Left atrial appendage implant

Abstract

An implant for occluding a left atrial appendage may include an expandable framework configured to transition between a collapsed configuration and an expanded configuration. The expandable framework includes a proximal hub and a distal hub. A longitudinal axis of the expandable framework extends from the proximal hub to the distal hub. A radiopaque marker may be positioned longitudinally between the proximal hub and the distal hub in the expanded configuration.

Description

Technical Field

[0001] The present disclosure generally relates to medical devices, and more particularly to medical devices adapted for use in percutaneous medical procedures, including implantation into the left atrial appendage (LAA) of the heart.

Background Art

[0002] The left atrial appendage is a small organ associated with the left atrium of the heart. During normal heart function, when the left atrium contracts to push blood into the left ventricle, the left atrial appendage contracts to push blood into the left atrium. The ability of the left atrial appendage to contract helps to improve the filling of the left ventricle and thereby plays a role in maintaining cardiac output. However, in patients suffering from atrial fibrillation, the left atrial appendage may not contract properly or may not empty, and may retain stagnant blood within it, leading to the formation of unwanted thrombi in the left atrial appendage.

[0003] Thrombi formed in the left atrial appendage can break free from this area and enter the bloodstream. Thrombi moving through the blood vessels can ultimately block smaller downstream blood vessels, thereby contributing to stroke or heart attack. Clinical studies have shown that the majority of blood clots in patients with atrial fibrillation originate from the left atrial appendage. As a treatment, medical devices have been developed that are configured to close the left atrial appendage. Each of the known medical devices and methods has specific advantages and disadvantages. There is a continuing need to provide alternative medical devices, as well as alternative methods for manufacturing and using medical devices.

Summary of the Invention

[0004] In one example, an implant for occluding the left atrial appendage is an expandable framework configured to transition between a collapsed form and an expanded form, the expandable framework including a proximal hub and a distal hub, the longitudinal axis of the expandable framework extending from the proximal hub to the distal hub, and in the expanded form, may comprise a radiopaque marker positioned longitudinally between the proximal hub and the distal hub.

[0005] In addition to, or alternatively to, any of the examples disclosed herein, the radiopaque marker is longitudinally oriented in the expanded configuration. In addition to, or alternatively to, any of the examples disclosed herein, the radiopaque marker includes a body portion, a proximal leg, a distal leg, a first lateral tab, and a second lateral tab. The body portion is disposed against an outer surface of an expandable framework.

[0006] In addition to, or alternatively to, any of the examples disclosed herein, the proximal and distal legs extend radially inwardly towards the interior of the expandable framework. In addition to, or alternatively to, any of the examples disclosed herein, the first and second lateral tabs wrap around a portion of the expandable framework.

[0007] In addition to, or alternatively to, any of the examples disclosed herein, the radiopaque marker is disposed radially inwardly of an inner surface of the expandable framework and includes a tubular member fixed to the inner surface of the expandable framework.

[0008] In addition to, or alternatively to, any of the examples disclosed herein, the radiopaque marker is disposed radially inwardly of an inner surface of the expandable framework and includes a flat plate fixed to the inner surface of the expandable framework.

[0009] In addition to, or alternatively to, any of the examples disclosed herein, the implant may further comprise an occlusion element disposed on at least a portion of the expandable framework. In addition to, or alternatively to, any of the examples disclosed herein, the radiopaque marker includes a flat element at least partially embedded within the occlusion element.

[0010] In addition to, or alternatively to, any of the examples disclosed herein, the radiopaque marker may include a plurality of radiopaque markers spaced around the outer periphery of the expandable framework.

[0011] In addition to, or alternatively to, any of the examples disclosed herein, a system for occluding a left atrial appendage may include a delivery sheath and a core wire slidably disposed within the lumen of the delivery sheath, and an implant for occluding the left atrial appendage that can be releasably secured to the distal end of the core wire. The implant may be an expandable framework configured to transition between a collapsed form and an expanded form, the expandable framework including a proximal hub and a distal hub, the longitudinal axis of the expandable framework extending from the proximal hub to the distal hub, and, in the expanded form, may include a radiopaque marker positioned longitudinally between the proximal hub and the distal hub.

[0012] In addition to, or alternatively to, any of the examples disclosed herein, the radiopaque marker is formed from a material different from that of the expandable framework. In addition to, or alternatively to, any of the examples disclosed herein, the radiopaque marker has a different density from that of the expandable framework.

[0013] In addition to, or alternatively to, any of the examples disclosed herein, the radiopaque marker includes a body portion, a proximal leg, and a distal leg. The body portion is disposed against the outer surface of the expandable framework. The proximal leg and the distal leg extend radially inwardly toward the interior of the expandable framework. When the implant is being moved within the lumen, the proximal leg engages the delivery sheath and biases the expandable framework radially inwardly away from the delivery sheath.

[0014] In addition to, or as an alternative to, any of the examples disclosed herein, a system for occluding a left atrial appendage may comprise a delivery sheath, a core wire slidably disposed within the lumen of the delivery sheath, and an implant for occluding the left atrial appendage that can be releasably secured to the distal end of the core wire. The implant is an expandable framework configured to transition between a collapsed form and an expanded form, the expandable framework including a proximal hub and a distal hub, the longitudinal axis of the expandable framework extending from the proximal hub to the distal hub, the expandable framework, a first radiopaque marker longitudinally positioned between the proximal hub and the distal hub in the expanded form, a second radiopaque marker longitudinally positioned between the proximal hub and the distal hub in the expanded form, and a third radiopaque marker longitudinally positioned between the proximal hub and the distal hub in the expanded form. The first radiopaque marker, the second radiopaque marker, and the third radiopaque marker may define a plane for positioning the expandable framework relative to the ostium of the left atrial appendage in the expanded form.

[0015] In addition to, or as an alternative to, any of the examples disclosed herein, the first radiopaque marker, the second radiopaque marker, and the third radiopaque marker each include a body portion, a proximal leg, and a distal leg. The body portion is disposed relative to the outer surface of the expandable framework. The proximal leg and the distal leg extend radially inwardly toward the interior of the expandable framework. When the implant is being moved within the lumen, the proximal leg engages the delivery sheath and biases the expandable framework radially inwardly away from the delivery sheath.

[0016] In addition to, or as an alternative to, any of the examples disclosed herein, the first radiopaque marker, the second radiopaque marker, and the third radiopaque marker each further include a first lateral tab and a second lateral tab. The first lateral tab and the second lateral tab wrap around a portion of the expandable framework.

[0017] In addition to, or alternatively to, any example disclosed herein, at least a portion of the second lateral tab overlaps the first lateral tab. In addition to, or alternatively to, any example disclosed herein, at least a portion of the second lateral tab extends radially inwardly closer to the longitudinal axis than the first lateral tab.

[0018] In addition to, or alternatively to, any example disclosed herein, the first radiopaque marker, the second radiopaque marker, and the third radiopaque marker each define a lateral extent and a longitudinal extent, and the longitudinal extent is greater than the lateral extent. The longitudinal extent is oriented longitudinally with respect to the expandable framework.

[0019] The above summaries of some embodiments, aspects, and / or examples are not intended to describe every embodiment or all implementations of the present disclosure. The drawings and the detailed description illustrate aspects of these embodiments more specifically.

Brief Description of the Drawings

[0020] The present disclosure may be more fully understood by considering the following detailed description in connection with the accompanying drawings.

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[0021] Aspects of the present disclosure are amenable to various modifications and alternative forms, and examples are shown in the drawings and described herein. However, it should be understood that the intention is not to limit aspects of the present disclosure to the specific embodiments described. Rather, the present disclosure is intended to cover all modifications, equivalents, and alternative forms within the spirit and scope thereof.

Mode for Carrying Out the Invention

[0022] The following description is to be read with reference to the drawings which are not necessarily to scale, and like reference numerals indicate like elements throughout several views. The detailed description and the drawings are intended to illustrate the present disclosure but not to limit it. Those skilled in the art will recognize that the various elements described and / or shown can be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and the drawings show exemplary embodiments of the present disclosure. However, for clarity and ease of understanding, not all features and / or elements may be shown in each drawing, but it can be understood that the features and / or elements exist nevertheless unless otherwise specified.

[0023] For the terms defined below, these definitions shall apply unless a different definition is provided in the claims or elsewhere in this specification. All numerical values are assumed to be modified by the term "about" whether explicitly indicated or not in this specification. The term "about" in the context of a numerical value generally refers to a range of numbers that a person of ordinary skill in the art would consider equivalent (e.g., having the same function or result) to the recited value. In many cases, the term "about" may include numbers that are rounded to the nearest significant digit. Other uses of the term "about" (e.g., in contexts other than numerical values) are to be understood from the context of this specification and may be assumed to have their ordinary customary definitions consistent with the context of this specification unless otherwise specified.

[0024] The recitation of a numerical range by endpoints includes all numbers within that range including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although some suitable dimensions, ranges, and / or values for various components, features, and / or specifications are disclosed, those skilled in the art driven by this disclosure will understand that the desired dimensions, ranges, and / or values may deviate from those explicitly disclosed.

[0025] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in the sense of "and / or" unless the context 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 though those features may be plural or repeated within the disclosed embodiments. Each example of a feature includes and / or may be encompassed by a singular disclosure unless explicitly stated otherwise. For purposes of simplicity and clarity, not all elements of the present disclosure are necessarily shown in each figure or described in detail below. However, it will be understood that the following description applies equally to any and / or all of the components present in more than one, unless explicitly stated otherwise. Further, for clarity, not all examples of some elements or features are shown in each figure.

[0026] Relative terms such as "proximal", "distal", "advancing", "retreating", and variations thereof may generally be considered with respect to the positioning, orientation, and / or movement of various elements relative to a user / operator / manipulator of the device, where "proximal" and "retreating" indicate or refer to being closer to or towards the user, and "distal" and "advancing" indicate or refer to being further from or away from the user. In some cases, the terms "proximal" and "distal" may be arbitrarily assigned for ease of understanding of the present disclosure, in which case it will be readily apparent to those skilled in the art. Other relative terms such as "upstream", "downstream", "inflow", and "outflow" refer to the direction of fluid flow within a lumen such as a body lumen, blood vessel, or within a device. Still other relative terms such as "axial", "circumferential", "longitudinal", "lateral", "radial", and / or variations thereof generally refer to the direction and / or orientation with respect to the central longitudinal axis of the disclosed structure or device.

[0027] The term "range" is to be understood to mean the maximum measured dimension of the stated or specified dimension, unless the range or dimension of the problem is preceded by "minimum" which can be understood to mean the minimum measured value of the stated or specified dimension or is specified as "minimum". For example, "outer range" may be understood to mean the outer dimension, "radial range" may be understood to mean the radial dimension, "longitudinal range" may be understood to mean the longitudinal dimension, and so on. Each example of "range" may be different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.) and will be apparent to those skilled in the art from the context of the individual usage. Generally, the "range" may be considered the largest dimension possible as measured according to the intended use, while the "minimum range" may be considered the smallest dimension possible as measured according to the intended use. In some cases, the "range" may generally be measured at right angles within a plane and / or cross-section, but may be measured differently, not limited to, angularly, radially, circumferentially (e.g., along an arc), etc., as will be apparent from the particular context.

[0028] The terms "monolithic" and "unitary" are generally intended to refer to one or more elements made or consisting of a single structure or base unit / element. Monolithic and / or unitary elements are to exclude structures and / or features made by assembling or otherwise joining a plurality of separate structures or elements together.

[0029] References to "embodiments", "some embodiments", "other embodiments", etc. in this specification are to be noted as indicating that the described embodiments may include certain features, structures, or characteristics, but not all embodiments necessarily include the specific features, structures, or characteristics. Further, such phrases do not necessarily refer to the same embodiment. Additionally, when a particular feature, structure, or property is described in relation to an embodiment, whether explicitly described or not, and unless clearly stated otherwise, it would be within the knowledge of those skilled in the art to bring about the particular feature, structure, or property in relation to other embodiments. That is, the various individual elements described below, even if not explicitly shown in a particular combination, are considered combinable or arrangeable with each other to form other additional embodiments or to complement and / or enhance the described embodiments, as would be understood by those skilled in the art.

[0030] For clarity, throughout the description and / or claims, certain identifying numerical nomenclature (e.g., first, second, third, fourth, etc.) may be used to name and / or distinguish the features of the various descriptions and / or claims. It is to be understood that the numerical nomenclature is not intended to be limiting and is merely illustrative. In some embodiments, for the sake of brevity and clarity, changes and departures from the previously used numerical nomenclature may be made. That is, a feature identified as the "first" element may later be referred to as the "second" element, the "third" element, etc., or may be completely omitted, and / or different features may be referred to as the "first" element. The meaning and / or name in each case will be apparent to those skilled in the art.

[0031] The following figures show selected components and / or arrangements of an implant for occluding the left atrial appendage, a system for occluding the left atrial appendage, and / or a method of using the implant and / or system. Note that in any given figure, some features may not be shown for simplicity or may be shown schematically. Further details regarding some of the components of the implant and / or system may be shown in more detail in other figures. Although described in the context of occluding the left atrial appendage, the implant and / or system may also be used for other interventions and / or percutaneous medical procedures within a patient. Similarly, the devices and methods described herein with respect to percutaneous placement may be used, as appropriate, in other types of surgical procedures. For example, in some instances, the device may be used in non-percutaneous procedures. The devices and methods according to the present disclosure may also be adapted and configured for other uses within an anatomical structure.

[0032] Figures 1-2 show selected components and / or arrangements of a system 10 for occluding the left atrial appendage 50 (e.g., FIG. 5). Note that in any given figure, some features of the system 10 may not be shown for simplicity or may be shown schematically. Further details regarding some of the components of the system 10 may be shown in more detail in other figures. The system 10 may be used to percutaneously deliver and / or position various medical implants (e.g., cardiovascular medical implants, occlusive medical implants, replacement heart valve implants, etc.) at one or more locations within an anatomical structure, which in some embodiments includes the heart, but is not limited thereto.

[0033] System 10 may include a delivery sheath 40 having a lumen 42 extending from a proximal opening to a distal opening, a core wire 30 slidably disposed within the lumen 42, and an implant 100 for occluding the left atrial appendage 50 (e.g., FIG. 5). The implant 100 may include an expandable framework (e.g., FIGS. 3-4) configured to transition between a collapsed configuration (e.g., FIG. 1) and an expanded configuration (e.g., FIG. 2), and the implant 100 is disposed near the distal opening within the lumen 42 in the collapsed configuration, and the implant 100 and / or the expandable framework 110 are configured to transition between the collapsed configuration and the expanded configuration when the implant 100 is disposed at the distal opening of the lumen 42 and / or distally of the delivery sheath 40 and / or when the implant 100 is not constrained by the delivery sheath 40. In at least some embodiments, the expandable framework 110 may be self-biased toward the expanded configuration.

[0034] The implant 100 may be disposed at and / or removably fixable to the distal portion and / or distal end of the core wire 30. The core wire 30 may be slidably and / or rotatably disposed within the lumen 42 of the delivery sheath 40. In some embodiments, the proximal end of the core wire 30 may extend proximally of the proximal end of the delivery sheath 40 and / or proximally of the proximal opening of the lumen 42 for manual manipulation by a clinician or practitioner. In some embodiments, the implant 100 may be removably attached, joined, fixed, or otherwise coupled to the distal end of the core wire 30. The core wire 30 may be configured to axially translate the implant 100 relative to the delivery sheath 40 and / or may be capable of axially translating. The delivery sheath 40 and / or the core wire 30 may have a selected level of axial stiffness and / or pushability characteristics while also having a selected level of flexibility that enables navigation through the patient's vasculature.

[0035] Some suitable but non-limiting examples of materials for the system 10, the core wire 30, the delivery sheath 40, and / or the implant 100, etc., are described below. It is contemplated that any and / or all of the exemplary implants disclosed herein may be used in accordance with and / or associated with the exemplary system 10 described above.

[0036] Next, referring to FIGS. 3 and 4, the implant 100 may include an expandable framework 110 configured to transition between a collapsed configuration and an expanded configuration along a longitudinal axis 102 (e.g., FIG. 4). In the collapsed configuration, the expandable framework 110 may be elongated axially and / or compressed radially. In the expanded configuration, the expandable framework 110 may be shortened axially and / or expanded radially. The expandable framework 110 may include a plurality of interconnected struts that define a plurality of cells. In some embodiments, the plurality of cells may be a plurality of closed cells. In some embodiments, the plurality of cells may be a plurality of open cells. In some embodiments, the plurality of cells may include a plurality of open cells and a plurality of closed cells in various combinations and / or arrangements. In some embodiments, the plurality of interconnected struts may converge, join, and / or connect at intersections or nodes.

[0037] The plurality of interconnected struts may be formed and / or cut out from a tubular member. In some embodiments, the plurality of interconnected struts may be integrally formed and / or cut out from a single member. In some embodiments, the plurality of interconnected struts are integrally formed and / or cut out from a single tubular member and then formed and / or heat set into the desired shape in the expanded form. In some embodiments, the plurality of interconnected struts are integrally formed and / or cut out from a single flat member or sheet and then wound or formed into a tubular structure and then formed and / or heat set into the desired shape in the expanded form. Some exemplary means and / or methods for fabricating and / or forming the plurality of interconnected struts include laser cutting, machining, punching, stamping, electrical discharge machining (EDM), chemical dissolution, and the like. Other means and / or methods are contemplated.

[0038] In some embodiments, the expandable framework 110 is flexible and can substantially conform to and / or engage in a sealing engagement with the shape and / or geometry of the sidewall of the left atrial appendage 50 (e.g., FIG. 5) in its expanded form. In some embodiments, the implant 100 may expand to a size, extent, or shape that is less than the maximum unconstrained extent or different from the maximum unconstrained extent as determined by the surrounding tissue and / or sidewall of the left atrial appendage 50. In some embodiments, reducing the thickness of various elements of the expandable framework 110 increases the flexibility and pliability of the expanded framework 110 and / or the implant 100, thereby enabling the expanded framework 110 and / or the implant 100 to conform to the surrounding tissue rather than conforming the tissue to the expanded framework 110 and / or the implant 100. In some embodiments, the expandable framework 110 and / or the implant 100 may be stronger and / or less flexible, and thus, the expandable framework 110 and / or the implant 100 may conform the tissue of the left atrial appendage 50 to the expandable framework 110 and / or the implant 100. Other configurations are contemplated.

[0039] As shown in FIG. 4, the expandable framework 110 may include a proximal hub 112 and a distal hub 114. The longitudinal axis 102 of the expandable framework 110 may extend from the proximal hub 112 to the distal hub 114. In at least some embodiments, the proximal hub 112 and / or the distal hub 114 may be centered about and / or coaxial with the longitudinal axis 102. A plurality of interconnected struts may be joined together and / or fixedly attached at the proximal hub 112 and / or the distal hub 114. The proximal hub 112 may be configured to releasably connect, secure, and / or attach the implant 100 and / or the expandable framework 110 to the core wire 30 (e.g., FIGS. 1-2). In some embodiments, the proximal hub 112 may include a female thread configured to rotatably and / or threadedly engage the male-threaded distal end of the core wire 30. Other configurations for releasably securing the implant 100 to the core wire 30 are also contemplated.

[0040] Returning to FIG. 3, in some embodiments, the implant 100 may optionally include an occlusion element 120 connected to, disposed on, disposed over, disposed around, and / or disposed radially outside of at least a portion of the expandable framework 110 and / or the plurality of interconnected struts. In some embodiments, the occlusion element 120 may be attached to the proximal hub 112 and / or attached to the expandable framework at the proximal hub 112. In some embodiments, the occlusion element 120 may extend radially outward from the proximal hub 112 and / or distally. In some embodiments, the occlusion element 120 may be attached and / or secured to the expandable framework 110 at a plurality of discrete locations.

[0041] In some embodiments, the occlusion element 120 may include a membrane, fabric, mesh, tissue element, or another suitable structure. In some embodiments, the occlusion element 120 may be porous. In some embodiments, the occlusion element 120 may be non-porous. In some embodiments, the occlusion element 120 may be permeable or impermeable to other fluids such as blood and / or water. In some embodiments, the occlusion element 120 may be designed, sized, and / or configured to prevent thrombus and / or embolic material from exiting the left atrial appendage 50 and entering the left atrium 58 (e.g., FIG. 5) and / or the patient's bloodstream. In some embodiments, the occlusion element 120 (e.g., a membrane, fabric, or tissue element, etc.) promotes endothelialization after implantation, thereby effectively excluding the target site (e.g., the left atrial appendage 50, etc.) from the patient's circulatory system. Some suitable but non-limiting examples of materials for the occlusion element 120 are described below.

[0042] Next, considering FIGS. 4 and 5, the implant 100 may include radiopaque markers 130. In some embodiments, the radiopaque markers 130 may include a plurality of radiopaque markers 130 spaced around the outer periphery of the expandable framework 110. In some embodiments, the implant 100 may include a first radiopaque marker 132, a second radiopaque marker 134, and a third radiopaque marker 136. More or fewer radiopaque markers 130 are also contemplated. For example, the implant 100 may include 4, 5, 6, 8, 10, 12, 15, 18, etc. radiopaque markers. In some embodiments, the plurality of radiopaque markers 130 may include at least a first radiopaque marker 132, a second radiopaque marker 134, and a third radiopaque marker 136. In some embodiments, the plurality of radiopaque markers 130 may be equally spaced around the outer periphery of the expandable framework 110. For example, the plurality of radiopaque markers 130 may be spaced approximately 120 degrees from each other. Other spacings are also contemplated and, in some embodiments, the spacing may depend on how many radiopaque markers 130 are present. For example, the plurality of radiopaque markers 130 may be spaced at intervals of approximately 180 degrees, approximately 120 degrees, approximately 90 degrees, approximately 72 degrees, approximately 60 degrees, approximately 45 degrees, approximately 30 degrees, etc. In some embodiments, the plurality of radiopaque markers 130 may be variably spaced around the outer periphery of the expandable framework 110. Other configurations are also contemplated.

[0043] As can be seen in the side partial cross-sectional view of FIG. 5, the implant 100 may be positioned within the left atrial appendage 50. The left atrial appendage 50 may have a complex geometry and / or an irregular surface area. The left atrial appendage 50 is associated with and communicates with the left atrium 58 of the patient's heart. One of ordinary skill in the art will recognize that the illustrated left atrial appendage 50 is but one of many possible shapes and sizes of left atrial appendages 50 that may vary from patient to patient. One of ordinary skill in the art will also recognize that the medical devices and methods disclosed herein may be adapted to various sizes and shapes of the left atrial appendage 50 as needed. The left atrial appendage 50 may include a generally longitudinal axis disposed along the depth of the body of the left atrial appendage 50 defined by the side wall 54. The left atrial appendage 50 may include a small aperture 52 that forms a proximal orifice into the left atrium 58. In some embodiments, the lateral extent of the small aperture 52 and / or the side wall 54 may be less than or at least less than the depth of the body, or the depth of the body may be greater than the lateral extent of the small aperture 56 and / or the side wall 54. In some embodiments, the left atrial appendage 50 may include a most distal region formed or disposed as a tail-like element associated with the distal portion of the body. In some embodiments, the most distal region may project radially or laterally away from the body.

[0044] The radiopaque marker 130 and / or a plurality of radiopaque markers 130 may be longitudinally positioned between the proximal hub 112 and the distal hub 114 in the expanded configuration. For example, the radiopaque marker 130 and / or a plurality of radiopaque markers 130 may be positioned distal to the proximal hub 112 and proximal to the distal hub 114. In another example, a plane oriented perpendicular to the longitudinal axis 102 and extending through the radiopaque marker 130 and / or a plurality of radiopaque markers 130 may be positioned distal to the proximal hub 112 and proximal to the distal hub 114. In some embodiments, the first radiopaque marker 132 may be longitudinally positioned between the proximal hub 112 and the distal hub 114 in the expanded configuration, the second radiopaque marker 134 may be longitudinally positioned between the proximal hub 112 and the distal hub 114 in the expanded configuration, and the third radiopaque marker 136 may be longitudinally positioned between the proximal hub 112 and the distal hub 114 in the expanded configuration. For example, the first radiopaque marker 132, the second radiopaque marker 134, and the third radiopaque marker 136 may be positioned distal to the proximal hub 112 and proximal to the distal hub 114. In another example, a plane oriented perpendicular to the longitudinal axis 102 and extending through the first radiopaque marker 132, the second radiopaque marker 134, and / or the third radiopaque marker 136 may be positioned distal to the proximal hub 112 and proximal to the distal hub 114. In some embodiments, the first radiopaque marker 132, the second radiopaque marker 134, and the third radiopaque marker 136 may define a plane 138 for positioning the expandable framework 110 within, at, and / or relative to the small aperture 52 of the left atrial appendage 50 in the expanded configuration.

[0045] In some embodiments, the radiopaque marker 130 and / or the plurality of radiopaque markers 130 may be used as reference markers for viewing their positions under fluoroscopy (or another type of imaging) relative to some background anatomical structures (e.g., ribs, etc.) when a tagging test is performed to evaluate the anchoring. If the radiopaque marker 130 and / or the plurality of radiopaque markers 130 are positioned at a starting position and end at another position, the imaging indicates that the implant 100 and / or the expandable framework 110 has migrated. Alternatively, if the radiopaque marker 130 and / or the plurality of radiopaque markers 130 remain fixed at the starting position after the test, the implant 100 and / or the expandable framework 110 has not moved and is securely anchored.

[0046] In some embodiments, the plurality of radiopaque markers 130 may be used as placement aids. For example, when the implant 100 and / or the expandable framework 110 exits the delivery sheath 40 and / or when the expandable framework 110 begins to transition to its expanded form, the plurality of radiopaque markers 130 can begin to move apart from each other under fluoroscopy (or another type of imaging), indicating that the implant 100 and / or the expandable framework 110 is opening and / or approaching the final stage of placement. In some embodiments, the plurality of radiopaque markers 130 can assist the physician in positioning the implant 100 during placement so that an ideal position can be achieved during the initial placement.

[0047] In some embodiments, the plurality of radiopaque markers 130 may be used to perform size measurements for compression under fluoroscopy (or another type of imaging). In some embodiments, the plurality of radiopaque markers 130 may be used to ensure sealing of the implant 100 against the ostium 52 and / or the sidewall 54 of the left atrial appendage 50 when a contrast agent puff is also used. Other configurations and / or uses are contemplated.

[0048] As described above, for ease of understanding, certain features of the present disclosure may be described in the singular, even if those features may be plural or repeated within the disclosed embodiments. Each example of a feature includes, and / or may be encompassed by, a singular disclosure unless explicitly stated otherwise. For purposes of simplification and clarity, not all elements of the present disclosure are necessarily shown in each figure or described in detail below. However, it will be understood that the following description may be equally applicable to any and / or all of the components present in more than one, unless explicitly stated otherwise. Thus, any one and / or all of a plurality of radiopaque markers 130, and / or a first radiopaque marker 132, a second radiopaque marker 134, and a third radiopaque marker 136, etc. may be encompassed by the present disclosure.

[0049] FIG. 6 shows a configuration of a radiopaque marker 130 (and / or a plurality of radiopaque markers 130, a first radiopaque marker 132, a second radiopaque marker 134, and a third radiopaque marker 136, etc.) when viewed from the outside of the implant 100 and / or the expandable framework 110. In some embodiments, the radiopaque marker 130 may include a body portion 140. In some embodiments, the radiopaque marker may include a proximal leg 142 and a distal leg 144. In some embodiments, the radiopaque marker may include a first lateral tab 146 and a second lateral tab 152. In at least some embodiments, the body portion 140 may be disposed and / or positioned relative to the outer surface of the expandable framework 110. In some alternative embodiments, the body portion 140 may be disposed and / or positioned relative to the inner surface of the expandable framework 110. Other configurations are contemplated.

[0050] In some embodiments, the body portion 140 may be positioned at and / or relative to an intersection or node of a plurality of interconnected struts of the expandable framework 110. In some embodiments, the body portion 140 may be positioned at and / or relative to a radially outermost intersection or node of a plurality of interconnected struts of the expandable framework 110. In some embodiments, the body portion 140 may be positioned at and / or relative to a proximal intersection or node of a plurality of interconnected struts of the expandable framework 110. Other configurations are contemplated.

[0051] As can be seen in the cross-sectional view of FIG. 7, the first lateral tab 146 may extend laterally in a first direction from the body portion 140. The second lateral tab 152 may extend laterally in a second direction opposite the first direction from the body portion 140. In some embodiments, the first intermediate portion 148 of the first lateral tab 146 may extend in the first direction from the body portion 140. The first intermediate portion 148 of the first lateral tab 146 may extend radially inwardly toward the longitudinal axis 102 and / or toward the interior of the implant 100 and / or the expandable framework 110. In some embodiments, the second intermediate portion 154 of the second lateral tab 152 may extend in the second direction from the body portion 140. The second intermediate portion 154 of the second lateral tab 152 may extend radially inwardly toward the longitudinal axis 102 and / or toward the interior of the implant 100 and / or the expandable framework 110. In some embodiments, the first free end 150 of the first lateral tab 146 may extend laterally in the second direction from the first intermediate portion 148 of the first lateral tab 146. In some embodiments, the second free end 156 of the second lateral tab 152 may extend laterally in the first direction from the second intermediate portion 154 of the second lateral tab 152. In some embodiments, the first lateral tab 146 and the second lateral tab 152 may be wrapped around a portion of the expandable framework 110. For example, the first lateral tab 146 and the second lateral tab 152 may be wrapped around the intersection or node of a plurality of interconnected struts of the expandable framework 110. In some embodiments, at least a portion of the second free end 156 of the second lateral tab 152 may overlap the first free end 150 of the first lateral tab 146. In some embodiments, at least a portion of the second lateral tab 152 may extend radially inwardly closer to the longitudinal axis 102 than the first lateral tab 146. In some embodiments, the second free end 156 of the second lateral tab 152 may extend radially inwardly closer to the longitudinal axis 102 than the first free end 150 of the first lateral tab 146.In some embodiments, the first free end 150 of the first transverse tab 146 may be adjacent to the second free end 156 of the second transverse tab 152. In such embodiments, the first free end 150 and the second free end 156 may be substantially equidistant from the longitudinal axis 102. Other configurations are contemplated.

[0052] Returning briefly to FIG. 6, the radiopaque marker 130 (and / or multiple radiopaque markers 130 and / or the first radiopaque marker 132, the second radiopaque marker 134, and the third radiopaque marker 136, etc.) may define a transverse extent 160 and a longitudinal extent 162. In at least some embodiments, the longitudinal extent 162 may be greater than the transverse extent 160. The longitudinal extent 162 may be oriented longitudinally with respect to the expandable framework 110. Other configurations are contemplated.

[0053] As seen in FIGS. 6 and 8, the proximal leg 142 may extend longitudinally from the body portion 140 towards the proximal end of the implant 100 and / or the expandable framework 110, and / or the proximal leg 142 may extend radially inwardly from the body portion 140 towards the longitudinal axis 102 and / or into the interior of the implant 100 and / or the expandable framework 110. The distal leg 144 may extend longitudinally from the body portion 140 towards the distal end of the implant 100 and / or the expandable framework 110, and / or the distal leg 144 may extend radially inwardly from the body portion 140 towards the longitudinal axis 102 and / or into the interior of the implant 100 and / or the expandable framework 110.

[0054] In some embodiments, the proximal leg portion 142 extends radially inwardly from the body portion 140 toward the longitudinal axis 102 and / or toward the interior of the implant 100 and / or the expandable framework 110 until the free end of the proximal leg portion 142 is disposed radially inwardly of the inner surface of the expandable framework 110. In some embodiments, the proximal leg portion 142 extends radially inwardly from the body portion 140 toward the longitudinal axis 102 and / or toward the interior of the implant 100 and / or the expandable framework 110 until the free end of the proximal leg portion 142 is disposed substantially in the same plane as the inner surface of the expandable framework 110. In some embodiments, the distal leg portion 144 extends radially inwardly from the body portion 140 toward the longitudinal axis 102 and / or toward the interior of the implant 100 and / or the expandable framework 110 until the free end of the distal leg portion 144 is disposed radially inwardly of the inner surface of the expandable framework 110. In some embodiments, the distal leg portion 144 extends radially inwardly from the body portion 140 toward the longitudinal axis 102 and / or toward the interior of the implant 100 and / or the expandable framework 110 until the free end of the distal leg portion 144 is disposed substantially in the same plane as the inner surface of the expandable framework 110. Other configurations are contemplated.

[0055] In some embodiments, the radiopaque marker 130 may be made by punching and / or stamping the radiopaque marker 130 from a flat sheet or strip of material and then formed using one or more suitable methods. In some embodiments, the radiopaque marker 130 may be laser cut from a flat sheet or strip of material and then formed using one or more suitable methods. In some embodiments, the radiopaque marker 130 may be formed by die casting, injection molding, or the like. In some embodiments, the radiopaque marker 130 may be cut out and formed using a progressive die in a stamping machine or other similar method. In some embodiments, the radiopaque marker 130 may be crimped onto the expandable framework 110. In some embodiments, the radiopaque marker 130 may be adhered and / or welded onto the expandable framework 110. Other configurations and / or methods are contemplated.

[0056] In some embodiments, the radiopaque marker 130 may be formed from a material different from that of the expandable framework 110. In some embodiments, the radiopaque marker 130 may have a density different from that of the expandable framework 110. In at least some embodiments, the radiopaque marker 130 may have a density greater than that of the expandable framework 110. Some suitable but non-limiting examples of materials for the radiopaque marker 130, the plurality of radiopaque markers 130, the first radiopaque marker 132, the second radiopaque marker 134, and the third radiopaque marker 136, etc. are described below.

[0057] As described above, the system 10 for occluding the left atrial appendage 50 may include a delivery sheath 40 having a lumen 42 extending therein and a core wire 30 slidably disposed within the lumen 42 of the delivery sheath 40. When preparing for the procedure, the implant 100 needs to be moved into the lumen 42 of the delivery sheath 40. In some examples, the implant 100 may need to be re-sheathed and / or moved back into the lumen 42 of the delivery sheath 40 in situ, such as when the implant 100 needs to be repositioned and / or removed before being released. FIG. 9 shows selected aspects of the system 10 and / or the implant 100 when the implant 100 is being moved into the lumen 42 of the delivery sheath 40. For clarity, not all elements and / or features of the implant 100 are shown (or not shown in their entirety).

[0058] As seen in FIG. 9, when the implant 100 is being moved into the lumen 42 of the delivery sheath 40, the proximal leg 142 of the radiopaque marker 130 (and / or multiple radiopaque markers 130, first radiopaque marker 132, second radiopaque marker 134, and third radiopaque marker 136, etc.) may engage the distal-most end 44 of the delivery sheath 40 and act as a ramp for guiding and / or biasing the expandable framework 110 radially inwardly away from the inner surface of the delivery sheath 40. In at least some embodiments, the occlusion element 120 may be disposed between the radiopaque marker 130 (and / or multiple radiopaque markers 130, first radiopaque marker 132, second radiopaque marker 134, and third radiopaque marker 136, etc.) and / or the proximal leg 142 and the distal-most end 44 of the delivery sheath 40. However, the occlusion element 120 does not adversely affect the inclination and / or guiding function of the proximal leg 142 of the radiopaque marker 130 (and / or multiple radiopaque markers 130, first radiopaque marker 132, second radiopaque marker 134, and third radiopaque marker 136, etc.).

[0059] FIG. 10 shows an alternative configuration of the radiopaque marker 230 associated with the implant 100. In accordance with other parts of the present disclosure, in some embodiments, the radiopaque marker 230 may include a plurality of radiopaque markers 230 and / or a first radiopaque marker, a second radiopaque marker, a third radiopaque marker, etc., and is described in the singular for simplicity. The radiopaque marker 230 may include a tubular member 240 disposed radially inward of the inner surface of the expandable framework 110. In some embodiments, the radiopaque marker 230 and / or the tubular member 240 may be fixed to the inner surface of the expandable framework 110. In some embodiments, the radiopaque marker 230 and / or the tubular member 240 may be positioned at and / or relative to the intersection or node of a plurality of interconnected struts of the expandable framework 110. In some embodiments, the radiopaque marker 230 and / or the tubular member 240 may be positioned at and / or relative to the radially outermost intersection or node of a plurality of interconnected struts of the expandable framework 110. In some embodiments, the radiopaque marker 230 and / or the tubular member 240 may be positioned at and / or relative to the proximal intersection or node of a plurality of interconnected struts of the expandable framework 110. Other configurations are contemplated.

[0060] In some embodiments, the radiopaque marker 230 and / or the tubular member 240 may be fixed to and / or with respect to the expandable framework 110 using a filament 244 that extends through the lumen 242 of the tubular member 240 and / or the radiopaque marker 230. In some embodiments, the filament 244 may be a suture, wire, or other suitable element. In some embodiments, the filaments 244 may be fixed and / or secured together at a fixing element 246. The fixing element 246 may be a knot, weld, or other means of fixing the filaments 244. Other configurations are contemplated.

[0061] In some embodiments, the radiopaque marker 230 (and / or multiple radiopaque markers 230 and / or a first radiopaque marker, a second radiopaque marker, and a third radiopaque marker, etc.) and / or the tubular member 240 may define a lateral extent and a longitudinal extent. In at least some embodiments, the longitudinal extent may be greater than the lateral extent. The longitudinal extent may be oriented longitudinally with respect to the expandable framework 110. Other configurations are contemplated.

[0062] FIG. 11 shows an alternative configuration of the radiopaque marker 330 associated with the implant 100. In accordance with other parts of the present disclosure, in some embodiments, the radiopaque marker 330 may include a plurality of radiopaque markers 330 and / or a first radiopaque marker, a second radiopaque marker, a third radiopaque marker, etc., and is described in the singular for simplicity. The radiopaque marker 330 may include a flat plate 340 disposed radially inward of the inner surface of the expandable framework 110. In some embodiments, the radiopaque marker 330 and / or the flat plate 340 may be fixed to the inner surface of the expandable framework 110. In some embodiments, the radiopaque marker 330 and / or the flat plate 340 may be positioned at and / or relative to an intersection or node of a plurality of interconnected struts of the expandable framework 110. In some embodiments, the radiopaque marker 330 and / or the flat plate 340 may be positioned at and / or relative to the radially outermost intersection or node of a plurality of interconnected struts of the expandable framework 110. In some embodiments, the radiopaque marker 330 and / or the flat plate 340 may be positioned at and / or relative to the proximal intersection or node of a plurality of interconnected struts of the expandable framework 110. Other configurations are contemplated.

[0063] In some embodiments, the radiopaque marker 330 and / or the flat plate 340 may be fixed to the inner surface of the expandable framework 110 using filaments 344. In some embodiments, the filaments 344 may be sutures, wires, or other suitable elements. In some embodiments, the filaments 344 may pass through one or more openings in the flat plate 340. In some embodiments, the filaments 344 may be fixed and / or anchored to the flat plate 340 at one or more fixing elements 346. The one or more fixing elements 346 may be knots, welds, or other means of fixing the filaments 344. In one example, the filaments 344 may be wires that are welded to the flat plate 340 at one or more fixing elements 346. Other configurations are contemplated.

[0064] In some embodiments, the radiopaque marker 330 (and / or multiple radiopaque markers 330 and / or a first radiopaque marker, a second radiopaque marker, and a third radiopaque marker, etc.) and / or the flat plate 340 may define a lateral extent and a longitudinal extent. In at least some embodiments, the longitudinal extent may be greater than the lateral extent. The longitudinal extent may be oriented longitudinally with respect to the expandable framework 110. Other configurations are contemplated.

[0065] FIG. 12 shows an alternative configuration of the radiopaque marker 430 associated with the implant 100 and / or the occlusion element 120. In accordance with other parts of the present disclosure, in some embodiments, the radiopaque marker 430 may include a plurality of radiopaque markers 430 and / or a first radiopaque marker, a second radiopaque marker, a third radiopaque marker, etc., and is described in the singular for simplicity. The radiopaque marker 430 may include a flat element 440 disposed radially outward of the outer surface of the expandable framework 110. In some embodiments, the radiopaque marker 430 and / or the flat element 440 may be positioned at and / or cover an intersection or node of a plurality of interconnected struts of the expandable framework 110. In some embodiments, the radiopaque marker 430 and / or the flat element 440 may be positioned at and / or cover the radially outermost intersection or node of a plurality of interconnected struts of the expandable framework 110. In some embodiments, the radiopaque marker 430 and / or the flat element 440 may be positioned at and / or cover the proximal intersection or node of a plurality of interconnected struts of the expandable framework 110. Other configurations are contemplated.

[0066] In contrast to other examples described herein, the radiopaque marker 430 and / or the flat element 440 may be fixed to and / or fixedly attached to the occlusion element 120. In some embodiments, the radiopaque marker 430 and / or the flat element 440 may be at least partially embedded within the occlusion element 120. In some embodiments, the flat element 440 may be partially exposed inside or outside the occlusion element 120, as seen in FIG. 13. In some embodiments, the flat element 440 may be completely embedded within the occlusion element 120.

[0067] In some embodiments, the occlusion element 120 may include a first layer 122 and a second layer 124. In some embodiments, at least a portion of the flat element 440 may be disposed between the first layer 122 and the second layer 124 of the occlusion element 120. In some embodiments, the first layer 122 and the second layer 124 of the occlusion element 120 may be fixedly attached to each other. In one example, the first layer 122 of the occlusion element 120 may be adhered to the second layer 124 of the occlusion element 120. In another example, the first layer 122 of the occlusion element 120 may be welded to the second layer 124 of the occlusion element 120. Other configurations are contemplated.

[0068] In some embodiments, the outer contact surface of the flat element 440 may be engaged with, adhered to, and / or face the inner contact surface of the occlusion element 120, the inner contact surface of the flat element 440 may face outwardly from the occlusion element 120, and / or may face toward the interior of the implant 100 and / or the expandable framework 110. Other configurations are contemplated.

[0069] In some embodiments, the flat element 440 may include a first flange 442 at and / or near the proximal end of the flat element 440 and a second flange 444 at and / or near the distal end of the flat element 440. In some embodiments, the first flange 442 and / or the second flange 444 may be embedded within the occlusion element 120 and / or may be disposed between the first layer 122 and the second layer 124 of the occlusion element 120. In some embodiments, the outer contact surface of the first flange 442 may face toward the first layer 122 of the occlusion element 120, and the inner contact surface of the first flange 442 may face toward the second layer 124 of the occlusion element 120. In some embodiments, the outer contact surface of the second flange 444 may face toward the first layer 122 of the occlusion element 120, and the inner contact surface of the second flange 444 may face toward the second layer 124 of the occlusion element 120. Other configurations are contemplated.

[0070] In some embodiments, the first flange 442 of the flat element 440 may be fixedly attached to the first layer 122 and / or the second layer 124 of the occlusion element 120. In some embodiments, the second flange 444 of the flat element 440 may be fixedly attached to the first layer 122 and / or the second layer 124 of the occlusion element 120. In some embodiments, the first flange 442 of the flat element 440 and the second flange 444 of the flat element 440 may be fixedly attached to the first layer 122 and / or the second layer 124 of the occlusion element 120. Other configurations are contemplated.

[0071] In some embodiments, the radiopaque marker 430 (and / or multiple radiopaque markers 430 and / or a first radiopaque marker, a second radiopaque marker, and a third radiopaque marker, etc.) and / or the flat element 440 may define a lateral extent and a longitudinal extent. In at least some embodiments, the longitudinal extent may be greater than the lateral extent. The longitudinal extent may be oriented longitudinally with respect to the expandable framework 110. Other configurations are contemplated.

[0072] The various components of the systems disclosed herein (and / or other elements disclosed herein) and the various materials that may be used for the various components of the various components may include those commonly associated with medical devices and / or systems. For simplicity, the following description refers to the system. However, this description may be applicable to, but not limited to, implants, delivery sheaths, core wires, expandable frameworks, occlusion elements, etc., and / or other elements, members, components, or devices disclosed herein such as those elements or components thereof, and this is not intended to limit the devices and methods described herein.

[0073] In some embodiments, the system and / or its components may be made of metal, metal alloy, polymer (some examples of which are disclosed below), metal-polymer composite material, ceramic, combinations thereof, etc., or other suitable materials.

[0074] Some examples of suitable metals and metal alloys include stainless steels such as 444V, 444L, and 314LV stainless steel; mild steel; nickel-titanium alloys such as linear elastic and / or superelastic Nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS:N06625 such as INCONEL® 625, UNS:N06022 such as HASTELLOY® C-22, UNS:N10276 such as HASTELLOY® C276, other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS:N04400 such as MONEL® 400, NICKELVAC™ 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035 such as MP35-N™), nickel-molybdenum alloys (e.g., UNS:N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS:R44003 such as ELGILOY®, PHYNOX®); platinum-reinforced stainless steel; titanium; combinations thereof; equivalents; or any other suitable materials.

[0075] As suggested herein, within the family of commercially available nickel-titanium alloys or nitinol alloys, there is a category referred to as "linear elastic" or "non-superelastic", which may be chemically similar to conventional shape memory and superelastic species, but may exhibit distinct useful mechanical properties. Linear elastic and / or non-superelastic nitinol can be distinguished from superelastic nitinol in that in its stress / strain curve, it does not exhibit a substantial "superelastic plateau" or "flag region" as shown by superelastic nitinol. Instead, in linear elastic and / or non-superelastic nitinol, as the recoverable strain increases, the stress increases in a relationship that is substantially linear, or somewhat linear but not necessarily perfectly linear until plastic deformation begins, or at least more linear than the superelastic plateau and / or flag region that can be seen in superelastic nitinol. Thus, for the purposes of the present disclosure, linear elastic and / or non-superelastic nitinol may also be referred to as "substantially" linear elastic and / or non-superelastic nitinol.

[0076] Also, in some cases, linear elastic and / or non-superelastic nitinol can be distinguished from superelastic nitinol in that it can tolerate strains up to about 2 - 5% while remaining substantially elastic (e.g., prior to plastic deformation), whereas superelastic nitinol can tolerate strains up to about 8% prior to plastic deformation. Both of these materials can be distinguished from other linear elastic materials, such as stainless steel, which can only tolerate strains of about 0.2 - 0.44 percent prior to plastic deformation (which can also be distinguished based on its composition).

[0077] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy is an alloy that does not exhibit a martensite / austenite phase change detectable by differential scanning calorimetry (DSC) and dynamic mechanical thermal analysis (DMTA) 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 change detectable by DSC and DMTA analysis in the range of about -60°C to about 120°C. Thus, the mechanical bending properties of such materials can generally be inert to the influence 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 temperature or room temperature are substantially the same as the mechanical properties at body temperature, for example, in that they do not exhibit a superelastic plateau and / or flag region. In other words, over a wide temperature range, the linear elastic and / or non-superelastic nickel-titanium alloy maintains its linear elastic and / or non-superelastic properties and / or characteristics.

[0078] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may be in the range of about 50 to about 60 weight percent nickel, with the balance being essentially titanium. In some embodiments, the composition is in the range of about 54 to about 57 weight percent nickel. An example of a suitable nickel-titanium alloy is the FHP-NT alloy commercially available from Furukawa Techno-Material Co., Ltd. located in Kanagawa Prefecture, Japan. Other suitable materials include ULTANIUM (trademark) (available from Neo-Metrics) and GUM METAL (registered trademark) (available from Toyota). In some other embodiments, a superelastic alloy, such as superelastic nitinol, may be used to achieve the desired properties.

[0079] In at least some embodiments, some or all of the systems and / or other elements disclosed herein may also be doped with a radiopaque material, made from a radiopaque material, or otherwise include a radiopaque material. A radiopaque material is understood to be a material that can generate a relatively bright image with a fluoroscopic screen or another imaging technique during a medical procedure. This relatively bright image assists the user in determining the position and / or orientation of the systems and / or other elements disclosed herein. Some examples of radiopaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, and the like.

[0080] In some embodiments, some degree of magnetic resonance imaging (MRI) compatibility is imparted to the systems and / or other elements disclosed herein. For example, the system and / or its components or parts may be made of a material that does not substantially distort the image and does not generate substantial artifacts (i.e., gaps within the image). For example, certain ferromagnetic materials may not be suitable as they may have the potential to generate artifacts in the MRI image. The system or a part thereof may be made of a material that can be imaged by an MRI machine. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R44003 such as ELGILOY®, PHYNOX®), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035 such as MP35-N™), nitinol, and others.

[0081] In some embodiments, the systems and / or other elements disclosed herein may be made of or include a polymer or other suitable material. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block ester, polyurethane (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester copolymers (e.g., other polyester elastomers such as butylene / poly(alkylene ether) phthalate and / or HYTREL® available from DuPont), polyamide (e.g., DURETHAN® available from Bayer or CRISTAMID™ available from Elf Atochem), elastomeric polyamide, block polyamide / ether, polyether block amide (PEBA, e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), MARLEX® high density polyethylene, MARLEX® low density polyethylene, linear low density polyethylene (e.g., REXELL™), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon 12 (EMS AmericanThose available from Grilon, such as GRILAMID®), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomer, biocompatible polymer, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites thereof, etc. may be mentioned. In some embodiments, the sheath may be mixed with a liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0082] In some embodiments, the systems and / or other elements disclosed herein may include a fabric material covering or disposed within a structure. The fabric material may be composed of a biocompatible material such as a polymer material or a biological material adapted to promote in-growth within the tissue. 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.

[0083] In some embodiments, the systems and / or other elements disclosed herein may include a textile material and / or may be formed from a textile material. Some examples of suitable textile materials may include synthetic yarns that can be flat, shaped, twisted, textured, pre-shrunk, or non-shrinking. Suitable synthetic biocompatible yarns for use in the present disclosure include polyesters including polyethylene terephthalate (PET) polyester, polypropylene, polyethylene, polyurethane, polyolefin, polyvinyl, polymethyl acetate, polyamide, naphthalene dicarboxylate derivatives, natural silk, and polytetrafluoroethylene, but are not limited thereto. Further, at least one of the synthetic yarns may be a metal yarn or a glass or ceramic yarn or fiber. Useful metal yarns include those made from or containing stainless steel, platinum, gold, titanium, tantalum, or Ni-Co-Cr-based alloys. The yarn may further include carbon, glass, or ceramic fibers. Desirably, the yarn is made from a thermoplastic material including, but not limited to, polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, etc. The yarn may be multifilament, monofilament, or of the staple type. The type and denier of the yarn selected may be selected to be biocompatible and implantable prostheses, more specifically, to form a vascular structure having desirable properties.

[0084] In some embodiments, the systems and / or other elements disclosed herein may include a suitable therapeutic agent and / or may be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents include, but are not limited to, antithrombotic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrorphan proline arginine chloromethyl ketone)); antiproliferative agents (such as enoxaparin, angiotensin, monoclonal antibodies that can block smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine); antitumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vincristine, vinblastine, epothilone, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (such as lidocaine, bupivacaine, and ropivacaine); anticoagulants (such as D-Phe-Pro-Arg chloromethyl ketone, RGD peptide-containing compounds, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides); vasocyte growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional activators, and translational promoters); vasocyte growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules consisting of growth factors and cytotoxins, bifunctional molecules consisting of antibodies and cytotoxins); cholesterol-lowering agents; vasodilators; and agents that interfere with the endogenous vasomotor mechanism.

[0085] It should be understood that the present disclosure is merely exemplary in many respects. Without departing from the scope of the present disclosure, changes may be made in detail, particularly with regard to the shape, size, and arrangement of steps. This may include, within appropriate limits, the use of any of the features of one exemplary embodiment in other embodiments. The scope of the present disclosure is, of course, defined by the language of the appended claims.

Claims

1. An expandable framework configured to transition between a collapsed form and an expanded form, the expandable framework including a proximal hub and a distal hub, and a longitudinal axis of the expandable framework extending from the proximal hub to the distal hub, the expandable framework; Including a radiopaque marker longitudinally positioned between the proximal hub and the distal hub in the expanded form; The radiopaque marker including a body portion, a proximal leg, a distal leg, a first lateral tab, and a second lateral tab, the body portion being disposed relative to an outer surface of the expandable framework, an implant for occluding a left atrial appendage.

2. The implant according to claim 1, wherein the radiopaque marker is longitudinally oriented in the expanded form.

3. The implant according to claim 1, wherein the proximal leg and the distal leg extend radially inwardly toward an interior of the expandable framework.

4. The implant according to claim 1, wherein the first lateral tab and the second lateral tab wrap around a portion of the expandable framework.

5. An expandable framework configured to transition between a collapsed form and an expanded form, the expandable framework including a proximal hub and a distal hub, and a longitudinal axis of the expandable framework extending from the proximal hub to the distal hub, the expandable framework; Including a radiopaque marker longitudinally positioned between the proximal hub and the distal hub in the expanded form; The radiopaque marker being disposed radially inwardly relative to an inner surface of the expandable framework and including a fixed tubular member or a flat plate, an implant for occluding a left atrial appendage.

6. An expandable framework configured to transition between a collapsed form and an expanded form, the expandable framework including a proximal hub and a distal hub, and a longitudinal axis of the expandable framework extending from the proximal hub to the distal hub, the expandable framework; Including a radiopaque marker longitudinally positioned between the proximal hub and the distal hub in the expanded form; comprising an occluding element disposed to cover at least a portion of the expandable framework, an implant for occluding a left atrial appendage, wherein the radiopaque marker comprises a flat element at least partially embedded within the occluding element. **Claim 7** The implant according to any one of claims 1 to 6, wherein the radiopaque marker comprises a plurality of radiopaque markers spaced around the outer periphery of the expandable framework. **Claim 8** a delivery sheath and a core wire slidably disposed within the lumen of the delivery sheath, a system for occluding a left atrial appendage, comprising the implant according to any one of claims 1 to 6, which can be releasably fixed to the distal end of the core wire. **Claim 9** The system according to claim 8, wherein the radiopaque marker is formed from a material different from that of the expandable framework. **Claim 10** The system according to claim 8, wherein the radiopaque marker has a density different from that of the expandable framework.

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