Patent Description:
<CIT> relates to a device for closing the left atrial appendage of a patient. The device comprises a retention member composed of a shape memory material and a mesh material supported by the retention member. The retention member has a first elongated configuration for delivery and a second expanded configuration for placement within the left atrial appendage. The mesh is configured to block blot clot migration from the appendage. In the second configuration the retention member moves toward a shape memory position. The retention member has a plurality of appendage wall engagement members to secure the retention member to the appendage.

<CIT> relates to a device frame. The device frame includes a plurality of elongate frame members, first and second hub members substantially aligned along a longitudinal axis of the device frame, and a coupling element that couples the first hub member to the second hub member. The device frame includes a face section, a laterally facing skirt section, and an inverted section. First portions of the elongate members define the face section and extend radially from the first hub member. Second portions of the elongate members define the laterally facing skirt section and extend in a distal, axial, and helical direction along a first rotational direction from the face section. Third portions of the elongate members define the inverted section and extend in a generally proximal direction from a distal portion of the laterally facing skirt section to the second hub member along a rotational direction opposite the first rotational direction.

<CIT> relates to a prosthesis that includes a stent comprising a plurality of circumferential bands, a plurality of linking members, at least one anchor. The anchor has an as-cut state and a set state. The anchor in the set state has a first twist region, a second twist region, and a middle region extending therebetween.

<CIT> relates to endovascular prostheses comprising struts and discloses alternating barb arrangements along said struts.

An example occlusive implant includes an expandable framework configured to shift between a collapsed configuration and an expanded configuration, wherein the expandable framework includes a plurality of strut members circumferentially spaced around a longitudinal axis of the expandable framework, wherein one or more of the plurality of strut members includes a first twisted portion and a face portion. The occlusive implant also includes a plurality of fixation members disposed along the face portion of one or more of the plurality of strut members.

In addition or alternatively, wherein the fixation members and the expandable framework are formed from a unitary tubular member.

In addition or alternatively, wherein one or more of the plurality of fixation members extends radially away from the longitudinal axis.

In addition or alternatively, wherein each of the plurality of strut members includes <NUM> or more fixation members disposed thereon.

In addition or alternatively, wherein the plurality of fixation members are positioned adjacent to the twisted portion of each of the strut members.

The one or more of the strut members includes a second twisted portion, and wherein the face portion is positioned between the first twisted portion and the second twisted portion.

In addition or alternatively, wherein the plurality of fixation members are formed by laser cutting.

In addition or alternatively, wherein the twisted portion is formed by a heat setting the one or more of the plurality of strut members.

In addition or alternatively, wherein the face portion of one or more of the plurality of strut members includes a curved region, and wherein the curved region is configured to extend radially away from the longitudinal axis of the expandable framework.

In addition or alternatively, wherein the curved region includes an apex, and wherein at least one of the plurality of fixation members is disposed along the apex of the curved region.

In addition or alternatively, wherein each of the plurality of strut members includes four or more fixation members disposed thereon.

In addition or alternatively, wherein the one or more of the strut members includes a second twisted portion, and wherein the face portion is positioned between the first twisted portion and the second twisted portion.

In addition or alternatively, wherein the occlusive member extends circumferentially around the outer surface of the occlusive member.

In addition or alternatively, wherein at least a portion of the plurality of fixation members extend through an aperture formed in the occlusive member.

A method for manufacturing an occlusive implant includes:.

While aspects of the disclosure are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. 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 intention is to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure.

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 claimed 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 example embodiments of the claimed 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.

For simplicity and clarity purposes, not all elements of the disclosure are necessarily shown in each figure or discussed in detail below.

The term "extent" may be understood to mean a 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 a smallest measurement of the stated or identified dimension. For example, "outer extent" may be understood to mean a maximum outer dimension, "radial extent" may be understood to mean a maximum radial dimension, "longitudinal extent" may be understood to mean a maximum 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 a greatest possible dimension measured according to the intended usage, while a "minimum extent" may be considered a 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 elements together.

The occurrence of thrombi in the left atrial appendage (LAA) during atrial fibrillation may be due to stagnancy of blood pooling in the LAA. The pooled blood may still be pulled out of the left atrium by the left ventricle, however less effectively due to the irregular contraction of the left atrium caused by atrial fibrillation. Therefore, instead of an active support of the blood flow by a contracting left atrium and left atrial appendage, filling of the left ventricle may depend primarily or solely on the suction effect created by the left ventricle. However, the contraction of the left atrial appendage may not be in sync with the cycle of the left ventricle. For example, contraction of the left atrial appendage may be out of phase up to <NUM> degrees with the left ventricle, which may create significant resistance to the desired flow of blood. Further still, most left atrial appendage geometries are complex and highly variable, with large irregular surface areas and a narrow ostium or opening compared to the depth of the left atrial appendage. These aspects as well as others, taken individually or in various combinations, may lead to high flow resistance of blood out of the left atrial appendage.

In an effort to reduce the occurrence of thrombi formation within the left atrial appendage and prevent thrombi from entering the blood stream from within the left atrial appendage, it may be desirable to develop medical devices and/or occlusive implants that close off the left atrial appendage from the heart and/or circulatory system, thereby lowering the risk of stroke due to thrombolytic material entering the blood stream from the left atrial appendage. Example medical devices and/or occlusive implants that close off the left atrial appendage are disclosed herein.

<FIG> illustrates an example occlusive implant <NUM>. The implant <NUM> may include an expandable framework <NUM>. The expandable framework <NUM> may include a first end region <NUM> and a second end region <NUM>. Additionally, the expandable framework <NUM> may include a plurality of strut members <NUM>. The strut members <NUM> may be interconnected with one another and extend circumferentially around the longitudinal axis <NUM> to define the expandable framework <NUM> of the occlusive implant <NUM>.

The occlusive implant <NUM> may also include an occlusive member <NUM> disposed on, disposed over, disposed about, or covering at least a portion of the expandable framework <NUM>. In some embodiments, the occlusive member <NUM> may be disposed on, disposed over, disposed about or cover at least a portion of an outer (or outwardly-facing) surface of the expandable framework <NUM>. <FIG> further illustrates that the occlusive member <NUM> may extend only partially along the longitudinal extent of the expandable framework <NUM>. However, this is not intended to be limiting. Rather, the occlusive member <NUM> may extend along the longitudinal extent of the expandable framework to any degree (e.g., the full longitudinal extend of the expandable framework <NUM>).

In some embodiments, the occlusive member <NUM> may be permeable or impermeable to blood and/or other fluids, such as water. In some embodiments, the occlusive member <NUM> may include a woven, braided and/or knitted material, a fiber, a sheet-like material, a fabric, a polymeric membrane, a metallic or polymeric mesh, a porous filter-like material, or other suitable construction. In some embodiments, the occlusive member <NUM> may prevent thrombi (i.e. blood clots, etc.) from passing through the occlusive member <NUM> and out of the left atrial appendage into the blood stream. In some embodiments, the occlusive member <NUM> may promote endothelization after implantation, thereby effectively removing the left atrial appendage from the patient's circulatory system. Some suitable, but non-limiting, examples of materials for the occlusive member <NUM> are discussed below.

As will be discussed in greater detail below, <FIG> further illustrates that the expandable framework <NUM> may include a plurality of fixation members <NUM> disposed about a periphery of the expandable framework <NUM>. For example, <FIG> shows that the fixation members <NUM> may be disposed along one or more of the strut members <NUM> which define the expandable framework <NUM>. Some suitable, but non-limiting, examples of materials for the expandable framework <NUM> and/or the plurality of anchor members <NUM> are discussed below. The plurality of fixation members <NUM> may extend radially outward from the strut members <NUM> of the expandable framework <NUM>. In other words, the plurality of fixation members <NUM> may extend radially away from the longitudinal axis <NUM> of the expandable framework <NUM>.

As shown in the detailed view of <FIG>, at least some of the plurality of fixation members <NUM> may each have and/or include a body portion <NUM> and a tip portion <NUM>. Further, the body portion <NUM> of some of the plurality of fixation members <NUM> (such as the fixation member <NUM> shown in the detailed view of <FIG>) may be curved. As will be discussed in greater detail below, the plurality of fixation member <NUM> may be curved such that the tip portion <NUM> points toward the second end region <NUM> of the expandable framework <NUM>. However, this is not intended to be limiting. Rather, it is contemplated that one or more of the fixation members may point toward the first end region <NUM> or in a direction other than toward the second end region <NUM>. Additionally, the shape of the fixation members <NUM> illustrated in <FIG> is non-limiting. Rather, it is contemplated that the fixation members <NUM> may include a variety of different shapes, geometries, etc..

Each of the individual fixation members <NUM> may have a "height" (e.g., the length of the fixation member <NUM> from its tip portion <NUM> to the base of its body portion <NUM>) of about <NUM> (<NUM>") to about <NUM> (<NUM>"), or, in some instances, about <NUM> (<NUM>"). However, the height of each fixation member <NUM> may be dependent on how many total fixation members <NUM> are positioned on the expandable framework <NUM>. For example, a greater the number of fixation members <NUM> on an expandable framework <NUM> may correspond a lower the height of each individual fixation member <NUM>. Conversely, the height of each individual fixation member <NUM> may be greater for example framework <NUM> designs which include relatively fewer fixation members <NUM>.

As will be discussed in greater detail below, the expandable framework <NUM> and the plurality of fixation members <NUM> may be integrally formed and/or cut from a unitary member. In some embodiments, the expandable framework <NUM> and the plurality of fixation members <NUM> may 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 framework <NUM> and the plurality of fixation members <NUM> may be integrally formed and/or cut from a unitary flat member, 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 framework <NUM> include laser cutting, machining, punching, stamping, electro discharge machining (EDM), chemical dissolution, etc. Other means and/or methods are also contemplated.

As illustrated in <FIG>, the plurality of fixation members <NUM> disposed along the expandable framework <NUM> may include several "rows" of fixation members <NUM> disposed along the strut members <NUM>. For example, the expandable framework <NUM> may include several fixation members <NUM> disposed along several strut members <NUM>. For example, in some instances one or more strut members <NUM> may include <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or more fixation members <NUM> disposed thereon. Additionally, one or more of the fixation members <NUM> may extend through the occlusive member <NUM>.

<FIG> illustrates that the occlusive implant <NUM> may be inserted and advanced through a body lumen via an occlusive implant delivery system <NUM>. <FIG> further illustrates the occlusive implant <NUM> being delivered and positioned within the left atrial appendage <NUM>. In some instances, an occlusive implant delivery system <NUM> may include a delivery catheter <NUM> which is guided toward the left atrium via various chambers and lumens of the heart (e.g., the inferior vena cava, the right atrium, etc.) to a position adjacent the left atrial appendage <NUM>.

The delivery system <NUM> may include a hub member <NUM> coupled to a proximal region of the delivery catheter <NUM>. The hub member <NUM> may be manipulated by a clinician to direct the distal end region of the delivery catheter <NUM> to a position adjacent the left atrial appendage <NUM>. In some embodiments, an occlusive implant delivery system may include a core wire <NUM>. Further, a proximal end of the expandable framework <NUM> may be configured to releasably attach, join, couple, engage, or otherwise connect to the distal end of the core wire <NUM>. In some embodiments, an end region of the expandable framework <NUM> may 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 a core wire <NUM>. Other means of releasably coupling and/or engaging the proximal end of the expandable framework <NUM> to the distal end of the core wire <NUM> are also contemplated.

<FIG> illustrates a left atrial appendage occlusive implant <NUM> positioned adjacent the left atrial appendage <NUM> via the delivery catheter <NUM> (described above with respect to <FIG>). As discussed above, in some examples, the occlusive implant <NUM> may be configured to shift between a collapsed configuration and an expanded configuration. For example, in some instances, the occlusive implant <NUM> may be in a collapsed configuration during delivery via an occlusion implant delivery system, whereby the occlusive implant <NUM> expands to an expanded configuration once deployed from the occlusion implant delivery system.

Additionally, <FIG> illustrates that the expandable framework <NUM> may be compliant and, therefore, substantially conform to and/or be in sealing engagement with the shape and/or geometry of a lateral wall of a left atrial appendage in the expanded configuration. In some embodiments, the occlusive implant <NUM> may expand to a size, extent, or shape less than or different from a maximum unconstrained extent, as determined by the surrounding tissue and/or lateral wall of the left atrial appendage. Additionally, <FIG> illustrates that the expandable framework <NUM> may be held fixed adjacent to the left atrial appendage by one or more fixation members <NUM>.

Further, it can be appreciated that the elements of the expandable framework <NUM> may be tailored to increase the flexibility and compliance of the expandable framework <NUM> and/or the occlusive implant <NUM>, thereby permitting the expandable framework <NUM> and/or the occlusive implant <NUM> to conform to the tissue around it, rather than forcing the tissue to conform to the expandable framework <NUM> and/or the occlusive implant <NUM>. Additionally, in some instances, it may be desirable to design the occlusive implant <NUM> discussed above to include various features, components and/or configurations which improve the sealing capabilities of the occlusive implant within the left atrial appendage.

As discussed above, the expandable implant <NUM> illustrated in <FIG> (including the expandable framework <NUM> and fixation members <NUM>) may be formed from a unitary member. For example, in some examples the expandable framework <NUM> may be formed by laser cutting a unitary member into a desired geometry and then expanding the unitary member to form the expendable framework <NUM> illustrated in <FIG>. Additionally, it can be appreciated that a utilizing a particular manufacturing methodology (e.g., laser cutting) may permit the expandable framework <NUM> to include "micro" elements. For example, in some examples the plurality of fixation members <NUM> may be described as "microbarbs" or "microfixation" elements. These elements may be very small as compared to the overall size of the expandable framework <NUM>. However, even though they may be relatively small, collectively, they may be able to engage the tissue of the left atrial appendage with the same or greater force as larger (but fewer) anchoring members.

<FIG> illustrates an initial manufacturing step (in a sequence of steps) utilized to form the expandable framework <NUM> (discussed above with respect to <FIG>). For example, <FIG> illustrates the expandable framework <NUM> in an unexpanded configuration after having been laser cut from a unitary member (e.g., a tubular member), but prior to being expanded to the configuration shown in <FIG>. As shown in <FIG>, the expandable framework <NUM> includes the first end region <NUM>, the second end region <NUM> and the longitudinal axis <NUM>. Further, it is noted that the expandable framework <NUM> shown in <FIG> does not include the occlusive member <NUM> (shown above). Additionally, the detailed view of <FIG> illustrates the struts <NUM> of the expandable framework <NUM> which includes the plurality of fixation members <NUM>. As shown in <FIG>, the tubular member (from which the expandable framework <NUM> is laser cut, for example) may be machined (e.g., laser cut) such that the fixation members <NUM> are formed as unitary elements of the strut members <NUM>. Further, each of the fixation members <NUM> may be laser cut to include the body portion <NUM> and the tip portion <NUM> (described above with respect to <FIG>).

Additionally, one advantage to utilizing a manufacturing process such as laser cutting to form the fixation members <NUM> is that it may be possible to reduce the size of the tubular member from which the expandable framework <NUM> may be cut. For example, <FIG> illustrates the fixation members <NUM> circumferentially aligned with the curvature of the outer surface of the tubular member. In other words, the laser cutting process may remove material between the strut members <NUM> and/or the fixation members <NUM>. The remaining material (e.g., the struts <NUM> and the fixation members <NUM>, for example) are simply what is left of the tubular member after laser cutting. Therefore, the laser cutting process may permit structure of the expandable framework <NUM> to be formed in a geometrically "tight" pattern. In other words, laser cutting the struts <NUM> and/or the fixation members <NUM> may permit the fixation members <NUM> to be tightly nested between the struts <NUM> in a spatially "efficient" pattern and/or geometry.

<FIG> shows another manufacturing step in the sequence of steps to form the expandable framework <NUM> from a solid tubular member. In particular, <FIG> illustrates a manufacturing step occurring after the laser cutting step discussed and illustrated with respect to <FIG>. Specifically, comparison of the expandable framework <NUM> shown in <FIG> to that shown in <FIG> illustrates each of the plurality of strut members <NUM> after having have been rotated (e.g., twisted) <NUM> degrees. Further, the detailed view of <FIG> illustrates twisted regions 30a, 30b of each of the strut members <NUM>. In some examples, each of the strut members <NUM> may include a first twisted region 30a and a second twisted region 30b. The first twisted region 30a may be spaced away from the second twisted region 30b. It can be appreciated that the <NUM> degree rotation of the strut members <NUM> also rotates each of the plurality of fixation members <NUM><NUM> degrees. Further, rotation of the fixation members <NUM> results in positioning each of the fixation members such that they are extending radially away from the longitudinal axis <NUM> of the expandable framework <NUM>. For example, the detailed view of <FIG> illustrates each of the fixation members <NUM> extending radially away from a face portion <NUM> of each of the strut members <NUM>. It can be appreciated that this rotated position permits the fixation members <NUM> to engage with the tissue surrounding the left atrial appendage upon deployment of the occlusive member within the left atrial appendage. Additionally, the rotation described above may be induced by a heat setting manufacturing step (e.g., in nitinol processing) to twist the strut or plastically deforming the strut without heat setting (e.g., for materials such as stainless steel). For example, the strut members <NUM> (including the fixation members <NUM>) may be "heat set" into the configuration shown in <FIG> (e.g., after having been twisted <NUM> degrees such that the fixation members <NUM> extend radially away from the longitudinal axis). Heat setting the strut members <NUM> may permit the strut members <NUM> to shift between the configuration shown in <FIG> (e.g., the configuration in which the fixation members <NUM> are positioned in a circumferential direction) and the configuration shown in <FIG> (e.g., the configuration of the struts <NUM> after having been twisted <NUM> degrees such that the fixation members <NUM> extend radially away from the longitudinal axis).

<FIG> illustrates another example of the expandable framework <NUM> in an unexpanded configuration after having been laser cut from a unitary member (e.g., a tubular member), but prior to being expanded to the configuration shown in <FIG>. As shown in <FIG>, the expandable framework <NUM> includes a first strut 117a positioned adjacent a second strut 117b. Each of the first strut 117a and the second strut 117b include fixation member 116a and fixation member 116b, respectively. Further, <FIG> illustrates that the fixation members 116a and 116b are cut such that the first fixation member 116a and the second fixation member 116b face opposing directions relative to one another. Further, the struts 117a and 117b and corresponding fixation members 116a and 116b are laser cut such that the fixation members 116a and 116b may nest (e.g., interdigitate) with one another. It can be appreciated that this pattern may permit the expandable framework <NUM> to be formed (e.g., laser cut) from a tubular member having a diameter (and corresponding surface area) which is less than that of the tubular member shown in <FIG> because the fixation members 116a and 116b may be able to be nested closer together. Further, it can be appreciated that each of the first strut 117a and the second strut 117b may be rotated such that the fixation members 116a and 116b extend radially away from the longitudinal axis (as described above with respect to <FIG>). However, in <FIG>, the strut member 117a and the strut member 117b may have to be rotated in opposite directions, respectively, to achieve the expanded configuration of the expendable member shown in <FIG>.

<FIG> illustrates another example of the expandable framework <NUM> in an unexpanded configuration after having been laser cut from a unitary member (e.g., a tubular member), but prior to being expanded to the configuration shown in <FIG>. As shown in <FIG>, the expandable framework <NUM> may include a plurality of strut members <NUM> positioned adjacent to one another. <FIG> shows the struts <NUM> positioned in a circumferential direction after having been laser cut from a tubular member (similar to the configuration shown in <FIG>). Additionally, each of the strut members <NUM> may include a curved region. Further, the curved region may include an apex portion <NUM>. As illustrated in <FIG>, a fixation member <NUM> may be disposed along the apex portion <NUM> of the curved region of each of the struts <NUM>.

Additionally, it can be appreciated that the struts <NUM> shown in <FIG> may be rotated similarly to the struts described above with respect to <FIG>. In other words, the struts may be rotated <NUM> degrees such that the fixation members <NUM> extend radially away from the longitudinal axis of the expandable framework. However, it can be further appreciated that the curved region of the strut member <NUM> may project the fixation members <NUM> radially outward to a greater extent than if the strut members <NUM> did not include a curved region. In other words, the curved regions of the struts <NUM> may provide a radial prominence to the struts <NUM> such that they project the fixation members <NUM> radially outward (as they engage the tissue of the left atrial appendage) to a greater extent than if the strut members <NUM> did not include a curved region.

The materials that can be used for the various components of the occlusive implant <NUM> (and variations, systems or components thereof disclosed herein) and the various elements thereof disclosed herein may include those commonly associated with medical devices. For simplicity purposes, the following discussion makes reference to the occlusive implant <NUM> (and variations, systems or components disclosed herein). 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.

In some embodiments, the occlusive implant <NUM> (and variations, systems or components thereof disclosed herein) 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. Some examples of suitable metals and metal alloys include stainless steel, such as 444V, <NUM>, and 314LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® <NUM>, UNS: N06022 such as HASTELLOY® C-<NUM>®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® <NUM>, NICKELVAC® <NUM>, NICORROS® <NUM>, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; platinum; palladium; gold; combinations thereof; and the like; or any other suitable material.

In at least some embodiments, portions or all of the occlusive implant <NUM> (and variations, systems or components thereof disclosed herein) may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids a user in determining the location of the occlusive implant <NUM> (and variations, systems or components thereof disclosed herein). Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of the occlusive implant <NUM> (and variations, systems or components thereof disclosed herein). to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into the occlusive implant <NUM> (and variations, systems or components thereof disclosed herein). For example, the occlusive implant <NUM> (and variations, systems or components thereof disclosed herein) and/or components or portions thereof, may be made of a material that does not substantially distort the image and create substantial artifacts (e.g., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. The occlusive implant <NUM> (and variations, systems or components disclosed herein) or portions thereof, may also be made from a material that the MRI machine can image. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035 such as MP35-N® and the like), nitinol, and the like, and others.

In some embodiments, the occlusive implant <NUM> (and variations, systems or components thereof disclosed herein) and/or portions thereof, may be made from or include a polymer or other suitable material. Some examples of suitable polymers may include copolymers, polyisobutylene-polyurethane, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-<NUM> (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-<NUM>-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, polyurethane silicone copolymers (for example, ElastEon® from Aortech Biomaterials or ChronoSil® from AdvanSource Biomaterials), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments, the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about <NUM> percent LCP.

In some embodiments, the occlusive implant <NUM> (and variations, systems or components thereof disclosed herein) may include 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 yams 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.

In some embodiments, the occlusive implant <NUM> (and variations, systems or components thereof disclosed herein) may include and/or be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents may include anti-thrombogenic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethylketone)); anti-proliferative agents (such as enoxaparin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine); antineoplastic/antiproliferative/anti-mitotic agents (such as paclitaxel, <NUM>-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin and thymidine kinase inhibitors); anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine); anti-coagulants (such as D-Phe-Pro-Arg chloromethyl keton, an RGD peptide-containing compound, heparin, anti-thrombin compounds, platelet receptor antagonists, anti-thrombin antibodies, anti-platelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides); vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional activators, and translational promoters); vascular cell growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies directed against growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin, bifunctional molecules consisting of an antibody and a cytotoxin); cholesterol-lowering agents; vasodilating agents; and agents which interfere with endogenous vascoactive mechanisms.

While the discussion above is generally directed toward an occlusive implant for use in the left atrial appendage of the heart, the aforementioned features may also be useful in other types of medical implants where a fabric or membrane is attached to a frame or support structure including, but not limited to, implants for the treatment of aneurysms (e.g., abdominal aortic aneurysms, thoracic aortic aneurysms, etc.), replacement valve implants (e.g., replacement heart valve implants, replacement aortic valve implants, replacement mitral valve implants, replacement vascular valve implants, etc.), and/or other types of occlusive devices (e.g., atrial septal occluders, cerebral aneurysm occluders, peripheral artery occluders, etc.). Other useful applications of the disclosed features are also contemplated.

Claim 1:
An occlusive implant (<NUM>), comprising:
an expandable framework (<NUM>) configured to shift between a collapsed configuration and an expanded configuration, wherein the expandable framework includes a plurality of strut members (<NUM>) circumferentially spaced around a longitudinal axis (<NUM>) of the expandable framework (<NUM>), wherein one or more of the plurality of strut members (<NUM>) includes a first twisted portion (30a) and a face portion (<NUM>); and
a plurality of fixation members (<NUM>) disposed along the face portion (<NUM>) of one or more of the plurality of strut members (<NUM>),
wherein the one or more of the strut members (<NUM>) includes a second twisted portion (30b), and wherein the face portion (<NUM>) is positioned between the first twisted portion (30a) and the second twisted portion (30b),
wherein the plurality of strut members comprises a first strut (117a) and a second strut (117b), the first strut being positioned adjacent the second strut, with the first strut comprising a first fixation member (116a) and the second strut comprising a second fixation member (116b), and
characterized in that when the framework is in a configuration prior to being expanded, the first fixation member and the second fixation member interdigitate with one another.