Left atrial appendage implant with sealed pocket

Abstract

An implant (800) for occluding a left atrial appendage (13) may include: an expandable frame (160, 805) configured to transition between a collapsed configuration and an expanded configuration; an occluding element disposed on the expandable frame; and a sealing member (40, 802) proximally spaced from the expandable frame by a gap distance (195). A system for occluding a left atrial appendage (13) may further include a delivery sheath and a core wire releasably secured to the implant (800). A method for occluding a left atrial appendage (13) may include: advancing an implant (800) into a left atrial appendage (13); deploying the expandable frame (160, 805) within the left atrial appendage (13); converting the expandable frame (160, 805) into an expanded configuration within the left atrial appendage (13); and deploying the sealing member (40, 802) near the opening of the left atrial appendage (13).

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Application Serial No. 62 / 777,495, filed on December 10, 2018, 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 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 function, 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 formation of unwanted blood clots within the left atrial appendage.

[0005] The occurrence of thrombus in the left atrial appendage during atrial fibrillation may be due to stagnation of blood pool in the left atrial appendage. Blood may still be pumped out of the left atrium by the left ventricle, however, its effect is less effective due to the irregular contraction of the left atrium caused by atrial fibrillation. Therefore, the filling of the left ventricle may depend primarily or only on the suction effect generated by the left ventricle, rather than actively supporting blood flow through the contracting left atrium and left atrial appendage. In addition, the contraction of the left atrial appendage may be asynchronous 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 produce significant resistance to the desired blood flow. In addition, the geometry of most left atrial appendages is complex, with large irregular surface areas and narrow mouths or openings 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 of blood out of the left atrial appendage and / or the formation of thrombus in the left atrial appendage.

[0006] Thrombi formed in the left atrial appendage may break away from the area and enter the bloodstream. Thrombi that migrate through blood vessels may eventually block smaller blood vessels downstream, leading to a stroke or heart attack. Clinical studies have shown that most blood clots in patients with atrial fibrillation originate from the left atrial appendage. As a treatment, medical devices that are deployed to close the left atrial appendage have been developed. Over time, the exposed surface of the implant across the left atrial appendage can be covered with tissue (a process called endothelialization), effectively removing the left atrial appendage from the circulatory system and reducing or eliminating the amount of thrombus that may enter the bloodstream from the left atrial appendage. Among the known medical devices and methods, each has certain advantages and disadvantages. There has always been a need to provide alternative medical devices and introducers and alternative methods for making and using medical devices and introducers. Summary of the invention

[0007] In a first aspect, an implant for occluding a left atrial appendage can include an expandable frame configured to transition between a collapsed configuration and an expanded configuration, and a sealing member proximally spaced apart from the expandable frame by a gap distance.

[0008] Additionally or alternatively, and in a second aspect, the sealing member is connected to the expandable frame by a flexible coupling.

[0009] Additionally or alternatively, and in a third aspect, the flexible coupling is tubular.

[0010] Additionally or alternatively, and in a fourth aspect, the gap distance is variable.

[0011] Additionally or alternatively, and in the fifth aspect, the implant can further include a tapered member configured to vary the gap distance.

[0012] Additionally or alternatively, and in a sixth aspect, the implant can further include a thread adjustment configured to change the gap distance.

[0013] Additionally or alternatively, and in a seventh aspect, a threaded adjustment couples the sealing member to the expandable frame.

[0014] Additionally or alternatively, and in an eighth aspect, the sealing member comprises an expandable disc-shaped member.

[0015] Additionally or alternatively, and in a ninth aspect, the sealing member comprises an expandable annular member defining a central space.

[0016] Additionally or alternatively, and in the tenth aspect, the sealing member includes a first layer extending across the central space and a second layer extending across the central space.

[0017] Additionally or alternatively, and in the eleventh aspect, the first layer is spaced apart from the second layer.

[0018] Additionally or alternatively, and in the twelfth aspect, at least one of the first layer or the second layer comprises a plurality of reinforcing fibers.

[0019] Additionally or alternatively, and in a thirteenth aspect, a system for occluding a left atrial appendage may include: a delivery sheath having an inner lumen; an implant for occluding the left atrial appendage, the implant comprising an expandable frame and a sealing member, the expandable frame being configured to transition between a collapsed configuration and an expanded configuration, the sealing member being connected to the expandable frame by a flexible connector and spaced proximally from the expandable frame; and a core wire releasably secured to the implant.

[0020] Additionally or alternatively, and in the fourteenth aspect, the system can further include an inflation lumen in fluid communication with the sealing member.

[0021] Additionally or alternatively, and in the fifteenth aspect, the inflation lumen extends through the core wire.

[0022] Additionally or alternatively, and in a sixteenth aspect, a method for occluding a left atrial appendage may include:

[0023] The implant is advanced into the left atrial appendage and consists of:

[0024] an expandable frame configured to transition between a stowed configuration and an expanded configuration; and

[0025] a sealing member proximally spaced apart from the expandable frame by a gap distance;

[0026] deploying an expandable frame within the left atrial appendage;

[0027] converting the expandable frame to an expanded configuration within the left atrial appendage; and

[0028] A sealing member is deployed proximate the opening of the left atrial appendage.

[0029] Additionally or alternatively, and in the seventeenth aspect, the method may further include expanding at least a portion of the sealing member until the sealing member is capable of sealingly engaging the port.

[0030] Additionally or alternatively, and in the eighteenth aspect, the method may further include adjusting the gap distance to position the sealing member against or within the port.

[0031] Additionally or alternatively, and in a nineteenth aspect, the sealing member is oriented at an oblique angle to a central longitudinal axis of the expandable frame.

[0032] Additionally or alternatively, and in a twentieth aspect, the sealing member comprises a mesh configured to promote endothelialization.

[0033] 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

[0034] The present disclosure may be more fully understood considering the following detailed description of various embodiments in conjunction with the accompanying drawings, in which:

[0035] Figure 1 is a schematic partial cross-sectional view of the heart;

[0036] Figure 2 is a schematic partial cross-sectional view of an exemplary left atrial appendage;

[0037] Figure 3-Figure 5 Aspects of systems, implants, and / or methods for occluding a left atrial appendage are shown;

[0038] Figure 6-Figure 8 Aspects of an apparatus for adjusting a gap distance between an exemplary expandable frame and an exemplary sealing member are shown;

[0039] Fig. 9 Aspects of an alternative means for adjusting a gap distance between an exemplary expandable frame and an exemplary sealing member are shown;

[0040] Figure 10-11 yes Fig. 9 cross-sectional views of selected portions of;

[0041] Fig.12 Various aspects of alternative sealing members are shown;

[0042] Figure 13A-13C It is shown Fig.12 A cross-sectional view of an alternative configuration of a sealing member;

[0043] Figure 14-18 Aspects of systems, implants, and / or methods for occluding a left atrial appendage are shown; and

[0044] Fig.19 An exemplary implant of the present disclosure is shown deployed within a left atrial appendage having an irregular configuration.

[0045] Although various aspects of the present disclosure are applicable to various modifications and alternative forms, the details thereof have been shown in the drawings by way of example 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 substitutes that fall within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0046] 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 exemplary 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, these features and / or elements may be understood to exist in any case unless otherwise stated.

[0047] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0048] 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.

[0049] 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).

[0050] While some suitable sizes, ranges and / or values ​​are disclosed in relation 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.

[0051] 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 that have more than one, unless there is a clear statement to the contrary. In addition, for clarity, not all instances of some elements or features are shown in each figure.

[0052] Relevant terms such as "proximal," "distal," "advance," "retract," 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 "retract" meaning or referring closer to or toward the user, and "distal" and "advance" meaning or referring farther away from or away from the user. In some cases, to aid in understanding 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 within a lumen (such as a body cavity), a vessel, or a device.

[0053] 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 an external dimension, "radial range" may be understood to mean a radial dimension, "longitudinal range" may be understood to mean a longitudinal dimension, and so on. Each instance of "range" may be different (e.g., axial, longitudinal, lateral, 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), and so on.

[0054] 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.

[0055] Note that references in the specification to "embodiments," "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 one embodiment, it is within the knowledge of those skilled in the art that the particular feature, structure, or characteristic may be implemented in conjunction with other embodiments, whether or not explicitly described, unless otherwise explicitly stated. That is, the various individual elements described below, even if not explicitly shown in a particular 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.

[0056] For clarity, certain numerically identified terms (e.g., first, second, third, fourth, etc.) may be used throughout the 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 numerical terms previously used may be modified and deviated from. That is, a feature identified as a "first" element may be referred to as a "second" element, a "third" element, etc., thereafter, or may be omitted entirely, and / or different features may be referred to as a "first" element. The meaning and / or name in each case will be apparent to a skilled practitioner.

[0057] Figure 1 1 is a partial cross-sectional view of certain elements of a human heart 10 and some selected adjacent blood vessels. The heart 10 may include a left ventricle 12, a right ventricle 14, a left atrium 16, and a right atrium 18. An aortic valve 22 is disposed between the left ventricle 12 and the aorta 20. A pulmonary valve or semilunar valve 26 is disposed between the right ventricle 14 and the pulmonary artery 24. The superior vena cava 28 and the inferior vena cava 30 return blood from the body to the right atrium 18. A mitral valve 32 is disposed between the left atrium 16 and the left ventricle 12. A tricuspid valve 34 is disposed between the right atrium 18 and the right ventricle 14. A pulmonary vein 36 returns blood from the lungs to the left atrium 16. A left atrial appendage 50 is attached to the left atrium 16 and is in fluid communication therewith.

[0058] Figure 2is a partial cross-sectional view of an exemplary left atrial appendage 50. As described above, the left atrial appendage 50 can have a complex geometry and / or an irregular surface area. Those skilled in the art will recognize that the illustrated left atrial appendage is only one of many possible shapes and sizes of the left atrial appendage, 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 applied to various sizes and shapes of the left atrial appendage as needed. The left atrial appendage 50 can include a general longitudinal axis arranged along the depth of the body 60 of the left atrial appendage 50. The body 60 can include a wall 54 and an orifice 56 forming a proximal mouth 58. In some embodiments, the lateral extent of the orifice 56 and / or the wall 54 can be less than or less than the depth of the body 60 along the longitudinal axis, or the depth of the body 60 can be greater than the lateral extent of the orifice 56 and / or the wall 54. In some embodiments, the left atrial appendage 50 can include a tail element associated with a distal portion of the body 60 that can protrude radially or laterally away from the body 60.

[0059] The following figures illustrate selected components and / or arrangements of implants for occluding the left atrial appendage, systems for occluding the left atrial appendage, and / or methods of using the implants and / or systems. It should be noted that in any given figure, some features may not be shown, or may be shown schematically, for simplicity. Additional details about some components of the implant and / or system may be shown in more detail in other figures. Although discussed in the context of occluding the left atrial appendage, the implant and / or system may also be used for other interventional and / or percutaneous medical procedures in the patient's body. Similarly, the devices and methods described herein for percutaneous deployment may be used for other types of surgical procedures as appropriate. For example, in some examples, the device may be used for non-percutaneous procedures. The devices and methods according to the present disclosure may also be adapted and constructed for other uses within anatomical structures.

[0060] Figure 3 is a partial cross-sectional view showing various elements of a system 100 for occluding a left atrial appendage 50. The system 100 may include a delivery sheath 110 having an inner lumen 120 extending to a distal end. The system 100 may include an implant 200 for occluding a left atrial appendage 50. The implant 200 may include an expandable frame 210 that is configured to transition between a collapsed configuration and an expanded configuration. When the implant 200 is disposed within the inner lumen 120 of the delivery sheath 110, the expandable frame 210 may be maintained and / or configured to be in the collapsed configuration, such as Figure 3In some embodiments, the implant 200 can optionally include an occlusive element 220 disposed and / or positioned on, over, and / or around at least a portion of the expandable frame 210. In at least some embodiments, the occlusive element 220 can be secured, attached, and / or connected to the expandable frame 210. In some embodiments, the occlusive element 220 can be secured, attached, and / or connected to the expandable frame 210 at a plurality of discrete locations. In at least some embodiments, the expandable frame 210 can include a plurality of anchoring members 212 (e.g., Figure 4 ), the plurality of anchoring members 212 are configured to engage the wall 54 of the body 60 of the left atrial appendage 50. Some suitable but non-limiting examples of materials for the delivery sheath 110, the expandable frame 210, the plurality of anchoring members 212, and the occluding element 220 are discussed below.

[0061] Implant 200 may include a sealing member 230, which is spaced apart proximally from expandable frame 210 by a flexible coupling 240. In at least some embodiments, sealing member 230 may be fixed to, attached to and / or connected to expandable frame 210 by a flexible coupling 240. In some embodiments, flexible coupling 240 is tubular (e.g., tubular member, hollow tube, etc.) and includes an inner cavity extending therethrough. In some embodiments, flexible coupling 240 may be formed by one or more filaments or sutures, one or more flexible members spaced apart from each other, a discontinuous flexible element in which a notch or cutout is formed, a coiled member or other suitable flexible structure. In at least some embodiments, sealing member 230 may be at least partially expandable. Sealing member 230 may be configured to switch between a conveying configuration and an expanded configuration. When implant 200 and / or sealing member 230 are disposed in the inner cavity 120 of conveying sheath 110, sealing member 230 may be maintained and / or disposed in a conveying configuration. In some embodiments, the sealing member 230 may include a mesh, fabric, or other surface treatment configured to promote endothelialization on and / or across the sealing member 230. In some embodiments, the sealing member 230 may include a mesh, fabric, or other surface treatment disposed on a portion of the outer surface of the sealing member 230 and / or around a portion of the outer surface of the sealing member. In some embodiments, the sealing member 230 may include a mesh, fabric, or other surface treatment disposed on and / or around the entire outer surface of the sealing member 230. In some embodiments, the mesh, fabric, or other surface treatment may be elastic and / or stretchable to accommodate changes in the shape and / or size of the sealing member 230 when the sealing member 230 is converted toward and / or enters the expanded configuration. Some suitable but non-limiting examples of materials for the sealing member 230 and the flexible connector 240 will be discussed below.

[0062] In some embodiments, the system 100 may include a core wire 130 that is releasably secured and / or releasably connected to the implant 200 at the distal end of the core wire 130. In some embodiments, the core wire 130 may be engaged, releasably secured and / or releasably connected to the expandable frame 210 or the sealing member 230. In some embodiments, where the core wire 130 is engaged, releasably secured and / or releasably connected to the expandable frame 210, the core wire 130 may pass through the sealing member 230. For example, the core wire 130 may pass through a self-sealing port and / or orifice extending through the sealing member 230. In some embodiments, the core wire 130 may extend through the flexible coupler 240 to engage with the expandable frame 210. In some embodiments, the core wire 130 may engage with the sealing member 230 and / or the flexible coupler 240. Some suitable but non-limiting examples of materials for the core wire 130 will be discussed below.

[0063] In some embodiments, the system 100 may include an inflation lumen 140 in fluid communication with the sealing member 230. The inflation lumen 140 may extend through the lumen 120 of the delivery sheath 110 to the sealing member 230. In some embodiments, the inflation lumen 140 may extend through the core wire 130 (e.g., Fig. 9 ). The sealing member 230 can expand under the internal pressure applied by the inflation fluid. In some embodiments, the inflation fluid can include a contrast agent for improving visualization under fluoroscopy. In some embodiments, the inflation fluid can be and / or include a hardener and / or a hardened or semi-hardened fluid. For example, the inflation fluid can include a biocompatible liquid, such as saline, a hydrogenated polymer, a hydrogel, or other suitable fluid. In at least some embodiments, the outer shape of the sealing member 230 can be compliant, flexible, and / or adaptable to its surrounding environment. For example, the outer shape of the sealing member 230 can be transformed and / or adapted to match the wall 54 and / or the opening 56 of the left atrial appendage 50 disposed adjacent to the sealing member 230 when implanted, thereby engaging the wall 54 and / or the opening 56 of the left atrial appendage 50 in a sealed manner.

[0064] A method for occluding a left atrial appendage 50 may include advancing an implant 200 into the left atrial appendage 50. For example, the implant 200 may be advanced into the left atrial appendage 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 converting the expandable frame 210 from a collapsed configuration to an expanded configuration within the left atrial appendage 50, for example, Figure 4. In the expanded configuration, the expandable frame 210 can be pushed to contact, engage and / or anchor to the wall 54 of the body 60 of the left atrial appendage 50. In addition, the method may include deploying the sealing member 230 near the mouth 56 of the left atrial appendage 50. In some embodiments, the sealing member 230 can be spaced apart from the expandable frame 210 at a gap distance G proximally. The gap distance G can generally be understood as the axial distance between the proximal surface of the expandable frame 210 and the distal surface of the sealing member 230, which is generally measured parallel to the central longitudinal axis of the implant 200, the expandable frame 210 and / or the sealing member 230. In some embodiments, the gap distance G can be fixed. In some embodiments, the gap distance G can be variable. The expandable frame 210 and / or multiple anchoring members 212 can be used as an anchoring mechanism for the sealing member 230.

[0065] In some embodiments, the sealing member 230 may include an expansion port 232 that is configured to receive and / or engage with the expansion lumen 140. In some embodiments, the expansion port 232 may be a self-sealing port, and / or may include a hemostatic valve or other features configured to seal the expansion port 232 in the absence of a structure (e.g., the expansion lumen 140, the core wire 130, etc.) disposed within the expansion port 232. In some embodiments, the core wire 130 may engage with and / or pass through the expansion port 232. In at least some embodiments, the sealing member 230 may be compliant and / or adaptable to its surrounding environment. As mentioned herein, the sealing member 230 may be converted and / or adapted to fit and / or match the contours of the wall 54 and / or the mouth 56 of the left atrial appendage 50 disposed adjacent to the sealing member 230 when implanted, thereby engaging the wall 54 and / or the mouth 56 of the left atrial appendage 50 in a sealed manner. In at least some embodiments, the method can further include expanding at least a portion of the sealing member 230 until the sealing member 230 is able to engage the ostium 56 of the left atrial appendage 50 in a sealing manner, such as in Figure 5 Visible in.

[0066] The system 100 and / or the implant 200 may include at least one device for adjusting the gap distance G. In some embodiments, the method for occluding the left atrial appendage 50 may include adjusting the gap distance G to position the sealing member 230 against and / or within the ostium 56 of the left atrial appendage 50. In some embodiments, the at least one device for adjusting the gap distance G may be configured to translate the sealing member 230 toward and / or into the ostium 56 of the left atrial appendage 50. For example, upon initial deployment of the implant 200, the expandable frame 210 may be pushed to contact, engage and / or anchor to the wall 54 of the body 60 of the left atrial appendage 50, and the sealing member 230 may be spaced apart from the ostium 56 of the left atrial appendage 50, for example, at Figure 6The at least one device for adjusting the gap distance G can be used to translate the sealing member 230 toward the opening 56 of the left atrial appendage 50 and / or translate it into the opening of the left atrial appendage, such as Figure 7 and Figure 8 shown.

[0067] In one example, implant 200 may include a tapered member 250 configured to change the gap distance G, such as Figure 6-Figure 8 As shown. The conical member 250 can be fixedly attached and / or connected to the flexible connector 240. In some embodiments, the conical member 250 can be fixedly attached and / or fixedly connected to the distal end of the flexible connector 240. In some embodiments, the proximally facing surface of the conical member 250 can engage and / or contact the expandable frame 210. In some embodiments, the conical member 250 can be prevented from translating through and / or approaching the expandable frame 210. In at least some embodiments, the conical member 250 can be an expandable conical member that is configured to expand axially and / or radially / laterally, wherein different degrees and / or magnitudes of expansion determine the adjustment of the gap distance G. For example, as the conical member 250 expands, the distal end of the flexible connector 240 can translate and / or be pulled distally through and / or relative to the expandable frame 210, thereby shortening and / or reducing the gap distance G, and translating the sealing member 230 toward and / or into the opening 56 of the left atrial appendage 50, for example as Figure 7 and Figure 8 In one example, the gap distance G can be shortened from its initial deployment 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 G can be shortened or reduced to zero. In some embodiments, the gap distance G can be shortened or reduced until the sealing member 230 contacts the tapered member 250.

[0068] In another example, the implant 200 can include a threaded adjustment configured to change the gap distance G. In some embodiments, the sealing member 230 and / or the flexible coupling 240 can include a threaded portion 260 configured to rotatably and / or threadably engage with a corresponding and / or complementary threaded portion 214 of the expandable frame 210, for example, Fig. 9Visible. In some embodiments, the threaded adjustment (and / or the threaded portion 260 / 214) couples the sealing member 230 to the expandable frame 210. In some embodiments, the sealing member 230 and the flexible connector 240 can be integrally formed into a single structure. In some embodiments, the sealing member 230 may include an expandable disc-shaped member. In some embodiments, the sealing member 230 may include an expandable disc-shaped member and an axial rod extending longitudinally away from the expandable disc-shaped member. For example, in some embodiments, the sealing member 230 may have a form or shape similar to a duckbill cap mushroom, which may be a substantially flat cap or head, rather than a round or spherical cap or head. In some embodiments, the sealing member 230 may have a regular or irregular surface or shape, a smooth or uneven surface or shape, and / or a concave or convex surface or shape. The sealing member 230 may be expandable, thereby engaging the wall 54 and / or the mouth 56 of the left atrial appendage 50 in a sealed manner.

[0069] exist Fig. 9 In the example shown, the distal portion of the core wire 130 may include an external keying structure 132 (e.g., Fig.11 ), the external keying structure is configured to non-rotatably engage the sealing member 230, the flexible connector 240 and / or the threaded portion 260. The core wire 130 can be hollow and / or tubular, having an inflation lumen 140 extending therethrough. The sealing member 230 can include an inflation port 232 disposed near a proximal portion and / or a proximal end of the sealing member 230. The distal portion of the core wire 130 can be configured to extend through the inflation port 232 and into the sealing member 230. When the distal end of the core wire 130 is disposed within the sealing member 230, injection of an inflation fluid through the inflation lumen 140 and / or the core wire 130 can cause the sealing member 230 to expand and / or inflate, thereby sealingly engaging the wall 54 and / or the opening 56 of the left atrial appendage 50.

[0070] The core wire 130 can be configured to extend and / or advance further distally to align the external keying structure 132 with the flexible coupling 240 and / or the internal keying feature 262 within the threaded portion 260 (e.g., Fig.10) engages. When the external keying structure 132 engages with the internal keying feature 262, the rotation of the core wire 130 can be transmitted to the sealing member 230, the flexible connector 240 and / or the threaded portion 260. The rotation of the sealing member 230, the flexible connector 240 and / or the threaded portion 260 relative to the expandable frame 210 and / or the threaded portion 214 can change the gap distance G by translating the sealing member 230 closer to or away from the expandable frame 210 in response to the threaded engagement. In some embodiments, the distal end of the core wire 130 (and / or another structure or feature) can extend through the flexible connector 240 and / or the threaded portion 260. For example, a guide wire can be positioned in the lumen of the core wire 130 for guiding the implant 200 through the patient's vascular system and / or to the left atrial appendage 50. Thus, the distal end of flexible coupler 240 and / or threaded portion 260 may be self-sealing and / or may include a hemostatic valve or other feature such that withdrawal of the distal end of core wire 130 therefrom allows sealing member 230 to retain inflation fluid therein.

[0071] In another example, the flexible coupling 240 may include and / or be formed by one or more filaments, sutures, or other flexible elements. The means for adjusting the gap distance G may include shortening the flexible coupling 240. For example, one or more filaments, sutures, or other flexible elements may be pulled through a lacing or latch feature, tied into one or more knots, twisted together, or other methods of shortening or tightening the slack in the flexible coupling 240. Other configurations and / or arrangements are also contemplated.

[0072] In alternative embodiments, implant 300 (e.g., Figure 14-15 ) may include a sealing member 330 having an expandable annular member 332, for example, Fig.12 As can be seen in the figure, the expandable annular member 332 defines the central space. The expandable annular member 332 can be formed of a polymeric material, a metallic material, and / or a composite material. In some embodiments, the expandable annular member 332 can be formed of a substantially compliant material. In some other embodiments, the expandable annular member 332 can be formed of a substantially non-compliant material. The sealing member 330 can include a first layer 334 extending across the central space and a second layer 336 extending across the central space, Figure 13A-13C In some embodiments, the first layer 334 can be spaced apart from the second layer 336 across at least a portion of the central space. In some embodiments, the first layer 334 can be spaced apart from the second layer 336 across the entire central space (e.g., Fig.13A). In some embodiments, the sealing member 330 may include a mesh 335, fabric, or other surface treatment configured to promote endothelialization on and / or across the sealing member 330. In some embodiments, the sealing member 330 may include a mesh 335, fabric, or other surface treatment disposed on a portion of the outer surface of the sealing member 330 and / or around a portion of the outer surface of the sealing member. In some embodiments, the sealing member 330 may include a mesh 335, fabric, or other surface treatment disposed on and / or around the entire outer surface of the sealing member 330. In some embodiments, the mesh 335, fabric, or other surface treatment may be elastic and / or stretchable to accommodate changes in the shape and / or size of the sealing member 330 as the sealing member 330 transitions toward and / or enters the expanded configuration. In some embodiments, the mesh 335, fabric, or other surface treatment may be spaced apart from the first layer 334 and / or the second layer 336 (e.g., Fig. 13B ). For example, a space 333 can be formed between the mesh 335, fabric, or other surface treatment and the first layer 334 and / or the second layer 336. The sealing member 330 can be configured to promote the formation of organized microthrombi to enhance endothelial migration and coverage. The space 333 can be configured to cause stasis and promote coagulation even in a fully anticoagulated patient, thereby producing a bound thrombus that can provide a medium for endothelial growth on the mesh 335, fabric, or other surface treatment. In addition, the bound thrombus and / or endothelial growth on the mesh 335, fabric, or other surface treatment can provide a matrix for external thrombus attachment, thereby preventing detachment and / or embolism of external thrombi. In some embodiments, the space 333 is formed to have a distance between 1% and 50% of the total thickness of the sealing member 330 and / or the expandable annular member 332. Other arrangements and / or configurations are also contemplated. In some embodiments, the first layer 334 can be spaced apart from the second layer 336 across at least a portion of the central space, and the first layer 334 can be discontinuously and / or intermittently affixed, connected, and / or bonded to the second layer 336 at one or more discrete locations (e.g., Fig. 13C ).

[0073] In some embodiments, at least one of the first layer 334 or the second layer 336 may include a plurality of reinforcing fibers 338, such as Fig.12As shown. In some embodiments, a plurality of reinforcing fibers 338 may include separate filaments, fabrics or textiles, meshes or other suitable reinforcing elements. Other configurations and / or arrangements are also contemplated. As the sealing member 330 and / or the expandable annular member 332 expand and / or expand, a plurality of reinforcing fibers 338 may prevent the stretching of the first layer 334 and / or the second layer 336. In some embodiments, the mesh 335, fabric or other surface treatment may be inelastic and / or non-compliant to prevent the shape and / or size of the sealing member 330, the first layer 334 and / or the second layer 336 from changing when the sealing member 330 is converted toward the expanded configuration and / or enters the expanded configuration. In some embodiments, the first layer 334 and / or the second layer 336 may be formed of a polymeric material, a metallic material and / or a composite material. In some embodiments, the first layer 334 and / or the second layer 336 may be formed of a substantially non-compliant material. In some other embodiments, the first layer 334 and / or the second layer 336 may be formed of at least partially compliant material. In some embodiments, the first layer 334 and / or the second layer 336 can be formed of the same material as the expandable annular member 332. In some embodiments, the first layer 334 and / or the second layer 336 can be formed of a different material than the expandable annular member 332. In some embodiments, the first layer 334 and / or the second layer 336 can be permeable or semi-permeable. In some embodiments, the first layer 334 and / or the second layer can be impermeable. Some suitable but non-limiting examples of materials for the sealing member 330, the expandable annular member 332, the first layer 334, the mesh 335, the second layer 336, and / or the plurality of reinforcing fibers 338 will be discussed below.

[0074] Fig.12 Alternative embodiments of the invention may have several features similar to other embodiments described herein. Implant 300 may include an expandable frame 310 that is configured to transition between a collapsed configuration and an expanded configuration. When implant 300 is disposed within lumen 120 of delivery sheath 110, expandable frame 310 may be maintained and / or configured to be in the collapsed configuration, such as Fig.14As shown. In some embodiments, the implant 300 can optionally include an occlusive element 320 disposed and / or positioned on, above, and / or around at least a portion of the expandable frame 310. In at least some embodiments, the occlusive element 320 can be fixed, attached, and / or connected to the expandable frame 310. In some embodiments, the occlusive element 320 can be fixed, attached, and / or connected to the expandable frame 310 at a plurality of discrete locations. In at least some embodiments, the expandable frame 310 can include a plurality of anchoring members 312 extending therefrom, the plurality of anchoring members 312 being configured to engage with the wall 54 of the body 60 of the left atrial appendage 50. Some suitable but non-limiting examples of materials for the expandable frame 310, the plurality of anchoring members 312, and the occlusive element 320 are discussed below.

[0075] Implant 300 may include a sealing member 330, which is spaced apart proximally from expandable frame 310 by a flexible coupling 340. In at least some embodiments, sealing member 330 may be fixed to, attached to and / or connected to expandable frame 310 by a flexible coupling 340. In some embodiments, flexible coupling 340 is tubular (e.g., tubular member, hollow tube, etc.) and includes an inner cavity extending therethrough. In some embodiments, flexible coupling 340 may be formed by one or more filaments or sutures, one or more flexible members spaced apart from each other, a discontinuous flexible element in which a notch or incision is formed, a coiled member or other suitable flexible structure. Sealing member 330 may be configured to switch between a conveying configuration and an expanded configuration. When implant 300 and / or sealing member 330 are disposed in the inner cavity 120 of conveying sheath 110, sealing member 330 may be maintained and / or disposed in a conveying configuration.

[0076] In some embodiments, the system 100 may include a core wire 130 that is releasably secured and / or releasably connected to the implant 300 at a distal end of the core wire 130. In some embodiments, the core wire 130 may be engaged, releasably secured and / or releasably connected to the expandable frame 310 or the sealing member 330. In some embodiments, where the core wire 130 is engaged, releasably secured and / or releasably connected to the expandable frame 310, the core wire 130 may pass through the sealing member 330. For example, the core wire 130 may extend through a hole through a self-sealing port and / or orifice of the sealing member 330. In some embodiments, the core wire 130 may extend through a flexible coupler 340 to engage with the expandable frame 310. In some embodiments, the core wire 130 may engage with the sealing member 330 and / or the flexible coupler 340.

[0077] In some embodiments, the system 100 may include an inflation lumen 150 in fluid communication with the sealing member 330. The inflation lumen 150 may extend to the sealing member 330 through the lumen 120 of the delivery sheath 110. The sealing member 330 may expand under the internal pressure applied by the inflation fluid. In some embodiments, the inflation fluid may include a contrast agent for improving visualization under fluoroscopy. In some embodiments, the inflation fluid may be and / or include a hardener and / or a hardened or semi-hardened fluid. For example, the inflation fluid may include a biocompatible liquid, such as saline, a hydrogenated polymer, a hydrogel, or other suitable fluid. In at least some embodiments, the outer shape of the sealing member 330 and / or the expandable annular member 332 may be compliant, flexible, and / or adaptable to its surrounding environment. For example, the outer shape of the sealing member 330 and / or the expandable annular member 332 can be transformed and / or adapted to match the wall 54 and / or the opening 56 of the left atrial appendage 50 disposed adjacent to the sealing member 330 and / or the expandable annular member 332 when implanted, thereby engaging the wall 54 and / or the opening 56 of the left atrial appendage 50 in a sealed manner.

[0078] A method for occluding a left atrial appendage 50 may include advancing an implant 300 into the left atrial appendage 50. For example, the implant 300 may be advanced into the left atrial appendage within the lumen 120 of the delivery sheath 110. The method includes deploying an expandable frame 310 from the delivery sheath 110 within the left atrial appendage 50. The method further includes expanding and / or converting the expandable frame 310 from a collapsed configuration to an expanded configuration within the left atrial appendage 50, for example, Fig.15 In the expanded configuration, the expandable frame 310 can be urged to contact, engage and / or anchor to the wall 54 of the body 60 of the left atrial appendage 50. In addition, the method can include deploying the sealing member 330 near the opening 56 of the left atrial appendage 50. In some embodiments, the sealing member 330 and / or the expandable annular member 332 can be spaced proximally from the expandable frame 310 by a gap distance G. Fig.16 . The gap distance G can generally be understood as the axial distance between the proximal surface of the expandable frame 310 and the distal surface of the sealing member 330 and / or the expandable annular member 332, which is generally measured parallel to the central longitudinal axis of the implant 300, the expandable frame 310 and / or the sealing member 330. In some embodiments, the gap distance G can be fixed. In some embodiments, the gap distance G can be variable. The expandable frame 310 and / or multiple anchoring members 312 can be used as an anchoring mechanism for the sealing member 330.

[0079] In some embodiments, the implant 300 can be configured to change the gap distance. For example, the second layer 336 can be fixedly attached to and / or connected to the flexible connector 340. In some embodiments, the second layer 336 can be fixedly attached to and / or fixedly connected to the proximal end of the flexible connector 340. In some embodiments, the second layer 336 can be non-compliant and / or non-stretchable relative to the expandable annular member 332, wherein the different expansion degrees and / or sizes of the expandable annular member 332 can determine the adjustment of the gap distance G. For example, as the expandable annular member 332 expands, the second layer 336 and / or the expandable annular member 332 can be axially translated toward the expandable frame 310, thereby shortening and / or reducing the gap distance G. In one example, the gap distance G can be shortened from its initial deployment distance by about 10%, about 20%, about 25%, about 30%, about 40%, about 50%, about 60%, about 75%, etc. In another example, the second layer 336 can be compliant and / or stretchable relative to the expandable annular member 332, thereby allowing the expandable frame 310 to be placed deeper in the left atrial appendage 50. In some embodiments, as the expandable annular member 332 expands, the second layer 336 and / or the expandable annular member 332 can translate axially away from the expandable frame 310, thereby increasing the gap distance G compared to a configuration in which the second layer 336 is oriented and / or disposed perpendicular to the central longitudinal axis of the core wire 130 and / or the implant 300. In some embodiments, the implant 300 may include a translation member, for example, disposed within and / or axially translatable relative to the core wire 130, which is configured to translate the expandable frame 310 axially relative to the expandable annular member 332. In some embodiments, the core wire 130 can be configured to translate the expandable frame 310 axially relative to the expandable annular member 332. For example, the gap distance G can be increased from its initial deployment distance by about 10%, about 30%, about 50%, about 70%, about 100%, about 150%, about 200%, etc. Fig.17 and Fig.18 Other arrangements and / or configurations are also contemplated. In at least some embodiments, as expandable annular member 332 expands, first layer 334 can remain substantially flat and / or non-compliant.

[0080] In some embodiments, the sealing member 330 may include an expansion port that is configured to receive and / or engage the expansion lumen 150. In some embodiments, the expansion port may be a self-sealing port, and / or may include a hemostatic valve or other features that are configured to seal the expansion port in the absence of a structure disposed within and / or engaged with the expansion port (e.g., the expansion lumen 150, etc.). In at least some embodiments, the sealing member 330 and / or the expandable annular member 332 may be compliant and / or adaptable to its surrounding environment. As mentioned herein, the sealing member 330 and / or the expandable annular member 332 may be converted and / or adapted to fit and / or match the contour of the wall 54 and / or the mouth 56 of the left atrial appendage 50 disposed adjacent to the sealing member 330 and / or the expandable annular member 332 when implanted, thereby engaging the wall 54 and / or the mouth 56 of the left atrial appendage 50 in a sealed manner. In at least some embodiments, the method can further include expanding at least a portion of the sealing member 330 (e.g., the expandable annular member 332) until the sealing member 330 and / or the expandable annular member 332 are able to engage the ostium 56 of the left atrial appendage 50 in a sealing manner.

[0081] In some embodiments, the sealing member 230 can be oriented at an oblique angle relative to the central longitudinal axis of the expandable frame 210. Fig.19 The flexible connector 240 can allow for off-axis orientation of the sealing member 230 and the expandable frame 210 relative to each other, which can facilitate positioning, implantation, and / or sealing within an irregularly shaped and / or oriented left atrial appendage 50. Although not explicitly shown for simplicity, Figure 12-Figure 18 The sealing member 330 in the expandable frame 310 can also be oriented at an oblique angle relative to the central longitudinal axis of the expandable frame 310. The flexible connector 340 can allow for off-axis orientation of the sealing member 330 and the expandable frame 310 relative to each other, which can facilitate positioning, implantation, and / or sealing within an irregularly shaped and / or oriented left atrial appendage 50.

[0082] The materials that can be used for the various components of the system 100, the delivery sheath 110, the core wire 130, the expansion lumen 140 / 150, the implant 200 / 300, the expandable frame 210 / 310, the occlusive element 220 / 320, the sealing member 230 / 330, the flexible connector 240 / 340, the tapered member 250, etc. (and / or other systems or components disclosed herein), and the various elements disclosed herein can include materials and elements that are commonly associated with medical devices. For simplicity, the following discussion refers to the system 100, the delivery sheath 110, the core wire 130, the expansion lumen 140 / 150, the implant 200 / 300, the expandable frame 210 / 310, the occlusive element 220 / 320, the sealing member 230 / 330, the flexible connector 240 / 340, the tapered member 250, etc. However, this is not intended to limit the devices and methods described herein, as the discussion may apply to other elements, components, parts, or devices disclosed herein, such as, but not limited to, multiple anchoring members 212 / 312, expandable annular member 332, first layer 334, second layer 336, multiple reinforcing fibers 338, etc., and / or elements or parts thereof.

[0083] In some embodiments, the system 100, the delivery sheath 110, the core wire 130, the inflation lumen 140 / 150, the implant 200 / 300, the expandable frame 210 / 310, the occlusive element 220 / 320, the sealing member 230 / 330, the flexible connector 240 / 340, the tapered member 250, etc., and / or its components can be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, etc., or other suitable materials. Some examples of suitable metals and metal alloys include: stainless steel, such as 444V, 444L and 314LV stainless steel; low carbon 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 UNS:N06022, such as UNS:N10276, such as other alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, such as etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as 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 (e.g., UNS: R44003, such as etc.); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof; etc.; or any other suitable material.

[0084] 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 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 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.

[0085] 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), 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.

[0086] 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 the linear elastic and / or non-superelastic nickel-titanium alloy, there may be no martensite / austenite phase transformation detectable by DSC and DMTA analysis within a range of about -60 degrees Celsius (°C) to about 120 (°C). Therefore, the mechanical bending properties of this material 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 platform and / or marking area. 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.

[0087] 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 composition contains nickel in the range of about 54 to about 57 weight percent. An example of a suitable nickel-titanium alloy is FHP-NT alloy commercially available from Furukawa TechnoMaterial, Inc. of 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.

[0088] In at least some embodiments, part or all of the system 100, the delivery sheath 110, the core wire 130, the inflation lumen 140 / 150, the implant 200 / 300, the expandable frame 210 / 310, the occlusive element 220 / 320, the sealing member 230 / 330, the flexible coupler 240 / 340, the tapered member 250, etc., and / or components thereof 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 determine the location of the system 100, the delivery sheath 110, the core wire 130, the expansion lumen 140 / 150, the implant 200 / 300, the expandable frame 210 / 310, the occlusive element 220 / 320, the sealing member 230 / 330, the flexible coupler 240 / 340, the tapered member 250, etc. 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 system 100, the delivery sheath 110, the core wire 130, the expansion lumen 140 / 150, the implant 200 / 300, the expandable frame 210 / 310, the occlusive element 220 / 320, the sealing member 230 / 330, the flexible coupler 240 / 340, the tapered member 250, etc. to achieve the same result.

[0089] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the system 100, the delivery sheath 110, the core wire 130, the expansion lumen 140 / 150, the implant 200 / 300, the expandable frame 210 / 310, the occlusive element 220 / 320, the sealing member 230 / 330, the flexible coupler 240 / 340, the tapered member 250, etc. For example, the system 100, the delivery sheath 110, the core wire 130, the expansion lumen 140 / 150, the implant 200 / 300, the expandable frame 210 / 310, the occlusive element 220 / 320, the sealing member 230 / 330, the flexible coupler 240 / 340, the tapered member 250, etc., and / or parts or portions thereof can be made of a material that does not substantially distort the image and produce a large number of artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may produce artifacts in the MRI image. The system 100, the delivery sheath 110, the core wire 130, the inflation lumen 140 / 150, the implant 200 / 300, the expandable frame 210 / 310, the occlusive element 220 / 320, the sealing member 230 / 330, the flexible connector 240 / 340, the tapered member 250, etc., or portions thereof may also be made of materials 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: R44003, for example). etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, such as etc.), Nitinol, etc., and other materials.

[0090] In some embodiments, the system 100, the delivery sheath 110, the core wire 130, the inflation lumen 140 / 150, the implant 200 / 300, the expandable frame 210 / 310, the occlusive element 220 / 320, the sealing member 230 / 330, the flexible coupler 240 / 340, the tapered member 250, etc., and / or portions thereof can be made of or include a polymer or other suitable material. Some examples of suitable polymers can include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., available 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 / ethers, polyether block amides (PEBA, for example, available under the trade name obtained), 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(p-phenylene terephthalate) (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 siloxane copolymers (e.g., or from AdvanSource Biomaterials ), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, etc. thereof. In some embodiments, the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0091] In some embodiments, the delivery sheath 110, core wire 130, expansion lumen 140 / 150, expandable frame 210 / 310, occlusive element 220 / 320, sealing member 230 / 330, flexible connector 240 / 340, etc. disclosed herein may include a fabric material disposed on or within at least a portion of 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.

[0092] In some embodiments, the delivery sheath 110, the core wire 130, the expansion lumen 140 / 150, the expandable frame 210 / 310, the occlusive element 220 / 320, the sealing member 230 / 330, the flexible coupling 240 / 340, etc. may include textile materials. Some examples of suitable textile materials may include synthetic yarns, which may be flat, shaped, twisted, textured, pre-contracted or uncontracted. The synthetic biocompatible yarns suitable for use in the present invention include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyester, polypropylene, polyethylene, polyurethane, polyolefins, ethylene polymers, polymethyl acetate, polyamide, naphthalate derivatives, natural silk and polytetrafluoroethylene. In addition, at least one of the synthetic yarns may be a metal yarn or a glass or ceramic yarn or fiber. Useful metal yarns include yarns made of stainless steel, platinum, gold, titanium, tantalum or nickel-cobalt-chromium alloys or yarns containing these materials. Yarns may further include carbon, glass or ceramic fibers. Ideally, the yarn is made of a thermoplastic material, including but not limited to polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, etc. The yarn can be multifilament, monofilament or staple type. The type and denier of the selected yarn can be selected based on the manner in which the biocompatible implantable prosthesis is formed, and more specifically, can be selected based on the vascular structure having the desired characteristics.

[0093] In some embodiments, the system 100, the delivery sheath 110, the core wire 130, the inflation lumen 140 / 150, the implant 200 / 300, the expandable frame 210 / 310, the occlusive element 220 / 320, the sealing member 230 / 330, the flexible connector 240 / 340, the conical member 250, etc. may include a suitable therapeutic agent 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); antitumor / antiproliferative / antimitotic 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-A The invention relates to agents that can be used to treat vascular endothelial cells and the like (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional activators and translational promoters); agents that can be used to inhibit vascular endothelial cells and the like (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules composed of growth factors and cytotoxins, and bifunctional molecules composed of antibodies and cytotoxins); cholesterol-lowering agents; vasodilators; and agents that interfere with endogenous vascular action mechanisms.

[0094] It should be understood that the present disclosure is in many respects illustrative only. Without exceeding the scope of the invention, changes may be made in detail, particularly in the arrangement of shape, size and steps. To the extent appropriate, this may include the use of any feature of an exemplary embodiment in other embodiments. Of course, the scope of the invention is limited by the language of the appended claims.

Claims

1. An implant for occluding a left atrial appendage, comprising: an expandable frame configured to transition between a stowed configuration and an expanded configuration; a sealing member proximally spaced apart from the expandable frame by a gap distance, the sealing member comprising an expandable annular member defining a central space and having an inflation port disposed proximate a proximal end of the sealing member, the sealing member further comprising a first layer extending across the central space and a second layer extending across the central space and spaced apart from the first layer; as well as an expansion lumen in fluid communication with the expandable annular member; wherein the sealing member is connected to the expandable frame via a flexible connector; wherein the second layer is secured to the flexible connector; Wherein, the sealing member is expandable under internal pressure exerted by an inflation fluid.

2. The implant according to claim 1, wherein The flexible coupling is tubular.

3. The implant according to any one of claims 1 to 2, wherein: The gap distance is variable.

4. The implant of claim 3, further comprising a tapered member configured to change the gap distance.

5. The implant of claim 3, further comprising a thread adjustment configured to change the gap distance.

6. The implant according to claim 5, wherein The threaded adjustment couples the sealing member to the expandable frame.

7. The implant according to claim 1, wherein: At least one of the first layer or the second layer includes a plurality of reinforcing fibers.

8. The implant according to claim 1, wherein The second layer is non-compliant, and the expandable annular member is configured such that when the expandable annular member is expanded, the second layer translates axially toward the expandable frame to reduce the gap distance.

9. The implant according to claim 1, wherein: The second layer is compliant, and the expandable annular member is configured such that when the expandable annular member is expanded, the second layer translates axially away from the expandable frame to increase the gap distance.

10. A system for occluding a left atrial appendage, comprising: a delivery sheath having an inner lumen; An implant according to any one of claims 1 to 9; as well as A core wire is releasably secured to the implant.

11. The system according to claim 10, wherein: The inflation lumen extends through the delivery sheath parallel to the core wire.

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