Closed medical devices

Abstract

An example closed implant is disclosed. The example closed implant includes an expandable frame configured to switch between a first configuration and an expanded configuration and a fixing member disposed along the expandable frame. The fixing member includes a first engagement portion and an anchoring portion. In addition, the first engagement portion is configured to be fixed to the expandable frame, and the anchoring portion extends away from the outer surface of the expandable frame.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority under 35 U.S.C. §119 to U.S. Provisional Application Serial No. 62 / 694,731, filed on July 6, 2018, the entire contents of which are incorporated herein by reference. Background Art

[0003] The left atrial appendage (LAA) is a small organ that is attached to the left atrium of the heart and extends in a bag-like shape. In patients with atrial fibrillation, the left atrial appendage may not contract properly with the left atrium, causing stagnant blood to accumulate inside it, which may lead to unwanted thrombosis in the left atrial appendage. Thrombi formed in the left atrial appendage may break away from the area and enter the blood stream. Thrombi that migrate through blood vessels may eventually plug smaller blood vessels downstream and thus cause stroke or heart attack. Clinical studies have shown that most blood clots in patients with atrial fibrillation are found in the left atrial appendage. As a treatment method, medical devices have been developed that are positioned in the left atrial appendage and deployed to close the mouth of the left atrial appendage. Over time, the exposed surface across the mouth of the left atrial appendage is covered with tissue (a process called endothelialization), effectively removing the left atrial appendage from the circulatory system and reducing or eliminating the number of thrombi that may enter the blood stream from the left atrial appendage. There is a continuing need for improved medical devices and methods to control thrombus formation within the left atrial appendage of patients suffering from atrial fibrillation. Summary of the invention

[0004] The present disclosure provides designs, materials, manufacturing methods and use alternatives for medical devices. An example closed implant includes an expandable frame configured to switch between a first configuration and an expanded configuration and a fixing member arranged along the expandable frame. The fixing member includes a first engagement portion and an anchoring portion. In addition, the first engagement portion is designed to be fixed to the expandable frame, and the anchoring portion extends away from the outer surface of the expandable frame.

[0005] Additionally or alternatively, wherein the first engagement portion is removably secured to the expandable frame.

[0006] Additionally or alternatively, wherein the first engagement portion is configured to be rigidly fixed to the expandable frame.

[0007] Additionally or alternatively, wherein the fixing member includes a first end, a second end opposite the first end, and an intermediate portion extending between the first end and the second end, and wherein the first engaging portion is positioned along the first end of the fixing member, and wherein the anchoring portion is positioned along the second end of the fixing member.

[0008] Additionally or alternatively, wherein the first engagement portion includes a first engagement member and a second engagement member, wherein the first engagement member and the second engagement member are both offset from the intermediate portion.

[0009] Additionally or alternatively, wherein at least a portion of the expandable frame is positioned between the first engagement member and the middle portion, and wherein at least a portion of the expandable frame is positioned between the second engagement member and the middle portion.

[0010] Additionally or alternatively, the fixation member is disposed along the expandable frame such that at least a portion of the first engagement member and at least a portion of the second engagement member are positioned along an outer surface of the expandable frame and at least a portion of the intermediate portion is positioned along an inner surface of the expandable frame.

[0011] Additionally or alternatively, wherein the expandable frame comprises first filaments interwoven with second filaments, and wherein the first filaments cross the second filaments at a crossover point, and wherein the fixation member is positioned adjacent the crossover point.

[0012] Additionally or alternatively, wherein the first filament is positioned between the first engagement member and the intermediate portion, and wherein the second filament is positioned between the second engagement member and the intermediate portion.

[0013] Additionally or alternatively, wherein the anchoring portion comprises a first protrusion and a second protrusion, and wherein the second protrusion is offset from the first protrusion.

[0014] Additionally or alternatively, each of the first protrusion and the second protrusion includes an arc-shaped portion.

[0015] Additionally or alternatively, wherein the fixing portion further comprises a second engagement portion positioned adjacent to the first engagement portion, and wherein the second engagement portion comprises a third engagement member and a fourth engagement member.

[0016] Additionally or alternatively, the fixing member is arranged along the expandable frame so that at least a portion of the third engaging member and at least a portion of the fourth engaging member are positioned along the outer surface of the expandable frame and at least a portion of the middle portion is positioned along the inner surface of the expandable frame.

[0017] Additionally or alternatively, at least one of the first engagement member, the second engagement member, the third engagement member, and the fourth engagement member is interleaved with at least a portion of the expandable frame.

[0018] A method of manufacturing a closure device in a left atrial appendage, comprising:

[0019] securing a fixation member to the expandable frame, wherein the fixation member comprises a first engagement portion, an intermediate portion, and an anchoring portion, and wherein the expandable frame is configured to transition between a first configuration and an expanded configuration;

[0020] Therein, the anchoring portion extends away from an outer surface of the expandable frame.

[0021] Additionally or alternatively, wherein securing the fixation member to the expandable frame comprises attaching the fixation member via a friction fixation.

[0022] Additionally or alternatively, wherein attaching the fixation member via friction fixation comprises positioning the expandable member between the first engagement portion and the intermediate portion.

[0023] Additionally or alternatively, wherein securing the fixation member to the expandable frame comprises rigidly attaching the fixation member to the expandable frame.

[0024] Additionally or alternatively, wherein securing the fixation member to the expandable frame comprises welding the fixation member to the expandable frame.

[0025] A method for closing a left atrial appendage, comprising:

[0026] A closure implant is advanced into the left atrial appendage, the closure implant comprising:

[0027] an expandable frame configured to transition between a first configuration and a second configuration; and

[0028] a fixation member disposed along the expandable frame, wherein the fixation member includes a first engagement portion and an anchoring portion;

[0029] wherein the anchoring portion extends away from an outer surface of the expandable frame;

[0030] wherein the first engagement portion is removably coupled to the expandable frame; and

[0031] The expandable frame is expanded within the left atrial appendage such that the expandable frame transitions between a first configuration and a second configuration.

[0032] 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

[0033] The present disclosure may be more fully understood by considering the following detailed description of various embodiments in conjunction with the accompanying drawings.

[0034] in:

[0035] Figure 1An example closure implant positioned in a heart is shown;

[0036] Figure 2 is a plan view of an example closure implant;

[0037] Figure 3 An example fixation member disposed along a closure implant is shown;

[0038] Figure 4 yes Figure 3 a perspective view of the fixing member shown;

[0039] Figure 5 yes Figure 4 A side view of the fixing member shown;

[0040] Figure 5A is a side view of another fixed member;

[0041] Figure 6 Another example fixation member disposed along a closure implant is shown;

[0042] Figure 7 yes Figure 6 a perspective view of the fixing member shown;

[0043] Figure 8 Another example securing member is shown;

[0044] Fig. 9 yes Figure 7 A side view of the fixing member shown;

[0045] Fig.10 Another example securing member is shown;

[0046] Fig.11 An example fixation member disposed along a closure implant is shown;

[0047] Fig.12 An example fixation member disposed along a closure implant is shown;

[0048] Fig.13 An example fixation member disposed along a closure implant is shown;

[0049] Fig.14 An example fixation member disposed along a closure implant is shown;

[0050] Fig.15 Shows Fig.14 an end view of the securing member shown in a retracted configuration;

[0051] Fig.16 Shows Fig.14 The fixation member is shown in an end view in an extended configuration.

[0052] Although various modifications and alternative forms are possible for various aspects of the present disclosure, the details thereof have been shown by way of example in the 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 purpose is to cover all modifications, equivalents and alternatives that fall within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0053] 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 several views. The detailed description and the accompanying drawings are intended to illustrate rather than limit the claimed disclosure. Those skilled in the art will recognize that the various elements described and / or shown may be arranged in various combinations and structures without departing from the scope of the present disclosure. The detailed description and the accompanying drawings illustrate example embodiments of the claimed disclosure. However, for the benefit of 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.

[0054] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0055] Whether or not explicitly stated, all numerical values ​​herein are considered to be 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 considered to have their ordinary and customary definitions, as understood from the context of the specification and consistent therewith.

[0056] The recitation of numerical ranges by endpoints includes 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).

[0057] While some suitable sizes, ranges and / or values ​​are disclosed with respect to various components, features and / or specifications, 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.

[0058] 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 used in its meaning that includes "and / or", unless the content clearly dictates otherwise. It should be noted that, for ease of understanding, certain features of the present disclosure may be described in the singular, even if these features may be plural or repeated in the disclosed embodiments. Each instance of these features may be included and / or contained in a separate disclosure, unless explicitly stated to the contrary. For the purpose of simplicity and clarity, not all elements of the present disclosure must be shown in each figure or discussed in detail below. However, it should be understood that the following discussion may be equally applicable to any and / or all parts where there is more than one, unless explicitly stated to the contrary. In addition, for clarity, all instances of some elements or features may not be shown in each figure.

[0059] Relevant terms such as "proximal," "distal," "advance," "retraction," and variations thereof may generally be considered relative to the positioning, orientation, and / or operation of various elements relative to a user / operator / manipulator of the device, with "proximal" and "retraction" meaning or referring to being closer to or toward the user, and "distal" and "advance" meaning or referring to being farther away from or away from the user. In some cases, to facilitate understanding of the present disclosure, the terms "proximal" and "distal" may be arbitrarily designated, and such cases will be apparent to those skilled in the art. Other relevant 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.

[0060] The term "range" may be understood to mean the maximum measurement of a 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 a described or identified dimension. For example, "external range" may be understood to mean the maximum external dimension, "radial range" may be understood to mean the maximum radial dimension, "longitudinal range" may be understood to mean the maximum longitudinal dimension, etc. Each instance of "range" may be different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.) and will be apparent to one skilled in the art from the context of individual use. Generally, "range" may be considered to be the maximum possible dimension measured for the intended use, while "minimum range" may be considered to be the minimum possible dimension measured for the intended use. In some cases, "range" may generally be measured orthogonally in a plane and / or cross section, but it will be apparent from the particular context that it may be measured differently - for example, but not limited to, angularly, radially, circumferentially (e.g., along an arc), etc.

[0061] The terms "integral" and "unitary" shall generally refer to an element or elements that are made or constructed from a single structure or basic unit / element. Integral and / or unitary elements shall exclude structures and / or features that are made by assembling or otherwise connecting multiple independent elements together.

[0062] Note that references in the specification to "an embodiment," "some embodiments," "other embodiments," etc. indicate that the described embodiments may include a particular feature, structure, or characteristic, but that each embodiment does not necessarily include the particular feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in conjunction with an embodiment, it is within the knowledge of those skilled in the art to implement the particular feature, structure, or characteristic in conjunction with other embodiments, whether or not explicitly described, unless otherwise explicitly stated. That is, even if not explicitly shown in a particular combination, the various individual elements described below 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.

[0063] For the sake of clarity, certain identification numbers of terms (e.g., first, second, third, fourth, etc.) can be used throughout the entire specification and / or claims to name and / or distinguish between various described and / or claimed features. It should be understood that the numerical terms are not meant to be restrictive, but are merely exemplary. In some embodiments, for the sake of brevity and clarity, the previously used numerical terms can be changed and deviated. That is, the feature identified as a "first" element can then be referred to as a "second" element, a "third" element, etc., or can be completely omitted, and / or different features can be referred to as a "first" element. The meaning and / or name in each case are obvious to a skilled practitioner.

[0064] The occurrence of thrombus in the left atrial appendage (LAA) during atrial fibrillation may be caused by stagnation of blood flow in the LAA. The stagnant blood may still be pumped out of the left atrium by the left ventricle, however, the effect is poor due to the irregular contraction of the left atrium caused by atrial fibrillation. Therefore, instead of actively supporting blood flow by contracting the left atrium and left atrial appendage, the filling of the left ventricle may depend primarily or solely on the suction effect generated by the left ventricle. However, the contraction of the left atrial appendage may be out of sync with the cycle of the left ventricle. For example, the contraction of the left atrial appendage may be up to 180 degrees out of phase with the left ventricle, which may create significant resistance to the flow of desired blood. Further, the geometry of most left atrial appendages is complex and highly variable, with a large irregular surface area and a narrow mouth or opening compared to the depth of the left atrial appendage. These aspects and other aspects, alone or in various combinations, may lead to high flow resistance to blood outflow from the left atrial appendage.

[0065] In order to reduce the occurrence of thrombus formation in the left atrial appendage and prevent thrombi from entering the blood stream from within the left atrial appendage, it may be desirable to develop a medical device and / or closure implant that seals the left atrial appendage from the heart and / or circulatory system, thereby reducing the risk of stroke caused by thrombolytic substances entering the blood stream from the left atrial appendage. Example medical devices and / or closure implants that seal the left atrial appendage (or other similar openings) are disclosed herein.

[0066] Figure 1 An example closure implant 10 is shown positioned within a left atrial appendage 50. Figure 1 It is further shown that the closure implant 10 can be inserted and advanced through a body cavity via a closure implant delivery system 20. In some cases, the closure implant delivery system 20 can include a delivery catheter 24 that is guided toward the left atrium to a location adjacent to the left atrial appendage 50 via various chambers and cavities of the heart (e.g., the inferior vena cava, the superior vena cava, the right atrium, etc.).

[0067] The delivery system 20 may include a hub 22. The clinician may manipulate the hub 22 to guide the distal end region of the delivery catheter 24 to a position adjacent to the left atrial appendage 50. In some embodiments, the closed implant delivery system 20 may include a core wire 18. In addition, the proximal end 11 of the closed implant 10 may be configured to be releasably attached, coupled, connected, engaged, or otherwise connected to the distal end of the core wire 18. In some embodiments, the proximal end region 11 of the closed implant 10 may include a threaded insert coupled thereto. In some embodiments, the threaded insert may be configured and / or adapted to be coupled, coupled, matched, or otherwise engaged with a threaded member disposed at the distal end of the core wire 18. Other ways of releasably coupling and / or engaging the proximal end of the closed implant 10 to the distal end of the core wire 18 may also be considered.

[0068] Figure 1 Also shown is a closed implant 10 positioned adjacent to the left atrial appendage 50 via a delivery catheter 24 (as described above). It will be appreciated that in some examples, the implant 10 can be configured to transition between a collapsed structure and an expanded structure. For example, in some cases, the closed implant 10 can be in a collapsed structure during delivery via the closed implant delivery system 20, whereby the closed implant 10 expands to an expanded structure once deployed from the closed implant delivery system 20.

[0069] also, Figure 1 The closure implant 10 is shown to include an expandable frame 12. The expandable frame 12 can be pliable and, therefore, substantially match and / or sealingly engage the shape and / or geometry of the sidewalls of the left atrial appendage 50 in the expanded structure. In some embodiments, the closure implant 10 can be expanded to a size, range, or shape that is less than or different than the maximum unconstrained range, as determined by the surrounding tissue and / or sidewalls of the left atrial appendage 50. In addition, it will be appreciated that elements of the expandable frame 12 can be customized to increase the flexibility of the expandable frame 12 and / or the closure implant 10, thereby allowing the expandable frame 12 and / or the closure implant 10 to match the tissue surrounding it, rather than forcing the tissue to match the expandable frame 12 and / or the closure implant 10. In addition, in some cases, it may be desirable to design the closure implant 10 to include various features, components, and / or structures that enhance the sealing capabilities of the closure implant 10 within the left atrial appendage.

[0070] Figure 1 It is shown that the distal end region 13 of the expandable frame 12 can extend further into the left atrial appendage 50 than the proximal end region 11 of the expandable frame 12. It will be appreciated that as the expandable frame 12 advances into the left atrial appendage 50, the distal end region 13 can engage with tissue that defines the left atrial appendage 50. In other words, in some examples, when the expandable frame enters the left atrial appendage 50, the distal end region 13 can be considered a "guide" region of the expandable frame 12. However, this is not meant to be restrictive. On the contrary, in some examples, when the expandable frame enters the left atrial appendage 50, the proximal end region 11 can be considered a "guide" region of the expandable frame 12.

[0071] Figure 2 An example closed implant 10 is shown. The implant 10 may include an expandable frame 12. Figure 2 As shown, in some examples, the expandable frame 12 can be formed as a braided structure (e.g., a frame formed by braiding one or more filaments together). For example, the expandable frame 12 can include a first filament 25 interwoven with a second filament 27 to form a braided expandable frame 12. The expandable frame 12 can include a proximal end region 11 and a distal end region 13. Figure 2 It is further shown that the expandable frame 12 may include one or more protrusions 17 extending in the proximal-distal direction. Figure 2 ), the plurality of protrusions 17 may extend circumferentially around the longitudinal axis 52 of the expandable frame 12. In other words, the protrusions 17 may resemble the tip of a "crown" extending circumferentially around the longitudinal axis 52 of the expandable frame 12. Although the above discussion (and Figure 2 The illustration shown in FIG. 1 shows multiple protrusions 17, but it is contemplated that the closure implant 10 may include 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or more individual protrusions 17 arranged in various arrangements along the expandable frame 12.

[0072] also, Figure 2 The proximal end region 11 of the expandable frame 12 is shown to include a plurality of support members 19 extending circumferentially around the longitudinal axis 52 of the expandable frame 12 . Figure 2 It is shown that the plurality of support members 19 may include one or more curved portions that are shaped such that they define a "recess" 21 extending distally into the expandable frame 12. Figure 2 As shown, the recess 21 may extend circumferentially around the longitudinal axis 52. In addition, Figure 2 It is shown that each of the plurality of support members 19 can be attached to the central hub 23. It will be appreciated that the central hub 23 can be aligned along the longitudinal axis 52 of the expandable frame 12. As will be described in more detail below, Figure 2 It is shown that the hub 23 may be positioned such that it is located within the recess 21 defined by the plurality of support members 19 .

[0073] Figure 2 It is further shown that the expandable frame 12 may include one or more fixation members 16 disposed about the perimeter of the expandable frame 12. As will be discussed in more detail below, each of the fixation members 16 may be secured to the expandable frame 12 such that a portion of each of the fixation members 16 may extend radially outward from an outer surface of the expandable frame 12. Some suitable but non-limiting examples of materials for the expandable frame 12 and / or the fixation members 16 are discussed below.

[0074] in addition, Figure 2 It is shown that one or more of the fixing members 16 can be offset by approximately 180 degrees from one or more adjacent fixing members 16. In other words, some fixing members 16 can be aligned so that they point from the proximal end region 11 to the distal end region 13, while other fixing members can be positioned so that they point from the distal end region 13 to the proximal end region 11. In addition, Figure 2Rather, it is contemplated that one or more of the fixation members 16 may be aligned along the expandable frame 12 in a variety of different orientations.

[0075] Although Figure 2 It is shown that the expandable frame 12 can be formed as a braided structure, but this is not meant to be restrictive. On the contrary, it is contemplated that the expandable member 12 may include various different structures that can be formed by various manufacturing techniques. For example, some example closed implants can be formed as a whole and / or cut from a single member. For example, in some embodiments, the expandable frame 12 can be formed as a whole and / or cut from a single tubular member, and then formed and / or heat-set to the desired shape in the expanded structure. Some exemplary ways and / or methods of manufacturing and / or forming the expandable frame 12 include laser cutting, machining, punching, stamping, electrical discharge machining (EDM), chemical dissolution, etc. Other ways and / or methods are also considered.

[0076] The closure implant 10 may also include a first closure member 14 disposed on, above, around, or covering at least a portion of the expandable frame 12. In some embodiments, the first closure member 14 may be disposed on, above, around, or covering at least a portion of an outer (or outward-facing) surface of the expandable frame 12. Figure 2 It is further shown that the first closure member 14 can extend only partially along the longitudinal extent of the expandable frame 12. However, this is not meant to be limiting. Instead, the first closure member 14 can extend to any extent along the longitudinal extent of the expandable frame 12 (e.g., the entire longitudinal extent of the expandable frame 12).

[0077] In some embodiments, the first closure member 14 may be permeable or impermeable to blood and / or other fluids, such as water. In some embodiments, the first closure member 14 may include a woven, braided and / or knitted material, a fiber, a sheet material, a fabric, a polymer film, a metal mesh or a polymer mesh, a porous filter-like material, or other suitable structure. In some embodiments, the first closure member 14 may prevent thrombi (i.e., blood clots, etc.) from passing through the first closure member 14 and leaving the left atrial appendage into the blood stream. In some embodiments, the first closure member 14 may promote endothelialization after implantation, thereby effectively removing the left atrial appendage from the patient's circulatory system. Some suitable but non-limiting examples of materials for the first closure member 14 will be discussed below.

[0078] Figure 3 An example fixing member 16 is shown. The example fixing member 16 may include an engagement portion 31 positioned on a first end of the fixing member 16 and an anchoring portion 33 positioned on a second end of the fixing member 16. Figure 3 As shown, the second end of the fixing member 16 can be positioned opposite to the first end of the fixing member 16. In addition, the fixing member 16 can include an intermediate portion 35 extending between the engagement portion 31 and the anchor portion 33. In other words, the intermediate portion 35 can span between the engagement portion 31 and the anchor portion 33.

[0079] Figure 3 It is further shown that the engagement portion 31 of the fixing member 16 may include a first engagement member 37 and a second engagement member 39. Each of the first engagement member 37 and the second engagement member 39 may be formed as an integral structure with the intermediate portion 35. Figure 3 It is understood that each of the first engagement member 37 and the second engagement member 39 can deviate from the middle portion 35. For example, in some cases, the combination of the first engagement member 37, the second engagement member 39 and the middle portion 35 can be similar to the shape of an "arrow". However, this is not meant to be restrictive. On the contrary, the first engagement member 37 and the second engagement member 39 can be positioned at various angles, deviations, etc. relative to the middle portion 35.

[0080] also, Figure 3 As shown, in some examples, the first engagement member 37 and / or the second engagement member 39 can cooperate with the intermediate portion 35 to releasably secure (e.g., couple, attach, secure, etc.) the fixation member 16 to the expandable frame 12. Figure 3 As shown, the first engagement member 37 and the second engagement member 39 can be positioned so that they extend along the outer surface of the expandable frame 12, and the middle portion 35 can be positioned so that it extends along the inner surface of the expandable frame 12 (note that the portion of the middle portion 35 extending along the inner surface of the expandable frame 12 is represented by Figure 3 In particular, Figure 3 It is shown that the first engagement member 37 can extend along the first filament 25 (e.g., the first engagement member 37 can be positioned on the outer surface of the first filament 25), and the second engagement member 39 can extend along the second filament 27 (e.g., the second engagement member 39 can be positioned on the outer surface of the second filament 27). In addition, Figure 3It is shown that the first filament 25 and the second filament 27 can cross each other at the intersection 45, whereby the middle portion 35 can extend along the inner surface of the intersection of the first filament 25 and the second filament 27. Therefore, it can be understood that positioning the first engagement member 37 and the second engagement member 39 on the outer surface of the expandable member 12 and positioning the middle portion 35 along the inner surface of the expandable member 12 can allow the first filament 25 and the second filament 27 to be fixed (e.g., attached, squeezed, clamped, etc.) between the first engagement member 37, the second engagement member 39 and the middle portion 35.

[0081] It will also be appreciated that the above-described design of the engagement portion 31 for positioning the expandable frame 12 between the first engagement member 37, the second engagement member 39, and the intermediate portion 35 of the fixation member 16 may allow the fixation member 16 to be manufactured as a separate component that may be releasably secured to the expandable member 12. For example, the fixation member 16 may be manufactured separately from the expandable frame 12, whereby the fixation member 16 may be subsequently secured to the expandable frame 12. This manufacturing technique may be advantageous because it may increase the manufacturing efficiency of the closure device 10. For example, designing the closure device 10 to include a separately attached fixation member 16 may allow for tighter manufacturing control of the fixation member 16.

[0082] Figure 3 It is further shown that the anchoring portion 33 of the fixing member 16 can include a first protrusion 41 and a second protrusion 43 positioned along the second end of the fixing member 16, opposite to the first engagement portion 31. As will be discussed in more detail below, each of the first protrusion 41 and the second protrusion 43 can extend away from the outer surface of the expandable member 12. It can be understood that each of the first protrusion 41 and the second protrusion 43 can be designed to engage tissue at a target location. In other words, the first protrusion 41 and the second protrusion 43 can be designed to pierce the tissue of the target site, thereby fixing the position of the closure device adjacent to the target site (e.g., the left atrial appendage).

[0083] Figure 4 Refer to the above Figure 2 and Figure 3 A perspective view of the fixing member 16 discussed. As mentioned above, Figure 4 It is shown that the fixing member 16 may include a first engaging portion 31 including a first engaging member 37 and a second engaging member 39. In addition, Figure 4 It is shown that the fixing member 16 may include an anchoring portion 33 including a first protrusion 41 and a second protrusion 43. In addition, Figure 4 An intermediate portion 35 extending between the engagement portion 31 and the anchoring portion 33 is shown.

[0084] If you will refer to Figure 5As shown in more detail, the first protrusion 41 and / or the second protrusion 43 may include a curved portion that causes the distal ends of the first protrusion 41 and the second protrusion 43 to extend outward from the middle portion 35 of the fixing member 16. For example, Figure 4 A first protrusion 41 and a second protrusion 43 extending outward from the plane of the paper are shown. Figure 4 It is shown that the first protrusion 41 can be separated from the second protrusion 43. In other words, Figure 4 It is shown that the first protrusion 41 and the second protrusion 43 may be separated from each other by an angle “θ”.

[0085] Figure 5 1 shows a side view of the fixing member 16. Specifically, Figure 5 It is shown that each of the first protrusion 41 and the second protrusion 43 can include an arcuate portion 47. As described above, the arcuate portion 47 can be configured to extend the distal end of each of the first protrusion 41 and the second protrusion 43 away from the medical portion 35 by a distance "X". In addition, it can be understood that the arcuate portion 47 can be configured to pierce and embed into the tissue of the target site (e.g., the left atrial appendage).

[0086] Figure 5A Shows Figure 5 Another example of a fixing member 16 is shown in FIG. 1 , whereby the distal ends of the first protrusion 41 and the second protrusion 43 are connected to form an atraumatic protrusion 44. Figure 5A As shown, the distal end of the first protrusion 41, the distal end of the second protrusion 43, or the distal ends of the first protrusion 41 and the second protrusion 43 can extend in a curved manner to form a continuous, curved atraumatic distal end 44. It can be appreciated that the atraumatic distal end 44 can allow the fixation member 16 to provide mechanical fixation by engaging the target tissue without piercing the tissue.

[0087] Figure 6 Another example fixing member 116 is shown. The fixing member 116 can be similar in form and function to other example fixing members described herein. For example, the example fixing member 116 can include an engagement portion 131 positioned on a first end of the fixing member 116 and an anchoring portion 133 positioned on a second end of the fixing member 116. The second end of the fixing member 116 can be positioned opposite the first end of the fixing member 116. In addition, the fixing member 116 can include an intermediate portion 135 that can extend between the engagement portion 131 and the anchoring portion 133.

[0088] Figure 6It is further shown that the engagement portion 131 of the fixing member 116 may include a first engagement member 137 and a second engagement member 139. Each of the first engagement member 137 and the second engagement member 139 may be formed as an integral structure with the intermediate portion 135. Figure 6 It is understood that each of the first engagement member 137 and the second engagement member 139 can be angularly offset from the intermediate portion 135. However, it is contemplated that the first engagement member 137 and the second engagement member 139 can be positioned at various angles, offsets, etc. relative to the intermediate portion 135.

[0089] Similar to the above Figure 3 Said, Figure 6 It is further shown that the first engaging member 137 can extend along the first filament 25 (e.g., the first engaging member 137 can be positioned on the outer surface of the first filament 25), and the second engaging member 139 can extend along the second filament 27 (e.g., the second engaging member 39 can be positioned on the outer surface of the second filament 27). In addition, Figure 6 The first filament 25 and the second filament 27 can cross each other at the intersection 45, whereby the middle portion 135 can extend along the inner surface of the first filament 25 and the second filament 27 (note that the portion of the middle portion 35 extending along the inner surface of the expandable frame 12 is Figure 6 ).

[0090] As mentioned above, Figure 6 It is further shown that the anchoring portion 133 of the fixing member 116 can include a first protrusion 141 and a second protrusion 143 positioned along the second end of the fixing member 116 relative to the first end of the fixing member 116. As will be discussed in more detail below, each of the first protrusion 141 and the second protrusion 143 can extend away from the outer surface of the expandable member 112. It can be understood that each of the first protrusion 141 and the second protrusion 143 can be designed to engage tissue at a target location. In other words, the first protrusion 141 and the second protrusion 143 can be designed to penetrate into the tissue at the target site, thereby fixing the position of the closure device adjacent to the target site (e.g., the left atrial appendage).

[0091] Figure 6 The example fixing member 116 is further shown to include a second engaging portion 147. The second engaging portion 147 can be located adjacent to the first engaging portion 131. In addition, the second engaging portion can include a third engaging member 149 and a fourth engaging member 151. Each of the third engaging member 149 and the fourth engaging member 151 can be formed as an integral structure with the intermediate portion 135. In addition, from Figure 6It will be appreciated that each of the third engagement member 149 and the fourth engagement member 151 may be offset from the intermediate portion 135. Figure 6 It is shown that the third and fourth engagement members 149, 151 can be positioned such that they are angled substantially toward the first and second engagement members 137, 139. However, it is contemplated that the third and fourth engagement members 149, 151 can be oriented at various angles, offsets, etc. relative to the intermediate portion 135 and / or the first and second engagement members 137, 139.

[0092] in addition, Figure 6 It is further shown that the third engaging member 149 can extend along the second filament 27 (e.g., the third engaging member 149 can be positioned on the outer surface of the second filament 27), and the fourth engaging member 151 can extend along the first filament 25 (e.g., the fourth engaging member 151 can be positioned on the outer surface of the first filament 25). In addition, Figure 6 It is shown that the first filament 25 and the second filament 27 can cross each other at the intersection point 45, whereby the intermediate portion 135 can extend along the inner surfaces of the first filament 25 and the second filament 27.

[0093] Similar to the above, the second engagement portion 147 can cooperate with the first engagement portion 131 to secure the fixation member 116 to the expandable frame 12. In particular, the third engagement member 149 and the fourth engagement member 151 can cooperate with the middle portion 135 of the fixation member 116 to secure (e.g., connect, attach, secure, etc.) the fixation member 116 to the expandable frame 12. Figure 6 As shown, the third engagement member 149 and the fourth engagement member 151 can be positioned so that they extend along the outer surface of the first filament 25 and the second filament 27, while the middle portion 135 can be positioned so that it extends along the inner surface of the expandable frame 12. Therefore, it can be understood that positioning the third engagement member 149 and the fourth engagement member 151 on the outer surface of the expandable member 12 and positioning the middle portion 135 along the inner surface of the expandable member 12 can allow the first filament 25 and the second filament 27 to be positioned (e.g., attached, squeezed, clamped, etc.) between the first engagement member 137, the second engagement member 139, the third engagement member 149, the fourth engagement member 151 and the middle portion 35.

[0094] Figure 7 Refer to the above Figure 6 A perspective view of the fixing member 116 discussed above. Figure 7 It is shown that the fixing member 116 can include a first engagement portion 131 including a first engagement member 137 and a second engagement member 139 . Figure 7It is further shown that the fixing member 116 may include a second engaging portion 147, which includes a third engaging member 149 and a fourth engaging member 151. In addition, Figure 7 It is shown that the fixing member 116 may include an anchoring portion 133, which includes a first protrusion 141 and a second protrusion 143. In addition, Figure 7 An intermediate portion 135 extending between the first engagement portion 131 , the second engagement portion 149 and the anchor portion 133 is shown.

[0095] Similar to reference Figure 4 As discussed above with respect to the fixing member 16 shown, the first protrusion 141 and / or the second protrusion 143 may include a curved portion that causes the distal ends of the first protrusion 141 and the second protrusion 143 to extend outwardly from the intermediate portion 135 of the fixing member 116. For example, Figure 7 A first protrusion 141 and a second protrusion 143 extending outward from the plane of the paper are shown. Figure 7 It is shown that the first protrusion 141 can be separated from the second protrusion 143. In other words, Figure 7 It is shown that the first protrusion 141 and the second protrusion 143 may be separated from each other by an angle “θ”.

[0096] Figure 8 Another example fixing member 216 is shown. The fixing member 216 can be similar in form and function to other example fixing members described herein. Figure 8 As shown, the fixing member 216 can include a first engagement member 237, a second engagement member 239, a third engagement member 241 and a fourth engagement member 243. The first engagement member 237, the second engagement member 239, the third engagement member 241 and the fourth engagement member 243 can all be positioned adjacent to the main body portion 235 of the fixing member 216 and / or be coupled to the main body portion 235 of the fixing member 216. Similar to other fixing members disclosed herein, the first engagement member 237, the second engagement member 239, the third engagement member 241 and / or the fourth engagement member 243 can be designed so that they engage one or more structural members (e.g., one or more filaments) of the expandable member of the closure device. For example, the first engagement member 237, the second engagement member 239, the third engagement member 241 and the fourth engagement member 243 can be designed to interlace with one or more filaments of the expandable member of the closure device, whereby the interlacing with the filaments can releasably couple the fixing member 216 to the closure device.

[0097] Figure 8It is further shown that the fixation member 216 can include an anchor portion 233 extending away from the body portion 235. The anchor portion 233 can include a projection 240 (e.g., a barb, etc.) that can be designed to penetrate into tissue at a target site, thereby fixing the position of the closure device adjacent to the target site (e.g., the left atrial appendage).

[0098] Fig. 9 216 is a side view of the fixing member 216. Fig. 9 As shown, in some examples, the main body portion 235 of the fixing device 216 can be relative to the first engaging member 237, the second engaging member 239 (which is hidden by the first engaging member 237 and thus in Fig. 9 ), the third joining member 241 and / or the fourth joining member 243 (hidden by the first third member 241 and thus in Fig. 9 The distal end region of the spherical portion (not visible in FIG. 1 ) extends radially outward. For example, Fig. 9 A dashed line 254 is shown which may represent the outer surface of the expandable member of the closure device.

[0099] also, Fig. 9 The first engaging member 237 and the second engaging member 239 (hidden by the first engaging member 237 and thus Fig. 9 ), the third joining member 241 and / or the fourth joining member 243 (hidden by the third joining member 241 and thus not visible in Fig. 9 The distal end region of the main body portion 235 (not visible in the figure) can extend inwardly from the outer surface of the expandable member (e.g., represented by dashed line 254), and thus the main body portion 235 can extend radially away from the outer surface 254 of the expandable member by a distance "Y". It can be appreciated that extending the main body portion 235 away from the outer surface 254 of the expandable member can position the protrusion 240 of the anchoring portion 233 closer to the target tissue of the left atrial appendage.

[0100] Fig.10 Another example fixing member 316 is shown. The fixing member 316 can be similar in form and function to other fixing members described herein. For example, the fixing member 316 can include an engagement portion 331, which includes a first engagement member 337 and a second engagement member 339, whereby the first engagement member 337 and the second engagement member 339 can be used to releasably couple the fixing member 316 to one or more structural members (e.g., filaments) of the closure device.

[0101] in addition, Fig.10The fixing member 316 is shown to include an anchoring portion 333 and an intermediate portion 335 extending between the engagement member 331 and the anchoring portion 333. In addition, the anchoring portion 333 may include a projection 341 (e.g., a barb, etc.) that may be designed to penetrate into tissue at a target site, thereby fixing the position of the closure device adjacent to the target site (e.g., left atrial appendage). Further, the projection 341 may be coupled to the base member 354 and / or extend away from the base member 354. The base member 354 may include one or more bosses 350 extending along the distal end of the base member 354.

[0102] Fig.10 It is further shown that the protrusion 341 can extend a distance "Z" away from the boss 350 extending along the distal end of the base member 354. It can be appreciated that the boss 350 can be designed to prevent the protrusion 341 from extending into the target tissue of the target site beyond the distance "Z". For example, the protrusion 341 can be advanced into the target tissue until the boss 350 contacts the target tissue, thereby preventing the protrusion 341 from being further advanced into the target tissue. In other words, the boss 350 can act as a limit stop to prevent the protrusion 341 from extending into the target tissue beyond the distance "Z".

[0103] Fig.11 Another example fixation member 416 is shown. The fixation member 416 may include a tubular support member 456. The tubular support member 456 may include a slit 460 extending along the length of the support member 456. It will be appreciated that the slit 460 may allow the support member 456 to wrap around a portion of the expandable frame of the closure device. For example, Fig.11 A support member 456 is shown releasably wrapping a portion of an example filament 425 of an expandable frame of a closure device. Similar to other fixation members described herein, the design of fixation member 416 can allow it to be fixed to a closure device as an additional manufacturing step distinct from the manufacture of the closure device.

[0104] Fig.11 It is further shown that the fixation member 416 can be designed to include one or more protrusions 458 extending away from the outer surface of the support member 456. Each protrusion can include a hook, barb, etc., which can be designed to penetrate into tissue at the target site, thereby fixing the closure device (to which the fixation member 416 can be attached) adjacent to the target site (e.g., the left atrial appendage).

[0105] Fig.12 Another example fixing member 516 is shown. The fixing member 516 may include a tubular support member 556. The tubular support member 556 may include a slit 560 extending along the length of the support member 556. Similar to the above reference Fig.11As described above, it can be appreciated that the slit 560 can allow the support member 556 to wrap around a portion of the expandable frame, thereby releasably coupling the fixation member 516 to the closure device. Similar to the other fixation members described herein, the design of the fixation member 516 can allow it to be coupled to the closure device as an additional manufacturing step other than the manufacture of the closure device.

[0106] Fig.12 It is further shown that the fixation member 516 can be designed to include one or more protrusions 558 extending away from the outer surface of the support member 556. Each of the protrusions can include an arc portion extending outward from the surface of the support member 556. The protrusions 558 can be designed to penetrate and / or clamp tissue at the target site, thereby fixing the closure device (to which the fixation member 516 can be attached) adjacent to the target site (e.g., the left atrial appendage).

[0107] Fig.13 Another example fixing member 616 is shown. The fixing member 616 may include a tubular support member 656. The tubular support member 656 may include a slit 660 extending along the length of the support member 656. Similar to the above reference Figure 11-12 As described above, it can be appreciated that the slit 660 can allow the support member 656 to wrap around a portion of the expandable frame, thereby releasably coupling the fixation member 616 to the closure device. Similar to the other fixation members described herein, the design of the fixation member 616 can allow it to be coupled to the closure device as an additional manufacturing step other than the manufacture of the closure device.

[0108] Fig.13 It is further shown that the fixing member 616 can be designed to include a wire member 662 positioned within the wall of the support member 656. The wire member 662 can extend along the entire length of the support member 656 (or, alternatively, only along a portion of the support member). In addition, in some examples, a portion of the wire member 662 can extend radially outward through the wall and away from the outer surface of the support member 656. Fig.13 As shown, the portion of the wire 662 extending away from the outer surface of the support member 656 may include hooks, barbs, etc. 658, which may be designed to penetrate into tissue at a target site, thereby securing the closure device (to which the fixing member 616 is attached) to the target site (e.g., the left atrial appendage).

[0109] Fig.14 Another example fixing member 716 is shown. Fig.14 As shown, the fixing member 716 can be designed so that it can be fixed to two structural members of the closure device. It is understood that Fig.14 The first filament 725 and the second filament 727 shown in the figure can represent two different filaments of the expandable member of the closure device. In other words, Fig.14 The fixation member 716 shown in FIG. 7 may be designed such that it spans (eg, extends between) two different filaments of the example closure device.

[0110] Fig.14 It is further shown that the fixing member 716 may include a base portion 756 having a first lateral side 760 fixed to the first filament 725 and a second lateral side 761 fixed to the second filament 727. Fig.14 As shown, each of the first lateral side 760 and the second lateral side 761 can include a curved portion designed to wrap around each of the first filament 725 and / or the second filament 727, respectively (e.g., curl, snap, attach, press fit, etc.).

[0111] in addition, Fig.14 It is shown that the base portion 756 can extend a length "L" along the first filament 725 and the second filament 727. In some examples, the base portion can include a flat sheet of material, a foil, etc. Note that although Fig.14 The shape of the base portion 756 is shown to be generally rectangular, but other shapes are also contemplated. For example, the base portion 756 may include a square, triangular, polygonal, circular, oval or other similarly shaped portion. In addition, the base portion 756 may be designed to include any necessary shape to fit within the space defined by the one or more filaments used to form the expandable member.

[0112] in addition, Fig.14 The securing member 716 is shown to include a protrusion 758 extending along the length "L" of the base portion 756. The protrusion 758 can be designed to engage tissue at the target site, thereby securing the closure device to the target site (e.g., the left atrial appendage). Fig.14 The projection 758 is shown as comprising a sharp point, but other shapes are also contemplated. For example, the projection may comprise an arc, a plurality of projections, a barb, a hook, a curve, etc.

[0113] In some cases, it may be desirable to design the fixing member 716 to switch from a first retracted configuration to an extended configuration. For example, it may be desirable to design the fixing member 716 to switch from a retracted configuration when the expandable member is in a collapsed configuration to an extended configuration when the expandable member is in an expanded configuration. This design feature may be beneficial because it may allow the closure device to collapse with a reduced profile for delivery via a delivery system, yet will also allow the protrusion 758 to anchor the closure device to the target tissue when the closure device is deployed (e.g., expanded).

[0114] Fig.15 and Fig.16The fixture 716 is shown transitioning from a retracted configuration to an extended configuration. For simplicity, it will be appreciated that Fig.15 can represent a portion of a closure device in a collapsed configuration, whereby the securing member 716 is retracted radially inwardly and Fig.16 The closure device can be shown in an expanded configuration, whereby the fixing member 716 extends radially outward. It can also be understood that the first filament 725 and the second filament 727 are in a retracted (e.g., collapsed) configuration (e.g., Fig.15 ) can be separated by a distance "W1", and the first filament 725 and the second filament 727 are in an extended (e.g., expanded) configuration (e.g., Fig.16 As shown in FIG. 1 , the distance W1 may be smaller than the distance W2. In addition, Fig.15 and Fig.16 It is shown that when the fixation member 756 is expanded from the collapsed configuration to the expanded configuration, the protrusion 758 can be transformed from a radially inward orientation (e.g., pointing away from the target tissue) to a radially outward orientation (e.g., pointing toward the target tissue). As described above, when the protrusion is oriented radially outward, it can be positioned to engage the target tissue.

[0115] The material of various components (and its modification, system or parts disclosed herein) and its various elements disclosed herein that can be used for closing implant 10 can include the material that is usually associated with medical device. For simplicity, the following discussion is with reference to closing implant 10 (and modification, system or parts disclosed herein). However, this is not intended to limit the device and method described herein, because this discussion can be applied to other elements, members, parts or devices disclosed herein.

[0116] In some embodiments, the closure implant 10 (and variations, systems, or components thereof disclosed herein) can 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. Some examples of suitable metals and metal alloys include stainless steels, such as 444V, 444L, and 314LV stainless steels; mild steels; nickel-titanium alloys, such as linear elastic and / or superelastic nitinol; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, e.g., 625, UNS: N06022 UNS: N10276 other Alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, etc. 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, etc.) etc.), nickel-molybdenum alloys (e.g., UNS: N10665, etc.) ALLOY ), 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: R44003 such as etc.); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof; etc.; or any other suitable material.

[0117] As suggested herein, within the family of commercially available nickel-titanium or nitinol alloys, there is a class referred to as "linear elastic" or "non-superelastic" that, while chemically similar to conventional shape memory and superelastic species, may exhibit distinct and useful mechanical properties. Linear elastic and / or non-superelastic nitinol may be distinguished 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 does superelastic nitinol. 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 relationship that is somewhat, but not necessarily completely, linear until plastic deformation begins, or at least in a more linear relationship than the superelastic plateau and / or marked region that may be seen with superelastic nitinol. Therefore, for 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.

[0118] In some cases, linear elastic and / or non-superelastic Nitinol can also be distinguished from superelastic Nitinol in that linear elastic and / or non-superelastic Nitinol can accept strains up to about 2-5% while remaining substantially elastic (e.g., before plastic deformation), whereas 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 (also distinguishable by their composition) stainless steel, which can only accept strains of about 0.2% to 0.44% before plastic deformation.

[0119] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy is an alloy that does not show any detectable martensite / austenite phase transformations over a wide temperature range by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) analysis. For example, in some embodiments, in a linear elastic and / or non-superelastic nickel-titanium alloy, there may be no detectable martensite / austenite phase transformations by DSC and DMTA analysis within a range of about -60 degrees Celsius (°C) to about 120°C. Therefore, the mechanical bending properties of such materials are generally ineffective over this very wide temperature range to the effect of temperature. 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 marking 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 characteristics and / or properties.

[0120] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may be about 50% by weight to about 60% by weight nickel, with the remainder being substantially titanium. In some embodiments, the composition is in the range of about 54% to about 57% by weight nickel. An example of a suitable nickel-titanium alloy is the FHP-NT alloy commercially available from Furukawa Techno Material Co. of Kanagawa, Japan. Other suitable materials may include ULTANIUM TM (available from Neo-Metrics) and GUMMETAL TM (Available from Toyota.) In some other embodiments, superelastic alloys, such as superelastic Nitinol, may be used to achieve the desired properties.

[0121] In at least some embodiments, part or all of the closure implant 10 (and its variants, systems or components disclosed herein) may also be doped with, made of or additionally include radiopaque materials. Radiopaque materials are understood to be materials that can produce relatively bright images on a fluoroscopic screen or other imaging techniques during medical procedures. This relatively bright image helps the user determine the position of the closure implant 10 (and its variants, systems or components disclosed herein). Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials loaded with radiopaque fillers, etc. In addition, other radiopaque marker bands and / or coils may also be incorporated into the design of the closure implant 10 (and its variants, systems or components disclosed herein) to achieve the same result.

[0122] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the closure implant 10 (and variations, systems, or components thereof disclosed herein). For example, the closure implant 10 (and variations, systems, or components thereof disclosed herein) and / or components or portions thereof may be made of materials that do not significantly distort images and produce significant artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may produce artifacts in MRI images. The closure implant 10 (and variations, systems, or components thereof disclosed herein) or portions thereof may also be made of materials that can be imaged by MRI machines. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, etc.), etc.), Nitinol, etc., and others.

[0123] In some embodiments, the closure implant 10 (and variations, systems, or components thereof disclosed herein) and / or portions thereof can be made of or include a polymer or other suitable material. Some examples of suitable polymers can include copolymers, polyisobutylene-polyurethane, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., available from DuPont), polyoxymethylene (POM ... ), 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 / ethers, polyether block amides (PEBA, for example, sold under the trade name Available), ethylene vinyl acetate copolymer (EVA), silicone, 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 paraphenylene terephthalamide (e.g. ), polysulfone, nylon, nylon-12 (e.g. available from EMS American Grilon ), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomers, polyurethane silicone copolymers (e.g., Aortech Biomaterials or AdvanSource Biomaterials ), biocompatible polymers, other suitable materials or mixtures, combinations, copolymers, polymer / metal composites, etc. In some embodiments, the sheath can be mixed with a liquid crystal polymer. For example, the mixture can contain up to about 6% LCP.

[0124] In certain embodiments, closed implant 10 (and its variant, system or parts disclosed herein) can include textile material.Some examples of suitable textile material can include synthetic yarn, which can be flat, shaped, twisted, textured, pre-shrinked or unshrinked.Synthetic biocompatible yarn suitable for use in the present disclosure includes but is not limited to polyester, including polyethylene terephthalate (PET) polyester, polypropylene, polyethylene, polyurethane, polyolefin, polyvinyl chloride, polymethyl acetate, polyamide, naphthalene dicarboxyl xylene derivatives, natural silk and polytetrafluoroethylene.In addition, at least one of the synthetic yarn can be metal yarn or glass or ceramic yarn or fiber.Useful metal yarn includes yarn made of stainless steel, platinum, gold, titanium, tantalum or nickel-cobalt-chromium alloy or containing stainless steel, platinum, gold, titanium, tantalum or nickel-cobalt-chromium alloy.Yarn can further include carbon, glass or ceramic fiber.Ideally, yarn is made of thermoplastic material, including but not limited to polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene etc. The yarns may be of the multifilament, monofilament or spun type. The type and denier of the selected yarn may be selected in such a way as to form a biocompatible and implantable prosthesis, more specifically a vascular structure, having the desired properties.

[0125] In some embodiments, the closure implant 10 (and variations, systems, or components thereof disclosed herein) may include and / or be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents may include antithrombotic agents (e.g., heparin, heparin derivatives, urokinase, and PPack (dextrorotatory phenylalanine proline arginine chloromethyl ketone)); antiproliferative agents (e.g., enoxaparin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (e.g., dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalazine); anti-tumor / antiproliferative / anti-mitotic agents (e.g., paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (e.g., lidocaine, bupivacaine, and ropivacaine); anticoagulants (e.g., 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 inhibitors, translation inhibitors, 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 intrinsic vasoactive mechanisms.

[0126] Although the above discussion is generally directed to closure implants for use in the left atrial appendage of the heart, the above features may also be used in other types of medical implants in which a fabric or membrane is attached to a frame or support structure, including but not limited to implants for treating aneurysms (e.g., abdominal aortic aneurysms, thoracic aortic aneurysms, etc.), replacement valve implants (e.g., replacement heart valve implants, replacement aortic valve implants, replacement mitral valve implants, replacement vascular valve implants, etc.), and / or other types of closure devices (e.g., atrial septal occluders, cerebral aneurysm occluders, peripheral artery occluders, etc.). Other useful applications of the disclosed features are also contemplated.

[0127] It should be understood that the present disclosure is in many respects illustrative only. Without exceeding the scope of the present disclosure, changes may be made in detail, particularly in shape, size and step arrangement. To the extent appropriate, this may include using any features of an example embodiment used in other embodiments. Of course, the scope of the present disclosure is limited by the language expressed by the appended claims.

Claims

1. A closed implant, comprising: an expandable frame configured to transition between a first configuration and an expanded configuration; as well as a fixation member disposed along the expandable frame, wherein the fixation member comprises a first engagement portion and an anchoring portion, wherein the first engagement portion is configured to be fixed to the expandable frame; wherein the anchoring portion extends away from an outer surface of the expandable frame, wherein the fixing member includes a first end, a second end opposite the first end, and an intermediate portion extending between the first end and the second end, and wherein the first engagement portion is located along the first end of the fixing member, and wherein the anchor portion is located along the second end of the fixing member, wherein the first engagement portion comprises a first engagement member and a second engagement member, wherein the first engagement member and the second engagement member are both offset from the middle portion, wherein the fixing member is arranged along the expandable frame such that at least a portion of the first engaging member and at least a portion of the second engaging member are positioned along an outer surface of the expandable frame and at least a portion of the intermediate portion is positioned along an inner surface of the expandable frame, Wherein the anchoring portion includes a first protrusion and a second protrusion, the second protrusion is offset from the first protrusion, and wherein each of the first protrusion and the second protrusion includes an arc portion.

2. The closure implant according to claim 1, wherein: The first engagement portion is removably secured to the expandable frame.

3. The closure implant according to claim 1, wherein: The first engagement portion is designed to be rigidly secured to the expandable frame.

4. The closure implant according to claim 1, wherein: At least a portion of the expandable frame is positioned between the first engagement member and the intermediate portion, and wherein at least a portion of the expandable frame is positioned between the second engagement member and the intermediate portion.

5. The closure implant according to claim 1, wherein: The expandable frame includes first filaments interwoven with second filaments, and wherein the first filaments cross the second filaments at a crossover point, and wherein the fixation member is positioned adjacent the crossover point.

6. The closure implant according to claim 5, wherein: The first filament is positioned between the first engagement member and the intermediate portion, and wherein the second filament is positioned between the second engagement member and the intermediate portion.

7. The closure implant according to any one of claims 1 to 6, wherein: The securing member further includes a second engagement portion positioned adjacent to the first engagement portion, and wherein the second engagement portion includes a third engagement member and a fourth engagement member.

8. The closure implant according to claim 7, wherein: The fixation member is disposed along the expandable frame such that at least a portion of the third engagement member and at least a portion of the fourth engagement member are positioned along an outer surface of the expandable frame and at least a portion of the intermediate portion is positioned along an inner surface of the expandable frame.

9. The closure implant according to claim 8, wherein: At least one of the first engagement member, the second engagement member, the third engagement member, and the fourth engagement member is interleaved with at least a portion of the expandable frame.

10. A method of manufacturing a closure device in a left atrial appendage, the method comprising: securing a fixation member to the expandable frame, wherein the fixation member comprises a first engagement portion, an intermediate portion, and an anchoring portion, and wherein the expandable frame is configured to transition between a first configuration and an expanded configuration; wherein the anchoring portion extends away from an outer surface of the expandable frame, wherein the fixing member includes a first end, a second end opposite the first end, and an intermediate portion extending between the first end and the second end, and wherein the first engagement portion is located along the first end of the fixing member, and wherein the anchor portion is located along the second end of the fixing member, wherein the first engagement portion comprises a first engagement member and a second engagement member, wherein the first engagement member and the second engagement member are both offset from the middle portion, wherein the fixing member is arranged along the expandable frame such that at least a portion of the first engaging member and at least a portion of the second engaging member are positioned along an outer surface of the expandable frame and at least a portion of the intermediate portion is positioned along an inner surface of the expandable frame, Wherein the anchoring portion includes a first protrusion and a second protrusion, the second protrusion is offset from the first protrusion, and wherein each of the first protrusion and the second protrusion includes an arc portion.

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