Occlusive medical device with sealing member

An example occlusive implant is disclosed. The 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.

BACKGROUND

The left atrial appendage (LAA) is a small organ attached to the left atrium of the heart as a pouch-like extension. In patients suffering from atrial fibrillation, the left atrial appendage may not properly contract with the left atrium, 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 are found in the left atrial appendage. As a treatment, medical devices have been developed which are positioned in the left atrial appendage and deployed to close off the ostium of the left atrial appendage. Over time, the exposed surface(s) spanning the ostium of the left atrial appendage becomes covered with tissue (a process called endothelization), effectively removing the left atrial appendage from the circulatory system and reducing or eliminating the number of thrombi which may enter the blood stream from the left atrial appendage. A continuing need exists for improved medical devices and methods to control thrombus formation within the left atrial appendage of patients suffering from atrial fibrillation.

SUMMARY

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: an expandable framework configured to shift between a collapsed configuration and an expanded configuration;

a plurality of anchor members disposed along the expandable framework;

a covering disposed along an outer surface of the expandable framework; and

a protrusion portion extending outward from the covering.

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 comprising:

advancing an occlusive implant to the left atrial appendage, the occlusive implant including:an expandable framework;an occlusive member coupled to the expandable framework; anda sealing member coupled to the occlusive member;

expanding the expandable framework within the left atrial appendage;

positioning the sealing member adjacent to the left atrial appendage.

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.

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 which follows more particularly exemplify these embodiments.

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 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.

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.

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 180 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.1illustrates an example occlusive implant10. The implant10may include an expandable framework12. The occlusive implant10may also include an occlusive member14disposed on, disposed over, disposed about, or covering at least a portion of the expandable framework12. In some embodiments, the occlusive member14may be disposed on, disposed over, disposed about or cover at least a portion of an outer (or outwardly-facing) surface of the expandable framework12.FIG.1further illustrates that the occlusive member14may extend only partially along the longitudinal extent of the expandable framework12. However, this is not intended to be limiting. Rather, the occlusive member14may extend along the longitudinal extent of the expandable framework to any degree (e.g., the full longitudinal extend of the expandable framework12).

In some embodiments, the occlusive member14may be permeable or impermeable to blood and/or other fluids, such as water. In some embodiments, the occlusive member14may 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 member14may prevent thrombi (i.e. blood clots, etc.) from passing through the occlusive member14and out of the left atrial appendage into the blood stream. In some embodiments, the occlusive member14may 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 member14are discussed below.

FIG.1further illustrates that the expandable framework12may include a plurality of anchor members16disposed about a periphery of the expandable framework12. The plurality of anchor members16may extend radially outward from the expandable framework12. In some embodiments, at least some of the plurality of anchor members16may each have and/or include a body portion and a tip portion projecting circumferentially therefrom, as shown inFIG.1. Some suitable, but non-limiting, examples of materials for the expandable framework12and/or the plurality of anchor members16are discussed below.

In some examples, the expandable framework12and the plurality of anchor members16may be integrally formed and/or cut from a unitary member. In some embodiments, the expandable framework12and the plurality of anchor members16may 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 framework12and the plurality of anchor members16may 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 framework12include laser cutting, machining, punching, stamping, electro discharge machining (EDM), chemical dissolution, etc. Other means and/or methods are also contemplated.

As illustrated inFIG.1, the plurality of anchor members16disposed along the expandable framework12may include two rows of anchor members16. However, this is not intended to be limiting. Rather, the expandable framework12may include a single row of anchor members16. In other examples, the expandable framework12may include more than two rows of anchor members16. For example, in some instances the expandable framework12may include 1, 2, 3, 4 or more rows of anchor members16.

FIG.2illustrates that the occlusive implant10may be inserted and advanced through a body lumen via an occlusive implant delivery system20.FIG.2further illustrates the occlusive implant10being delivered and positioned within the left atrial appendage50. In some instances, an occlusive implant delivery system20may include a delivery catheter24which 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 appendage50.

The delivery system20may include a hub member22coupled to a proximal region of the delivery catheter24. The hub member22may be manipulated by a clinician to direct the distal end region of the delivery catheter24to a position adjacent the left atrial appendage50. In some embodiments, an occlusive implant delivery system may include a core wire18. Further, a proximal end of the expandable framework12may be configured to releasably attach, join, couple, engage, or otherwise connect to the distal end of the core wire18. In some embodiments, an end region of the expandable framework12may 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 wire18. Other means of releasably coupling and/or engaging the proximal end of the expandable framework12to the distal end of the core wire18are also contemplated.

FIG.3illustrates a left atrial appendage occlusive implant10positioned adjacent the left atrial appendage50via the delivery catheter24(described above with respect toFIG.2). As discussed above, in some examples, the implant10may 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.3illustrates that the expandable framework12may 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 implant10may 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.3illustrates that the expandable framework12may be held fixed adjacent to the left atrial appendage by one or more anchoring members16.

Further, it can be appreciated that the elements of the expandable framework12may be tailored to increase the flexibility and compliance of the expandable framework12and/or the occlusive implant10, thereby permitting the expandable framework12and/or the occlusive implant10to conform to the tissue around it, rather than forcing the tissue to conform to the expandable framework12and/or the occlusive implant10. Additionally, in some instances, it may be desirable to design the occlusive implant10discussed 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.4illustrates an example occlusion implant device110. The occlusion implant device110may be similar in form and function to other occlusion implant devices disclosed herein. For example, the occlusion implant device110may include an expandable frame112, an occlusion member114and one or more anchoring members116. Additionally,FIG.4illustrates that the occlusion device110may include a sealing member126. The sealing member126may extend outward from the occlusion member114and/or the expandable framework112. For example, the sealing member126may extend radially away from the occlusion member114and/or the expandable framework112.

As illustrated inFIG.4, the sealing member126may include a folded portion. It can be appreciated that the folded portion of the sealing member126adds “extra” material the occlusion device110which, as stated above, extends radially outward from the occlusion member114and/or the expandable framework112. 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 member126may 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 member126may be formed from the same material as the material forming the occlusive member114. For example, in some instances the sealing member126may be formed integral with the occlusive member114. In other words, the material forming the sealing member126may be an extension of the material forming the occlusive member114. For example, in some instances the occlusive member114may 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 member126may be formed from a material which is distinct from the material forming the occlusive member114. For example, in some instances the sealing member126may be formed separate from and later attached (e.g., joined, adhered, sewn, etc.) to the occlusive member114. Some suitable, but non-limiting, examples of materials for the occlusive members disclosed herein are discussed below.

Additionally, it is contemplated that the sealing member126illustrated inFIG.4may extend either partially or entirely around the outer surface of the occlusive member114. For example, the sealing member126may extend either partially or entirely around the circumference of the occlusive member114and/or expandable framework112. It can be appreciated that in instances in which the sealing member126extends entirely around the outer surface of the occlusive member112, the sealing member126may 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 member126to sufficiently seal against the lateral wall of the left atrial appendage.

FIG.5illustrates another example occlusion implant device210. The occlusion implant device210may be similar in form and function to other occlusion implant devices disclosed herein. For example, the occlusion implant device210may include an expandable frame212, an occlusion member214and one or more anchoring members216. Additionally,FIG.5illustrates that the occlusion device210may include a sealing member228.

The sealing member228may be similar in form and function to the sealing member126described above with respect toFIG.4. For example, the sealing member228may extend outward from the occlusion member214and/or the expandable framework212. Additionally, the sealing member228may be formed from the same material as the material forming the occlusive member214. In other words, the material forming the sealing member228may be an extension of the material forming the occlusive member214. However, this is not intended to be limiting. Rather, it is contemplated that in some examples the sealing member228may be formed from a material which is distinct from the material forming the occlusive member214. Additionally, it is contemplated that the sealing member228illustrated inFIG.5may extend either partially or entirely around the outer surface of the occlusion member214and/or the expandable member212. For example, the sealing member228may extend either partially or entirely around the circumference of the expandable member212.

FIG.5further illustrates that in some examples the occlusion device210may include a conformable material230which is positioned behind, along or adjacent the sealing member228and/or the occlusion member214. For example, in some instances, the conformable material230maybe positioned within a pocket created between the occlusion member214and the sealing member228. The conformable material230may include a sheath, mesh, fabric, sheet or similar type material. Further, it can be appreciated that the conformable material230illustrated inFIG.5may extend either partially or entirely around the outer surface of the occlusion member214and/or the expandable member212. For example, the conformable material230may extend either partially or entirely around the circumference of the expandable member212.

However, in other examples the conformable material230may be positioned directly atop the expandable framework212and underneath the occlusion member214(e.g., between the expandable framework212and the occlusion member214). For example,FIG.5Aillustrates the conformable material230positioned directly atop the expandable framework212and underneath the occlusion member214. This configuration may reduce the likelihood of thrombus formation within the occlusion device210because the conformable material230would be positioned underneath the occlusion member214when sealing the left atrial appendage.

In some instances the conformable material230described above may be formed from a material which is designed to expand and/or swell upon placement of the occlusion device210. For example, in some instances the conformable material230may 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 material230(described with respect toFIG.5andFIG.5A) to include an expandable material may permit the sealing member228to effectively seal irregular anatomical geometries of the left atrial appendage.FIG.6illustrates the conformable material230described with respect toFIG.5andFIG.5Ain an expanded state. It can be appreciated that as the conformable material230expands (e.g., when adjacent the left atrial appendage), it may conform to the specific geometries of the wall of the left atrial appendage.

FIG.7illustrates another example occlusion implant device310. The occlusion implant device310may be similar in form and function to other occlusion implant devices disclosed herein. For example, the occlusion implant device310may include an expandable frame312, an occlusion member314and one or more anchoring members316.

Additionally,FIG.7illustrates that the occlusion device310may include one or more sealing members332. Sealing members332may extend radially away from the expandable member312and/or the occlusion member314. In some examples the sealing members332may resemble “paddles” which extend radially outward from the expandable member312and/or the occlusion member314. For example,FIG.8illustrates a top-view of the occlusive device310shown inFIG.7.FIG.8shows that the sealing members332may include a curved portion which extends radially outward from the expandable framework312.

Further, while the occlusive device310shown inFIG.8includes two sealing members332, this is not intended to be limiting. Rather, it is contemplated that the occlusive device310may include 1, 2, 3, 4, or more sealing members332. Further, the sealing members332may be positioned symmetrically around the perimeter of the expandable framework312. In other instances, however, the sealing members332may be positioned asymmetrically around the expendable framework312. It can be appreciated that the sealing members332described 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 members332shown inFIG.8may 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 device310in a specific orientation within the left atrial appendage to optimize the sealing ability of the occlusive device310. Therefore, in some instances, it may be desirable to design the occlusive device310to permit a clinician to visualize the orientation of the sealing members332within the left atrial appendage. For example,FIG.8illustrates that in some examples the occlusive device310may include one or more radiopaque marker bands333which are aligned with each of the sealing members332, respectively. It can be appreciated that these marker bands may permit a clinician to visual the orientation of the occlusive device310within the left atrial appendage. The arrangement of the marker bands333shown inFIG.8are not limiting, rather, other arrangements and configurations of the marker bands are contemplated.

FIG.9illustrates another example occlusion implant device410. The occlusion implant device410may be similar in form and function to other occlusion implant devices disclosed herein. For example, the occlusion implant device410may include an expandable frame412, an occlusion member414and one or more anchoring members416.

Additionally,FIG.9illustrates that the occlusion device410may include one or more sealing members434. In some examples, the sealing members434may be positioned directly adjacent one another. However, in other examples the sealing members434may be spaced from one another. Sealing members434may extend radially away from the expandable member412and/or the occlusion member414. In some examples the sealing members434may resemble “pillows” which extend radially outward from the expandable member412and/or the occlusion member414.

As illustrated inFIG.9, the sealing members434may include “extra” material that extends radially outward from the occlusion member414and/or the expandable framework412. It can be further appreciated that this extra material (defining the sealing members434) 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 members434may 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 members434may be formed from the same material as the material forming the occlusive member414. In other words, the material forming the sealing members434may be an extension of the material forming the occlusive member414. For example, in some instances the occlusive member414may 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 members434may be formed from a material which is distinct from the material forming the occlusive member414. It is contemplated that the sealing members434may 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 members434may extend around the expandable framework in a helical manner.

Additionally, it is contemplated that the sealing members434illustrated inFIG.9may extend either partially or entirely around the outer surface of the occlusive member414. For example, the sealing members434may extend either partially or entirely around the circumference of the occlusive member414and/or expandable framework412. It can be appreciated that in instances in which the sealing members434extend entirely around the outer surface of the occlusive member414, the sealing members434may resemble annular rings extending around the outer surface of the occlusive member414.

FIG.10illustrates another example occlusion implant device510. The occlusion implant device510may be similar in form and function to other occlusion implant devices disclosed herein. For example, the occlusion implant device510may include an expandable frame512, an occlusion member514and one or more anchoring members516.

Additionally,FIG.10illustrates that the occlusion device510may include one or more sealing members538. The sealing members538may be similar to the sealing members434described above with respect toFIG.9. However, the sealing members538may be arranged in “vertical” orientation with respect to the longitudinal axis of the occlusion device510(versus being arranged horizontally around the perimeter of the occlusion device510as shown inFIG.9). However, similar to the sealing members434described with respect toFIG.9, the sealing members538may extend radially away from the expandable member512and/or the occlusion member514. In some examples the sealing members538may resemble vertical “pillows” which extend radially outward from the expandable member512and/or the occlusion member514.

FIG.11illustrates a top-view of the occlusive device510shown inFIG.10. In some examples, the sealing members538may be positioned directly adjacent one another. However, in other examples the sealing members538may be spaced from one another. Additionally,FIG.11shows that the sealing members538may include a curved portion which extends radially outward from the expandable framework512. Further, while the occlusive device510shown inFIG.11includes ten sealing members538, this is not intended to be limiting. Rather, it is contemplated that the occlusive device510may include more or less than ten sealing members538. For example, the occlusive device510may include 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 or more sealing members538.

Additionally, the sealing members538may be positioned symmetrically around the perimeter of the expandable framework512. In other instances, however, the sealing members538may be positioned asymmetrically around the expendable framework512. It can be appreciated that the sealing members538described 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 members538shown inFIG.10andFIG.11may be designed to conform to the specific geometries of the wall of the left atrial appendage. As illustrated inFIG.10andFIG.11, the sealing members538may include “extra” material that extends radially outward from the occlusion member514and/or the expandable framework512. It can be further appreciated that this extra material (defining the sealing members538) 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 members538are configured to lengthen along the vertical axis of the occlusion device510in instances in which the occlusion device510lengthens along its longitudinal axis.

FIG.12illustrates another example occlusion implant device610. The occlusion implant device610may be similar in form and function to other occlusion implant devices disclosed herein. For example, the occlusion implant device610may include an expandable frame612, an occlusion member614and one or more of the anchoring members616.

Additionally,FIG.12illustrates that the occlusion device610may include a sealing member640. The sealing member640may resemble an “annular flap” that extends around the outer surface of the occlusion member614and/or the expandable member612. The sealing member640may extend radially away from the expandable member612and/or the occlusion member614. It can be appreciated that the sealing member640may 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 member640may 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 member640may be formed from the same material as the material forming the occlusive member614. In other words, the material forming the sealing member640may be an extension of the material forming the occlusive member614. For example, in some instances the occlusive member614may be formed from a fabric material, and therefore, in some instances the sealing member640may be formed from the same fabric. However, this is not intended to be limiting. Rather, it is contemplated that in some examples the sealing member640may be formed from a material which is distinct from the material forming the occlusive member614. Some suitable, but non-limiting, examples of materials for the occlusive members disclosed herein are discussed below.

Additionally, it is contemplated that the sealing member640illustrated inFIG.12may extend either partially or entirely around the outer surface of the occlusive member614. For example, the sealing member640may extend either partially or entirely around the circumference of the occlusive member614and/or expandable framework612. It can be appreciated that in instances in which the sealing member640extends entirely around the outer surface of the occlusive member612, the sealing member640may resemble a flat, annular ring extending entirely around the outer surface of the occlusive member612.

FIG.13illustrates a top view of another example occlusion implant device710. The occlusion implant device710may be similar in form and function to other occlusion implant devices disclosed herein. For example, the occlusion implant device710may include an expandable frame712and one or more sealing members752. As illustrated inFIG.13, sealing members752may include a support member754which may extend radially away from the expandable frame712. Additionally, the sealing members752may include an occlusion member756which may be coupled to both the support member754and a portion of the expandable frame712. The occlusion members756may extend along the entire longitudinal length of the expandable frame712.

FIG.14illustrates that in some instances, the support arms754may bend and/or pivot around the outer circumference of the expandable frame712. In some instances, the support arms754may pivot and collapse around the perimeter of the expandable frame712(as shown inFIG.14), as each of the support arms754engage 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 arms754pivot and collapse with the lateral wall of the left atrial appendage, the occlusion material756that is coupled to the support arms754and the expandable frame712may seal the occlusive device710against the lateral wall of the left atrial appendage.

FIG.15illustrates another example occlusion implant device810. The occlusion implant device810may be similar in form and function to other occlusion implant devices disclosed herein. For example, the occlusion implant device810may include an expandable frame812, an occlusion member814and one or more of the anchoring members816. Additionally,FIG.15illustrates that in some instances the occlusion member814may include one or more apertures842which permit one or more of the anchoring members816to extend therethrough. It can be appreciated that the apertures842may be strategically positioned along the occlusion member814to align with one or more anchoring members816. It can be further appreciated that the anchoring members816may be arranged along the expandable frame812to provide an optimal anchoring of the occlusion implant device810within the left atrial appendage. It is contemplated that the apertures842described 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 implant10(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 implant10(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 implant10(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.

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.