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

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

<CIT> relates to an occlusive implant. The occlusive implant includes an expandable framework including a height and a plurality of support members defining a proximal end region of the expandable framework and a central hub member attached to the plurality of support members. Additionally, the expandable framework is configured to shift between a first configuration and a second configuration, wherein the height of the expandable framework remains substantially the same in both the first configuration and the second configuration. Further, the central hub member is configured to shift relative to the proximal end region while the expandable framework shifts between the first configuration and the second configuration.

In a first aspect, an implant for occluding a left atrial appendage may comprising an expandable framework including a body portion and a disk portion, wherein the expandable framework may be configured to shift between a collapsed configuration and an expanded configuration, and an occlusive disk element disposed within the disk portion. The disk portion may include a first disk portion integrally formed with the body portion, and a second disk portion movably attached to the first disk portion by at least one hinge member.

In addition or alternatively to any aspect herein, the second disk portion is structurally independent of the first disk portion.

In addition or alternatively to any aspect herein, the second disk portion includes a proximal hub configured to releasably connect the implant to a delivery device.

In addition or alternatively, the first disk portion is oriented substantially transverse to a central longitudinal axis of the body portion in the expanded configuration.

In addition or alternatively to any aspect herein, at least half of the first disk portion is substantially planar in the expanded configuration.

In addition or alternatively to any aspect herein, the second disk portion is oriented substantially transverse to a central longitudinal axis of the body portion in the expanded configuration.

In addition or alternatively to any aspect herein, at least half of the second disk portion is substantially planar in the expanded configuration.

In addition or alternatively to any aspect herein, the occlusive disk element is sandwiched between the first disk portion and the second disk portion in the expanded configuration.

In addition or alternatively to any aspect herein, the disk portion has an oblong perimeter shape in the expanded configuration.

In addition or alternatively, an implant for occluding a left atrial appendage may comprise an expandable framework including a body portion and a disk portion, wherein the expandable framework may be configured to shift between a collapsed configuration and an expanded configuration, and an occlusive disk element coupled to the disk portion by at least one hinge member.

In addition or alternatively to any aspect herein, the disk portion may include a first disk portion integrally formed with the body portion, and a second disk portion movably attached to the first disk portion by the at least one hinge member.

In addition or alternatively to any aspect herein, the occlusive disk element is disposed between the first disk portion and the second disk portion.

In addition or alternatively to any aspect herein, each of the at least one hinge member includes a coiled element.

In addition or alternatively to any aspect herein, the coiled element includes a piercing point on at least one end.

In addition or altematively to any aspect herein, the disk portion is disposed proximal of the body portion.

In addition or altematively, an implant for occluding a left atrial appendage may comprise an expandable framework including a body portion and a disk portion, wherein the expandable framework may be configured to shift between a collapsed configuration and an expanded configuration, and an occlusive disk element disposed within the disk portion. The disk portion may include a first disk portion integrally formed with the body portion, and a second disk portion pivotably attached to the first disk portion by at least one hinge member encircling at least a portion of the first disk portion and at least a portion of the second disk portion. The occlusive disk element may be coupled to the disk portion by the at least one hinge member.

In addition or alternatively to any aspect herein, the first disk portion includes a first pocket disposed along a perimeter of the first disk portion, and the second disk portion includes a second pocket disposed along a perimeter of the second disk portion, wherein the first pocket is aligned with the second pocket in the expanded configuration to form a pocket assembly.

In addition or alternatively to any aspect herein, the at least one hinge member is positioned within the first pocket and the second pocket.

In addition or alternatively to any aspect herein, the first disk portion includes a plurality of first pockets disposed along the perimeter of the first disk portion, and the second disk portion includes a plurality of second pockets disposed along the perimeter of the second disk portion. The plurality of first pockets may be aligned with the plurality of second pockets to form a plurality of pocket assemblies, wherein one hinge member is positioned within each pocket assembly.

In addition or alternatively to any aspect herein, the disk portion is spaced apart from the body portion by a neck portion.

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 invention. 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 invention. 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 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 an outer dimension, "radial extent" may be understood to mean a radial dimension, "longitudinal extent" may be understood to mean a longitudinal dimension, etc. Each instance of an "extent" may be different (e.g., axial, longitudinal, lateral, radial, circumferential, etc.) and will be apparent to the skilled person from the context of the individual usage. Generally, an "extent" may be considered 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.

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

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

<FIG> is a partial cross-sectional view illustrating elements of a delivery device <NUM> and an implant <NUM> for occluding the left atrial appendage <NUM>. The delivery device <NUM> may include a delivery sheath <NUM> having a lumen <NUM> extending to a distal end of the delivery sheath <NUM> and a core wire <NUM> slidably disposed within the lumen <NUM>. The core wire <NUM> may be configured to and/or may be capable of axially translating the implant <NUM> relative to the delivery sheath <NUM>. The delivery sheath <NUM> and/or the core wire <NUM> may have a selected level of axial stiffness and/or pushability characteristics while also having a selected level of flexibility to permit navigation through the patient's vasculature. Some suitable, but non-limiting, examples of materials for the delivery sheath <NUM> and the core wire <NUM> are discussed below.

The implant <NUM> may comprise an expandable framework <NUM> configured to shift between a collapsed configuration and an expanded configuration. The expandable framework <NUM> may be configured to releasably connect the implant <NUM> to the delivery device <NUM>. The expandable framework <NUM> may include a body portion <NUM> and a disk portion <NUM>. In some embodiments, the disk portion <NUM> may be spaced apart from the body portion <NUM> by a neck portion <NUM> (e.g., <FIG>). In at least some embodiments, the disk portion <NUM> may be secured to, attached to, and/or connected to the body portion <NUM> by the neck portion <NUM>. In some embodiments, the neck portion <NUM> is tubular (e.g., a tubular member, annular, etc.) and includes a lumen extending therethrough. In some embodiments, the neck portion <NUM> may be integrally formed with the body portion <NUM> as a unitary structure. For example, the neck portion <NUM> may be formed from the same structural elements (e.g., cut tube, braided filaments, etc.) as the body portion <NUM>. The disk portion <NUM> may be disposed proximal of the body portion <NUM>. Additional details related to the disk portion <NUM> are described below.

When the implant <NUM> is disposed within the lumen <NUM> of the delivery sheath <NUM>, the expandable framework <NUM> may be held and/or disposed in the collapsed configuration, as shown in <FIG> for example. The body portion <NUM> and the disk portion <NUM> may be configured to shift between the collapsed configuration (e.g., <FIG>) and the expanded configuration (e.g., <FIG>). In some embodiments, the implant <NUM> may optionally include an occlusive body element <NUM> disposed and/or positioned on, over, and/or around at least a portion of the expandable framework <NUM>. For example, the implant <NUM> may optionally include an occlusive body element <NUM> (e.g., a mesh, a fabric, a membrane, and/or other surface treatment) disposed and/or positioned on, over, and/or around at least a portion of the body portion <NUM> of the expandable framework <NUM>. In at least some embodiments, the occlusive body element <NUM> may be secured to, attached to, and/or connected to the expandable framework <NUM> and/or the body portion <NUM> of the expandable framework <NUM>. In some embodiments, the occlusive body element <NUM> may be secured to, attached to, and/or connected to the expandable framework <NUM> and/or the body portion <NUM> of the expandable framework <NUM> at a plurality of discrete locations.

In some embodiments, the occlusive body element <NUM> may be porous. In some embodiments, the occlusive body element <NUM> may be non-porous. In some embodiments, the occlusive body element <NUM> may be designed, sized, and/or configured to prevent thrombus and/or embolic material from passing out of the left atrial appendage <NUM> into the left atrium and/or the patient's bloodstream. In some embodiments, the occlusive body element <NUM> may be configured to promote endothelization. In at least some embodiments, the occlusive body element <NUM> may be secured to the neck portion <NUM> by an annular marker band <NUM> (e.g., <FIG>, <FIG>). In some embodiments, the occlusive body element <NUM> may be adhesively bonded to the annular marker band <NUM>. In some embodiments, the annular marker band <NUM> may be embedded within the occlusive body element <NUM>. The annular marker band <NUM> may be formed from and/or doped with a radiopaque material for improved visualization. In some embodiments, the annular marker band <NUM> may compress, pinch, and/or otherwise gather the neck portion <NUM> tightly together to reduce and/or minimize fluid passage and/or leakage through the neck portion <NUM>. Some suitable, but non-limiting, examples of materials for the occlusive body element <NUM> and the annular marker band <NUM> are discussed below.

The disk portion <NUM> may include a first disk portion <NUM> and a second disk portion <NUM> movably attached to the first disk portion <NUM> by at least one hinge member <NUM>. The disk portion <NUM> may extend proximally from the body portion <NUM> in the collapsed configuration and/or within the lumen <NUM> of the delivery sheath <NUM> to a proximal hub <NUM>. In some embodiments, the second disk portion <NUM> may include the proximal hub <NUM>. The proximal hub <NUM> may be configured to releasably connect and/or attach the implant <NUM> to the core wire <NUM> of the delivery device <NUM>. In some embodiments, the proximal hub <NUM> may include internal threads configured to rotatably and/or threadably engage an externally threaded distal end <NUM> of the core wire <NUM> (e.g., <FIG>). Other configurations for releasably connecting the implant <NUM> to the core wire <NUM> are also contemplated.

In at least some embodiments, the expandable framework <NUM> and/or the body portion <NUM> of the expandable framework <NUM> may include a plurality of anchor members <NUM> extending outward from the expandable framework <NUM> and/or the body portion <NUM>, as seen in <FIG>. The plurality of anchor members <NUM> may be configured to engage with the wall <NUM> of the main body <NUM> of the left atrial appendage <NUM> (e.g., <FIG>). In some embodiments, the plurality of anchor members <NUM> may be formed as J-shaped hooks having a free end extending in and/or directed toward a proximal direction with respect to a central longitudinal axis of the expandable framework <NUM>. Other configurations are also contemplated. In some embodiments, the plurality of anchor members <NUM> may extend through the occlusive body element <NUM>, where present, as shown in <FIG>. Some suitable, but non-limiting, examples of materials for the expandable framework <NUM>, the plurality of anchor members <NUM>, the body portion, the disk portion <NUM>, etc. are discussed below.

As shown in <FIG>, the disk portion <NUM> may include the first disk portion <NUM> and the second disk portion <NUM>. In at least some embodiments, the first disk portion <NUM> may be integrally formed with the neck portion <NUM> and/or the body portion <NUM> (e.g., <FIG>). For example, in some embodiments, the body portion <NUM> may include the neck portion <NUM>, or the first disk portion <NUM> may include the neck portion <NUM>. Additionally, in at least some embodiments, the body portion <NUM>, the neck portion <NUM>, and the first disk portion <NUM> may be integrally formed as a single unitary structure. In some embodiments, the second disk portion <NUM> may be structurally independent of the first disk portion <NUM>. For example, the first disk portion <NUM> and the second disk portion <NUM> may be formed as separate pieces or structures, and/or the first disk portion <NUM> and the second disk portion <NUM> may be formed independently of each other. In some embodiments, the second disk portion <NUM> may be disposed proximally of the first disk portion <NUM>. The first disk portion <NUM> and the second disk portion <NUM> may be disposed proximally of the body portion <NUM> in the collapsed configuration and/or in the expanded configuration. In some embodiments, the proximal hub <NUM> may be disposed coaxially with and/or may be axially aligned with the central longitudinal axis of the expandable framework <NUM>.

In some embodiments, the implant <NUM> may include an occlusive disk element <NUM> (e.g., a mesh, a fabric, a membrane, and/or other surface treatment) configured to promote endothelization on and/or across the disk portion <NUM>. In some embodiments, the implant <NUM> may include the occlusive disk element <NUM> disposed on and/or surrounding a portion of an outer surface of the disk portion <NUM>. In some embodiments, the implant <NUM> may include the occlusive disk element <NUM> disposed within the disk portion <NUM>. In some embodiments, the occlusive disk element <NUM> may be disposed and/or sandwiched between the first disk portion <NUM> and the second disk portion <NUM> in the expanded configuration. In some embodiments, the occlusive disk element <NUM> may be elastic and/or stretchable to accommodate changes in shape and/or size of the disk portion <NUM> when the disk portion <NUM> are shifted toward and/or into the expanded configuration.

In some embodiments, the occlusive disk element <NUM> may be porous. In some embodiments, the occlusive disk element <NUM> may be non-porous. In some embodiments, the occlusive disk element <NUM> may be designed, sized, and/or configured to prevent thrombus and/or embolic material from passing out of the left atrial appendage <NUM> into the left atrium and/or the patient's bloodstream. In some embodiments, the occlusive disk element <NUM> may be configured to promote endothelization across the ostium <NUM> and/or the proximal mouth <NUM> of the left atrial appendage <NUM> to effectively remove the left atrial appendage <NUM> from the patient's bloodstream. Some suitable, but non-limiting, examples of materials for the occlusive disk element <NUM> are discussed below.

In some embodiments, the second disk portion <NUM> may be movably and/or pivotably attached to the first disk portion <NUM> by at least one hinge member <NUM>, as shown in greater detail in <FIG>. In some embodiments, the at least one hinge member <NUM> may encircle at least a portion of the first disk portion <NUM> and at least a portion of the second disk portion <NUM>. In some embodiments, the first disk portion <NUM> may include a first pocket <NUM> disposed along a perimeter of the first disk portion <NUM>. In some embodiments, the second disk portion <NUM> may include a second pocket <NUM> disposed along a perimeter of the second disk portion <NUM>. In some embodiments, the first pocket <NUM> may be aligned with the second pocket <NUM> in the expanded configuration to form a pocket assembly <NUM>. In some embodiments, the at least one hinge member <NUM> may be positioned within the first pocket <NUM> and the second pocket <NUM>.

In some embodiments, the first disk portion <NUM> may include a plurality of first pockets <NUM> disposed along the perimeter of the first disk portion <NUM>, as seen in the partially exploded view of <FIG>. In some embodiments, the second disk portion <NUM> may include a plurality of second pockets <NUM> disposed along the perimeter of the second disk portion <NUM>. In some embodiments, the plurality of first pockets <NUM> may be aligned with the plurality of second pockets <NUM> in the expanded configuration to form a plurality of pocket assemblies <NUM>, wherein one hinge member <NUM> is positioned within each pocket assembly <NUM>, as shown in <FIG> and <FIG>.

In at least some embodiments, the occlusive disk element <NUM> may be coupled to the disk portion <NUM> by the at least one hinge member <NUM>. In some embodiments, the occlusive disk element <NUM> may be coupled to the first disk portion <NUM> and/or the second disk portion <NUM> by the at least one hinge member <NUM>. In some embodiments, the occlusive disk element <NUM> may be coupled to the disk portion <NUM> by other and/or additional means, including but not limited to, sutures or filaments, adhesive bonding, encapsulation, etc. In some embodiments, the implant <NUM> may be devoid of any other structure or means coupling the occlusive disk element <NUM> to the disk portion <NUM> besides the at least one hinge member <NUM>. For example, in some embodiments, only the at least one hinge member <NUM> may couple the occlusive disk element <NUM> to the disk portion <NUM>.

In some embodiments, the first disk portion <NUM> may be oriented substantially transverse to the central longitudinal axis of the expandable framework <NUM> and/or the body portion <NUM> in the expanded configuration (when otherwise unconstrained and/or unstressed). In some embodiments, the first disk portion <NUM> may be oriented substantially perpendicular to the central longitudinal axis of the expandable framework <NUM> and/or the body portion <NUM> in the expanded configuration (when otherwise unconstrained and/or unstressed). In some embodiments, at least half (e.g. a majority) of the first disk portion <NUM> may be substantially planar in the expanded configuration (when otherwise unconstrained and/or unstressed). In some embodiments, the first disk portion <NUM> may be generally tubular or annular in the collapsed configuration. In some embodiments, the second disk portion <NUM> may be oriented substantially transverse to the central longitudinal axis of the expandable framework <NUM> and/or the body portion <NUM> in the expanded configuration (when otherwise unconstrained and/or unstressed). In some embodiments, the second disk portion <NUM> may be oriented substantially perpendicular to the central longitudinal axis of the expandable framework <NUM> and/or the body portion <NUM> in the expanded configuration (when otherwise unconstrained and/or unstressed). In some embodiments, at least half (e.g. a majority) of the second disk portion <NUM> may be substantially planar in the expanded configuration (when otherwise unconstrained and/or unstressed). In some embodiments, the second disk portion <NUM> may be generally tubular or annular in the collapsed configuration (as seen in <FIG> for example).

Detailed <FIG> illustrates selected aspects of the second pocket <NUM> of the second disk portion <NUM>. It will be readily understood that the same features and/or aspects also apply to the first pocket <NUM> of the first disk portion <NUM>. The second disk portion <NUM> may include and/or may be formed from a plurality of interconnected struts <NUM> extending away from the central longitudinal axis of the implant <NUM> and/or the expandable framework <NUM> toward the perimeter of the second disk portion <NUM> in the expanded configuration. Each instance of the second pocket <NUM> may be formed from two adjacent interconnected struts <NUM>. At the perimeter of the second disk portion <NUM>, each of the adjacent interconnected struts <NUM> may bend back toward the central longitudinal axis of the implant <NUM> and/or the expandable framework <NUM> in the expanded configuration to form a radially extending segment <NUM>. The adjacent radially extending segments <NUM> maybe joined and/or connected by a circumferentially extending segment <NUM> to form a continuous portion of the expandable framework <NUM> and/or the second disk portion <NUM>. In some embodiments, a length of the radially extending segment <NUM> may be at least about <NUM>%, at least about <NUM>%, at least about <NUM>%, at least about <NUM>%, at least about <NUM>%, etc. of a thickness <NUM> of the at least one hinge member <NUM> (e.g., <FIG>). In some embodiments, the length of the radially extending segment <NUM> may be greater than an inner extent and/or an inner diameter of the at least one hinge member <NUM>. In some embodiments, a length of the circumferentially extending segment <NUM> may be from about <NUM>% to about <NUM>% of a length of the at least one hinge member <NUM>. As such, the at least one hinge member <NUM> may be captured within the second pocket <NUM> between the two adjacent radially extending segments <NUM> when the hinge member <NUM> is disposed on and/or around the circumferentially extending segment <NUM>.

<FIG> illustrates an example configuration of the at least one hinge member <NUM>. Any and/or all related description herein may apply to one, more than one, each, and/or all instances of the at least one hinge member <NUM>. In some embodiments, the at least one hinge member <NUM> may include a coiled element. In some embodiments, each of the at least one hinge member <NUM> may include a coiled element. In some embodiments, the coiled element may include a piercing point <NUM> on at least one end. In some embodiments, the coiled element may include the piercing point <NUM> on both ends, opposing ends, each end, etc. of the coiled element. The piercing point <NUM> may be configured to and/or be capable of piercing the occlusive disk element <NUM> during assembly of the implant <NUM> to couple the occlusive disk element <NUM> to the disk portion <NUM>. The at least one hinge member <NUM> and/or the coiled element may have a thickness <NUM> defined by a cross-sectional dimension of an individual winding of the at least one hinge member <NUM> and/or the coiled element. While the at least one hinge member <NUM> and/or the coiled element is illustrated as a wire having a round outer profile, other configurations, include rectangular, polygonal, or irregular outer profiles, are also contemplated. Some suitable, but non-limiting, examples of materials for the at least one hinge member <NUM> are discussed below.

<FIG> illustrates an alternative configuration of the disk portion <NUM>. In some embodiments, the disk portion <NUM>, including the first disk portion <NUM> and the second disk portion <NUM>, may have an oblong perimeter shape in the expanded configuration. The oblong perimeter shape may permit the implant <NUM> to better fit asymmetrical and/or irregular anatomies. In some embodiments, the disk portion <NUM> may be made by forming and/or adding notches <NUM> in the struts <NUM> of the first pocket(s) <NUM> and the second pocket(s) <NUM> corresponding to and/or intended to be aligned with the first pocket(s) <NUM> during manufacture of the first disk portion <NUM> and the second disk portion <NUM>, respectively, and/or during assembly of the disk portion <NUM>, as shown in <FIG>. The notches <NUM> may weaken the struts <NUM> to permit removal of the desired first pocket(s) <NUM> and the second pocket(s) <NUM> corresponding to and/or intended to be aligned with the first pocket(s) <NUM>, such as by hand and/or without further mechanical assistance, for example. In embodiments having the alternative configuration of the disk portion <NUM> described herein, the occlusive disk element <NUM> may also be trimmed to an oblong shape matching and/or corresponding to the oblong perimeter shape of the disk portion <NUM>.

A method for occluding the left atrial appendage <NUM> may comprise advancing the implant <NUM> into the left atrial appendage <NUM>. For example, the implant <NUM> may be advanced to the left atrial appendage <NUM> within the lumen <NUM> of the delivery sheath <NUM> in the collapsed configuration. The method includes deploying the expandable framework <NUM> from the delivery sheath <NUM> within the left atrial appendage <NUM>. The method further includes expanding and/or shifting the expandable framework <NUM> from the collapsed configuration to the expanded configuration within the left atrial appendage <NUM>. In the expanded configuration, the expandable framework <NUM> may be urged into contact with, engaged with, and/or anchored to the wall <NUM> of the main body <NUM> of the left atrial appendage <NUM>, as seen in <FIG>. Additionally, the method may include deploying and/or expanding the disk portion <NUM> from the collapsed configuration to the expanded configuration proximate the ostium <NUM> of the left atrial appendage <NUM>. In some embodiments, the method may include deploying and/or expanding the disk portion <NUM> to engage the wall <NUM> and/or the ostium <NUM> of the left atrial appendage <NUM> in a sealing manner. In at least some embodiments, the disk portion <NUM> may span across the ostium <NUM> of the left atrial appendage <NUM>. In some embodiments, the disk portion <NUM> may span completely across the ostium <NUM> of the left atrial appendage <NUM>, thereby effectively removing the left atrial appendage <NUM> from the circulatory system of the patient.

In some embodiments, the disk portion <NUM> may be spaced apart proximally from the expandable framework <NUM> by a gap distance. The gap distance may be generally understood as the axial distance between a proximal surface of the expandable framework <NUM> and a distal surface of the disk portion <NUM> measured generally parallel to a central longitudinal axis of the implant <NUM>, the expandable framework <NUM>, and/or the disk portion <NUM>. In some embodiments, the gap distance may be fixed. In some embodiments, the gap distance may be variable. In some embodiments, the gap distance may be defined by the neck portion <NUM>.

The expandable framework <NUM> and/or the plurality of anchor members <NUM> may function as an anchoring mechanism for the disk portion <NUM>. In some embodiments, the delivery device <NUM> and/or the implant <NUM> may include at least one means of adjusting the gap distance. In some embodiments, the method for occluding the left atrial appendage <NUM> may comprise adjusting the gap distance to position the disk portion <NUM> against and/or within the ostium <NUM> of the left atrial appendage <NUM>. In some embodiments, the at least one means of adjusting the gap distance may be configured to translate the disk portion <NUM> towards and/or into the ostium <NUM> of the left atrial appendage <NUM>. For example, upon initial deployment of the implant <NUM>, the disk portion <NUM> may be spaced apart from the ostium <NUM> of the left atrial appendage <NUM>. In some embodiments, the implant <NUM> and/or the expandable framework <NUM> may be advanced deeper into the main body <NUM> of the left atrial appendage <NUM> until the disk portion <NUM> engages the ostium <NUM> of the left atrial appendage. In some embodiments, the at least one means of adjusting the gap distance may be used to translate the disk portion <NUM> towards and/or into the ostium <NUM> of the left atrial appendage <NUM>. In one example, the gap distance may be shortened by about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, etc. from its initial deployment distance. In another example, the gap distance may be shortened or reduced to zero.

In some embodiments, the disk portion <NUM> may be oriented at an oblique angle to the central longitudinal axis of the expandable framework <NUM>. In some embodiments, the neck portion <NUM> may be flexible and/or may permit off-axis orientation of the disk portion <NUM> relative to the expandable framework <NUM>, which may ease positioning, implantation, and/or sealing within an irregularly shaped and/or oriented left atrial appendage <NUM>.

When satisfied with the positioning of the body portion <NUM> within the left atrial appendage <NUM> and/or the disk portion <NUM> against the ostium <NUM> of the left atrial appendage <NUM>, the delivery device <NUM> may be disconnected from the implant <NUM>, as seen in <FIG>, thereby leaving the implant <NUM> disposed at and/or in the left atrial appendage <NUM>. In some embodiments, disconnecting the delivery device <NUM> from the implant <NUM> may include rotating the externally threaded distal end <NUM> of the core wire <NUM> relative to the implant <NUM> and/or the proximal hub <NUM> to disengage the core wire <NUM> from the implant <NUM>.

In some embodiments, the delivery system may include a keying structure configured to prevent rotation of the core wire <NUM> relative to the disk portion <NUM>. In such embodiments, the keying structure is disengaged prior to rotating the core wire <NUM> relative to the implant <NUM> and/or the proximal hub <NUM>. When the keying structure is engaged, rotation of the core wire <NUM> may be transmitted to the disk portion <NUM>, the body portion <NUM>, and/or the expandable framework <NUM>. In some embodiments, rotation of the disk portion <NUM>, the body portion <NUM>, and/or the expandable framework <NUM> may facilitate positioning and/or orientation of the disk portion <NUM>, the body portion <NUM>, and/or the expandable framework <NUM> relative to the left atrial appendage <NUM>, for example, with respect to an asymmetrical and/or irregular ostium <NUM> and/or left atrial appendage <NUM>. In some embodiments, rotation of the disk portion <NUM>, the body portion <NUM>, and/or the expandable framework <NUM> may vary the gap distance by translating the disk portion <NUM> closer to or farther from the body portion <NUM> of the expandable framework <NUM>. Other configurations, purposes, and/or results are also contemplated.

The materials that can be used for the various components of the delivery device <NUM> and/or the implant <NUM> and the various elements thereof disclosed herein may include those commonly associated with medical devices. For simplicity purposes, the following discussion refers to the delivery device <NUM> and/or the implant <NUM>. However, this is not intended to limit the devices and methods described herein, as the discussion may be applied to other elements, members, components, or devices disclosed herein, such as, but not limited to, the delivery sheath <NUM>, the core wire <NUM>, the expandable framework <NUM>, the plurality of anchor members <NUM>, the neck portion <NUM>, the occlusive body element <NUM>, the annular marker band <NUM>, the body portion <NUM>, the disk portion <NUM>, the first disk portion <NUM>, the second disk portion <NUM>, the proximal hub <NUM>, the occlusive disk element <NUM>, the at least one hinge member <NUM>, and/or elements or components thereof.

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

Some examples of suitable polymers may include 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, 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.

Some examples of suitable metals and metal alloys include stainless steel, such as 304V, <NUM>, and 316LV 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: R30035 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: R30003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.

In at least some embodiments, portions or all of the delivery device <NUM> and/or the implant <NUM>, and/or components thereof, 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 the user of the delivery device <NUM> and/or the implant <NUM> in determining its location. 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 delivery device <NUM> and/or the implant <NUM> to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into the delivery device <NUM> and/or the implant <NUM> and/or other elements disclosed herein. For example, the delivery device <NUM> and/or the implant <NUM>, and/or components or portions thereof, may be made of a material that does not substantially distort the image and create substantial artifacts (i.e., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. The delivery device <NUM> and/or the implant <NUM>, 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: R30003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, and the like, and others.

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

In some embodiments, the delivery device <NUM> and/or the implant <NUM> and/or other elements disclosed herein may include and/or be formed from a textile material. Some examples of suitable textile materials may include synthetic yarns that may be flat, shaped, twisted, textured, pre-shrunk or un-shrunk. Synthetic biocompatible yams suitable for use in the present invention 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 yams 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 yams may further include carbon, glass or ceramic fibers. Desirably, the yams 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 delivery device <NUM> and/or the implant <NUM> and/or other elements 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 vasoactive mechanisms.

Claim 1:
An implant (<NUM>) for occluding a left atrial appendage (<NUM>), comprising:
an expandable framework (<NUM>) including a body portion (<NUM>) and a disk portion (<NUM>);
wherein the expandable framework is configured to shift between a collapsed configuration and an expanded configuration,
characterized by
an occlusive disk element (<NUM>) coupled to the disk portion by at least one hinge member (<NUM>).