Patent Description:
<CIT> discloses an exemplary device for closing the left atrial appendage. <CIT> and <CIT> respectively disclose exemplary ventricular partitioning devices.

Aspects, embodiments and/or examples which do not fall within the scope of the claims are provided for illustrative purpose.

An example occlusive implant includes an expandable framework configured to shift between a collapsed configuration and an expanded configuration, an occlusive member disposed along at least a portion of the expandable framework and a sealing member disposed along the occlusive member.

In addition or alternatively, wherein the sealing member extends radially outward from the occlusive member.

In addition or alternatively, wherein the occlusive member, the sealing member or both the occlusive member and the sealing member are formed from a fabric.

In addition or alternatively, wherein the sealing member extends around only a portion of the outer surface of the occlusive member.

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

In addition or alternatively, wherein the sealing member forms a folded portion along an outer surface of the occlusive member.

In addition or alternatively, wherein the occlusive member includes a woven fiber and wherein the sealing member is formed from the woven fiber of the occlusive member.

In addition or alternatively, wherein the sealing member includes an expandable element disposed along a portion of the sealing member.

In addition or alternatively, wherein the sealing member includes one or more flaps extending radially away from the occlusive member.

In addition or alternatively, wherein the expandable framework includes a plurality of anchor members extending radially outward from the expandable framework.

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

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

Another example medical implant for occluding a left atrial appendage, comprising:.

In addition or alternatively, wherein the covering is formed from a fabric.

In addition or alternatively, wherein the covering extends along only a portion of the covering of the expandable framework.

In addition or alternatively, wherein the protrusion portion extends circumferentially around an outer surface of the covering.

In addition or alternatively, wherein the protrusion portion forms a fold along an outer surface of the covering.

An example method for occluding a left atrial appendage, the method not forming part of the claimed invention, comprises.

In addition or alternatively, wherein positioning the sealing member adjacent to the left atrial appendage further includes conforming the sealing member to the contour of the left atrial appendage.

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 invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the claims.

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 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.

<FIG> further illustrates that the expandable framework <NUM> may include a plurality of anchor members <NUM> disposed about a periphery of the expandable framework <NUM>. The plurality of anchor members <NUM> may extend radially outward from the expandable framework <NUM>. In some embodiments, at least some of the plurality of anchor members <NUM> may each have and/or include a body portion and a tip portion projecting circumferentially therefrom, as shown in <FIG>. Some suitable, but non-limiting, examples of materials for the expandable framework <NUM> and/or the plurality of anchor members <NUM> are discussed below.

In some examples, the expandable framework <NUM> and the plurality of anchor members <NUM> may be integrally formed and/or cut from a unitary member. In some embodiments, the expandable framework <NUM> and the plurality of anchor 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 anchor 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 anchor members <NUM> disposed along the expandable framework <NUM> may include two rows of anchor members <NUM>. However, this is not intended to be limiting. Rather, the expandable framework <NUM> may include a single row of anchor members <NUM>. In other examples, the expandable framework <NUM> may include more than two rows of anchor members <NUM>. For example, in some instances the expandable framework <NUM> may include <NUM>, <NUM>, <NUM>, <NUM> or more rows of anchor members <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 implant <NUM> may be configured to shift between a collapsed configuration and an expanded configuration. For example, in some instances, the occlusive implant may be in a collapsed configuration during delivery via occlusion implant delivery system, whereby the occlusive implant 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 anchoring 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. Several example occlusion devices including various sealing features are disclosed below.

<FIG> illustrates an example occlusion implant device <NUM>. The occlusion implant device <NUM> may be similar in form and function to other occlusion implant devices disclosed herein. For example, the occlusion implant device <NUM> may include an expandable frame <NUM>, an occlusion member <NUM> and one or more anchoring members <NUM>. Additionally, <FIG> illustrates that the occlusion device <NUM> may include a sealing member <NUM>. The sealing member <NUM> may extend outward from the occlusion member <NUM> and/or the expandable framework <NUM>. For example, the sealing member <NUM> may extend radially away from the occlusion member <NUM> and/or the expandable framework <NUM>.

As illustrated in <FIG>, the sealing member <NUM> may include a folded portion. It can be appreciated that the folded portion of the sealing member <NUM> adds "extra" material the occlusion device <NUM> which, as stated above, extends radially outward from the occlusion member <NUM> and/or the expandable framework <NUM>. It can be further appreciated that this extra material (defining the sealing member) may be able to conform to the specific shape and/or geometry of a lateral wall of a left atrial appendage. In other words, the sealing member <NUM> may resemble extra material which may bunch, fill and/or conform to the specific shape and/or geometry of a lateral wall of a left atrial appendage when positioned adjacent thereto.

In some instances, the sealing member <NUM> may be formed from the same material as the material forming the occlusive member <NUM>. For example, in some instances the sealing member <NUM> may be formed integral with the occlusive member <NUM>. In other words, the material forming the sealing member <NUM> may be an extension of the material forming the occlusive member <NUM>. For example, in some instances the occlusive member <NUM> may be formed from a fabric material, and therefore, in some instances the sealing member may be formed from the same fabric. However, this is not intended to be limiting. Rather, it is contemplated that in some examples the sealing member <NUM> may be formed from a material which is distinct from the material forming the occlusive member <NUM>. For example, in some instances the sealing member <NUM> may be formed separate from and later attached (e.g., joined, adhered, sewn, etc.) to the occlusive member <NUM>. Some suitable, but non-limiting, examples of materials for the occlusive members disclosed herein are discussed below.

Additionally, it is contemplated that the sealing member <NUM> illustrated in <FIG> may extend either partially or entirely around the outer surface of the occlusive member <NUM>. For example, the sealing member <NUM> may extend either partially or entirely around the circumference of the occlusive member <NUM> and/or expandable framework <NUM>. It can be appreciated that in instances in which the sealing member <NUM> extends entirely around the outer surface of the occlusive member <NUM>, the sealing member <NUM> may resemble an annular ring having an open space existing therein. It can be appreciated that the open space permits the sealing member to conform to the specific geometry of the let atrial appendage, thereby permitting the sealing member <NUM> to sufficiently seal against the lateral wall of the left atrial appendage.

<FIG> illustrates another example occlusion implant device <NUM>. The occlusion implant device <NUM> may be similar in form and function to other occlusion implant devices disclosed herein. For example, the occlusion implant device <NUM> may include an expandable frame <NUM>, an occlusion member <NUM> and one or more anchoring members <NUM>. Additionally, <FIG> illustrates that the occlusion device <NUM> may include a sealing member <NUM>.

The sealing member <NUM> may be similar in form and function to the sealing member <NUM> described above with respect to <FIG>. For example, the sealing member <NUM> may extend outward from the occlusion member <NUM> and/or the expandable framework <NUM>. Additionally, the sealing member <NUM> may be formed from the same material as the material forming the occlusive member <NUM>. In other words, the material forming the sealing member <NUM> may be an extension of the material forming the occlusive member <NUM>. However, this is not intended to be limiting. Rather, it is contemplated that in some examples the sealing member <NUM> may be formed from a material which is distinct from the material forming the occlusive member <NUM>. Additionally, it is contemplated that the sealing member <NUM> illustrated in <FIG> may extend either partially or entirely around the outer surface of the occlusion member <NUM> and/or the expandable member <NUM>. For example, the sealing member <NUM> may extend either partially or entirely around the circumference of the expandable member <NUM>.

<FIG> further illustrates that in some examples the occlusion device <NUM> may include a conformable material <NUM> which is positioned behind, along or adjacent the sealing member <NUM> and/or the occlusion member <NUM>. According to the claimed invention, the conformable material <NUM> is positioned within a pocket created between the occlusion member <NUM> and the sealing member <NUM>. The conformable material <NUM> may include a sheath, mesh, fabric, sheet or similar type material. Further, it can be appreciated that the conformable material <NUM> illustrated in <FIG> may extend either partially or entirely around the outer surface of the occlusion member <NUM> and/or the expandable member <NUM>. For example, the conformable material <NUM> may extend either partially or entirely around the circumference of the expandable member <NUM>.

However, in other examples the conformable material <NUM> may be positioned directly atop the expandable framework <NUM> and underneath the occlusion member <NUM> (e.g., between the expandable framework <NUM> and the occlusion member <NUM>). For example, <FIG> illustrates the conformable material <NUM> positioned directly atop the expandable framework <NUM> and underneath the occlusion member <NUM>. This configuration may reduce the likelihood of thrombus formation within the occlusion device <NUM> because the conformable material <NUM> would be positioned underneath the occlusion member <NUM> when sealing the left atrial appendage.

In some instances the conformable material <NUM> described above may be formed from a material which is designed to expand and/or swell upon placement of the occlusion device <NUM>. For example, in some instances the conformable material <NUM> may be constructed from a hydrogel material. The hydrogel material may swell due to its interaction with water and/or thermal phase changes. However, this is not intended to be limiting. Other materials which may expand or swell are contemplated herein.

It can be appreciated that designing the conformable material <NUM> (described with respect to <FIG> and <FIG>) to include an expandable material may permit the sealing member <NUM> to effectively seal irregular anatomical geometries of the left atrial appendage. <FIG> illustrates the conformable material <NUM> described with respect to <FIG> and <FIG> in an expanded state. It can be appreciated that as the conformable material <NUM> expands (e.g., when adjacent the left atrial appendage), it may conform to the specific geometries of the wall of the left atrial appendage.

<FIG> illustrates another example occlusion implant device <NUM>. The occlusion implant device <NUM> may be similar in form and function to other occlusion implant devices disclosed herein. For example, the occlusion implant device <NUM> may include an expandable frame <NUM>, an occlusion member <NUM> and one or more anchoring members <NUM>.

Additionally, <FIG> illustrates that the occlusion device <NUM> may include one or more sealing members <NUM>. Sealing members <NUM> may extend radially away from the expandable member <NUM> and/or the occlusion member <NUM>. In some examples the sealing members <NUM> may resemble "paddles" which extend radially outward from the expandable member <NUM> and/or the occlusion member <NUM>. For example, <FIG> illustrates a top-view of the occlusive device <NUM> shown in <FIG>. <FIG> shows that the sealing members <NUM> may include a curved portion which extends radially outward from the expandable framework <NUM>.

Further, while the occlusive device <NUM> shown in <FIG> includes two sealing members <NUM>, this is not intended to be limiting. Rather, it is contemplated that the occlusive device <NUM> may include <NUM>, <NUM>, <NUM>, <NUM>, or more sealing members <NUM>. Further, the sealing members <NUM> may be positioned symmetrically around the perimeter of the expandable framework <NUM>. In other instances, however, the sealing members <NUM> may be positioned asymmetrically around the expendable framework <NUM>. It can be appreciated that the sealing members <NUM> described above may be designed to seal against the left atrial appendage in a manner similar to other sealing members described herein. For example, the sealing members <NUM> shown in <FIG> may designed to conform to the specific geometries of the wall of the left atrial appendage.

Further, it can be appreciated that in some instances, a clinician may position the occlusive device <NUM> in a specific orientation within the left atrial appendage to optimize the sealing ability of the occlusive device <NUM>. Therefore, in some instances, it may be desirable to design the occlusive device <NUM> to permit a clinician to visualize the orientation of the sealing members <NUM> within the left atrial appendage. For example, <FIG> illustrates that in some examples the occlusive device <NUM> may include one or more radiopaque marker bands <NUM> which are aligned with each of the sealing members <NUM>, respectively. It can be appreciated that these marker bands may permit a clinician to visual the orientation of the occlusive device <NUM> within the left atrial appendage. The arrangement of the marker bands <NUM> shown in <FIG> are not limiting, rather, other arrangements and configurations of the marker bands are contemplated.

Additionally, <FIG> illustrates that the occlusion device <NUM> may include one or more sealing members <NUM>. In some examples, the sealing members <NUM> may be positioned directly adjacent one another. However, in other examples the sealing members <NUM> may be spaced from one another. Sealing members <NUM> may extend radially away from the expandable member <NUM> and/or the occlusion member <NUM>. In some examples the sealing members <NUM> may resemble "pillows" which extend radially outward from the expandable member <NUM> and/or the occlusion member <NUM>.

As illustrated in <FIG>, the sealing members <NUM> may include "extra" material that extends radially outward from the occlusion member <NUM> and/or the expandable framework <NUM>. It can be further appreciated that this extra material (defining the sealing members <NUM>) may be able to conform to the specific shape and/or geometry of a lateral wall of a left atrial appendage. In other words, the sealing members <NUM> may resemble extra material that may bunch, fill and/or conform to the specific shape and/or geometry of a lateral wall of a left atrial appendage when positioned adjacent thereto.

In some instances, the sealing members <NUM> may be formed from the same material as the material forming the occlusive member <NUM>. In other words, the material forming the sealing members <NUM> may be an extension of the material forming the occlusive member <NUM>. For example, in some instances the occlusive member <NUM> may be formed from a fabric material, and therefore, in some instances the sealing member may be formed from the same fabric. However, this is not intended to be limiting. Rather, it is contemplated that in some examples the sealing members <NUM> may be formed from a material which is distinct from the material forming the occlusive member <NUM>. It is contemplated that the sealing members <NUM> may be formed from a variety of fibers, bands, sheet material, mesh materials, ring strictures, or the like. These materials may be woven, braided, knitted, or combined using a variety of manufacturing techniques. In some examples the sealing members <NUM> may extend around the expandable framework in a helical manner.

Additionally, it is contemplated that the sealing members <NUM> illustrated in <FIG> may extend either partially or entirely around the outer surface of the occlusive member <NUM>. For example, the sealing members <NUM> may extend either partially or entirely around the circumference of the occlusive member <NUM> and/or expandable framework <NUM>. It can be appreciated that in instances in which the sealing members <NUM> extend entirely around the outer surface of the occlusive member <NUM>, the sealing members <NUM> may resemble annular rings extending around the outer surface of the occlusive member <NUM>.

Additionally, <FIG> illustrates that the occlusion device <NUM> may include one or more sealing members <NUM>. The sealing members <NUM> may be similar to the sealing members <NUM> described above with respect to <FIG>. However, the sealing members <NUM> may be arranged in "vertical" orientation with respect to the longitudinal axis of the occlusion device <NUM> (versus being arranged horizontally around the perimeter of the occlusion device <NUM> as shown in <FIG>). However, similar to the sealing members <NUM> described with respect to <FIG>, the sealing members <NUM> may extend radially away from the expandable member <NUM> and/or the occlusion member <NUM>. In some examples the sealing members <NUM> may resemble vertical "pillows" which extend radially outward from the expandable member <NUM> and/or the occlusion member <NUM>.

<FIG> illustrates a top-view of the occlusive device <NUM> shown in <FIG>. In some examples, the sealing members <NUM> may be positioned directly adjacent one another. However, in other examples the sealing members <NUM> may be spaced from one another. Additionally, <FIG> shows that the sealing members <NUM> may include a curved portion which extends radially outward from the expandable framework <NUM>. Further, while the occlusive device <NUM> shown in <FIG> includes ten sealing members <NUM>, this is not intended to be limiting. Rather, it is contemplated that the occlusive device <NUM> may include more or less than ten sealing members <NUM>. For example, the occlusive device <NUM> may include <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or more sealing members <NUM>.

Additionally, the sealing members <NUM> may be positioned symmetrically around the perimeter of the expandable framework <NUM>. In other instances, however, the sealing members <NUM> may be positioned asymmetrically around the expendable framework <NUM>. It can be appreciated that the sealing members <NUM> described above may be designed to seal against the left atrial appendage in a manner similar to other sealing members described herein. For example, the sealing members <NUM> shown in <FIG> and <FIG> may be designed to conform to the specific geometries of the wall of the left atrial appendage. As illustrated in <FIG> and <FIG>, the sealing members <NUM> may include "extra" material that extends radially outward from the occlusion member <NUM> and/or the expandable framework <NUM>. It can be further appreciated that this extra material (defining the sealing members <NUM>) may be able to conform to the specific shape and/or geometry of a lateral wall of a left atrial appendage. Additionally, while not shown in the figures, it is contemplated that the sealing members <NUM> are configured to lengthen along the vertical axis of the occlusion device <NUM> in instances in which the occlusion device <NUM> lengthens along its longitudinal axis.

<FIG> illustrates another example occlusion implant device <NUM>. The occlusion implant device <NUM> may be similar in form and function to other occlusion implant devices disclosed herein. For example, the occlusion implant device <NUM> may include an expandable frame <NUM>, an occlusion member <NUM> and one or more of the anchoring members <NUM>.

Additionally, <FIG> illustrates that the occlusion device <NUM> may include a sealing member <NUM>. The sealing member <NUM> may resemble an "annular flap" that extends around the outer surface of the occlusion member <NUM> and/or the expandable member <NUM>. The sealing member <NUM> may extend radially away from the expandable member <NUM> and/or the occlusion member <NUM>. It can be appreciated that the sealing member <NUM> may provide extra material which is able to conform to the specific shape and/or geometry of a lateral wall of a left atrial appendage. In other words, the sealing member <NUM> may resemble extra material which may bunch, fill and/or conform to the specific shape and/or geometry of a lateral wall of a left atrial appendage when positioned adjacent thereto.

In some instances, the sealing member <NUM> may be formed from the same material as the material forming the occlusive member <NUM>. In other words, the material forming the sealing member <NUM> may be an extension of the material forming the occlusive member <NUM>. For example, in some instances the occlusive member <NUM> may be formed from a fabric material, and therefore, in some instances the sealing member <NUM> may be formed from the same fabric. However, this is not intended to be limiting. Rather, it is contemplated that in some examples the sealing member <NUM> may be formed from a material which is distinct from the material forming the occlusive member <NUM>. Some suitable, but non-limiting, examples of materials for the occlusive members disclosed herein are discussed below.

Additionally, it is contemplated that the sealing member <NUM> illustrated in <FIG> may extend either partially or entirely around the outer surface of the occlusive member <NUM>. For example, the sealing member <NUM> may extend either partially or entirely around the circumference of the occlusive member <NUM> and/or expandable framework <NUM>. It can be appreciated that in instances in which the sealing member <NUM> extends entirely around the outer surface of the occlusive member <NUM>, the sealing member <NUM> may resemble a flat, annular ring extending entirely around the outer surface of the occlusive member <NUM>.

<FIG> illustrates a top view of another example occlusion implant device <NUM>. The occlusion implant device <NUM> may be similar in form and function to other occlusion implant devices disclosed herein. For example, the occlusion implant device <NUM> may include an expandable frame <NUM> and one or more sealing members <NUM>. As illustrated in <FIG>, sealing members <NUM> may include a support member <NUM> which may extend radially away from the expandable frame <NUM>. Additionally, the sealing members <NUM> may include an occlusion member <NUM> which may be coupled to both the support member <NUM> and a portion of the expandable frame <NUM>. The occlusion members <NUM> may extend along the entire longitudinal length of the expandable frame <NUM>.

<FIG> illustrates that in some instances, the support arms <NUM> may bend and/or pivot around the outer circumference of the expandable frame <NUM>. In some instances, the support arms <NUM> may pivot and collapse around the perimeter of the expandable frame <NUM> (as shown in <FIG>), as each of the support arms <NUM> engage with the lateral wall of the left atrial appendage (for example, as the occlusion implant device is being positioned adjacent the left atrial appendage). It can be appreciated that as each of the support arms <NUM> pivot and collapse with the lateral wall of the left atrial appendage, the occlusion material <NUM> that is coupled to the support arms <NUM> and the expandable frame <NUM> may seal the occlusive device <NUM> against the lateral wall of the left atrial appendage.

<FIG> illustrates another example occlusion implant device <NUM>. The occlusion implant device <NUM> may be similar in form and function to other occlusion implant devices disclosed herein. For example, the occlusion implant device <NUM> may include an expandable frame <NUM>, an occlusion member <NUM> and one or more of the anchoring members <NUM>. Additionally, <FIG> illustrates that in some instances the occlusion member <NUM> may include one or more apertures <NUM> which permit one or more of the anchoring members <NUM> to extend therethrough. It can be appreciated that the apertures <NUM> may be strategically positioned along the occlusion member <NUM> to align with one or more anchoring members <NUM>. It can be further appreciated that the anchoring members <NUM> may be arranged along the expandable frame <NUM> to provide an optimal anchoring of the occlusion implant device <NUM> within the left atrial appendage. It is contemplated that the apertures <NUM> described herein may be applied to any of the occlusion implant device configurations described herein.

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-b-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 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.

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;
an occlusive member (<NUM>) disposed along at least a portion of the expandable framework;
a sealing member (<NUM>) disposed along the occlusive member,
wherein the sealing member extends radially outward from the occlusive member; and characterized by
a conformable material (<NUM>) positioned within a pocket between the occlusive member and the sealing member.