branch454may be configured to penetrate tissue in the expanded configuration.

In some embodiments, the first branch452and/or the third branch456may extend proximally more than the second branch454as measured parallel to the central longitudinal axis102of the expandable framework110in the expanded configuration. In some embodiments, the second branch454and/or the sharpened tip thereof may be disposed distal of the first branch452and/or the third branch456and/or the rounded tip(s) thereof as measured parallel to the central longitudinal axis102of the expandable framework110in the expanded configuration.

In some embodiments, the second branch454may extend radially outward a greater distance from the central longitudinal axis102of the expandable framework110and/or the occlusive implant100(as measured along a radius in a plane normal to the central longitudinal axis102) than the first branch452and/or the third branch456in the expanded configuration.

In some embodiments, the first branch452of the plurality of branches450may be curved in the expanded configuration. In some embodiments, the second branch454of the plurality of branches450may be curved in the expanded configuration. In some embodiments, the third branch456of the plurality of branches450may be curved in the expanded configuration. In some embodiments, each branch of the plurality of branches450may be curved in the expanded configuration. In some embodiments, the first branch452of the plurality of branches450may be curved in a radially outward direction from the trunk portion444in the expanded configuration. In some embodiments, the second branch454of the plurality of branches450may be curved in the radially outward direction from the trunk portion444in the expanded configuration. In some embodiments, the third branch456of the plurality of branches450may be curved in the radially outward direction from the trunk portion444in the expanded configuration. In some embodiments, each branch of the plurality of branches450may be curved in the radially outward direction from the trunk portion444in the expanded configuration. In some embodiments, the first branch452of the plurality of branches450may be curved in a proximal direction from the trunk portion444in the expanded configuration. In some embodiments, the second branch454of the plurality of branches450may be curved in the proximal direction from the trunk portion444in the expanded configuration. In some embodiments, the third branch456of the plurality of branches450may be curved in the proximal direction from the trunk portion444in the expanded configuration. In some embodiments, each branch of the plurality of branches450may be curved in the proximal direction from the trunk portion444in the expanded configuration.

In some embodiments, at least one branch of the plurality of branches450may have a concave cross-section facing toward the proximal end114of the expandable framework110in the expanded configuration. In some embodiments, the first branch452of the plurality of branches450may have a concave cross-section facing toward the proximal end114of the expandable framework110in the expanded configuration. In some embodiments, the second branch454of the plurality of branches450may have a concave cross-section facing toward the proximal end114of the expandable framework110in the expanded configuration. In some embodiments, the third branch456of the plurality of branches450may have a concave cross-section facing toward the proximal end114of the expandable framework110in the expanded configuration. In some embodiments, each branch of the plurality of branches450may have a concave cross-section facing toward the proximal end114of the expandable framework110in the expanded configuration.

In some embodiments, the first branch452of the plurality of branches450may include a proximally facing first curved surface460defined by a first radius462and a first center464in the expanded configuration. In some embodiments, the second branch454of the plurality of branches450may include a proximally facing second curved surface470defined by a second radius472and a second center474in the expanded configuration. In some embodiments, the third branch456of the plurality of branches450may include a proximally facing third curved surface480defined by a third radius482and a third center484in the expanded configuration. In some embodiments, the second center474may be offset radially outward from the first center464and/or the third center484relative to the central longitudinal axis102of the expandable framework110in the expanded configuration.

In some embodiments, at least a portion of the trunk portion444curves radially outward relative to the root portion442in the expanded configuration and is defined by a center445. In some embodiments, the first center464of the first curved surface460of the first branch452, the third center484of the third curved surface480of the third branch456, and the center445of the at least a portion of the trunk portion444that curves radially outward relative to the root portion442are disposed a first radial distance466from the central longitudinal axis102of the expandable framework in the expanded configuration, and the second center474of the second curved surface470of the second branch454is disposed a second radial distance476from the central longitudinal axis102greater than the first radial distance466in the expanded configuration.

In some alternative embodiments, at least a portion of the first branch452, the second branch454, and/or the third branch456extending radially outward from the at least a portion of the trunk portion444that curves radially outward relative to the root portion442may be substantially straight and/or may be devoid of a curve, a radius, and/or a defined center, similar to the alternative embodiment(s) shown inFIG.6A.

FIGS.11-12illustrate an example embodiment of one of a plurality of anchor members540associated with the occlusive implant100. As will be understood, the discussion herein related to the plurality of anchor members540may be applied equally to and/or may be used in place of each of, some of, or one of the plurality of anchor members140shown inFIGS.3-4, as desired. References to the expandable framework110and/or elements thereof discussed herein, while not expressly shown, may be understood to be as shown and/or discussed in the context ofFIGS.3-4.

As discussed herein, the expandable framework110may include a plurality of anchor members540extending radially outward from the expandable framework110in the expanded configuration. In some embodiments, each anchor member of the plurality of anchor members540may include a root portion542directly and/or fixedly attached to and/or at the expandable framework110and/or the plurality of interconnected struts112and extending distally to a trunk portion544in the expanded configuration. In some embodiments, a proximal trunk portion may extend along and/or generally parallel to the expandable framework110in the expanded configuration. In some embodiments, the proximal trunk portion may extend distally from the root portion542and generally parallel to the central longitudinal axis102of the expandable framework110. In some embodiments, the proximal trunk portion may extend distally from the root portion542and radially inward toward the central longitudinal axis102in the expanded configuration. In some embodiments, the proximal trunk portion may extend distally from the root portion542and radially outward away from the central longitudinal axis102in the expanded configuration. In some embodiments, at least a portion of the trunk portion544extends radially outward of and/or relative to the root portion542in the expanded configuration. In some embodiments, a distal trunk portion may extend radially outward of and/or relative to the root portion542in the expanded configuration. In some embodiments, the distal trunk portion may include a bend extending radially outward from the proximal trunk portion such that at least a portion of the distal trunk portion extends radially outward of and/or relative to the root portion542in the expanded configuration.

In some embodiments, at least one of the plurality of anchor members540may include a plurality of branches550extending radially outward from the trunk portion544in the expanded configuration. In some embodiments, a tip portion of each branch of the plurality of branches550may extend proximally of and/or from a distalmost portion of its respective branch in the expanded configuration. In some embodiments, the plurality of branches550may include a first branch552and a second branch554. In some embodiments, the plurality of branches550may further include a third branch556. The plurality of branches550may be circumferentially and/or laterally offset from each other. In some embodiments, the first branch552may be circumferentially and/or laterally offset from the second branch554and/or the third branch556. In some embodiments, the second branch554may be circumferentially and/or laterally offset from the first branch552and/or the third branch556. In some embodiments, the third branch556may be circumferentially and/or laterally offset from the first branch552and/or the second branch554.

In some embodiments, the second branch554may be circumferentially and/or laterally offset from the first branch552in a first circumferential direction (e.g., counterclockwise as viewed from the proximal end114toward the distal end116of the expandable framework110) and/or a first lateral direction. In some embodiments, the third branch556may be circumferentially and/or laterally offset from the first branch552and/or the second branch554in a second circumferential direction opposite the first circumferential direction (e.g., clockwise as viewed from the proximal end114toward the distal end116of the expandable framework110) and/or in a second lateral direction opposite the first lateral direction. In some embodiments, the first branch552may be disposed circumferentially between the second branch554and the third branch556.

In some embodiments, the first branch552is not axially and/or longitudinally aligned with the second branch554and/or the third branch556. In some embodiments, the second branch554is not axially and/or longitudinally aligned with the first branch552and/or the third branch556. In some embodiments, the third branch556is not axially and/or longitudinally aligned with the first branch552and/or the second branch554. Other configurations are also contemplated.

In some embodiments, at least one of the plurality of branches550may include a rounded tip. In some embodiments, at least one of the first branch552, the second branch554, and the third branch556may include a rounded tip. In some embodiments, other branches of the plurality of branches550may each include a sharpened tip. In some embodiments, the first branch552may include a rounded tip, the second branch554may include a sharpened tip, and the third branch556may include a sharpened tip. Other configurations are also contemplated. In some embodiments, each branch of the plurality of branches550may be configured to penetrate tissue in the expanded configuration. In some embodiments, only the sharpened tip of the second branch554and/or the third branch556may be configured to penetrate tissue in the expanded configuration.

In some embodiments, the first branch552may extend proximally more than the second branch554and/or the third branch556as measured parallel to the central longitudinal axis102of the expandable framework110in the expanded configuration. In some embodiments, the second branch554, the third branch556, and/or the sharpened tip(s) thereof may be disposed distal of the first branch552and/or the rounded tip thereof as measured parallel to the central longitudinal axis102of the expandable framework110in the expanded configuration.

In some embodiments, the second branch554and/or the third branch556may extend radially outward a greater distance from the central longitudinal axis102of the expandable framework110and/or the occlusive implant100(as measured along a radius in a plane normal to the central longitudinal axis102) than the first branch552in the expanded configuration.

In some embodiments, the first branch552of the plurality of branches550may be curved in the expanded configuration. In some embodiments, the second branch554of the plurality of branches550may be curved in the expanded configuration. In some embodiments, the third branch556of the plurality of branches550may be curved in the expanded configuration. In some embodiments, each branch of the plurality of branches550may be curved in the expanded configuration. In some embodiments, the first branch552of the plurality of branches550may be curved in a radially outward direction from the trunk portion544in the expanded configuration. In some embodiments, the second branch554of the plurality of branches550may be curved in the radially outward direction from the trunk portion544in the expanded configuration. In some embodiments, the third branch556of the plurality of branches550may be curved in the radially outward direction from the trunk portion544in the expanded configuration. In some embodiments, each branch of the plurality of branches550may be curved in the radially outward direction from the trunk portion544in the expanded configuration. In some embodiments, the first branch552of the plurality of branches550may be curved in a proximal direction from the trunk portion544in the expanded configuration. In some embodiments, the second branch554of the plurality of branches550may be curved in the proximal direction from the trunk portion544in the expanded configuration. In some embodiments, the third branch556of the plurality of branches550may be curved in the proximal direction from the trunk portion544in the expanded configuration. In some embodiments, each branch of the plurality of branches550may be curved in the proximal direction from the trunk portion544in the expanded configuration.

In some embodiments, at least one branch of the plurality of branches550may have a concave cross-section facing toward the proximal end114of the expandable framework110in the expanded configuration. In some embodiments, the first branch552of the plurality of branches550may have a concave cross-section facing toward the proximal end114of the expandable framework110in the expanded configuration. In some embodiments, the second branch554of the plurality of branches550may have a concave cross-section facing toward the proximal end114of the expandable framework110in the expanded configuration. In some embodiments, the third branch556of the plurality of branches550may have a concave cross-section facing toward the proximal end114of the expandable framework110in the expanded configuration. In some embodiments, each branch of the plurality of branches550may have a concave cross-section facing toward the proximal end114of the expandable framework110in the expanded configuration.

In some embodiments, the first branch552of the plurality of branches550may include a proximally facing first curved surface560defined by a first radius562and a first center564in the expanded configuration. In some embodiments, the second branch554of the plurality of branches550may include a proximally facing second curved surface570defined by a second radius572and a second center574in the expanded configuration. In some embodiments, the third branch556of the plurality of branches550may include a proximally facing third curved surface580defined by a third radius582and a third center584in the expanded configuration. In some embodiments, the second center574and/or the third center584may be offset radially outward from the first center564relative to the central longitudinal axis102of the expandable framework110in the expanded configuration.

In some embodiments, at least a portion of the trunk portion544curves radially outward relative to the root portion542in the expanded configuration and is defined by a center545. In some embodiments, the first center564of the first curved surface560of the first branch552and the center545of the at least a portion of the trunk portion544that curves radially outward relative to the root portion542are disposed a first radial distance566from the central longitudinal axis102of the expandable framework in the expanded configuration, and the second center574of the second curved surface570of the second branch554and the third center584of the third curved surface580of the third branch556is disposed a second radial distance576from the central longitudinal axis102greater than the first radial distance566in the expanded configuration.

In some alternative embodiments, at least a portion of the first branch552, the second branch554, and/or the third branch556extending radially outward from the at least a portion of the trunk portion544that curves radially outward relative to the root portion542may be substantially straight and/or may be devoid of a curve, a radius, and/or a defined center, similar to the alternative embodiment(s) shown inFIG.6A.

FIGS.13A-13Dillustrate aspects of the occlusive implant system10during capture and/or recapture of the occlusive implant100. As will be understood, the following discussion shows and refers to one of the plurality of anchor members240for ease of understanding. However, it shall be understood that any of the plurality of anchor members340,440,540described herein may be applied equally to and/or may be used in place of the plurality of anchor members240shown inFIGS.13A-13D, as desired. References to the expandable framework110and/or elements thereof discussed herein, while not expressly shown, may be understood to be as shown and/or discussed in the context ofFIGS.3-4.

FIGS.13A-13Dshow the sheath40disposed alongside and/or radially outward of the occlusive implant100(not expressly shown but represented by the plurality of anchor members240). As discussed herein, the plurality of anchor members240may extend radially outward from the expandable framework110in the expanded configuration. In at least some embodiments, capturing and/or recapturing the occlusive implant100within the implant containment area of the sheath40after shifting the expandable framework110and/or the occlusive implant100to the expanded configuration may include advancing the distal end of the sheath40distally into contact with the plurality of anchor members240and/or withdrawing the expandable framework110and/or the occlusive implant100proximally relative to the sheath40(using the core wire30, for example). Contact between the distal end of the sheath40and at least one of the plurality of branches250may urge remaining branches of the plurality of branches250away from contact with the sheath40, as shown inFIGS.13A-13D. In some embodiments, contact between the distal end of the sheath40and the first branch252of the plurality of branches250urges the second branch254away from contact with the sheath40.

In at least some embodiments, each branch of the plurality of branches250contacted by the distal end of the sheath40includes a rounded tip and each remaining branch of the plurality of branches250includes a sharpened tip. In some embodiments, each sharpened tip is disposed distal of each rounded tip as measured parallel to the central longitudinal axis102of the expandable framework110. In some embodiments, distal advancement of the sheath40relative to the expandable framework110and/or the occlusive implant100, and/or proximal withdrawal of the expandable framework110and/or the occlusive implant100relative to the distal end of the sheath40, after contact between the distal end of the sheath40and at least one of the plurality of branches250deflects the at least one of the plurality of anchor members240at the trunk portion244, as seen inFIGS.13B-13D. The above-described behavior may permit the sharpened tip(s) of the plurality of anchor members240to enhance anchoring within the tissue of the patient while preventing contact with the sheath40during recapture, which may cause damage and/or increased stress and/or forces within the occlusive implant100and/or the occlusive implant system10.

In some embodiments, after recapture of the occlusive implant100within the implant containment area of the sheath40, the first branch252may be disposed more proximally than the second branch254as measured parallel to the central longitudinal axis102of the expandable framework110. In some embodiments, after recapture of the occlusive implant100within the implant containment area of the sheath40, the second branch254and/or the sharpened tip thereof may be disposed distal of the first branch252and/or the rounded tip thereof as measured parallel to the central longitudinal axis102of the expandable framework110. In some embodiments, after recapture of the occlusive implant100within the implant containment area of the sheath40, the first branch252may extend radially outward a greater distance from the central longitudinal axis102of the expandable framework110and/or the occlusive implant100(as measured along a radius in a plane normal to the central longitudinal axis102) than the second branch254.

In some embodiments, a method of manufacturing the occlusive implant100may include cutting the expandable framework110from a tubular member, such as a nitinol tube, a metallic tube, etc. as discussed herein. In some embodiments, cutting the expandable framework110may include cutting the plurality of anchor members140from the tubular member as a monolithic and/or unitary structure with the expandable framework110. In some embodiments, shape set tooling600may be used to form a shape of the plurality of anchor members140in the expanded configuration. A portion of the shape set tooling600is shown inFIGS.14-15. The method may include inserting the expandable framework110into the shape set tooling600such that the plurality of anchor members140extends into a recess formed in the shape set tooling600that is configured to receive the plurality of anchor members140therein. For illustrative purposes, the plurality of anchor members240is illustrated. However, it shall be understood that discussion referring to the plurality of anchor members140may refer equally and/or interchangeably to the plurality of anchor members240,340,440,540herein. The skilled person will recognize and understand minor modification to the shape set tooling600may be made to accommodate differences between the described embodiments, configurations, and/or alternatives. Thereafter, the method may include heat setting the plurality of anchor members140and/or the expandable framework110in the expanded configuration.

As seen inFIG.14, the shape set tooling600may include a curved surface610configured to form the at least a portion of the trunk portion that curves radially outward relative to the root portion and/or the first curved surface of the first branch of the plurality of branches. The shape set tooling600may be configured to constrain the first branch of the plurality of branches against the curved surface610of the shape set tooling600. In at least some embodiments, the shape set tooling600may be configured to leave branches of the plurality of branches other than the first branch unconstrained, thereby allowing those other branches to deflect differently than the first branch, as shown inFIG.14.

In some embodiments, the plurality of anchor members140and/or the plurality of branches may be formed with a curve (e.g., the at least a portion of the trunk portion that curves radially outward relative to the root portion and/or the first curved surface of the first branch of the plurality of branches) prior to inserting into the shape set tooling600. In such embodiments, the shape set tooling600in combination with the heat setting step may be configured to heat set the plurality of anchor members140in a desired configuration. For example, the first branch and the second branch may be defined by identical radii (e.g., a common radius length) but different centers after heat setting in the shape set tooling600. Other configurations are also contemplated.

FIG.15illustrates an alternative configuration of the shape set tooling600further including a second curved surface620configured to form the second curved surface of the second branch of the plurality of branches. In such a configuration, the shape set tooling600may be configured to constrain the first branch of the plurality of branches against the curved surface610of the shape set tooling600and the second branch of the plurality of branches against the second curved surface620of the shape set tooling600. In such a configuration, it may be possible to skip forming one or more curves in the plurality of anchor members140and/or the plurality of branches prior to inserting into the shape set tooling600and/or prior to the heat setting step. Other configurations are also contemplated.

The materials that can be used for the various components of the system (and/or other elements disclosed herein) and the various components thereof disclosed herein may include those commonly associated with medical devices and/or systems. For simplicity purposes, the following discussion refers to the system. However, this is not intended to limit the devices and methods described herein, as the discussion may be applied to other elements, members, components, or devices disclosed herein, such as, but not limited to, the occlusive implant, the sheath, the core wire, the expandable framework, the occlusive element, the shape set tooling, etc. and/or elements or components thereof.

In some embodiments, the system and/or components thereof may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material.

In some embodiments, the system and/or other elements disclosed herein may include a fabric material disposed over or within the structure. The fabric material may be composed of a biocompatible material, such a polymeric material or biomaterial, adapted to promote tissue ingrowth. In some embodiments, the fabric material may include a bioabsorbable material. Some examples of suitable fabric materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), a polyolefinic material such as a polyethylene, a polypropylene, polyester, polyurethane, and/or blends or combinations thereof.

In some embodiments, the system and/or other elements disclosed herein may include and/or be formed from a textile material. Some examples of suitable textile materials may include synthetic yarns that may be flat, shaped, twisted, textured, pre-shrunk or un-shrunk. Synthetic biocompatible yarns suitable for use in the present disclosure include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyesters, polypropylenes, polyethylenes, polyurethanes, polyolefins, polyvinyls, polymethylacetates, polyamides, naphthalene dicarboxylene derivatives, natural silk, and polytetrafluoroethylenes. Moreover, at least one of the synthetic yarns may be a metallic yarn or a glass or ceramic yarn or fiber. Useful metallic yarns include those yarns made from or containing stainless steel, platinum, gold, titanium, tantalum or a Ni—Co—Cr-based alloy. The yarns may further include carbon, glass or ceramic fibers. Desirably, the yarns are made from thermoplastic materials including, but not limited to, polyesters, polypropylenes, polyethylenes, polyurethanes, polynaphthalenes, polytetrafluoroethylenes, and the like. The yarns may be of the multifilament, monofilament, or spun types. The type and denier of the yarn chosen may be selected in a manner which forms a biocompatible and implantable prosthesis and, more particularly, a vascular structure having desirable properties.