Left atrial appendage implant with sealing disc

Abstract

An implant for closing a left atrial appendage may include an expandable frame including a body portion and a disc portion, wherein the expandable frame is configured to transition between a collapsed configuration and an expanded configuration, and a closing disc element disposed within the disc portion. The disc portion may include a first disc portion integrally formed with the body portion, and a second disc portion movably attached to the first disc portion by at least one hinge member.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 62 / 894,296, filed on August 30, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates generally to medical devices, and more particularly to medical devices suitable for use in percutaneous medical procedures including implantation into the left atrial appendage (LAA) of the heart. Background Art

[0004] The left atrial appendage is a small organ attached to the left atrium of the heart. During normal heart operation, as the left atrium contracts and forces blood into the left ventricle, the left atrial appendage contracts and forces blood into the left atrium. The ability of the left atrial appendage to contract helps improve the filling of the left ventricle, thereby 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 collect inside it, which may lead to the undesirable formation of blood clots within the left atrial appendage.

[0005] A thrombus that forms in the left atrial appendage may break away from the area and enter the bloodstream. A thrombus that migrates through a blood vessel may eventually block a smaller blood vessel downstream, leading to a stroke or heart attack. Clinical studies have shown that the majority of blood clots in patients with atrial fibrillation originate from the left atrial appendage. As a treatment method, medical devices that are deployed to occlude the left atrial appendage have been developed. Of the known medical devices and methods, each medical device has certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and introducers and alternative methods for making and using medical devices and introducers. Summary of the invention

[0006] In a first aspect, an implant for closing a left atrial appendage may include: an expandable frame including a body portion and a disc portion, wherein the expandable frame may be configured to transition between a collapsed configuration and an expanded configuration; and a closing disc element disposed within the disc portion. The disc portion may include a first disc portion integrally formed with the body portion, and a second disc portion movably attached to the first disc portion by at least one hinge member.

[0007] Additionally or alternatively to any aspect herein, the second tray portion is structurally independent from the first tray portion.

[0008] Additionally or alternatively to any of the aspects herein, the second disc portion includes a proximal hub configured to releasably connect the implant to a delivery device.

[0009] Additionally or alternatively, in the expanded configuration, the first disc portion is oriented substantially transverse to a central longitudinal axis of the body portion.

[0010] Additionally or alternatively to any aspect herein, in the expanded configuration, at least half of the first disk portion is substantially planar.

[0011] Additionally or alternatively to any aspect herein, in the expanded configuration, the second disc portion is oriented substantially transverse to a central longitudinal axis of the body portion.

[0012] Additionally or alternatively to any aspect herein, in the expanded configuration, at least half of the second disc portion is substantially planar.

[0013] Additionally or alternatively to any aspect herein, in the expanded configuration, the closure disc element is sandwiched between the first disc portion and the second disc portion.

[0014] Additionally or alternatively to any aspect herein, in the expanded configuration, the disc portion has an oblong perimeter shape.

[0015] Additionally or alternatively, an implant for closing a left atrial appendage may include: an expandable frame comprising a main body portion and a disc portion, wherein the expandable frame may be constructed to transition between a collapsed configuration and an expanded configuration; and a closing disc element connected to the disc portion by at least one hinge member.

[0016] Additionally or alternatively to any aspect herein, the tray portion may include a first tray portion integrally formed with the body portion, and a second tray portion movably attached to the first tray portion by at least one hinge member.

[0017] Additionally or alternatively to any of the aspects herein, a closure disc element is disposed between the first disc portion and the second disc portion.

[0018] Additionally or alternatively to any aspect herein, each of the at least one hinge members includes a wrap element.

[0019] Additionally or alternatively to any aspect herein, the coiled element includes a piercing point on at least one end.

[0020] Additionally or alternatively to any aspect herein, the disc portion is disposed proximally of the body portion.

[0021] Additionally or alternatively, an implant for closing a left atrial appendage may include: an expandable frame including a body portion and a disc portion, wherein the expandable frame may be configured to transition between a collapsed configuration and an expanded configuration, and a closure disc element disposed within the disc portion. The disc portion may include a first disc portion integrally formed with the body portion, and a second disc portion pivotally attached to the first disc portion by at least one hinge member, the hinge member surrounding at least a portion of the first disc portion and at least a portion of the second disc portion. The closure disc element may be coupled to the disc portion by at least one hinge member.

[0022] In addition to or in lieu of any aspect of the present invention, the first disk portion includes a first recess disposed along a perimeter of the first disk portion, and the second disk portion includes a second recess disposed along a perimeter of the second disk portion, wherein, in the expanded configuration, the first recess is aligned with the second recess to form a recess assembly.

[0023] Additionally or alternatively to any aspect herein, at least one hinge member is positioned within the first recess and the second recess.

[0024] Additionally or alternatively to any aspect of the present invention, the first tray portion includes a plurality of first recesses disposed along a perimeter of the first tray portion, and the second tray portion includes a plurality of second recesses disposed along a perimeter of the second tray portion. The plurality of first recesses may be aligned with the plurality of second recesses to form a plurality of recess assemblies, wherein a hinge member is positioned within each recess assembly.

[0025] Additionally or alternatively to any aspect herein, the disc portion is spaced apart from the body portion by a neck portion.

[0026] The above summary of some embodiments, aspects, and / or examples is not intended to describe each embodiment or every implementation of the present disclosure. The figures and the following detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The present disclosure may be more fully understood considering the following detailed description of various embodiments in conjunction with the accompanying drawings, in which:

[0028] Figure 1 is a schematic partial cross-sectional view of an exemplary left atrial appendage;

[0029] Figure 2 Aspects of a delivery device and implant for closing a left atrial appendage are shown;

[0030] Figure 3 and 3A Aspects of an implant for closing a left atrial appendage are shown;

[0031] Figure 4 yes Figure 3 A partially exploded view of an implant;

[0032] Figure 4A Aspects of an exemplary disc portion are shown;

[0033] Figure 5 Aspects of an exemplary hinge member are shown;

[0034] Figure 6 Aspects of alternative configurations of implants for closing left atrial appendages are shown; and

[0035] Figure 7 Shows Figure 6 Aspects of alternative configurations of the implants shown; and

[0036] Figure 8-9 Placement of an exemplary implant of the present disclosure within the left atrial appendage is shown.

[0037] Although various aspects of the present disclosure are applicable to various modifications and alternative forms, the details thereof have been illustrated by the examples in the accompanying drawings and will be described in detail. However, it should be understood that the purpose is not to limit the various aspects of the present disclosure to the specific embodiments described. On the contrary, the present invention is intended to cover all modifications, equivalents and substitutes that fall within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0038] The following description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, wherein the same reference numerals represent the same elements throughout the several views. The detailed description and the accompanying drawings are intended to illustrate, rather than 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 present disclosure. The detailed description and the accompanying drawings illustrate example embodiments of the claimed invention. However, for clarity and ease of understanding, although each feature and / or element may not be shown in each of the accompanying drawings, the features and / or elements may be understood to be present in any case unless otherwise stated.

[0039] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0040] Whether explicitly stated or not, all numerical values ​​assumed herein are modified by the term "approximately". In the context of numerical values, the term "approximately" generally refers to a numerical range that is considered by those skilled in the art to be equivalent to the value (e.g., having the same function or result). In many cases, the term "approximately" may include numbers rounded to the nearest significant figure. Unless otherwise stated, other uses of the term "approximately" (e.g., in contexts other than numerical values) may be assumed to have their ordinary and customary definitions understood from the context of the specification and consistent with the context of the specification.

[0041] The recitations of numerical ranges by endpoints include all numbers within that range, inclusive of the endpoints (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0042] Although some suitable sizes, ranges and / or values ​​associated with various components, features and / or specifications are disclosed, those skilled in the art, in light of this disclosure, will appreciate that the desired sizes, ranges and / or values ​​may deviate from those explicitly disclosed.

[0043] As used in this specification and the appended claims, the singular forms "one", "an" and "the" include plural referents, unless the content clearly stipulates otherwise. As used in this specification and the appended claims, the term "or" is generally used with its meaning that includes "and / or", unless the content clearly stipulates otherwise. It should be noted that, for ease of understanding, certain features of the present disclosure can be described in the singular, even if these features can be plural or repeated in the disclosed embodiments. Each instance of these features can be included and / or contained in a separate disclosure, unless there is a clear statement to the contrary. For the purpose of simplicity and clarity, not all elements of the disclosed invention must be shown in each figure or discussed in detail below. However, it should be understood that the following discussion can be equally applicable to any and / or all parts where there are more than one part, unless there is a clear statement to the contrary. In addition, for clarity, all instances of some elements or features may not be shown in each figure.

[0044] Relative terms such as "proximal", "distal", "advance", "recess", and variations thereof, etc., can generally be considered relative to the positioning, orientation, and / or operation of various elements relative to the user / operator / manipulator of the device, where "proximal" and "recess" mean or refer to being closer to or toward the user, and "distal" and "advance" mean or refer to being farther away from or away from the user. In some cases, the terms "proximal" and "distal" can be arbitrarily designated to aid in understanding the present disclosure, and these situations are apparent to those skilled in the art. Other relative terms, such as "upstream", "downstream", "inflow", and "outflow", refer to the direction of fluid flow in a lumen (e.g., a body cavity, a blood vessel, or a device).

[0045] The term "range" may be understood to mean the maximum measurement of the described or identified dimension, unless the range or dimension in question is preceded or identified as "minimum", which may be understood to mean the minimum measurement of the described or identified dimension. For example, "external range" may be understood as an external dimension, "radial range" may be understood as a radial dimension, "longitudinal range" may be understood as a longitudinal dimension, etc. Each instance of "range" may be different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.) and is obvious to those skilled in the art from the context of individual use. Typically, "range" may be considered to be the maximum possible dimension measured according to the intended use, while "minimum range" may be considered to be the minimum possible dimension measured according to the intended use. In some cases, "range" may generally be measured orthogonally in a plane and / or cross section, but it is apparent from a particular context that it may be measured differently - such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), etc.

[0046] The terms "integral" and "unitary" generally refer to one or more elements made or composed of a single structure or basic unit / element. Integral and / or unitary elements shall exclude structures and / or features made by assembling or otherwise combining multiple discrete elements.

[0047] Note that references in the specification to "an embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiments may include specific features, structures, or characteristics, but that each embodiment does not necessarily include the specific features, structures, or characteristics. Furthermore, such phrases do not necessarily refer to the same embodiment. Furthermore, when specific features, structures, or characteristics are described in conjunction with an embodiment, it is within the knowledge of those skilled in the art to implement the specific features, structures, or characteristics in conjunction with other embodiments, whether or not explicitly described, unless explicitly stated to the contrary. That is, the various individual elements described below, even if not explicitly shown in a specific combination, are still considered to be combinable or arrangable with each other to form other additional embodiments or to supplement and / or enrich the described embodiments, as will be understood by those of ordinary skill in the art.

[0048] For the sake of clarity, certain specified numerical terms (e.g., first, second, third, fourth, etc.) can be used to name and / or distinguish various described and / or claimed features throughout the description and / or claims. It should be understood that the numerical terms are not intended to be restrictive, but merely exemplary. In certain embodiments, for the sake of brevity and clarity, the numerical terms previously used can be changed and deviated. That is, the feature identified as a "first" element can be referred to as a "second" element, a "third" element, etc., later, or can be omitted completely, and / or different features can be referred to as a "first" element. The meaning and / or naming in each case are clear and understandable to a skilled practitioner.

[0049] Figure 1 is a partial cross-sectional view of an exemplary left atrial attachment 50 that can be attached to and in fluid communication with the left atrium of a patient's heart. In some aspects, the left atrial attachment 50 can have a complex geometry and / or an irregular surface area. Those skilled in the art will recognize that the illustrated left atrial attachment is only one of many possible shapes and sizes of the left atrial attachment, which may 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 various sizes and shapes of left atrial attachments as desired. The left atrial attachment 50 can include an overall longitudinal axis disposed along the depth of a main body 60 of the left atrial attachment 50. The main body 60 can include a wall 54 and an opening 56 forming a proximal mouth 58. In some embodiments, the lateral extent of the opening 56 and / or the wall 54 can be less than or less than the depth of the main body 60 along the longitudinal axis, or the depth of the main body 60 can be greater than the lateral extent of the opening 56 and / or the wall 54. In some embodiments, the left atrial attachment 50 can include a tail-like element associated with a distal portion of the main body 60 that can project radially or laterally away from the main body 60 .

[0050] The following figures illustrate selected components and / or arrangements of an implant for closing a left atrial appendage, a system for closing a left atrial appendage, and / or a method of using an implant and / or 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 about some components of the implant and / or system may be shown in more detail in other figures. Although discussed in the context of closing a left atrial appendage, the implant and / or system may also be used for other interventional and / or percutaneous medical procedures in a patient's body. Similarly, the devices and methods described herein for percutaneous deployment may be appropriately used in other types of surgical procedures. For example, in some examples, the device may be used in non-percutaneous procedures. The devices and methods according to the present disclosure may also be adapted and constructed for other uses within anatomical structures.

[0051] Figure 2 is a partial cross-sectional view showing elements of a delivery device 100 and an implant 200 for enclosing a left atrial appendage 50. The delivery device 100 can include a delivery sheath 110 having an inner cavity 120 extending to a distal end of the delivery sheath 110, and a core wire 130 slidably disposed within the inner cavity 120. The core wire 130 can be configured and / or capable of axially flattening the implant 200 relative to the delivery sheath 110. The delivery sheath 110 and / or the core wire 130 can have a selected level of axial stiffness and / or pushability characteristics while also having a selected level of flexibility to allow delivery through a patient's blood vessel. Some suitable but non-limiting examples of materials for the delivery sheath 110 and the core wire 130 are discussed below.

[0052] Implant 200 may include an expandable frame 210 that is configured to transition between a collapsed configuration and an expanded configuration. Expandable frame 210 may be configured to releasably connect implant 200 to delivery device 100. Expandable frame 210 may include a body portion 220 and a disc portion 230. In some embodiments, disc portion 230 may be spaced apart from body portion 220 by neck portion 214 (e.g., Figure 8-9 ). In at least some embodiments, the disc portion 230 can be fixed, attached and / or connected to the main body portion 220 by the neck portion 214. In some embodiments, the neck portion 214 is tubular (e.g., a tubular member, annular, etc.) and includes an inner cavity extending therethrough. In some embodiments, the neck portion 214 can be integrally formed with the main body portion 220 as a single structure. For example, the neck portion 214 can be formed of the same structural elements as the main body portion 220 (e.g., a cutting tube, a braided wire, etc.). The disc portion 230 can be disposed proximally of the main body portion 220. Additional details related to the disc portion 230 are described below.

[0053] When the implant 200 is disposed within the lumen 120 of the delivery sheath 110, the expandable frame 210 can be maintained and / or disposed in a collapsed configuration, such as Figure 2 The body portion 220 and the tray portion 230 may be configured to be in a collapsed configuration (e.g., Figure 2 ) and expansion structures (e.g. Figure 3 ). In some embodiments, the implant 200 may optionally include a closed body element 216 that is disposed and / or positioned on, above, and / or around at least a portion of the expandable frame 210. For example, the implant 200 may optionally include a closed body element 216 (e.g., a mesh, fabric, membrane, and / or other surface treatment) that is disposed and / or positioned on, above, and / or around at least a portion of the main portion 220 of the expandable frame 210. In at least some embodiments, the closed body element 216 may be fixed, attached, and / or connected to the expandable frame 210 and / or the main portion 220 of the expandable frame 210. In some embodiments, the closed body element 216 may be fixed, attached, and / or connected to the expandable frame 210 and / or the main portion 220 of the expandable frame 210 at multiple discrete locations.

[0054] In some embodiments, the closure body element 216 can be porous. In some embodiments, the closure body element 216 can be non-porous. In some embodiments, the closure body element 216 can be designed, sized, and / or configured to prevent thrombus and / or embolic material from passing through the left atrial appendage 50 into the left atrium and / or the patient's bloodstream.

[0055] In some embodiments, the closure body component 216 can be configured to promote endothelialization. In at least some embodiments, the closure body component 216 can be secured to the neck portion 214 (e.g., Figure 2 , 8 -9). In some embodiments, the closed body element 216 can be adhesively bonded to the annular marker band 218. In some embodiments, the annular marker band 218 can be embedded in the closed body element 216. The annular marker band 218 can be formed of a radiopaque material and / or doped with a radiopaque material to improve visibility. In some embodiments, the annular marker band 218 can be compressed, pinched and / or otherwise tightly gathered with the neck portion 214 to reduce and / or minimize the passage and / or leakage of fluid through the neck portion 214. Some suitable but non-limiting examples of materials for the closed body element 216 and the annular marker band 218 are discussed below.

[0056] The disc portion 230 may include a first disc portion 240 and a second disc portion 250 that is movably attached to the first disc portion 240 by at least one hinge member 270. The disc portion 230 may extend proximally from the body portion 220 in the stowed configuration and / or within the lumen 120 of the delivery sheath 110 to a proximal hub 254. In some embodiments, the second disc portion 250 may include a proximal hub 254. The proximal hub 254 may be configured to releasably connect and / or attach the implant 200 to the core wire 130 of the delivery device 100. In some embodiments, the proximal hub 254 may include an internal thread that is configured to rotatably and / or threadably engage the externally threaded distal end 132 (e.g., Fig. 9 Other configurations for releasably connecting the implant 200 to the core wire 130 are also contemplated.

[0057] In at least some embodiments, the expandable frame 210 and / or the body portion 220 of the expandable frame 210 may include a plurality of anchor members 212 extending outwardly from the expandable frame 210 and / or the body portion 220, such as Figure 3 The plurality of anchor members 212 may be configured to engage with the wall 54 of the main body 60 of the left atrial appendage 50 (eg, Figure 8-9 In some embodiments, the plurality of anchor members 212 can be formed as J-shaped hooks with free ends extending and / or pointing in a proximal direction relative to the central longitudinal axis of the expandable frame 210. Other configurations are also contemplated. In some embodiments, the plurality of anchor members 212 can extend through the closed body element 216 (if present), such as Figure 3 Some suitable but non-limiting examples of materials for the expandable frame 210, the plurality of anchor members 212, the body portion, the disk portion 230, etc. are discussed below.

[0058] like Figure 3-4 As shown, the disk portion 230 may include a first disk portion 240 and a second disk portion 250. In at least some embodiments, the first disk portion 240 may be integrally formed with the neck portion 214 and / or the body portion 220 (e.g., Figure 8-9). For example, in some embodiments, the body portion 220 may include the neck portion 214, or the first disc portion 240 may include the neck portion 214. In addition, in at least some embodiments, the body portion 220, the neck portion 214, and the first disc portion 240 may be integrally formed as a single unitary structure. In some embodiments, the second disc portion 250 may be structurally independent of the first disc portion 240. For example, the first disc portion 240 and the second disc portion 250 may be formed as separate pieces or structures, and / or the first disc portion 240 and the second disc portion 250 may be formed independently of each other. In some embodiments, the second disc portion 250 may be disposed proximally of the first disc portion 240. The first disc portion 240 and the second disc portion 250 may be disposed proximally of the body portion 220 in the stowed configuration and / or the expanded configuration. In some embodiments, the proximal hub 254 may be coaxially disposed and / or axially aligned with the central longitudinal axis of the expandable frame 210.

[0059] In some embodiments, the implant 200 may include a closed disc element 260 (e.g., a mesh, fabric, film, and / or other surface treatment) configured to promote endothelialization on and / or across the disc portion 230. In some embodiments, the implant 200 may include a closed disc element 260 disposed on and / or around a portion of the outer surface of the disc portion 230. In some embodiments, the implant 200 may include a closed disc element 260 disposed within the disc portion 230. In some embodiments, the closed disc element 260 may be disposed and / or sandwiched between the first disc portion 240 and the second disc portion 250 in the expanded configuration. In some embodiments, the closed disc element 260 may be elastic and / or stretchable to accommodate changes in the shape and / or size of the disc portion 230 as the disc portion 230 transitions toward and / or enters the expanded configuration.

[0060] In some embodiments, the closure disc element 260 can be porous. In some embodiments, the closure disc element 260 can be non-porous. In some embodiments, the closure disc element 260 can be designed, sized, and / or configured to prevent thrombotic and / or embolic material from entering the left atrium and / or the patient's bloodstream through the left atrial appendage 50. In some embodiments, the closure disc element 260 can be configured to promote endothelialization across the opening 56 and / or the proximal mouth 58 of the left atrial appendage 50 to effectively remove the left atrial appendage 50 from the patient's bloodstream. Some suitable but non-limiting examples of materials for the closure disc element 260 are discussed below.

[0061] In some embodiments, the second tray portion 250 may be movably and / or pivotally attached to the first tray portion 240 via at least one hinge member 270, such as Figure 3A2. In some embodiments, at least one hinge member 270 can surround at least a portion of the first tray portion 240 and at least a portion of the second tray portion 250. In some embodiments, the first tray portion 240 can include a first recess 242 disposed along a perimeter of the first tray portion 240. In some embodiments, the second tray portion 250 can include a second recess 252 disposed along a perimeter of the second tray portion 250. In some embodiments, in the expanded configuration, the first recess 242 can be aligned with the second recess 252 to form a recess assembly 280. In some embodiments, the at least one hinge member 270 can be positioned within the first recess 242 and the second recess 252.

[0062] In some embodiments, the first plate portion 240 may include a plurality of first recesses 242 disposed along the perimeter of the first plate portion 240, such as Figure 4 In some embodiments, the second plate portion 250 can include a plurality of second recesses 252 disposed along the perimeter of the second plate portion 250. In some embodiments, in the expanded configuration, the plurality of first recesses 242 can be aligned with the plurality of second recesses 252 to form a plurality of recess assemblies 280, wherein a hinge member 270 is positioned within each recess assembly 280, such as Figure 3 and 3A shown.

[0063] In at least some embodiments, the closure disc element 260 can be coupled to the disc portion 230 by at least one hinge member 270. In some embodiments, the closure disc element 260 can be coupled to the first disc portion 240 and / or the second disc portion 250 by at least one hinge member 270. In some embodiments, the closure disc element 260 can be coupled to the disc portion 230 by other and / or additional means, including but not limited to sutures or filaments, adhesive bonding, encapsulation, etc. In some embodiments, the implant 200 can be free of any other structure or device that couples the closure disc element 260 to the disc portion 230 in addition to the at least one hinge member 270. For example, in some embodiments, only the at least one hinge member 270 can couple the closure disc element 260 to the disc portion 230.

[0064] In some embodiments, in the expanded configuration, the first disc portion 240 can be oriented substantially transverse to the central longitudinal axis of the expandable frame 210 and / or the main body portion 220 (when there is no constraint and / or no stress). In some embodiments, in the expanded configuration, the first disc portion 240 can be oriented substantially perpendicular to the central longitudinal axis of the expandable frame 210 and / or the main body portion 220 (when there is no constraint and / or no stress). In some embodiments, in the expanded configuration, at least half (e.g., a majority) of the first disc portion 240 can be substantially planar (when there is no constraint and / or no stress). In some embodiments, in the collapsed configuration, the first disc portion 240 can be generally tubular or annular. In some embodiments, in the expanded configuration, the second disc portion 250 can be oriented substantially transverse to the central longitudinal axis of the expandable frame 210 and / or the main body portion 220 (when there is no constraint and / or no stress). In some embodiments, in the expanded configuration, the second disk portion 250 can be oriented substantially perpendicular to a central longitudinal axis of the expandable frame 210 and / or body portion 220 (when unconstrained and / or unstressed). In some embodiments, in the expanded configuration, at least half (e.g., a majority) of the second disk portion 250 can be substantially planar (when unconstrained and / or unstressed). In some embodiments, in the collapsed configuration, the second disk portion 250 can be generally tubular or annular (e.g., as Figure 2 shown).

[0065] Detailed Figure 4A Selected aspects of the second recess 252 of the second disc portion 250 are shown. It will be readily appreciated that the same features and / or aspects also apply to the first recess 242 of the first disc portion 240. The second disc portion 250 may include and / or be formed of a plurality of interconnected struts 256 that extend from the central longitudinal axis of the implant 200 and / or expandable frame 210 toward the perimeter of the second disc portion 250 in the expanded configuration. Each instance of the second recess 252 may be formed by two adjacent interconnected struts 256. In the expanded configuration, at the perimeter of the second disc portion 250, each of the adjacent interconnected struts 256 may be bent back toward the central longitudinal axis of the implant 200 and / or expandable frame 210 to form a radially extending segment 257. Adjacent radially extending segments 257 may be joined and / or connected by circumferentially extending segments 258 to form a continuous portion of the expandable frame 210 and / or the second disc portion 250. In some embodiments, the length of the radially extending segment 257 may be at least one hinge member 270 (eg, Figure 5) is at least about 75%, at least about 100%, at least about 125%, at least about 150%, at least about 200%, etc. of the thickness 274 of the circumferentially extending segments 257. In some embodiments, the length of the radially extending segments 257 can be greater than the inner extent and / or inner diameter of at least one hinge member 270. In some embodiments, the length of the circumferentially extending segments 258 can be about 80% to about 120% of the length of at least one hinge member 270. Thus, when the hinge member 270 is disposed on and / or around the circumferentially extending segments 258, at least one hinge member 270 can be captured within the second recess 252 between two adjacent radially extending segments 257.

[0066] Figure 5 An exemplary configuration of at least one hinge member 270 is shown. Any and / or all related descriptions herein may apply to one, more than one, each and / or all instances of at least one hinge member 270. In some embodiments, at least one hinge member 270 may include a winding element. In some embodiments, each of at least one hinge member 270 may include a winding element. In some embodiments, the winding element may include a piercing point 272 on at least one end. In some embodiments, the winding element may include a piercing point 272 on both ends, opposite ends, each end, etc. of the winding element. The piercing point 272 may be configured and / or capable of piercing the closed disk element 260 during assembly of the implant 200 to couple the closed disk element 260 to the disk portion 230. The thickness 274 of at least one hinge member 270 and / or the winding element may be determined by the cross-sectional dimensions of a single winding of the at least one hinge member 270 and / or the winding element. While the at least one hinge member 270 and / or the winding element are shown as wires having a circular outer contour, other configurations are contemplated, including rectangular, polygonal, or irregular outer contours. Some suitable but non-limiting examples of materials for the at least one hinge member 270 are discussed below.

[0067] Figure 6 An alternative configuration of a disc portion 230 is shown. In some embodiments, the disc portion 230, including the first disc portion 240 and the second disc portion 250, can have an oblong perimeter shape in the expanded configuration. The oblong perimeter shape can allow the implant 200 to better fit asymmetric and / or irregular anatomical structures. In some embodiments, the disc portion 230 can be made by forming and / or adding notches 255 in struts 256 of the first recess 242 and the second recess 252 corresponding to the first recess and / or intended to be aligned with the first recess 242, respectively, during manufacture of the first disc portion 240 and the second disc portion 250 and / or during assembly of the disc portion 230, as shown in FIG. Figure 7The notch 255 can weaken the support 256 to allow removal of the desired first recess 242 and the second recess 252 corresponding to and / or intended to be aligned with the first recess 242, such as by hand and / or without further mechanical assistance. In embodiments having alternative configurations of the disk portion 230 described herein, the closure disk element 260 can also be trimmed into an oblong shape that matches and / or corresponds to the oblong perimeter shape of the disk portion 230.

[0068] A method for sealing a left atrial appendage 50 may include advancing an implant 200 into the left atrial appendage 50. For example, the implant 200 in a collapsed configuration may be advanced into the left atrial appendage 50 within the lumen 120 of the delivery sheath 110. The method includes deploying an expandable frame 210 from the delivery sheath 110 within the left atrial appendage 50. The method further includes expanding and / or transitioning the expandable frame 210 from the collapsed configuration to an expanded configuration within the left atrial appendage 50. In the expanded configuration, the expandable frame 210 may be urged to contact, engage and / or anchor to the wall 54 of the main body 60 of the left atrial appendage 50, such as Figure 8 As shown. In addition, the method can include deploying and / or expanding the disc portion 230 from a collapsed configuration to an expanded configuration near the opening 56 of the left atrial appendage 50. In some embodiments, the method can include deploying and / or expanding the disc portion 230 to engage the wall 54 and / or the opening 56 of the left atrial appendage 50 in a sealing manner. In at least some embodiments, the disc portion 230 can span the opening 56 of the left atrial appendage 50. In some embodiments, the disc portion 230 can completely span the opening 56 of the left atrial appendage 50, thereby effectively removing the left atrial appendage 50 from the patient's circulatory system.

[0069] In some embodiments, the disc portion 230 can be spaced apart from the expandable frame 210 proximally by a gap distance. The gap distance can generally be understood as the axial distance between the proximal surface of the expandable frame 210 and the distal surface of the disc portion 230, which is generally measured parallel to the central longitudinal axis of the implant 200, the expandable frame 210 and / or the disc portion 230. In some embodiments, the gap distance can be fixed. In some embodiments, the gap distance can be variable. In some embodiments, the gap distance can be defined by the neck portion 214.

[0070] The expandable frame 210 and / or the plurality of anchor members 212 can serve as an anchoring mechanism for the disc portion 230. In some embodiments, the delivery device 100 and / or the implant 200 can include at least one means for adjusting the gap distance. In some embodiments, the method for closing the left atrial appendage 50 can include adjusting the gap distance to position the disc portion 230 against and / or within the opening 56 of the left atrial appendage 50. In some embodiments, the at least one means for adjusting the gap distance can be configured to translate the disc portion 230 toward and / or into the opening 56 of the left atrial appendage 50. For example, upon initial deployment of the implant 200, the disc portion 230 can be spaced apart from the opening 56 of the left atrial appendage 50. In some embodiments, the implant 200 and / or the expandable frame 210 can be advanced deeper into the main body 60 of the left atrial appendage 50 until the disc portion 230 engages the opening 56 of the left atrial appendage. In some embodiments, at least one device for adjusting the gap distance can be used to translate the disc portion 230 toward and / or into the opening 56 of the left atrial appendage 50. In one example, the gap distance can be shortened from its initial deployed distance by about 10%, about 20%, about 25%, about 30%, about 40%, about 50%, about 60%, about 75%, etc. In another example, the gap distance can be shortened or reduced to zero.

[0071] In some embodiments, the disc portion 230 can be oriented at an oblique angle relative to the central longitudinal axis of the expandable frame 210. In some embodiments, the neck portion 214 can be flexible and / or can allow for off-axis orientation of the disc portion 230 relative to the expandable frame 210, which can simplify positioning, implantation, and / or sealing within an irregularly shaped and / or irregularly oriented left atrial appendage 50.

[0072] When the positioning of the body portion 220 within the left atrial appendage 50 and / or the disc portion 230 against the opening 56 of the left atrial appendage 50 is satisfactory, the delivery device 100 can be disconnected from the implant 200, such as Fig. 9 As shown, the implant 200 is disposed at and / or in the left atrial appendage 50. In some embodiments, disconnecting the delivery device 100 from the implant 200 can include rotating the outer threaded distal end 132 of the core wire 130 relative to the implant 200 and / or the proximal hub 254 to separate the core wire 130 from the implant 200.

[0073] In some embodiments, the delivery system can include a key structure configured to prevent the core wire 130 from rotating relative to the disc portion 230. In these embodiments, the key structure is disengaged prior to rotating the core wire 130 relative to the implant 200 and / or the proximal hub 254. When the key structure is engaged, the rotation of the core wire 130 can be transmitted to the disc portion 230, the body portion 220, and / or the expandable frame 210. In some embodiments, for example, for asymmetric and / or irregular openings 56 and / or left atrial attachments 50, the rotation of the disc portion 230, the body portion 220, and / or the expandable frame 210 can facilitate the positioning and / or orientation of the disc portion 230, the body portion 220, and / or the expandable frame 210 relative to the left atrial attachment 50. In some embodiments, the rotation of the disc portion 230, the body portion 220, and / or the expandable frame 210 can change the gap distance by translating the disc portion 230 closer to or further away from the body portion 220 of the expandable frame 210. Other configurations, purposes and / or outcomes are also contemplated.

[0074] The materials that can be used for the various components of the delivery device 100 and / or implant 200 disclosed herein and the various elements thereof can include materials commonly associated with medical devices. For simplicity, the following discussion relates to the delivery device 100 and / or implant 200. However, this is not intended to limit the devices and methods described herein, as the discussion can be applied to other elements, components, components or devices disclosed herein, such as but not limited to the delivery sheath 110, the core wire 130, the expandable frame 210, the plurality of anchor members 212, the neck portion 214, the closed body element 216, the annular marker band 218, the body portion 220, the disc portion 230, the first disc portion 240, the second disc portion 250, the proximal hub 254, the closed disc element 260, at least one hinge member 270 and / or its elements or components.

[0075] In some embodiments, the delivery device 100 and / or implant 200 and / or components thereof may be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or the like, or other suitable materials.

[0076] Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, available, for example, from DuPont ), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., available from DSM Engineering Plastics ), ether or ester based copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers, such as those available from DuPont ), polyamides (e.g., available from Bayer or available from Elf Atochem ), elastic polyamides, block polyamide / ether, polyether block amide (PEBA, for example, can be ), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g., ), 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(p-phenylene terephthalate) (e.g., ), polysulfone, nylon, nylon-12 (e.g., available from EMS American Grilon ), perfluoro(propyl vinyl ether) (PFA), ethyl vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonate, polyurethane siloxane copolymers (e.g., or AdvanSource Biomaterials ), biocompatible polymers, other suitable materials or mixtures, combinations, copolymers, polymer / metal composites, etc. In some embodiments, the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6 percent LCP.

[0077] 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 superelastic nitinol; other nickel alloys, such as nickel-chromium-molybdenum alloys (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 etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as ), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten alloys or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (for example, UNS: R30003, such as etc.); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.

[0078] As mentioned herein, within the family of commercially available nickel-titanium or Nitinol alloys, there is a class of alloys referred to as "linear elastic" or "non-superelastic" alloys that, while chemically similar to conventional shape memory and superelastic species, may exhibit different and useful mechanical properties. Linear elastic and / or non-superelastic Nitinol differs from superelastic Nitinol in that linear elastic and / or non-superelastic Nitinol does not exhibit a significant "superelastic plateau" or "marked region" in its stress / strain curve as superelastic Nitinol does. In contrast, in linear elastic and / or non-superelastic Nitinol, as recoverable strain increases, stress continues to increase in a substantially linear relationship, or in a somewhat, but not necessarily completely, linear relationship, until plastic deformation begins, or at least in a more linear relationship than the superelastic plateau and / or marked region that can be seen with superelastic Nitinol. Therefore, for the purposes of this disclosure, linear elastic and / or non-superelastic Nitinol may also be referred to as "substantially" linear elastic and / or non-superelastic Nitinol.

[0079] In some cases, linear elastic and / or non-superelastic Nitinol can also be distinguished from superelastic Nitinol, because linear elastic and / or non-superelastic Nitinol can accept strains up to about 2-5% while remaining substantially elastic (e.g., before plastic deformation), while superelastic Nitinol can accept strains up to about 8% before plastic deformation. Both of these materials can be distinguished from other linear elastic materials, such as stainless steel (which can also be distinguished based on its composition), which can only accept strains of about 0.2% to 0.44% before plastic deformation.

[0080] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy is an alloy that does not show any martensite / austenite phase transformation detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) analysis over a wide temperature range. For example, in some embodiments, in a linear elastic and / or non-superelastic nickel-titanium alloy, there may be no martensite / austenite phase transformation detectable by DSC and DMTA analysis over a range of about -60 degrees Celsius (°C) to about 120 (°C). Therefore, the mechanical bending properties of such materials may be generally inert to the effects of temperature over this very wide temperature range. In some embodiments, the mechanical bending properties of the linear elastic and / or non-superelastic nickel-titanium alloy at ambient or room temperature are substantially the same as the mechanical properties at body temperature, for example, because they do not show a superelastic plateau and / or signature region. In other words, over a wide temperature range, the linear elastic and / or non-superelastic nickel-titanium alloy maintains its linear elastic and / or non-superelastic properties and / or performance.

[0081] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may be nickel in the range of about 50 to about 60 weight percent, with the remainder being substantially titanium. In some embodiments, the weight percent of nickel in the composition is in the range of about 54% to about 57%. An example of a suitable nickel-titanium alloy is FHP-NT alloy available from Furukawa TechnoMaterial, Kanagawa, Japan. Other suitable materials may include ULTANIUM TM (available from Neo-Metrics) and GUM METAL TM (Available from Toyota.) In some other embodiments, superelastic alloys, such as superelastic Nitinol, may be used to achieve the desired properties.

[0082] In at least some embodiments, part or all of the delivery device 100 and / or implant 200 and / or its components may also be doped with, made of, or otherwise include a radiopaque material. A radiopaque material is understood to be a material that is capable of producing a relatively bright image on a fluoroscopic screen or another imaging technique during a medical procedure. This relatively bright image helps the user of the delivery device 100 and / or implant 200 determine its position. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials loaded with radiopaque fillers, and the like. In addition, other radiopaque marker bands and / or coils may also be incorporated into the design of the delivery device 100 and / or implant 200 to achieve the same results.

[0083] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the delivery device 100 and / or implant 200 and / or other elements disclosed herein. For example, the delivery device 100 and / or implant 200 and / or components or portions thereof can be made of a material that does not substantially distort the image and produce a large number of artifacts (i.e., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may produce artifacts in MRI images. The delivery device 100 and / or implant 200 or portions thereof can also be made of a material that can be imaged by an MRI machine. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as etc.), Nitinol, etc., and other materials.

[0084] In some embodiments, the delivery device 100 and / or implant 200 and / or other elements disclosed herein may include a fabric material arranged above or inside the structure. The fabric material may be composed of a biocompatible material, such as a polymeric material or a biomaterial, suitable for promoting 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), polyolefin materials such as polyethylene, polypropylene, polyester, polyurethane and / or mixtures or combinations thereof.

[0085] In some embodiments, the delivery device 100 and / or implant 200 and / or other elements disclosed herein may include and / or be formed by textile materials. Some examples of suitable textile materials may include synthetic yarns, which may be flat, shaped, twisted, textured, pre-contracted or uncontracted. Suitable synthetic biocompatible yarns used in the present invention include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyester, polypropylene, polyethylene, polyurethane, polyolefins, ethylene polymers, polymethyl acetate, polyamide, naphthalene glycol derivatives, natural silk and polytetrafluoroethylene. In addition, at least one synthetic yarn may be a metal yarn or glass or ceramic yarn or fiber. Useful metal yarns include yarns made of stainless steel, platinum, gold, titanium, tantalum or nickel-cobalt-chromium-based alloys or yarns containing these materials. Yarn may further include carbon, glass or ceramic fibers. Ideally, yarn is made of thermoplastic materials, including but not limited to polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, etc. The yarns may be of the multifilament, monofilament or staple type. The type and denier of the yarn selected may be selected based on the manner in which the biocompatible and implantable prosthesis is to be formed, and more specifically, may be selected based on the vascular structure having the desired properties.

[0086] In some embodiments, the delivery device 100 and / or the implant 200 and / or other components disclosed herein may include and / or be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents may include antithrombotic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrorotatory phenylalanine proline arginine chloromethyl ketone)); antiproliferative agents (such as enoxaparin, angiopeptide, 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 mesalazine); anti-tumor / antiproliferative / anti-mitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (such as lidocaine, bupivacaine, and ropivacaine); anticoagulants (such as D-Phe-Pro- Arg chloromethyl ketone, compounds containing RGD peptides, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors and tick antiplatelet peptides); vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcription activators and translation promoters); vascular cell growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules composed of growth factors and cytotoxins, bifunctional molecules composed of antibodies and cytotoxins); cholesterol-lowering agents; vasodilators; and agents that interfere with endogenous vascular mechanisms of action.

[0087] It should be understood that the present disclosure is in many respects illustrative only. Changes may be made in detail, particularly in shape, size, and arrangement of steps, without exceeding the scope of the invention. To the extent appropriate, this may include using any feature of an example embodiment used in other embodiments. Of course, the scope of the invention is defined by the language expressed in the appended claims.

Claims

1. An implant for closing a left atrial appendage, comprising: an expandable frame, the expandable frame comprising a body portion and a disc portion; wherein the expandable frame is configured to transition between a collapsed configuration and an expanded configuration; and a closure disc element disposed within the disc portion; Wherein, the disk portion comprises: a first disc portion, the first disc portion being integrally formed with the body portion; and a second tray portion movably attached to the first tray portion by at least one hinge member; wherein the first disc portion includes a plurality of first recesses disposed along a perimeter of the first disc portion, and the second disc portion includes a plurality of second recesses disposed along a perimeter of the second disc portion; wherein, in the expanded configuration, the plurality of first recesses are aligned with the plurality of second recesses to form a plurality of recess assemblies that are circumferentially spaced apart from one another; Wherein, a hinge component is arranged in each recess component.

2. The implant according to claim 1, wherein The second tray portion is structurally independent from the first tray portion.

3. The implant according to any one of claims 1 to 2, wherein: The second disc portion includes a proximal hub configured to releasably connect the implant to a delivery device.

4. The implant according to claim 1, wherein In the expanded configuration, the first disk portion is oriented substantially transverse to a central longitudinal axis of the body portion.

5. The implant according to claim 4, wherein In the expanded configuration, at least half of the first disk portion is substantially planar.

6. The implant according to claim 1, wherein In the expanded configuration, the second disc portion is oriented substantially transverse to a central longitudinal axis of the body portion.

7. The implant according to claim 6, wherein In the expanded configuration, at least half of the second disk portion is substantially planar.

8. The implant according to claim 1, wherein In the expanded configuration, the closure disc element is sandwiched between the first and second disc portions.

9. The implant according to claim 1, wherein: In the expanded configuration, the disc portion has an oblong perimeter shape.

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