Left atrial appendage occlusion device

Abstract

The left atrial appendage closure device may include an expandable scaffold having a plurality of struts joined at a proximal hub and a distal hub. When the scaffold is fully constrained in a first position, a first segment of the strut extends distally from the distal hub to a first bend parallel to the central longitudinal axis, and a second segment of the strut extends proximally from the first bend. The first amount of the scaffold is unconstrained in a second position, in which the first segment extends distally from the distal hub to the first bend parallel to the central longitudinal axis, the second segment extends proximally and radially outward from the first bend to a second bend, a third segment of the strut extends proximally and radially inward from the second bend to a third bend, and a fourth segment of the strut extends proximally from the third bend into the delivery sheath.

Description

Technical Field

[0001] The present disclosure generally relates to medical devices, and more specifically to medical devices suitable 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 attached to the left atrium of the heart. When the heart is functioning normally, when the left atrium contracts to pump blood into the left ventricle, the left atrial appendage contracts to pump blood into the left atrium. The contractile ability of the left atrial appendage helps to 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 properly or may empty, causing stagnant blood to accumulate inside, which may lead to the formation of unwanted thrombi within the left atrial appendage.

[0003] Thrombi formed within the left atrial appendage can break off from this area and enter the bloodstream. Thrombi moving within the blood vessels can ultimately block smaller downstream blood vessels, thereby causing a stroke or a heart attack. Clinical studies have shown that the majority of thrombi in patients with atrial fibrillation originate from the left atrial appendage. As a treatment, medical devices have been developed to occlude the left atrial appendage. Known medical devices and methods each have certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and introducers, as well as alternative methods for manufacturing and using medical devices and introducers.

Summary of the Invention

[0004] In one example, the left atrial appendage closure device may include an expandable framework having a plurality of struts disposed about a central longitudinal axis, the plurality of struts being coupled to each other by a proximal hub and a distal hub. When the expandable framework is fully constrained in a first position by a delivery sheath, a first segment of the plurality of struts extends distally from the distal hub to a first bend parallel to the central longitudinal axis, and a second segment of the plurality of struts extends proximally from the first bend. A first amount of the expandable framework is not constrained by the delivery sheath in a second position. In the second position, the first segment of the plurality of struts extends distally from the distal hub to the first bend parallel to the central longitudinal axis, the second segment of the plurality of struts extends proximally and radially outward from the first bend to a second bend, a third segment of the plurality of struts extends proximally and radially inward from the second bend to a third bend, and a fourth segment of the plurality of struts extends proximally from the third bend into the delivery sheath.

[0005] In addition to, or instead of, any of the examples disclosed herein, in the second position, the first segment and the second segment form an acute angle that opens inwardly toward the interior of the expandable framework.

[0006] In addition to, or instead of, any of the examples disclosed herein, a second amount of the expandable framework that is greater than the first amount is not constrained by the delivery sheath in a third position. In the third position, the first segment of the plurality of struts extends distally from the distal hub to the first bend parallel to the central longitudinal axis, the second segment of the plurality of struts extends radially outward from the first bend to the second bend substantially perpendicular to the central longitudinal axis, the third segment of the plurality of struts extends proximally and radially inward from the second bend to the third bend, and the fourth segment of the plurality of struts extends proximally from the third bend toward the proximal hub disposed within the delivery sheath.

[0007] In addition to, or in place of, any of the examples disclosed herein, at the third position, the second segment and the third segment form an acute angle that opens inwardly toward the central longitudinal axis.

[0008] In addition to, or in place of, any of the examples disclosed herein, at the third position, the third segment and the fourth segment form an obtuse angle that opens outwardly with respect to the central longitudinal axis.

[0009] In addition to, or in place of, any of the examples disclosed herein, a third amount of the expandable framework that is greater than the second amount is not constrained by the delivery sheath at the fourth position. At the fourth position, the first segment of the plurality of struts extends distally from the distal hub to the first bend parallel to the central longitudinal axis, the second segment of the plurality of struts extends distally and radially outward from the first bend to the second bend, the third segment of the plurality of struts extends proximally and radially inward from the second bend toward the third bend, and the fourth segment of the plurality of struts extends proximally from the third bend toward the proximal hub disposed within the delivery sheath.

[0010] In addition to, or in place of, any of the examples disclosed herein, at the fourth position, the first segment and the second segment form an obtuse angle that opens inwardly toward the interior of the expandable framework.

[0011] In addition to, or in place of, any of the examples disclosed herein, at the fourth position, the second segment and the third segment form an acute angle that opens inwardly toward the central longitudinal axis.

[0012] In addition to, or in place of, any of the examples disclosed herein, at the fourth position, the third segment and the fourth segment form an obtuse angle that opens outwardly with respect to the central longitudinal axis.

[0013] In addition to, or in place of, any example disclosed herein, a fourth amount of the expandable framework that is greater than the third amount is not constrained by the delivery sheath at the fifth position. At the fifth position, the first segment of the plurality of struts extends distally from the distal hub to the first bend parallel to the central longitudinal axis, the second segment of the plurality of struts extends distally and radially outward from the first bend to the second bend, the third segment of the plurality of struts extends proximally from the second bend to the third bend, and the fourth segment of the plurality of struts extends radially inward from the third bend toward the proximal hub.

[0014] In addition to, or in place of, any example disclosed herein, at the fifth position, the first segment and the second segment form an obtuse angle that opens inward. In addition to, or in place of, any example disclosed herein, at the fifth position, the second segment and the third segment form an acute angle that opens inward.

[0015] In addition to, or in place of, any example disclosed herein, at the fifth position, the third segment and the fourth segment form an angle of about 90 degrees or less that opens inward.

[0016] In addition to, or in place of, any example disclosed herein, the distal hub is disposed proximal to the first bend. In addition to, or in place of, any example disclosed herein, at the second position, the distal hub is disposed distal to the second bend.

[0017] In addition to, or instead of, any of the examples disclosed herein, the left atrial appendage closure device may include an expandable framework having a plurality of struts disposed about a central longitudinal axis, the plurality of struts being coupled to one another by a proximal hub and a distal hub. As the expandable framework transitions from a fully constrained state to a not fully constrained state, the expandable framework continuously transitions through a plurality of positions. In a first position, a first segment of the plurality of struts extends distally from the distal hub to a first bend parallel to the central longitudinal axis, and a second segment of the plurality of struts extends proximally from the first bend and substantially parallel to the central longitudinal axis. In a second position, when the second segment of the plurality of struts rotates circumferentially about the central longitudinal axis, it defines a generally conical shape that tapers radially outwardly in the proximal direction from the first bend toward a second bend.

[0018] In addition to, or instead of, any of the examples disclosed herein, in the second position, the distal hub is disposed proximal to the first bend and the distal hub is disposed distal to the second bend.

[0019] In addition to, or instead of, any of the examples disclosed herein, in the third position, when the second segment of the plurality of struts rotates circumferentially about the central longitudinal axis, it defines a generally flat shape that is oriented substantially perpendicular to the central longitudinal axis.

[0020] In addition to, or instead of, any of the examples disclosed herein, in the fourth position, when the second segment of the plurality of struts rotates circumferentially about the central longitudinal axis, it defines a generally conical shape that tapers radially outwardly in the distal direction from the first bend toward the second bend.

[0021] In addition to, or instead of, any of the examples disclosed herein, the left atrial appendage closure device system may include the delivery sheath having a lumen extending therein, and a left atrial appendage closure device comprising an expandable framework having a plurality of struts disposed about a central longitudinal axis and having the plurality of struts coupled to each other by a proximal hub and a distal hub. When the expandable framework is disposed at a first position within the lumen of the delivery sheath, a first segment of the plurality of struts extends distally from the distal hub to a first bend parallel to the central longitudinal axis, and a second segment of the plurality of struts extends proximally from the first bend. Relative axial movement between the delivery sheath and the expandable framework exposes a portion of the expandable framework at a second position. At the second position, the first segment of the plurality of struts extends distally from the distal hub to the first bend parallel to the central longitudinal axis, the second segment of the plurality of struts extends proximally and radially outward from the first bend to a second bend, a third segment of the plurality of struts extends proximally and radially inward from the second bend to a third bend, and a fourth segment of the plurality of struts extends proximally from the third bend into the delivery sheath. Relative axial movement between the delivery sheath and the expandable framework causes the expandable framework to be more exposed at a third position than at the second position. At the third position, the first segment of the plurality of struts extends distally from the distal hub to the first bend parallel to the central longitudinal axis, the second segment of the plurality of struts extends radially outward from the first bend to the second bend substantially perpendicular to the central longitudinal axis, the third segment of the plurality of struts extends proximally and radially inward from the second bend to the third bend, and the fourth segment of the plurality of struts extends proximally from the third bend toward the proximal hub disposed within the delivery sheath. Relative axial movement between the delivery sheath and the expandable framework causes the expandable framework to be more exposed at a fourth position than at the third position.At the fourth position, the first segments of the plurality of struts extend distally from the distal hub to the first bend parallel to the central longitudinal axis, the second segments of the plurality of struts extend distally and radially outward from the first bend to the second bend, the third segments of the plurality of struts extend proximally and radially inward from the second bend toward the third bend, and the fourth segments of the plurality of struts extend proximally from the third bend toward the proximal hub disposed within the delivery sheath. Relative axial movement between the delivery sheath and the expandable framework causes all of the expandable framework to be exposed at the fifth position. At the fifth position, the first segments of the plurality of struts extend distally from the distal hub to the first bend parallel to the central longitudinal axis, the second segments of the plurality of struts extend distally and radially outward from the first bend to the second bend, the third segments of the plurality of struts extend proximally from the second bend to the third bend, and the fourth segments of the plurality of struts extend radially inward from the third bend toward the proximal hub.

[0022] 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 detailed description illustrate aspects of these embodiments more specifically.

Brief Description of the Drawings

[0023] The present disclosure can be more fully understood by considering the following detailed description in conjunction with the accompanying drawings.

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[0024] Aspects of the present disclosure can follow various modifications and alternative forms. Examples are shown in the drawings and described herein. However, it should be understood that the aspects of the present disclosure are not intended to be limited to the specific embodiments described. On the contrary, the present disclosure is intended to cover all modifications, equivalents, and alternatives within its spirit and scope.

[0025] **DETAILED DESCRIPTION** The following description should be read with reference to the drawings, which are not necessarily to scale, and like reference numerals indicate like elements throughout several figures. The detailed description and the drawings are intended to illustrate the present disclosure and 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 aspects of the present disclosure. However, for clarity and ease of understanding, not all features and / or elements may be shown in each drawing, but such features and / or elements can be understood to exist unless otherwise specified.

[0026] For the terms defined below, these definitions shall apply unless different definitions are provided in the claims or elsewhere in this specification. In this specification, all numerical values are considered to be modified by the term "about", whether or not explicitly indicated. The term "about" in the context of a numerical value generally refers to a range of numerical values 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 numerical values rounded to the nearest significant digit. Other uses of the term "about" (e.g., in contexts other than numerical values) may be understood from the context of this specification and may be considered to have their ordinary conventional definitions consistent with the context of this specification, unless otherwise specified.

[0027] The recitation of a numerical range by upper and lower limits includes all numerical values within that range including the upper and lower limits (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0028] Although some appropriate dimensions, ranges, and / or values are disclosed for various components, features, and / or specifications, a person of ordinary skill in the art will understand that, triggered by this disclosure, the desired dimensions, ranges, and / or values may deviate from those explicitly disclosed.

[0029] 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. The term "or" as used in this specification and the appended claims is generally used in the sense of "and / or" unless the context clearly dictates otherwise. For ease of understanding, it should be noted that certain features of the present disclosure may be described in the singular even if they are plural or repeated within the disclosed embodiments. Each example of a feature may include and / or be encompassed by a single disclosure unless expressly stated to the contrary. 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 equally apply to any and / or all of the plurality of components unless expressly stated to the contrary. Further, for purposes of clarity, not all examples of some elements or features may be shown in each figure.

[0030] Relative terms such as "proximal", "distal", "advancing", "retreating", and variations thereof are typically considered with respect to the positioning, orientation, and / or manipulation of various elements relative to the user / operator / manipulator of the device. Here, "proximal" and "retreating" indicate or refer to being close to or moving towards the user, and "distal" and "advancing" indicate or refer to being far from or moving away from the user. In some cases, the terms "proximal" and "distal" may be arbitrarily assigned for ease of understanding of the present disclosure, and such examples 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", "transverse", "radial", and / or variations thereof typically refer to the direction and / or orientation with respect to the central longitudinal axis of the disclosed structure or device.

[0031] The term "range" can be understood to mean the maximum measured value of the dimension described or specified, provided that if "minimum" is prefixed to or identified as such for that range or dimension, this can be understood to mean the minimum measured value of the dimension described or specified. For example, an "outer range" can be understood to mean an outer dimension, a "radial range" can be understood to mean a radial dimension, and a "longitudinal range" can be understood to mean a longitudinal dimension. Each example of a "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. Usually, a "range" is considered to be the maximum possible dimension measured in accordance with the intended usage, while a "minimum range" is considered to be the minimum possible dimension measured in accordance with the intended usage. In some cases, a "range" can usually be measured at right angles within a plane and / or cross-section, but may also be measured in different ways (but not limited to) such as angularly, radially, circumferentially (e.g., along an arc), etc., as is apparent from the particular context.

[0032] The terms "monolithic" and "single" shall generally refer to an element made of or consisting of a single structure or basic unit / element. Monolithic and / or single elements shall not include structures and / or features made by assembling or combining a plurality of individual structures or elements.

[0033] References to "one embodiment", "some embodiments", "other embodiments", etc. in this specification indicate that the described embodiments may include certain features, structures, or characteristics, but it should be noted that not all embodiments necessarily include those specific features, structures, or characteristics. Further, such phrases do not necessarily refer to the same embodiment. Additionally, when a particular feature, structure, or characteristic is described in relation to an embodiment, unless there is an express contrary statement, making that particular feature, structure, or characteristic effective in relation to other embodiments is within the knowledge of those skilled in the art, whether or not it is explicitly described. That is, the various individual elements described below can be combined with each other or arranged to form other additional embodiments, or to supplement and / or enrich the described embodiments, so that they can be understood by those skilled in the art even if they are not explicitly shown in a specific combination.

[0034] For the purpose of clarity, throughout this specification and / or the entire scope of the claims, a specific numerical nomenclature for identification (e.g., first, second, third, fourth, etc.) may be used to name and / or distinguish the various features described and / or claimed. It should 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 deviations from the previously used numerical nomenclature may occur. 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 called the "first" element. The meaning and / or name in each case will be apparent to those skilled in the art.

[0035] The left atrial appendage is attached to the left atrium of a patient's heart and can communicate with the left atrium. In some patients, the left atrial appendage may have a complex shape and / or an irregular surface area. Those skilled in the art will also recognize that the medical devices and methods disclosed herein can be adapted to various sizes and shapes of the left atrial appendage as needed. The left atrial appendage may include a generally longitudinal axis disposed along the depth of the body of the left atrial appendage. The body may include a wall forming a proximal orifice and small holes. In some embodiments, the lateral extent of the small holes and / or the wall may be less than the depth of the body along the longitudinal axis, or the depth of the body may be greater than the lateral extent of the small holes and / or the wall. In some embodiments, the left atrial appendage may include a caudal element associated with the distal portion of the body, and this element may project radially or laterally from the body.

[0036] The following figures illustrate selected components and / or arrangements of a left atrial appendage closure device, a left atrial appendage closure device system, and / or a method of using a left atrial appendage closure device and / or a left atrial appendage closure device system. Note that in any of the figures, some features may not be shown or may be shown schematically for simplicity. Additional details regarding some components of the implant and / or system may be shown in more detail in other figures. Although left atrial appendage occlusion is described, the left atrial appendage closure device and / or the left atrial appendage closure device system can also be used for other interventions and / or percutaneous medical procedures in a patient. Similarly, the devices and methods described herein with respect to percutaneous deployment can be used for other types of surgical procedures as needed. For example, in some instances, the device can be used in a non-percutaneous procedure. The devices and methods according to the present disclosure can also be adapted and configured for other uses within anatomical structures.

[0037] Figures 1-2 show selected components and / or arrangements of a left atrial appendage occlusion device system 10 that can be used to occlude the left atrial appendage. Note that in each figure, some features of the left atrial appendage occlusion device system 10 may not be shown or may be shown schematically for simplicity. Additional details regarding some components of the left atrial appendage occlusion device system 10 may be shown in more detail in other figures.

[0038] The left atrial appendage occlusion device system 10 can 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 a left atrial appendage occlusion device 100 for occluding the left atrial appendage. The left atrial appendage occlusion device 100 can include an expandable framework 110 (e.g., FIG. 3) configured to transition between a fully constrained configuration (e.g., FIG. 1) in which the left atrial appendage occlusion device 100 is disposed within the lumen 42 proximal to the distal opening in a delivery configuration and a non-fully constrained configuration (e.g., FIG. 2), and the left atrial appendage occlusion device 100 and / or the expandable framework 110 are configured to transition between a fully constrained configuration and a non-fully constrained configuration as the left atrial appendage occlusion device 100 translates parallel to the delivery sheath 40. In at least some embodiments, the expandable framework 110 can be self-biased toward the non-fully constrained configuration.

[0039] The left atrial appendage occlusion device 100 can be disposed at the distal portion of the core wire 30 and / or releasably fixed to the distal portion of the core wire 30. The core wire 30 can 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 can extend proximal to the proximal end of the delivery sheath 40 and / or the proximal opening of the lumen 42 for manual operation by a clinician or practitioner. In some embodiments, the left atrial appendage occlusion device 100 can be removably attached, joined, fixed, or otherwise connected to the distal end of the core wire 30. The core wire 30 can be configured to axially move the left atrial appendage occlusion device 100 relative to the delivery sheath 40 and / or be movable in such a manner. In one example, the core wire 30 can be advanced distally while holding the delivery sheath 40 in a fixed position. In another example, the core wire 30 can be advanced distally while retracting the delivery sheath 40 proximally. In yet another example, the core wire 30 can be held in a fixed position while retracting the delivery sheath 40 proximally relative to the core wire 30 and / or the left atrial appendage occlusion device 100. Other configurations are contemplated. The delivery sheath 40 and / or the core wire 30 can 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.

[0040] Some suitable but non-limiting examples of materials for the left atrial appendage occlusion device system 10, the core wire 30, the delivery sheath 40, and / or the left atrial appendage occlusion device 100 are described below. It is contemplated that any exemplary left atrial appendage occlusion device disclosed herein can be used in accordance with and / or in association with the exemplary left atrial appendage occlusion device system 10 described above.

[0041] The left atrial appendage occlusion device 100 may include an expandable framework 110 configured to transition axially and / or radially along a central longitudinal axis between a fully constrained configuration and a not fully constrained configuration. In the fully constrained configuration, the expandable framework 110 may be elongated axially and / or compressed radially. In the not fully constrained configuration, the expandable framework 110 may be shortened axially and / or expanded radially.

[0042] As seen in FIG. 3 showing selected aspects of the left atrial appendage occlusion device 100 in the not fully constrained configuration, the expandable framework 110 may have a plurality of struts disposed about a central longitudinal axis. In some embodiments, the plurality of struts may define a plurality of compartments. In some embodiments, the plurality of compartments may be a plurality of closed compartments. In some embodiments, the plurality of compartments may be a plurality of open compartments. In some embodiments, the plurality of compartments may include a plurality of open compartments and a plurality of closed compartments in various combinations and / or arrangements.

[0043] The expandable framework 110 may include a proximal hub 112 and a distal hub 114. In some embodiments, the proximal hub 112 and / or the distal hub 114 may have their centers on the longitudinal axis and / or be coaxial with the longitudinal axis. The plurality of struts may be coupled to each other and / or fixedly attached to 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 left atrial appendage occlusion device 100 and / or the expandable framework 110 to the core wire 30. In some embodiments, the proximal hub 112 may include a female thread configured to rotatably engage and / or thread onto the threaded distal end of the core wire 30. Other configurations for removably securing the left atrial appendage occlusion device 100 to the core wire 30 are also contemplated. As described herein, there are figures in which some features are not shown for clarity purposes.

[0044] The expandable framework 110 and / or the plurality of struts can be formed and / or cut from a tubular member. In some embodiments, the expandable framework 110 and / or the plurality of struts can be integrally formed and / or cut out from a single member. In some embodiments, the expandable framework 110 and / or the plurality of struts are integrally formed and / or cut from a single tubular member and then formed and / or heat cured into a desired shape in a configuration that is not fully constrained. In some embodiments, the expandable framework 110 and / or the plurality of struts are integrally formed and / or cut from a single flat member or sheet and then rolled or formed into a tubular structure and subsequently formed and / or heat cured into a desired shape in a configuration that is not fully constrained. Some exemplary means and / or methods for creating and / or forming the expandable framework 110 and / or the plurality of struts include laser cutting, machining, punching, stamping, electrical discharge machining (EDM), chemical dissolution, and the like. Other means and / or methods are also contemplated.

[0045] As will be appreciated by those skilled in the art, the size and / or shape of anatomical features can vary. In some embodiments, the left atrial appendage can have an irregular (e.g., elongated and / or rectangular) cross-sectional shape. In some embodiments, the expandable framework 110, when deployed and / or expanded within the left atrial appendage, is conformal to, substantially conforms to, and / or seals against the outer profile and / or surface shape of the sidewalls of the left atrial appendage. In some embodiments, the left atrial appendage closure device 100 can expand to a size, degree, or shape that is smaller than or different from a configuration that is not fully constrained, as determined by the surrounding tissue and / or the sidewalls of the left atrial appendage. In some embodiments, the expandable framework 110 can be configured to mold and / or stretch the tissue of the left atrial appendage such that the sidewalls of the left atrial appendage substantially conform to the outer profile of the expandable framework 110. Other configurations are also contemplated.

[0046] In some embodiments, the expandable framework 110 may include at least one fixation member 116 that extends radially outward therefrom in a configuration that is not fully constrained. In some embodiments, the expandable framework 110 may include at least one fixation member 116 that extends radially outward from the expandable framework 110. In some embodiments, the expandable framework 110 may include at least one fixation member 116 that extends radially outward from the expandable framework 110 proximate to the proximal shoulder of the expandable framework 110. In some embodiments, the expandable framework 110 may include at least one fixation member 116 that extends radially outward from the expandable framework 110 proximate to the central portion of the expandable framework 110. In some embodiments, at least one fixation member 116 may be configured to engage the sidewall of the body of the left atrial appendage. In some embodiments, at least one fixation member 116 may be formed as a J-shaped hook having a free end that extends and / or is oriented in a proximal direction relative to the central longitudinal axis of the left atrial appendage closure device 100 and / or the expandable framework 110. Other configurations are contemplated.

[0047] In some embodiments, the left atrial appendage closure device 100 may optionally include an occluding element 120 that is connected to, in contact with, disposed on, disposed around, and / or disposed radially outside at least a portion of the expandable framework 110 and / or the plurality of struts, as seen in FIG. 4. In some embodiments, the occluding 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 occluding element 120 may extend radially outward from the proximal hub 112 and / or extend distally from the proximal hub 112. In some embodiments, the occluding element 120 may be attached to and / or secured to the expandable framework 110 at multiple discrete locations. In some embodiments, one, some, and / or all of the at least one fixation member 116 may be able to extend through the occluding element 120 (if present).

[0048] In some embodiments, the occluding element 120 may include a membrane, fabric, mesh, tissue component, or another suitable structure. In some embodiments, the occluding element 120 may be porous. In some embodiments, the occluding element 120 may be non-porous. In some embodiments, the occluding element 120 may be permeable to selected gases and / or fluids. In some embodiments, the occluding element 120 may be substantially impermeable to selected gases and / or fluids such as blood, water, etc. In some embodiments, the occluding element 120 may be designed, sized, and / or configured to prevent thrombus and / or embolic material from flowing out of the left atrial appendage into the left atrium and / or the patient's bloodstream. In some embodiments, the occluding element 120 may be configured to promote endothelialization after implantation, thereby effectively removing the target site (e.g., the left atrial appendage, etc.) from the patient's circulatory system. Some suitable but non-limiting examples of materials for the occluding element 120 are described below.

[0049] Figures 5-9 schematically illustrate selected aspects of the left atrial appendage occlusion device 100 and / or the left atrial appendage occlusion device system 10 during deployment of the left atrial appendage occlusion device 100. For clarity and ease of understanding, some elements of the left atrial appendage occlusion device 100 are not shown but should be understood to be present in accordance with and / or consistent with other figures and / or descriptions of the present disclosure. Figures 5-8 show partial cross-sectional views of the left atrial appendage occlusion device 100. Figure 9 shows the left atrial appendage occlusion device 100 using dashed lines to show hidden features, as can be understood from the other figures. The occluding element 120 is not shown in Figure 9. It can be seen from Figures 5-9 that as the expandable framework 110 of the left atrial appendage occlusion device 100 transitions from a fully constrained state to a not fully constrained state, the expandable framework 110 can transition continuously through a plurality of positions. In some embodiments, the plurality of positions may include a first position, a second position, a third position, a fourth position, and / or a fifth position, as described herein. In some embodiments, the plurality of positions may include additional positions and / or other positions.

[0050] Returning now to FIG. 5, in some embodiments, the expandable framework 110 can be fully constrained in the first position by the delivery sheath 40. In some embodiments, the expandable framework 110 can be disposed within the lumen 42 of the delivery sheath 40 in the first position. In some embodiments, at the first position, the first segment 130 of the plurality of struts of the expandable framework 110 extends distally from the distal hub 114 to the first bend 132 substantially parallel to the central longitudinal axis, and the second segment 140 of the plurality of struts of the expandable framework 110 can extend proximally from the first bend 132. In some embodiments, at the first position, the second segment 140 can extend proximally from the first bend 132 substantially parallel to the central longitudinal axis. At the first position, the distal hub 114 can be disposed proximal to the first bend 132. In some embodiments, the first segment 130 can be fixed to the distal hub 114. In some embodiments, the first segment 130 can be fixedly attached to the distal hub 114. For example, the first segment 130 can be welded, adhered, etc. to the distal hub 114. Other configurations are also contemplated.

[0051] In some embodiments, as seen in FIG. 6, relative axial movement between the delivery sheath 40 and the expandable framework 110 may cause a portion of the expandable framework 110 and / or the plurality of struts to be exposed at the second position. In some embodiments, a first amount of the expandable framework 110 and / or the plurality of struts is exposed from the delivery sheath 40 at the second position and / or is not constrained by the delivery sheath 40. In some embodiments, the first amount may be less than about 55% of the axial length, volume, weight, and / or surface area of the expandable framework 110 and / or the plurality of struts. In some embodiments, the first amount may be from about 15% to about 55% of the axial length, volume, weight, and / or surface area of the expandable framework 110 and / or the plurality of struts. Other configurations and / or ranges are contemplated. In some embodiments, at the second position, the expandable framework 110 may have a maximum radial extent from about 6 millimeters (mm) to about 10 mm. In some embodiments, at the second position, the expandable framework 110 may have a maximum radial extent of about 8 mm. In some embodiments, at the second position, the maximum radial extent of the expandable framework 110 may be about two times or about 200% of the maximum outer extent of the distal end of the delivery sheath 40. Other configurations and / or sizes are contemplated.

[0052] In some embodiments, at the second position, the first segment 130 of the plurality of struts of the expandable framework 110 may extend distally from the distal hub 114, generally parallel to the central longitudinal axis, to the first bend 132. At the second position, the second segment 140 of the plurality of struts of the expandable framework 110 may extend proximally and radially outward from the first bend 132, toward and / or to the second bend 142. At the second position, the third segment 150 of the plurality of struts of the expandable framework 110 may extend proximally and radially inward from the second bend 142, toward and / or to the third bend 152. In some embodiments, at the second position, the fourth segment 160 of the plurality of struts of the expandable framework 110 may extend proximally into the lumen 42 of the delivery sheath 40 from the third bend 152. In some embodiments, at the second position, the fourth segment 160 of the plurality of struts of the expandable framework 110 may extend proximally toward the proximal hub 112 disposed within the lumen 42 of the delivery sheath 40 from the third bend 152.

[0053] In some embodiments, at the second position, the distal hub 114 is disposed proximal to the first bend 132. In some embodiments, at the second position, the distal hub 114 can be disposed distal to the second bend 142. For example, at the second position, the distal hub 114 can include at least a portion of the second bend 142 and / or be disposed distal to a plane that is in contact with the second bend 142 and is oriented perpendicular to the central longitudinal axis. In some embodiments, at the second position, the first segment 130 of the plurality of struts and the second segment 140 of the plurality of struts can form, and / or intersect to form, an acute angle that opens inwardly toward the interior of the expandable framework 110. In some embodiments, at the second position, the first segment 130 of the plurality of struts and the second segment 140 of the plurality of struts can form, and / or intersect to form, an acute angle that opens radially outward from the central longitudinal axis. In some embodiments, at the second position, the second segment 140 of the plurality of struts of the expandable framework 110 can define a generally conical shape that tapers radially outward in the proximal direction from the first bend 132 toward the second bend 142 when rotated circumferentially about the central longitudinal axis.

[0054] In some embodiments, due to relative axial movement between the delivery sheath 40 and the expandable framework 110, as seen in FIG. 7, the expandable framework 110 and / or the plurality of struts can be more exposed at a third position than at the second position. In some embodiments, a second amount of the expandable framework 110 and / or the plurality of struts that is greater than a first amount is exposed from the delivery sheath 40 and / or is not constrained by the delivery sheath 40 at the third position. In some embodiments, the second amount can be less than about 75% of the axial length, volume, weight, and / or surface area of the expandable framework 110 and / or the plurality of struts. In some embodiments, the second amount can be from about 40% to about 75% of the axial length, volume, weight, and / or surface area of the expandable framework 110 and / or the plurality of struts. Other configurations and / or ranges are contemplated.

[0055] In some embodiments, at the third position, the first segment 130 of the plurality of struts of the expandable framework 110 may extend distally from the distal hub 114 to the first bend 132 substantially parallel to the central longitudinal axis. At the third position, the second segment 140 of the plurality of struts of the expandable framework 110 may extend radially outward and substantially perpendicular to the central longitudinal axis from the first bend 132 toward and / or to the second bend 142. At the third position, the third segment 150 of the plurality of struts of the expandable framework 110 may extend proximally and radially inward from the second bend 142 toward and / or to the third bend 152. In some embodiments, at the third position, the fourth segment 160 of the plurality of struts of the expandable framework 110 may extend proximally into the lumen 42 of the delivery sheath 40 from the third bend 152. In some embodiments, at the third position, the fourth segment 160 of the plurality of struts of the expandable framework 110 may extend proximally from the third bend 152 toward the proximal hub 112 disposed within the lumen 42 of the delivery sheath 40.

[0056] In some embodiments, at the third position, the distal hub 114 is disposed proximal to the first bend 132. In some embodiments, at the third position, the first segment 130 of the plurality of struts and the second segment 140 of the plurality of struts may form, and / or intersect to form, a substantially right angle that opens toward the interior of the expandable framework 110. In some embodiments, at the third position, the first segment 130 of the plurality of struts and the second segment 140 of the plurality of struts may form, and / or intersect to form, a substantially right angle that opens radially outward from the central longitudinal axis. In some embodiments, at the third position, the second segment 140 of the plurality of struts and the third segment 150 of the plurality of struts may form, and / or intersect to form, an acute angle that opens radially inward toward the interior of the expandable framework 110. In some embodiments, at the third position, the second segment 140 of the plurality of struts and the third segment 150 of the plurality of struts may form, and / or intersect to form, an acute angle that opens radially inward toward the central longitudinal axis. In some embodiments, at the third position, the third segment 150 of the plurality of struts and the fourth segment 160 of the plurality of struts may form, and / or intersect to form, an obtuse angle that opens radially outward from the central longitudinal axis. In some embodiments, at the third position, the second segment 140 of the plurality of struts of the expandable framework 110 may define a generally planar shape that is oriented generally perpendicular to the central longitudinal axis when rotated circumferentially about the central longitudinal axis.

[0057] In some embodiments, due to the relative axial movement between the delivery sheath 40 and the expandable framework 110, as seen in FIG. 8, the expandable framework 110 and / or the plurality of struts may be more exposed at the fourth position than at the third position. In some embodiments, a third amount of the expandable framework 110 and / or the plurality of struts that is greater than a second amount is exposed from the delivery sheath 40 and / or not constrained by the delivery sheath 40 at the fourth position. In some embodiments, the third amount can be less than about 95% of the axial length, volume, weight, and / or surface area of the expandable framework 110 and / or the plurality of struts. In some embodiments, the third amount can be from about 60% to about 95% of the axial length, volume, weight, and / or surface area of the expandable framework 110 and / or the plurality of struts. Other configurations and / or ranges are also contemplated.

[0058] In some embodiments, at the fourth position, a first segment 130 of the plurality of struts of the expandable framework 110 can extend distally from the distal hub 114 to a first bend 132 substantially parallel to the central longitudinal axis. At the fourth position, a second segment 140 of the plurality of struts of the expandable framework 110 can extend distally and radially outward from the first bend 132 toward and / or to a second bend 142. At the fourth position, a third segment 150 of the plurality of struts of the expandable framework 110 can extend proximally and radially inward from the second bend 142 toward and / or to a third bend 152. In some embodiments, at the fourth position, a fourth segment 160 of the plurality of struts of the expandable framework 110 can extend proximally toward the proximal hub 112 disposed within the lumen 42 of the delivery sheath 40 from the third bend 152.

[0059] In some embodiments, at the fourth position, the distal hub 114 is disposed proximal to the first bend 132. In some embodiments, at the fourth position, the first segment 130 of the plurality of struts and the second segment 140 of the plurality of struts may intersect to form, and / or form, an obtuse angle that opens inwardly toward the interior of the expandable framework 110. In some embodiments, at the fourth position, the second segment 140 of the plurality of struts and the third segment 150 of the plurality of struts may intersect to form, and / or form, an acute angle that opens radially inwardly toward the central longitudinal axis. In some embodiments, at the fourth position, the third segment 150 of the plurality of struts and the fourth segment 160 of the plurality of struts may intersect to form, and / or form, an obtuse angle that opens radially outwardly from the central longitudinal axis. In some embodiments, at the fourth position, the second segment 140 of the plurality of struts of the expandable framework 110 may define a generally conical shape that tapers radially outwardly in a distal direction from the first bend 132 toward the second bend 142 when rotated circumferentially about the central longitudinal axis.

[0060] In some embodiments, due to the relative axial movement between the delivery sheath 40 and the expandable framework 110, substantially all of the expandable framework 110 and / or the plurality of struts in the fifth position may be exposed, as seen in FIG. 9. In some embodiments, a fourth amount of the expandable framework 110 and / or the plurality of struts that is greater than a third amount is exposed from the delivery sheath 40 and / or not constrained by the delivery sheath 40 at the fifth position. In some embodiments, the fourth amount may exceed about 95% of the axial length, volume, weight, and / or surface area of the expandable framework 110 and / or the plurality of struts. In some embodiments, the fourth amount may be about 100% of the axial length, volume, weight, and / or surface area of the expandable framework 110 and / or the plurality of struts. Other configurations and / or ranges are contemplated.

[0061] In some embodiments, the expandable framework 110 may be configured to not be fully constrained at the fifth position. In some embodiments, in the not fully constrained configuration, the expandable framework may have a maximum radial range from about 16 millimeters (mm) to about 40 mm. In some embodiments, in the not fully constrained configuration, the expandable framework may have a maximum radial range of about 16 mm. In some embodiments, in the not fully constrained configuration, the expandable framework may have a maximum radial range of about 20 mm. In some embodiments, in the not fully constrained configuration, the expandable framework may have a maximum radial range of about 25 mm. In some embodiments, in the not fully constrained configuration, the expandable framework may have a maximum radial range of about 30 mm. In some embodiments, in the not fully constrained configuration, the expandable framework may have a maximum radial range of about 35 mm. In some embodiments, in the not fully constrained configuration, the expandable framework may have a maximum radial range of about 40 mm. Other configurations and / or sizes are also contemplated.

[0062] In some embodiments, at the fifth position, the first segment 130 of the plurality of struts of the expandable framework 110 may extend distally from the distal hub 114 to the first bend 132 substantially parallel to the central longitudinal axis. At the fifth position, the second segment 140 of the plurality of struts of the expandable framework 110 may extend distally and radially outward from the first bend 132 toward and / or to the second bend 142. At the fifth position, the third segment 150 of the plurality of struts of the expandable framework 110 may extend proximally from the second bend 142 toward and / or to the third bend 152. In some embodiments, at the fifth position, the third segment 150 of the plurality of struts of the expandable framework 110 may extend proximally from the second bend 142 toward the third bend 152 substantially parallel to the central longitudinal axis. In some embodiments, at the fifth position, the fourth segment 160 of the plurality of struts of the expandable framework 110 may extend radially inward from the third bend 152 toward and / or to the proximal hub 112.

[0063] In some embodiments, at the fifth position, the distal hub 114 is disposed proximal to the first bend 132. In some embodiments, at the fifth position, the first segment 130 of the plurality of struts and the second segment 140 of the plurality of struts may intersect to form, and / or be configured to form, an obtuse angle that opens inwardly toward the interior of the expandable framework 110. In some embodiments, at the fifth position, the second segment 140 of the plurality of struts and the third segment 150 of the plurality of struts may intersect to form, and / or be configured to form, an acute angle that opens radially inwardly toward the central longitudinal axis. In some embodiments, at the fifth position, the third segment 150 of the plurality of struts and the fourth segment 160 of the plurality of struts may intersect to form, and / or be configured to form, an angle of about 90 degrees or less that opens radially inwardly toward the interior of the expandable framework 110. In some embodiments, at the fifth position, the third segment 150 of the plurality of struts and the fourth segment 160 of the plurality of struts may intersect to form, and / or be configured to form, an angle of about 90 degrees or less that opens radially inwardly toward the central longitudinal axis.

[0064] A method for occluding a left atrial appendage may include advancing a left atrial appendage closure device 100 into the left atrial appendage of a patient's heart. For example, the left atrial appendage closure device 100 can be advanced to the left atrial appendage in a configuration that is fully constrained within the lumen 42 of the delivery sheath 40. The method may include deploying the expandable framework 110 from the delivery sheath 40 within the left atrial appendage. The method may further include expanding and / or transitioning the expandable framework 110 from a fully constrained configuration to a not fully constrained configuration within the left atrial appendage.

[0065] As the expandable framework 110 transitions from a fully constrained state to a not fully constrained state, the expandable framework 110 can transition continuously through a plurality of positions, as described herein. In some embodiments, at a second position, the expandable framework 110 can be moved and / or navigated within the patient's heart, left atrium, and / or left atrial appendage. At the second position, the expandable framework 110 can generally form a rounded, non-traumatic shape. In some embodiments, at the second position, the maximum radial extent of the expandable framework 110 can be about two times or about 200% of the maximum outer extent of the distal end of the delivery sheath 40. In some embodiments, at the second position, the maximum radial extent of the expandable framework 110 can be about 8 millimeters. Other configurations and / or sizes are contemplated. In some embodiments, a physician can use a generally rounded, non-traumatic shape as a navigation tool within the patient's anatomical structure.

[0066] In a configuration that is not fully constrained (e.g., the fifth position) and / or near it, the expandable framework 110 may be pressed against, engaged with, and / or fixed to the side wall of the body of the left atrial appendage. In some embodiments, the expandable framework 110 may not be able to fully achieve a configuration that is not fully constrained (e.g., the fifth position) due to contact with the wall of the left atrial appendage. However, the inverted shape of the distal portion of the expandable framework 110 (e.g., the first segment 130, the first bend 132, the second segment 140, and the second bend 142) can prevent the expandable framework 110 from extending distally. Thereby, placing the left atrial appendage closure device 100 and / or the expandable framework 110 into the left atrial appendage, sealing the left atrial appendage closure device 100 and / or the expandable framework 110 against the left atrial appendage, and / or fixing the left atrial appendage closure device 100 and / or the expandable framework 110 within the left atrial appendage may be impaired. Instead, a compressive force may be applied to the third segment 150, and / or the second bend 142 may bias the distal hub 114 proximally toward the proximal hub 112. Thus, the final shape of the left atrial appendage closure device 100 and / or the expandable framework 110 is more predictable, and the placement and fixation of the left atrial appendage closure device 100 and / or the expandable framework 110 within the left atrial appendage can be improved.

[0067] In at least some embodiments, the left atrial appendage closure device 100 and / or the expandable framework 110 may extend across the ostium of the left atrial appendage. In some embodiments, the left atrial appendage closure device 100 and / or the expandable framework 110 extends completely across the ostium of the left atrial appendage, thereby effectively isolating the left atrial appendage from the patient's circulatory system.

[0068] Once satisfied with the positioning of the left atrial appendage occlusion device 100 within the left atrial appendage, the core wire 30 can be detached from the left atrial appendage occlusion device 100, thereby leaving the left atrial appendage occlusion device 100 positioned within and / or within the left atrial appendage. In some embodiments, detaching the core wire 30 from the left atrial appendage occlusion device 100 can include disengaging the threaded distal end of the core wire 30 from the left atrial appendage occlusion device 100 and / or the proximal hub 112 by rotating it relative to the left atrial appendage occlusion device 100 and / or the proximal hub 112.

[0069] In some embodiments, the delivery sheath 40 and / or the core wire 30 can include a key structure configured to prevent rotation of the core wire 30 relative to the proximal hub 112. In such embodiments, the key structure is released prior to rotating the core wire 30 relative to the left atrial appendage occlusion device 100 and / or the proximal hub 112. When the key structure engages, rotation of the core wire 30 can be transmitted to the left atrial appendage occlusion device 100 and / or the expandable framework 110. In some embodiments, rotation of the left atrial appendage occlusion device 100 and / or the expandable framework 110 can facilitate positioning and / or orientation of the left atrial appendage occlusion device 100 and / or the expandable framework 110 relative to the left atrial appendage, for example, with respect to asymmetric and / or irregular small holes and / or the left atrial appendage. Other configurations, purposes, and / or results are also contemplated.

[0070] The various components of the system (and / or other elements disclosed herein) and the materials that can be used for the various components disclosed herein can include materials commonly associated with medical devices and / or systems. For the sake of brevity, the following description refers to the system. However, this is not intended to limit the devices and methods described herein, and this discussion can also apply to other elements, members, components, or devices disclosed herein, for example, but not limited to, left atrial appendage occlusion devices, delivery sheaths, core wires, expandable frameworks, occlusion elements, etc., and / or their elements or components.

[0071] In some embodiments, the system and / or its components can 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.

[0072] Examples of suitable metals and alloys include stainless steels such as 444V, 444L, and 314LV stainless steels; 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, e.g., INCONEL® 625, UNS:N06022, e.g., HASTELLOY® C-22, UNS:N10276, e.g., HASTELLOY® C276, and other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS:N04400, e.g., MONEL® 400, NICKELVAC™ 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035, e.g., MP35-N, etc.), nickel-molybdenum alloys (e.g., UNS:N10665, e.g., HASTELLOY® ALLOY B2, etc.), 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, e.g., ELGILOY®, PHYNOX®, etc.); high-platinum-containing stainless steels; titanium; combinations thereof; etc.; or other suitable materials.

[0073] As suggested herein, there is a category of commercially available nickel-titanium alloys or nitinol alloys referred to as "linear elastic" or "non-superelastic." These may be chemically similar to conventional shape memory and superelastic types, but can exhibit unique and 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" like that of superelastic nitinol. Instead, in linear elastic and / or non-superelastic nitinol, as recoverable strain increases, stress continues to increase in a substantially or somewhat linear relationship (not necessarily a perfectly linear relationship) until plastic deformation begins, or at least in a relationship that is closer to linear than the superelastic plateau and / or flag region seen in superelastic nitinol. Thus, for the purposes of this disclosure, linear elastic and / or non-superelastic nitinol is also referred to as "substantially" linear elastic and / or non-superelastic nitinol.

[0074] 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 up to about 2-5% strain while substantially maintaining elasticity (e.g., before plastic deformation), whereas superelastic nitinol can accept up to about 8% strain before plastic deformation. Both of these materials can be distinguished from other linear elastic materials, such as stainless steel, which can only accept up to about 0.2-0.44% strain before plastic deformation (which can also be distinguishable based on composition).

[0075] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy is an alloy that shows no martensite / austenite phase change detectable by differential scanning calorimetry (DSC) and dynamic metal 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 degrees Celsius (°C) to about 120 °C. Thus, the mechanical bending properties of such materials can typically be temperature-independent 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, for example, substantially the same as the mechanical properties at body temperature, at which temperature no superelastic plateau and / or flag region is shown. 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.

[0076] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may be one having nickel in the range of about 50 to about 60 weight percent and 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. 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, desired properties can be achieved by using a superelastic alloy, such as superelastic nitinol.

[0077] In at least some embodiments, some or all of the systems and / or other elements disclosed herein may be doped with a radiopaque material, made of 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 on a fluoroscopic screen or other imaging technique during a medical procedure. This relatively bright image helps a user to determine the position 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 filled with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils can also be incorporated into the design of the systems and / or other elements disclosed herein to achieve the same result.

[0078] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is provided to the systems and / or other elements disclosed herein. For example, the system and / or its components or a portion thereof may be made of a material that does not substantially distort an image and also does not create substantial artifacts (e.g., gaps within the image). For example, certain ferromagnetic materials may not be suitable as they can potentially create artifacts in an MRI image. The system or a portion thereof may be made of a material that can be imaged by an MRI device. 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.

[0079] In some embodiments, the systems and / or other elements disclosed herein can be made of or include polymers or other suitable materials. 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-based copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers, e.g., 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 can be blended with a liquid crystal polymer(LCP). For example, the mixture can contain up to about 6 percent LCP.

[0080] In some embodiments, the systems and / or other elements disclosed herein may include a fabric material disposed structurally or within a structure. The fabric material can be composed of a biocompatible material such as a polymer material or a biological material adapted to promote in-growth of tissue. In some embodiments, the fabric material can include a bioabsorbable material. Some examples of suitable fabric materials include, but are not limited to, polyolefin materials such as polyethylene glycol(PEG), nylon, polytetrafluoroethylene(PTFE, ePTFE), polyethylene, polypropylene, polyester, polyurethane, and / or blends or combinations thereof.

[0081] In some embodiments, the systems and / or other elements disclosed herein may include and / or be formed from a fibrous material. Some examples of suitable fibrous materials include flat, shaped, twisted, textured, shrink-proofed, or unshrunk synthetic yarns. Synthetic biocompatible yarns suitable for use in the present disclosure include, but are not limited to, polyesters including polyethylene terephthalate (PET) polyester, polypropylene, polyethylene, polyurethane, polyolefin, polyvinyl, polymethyl acetate, polyamide, naphthalenedicarboxylate derivatives, natural silk, and polytetrafluoroethylene. Further, at least one synthetic yarn may be a metal yarn or a glass or ceramic yarn or fiber. Useful metal yarns include those made from or including stainless steel, platinum, gold, titanium, tantalum, or Ni-Co-Cr 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 can be of the multifilament, monofilament, or spun type. The type and denier of the yarn selected can be chosen in a way that forms a biocompatible and implantable prosthesis, more specifically a vascular structure having desirable properties.

[0082] In some embodiments, the systems and / or other elements disclosed herein may contain a suitable therapeutic agent and / or may be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents include 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, vinblastine, vincristine, 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.

[0083] It should be understood that the present disclosure is merely illustrative in many respects. Without departing from the scope of the present disclosure, changes can be made in details, particularly with regard to the shape, size, and order of steps. This can include, within an appropriate range, using any of the features of one exemplary embodiment in other embodiments. Of course, the scope of the present disclosure is defined by the language expressed in the appended claims.

Claims

Claim 1 A left atrial appendage occlusion device comprising a plurality of struts disposed about a central longitudinal axis, the plurality of struts including an expandable framework having proximal and distal hubs coupled to one another wherein when the expandable framework is fully constrained in a first position by a delivery sheath, a first segment of the plurality of struts extends distally from the distal hub to a first bend parallel to the central longitudinal axis, and a second segment of the plurality of struts extends proximally from the first bend wherein a first amount of the expandable framework is not constrained by the delivery sheath in a second position wherein in the second position, the first segment of the plurality of struts extends distally from the distal hub to the first bend parallel to the central longitudinal axis, the second segment of the plurality of struts extends proximally and radially outwardly from the first bend to a second bend, a third segment of the plurality of struts extends proximally and radially inwardly from the second bend to a third bend, and a fourth segment of the plurality of struts extends proximally into the delivery sheath from the third bend wherein a second amount of the expandable framework greater than the first amount is not constrained by the delivery sheath in a third position wherein in the third position, the first segment of the plurality of struts extends distally from the distal hub to the first bend parallel to the central longitudinal axis, the second segment of the plurality of struts extends radially outwardly from the first bend to the second bend substantially perpendicular to the central longitudinal axis, the third segment of the plurality of struts extends proximally and radially inwardly from the second bend to the third bend, and the fourth segment of the plurality of struts extends proximally toward the proximal hub disposed within the delivery sheath from the third bend wherein a third amount of the expandable framework greater than the second amount is not constrained by the delivery sheath in a fourth position At the fourth position, the first segment of the plurality of struts extends distally from the distal hub to the first bend parallel to the central longitudinal axis, the second segment of the plurality of struts extends distally and radially outward from the first bend to the second bend, the third segment of the plurality of struts extends proximally and radially inward from the second bend toward the third bend, and the fourth segment of the plurality of struts extends proximally from the third bend toward the proximal hub disposed within the delivery sheath. Left atrial appendage closure device.

2. The left atrial appendage closure device according to claim 1, wherein at the second position, the first segment and the second segment form an acute angle that opens inward toward the inside of the expandable framework.

3. The left atrial appendage closure device according to claim 1, wherein at the third position, the second segment and the third segment form an acute angle that opens inward toward the central longitudinal axis.

4. The left atrial appendage closure device according to claim 1, wherein at the third position, the third segment and the fourth segment form an obtuse angle that opens outward with respect to the central longitudinal axis.

5. The left atrial appendage closure device according to claim 1, wherein at the fourth position, the first segment and the second segment form an obtuse angle that opens inward toward the inside of the expandable framework.

6. The left atrial appendage closure device according to claim 1, wherein at the fourth position, the second segment and the third segment form an acute angle that opens inward toward the central longitudinal axis.

7. The left atrial appendage closure device according to claim 1, wherein at the fourth position, the third segment and the fourth segment form an obtuse angle that opens outward with respect to the central longitudinal axis.

8. The fourth amount of the expandable framework, which is greater than the third amount, is not constrained by the delivery sheath at the fifth position. At the fifth position, the first segment of the plurality of struts extends distally from the distal hub to the first bend parallel to the central longitudinal axis, the second segment of the plurality of struts extends distally and radially outward from the first bend to the second bend, the third segment of the plurality of struts extends proximally from the second bend to the third bend, and the fourth segment of the plurality of struts extends radially inward from the third bend toward the proximal hub. The left atrial appendage closure device according to claim 1.

9. At the fifth position, the first segment and the second segment form an obtuse angle opening inward. The left atrial appendage closure device according to claim 8.

10. At the fifth position, the second segment and the third segment form an acute angle opening inward. The left atrial appendage closure device according to claim 8.

11. At the fifth position, the third segment and the fourth segment form an angle of about 90 degrees or less opening inward. The left atrial appendage closure device according to claim 8.

12. The distal hub is disposed proximal to the first bend. The left atrial appendage closure device according to claim 1.

13. At the second position, the distal hub is disposed distal to the second bend. The left atrial appendage closure device according to claim 1.

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