Continuously covered left atrial appendage implant

Abstract

An implant for occluding the left atrial appendage can include an expandable frame configured to shift between a collapsed configuration and an expanded configuration, wherein the expandable frame includes an attachment point configured to secure the expandable frame to a delivery device, and an occlusion element disposed on a proximal portion of the expandable frame, wherein the occlusion element covers the attachment point.

Description

[0001] Cross-application of related applications

[0002] This application claims priority to U.S. Provisional Application No. 62 / 875,040, filed July 17, 2019, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This invention relates generally to medical devices, and more specifically to medical devices suitable for use in percutaneous medical procedures, including the left atrial appendage (LAA) implanted in the heart. Background Technology

[0004] The left atrial appendage is a small organ attached to the left atrium of the heart. During normal heart function, the left atrial appendage contracts and forces blood into the left atrium as the left atrium contracts and forces blood into the left ventricle. The ability of the left atrial appendage to contract helps improve the filling of the left ventricle, thus playing a role in maintaining cardiac output. However, in patients with atrial fibrillation, the left atrial appendage may not contract or empty properly, causing stagnant blood to accumulate inside, which can lead to unwanted thrombus formation within the left atrial appendage.

[0005] The formation of left atrial appendage thrombi during atrial fibrillation may be due to blood pooling and stagnation within the left atrial appendage. Blood may still be pumped from the left atrium by the left ventricle; however, this is less effective due to the irregular contractions of the left atrium caused by atrial fibrillation. Therefore, left ventricular filling may depend primarily or solely on the suction generated by the left ventricle, rather than on the active support of blood flow by the contracting left atrium and left atrial appendage. Furthermore, the contraction of the left atrial appendage may be out of sync with the left ventricular cycle. For example, the contraction of the left atrial appendage may be up to 180° out of phase with the left ventricle, which can significantly impede the desired blood flow. In addition, the geometry of most left atrial appendages is complex compared to their depth, with large irregular surface areas and narrow ostia or openings. These aspects, along with others, individually or in various combinations, may contribute to high flow resistance to blood outflow from the left atrial appendage and / or thrombus formation within the left atrial appendage.

[0006] Thrombi formed in the left atrial appendage can break loose from the area and enter the bloodstream. Blood clots migrating through the blood vessels can eventually block smaller blood vessels downstream, causing a stroke or heart attack. Clinical studies have shown that a large percentage of blood clots in patients with atrial fibrillation originate from the left atrial appendage. As a treatment, medical devices for isolating the left atrial appendage have been developed. Over time, the exposed surface of the implant spanning the left atrial appendage can become covered with tissue (a process known as endothelialization), effectively removing the left atrial appendage from the circulatory system and reducing or eliminating the amount of thrombus that can enter the bloodstream from the left atrial appendage. In known medical devices and methods, each has certain advantages and disadvantages. There is a current need to provide alternative medical devices and introducers and alternative methods of manufacturing and using medical devices and introducers. SUMMARY

[0007] In a first aspect, an implant for occluding a left atrial appendage can include an expandable frame configured to shift between a collapsed configuration and an expanded configuration, wherein the expandable frame includes an attachment point configured to secure the expandable frame to a delivery device; and an occlusion element disposed on a proximal portion of the expandable frame, wherein the occlusion element covers the attachment point.

[0008] Additionally or alternatively, the expandable frame includes a proximal hub.

[0009] Additionally or alternatively, the attachment point is a pin extending laterally across the proximal hub.

[0010] Additionally or alternatively, the implant can further include a fastening element securing the occlusion element to the pin.

[0011] Additionally or alternatively, the implant can further include a plurality of anchor members configured to secure the implant to tissue within the left atrial appendage.

[0012] Additionally or alternatively, the occlusion element includes a porous mesh.

[0013] Additionally or alternatively, a system for occluding a left atrial appendage can include a delivery device including an outer sheath and an inner elongate member slidably disposed in a lumen of the outer sheath, and an implant configured to occlude a left atrial appendage. The implant can include an expandable frame configured to shift between a collapsed configuration (when disposed within the outer sheath) and an expanded configuration (when disposed outside of the outer sheath), wherein the expandable frame includes an attachment point configured to secure the expandable frame to the delivery device; and an occlusion element disposed on a proximal portion of the expandable frame, wherein the occlusion element covers the attachment point.

[0014] Additionally or alternatively, the system can further include a tether extending longitudinally within the inner elongate member, the tether engaging the attachment point in the delivery configuration.

[0015] Additionally or alternatively, in the delivery configuration, the tether extends through the closure element.

[0016] Additionally or alternatively, the tether is disengaged from the attachment point in the release configuration.

[0017] Additionally or alternatively, the system can further include a release mechanism disposed in a lumen of the inner elongate member, wherein the release mechanism is configured to sever the tether in the lumen of the inner elongate member.

[0018] Additionally or alternatively, the release mechanism includes a cutting blade disposed within the inner elongate member.

[0019] Additionally or alternatively, the system can further include a rotation gate movably engaged with a proximal end of the inner elongate member.

[0020] Additionally or alternatively, the attachment point can include a cam member extending laterally across a proximal hub of the expandable frame. The cam member can be configured to mate with a distal end of the inner elongate member.

[0021] Additionally or alternatively, the tether extends around the cam member such that axial translation of the tether is configured to angle the expandable frame relative to a central longitudinal axis of the delivery device.

[0022] Additionally or alternatively, a method of occluding a left atrial appendage can include advancing an implant configured to occlude the left atrial appendage into the left atrial appendage, wherein the implant includes an expandable frame configured to shift between a collapsed configuration and an expanded configuration, wherein the expandable frame includes an attachment point configured to secure the expandable frame to a delivery device, and a closure element disposed on a proximal portion of the expandable frame, wherein the closure element covers the attachment point; deploying the implant within the left atrial appendage; and releasing the implant within the left atrial appendage. Upon releasing the implant, all metallic material of the implant can be disposed away from a proximally-facing surface of the closure element.

[0023] Additionally or alternatively, releasing the implant includes severing a tether securing the implant to the delivery device.

[0024] Additionally or alternatively, axial translation of the tether prior to severing the tether angles the expandable frame relative to a central longitudinal axis of the delivery device.

[0025] Additionally or alternatively, rotation of the rotation gate relative to a proximal end of the delivery device severs the tether.

[0026] Additionally or alternatively, subsequent proximal retraction of the rotation gate disengages the tether from the implant.

[0027] 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 details of one or more embodiments of the present disclosure are also described herein in more detail below. BRIEF DESCRIPTION OF DRAWINGS

[0028] The present disclosure can be more completely understood in consideration of the following detailed description in connection with the following drawings, in which:

[0029] Figures 1-2 Aspects of a system and implant for occluding the left atrial appendage are shown;

[0030] Figure 3 is a partial cutaway view of an implant for occluding the left atrial appendage;

[0031] Figures 4-5 is a detailed top view showing selected aspects of an implant for occluding the left atrial appendage;

[0032] Figure 6 is a detailed view showing selected aspects of a system and implant for occluding the left atrial appendage;

[0033] Figure 7 is a detailed view showing selected aspects of a system and implant for occluding the left atrial appendage;

[0034] Figures 8-11 is a detailed view showing selected aspects of a system and implant for occluding the left atrial appendage;

[0035] Figures 12-15 is a detailed view showing selected aspects of a system and implant for occluding the left atrial appendage;

[0036] Figures 16-18 is a detailed view showing selected aspects of a system and implant for occluding the left atrial appendage; and

[0037] Figures 19-20 is a detailed view showing selected alternative aspects of a system and implant for occluding the left atrial appendage.

[0038] While aspects of the present disclosure can be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and will be described in detail herein. It should be understood however that the intention is not to limit the aspects of the present disclosure to the particular embodiments described. Rather, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0039] The following description should be read with reference to the drawings, which are not necessarily to scale, wherein like reference numerals in different drawings identify similar elements. The detailed description and drawings illustrate embodiments of the claimed application. Those of ordinary skill in the art will realize that the various elements described and / or illustrated can be arranged at varying combinations, sequences and / or relative placement depending in part on particular application and / or design constraints. The detailed description and drawings illustrate embodiments of the claimed application. However, for clarity and ease of understanding, each feature and / or element can be shown and / or described in particular embodiments without necessarily being in the scope of each and every embodiment. The detailed description and drawings illustrate embodiments of the claimed application.

[0040] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

[0041] All numerical values assumed herein are modified by the term “about” whether explicitly indicated or not. In the context of a numerical value, the term “about” generally refers to a range of numbers that a person of skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the term “about” can include an amount rounded to the nearest significant figure. Other uses of the term “about” (e.g., in contexts other than numerical values) can be assumed to have its ordinary and customary definition, as understood from the context of the specification and consistent with the context of the specification.

[0042] Recitation of ranges of values by endpoints includes all values between, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0043] While certain dimensions, ranges, and / or values associated with various components, features, and / or specifications are disclosed, those of ordinary skill in the art, having the benefit of the present disclosure, will appreciate that desired dimensions, ranges, and / or values can deviate from those explicitly disclosed.

[0044] As used in this specification and the appended claims, the singular forms“a,”“an,” and“the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term“or” is generally employed in its sense of“and / or,” unless the content clearly dictates otherwise. It should be noted that certain features of the disclosure can be described using a singular throughout, even though these features can be plural or repeated in the disclosed embodiments. Each instance of a feature can be included and / or encompassed in a single disclosure, unless expressly stated to the contrary. Not all elements of the disclosed invention need be shown in every figure or discussed in detail below for the purposes of simplicity and clarity. However, it should be understood that the discussion below can apply equally to any and / or all components having multiple parts, unless expressly stated to the contrary. Furthermore, not all instances of certain elements or features are shown in every figure for the purposes of clarity.

[0045] Related terms such as“proximal,”“distal,”“advance,”“retreat,” and variations thereof, can generally be considered with respect to the positioning, orientation, and / or operation of various elements of the device relative to the user / operator / manipulator, where“proximal” and“retreat” mean or refer to being closer to or toward the user, and“distal” and“advance” mean or refer to being further away or from the user. In some cases, the terms“proximal” and“distal” can be arbitrarily assigned to facilitate understanding of the disclosure, and these cases will be apparent to those skilled in the art. Other related terms, such as“upstream,”“downstream,”“inflow,” and“outflow,” refer to the direction of fluid flow in, for example, a body lumen, a blood vessel, or a lumen within a device.

[0046] The term“extent” can be understood to mean the maximum measurement of the stated or identified dimension, unless the stated extent or dimension is preceded by or identified as“minimum,” which can be understood to mean the minimum measurement of the stated or identified dimension. For example,“outer extent” can be understood as the outer dimension,“radial extent” can be understood as the radial dimension,“longitudinal extent” can be understood as the longitudinal dimension, and so on. Each instance of“extent” can be different (e.g., axial, longitudinal, lateral, radial, circumferential, etc.) and apparent to those skilled in the art from the context in which it is used alone. Generally,“extent” can be considered the maximum possible dimension as measured according to the intended use, while“minimum extent” can be considered the minimum possible dimension as measured according to the intended use. In some cases,“extent” can generally be measured orthogonally within a plane and / or cross-section, but can be apparent from the particular context to be measured differently, such as but not limited to angular, radial, circumferential (e.g., along an arc), and so on.

[0047] The terms “monolithic” and “single” generally refer to one or more elements made or composed of a single structural or basic unit / element. Monolithic elements and / or single elements should exclude structures and / or features formed by assembling or otherwise joining multiple discrete elements together.

[0048] Note that references to "embodiments," "some embodiments," "other embodiments," etc., in the specification indicate that the described embodiments may include specific features, structures, or characteristics, but each embodiment does not necessarily include those specific features, structures, or characteristics. Furthermore, such phrases do not necessarily refer to the same embodiment. Moreover, when a specific feature, structure, or characteristic is described in connection with an embodiment, unless explicitly stated otherwise, those skilled in the art will, to the best of their knowledge, implement that specific feature, structure, or characteristic in combination with other embodiments, whether explicitly described or not. That is, the various individual elements described below, even if not explicitly shown in a specific combination, are still considered to be combinable or arrangeable to form other additional embodiments, or to supplement and / or enrich the described embodiments, as understood by those skilled in the art.

[0049] For clarity, certain identifying numerical designations (e.g., first, second, third, fourth, etc.) may be used throughout the specification and / or claims to name and / or distinguish various described and / or claimed features. It should be understood that the numerical designations are not restrictive but merely exemplary. In some embodiments, modifications and deviations from previously used numerical designations may be made for brevity and clarity. That is, a feature identified as a “first” element may later be referred to as a “second” element, a “third” element, etc., or may be omitted entirely, and / or a different feature may be referred to as a “first” element. The meaning and / or name in each case will be obvious to a skilled practitioner.

[0050] The following figures illustrate selected components and / or arrangements of implants for occluding the left atrial appendage, systems for occluding the left atrial appendage, and / or methods of using the implants and / or systems. 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 components of the implants and / or systems may be shown in more detail in other figures. Although discussed in the context of occluding the left atrial appendage, the implants and / or systems can also be used for other interventions and / or percutaneous medical procedures within the patient. Similarly, the devices and methods described herein for percutaneous deployment can be suitably used for other types of surgical procedures. For example, the implants and / or systems can be used for non-percutaneous procedures. The devices and methods according to this disclosure can also be adapted and configured for other uses within anatomical structures.

[0051] Figure 1 andFigure 2 A system 100 for closing the left atrial appendage is shown (e.g., Figures 15-17 The system 100 may include a delivery device comprising an outer sheath 110 having a lumen 120 extending distally. The system 100 may include an implant 200 for occluding the left atrial appendage. The implant 200 may include an expandable frame 210 configured to shift between a contractile configuration and an expandable configuration. When the implant 200 is disposed within the lumen 120 of the outer sheath 110, the expandable frame 210 may be held and / or disposed within the contractile configuration, for example as... Figure 1 As shown. When the implant 200 is positioned outside the lumen 120 of the outer sheath 110, the expandable frame 210 can expand and / or move toward and / or into the expandable structure, for example, as Figure 2 As shown. Examples of suitable, but not limiting, materials for the outer sheath 110 are discussed below.

[0052] System 100 and / or delivery device may include an internal elongated member 130 slidably disposed within a lumen 120 of an outer sheath 110. In some embodiments, the internal elongated member 130 may include a lumen extending axially and / or longitudinally from a proximal end of the internal elongated member 130 to a distal end of the internal elongated member 130. In some embodiments, the internal elongated member 130 may include a plurality of lumens extending axially and / or longitudinally from a proximal end of the internal elongated member 130 to a distal end of the internal elongated member 130. In at least some embodiments, the internal elongated member 130 and / or the outer sheath 110 may include one or more seals and / or sealing structures in its lumen to reduce and / or prevent fluid (e.g., blood) from flowing through its lumen from the distal end to the proximal end. The internal elongated member 130 may be axially and / or longitudinally movable relative to the outer sheath 110. In some embodiments, the internal elongated member 130 may be used to advance (e.g., push) an implant 200 from the lumen 120 of the outer sheath 110. In some embodiments, when the outer sheath 110 is retracted proximally and / or axially translated relative to the implant 200 to expose the implant 200 from the lumen 120 of the outer sheath 110, the inner elongated member 130 may be used to retain and / or maintain the axial and / or longitudinal position of the implant 200. Examples of suitable, but not limiting, materials for the inner elongated member 130 will be discussed below.

[0053] The system 100 and / or the delivery device can further include a tether 140 that extends longitudinally within a lumen (or at least one of multiple lumens) of the inner elongated member 130. In some embodiments, the tether 140 can include a first longitudinally extending portion 142 and a second longitudinally extending portion 144. In some embodiments, the first longitudinally extending portion 142 and / or the second longitudinally extending portion 144 can extend completely through an entire length of the lumen of the inner elongated member 130. In some embodiments, the second longitudinally extending portion 144 can extend only along a portion (e.g., less than the entire length) of the entire length of the lumen of the inner elongated member 130. In some embodiments, the first longitudinally extending portion 142 can extend completely through an entire length of a first lumen of multiple lumens of the inner elongated member 130. In some embodiments, the second longitudinally extending portion 144 can extend completely through an entire length of a second lumen of multiple lumens of the inner elongated member 130. In some embodiments, the second longitudinally extending portion 144 can extend only along a portion (e.g., less than the entire length) of the entire length of the second lumen of multiple lumens of the inner elongated member 130. Examples of some suitable, but non-limiting, materials for the tether 140 will be discussed below.

[0054] In some embodiments, the implant 200 includes a closure element 290 disposed and / or positioned on, over, and / or around at least a portion of the expandable frame 210, as shown. Figure 2 In at least some embodiments, the closure element 290 can be secured, attached, and / or connected to the expandable frame 210. In some embodiments, the closure element 290 can be secured, attached, and / or connected to the expandable frame 210 at a plurality of discrete locations. In some embodiments, the expandable frame 210 can include a plurality of anchor members 212 extending therefrom that are configured to secure the implant 200 and / or the expandable frame 210 to tissue within the left atrial appendage. For example, the plurality of anchor members 212 are configured to engage with a wall of a body of the left atrial appendage (e.g., Figures 16-18 In at least some embodiments, the plurality of anchor members 212 can extend through the closure element 290, with a base of each of the expandable frame 210 and the plurality of anchor members 212 disposed at a first side (e.g., an inner side) of the closure element 290 and a free end or tip of each of the plurality of anchor members 212 disposed at a second side (e.g., an outer side) of the closure element 290.

[0055] Figure 3A partial cross-sectional view of implant 200 is shown, with a portion of the closure element 290 removed to illustrate aspects of the expandable frame 210. In at least some embodiments, the closure element 290 may extend across a proximal portion of the expandable frame 210. In some embodiments, the closure element 290 may be spaced apart from at least some portions of the proximal portion of the expandable frame 210. When unconstrained, the expandable frame 210 may be manually expanded and / or configured to expand from a contracted configuration to an expanded configuration. For example, in some embodiments, the expandable frame 210 may be made of a shape memory material. In some embodiments, the expandable frame 210 may include and / or may be formed of a plurality of interconnected struts and / or frame segments. The base of each of the plurality of anchor members 212 may be securely attached to the expandable frame 210 and / or the plurality of interconnected struts and / or frame segments.

[0056] In some embodiments, the implant 200 and / or the expandable frame 210 may include a proximal hub 220 and / or a distal hub 230. Multiple interconnected struts and / or frame segments may be securely attached to the proximal hub 220 and / or the distal hub 230 and / or attached to the proximal hub and / or the distal hub. In some embodiments, the expandable frame 210 may include attachment points 240 configured to secure the expandable frame 210 to the delivery device and / or tether 140. In some embodiments, the attachment point 240 may be a pin 222 extending laterally across the proximal hub 220, such as... Figure 4 As shown in the top view. Figure 4 In this image, the closed element 290 has been removed to reveal other details and / or features.

[0057] In some embodiments, the implant 200 may include a fastening element 250 that secures the closure element 290 to the pin 222 and / or attachment point 240, such as Figure 5 As shown in the top view. The closure element 290 may extend across and / or may cover the pin 222 and / or attachment point 240. Also as... Figure 5As shown, the occlusive element 290 can include a porous mesh. For the sake of clarity, some details of the occlusive element 290 are not shown in all of the figures, but it should be understood that the occlusive element 290 can be and / or can include a porous mesh in some, any, and / or all of the figures showing the occlusive element 290. In some embodiments, the porous mesh can be a woven structure, a fabric structure, a textile structure, and / or a membrane or film having a plurality of pores formed therein and / or extending therethrough. In some embodiments, the porous mesh can include a plurality of eyelets, openings, and / or pores extending through the occlusive element 290 from a first side to a second side. In some embodiments, the plurality of eyelets, openings, and / or pores extending through the occlusive element 290 can have a size and / or extent of between about 5 micrometers (pm) and about 500 micrometers, between about 50 micrometers and about 300 micrometers, between about 100 micrometers and about 220 micrometers, between about 140 micrometers and about 180 micrometers, and / or about 160 micrometers. In some embodiments, the plurality of eyelets, openings, and / or pores extending through the occlusive element 290 can have a maximum size and / or extent of about 1 millimeter (e.g., 1000 micrometers).

[0058] In some embodiments, the occlusive element 290 can include a surface treatment configured to promote endothelialization on and / or across the occlusive element 290. In some embodiments, the occlusive element 290 can include a surface treatment disposed on and / or around a portion of an outer surface and / or proximally-facing surface of the occlusive element 290. In some embodiments, the occlusive element 290 can include a surface treatment disposed on and / or around an entire outer surface and / or an entire proximally-facing surface of the occlusive element 290. In some embodiments, the occlusive element 290 can be elastic and / or stretchable to accommodate changes in shape and / or size of the expandable framework 210 as the expandable framework 210 is moved toward and / or into the expanded configuration. Examples of some suitable, but non-limiting, materials for the expandable framework 210, the plurality of interconnected struts and / or frame segments, the plurality of anchor members 212, the proximal hub 220, the pin 222, the distal hub 230, the fastening element 250, and / or the occlusive element 290 will be discussed below.

[0059] As Figure 5As shown, the fastening element 250 can extend through two or more of the plurality of eyelets, openings, and / or holes that extend through the closure element 290 from the first side to the second side. For example, the fastening element 250 can pass through an existing eyelet, opening, and / or hole through the closure element 290 to avoid puncturing and / or otherwise compromising the integrity of the closure element 290. The fastening element 250 can extend around the pin 222 and / or the attachment point 240. In some embodiments, the fastening element 250 can wrap around the pin 222 and / or the attachment point 240 multiple times. In some embodiments, the fastening element 250 can be attached to (e.g., tied to, adhered to, bonded to, etc.) the pin 222, the attachment point 240, and / or the closure element 290. In some embodiments, the fastening element 250 can be attached to (e.g., tied to, adhered to, bonded to, etc.) itself. For example, the fastening element 250 can be knotted and / or can be bonded to itself to form a single continuous loop and / or structure. In some embodiments, the fastening element 250 can be configured to stabilize the closure element 290 relative to the expandable framework 210 and / or the proximal hub 220. For example, the fastening element 250 can reduce and / or prevent axial movement (e.g., "flapping") of the closure element 290 relative to the expandable framework 210 and / or the proximal hub 220 that is caused by normal flow and pressure changes within the left atrium as the heart beats. In some embodiments, the fastening element 250 can be a filament, a wire, a suture, or other suitable flexible elongate element.

[0060] Turning now to Figure 6 , the tether 140 can extend through two or more of the plurality of eyelets, openings, and / or holes that extend through the closure element 290 from the first side to the second side of the closure element 290. For example, the tether 140 can pass through an existing eyelet, opening, and / or hole through the closure element 290 to avoid puncturing and / or otherwise compromising the integrity of the closure element 290. The tether 140 can extend around the pin 222 and / or the attachment point 240. The first longitudinally extending portion 142 can extend through a first eyelet, opening, and / or hole, and / or the second longitudinally extending portion 144 can extend through a second eyelet, opening, and / or hole that is different than the first eyelet, opening, and / or hole.

[0061] In some embodiments, the tether 140 can extend around the pin 222 and / or the attachment point 240 once, without wrapping and / or completely encircling the pin 222 and / or the attachment point 240. However, it is contemplated that, in some embodiments, the tether 140 can wrap around the pin 222 and / or the attachment point 240 multiple times. The first longitudinally extending portion 142 can be disposed on a first side of the pin 222 and / or the attachment point 240, and the second longitudinally extending portion 144 can be disposed on a second side of the pin 222 and / or the attachment point 240. Although in the illustrated embodiment the first longitudinally extending portion 142 and the second longitudinally extending portion 144 are disposed on opposite sides of the pin 222 and / or the attachment point 240, it is contemplated that, in some embodiments, the first longitudinally extending portion 142 and the second longitudinally extending portion 144 can be disposed on the same side of the pin 222 and / or the attachment point 240. Figure 6not explicitly shown, but the fastening element 250 can be used with and / or present with the tether 140, and it should be understood that Figure 6 part of the structure shown.

[0062] The tether 140 can be used to secure the implant 200 to the delivery device. Tension applied to the tether 140 relative to the inner elongated member 130 can pull the implant 200 and / or the expandable frame 210 into engagement with and / or against the distal end of the inner elongated member 130, as Figure 7 shown. The closure element 290 can be squeezed and / or clamped between the expandable frame 210 and the distal end of the inner elongated member 130. The tether 140 can be used for positioning, repositioning, and / or retrieval of the implant 200.

[0063] Figure 7 and Figure 8 Additional aspects of the system 100 are shown. As shown, the tether 140 can extend longitudinally within the lumen of the inner elongated member 130 (or at least one of the lumens, if multiple). The tether 140 can engage the pin 222 and / or the attachment point 240 in the delivery configuration of the system 100, for example, as Figure 6 and Figure 7 shown. As described herein, the tether 140 can extend through the closure element 290 in the delivery configuration of the system 100.

[0064] In some embodiments, the second longitudinally extending portion 144 of the tether 140 can be fixed and / or fixedly attached to the inner elongated member 130 at a tether attachment point 148 proximate the distal end of the inner elongated member 130, such as by gluing, mechanical attachment, or other suitable means. In some embodiments, the distal end of the tether 140 can be fixed and / or fixedly attached to the inner elongated member 130 at a tether attachment point 148 proximate the distal end of the inner elongated member 130. Application of tension to the first longitudinally extending portion 142 of the tether 140 can pull the implant 200 and / or the expandable frame 210 into engagement with and / or against the distal end of the inner elongated member 130.

[0065] The system 100 can further include a release mechanism disposed in the lumen of the delivery device, the outer sheath 110, and / or the inner elongated member 130. For purposes of illustration, Figure 8 the release mechanism is shown in the lumen of the inner elongated member 130, but this is not limiting as the release mechanism can be disposed in the lumen of the outer sheath 110 and / or can be disposed alongside (and outside of) the inner elongated member 130. The release mechanism can be configured to sever the tether 140 within the lumen of the inner elongated member 130 and / or the outer sheath 110.

[0066] In some embodiments, the release mechanism can include a cutting blade 150 disposed within the delivery device, the inner elongated member 130, and / or the outer sheath 110. In Figure 8 In the illustrated configuration, the release mechanism can be movably and / or slidably disposed within the delivery device, the inner elongated member 130, and / or the outer sheath 110. The release mechanism can include an elongated shaft 160 movably and / or slidably disposed within an elongated tube 162. The elongated tube 162 is slidably disposed within the delivery device, the inner elongated member 130, and / or the outer sheath 110. The cutting blade 150 is pivotally attached at a distal end of the elongated shaft 160 such that axial translation of the elongated shaft 160 relative to the elongated tube 162 can actuate the cutting blade 150. For example, distal relative movement of the elongated tube 162 over the elongated shaft 160 can force the distal end of the elongated tube 162 into contact with the cutting blade 150, thereby pivoting and / or actuating the cutting blade 150 as the elongated tube 162 is advanced over the cutting blade 150. Similarly, proximal retraction of the elongated shaft 160 relative to the elongated tube 162 can force the distal end of the elongated tube 162 into contact with the cutting blade 150, thereby pivoting and / or actuating the cutting blade 150 as the elongated shaft 160 and / or the cutting blade 150 are retracted within the elongated tube 162. When the user is ready to release the implant 200, the cutting blade 150 can engage the tether 140 proximate, adjacent, and / or near the tether attachment point 148, the distal end of the inner elongated member 130, and / or the distal end of the outer sheath 110, and the release mechanism can be actuated to sever the tether 140.

[0067] In another configuration, the release mechanism can include a cutting blade 170 disposed within the delivery device, the inner elongated member 130, and / or the outer sheath 110. In Figures 9-11 In the illustrated configuration, the cutting blade 170 can be fixedly attached to an inner surface of the inner elongated member 130 and / or the outer sheath 110. For simplicity, in Figures 9-11only the inner elongated member 130 is shown, but it should be understood that the outer sheath 110 can be used in place of the inner elongated member 130 shown and / or the outer sheath 110 can also be present as described herein. In some embodiments, the cutting blade 170 can extend through a sidewall of the inner elongated member 130 and / or the outer sheath 110. In some embodiments, the cutting blade 170 can be retracted and / or moved relative to the sidewall of the inner elongated member 130 and / or the outer sheath 110. For example, the cutting blade 170 can be laterally extended and / or inserted through the sidewall of the inner elongated member 130 and / or the outer sheath 110 by a user when the user is ready to sever the tether 140. In some embodiments, the cutting blade 170 can be disposed proximal, adjacent, and / or near the proximal end of the inner elongated member 130 and / or the outer sheath 110. In some embodiments, the system 100 and / or the release mechanism can further include a rotating gate 180 movably engaged with the proximal end of the inner elongated member 130 and / or the outer sheath 110. The rotating gate 180 can be rotated and / or axially translated relative to the proximal end of the delivery device, the inner elongated member 130, and / or the outer sheath 110. A distally facing shoulder 182 of the rotating gate 180 can be engaged with the proximal end of the delivery device, the inner elongated member 130, and / or the outer sheath 110. The distally facing shoulder 182 can limit and / or prevent the rotating gate 180 from translating distally relative to the proximal end of the delivery device, the inner elongated member 130, and / or the outer sheath 110 in the delivery configuration while allowing the rotating gate 180 to translate proximally relative to the proximal end of the delivery device, the inner elongated member 130, and / or the outer sheath 110 in the delivery configuration.

[0068] The tether 140 can extend through a lumen of the inner elongated member 130 and / or the outer sheath 110. The second longitudinally extending portion 144 can be fixedly attached to the rotating gate 180 at a tether attachment point 184. The first longitudinally extending portion 142 can extend through the rotating gate 180 to be engaged with a first adjustment element 186. The first adjustment element 186 can be configured to axially translate relative to the rotating gate 180 to adjust a tension applied to the tether 140. In some embodiments, the first adjustment element 186 can include a threaded member, a spring member, a sliding member, a cam member, or other suitable means to apply tension to the tether 140 such as via axial translation. In some embodiments, the second longitudinally extending portion 144 can extend through the rotating gate 180 to be engaged with a second adjustment element 188 (e.g., Figure 12 ) that can have a similar form and / or structure as the first adjustment element 186. Only one of the first adjustment element 186 and the second adjustment element 188 need be adjusted to change the tension applied to the tether 140, but either (or both) of the first adjustment element 186 and / or the second adjustment element 188 can be adjusted as needed or desired to apply tension to the tether 140.

[0069] When the user is ready to release the implant 200, the rotating grid 180 can rotate relative to the proximal end of the delivery device, the internal elongated member 130, and / or the outer sheath 110, to engage the tether 140 with the cutting blade 170, thereby cutting the tether 140. Figure 10 As shown. In some embodiments, the cutting blade 170 extending through and / or inserted into the sidewall of the inner elongated member 130 and / or the outer sheath 110 can partially cut the tether 140, but the rotating grid 180 still needs to ensure that the tether 140 is completely cut. After the tether 140 is cut, the rotating grid 180 can be translated proximally relative to the proximal end of the conveying device, the inner elongated member 130 and / or the outer sheath 110, thereby pulling the tether 140 around the pin 222 and / or attachment point 240 and through the closure element 290, so that the tether 140 is disengaged from the pin 222 and / or attachment point 240, as shown. Figure 11 As shown. In the release configuration of system 100, the tether 140 can be disengaged from pin 222 and / or attachment point 240.

[0070] In some embodiments, system 100 may include one or more features that allow implant 200 to be angled relative to the central longitudinal axis of delivery device, internal elongated member 130, and / or outer sheath 110, such as Figures 12-15 As shown. In some embodiments, the internal elongated member 130 may include a curved, convex, and / or rounded distal end. In some embodiments, the attachment point 240 may include a cam member 224 that extends laterally across the proximal hub 220 of the expandable frame 210. The cam member 224 may include a convex distal side and a concave proximal side configured to mate with the distal end of the internal elongated member 130. The closure element 290 may extend across and / or cover the proximal hub 220 and / or the cam member 224 such that the proximal hub 220 and / or the cam member 224 are fully disposed on a second (e.g., distal) side of the closure element 290.

[0071] For example, Figures 12-15As shown, the tether 140 can engage the cam member 224 and / or the attachment point 240 in the delivery configuration of the system 100. As described herein, the tether 140 can extend through the closure element 290 in the delivery configuration of the system 100. The tether 140 can extend through two or more of a plurality of eyelets, openings, and / or holes that extend through the closure element 290 from a first side of the closure element 290 to a second side of the closure element 290. For example, the tether 140 can avoid puncturing and / or otherwise compromising the integrity of the closure element 290 by passing through an existing eyelet, opening, and / or hole of the closure element 290. The tether 140 can extend around the cam member 224 and / or the attachment point 240. The first longitudinally extending portion 142 can extend through a first eyelet, opening, and / or hole, and / or the second longitudinally extending portion 144 can extend through a second eyelet, opening, and / or hole that is different than the first eyelet, opening, and / or hole. The cam member engagement portion 143 of the tether 140 can extend around the cam member 224 and / or the attachment point 240 between the first longitudinally extending portion 142 and the second longitudinally extending portion 144.

[0072] Figure 13 A cam member 224 is shown as viewed from a bottom or rear side view of the proximal hub 220. The cam member 224 extends laterally across the proximal hub 220 of the expandable frame 210. The cam member 224 can be fixedly attached to the proximal hub 220. The convex distal side of the cam member 224 can include a first lateral shoulder 226 and a second lateral shoulder 228. The first lateral shoulder 226 and the second lateral shoulder 228 can form a channel 227 extending laterally through the proximal hub 220 between the first lateral shoulder 226 and the second lateral shoulder 228. The channel 227 can be configured to receive and / or engage the cam member engagement portion 143 of the tether 140. The cam member engagement portion 143 can be disposed between the first longitudinally extending portion 142 and the second longitudinally extending portion 144. The tether 140 can pass through an opening disposed between the cam member 224 and the proximal hub 220 at two opposing lateral ends and / or sides of the cam member 224.

[0073] In some embodiments, the cam member engagement portion 143 of the tether 140 can wrap around the convex distal extension of the cam member 224 and / or the attachment point 240 once, without wrapping around and / or completely encircling the cam member 224 and / or the attachment point 240. However, it is contemplated that, in some embodiments, the cam member engagement portion 143 of the tether 140 can wrap around the cam member 224 and / or the attachment point 240 multiple times. The first longitudinally extending portion 142 can be disposed on a first lateral side of the cam member 224 and / or the attachment point 240, and the second longitudinally extending portion 144 can be disposed on a second lateral side of the cam member 224 and / or the attachment point 240. Both the first longitudinally extending portion 142 and the second longitudinally extending portion 144 can extend proximally away from the cam member 224 and / or the attachment point 240.

[0074] The tether 140 can be used to secure the implant 200 to the delivery device. Returning to Figure 12 , tension applied to the first longitudinally extending portion 142 and the second longitudinally extending portion 144 of the tether 140 relative to the inner elongated member 130 can pull the concave proximal side of the cam member 224, the expandable frame 210, the proximal hub 220, and / or the implant 200 into engagement with and / or against the distal end of the inner elongated member 130. When tension is applied to the tether 140, the closure element 290 can be pinched and / or clamped between the distal end of the inner elongated member 130 and the concave proximal side of the proximal hub 220 and / or the cam member 224.

[0075] In some embodiments, the concave proximal side of the cam member 224 can act as a rocker and / or slider feature that cooperates with the distal end of the inner elongated member 130. Tension and / or axial translation in a proximal direction applied to the first longitudinally extending portion 142 using the first adjustment element 186 (and / or relaxation caused by tension and / or axial translation in a distal direction applied to the second longitudinally extending portion 144 using the second adjustment element 188) can cause the cam member 224, the expandable frame 210, and / or the implant 200 to move laterally relative to the central longitudinal axis of the delivery device, the inner elongated member 130, and / or the outer sheath 110. As such, tension and / or axial translation in a proximal direction applied to the first longitudinally extending portion 142 using the first adjustment element 186 (and / or relaxation caused by tension and / or axial translation in a distal direction applied to the second longitudinally extending portion 144 using the second adjustment element 188) can be configured to cause the expandable frame 210 to angle relative to the central longitudinal axis of the delivery device, the inner elongated member 130, and / or the outer sheath 110, as shown in FIG. 17. In some embodiments, the expandable frame 210 can angle and / or be oriented at an oblique angle relative to the central longitudinal axis of the delivery device, the inner elongated member 130, and / or the outer sheath 110. Figure 14 ​

[0076] Similarly, tension in the proximal direction and / or axial translation imparted to the second longitudinal extension 144 using the second adjustment element 188 (and / or relaxation caused by distal direction tension and / or axial translation imparted to the first longitudinal extension 142 using the first adjustment element 186) can cause the cam member 224, the expandable framework 210, and / or the implant 200 to move laterally relative to the central longitudinal axis of the delivery device, the inner elongate member 130, and / or the outer sheath 110. As such, tension in the proximal direction and / or axial translation imparted to the second longitudinal extension 144 using the second adjustment element 188 (and / or relaxation caused by distal direction tension and / or axial translation imparted to the first longitudinal extension 142 using the first adjustment element 186) can be configured to angle the expandable framework 210 relative to the central longitudinal axis of the delivery device, the inner elongate member 130, and / or the outer sheath 110, as shown. Figure 15 In some embodiments, the expandable framework 210 can be angled and / or oriented at an oblique angle relative to the central longitudinal axis of the delivery device, the inner elongate member 130, and / or the outer sheath 110.

[0077] Figures 16-18 A partial cross-sectional view of an example left atrial appendage 50 is shown, which can be attached to and in fluid communication with the left atrium of the heart (not shown). The left atrial appendage 50 can 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 of left atrial appendages, which can vary from patient to patient. Those skilled in the art will also recognize that the medical devices and methods disclosed herein can be adapted to left atrial appendages of various sizes and shapes, as necessary. The left atrial appendage 50 can include a generally longitudinal axis disposed along a depth of a body 60 of the left atrial appendage 50. The body 60 can include a wall 54 and an ostium 56, forming a proximal mouth 58 in communication with the left atrium of the heart. In some embodiments, the lateral extent of the ostium 56 and / or the wall 54 can be less than or less than the depth of the body 60 along the longitudinal axis, or the depth of the body 60 can be greater than the lateral extent of the ostium 56 and / or the wall 54. In some embodiments, the left atrial appendage 50 can include a caudal element associated with a distal portion of the body 60 relative to the ostium 56, which can project radially or laterally away from the body 60.

[0078] A method of occluding the left atrial appendage 50 can include advancing the implant 200 configured to occlude the left atrial appendage 50 in a delivery configuration within a lumen of the delivery device and / or the outer sheath 110 into the left atrial appendage 50, where the expandable framework 210 is in a collapsed configuration (e.g., Figure 1). In some embodiments, implant 200 can be advanced into left atrial appendage 50 within and / or using system 100. In some embodiments, implant 200 can be percutaneously advanced within a patient's vasculature to left atrial appendage 50. In some embodiments, implant 200 can be advanced using different access methods, including but not limited to transapical intervention, transseptal intervention, or other surgical intervention.

[0079] The method can include deploying implant 200 within left atrial appendage 50, for example as shown in Figure 16 . Deploying implant 200 can include expanding and / or moving expandable frame 210 to an expanded configuration. In some embodiments, deploying implant 200 can include axially translating outer sheath 110 relative to inner elongate member 130 to expose implant 200. Inner elongate member 130 can be engaged with expandable frame 210 and / or proximal hub 220 during delivery and / or deployment of implant 200. In the expanded configuration, a plurality of anchor members 212 can be engaged with wall 54 of left atrial appendage 50.

[0080] The method can include releasing implant 200 within left atrial appendage 50. In some embodiments, releasing implant 200 can include severing tether 140 that secures implant 200 to the delivery device. Figure 17 Tether 140 is shown after being severed using the release mechanism of system 100. In some embodiments, as described herein, rotation of rotation gate 180 relative to the proximal end of the delivery device, inner elongate member 130, and / or outer sheath 110 (e.g., Figure 10 ) severs tether 140. In some embodiments, prior to severing tether 140, axial translation of tether 140 angles expandable frame 210 relative to the central longitudinal axis of the delivery device, inner elongate member 130, and / or outer sheath 110. Similarly, in some embodiments, prior to severing tether 140, axial translation of tether 140 can angle expandable frame 210 relative to the generally longitudinal axis of left atrial appendage 50.

[0081] In some embodiments, implant 200 and / or expandable frame 210 can be oriented at an oblique angle relative to the generally longitudinal axis of left atrial appendage 50. Engagement of the distal end of inner elongate member 130 with cam member 224 can allow and / or facilitate off-axes orientation of implant 200 and / or expandable frame 210 relative to the generally longitudinal axis of left atrial appendage 50, which can facilitate positioning, implantation, and / or sealing within an irregularly shaped and / or irregularly oriented left atrial appendage 50.

[0082] Upon release of the implant 200, all of the metallic material of the implant 200 can be disposed distally from the proximally-facing surface 292 of the closure element 290 such that all of the metallic material is effectively removed from the blood flow and / or no longer exposed to the moving fluid and / or blood within the patient’s circulatory system, including the left atrium of the heart. In some embodiments, upon release of the implant 200, all other structures of the implant 200 and / or expandable frame 210 can be disposed distally from the proximally-facing surface 292 of the closure element 290 such that only the proximally-facing surface 292 of the closure element 290 remains exposed to and / or in close contact with the blood flow and / or moving fluid and / or blood within the patient’s circulatory system, including the left atrium of the heart. For example, the expandable frame 210, proximal hub 220, distal hub 230, attachment points 240, plurality of anchor members 212, etc. can be disposed distally from the proximally-facing surface 292 of the closure element 290.

[0083] Upon release of the implant 200, proximal retraction of the rotation gate 180 relative to the delivery device (e.g., Figure 11 ), the inner elongated member 130, and / or the proximal end of the outer sheath 110 can decouple the tether 140 from the implant 200, expandable frame 210, and / or attachment points 240, as shown in Figure 18 some embodiments. In some embodiments, proximal retraction of the rotation gate 180 relative to the delivery device (e.g., Figure 11 ), the inner elongated member 130, and / or the proximal end of the outer sheath 110 can pull the tether 140 through the plurality of eyelets, openings, and / or holes extending through the closure element 290. In the released configuration, the tether 140 can be decoupled from the attachment points 240, pin 222, and / or cam member 224.

[0084] In some embodiments, the system 100 can include one or more features that allow the implant 200 to be angled relative to the central longitudinal axis of the delivery device, inner elongated member 130, and / or outer sheath 110, as shown in Figures 19-20 some embodiments. In some embodiments, the inner elongated member 130 can include a curved, convex, and / or rounded distal end. In some embodiments, the attachment points 240 can include a cam member 224 that laterally extends across the proximal hub 220 of the expandable frame 210. The cam member 224 can include a convex distal side and a concave proximal side that is configured to mate with the distal end of the inner elongated member 130. The closure element 290 can extend across and / or cover the proximal hub 220 and / or cam member 224 such that the proximal hub 220 and / or cam member 224 are entirely disposed on the second (e.g., distal) side of the closure element 290.

[0085] In the delivery configuration of system 100, tether 140 can engage cam member 224 and / or attachment point 240. As described herein, tether 140 can extend through closure element 290 in the delivery configuration of system 100. Tether 140 can extend through two or more of a plurality of eyelets, openings, and / or holes that extend through closure element 290 from a first side of closure element 290 to a second side of closure element 290. For example, tether 140 can pass through an existing eyelet, opening, and / or hole of closure element 290 to avoid puncturing and / or otherwise compromising the integrity of closure element 290. Tether 140 can extend around cam member 224 and / or attachment point 240. First longitudinally extending portion 142 can extend through a first eyelet, opening, and / or hole, and / or second longitudinally extending portion 144 can extend through a second eyelet, opening, and / or hole that is different than the first eyelet, opening, and / or hole. Cam member engagement portion 143 of tether 140 can extend around cam member 224 and / or attachment point 240 between first longitudinally extending portion 142 and second longitudinally extending portion 144.

[0086] In some embodiments, inner elongated member 130 can include a rotatable wheel 190 protruding from inner elongated member 130 such that rotatable wheel 190 can be rotated clockwise and / or counterclockwise (as viewed from the side of system 100 and / or inner elongated member 130) as shown. Figure 19 First longitudinally extending portion 142 of tether 140 can be fixedly attached to and / or configured to wrap around a first spool 194 fixedly attached to a first side of rotatable wheel 190. Second longitudinally extending portion 144 of tether 140 can be fixedly attached to and / or configured to wrap around a second spool 192 fixedly attached to a second side of rotatable wheel 190 opposite the first side. First longitudinally extending portion 142 and second longitudinally extending portion 144 can be configured to wrap around first spool 194 and second spool 192, respectively, in opposite directions. For example, first longitudinally extending portion 142 can wrap around first spool 192 in a clockwise direction, and second longitudinally extending portion 144 can wrap around second spool 194 in a counterclockwise direction, or vice versa. In some embodiments, as shown, rotatable wheel 190 can include a detent clicker 198 or similar structure configured to engage with a detent element extending from and / or fixedly attached to inner elongated member 130 to hold rotatable wheel in a fixed rotational position when a user is not rotating rotatable wheel 190. Figure 20

[0087] ​In some embodiments, the concave proximal side of cam member 224 can function as a rocker and / or slider feature that cooperates with the distal end of inner elongate member 130. Similar to other configurations described herein, use of rotatable wheel 190, tension and / or axial translation applied in a proximal direction to first longitudinally extending portion 142 and / or tension and / or axial translation applied in a distal direction to second longitudinally extending portion 144 (or vice versa) can cause cam member 224, expandable frame 210, and / or implant 200 to be laterally displaced relative to the central longitudinal axis of delivery device, inner elongate member 130, and / or outer sheath 110. Likewise, use of rotatable wheel 190, tension and / or axial translation applied in a proximal direction to first longitudinally extending portion 142 and / or tension and / or axial translation applied in a distal direction to second longitudinally extending portion 144 (or vice versa) can be configured to cause expandable frame 210 to be angled relative to the central longitudinal axis of delivery device, inner elongate member 130, and / or outer sheath 110 (e.g., Figures 14-15 ) in at least some embodiments, expandable frame 210 can be angled and / or oriented at an oblique angle relative to the central longitudinal axis of delivery device, inner elongate member 130, and / or outer sheath 110.

[0088] In at least some embodiments, inner elongate member 130 can include a tether release element 196 configured to sever tether 140, as shown in Figure 19 One example, tether release element 196 can include a button having a cutting element or blade disposed on and / or fixed to opposite ends of the button. When the user is satisfied with the positioning of implant 200, tether release element 196 can be actuated to sever tether 140, thereby releasing implant 200 from delivery device as described herein. Other configurations of tether release element 196 are also contemplated, including but not limited to an axial slider, a rotating knob, a scissors-like cutter, an automatic release system, and the like.

[0089] The materials that can be used for the various components of system 100 and implant 200, and the various elements thereof, disclosed herein can include materials that are generally associated with medical devices. For simplicity, the following discussion is referenced to system 100 and implant 200. However, this is not intended to limit the devices and methods described herein, as the discussion can apply to other elements, members, components, or devices disclosed herein, such as but not limited to delivery devices, outer sheaths, inner elongate members, tethers, release mechanisms, cutting blades, adjustment elements, expandable frames, anchor members, proximal hubs, distal hubs, pins, cam members, closure elements, and / or elements or components thereof.

[0090] In some embodiments, system 100 and implant 200 and / or components thereof can be made from 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.

[0091] Some examples of suitable polymers can include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyamide (for example, NYLON® available from DuPont or DURETHIC® available from Elf Atochem), elastomeric polyamides, block polyamides / ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), polyvinylfluorides (PVF), polyvinylidenefluorides (PVDF), ethylene-vinyl acetate copolymers (EVA), polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyvinylidene cloride (PVdC), polyimides (PI), acrylic polymers (for example, poly(methyl methacrylate), polymethyl methacrylate, polyacrylonitrile), copolymers of PVC and polyurethanes (for example, MORTHANE®), polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM), polyamide (for example, MOTHANE®, NYLON®), elastomeric polyamides, block polyamides / ethers, polyether block amide (PEBA), polyethylene ether ether ketone, polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyphenylene sulfide (PPS), nylon-12 (such as GRILAMID® available from EMS American Grilon), acrylonitrile copolymers such as acrylonitrile butadiene styrene, polystyrene, epoxy, polyvinylalcohol, polybutylene terephthalate, polyester, thermoplastic polyesters (e.g., HYTREL® available from DuPont), polytrimethylene ether ether ketone, co-polymers of PKV and PKHD, ethylene vinyl acetate copolymers, polyurethanes, block copolymers of polybutadiene, poly isoprene, or other diene polymers, silicone polyvinyl chloride, polyvinyl ethers, polyvinyl alcohols, polythyroethylene, polycyclohexylethylene, acrylonitrile homopolymers or copolymers thereof, or blends of these or other thermoplastic polymers, polyurethane, polystyrene, polyisobutylene, polyether-ester, polyether, polyurethane-urea, and / or poly HBAs, hyaluronic acid, and / or other classes of biocompatible polymers, such as biostable and / or biosorbable polymers or blends of these. ​​​​​​​), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, and the like thereof. In some embodiments, the sheath can be mixed with a liquid crystal polymer (LCP). For example, the mixture can include up to about 6% LCP.

[0092] Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloys such as linear-elastic and / or super-elastic nitinol; other nickel alloys such as nickel-chromium alloy (e.g., UNS: N06625 such as 625, UNS: N06022 such as UNS: N10276 such as Other alloys, etc.), nickel-copper alloys (e.g., UNS: N04400 such as 400, 400, 400, etc.), nickel -cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and etc.), nickel-molybdenum alloys (e.g., UNS: N 10665 such as Hayes® alloys, ), 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, etc.; cobalt-chromium alloys; cobalt-chromium- molybdenum alloys (e.g., UNS: R30003 such as etc.); platinum-rich stainless steels; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.

[0093] In some embodiments, linear-elastic and / or non-super-elastic nickel-titanium alloys can be in the range of about 50 to about 60 weight percent nickel, with the remainder being essentially titanium. In some implementations, the composition comprises nickel in the range of about 54 to about 57 weight percent. One example of a suitable nickel-titanium alloy is FHP-NT alloy, which is commercially available from Furukawa Techno Metal Co. of Kanagawa, Japan. Other suitable materials can include TM (available from Neo-Metrics) and GUM METAL TM (available from Toyota). In some other embodiments, a superelastic alloy such as superelastic nitinol can be used to achieve the desired performance characteristics.

[0094] In at least some embodiments, portions or all of system 100 and implant 200 and / or components thereof can also be doped with, made out of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing an image suitable for diagnosis or therapy on a fluoroscopy screen or other imaging technique. Such relatively bright image assists users of system 100 and implant 200 in determining the location of the components. 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 material, and the like. Additionally, other radiopaque markers and / or coils can also be incorporated into the design of system 100 and implant 200 to achieve the same result.

[0095] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to system 100 and implant 200 and / or other elements disclosed herein. For example, system 100 and implant 200 and / or components or portions thereof can be made from a material that does not substantially distort the image and create substantial artifacts (i.e., gaps in the image) in an MRI machine. Certain ferromagnetic materials, for example, can not be suitable because they can create artifacts in the MRI image. System 100 and implant 200 or portions thereof can also be made from a material that the MRI machine can image. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as CONART® available from Koninklijke Philips N.V. of Eindhoven, Netherlands), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® available from and the like), nitinol, and the like, and others. and the like), nitinol, and the like, and others.

[0096] In some embodiments, system 100 and implant 200 and / or other elements disclosed herein can include a fabric material disposed on or within a structure. The fabric material can be composed of a biocompatible material suitable to promote tissue ingrowth, such as a polymeric material or a biological material. In some embodiments, the fabric material can include a bioabsorbable material. Some examples of suitable fabric materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), polyolefin materials such as polyethylene, polypropylene, polyesters, polyurethanes, and / or mixtures or combinations thereof.

[0097] In some embodiments, the system 100 and implant 200 and / or other elements disclosed herein can include and / or be formed from a textile material. Some examples of suitable textile materials can include synthetic yarns, which can be flat, shaped, twisted, textured, pre-shrunk, or unshrunk. Synthetic biocompatible yarns suitable for use in the present invention include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyester, polypropylene, polyethylene, polyurethane, polyolefins, polyethylene, polyacetate, polyamides, ethylene naphthalate derivatives, natural silk, and polytetrafluoroethylene. In addition, at least one synthetic yarn can be a metallic yarn or a glass or ceramic yarn or fiber. Useful metallic yarns include yarns made from or containing stainless steel, platinum, gold, titanium, tantalum, or nickel-cobalt-chromium based alloys. The yarns can 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 can be multifilament, monofilament, or spun types. The type and denier of the selected yarns can be selected in a manner that forms a biocompatible and implantable prosthesis, and more particularly, a vascular structure having desired properties.

[0098] In some embodiments, the system 100 and implant 200 and / or other elements disclosed herein can include and / or be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents can include antithrombogenic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethylketone)); antiproliferatives (such as enoxaparin, hirudin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, angiopeptin, and acetylsalicylic acid); antiinflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulindac, and mesalamine); antineoplastic / antiproliferative / antineoplastic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine); anticoagulants (such as D-Phe-Pro-Arg chloromethylketone, RGD peptide-containing compounds, heparin, anti-thrombin antibodies, 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 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.

[0099] It should be understood that the disclosure is only illustrative in many respects. Changes can be made in the details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the application. To the appropriate extent, this can include the use of any feature of one illustrative embodiment in other embodiments. Of course, the scope of the application is to be defined by the language of the appended claims.

Claims

1. A system for occluding the left atrial appendage, the system comprising: a delivery device, the delivery device comprising an outer sheath and an inner elongate member slidably disposed within a lumen of the outer sheath; an implant for occluding the left atrial appendage, the implant comprising: an expandable frame configured to shift between a collapsed configuration and an expanded configuration, wherein the expandable frame comprises an attachment point configured to secure the expandable frame to the delivery device; and an occlusion element disposed on a proximal portion of the expandable frame, wherein the occlusion element covers the attachment point, and a tether extending longitudinally within the inner elongate member, the tether engaging the attachment point in a delivery configuration, wherein the attachment point comprises a cam member extending laterally across a proximal hub of the expandable frame, wherein the cam member is configured to mate with a distal end of the inner elongate member; wherein the tether extends around the cam member such that axial translation of the tether causes the cam member to mate with the distal end of the inner elongate member, such that axial translation of the tether is configured to angle the expandable frame relative to a central longitudinal axis of the delivery device.

2. The system of claim 1, wherein, the attachment point is a pin extending laterally across the proximal hub.

3. The system of claim 2, further comprising a fastening element securing the occlusion element to the pin.

4. The system of any of claims 1-3, further comprising a plurality of anchor members configured to secure the implant to tissue within the left atrial appendage.

5. The system of any one of claims 1-3, wherein, the occlusion element comprises a porous mesh.

6. The system of claim 4, wherein, the occlusion element comprises a porous mesh.

7. The system of claim 1, wherein, the tether extends through the occlusion element in the delivery configuration.

8. The system of claim 7, wherein, the tether is disengaged from the attachment point in a release configuration.

9. The system of any of claims 7 or 8, further comprising a release mechanism disposed in a lumen of the inner elongated member, wherein, the release mechanism is configured to sever the tether in the lumen of the inner elongate member.

10. The system of claim 9, wherein, the release mechanism comprises a cutting blade disposed within the inner elongate member.

11. The system of claim 9, further comprising a rotation gate movably engaged with a proximal end of the inner elongate member.

12. The system of claim 10, further comprising a rotation gate movably engaged with a proximal end of the inner elongate member.

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