Medical device for occluding left atrial appendage

Abstract

A medical implant for occluding a left atrial appendage may include an expandable frame configured to transition between a contracted configuration and an expanded configuration, and an occluding element secured to the expandable frame. The expandable frame includes a proximal hub and a plurality of interconnected struts extending from the proximal hub, the plurality of interconnected struts defining a body in an expanded configuration. The expandable frame includes a plurality of elongate anchoring attachments extending from the body, the plurality of elongate anchoring attachments each including a plurality of anchoring barbs extending therefrom.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 388,802, filed on July 13, 2022, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] The present disclosure relates to medical devices and systems and methods of making and using the medical devices and systems. More particularly, the present disclosure relates to medical implants for occluding the left atrial appendage. Background Art

[0004] Diseases and / or medical conditions that affect the cardiovascular system are extremely common throughout the world. Traditionally, treatments for the cardiovascular system have usually been performed by directly approaching the affected part of the system. Recently, less invasive therapies have been developed and are gaining widespread acceptance among patients and clinicians.

[0005] Atrial fibrillation is a common persistent heart rhythm disorder that is estimated to affect more than 30 million people worldwide. Atrial fibrillation is an irregular, chaotic beating of the upper chambers of the heart. Electrical impulses are released so quickly that the atrial muscles quiver or tremble. Episodes of atrial fibrillation may last from minutes to days. The most serious consequence of atrial fibrillation is ischemic stroke. It is estimated that up to 20% of strokes are associated with atrial fibrillation. Most patients with atrial fibrillation, regardless of the severity of their symptoms or the frequency of their episodes, require treatment to reduce their risk of stroke. The left atrial appendage is a small, pouch-like extension of the left atrium of the heart. In patients with atrial fibrillation, the left atrial appendage may not contract properly with the left atrium, causing blood to pool inside it, which may lead to the formation of unwanted blood clots within the left atrial appendage. Blood clots that form in the left atrial appendage may break off from the area and enter the bloodstream. Blood clots that migrate through blood vessels may eventually block smaller blood vessels downstream, causing a stroke or heart attack. Clinical studies have shown that the majority of blood clots in patients with atrial fibrillation are found in the left atrial appendage. As a treatment approach, several medical devices have been developed that are positioned in the left atrial appendage and deployed to close the orifice of the left atrial appendage. Over time, the exposed surface across the orifice of the left atrial appendage becomes covered with tissue (a process called endothelialization), effectively removing the left atrial appendage from the circulatory system and reducing or eliminating the number of blood clots that may enter the bloodstream from the left atrial appendage.

[0006] The present disclosure relates to medical implants for occluding the left atrial appendage. Of the known medical devices, systems and methods, each has certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and systems and alternative methods for making and using medical devices and systems. Summary of the invention

[0007] In one example, a medical implant for occluding a left atrial appendage may include an expandable frame configured to transition between a contracted configuration and an expanded configuration and an occluding element secured to the expandable frame. The expandable frame may include a proximal hub and a plurality of interconnected struts extending from the proximal hub, the plurality of interconnected struts defining a body in the expanded configuration. The expandable frame may include a plurality of elongated anchoring attachments extending from the body, the plurality of elongated anchoring attachments each including a plurality of anchoring barbs extending from the plurality of elongated anchoring attachments.

[0008] Additionally or alternatively to any examples disclosed herein, each of the plurality of elongated anchor attachments is fixedly attached to the expandable frame at a first end and extends to a free end opposite the first end.

[0009] Additionally or alternatively to any examples disclosed herein, a plurality of elongated anchoring appendages are integrally formed with the body as a single unitary structure.

[0010] Additionally or alternatively to any examples disclosed herein, each elongated anchor attachment in the plurality of elongated anchor attachments may not have a direct connection to any other elongated anchor attachment in the plurality of elongated anchor attachments.

[0011] Additionally or alternatively to any examples disclosed herein, the plurality of elongated anchoring appendages are configured to transition between a first configuration and a second configuration relative to the body when the expandable frame is in the expanded configuration.

[0012] Additionally or alternatively to any examples disclosed herein, in a first configuration, a plurality of elongated anchoring appendages are disposed within the interior of the body.

[0013] Additionally or alternatively to any examples disclosed herein, in the second configuration, a plurality of elongated anchoring appendages extend away from the body.

[0014] Additionally or alternatively to any examples disclosed herein, in the second configuration, the plurality of elongated anchoring appendages extend distally an axial distance from the body and extend outwardly a radial distance from the body.

[0015] Additionally or alternatively to any examples disclosed herein, the axial distance is greater than the radial distance.

[0016] Additionally or alternatively to any examples disclosed herein, the radial distance is greater than the axial distance.

[0017] Additionally or alternatively to any examples disclosed herein, the plurality of elongated anchoring appendages are self-biased toward the second configuration.

[0018] Additionally or alternatively to any examples disclosed herein, the plurality of elongated anchoring appendages are pulled to the first configuration by at least one tether.

[0019] In addition to or as an alternative to any examples disclosed herein, a medical implant for occluding a left atrial appendage may include an expandable frame configured to transition between a contracted configuration and an expanded configuration and an occluding element secured to the expandable frame. The expandable frame may include a proximal hub and a plurality of interconnected struts extending from the proximal hub to the distal hub to define a body in the expanded configuration. The expandable frame may include a plurality of elongated anchoring attachments fixedly attached to and extending from the outer periphery of the body, the plurality of elongated anchoring attachments each including a plurality of anchoring barbs extending from the plurality of elongated anchoring attachments.

[0020] Additionally or alternatively to any examples disclosed herein, a plurality of elongated anchoring appendages are configured to extend radially outward from the occlusive element in the expanded configuration.

[0021] Additionally or alternatively to any examples disclosed herein, each of the plurality of elongated anchor attachments is fixedly attached to the outer perimeter of the body at a single location.

[0022] Additionally or alternatively to any examples disclosed herein, a plurality of elongated anchoring appendages are disposed proximally of the distal hub in a collapsed configuration.

[0023] In addition to or alternatively to any of the examples described herein, a medical device system may include a catheter, a core wire movably disposed within the lumen of the catheter, and a medical implant for occluding the left atrial appendage, the medical implant being releasably connected to a distal portion of the core wire. The medical implant may include an expandable frame configured to transition between a contracted configuration and an expanded configuration, and an occluding element secured to the expandable frame. The expandable frame may include a proximal hub and a plurality of interconnected struts extending from the proximal hub, the plurality of interconnected struts defining a body in an expanded configuration. The expandable frame may include a plurality of elongated anchoring attachments extending from the body, the plurality of elongated anchoring attachments each including a plurality of anchoring barbs extending from the plurality of elongated anchoring attachments.

[0024] Additionally or alternatively to any examples disclosed herein, the expandable frame is configured to be in a collapsed configuration when the medical implant is disposed within the lumen of the catheter, and the expandable frame is configured to transition toward an expanded configuration when the medical implant is disposed outside the lumen of the catheter.

[0025] Additionally or alternatively to any examples disclosed herein, the plurality of elongated anchoring appendages are configured to be selectively transitionable between a first configuration and a second configuration when the medical implant is in the expanded configuration.

[0026] Additionally or alternatively to any examples disclosed herein, the plurality of elongated anchoring appendages are configured to engage a wall of the left atrial appendage in the second configuration to retain the medical implant within the left atrial appendage.

[0027] The above summary of some embodiments, aspects, and / or examples is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The figures and detailed description below more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The present disclosure may be more fully understood upon consideration of the following detailed description taken in conjunction with the accompanying drawings, in which:

[0029] Figure 1-Figure 2 is a side view of an exemplary medical device system;

[0030] Figure 3-Figure 4 is a perspective view showing selected aspects of a medical implant according to the present disclosure;

[0031] Figure 5-Figure 7 is a partial cross-sectional view showing selected aspects associated with deployment of a medical implant according to the present disclosure of one of a plurality of strut groups of an expandable frame in a first configuration;

[0032] Figure 8-Figure 9 is a perspective view showing selected aspects of a medical implant according to the present disclosure; and

[0033] Fig.10 is a partial cross-sectional view showing a medical implant according to the present disclosure deployed in a left atrial appendage of a patient.

[0034] Although various aspects of the present disclosure may be subjected to various modifications and alternative forms, the details thereof have been illustrated by way of example in the accompanying drawings and will be described in detail. However, it should be understood that the purpose is not to limit the various aspects of the present disclosure to the specific embodiments described. On the contrary, the present invention encompasses all modifications, equivalents, and alternatives that fall within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0035] The following description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, wherein similar reference numerals indicate similar elements throughout the multiple views. The detailed description and the accompanying drawings are intended to illustrate rather than limit the present disclosure. 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 accompanying drawings illustrate exemplary aspects of the present disclosure.

[0036] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0037] All numerical values ​​assumed herein are modified by the term "approximately", whether or not explicitly stated. In the context of numerical values, the term "approximately" generally refers to a numerical range that is considered by those skilled in the art to be equivalent to the value (e.g., having the same function or result). In many cases, the term "approximately" may include numbers rounded to the nearest significant figure. Unless otherwise specified, other uses of the term "approximately" (e.g., in contexts other than numerical values) may be assumed to have their common and customary definitions, as understood from the context of the specification and consistent with the context of the specification.

[0038] The recitation of numerical ranges by endpoints includes all numbers within that range, inclusive of the endpoints (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0039] Although some suitable sizes, ranges and / or values ​​associated with various components, features and / or specifications are disclosed, those skilled in the art inspired by this disclosure will appreciate that the desired sizes, ranges and / or values ​​may deviate from those explicitly disclosed.

[0040] 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 a sense that includes "and / or" unless the content clearly dictates otherwise. It should be noted that, for ease of understanding, certain features of the present disclosure may be described in the singular even though such features may be plural or repeated in the disclosed embodiments. Each instance of a feature may be included and / or contained in a single disclosure unless expressly specified to the contrary. It should be understood that the discussion herein applies equally to any and / or all components where there is more than one component, unless expressly specified to the contrary.

[0041] Relative terms such as "proximal", "distal", "advance", "retract" and variations thereof may generally be considered with respect to the positioning, orientation and / or operation of various elements relative to a user / operator / manipulator of the device, wherein "proximal" and "retract" mean or refer to being closer to or toward the user, while "distal" and "advance" mean or refer to being farther away from or away from the user. In some cases, the terms "proximal" and "distal" may be arbitrarily designated to aid in understanding the present disclosure, and these situations are clear to those skilled in the art. Other relative terms, such as "upstream", "downstream", "inflow" and "outflow", refer to the direction of fluid flow in a lumen (such as within a body cavity, blood vessel or device). Still other relative terms, such as "axial", "circumferential", "longitudinal", "lateral", "radial", etc. and / or variations thereof generally refer to a direction and / or orientation relative to a central longitudinal axis of the disclosed structure or device.

[0042] The term "range" may be understood to mean the maximum measurement of a described or identified dimension, unless the range or dimension in question is preceded or identified as a "minimum," which may be understood to mean the minimum measurement of the described or identified dimension. For example, "external range" may be understood to mean the maximum external dimension, "radial range" may be understood to mean the maximum radial dimension, "longitudinal range" may be understood to mean the maximum longitudinal dimension, and so on. Each instance of "range" may be different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.) and will be clear to one skilled in the art from the context of individual use. In some cases, "range" may be measured orthogonally within a plane and / or cross section, but it will be apparent from the particular context that it may be measured in different ways, such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), and so on.

[0043] The terms "integral" and "unitary" generally refer to one or more elements that are made or composed of a single structure or basic unit / element. Integral elements and / or unitary elements should exclude structures and / or features formed by assembling or otherwise joining together multiple discrete structures or elements.

[0044] It should be noted that references in the specification to "an embodiment," "some embodiments," "other embodiments," etc. indicate that the described embodiments may include specific features, structures, or characteristics, but each embodiment does not necessarily include the specific features, structures, or characteristics. In addition, such phrases do not necessarily refer to the same embodiment. In addition, when specific features, structures, or characteristics are described in conjunction with an embodiment, unless explicitly stated to the contrary, it is within the scope of one's knowledge to use the specific features, structures, or characteristics in conjunction with other embodiments, whether or not explicitly described. That is, the various individual elements described below, even if not explicitly shown in a specific combination, are still considered to be combinable or arrangable with each other to form other additional embodiments, or to supplement and / or enrich the described embodiments, as understood by a person of ordinary skill in the art.

[0045] For the sake of clarity, the digital designations of certain identifiers (e.g., first, second, third, fourth, etc.) can be used to name and / or distinguish various descriptions and / or claimed features throughout the specification and / or claims. It should be understood that the digital designations are not restrictive, but merely exemplary. In certain embodiments, for the sake of brevity and clarity, the digital designations previously used may be changed and deviated from. In other words, the feature identified as a "first" element may be referred to as a "second" element, a "third" element, etc., later, or may be completely omitted, and / or different features may be referred to as a "first" element. The meaning and / or name in each case are clear to a skilled practitioner or technician.

[0046] The accompanying drawings show selected components and / or arrangements of medical implants, systems and methods of making the same. It should be noted that in any given accompanying drawings, for the sake of brevity, some features of medical implants, systems and methods may not be shown, or may be schematically shown. Additional details about certain elements may be shown in more detail in other accompanying drawings. Devices and / or methods disclosed herein can provide many desired features and benefits, as described in more detail below.

[0047] Figure 1-Figure 2 Schematically illustrated are selected components and / or arrangements of the medical device system 10. The medical device system 10 may be used to deliver and / or deploy a variety of medical implants (e.g., cardiovascular medical implants, occlusive medical implants, etc.) to one or more locations within a patient's anatomy, including but not limited to the heart and / or vasculature.

[0048] The medical device system 10 may include a catheter 40 having a lumen 42 extending from a proximal opening to a distal opening, a core wire 30 movably and / or slidably disposed within the lumen 42, and a medical implant 100 (e.g., a cardiovascular medical implant, an occlusive medical implant, etc.). The medical implant 100 is schematically illustrated, and variations and / or changes to the illustrated example are contemplated. The medical implant 100 may be configured to occlude the left atrial appendage of a patient.

[0049] The medical implant 100 may include an expandable frame 110 that is configured to expand in a collapsed configuration (e.g., Figure 1 ) and expansion structures (e.g. Figure 2 ), in which the medical implant 100 is disposed within the lumen 42 near the distal opening, and in which the medical implant 100 and / or the expandable frame 110 are configured to radially transition between the contracted structure and the expanded structure relative to the central longitudinal axis when the medical implant 100 is disposed distal to the distal opening of the lumen 42 and / or the catheter 40 and / or when the medical implant 100 is not constrained by the catheter 40.

[0050] In some embodiments, the medical implant 100 may include an occlusive element 120 disposed on and / or affixed to the expandable frame 110. In some embodiments, the occlusive element 120 may be disposed on, along, and / or cover an outer surface of the expandable frame 110. Alternatively, in some embodiments, the occlusive element 120 may surround and / or be embedded in at least a portion of the expandable frame 110.

[0051] In some embodiments, the occlusive element 120 can be and / or can include a porous mesh. In some embodiments, the occlusive element 120 and / or the porous mesh can be a woven structure, a fabric structure, a textile structure, and / or a membrane or film having a plurality of pores formed therein and / or extending therethrough.

[0052] In some embodiments, the occlusive element 120 can cover at least 20% of the expandable frame 110 in the expanded configuration. In some embodiments, the occlusive element 120 can cover at least 30% of the expandable frame 110 in the expanded configuration. In some embodiments, the occlusive element 120 can cover at least 40% of the expandable frame 110 in the expanded configuration. In some embodiments, the occlusive element 120 can cover at least 50% of the expandable frame 110 in the expanded configuration. In some embodiments, the occlusive element 120 can cover at least 60% of the expandable frame 110 in the expanded configuration. In some embodiments, the occlusive element 120 can cover at least 70% of the expandable frame 110 in the expanded configuration. Other configurations are also contemplated.

[0053] The medical implant 100 can be disposed at and / or releasably connected to the distal portion of the core wire 30. In some embodiments, the medical implant 100 can be releasably connected to the distal end of the core wire 30. The core wire 30 can be slidably and / or rotatably disposed within the lumen 42 of the catheter 40. In some embodiments, the proximal end of the core wire 30 can extend proximally at the proximal end of the catheter 40 and / or the proximal opening of the lumen 42 for manual operation by a clinician or a practitioner.

[0054] Some suitable but non-limiting examples of materials for the medical device system 10, core wire 30, catheter 40 and / or medical implant 100, etc. are discussed below. It is contemplated that any and / or all embodiments and / or configurations of the medical implant 100 disclosed herein can be used in accordance with and / or associated with the above-described medical device system 10.

[0055] Figure 3-Figure 4 1 shows selected aspects of a medical implant 100 according to the present disclosure. The medical implant 100 includes a device configured to be in a collapsed configuration (e.g., Figure 1 ) and expansion structures (e.g. Figure 2-Figure 4 ). The expandable frame 110 may include a proximal hub 112 and / or a plurality of interconnected struts 114 extending from the proximal hub 112. In some embodiments, the expandable frame 110 may optionally include a distal hub 118. In at least some embodiments, the plurality of interconnected struts 114 may extend from the proximal hub 112 to the distal hub 118. The expandable frame 110 may have a central longitudinal axis extending from the proximal hub 112 to the distal hub 118 (if present).

[0056] The proximal hub 112 of the expandable frame 110 can be configured to releasably attach or connect to the distal end of the core wire 30. The proximal hub 112 of the expandable frame 110 can include a threaded insert 113 (e.g., Figure 5-Figure 7 ), the threaded insert 113 is configured to engage the threaded member 32 disposed at the distal end of the core wire 30 of the medical device system 10 to releasably connect the medical implant 100 and / or the expandable frame 110 to the distal end of the core wire 30. The expandable frame 110 can be configured to be in a contracted configuration when the medical implant 100 is disposed within the lumen 42 of the catheter 40 of the medical device system 10. The expandable frame 110 can be configured to transition toward an expanded configuration when the medical implant 100 is disposed outside the lumen 42 of the catheter 40 of the medical device system 10 and / or when the medical implant 100 and / or the expandable frame 110 are not constrained by the catheter 40.

[0057] In the expanded configuration, a plurality of interconnected struts 114 can define a body 116 of the expandable frame 110. In some embodiments, in the expanded configuration, a plurality of interconnected struts 114 can extend from the proximal hub 112 to the distal hub 118 to define the body 116. The body 116 can extend radially outward from the central longitudinal axis. In some embodiments, in the expanded configuration, the body 116 can have a transverse width (e.g., a diameter) measured perpendicular to the central longitudinal axis that is greater than an axial length measured parallel to the central longitudinal axis. Other configurations are also contemplated.

[0058] The expandable frame 110 may include a plurality of elongated anchor attachments 130 extending from the body 116. In some embodiments, the plurality of elongated anchor attachments 130 may be fixedly attached to the expandable frame 110 and / or the body 116 at a first end 132 and extend to a free end 134 opposite the first end 132. In some embodiments, the plurality of elongated anchor attachments 130 may be fixedly attached to the outer periphery of the body 116 and may extend from the outer periphery of the body. In some embodiments, each of the plurality of elongated anchor attachments 130 may be fixedly attached to the outer periphery of the body 116 at a single location or at a single attachment point. In at least some embodiments, each of the plurality of elongated anchor attachments 130 may not exist and / or may be significantly free of direct connection and / or direct attachment to any other elongated anchor attachment of the plurality of elongated anchor attachments 130.

[0059] In some embodiments, the plurality of elongated anchor attachments 130 may each include a plurality of anchor barbs 140 extending from the plurality of elongated anchor attachments. In some embodiments, the plurality of anchor barbs 140 may include two anchor barbs, three anchor barbs, four anchor barbs, etc. Other configurations are also contemplated, including embodiments where each of the plurality of elongated anchor attachments 130 includes only one anchor barb. Alternatively, in some embodiments, the expandable frame 110 and / or the plurality of elongated anchor attachments 130 may be free of any anchor barbs extending and / or protruding therefrom.

[0060] In one non-limiting example, when medical implant 100 and / or expandable framework 110 are in expansion configuration, multiple anchoring barbs 140 can be shaped as J-shaped hook structure. When medical implant 100 and / or expandable framework 110 are in expansion configuration, the free end or end of J-shaped hook can extend in the proximal direction. In another non-limiting example, when medical implant 100 and / or expandable framework 110 are in expansion configuration, multiple anchoring barbs 140 can extend proximally from their corresponding elongated anchoring attachments to form a certain oblique angle with elongated anchoring attachments. In certain embodiments, multiple anchoring barbs 140 can be formed separately from expandable framework 110 and / or multiple elongated anchoring attachments 130, and then fixedly attached to this expandable framework and / or multiple elongated anchoring attachments. In certain embodiments, multiple anchoring barbs 140 can be formed into a single integral structure with expandable framework 110 and / or multiple elongated anchoring attachments 130.

[0061] In some embodiments, the expandable frame 110 can be formed and / or cut from a single tubular member. Alternatively, the expandable frame 110 can be formed and / or cut from a flat sheet of material that is subsequently rolled and / or formed into a tubular member. After the flat sheet of material is formed into the tubular member, the tubular member can be welded or otherwise fixedly affixed into a tubular shape. In some embodiments, forming and / or cutting the expandable frame 110 can be accomplished via lasers, water jets, machining, etc. Other manufacturing methods and / or processes are also contemplated.

[0062] In some embodiments, a plurality of elongated anchoring attachments 130 can be integrally formed with a plurality of interconnected struts 114 and / or the body 116 as a single unitary structure to form the expandable frame 110 as a whole. In some alternative embodiments, a plurality of elongated anchoring attachments 130 can be formed separately and then fixedly attached to a plurality of interconnected struts 114 and / or the body 116 to form the expandable frame 110 as a whole. In some embodiments, a plurality of elongated anchoring attachments 130 can be fixedly attached to a plurality of interconnected struts 114 and / or the body 116 by welding, brazing, bonding, etc. Other configurations are also contemplated. In some embodiments, the occlusive element 120 can be fixedly attached to the expandable frame 110 after the medical implant 100 and / or the expandable frame 110 is formed and / or heat-set into an expanded configuration.

[0063] In some embodiments, one or more of the plurality of elongated anchor attachments 130 can extend through the occlusive element 120. In some embodiments, at least some of the plurality of anchor barbs 140 can extend through the occlusive element 120. In some embodiments, the occlusive element 120 can be secured to the expandable frame 110 and / or the plurality of interconnected struts 114 using a plurality of hooks on the body 116. In some embodiments, the occlusive element 120 can be secured to the expandable frame 110 using an adhesive or other suitable attachment means. In some embodiments, a portion of the expandable frame 110, the plurality of interconnected struts 114, and / or the body 116 can be embedded within the occlusive element 120. Other configurations are also contemplated.

[0064] Figure 5-Figure 7 is a partial cross-sectional view illustrating selected aspects associated with deploying the medical implant 100 . Figure 5 The medical implant 100 and / or expandable frame 110 is shown in a collapsed configuration and coupled to a distal portion of the core wire 30 via threaded members 32 and threaded inserts 113. In some embodiments, in the collapsed configuration, a plurality of elongated anchoring appendages 130 can be disposed proximal to the distal hub 118 (if present). Figure 6 The medical implant 100 and / or expandable frame 110 is shown in an expanded configuration. Figure 6-Figure 7 It can be seen that in some embodiments, when the expandable frame 110 is in the expanded configuration, the plurality of elongated anchor attachments 130 can be configured to be in a first configuration (e.g., Figure 6 ) and a second configuration (e.g., Figure 7 ). Figure 6As shown, in a first configuration, a plurality of elongated anchor attachments 130 may be disposed within the interior of the body 116 and / or radially within an imaginary cylinder defined by the central longitudinal axis and the outer perimeter of the body 116. Figure 7 As shown, in the second configuration (and when the expandable frame 110 is in the expanded configuration), a plurality of elongated anchoring appendages 130 can extend away from the body 116 and / or can extend radially outward from an imaginary column defined by the central longitudinal axis and the outer periphery of the body 116 .

[0065] like Figure 4 and Figure 7 As shown, in the second configuration (and when the expandable frame 110 is in the expanded configuration), the plurality of elongated anchoring attachments 130 may extend an axial distance 136 distally from the body 116 and extend a radial distance 138 outwardly from the body 116, an imaginary cylinder defined by the central longitudinal axis and the outer periphery of the body 116, and / or the occluding element 120. In some embodiments, in the second configuration (and when the expandable frame 110 is in the expanded configuration), at least some of the plurality of elongated anchoring attachments 130 may extend an axial distance 136 distally from the body 116 and extend a radial distance 138 outwardly from the body 116, an imaginary cylinder defined by the central longitudinal axis and the outer periphery of the body 116, and / or the occluding element 120. In some embodiments, in the second configuration (and when the expandable frame 110 is in the expanded configuration), each of the plurality of elongated anchor attachments 130 can extend an axial distance 136 distally from the body 116 and a radial distance 138 outwardly from the body 116, an imaginary cylinder defined by the central longitudinal axis and the outer perimeter of the body 116, and / or the occlusive element 120. In at least some embodiments, the axial distance 136 can be greater than the radial distance 138.

[0066] In some embodiments, the plurality of elongated anchoring attachments 130 can be self-biased toward the second configuration. In some embodiments, the plurality of elongated anchoring attachments 130 can be pulled into the interior of the body 116 and / or pulled into the first configuration by at least one tether 150. In some embodiments, the tension applied to the free ends 134 of the plurality of elongated anchoring attachments 130 using the at least one tether 150 can hold and / or maintain the plurality of elongated anchoring attachments 130 in the first configuration. The at least one tether 150 can extend through the proximal hub 112 into the interior of the body 116. In some embodiments, the at least one tether 150 can extend within, through, and / or along the core wire 30 to the free ends 134 of the plurality of elongated anchoring attachments 130.

[0067] At least one tether 150 can be releasably coupled to the free ends 134 of the plurality of elongated anchor attachments 130. In some embodiments, the free ends 134 can include an eyelet, and the at least one tether 150 can be passed through the eyelet and / or can be removably connected to the eyelet. In at least some embodiments, the eyelet at the free end 134 can be a closed eyelet with a rounded distal-most end. In some embodiments, the eyelet can have a circumferential extent (relative to the central longitudinal axis) that is approximately 3 times greater from the lateral extent of its corresponding elongated anchor attachment and / or greater than the lateral extent (e.g., width) of its corresponding elongated anchor attachment. In some embodiments, the eyelet can have a circumferential extent (relative to the central longitudinal axis) that is approximately 5 times greater from the lateral extent of its corresponding elongated anchor attachment and / or greater than the lateral extent (e.g., width) of its corresponding elongated anchor attachment. In some embodiments, the eyelet can have a circumferential extent (relative to the central longitudinal axis) that is approximately 7 times greater from the lateral extent of its corresponding elongated anchor attachment and / or greater than the lateral extent (e.g., width) of its corresponding elongated anchor attachment. In some embodiments, the eyelet can have a lateral extent from its corresponding elongated anchoring attachment and / or a circumferential extent (relative to the central longitudinal axis) that is approximately 10 times greater than the lateral extent (e.g., width) of its corresponding elongated anchoring attachment. In some embodiments, the eyelet can have a lateral extent from its corresponding elongated anchoring attachment and / or a circumferential extent (relative to the central longitudinal axis) that is approximately 15 times greater than the lateral extent (e.g., width) of its corresponding elongated anchoring attachment. In some embodiments, the eyelet can have a lateral extent from its corresponding elongated anchoring attachment and / or a circumferential extent (relative to the central longitudinal axis) that is approximately 20 times greater than the lateral extent (e.g., width) of its corresponding elongated anchoring attachment. Other configurations are also contemplated. In at least some embodiments, an eyelet having a lateral extent or circumferential extent that is greater than the lateral extent of its corresponding elongated anchoring attachment can render the plurality of elongated anchoring attachments 130 more atraumatic relative to tissue at a treatment site (e.g., the wall of the left atrial appendage).

[0068] In some embodiments, each of the plurality of elongated anchoring attachments 130 may have one of the at least one tethers 150 associated therewith. For example, but not limited to, a medical implant 100 having twelve elongated anchoring attachments may have at least one tether 150 associated therewith. The number twelve is selected as an example only, and other numbers (e.g., two, three, four, six, eight, ten, fifteen, twenty, etc.) are also contemplated. In some embodiments, a medical implant 100 having twelve elongated anchoring attachments may include twelve separate tethers, each tether coupled to each of the plurality of elongated anchoring attachments 130. In some embodiments, a medical implant 100 having twelve elongated anchoring attachments (and / or at least one tether 150 associated therewith) may include one core tether extending through the proximal hub 112 and twelve distal tethers, wherein one distal tether extends from one core tether to each of the plurality of elongated anchoring attachments 130. Other configurations are also contemplated.

[0069] In some embodiments, when the medical implant 100 and / or the expandable frame 110 is in the expanded configuration, the plurality of elongated anchoring attachments 130 can be configured to selectively switch between the first configuration and the second configuration. In some embodiments, the plurality of elongated anchoring attachments 130 can be bistable, such that the plurality of elongated anchoring attachments 130 can be stable and / or can be self-biased to be in the first configuration and / or the second configuration.

[0070] In some alternative embodiments, an external force may be required to transform the plurality of elongated anchoring appendages 130 from the first configuration toward the second configuration, or vice versa. In some embodiments, the plurality of elongated anchoring appendages 130 may be formed of a shape memory material that is responsive to an external stimulus, such as, for example, temperature. Other configurations are also contemplated.

[0071] like Figure 5-Figure 6 As shown, in the first configuration, a plurality of elongated anchoring attachments 130 and / or a plurality of anchoring barbs 140 can be disposed within the body 116 of the expandable frame 110 and / or can be spaced apart from tissue at a treatment site (e.g., a wall of a left atrial appendage). This can be beneficial when placing the medical implant 100 because the medical implant 100 can be repositioned if necessary prior to anchoring and release from the core wire 30 while minimizing damage and / or injury to tissue (e.g., a wall of a left atrial appendage). In some embodiments, the plurality of elongated anchoring attachments 130 can be self-biased toward the second configuration, and during deployment of the medical implant 100 and / or when the expandable frame 110 is converted from a contracted configuration to an expanded configuration, the plurality of elongated anchoring attachments 130 can be maintained or retained in the first configuration by tension applied to at least one tether 150.

[0072] Once the medical implant 100 is placed to the satisfaction of the practitioner (which may be verified using appropriate imaging means), the plurality of elongated anchoring attachments 130 may be released from the first configuration and / or may be selectively transformed toward a second configuration in which the plurality of elongated anchoring attachments 130 extend away from the expandable frame 110 and / or the body 116 to engage tissue (e.g., the wall of the left atrial appendage) to anchor the medical implant 100 in place. If desired, at least one tether 150 may be used to pull the plurality of elongated anchoring attachments 130 back toward the first configuration if the medical implant 100 needs to be recaptured and / or repositioned.

[0073] like Figure 7 As shown, after the plurality of elongated anchoring attachments 130 are deployed and the medical implant 100 is anchored in place, at least one tether 150 can be released and / or disconnected from the free ends 134 of the plurality of elongated anchoring attachments 130. In some embodiments, releasing at least one tether 150 can include cutting at least one tether 150, relaxing or releasing tension on at least one tether 150, releasing one end of at least one tether 150 when at least one tether 150 is looped through an eyelet at the free end 134 so that at least one tether 150 can be pulled through the medical implant 100, etc. Other configurations are also contemplated. Finally, the core wire 30 and / or the threaded member 32 can be disconnected from the medical implant 100, the proximal hub 112, and / or the threaded insert 113, as also shown. Figure 7 shown.

[0074] Figure 8-Figure 9 Shows Figure 3-Figure 4 100, wherein a plurality of elongated anchoring attachments 130 are shown in an alternative arrangement of a second configuration. Fig. 9 As shown, and similar to the above Figure 4 and Figure 7In the described configuration, in the second configuration (and when the expandable frame 110 is in the expanded configuration), the plurality of elongated anchoring attachments 130 may extend an axial distance 136 distally from the body 116 and extend a radial distance 138 outwardly from the body 116, an imaginary cylinder defined by the central longitudinal axis and the outer periphery of the body 116, and / or the occluding element 120. In some embodiments, in the second configuration (and when the expandable frame 110 is in the expanded configuration), at least some of the plurality of elongated anchoring attachments 130 may extend an axial distance 136 distally from the body 116 and extend a radial distance 138 outwardly from the body 116, an imaginary cylinder defined by the central longitudinal axis and the outer periphery of the body 116, and / or the occluding element 120. In some embodiments, in the second configuration (and when the expandable frame 110 is in the expanded configuration), each of the plurality of elongated anchoring attachments 130 can extend distally an axial distance 136 from the body 116 and extend outwardly a radial distance 138 from the body 116, an imaginary cylinder defined by the central longitudinal axis and the outer periphery of the body 116, and / or the occluding element 120.

[0075] In at least some embodiments, radial distance 138 may be greater than axial distance 136, for example, Figure 8-Figure 9 In some embodiments, if and / or when the plurality of elongated anchoring appendages 130 are radially compressed by tissue toward the body 116 and / or toward the first configuration, a radial distance 138 greater than the axial distance 136 can provide additional radial force against tissue at the treatment site (e.g., a wall of the left atrial appendage), thereby further improving anchoring of the medical implant 100 within the left atrial appendage.

[0076] Fig.10 The left atrial appendage 200 and selected aspects of a medical implant 100 implanted and / or placed in the left atrial appendage are shown. The left atrial appendage 200 may include an orifice 210 where the left atrial appendage opens into the left atrium of the patient's heart. Fig.10 As shown, the plurality of elongated anchoring appendages 130 and / or the plurality of anchoring barbs 140 can be configured to engage the wall 220 of the left atrial appendage 200 in the second configuration to retain the medical implant 100 within the left atrial appendage 200. In some patients, the left atrial appendage 200 can be irregularly shaped and / or can include recesses and / or protrusions along the wall 220 of the left atrial appendage. The plurality of elongated anchoring appendages 130 can be sufficiently flexible while also being radially biased outward to follow the wall 220 of the left atrial appendage 200 in the second configuration and be disposed in juxtaposition thereto.

[0077] The material that can be used for the various parts of medical implant and / or medical device system disclosed herein can include those materials that are usually relevant to medical device.For simplicity, the discussion below relates to system.However, this is not intended to limit system, device and / or method as described herein, because the discussion can be applied to other elements, members, parts or devices disclosed herein (such as but not limited to expandable framework, a plurality of interconnected pillars, a plurality of elongated anchoring attachments, occlusive elements etc.) and / or its elements or parts.

[0078] In some embodiments, the system and / or components thereof may be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or the like, or other suitable materials.

[0079] Some examples of suitable polymers may include: polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g. ), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ), ether or ester based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers, such as ), polyamides (e.g. or ), elastic polyamides, block polyamide / ether, polyether block amide (PEBA, for example, can be Trademark), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), High density polyethylene, Low-density polyethylene, linear low-density polyethylene (e.g. ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., ), polysulfone, nylon, nylon-12 (e.g. ), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, polyurethane silicone copolymers (e.g., Elast- or ), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, etc. thereof. In some embodiments, the system and / or its components can be mixed with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6 percent LCP.

[0080] Some examples of suitable metals and metal alloys include: stainless steels, such as 304V, 304L, and 316LV stainless steel; low carbon steel; nickel titanium alloys, such as linear elastic and / or superelastic nitinol; other nickel alloys, such as nickel chromium molybdenum alloys (e.g., UNS: N06625, such as 625, UNS: N06022, such as UNS: N10276, such as other alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as alloy ), 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 (for example, UNS: R30003, such as etc.); platinum-rich stainless steel, titanium, platinum, palladium, gold, combinations thereof, or any other suitable material.

[0081] In some embodiments, part or all of the system and / or its components may be doped with, made of, or otherwise include radiopaque materials. Radiopaque materials are understood to be materials that can produce relatively bright images on a fluoroscopic examination screen or another imaging technique during medical procedures (e.g., ultrasound examinations, etc.). This relatively bright image helps the user determine the position of the system. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials loaded with radiopaque fillers, etc. In addition, other radiopaque marker bands and / or coils may also be incorporated into the design of the system to achieve the same results.

[0082] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the system. For example, the system and / or its components or portions may be made of materials that do not substantially distort the image and produce a large number of artifacts (i.e., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may produce artifacts in MRI images. The system or portions thereof may also be made of materials that can be imaged by MRI machines. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003, such as etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, such as etc.), Nitinol, etc., and other materials.

[0083] In some embodiments, the system may include a fabric material. Some examples of suitable fabric materials may include: synthetic yarns, which may be flat, shaped, twisted, textured, pre-shrinked or unshrinked. Synthetic biocompatible yarns suitable for the present invention include, but are not limited to: polyesters, including polyethylene terephthalate (PET) polyesters, polypropylene, polyethylene, polyurethanes, polyolefins, ethylene polymers, polyacetates, polyamides, ethylene naphthalate derivatives, natural silk and polytetrafluoroethylene. In addition, at least one synthetic yarn in the synthetic yarn may be a metal yarn or a glass or ceramic yarn or fiber. Effective metal yarns include yarns made of stainless steel, platinum, gold, titanium, tantalum or nickel-cobalt-chromium-based alloys or containing these materials. Yarns may further include carbon, glass or ceramic fibers. In some embodiments, yarns may be made of thermoplastic materials, including but not limited to polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, etc. Yarns may be multifilaments, monofilaments or spinning types. The type and denier of the selected yarns may be selected in a manner to form a biocompatible system.

[0084] In some embodiments, the system and / or other components may include and / or be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents may include: antithrombotic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrorotatory phenylalanine proline arginine chloromethyl ketone)); antiprotein and / or antibacterial agents (such as 2-methacryloyloxyethyl phosphorylcholine (MPC) and its polymers or copolymers); antiproliferative agents (such as enoxaparin, angiopeptide, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine); antitumor / antiproliferative / antimitotic drugs (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (such as lidocaine, bupivacaine, and ro antiplatelet peptides); angiogenic agents (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional activators, and translational promoters); angiogenic 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, and bifunctional molecules consisting of antibodies and cytotoxins); cholesterol-lowering agents; vasodilators; and drugs that interfere with endogenous vasoactive mechanisms.

[0085] It should be understood that the present disclosure is in many respects illustrative only. Changes in detail, particularly in the arrangement of shapes, sizes, and steps, may be made without exceeding the scope of the present disclosure. To the extent appropriate, this may include using any features of an exemplary embodiment used in other embodiments. Of course, the scope of the present disclosure is defined in the language of the appended claims.

Claims

1. A medical implant for occluding a left atrial appendage, comprising: an expandable frame configured to transition between a collapsed configuration and an expanded configuration; as well as an occlusive element secured to the expandable frame; wherein the expandable frame comprises a proximal hub and a plurality of interconnected struts extending from the proximal hub, the plurality of interconnected struts defining a body in the expanded configuration; Wherein, the expandable frame includes a plurality of elongated anchoring attachments extending from the body, and each of the plurality of elongated anchoring attachments includes a plurality of anchoring barbs extending from the plurality of elongated anchoring attachments.

2. The medical implant according to claim 1, wherein Each elongated anchor attachment of the plurality of elongated anchor attachments is fixedly attached to the expandable frame at a first end and extends to a free end opposite the first end.

3. The medical implant according to claim 2, wherein: The plurality of elongated anchor attachments are integrally formed with the body as a single unitary structure.

4. The medical implant according to any one of claims 1 to 3, wherein: Each elongated anchor attachment of the plurality of elongated anchor attachments has no direct connection to any other elongated anchor attachment of the plurality of elongated anchor attachments.

5. The medical implant according to any one of claims 1 to 4, wherein: The plurality of elongated anchoring appendages transition between a first configuration and a second configuration relative to the body when the expandable frame is in the expanded configuration.

6. The medical implant according to claim 5, wherein In the first configuration, the plurality of elongated anchor appendages are disposed within an interior of the body.

7. The medical implant according to any one of claims 5-6, wherein: In the second configuration, the plurality of elongated anchor appendages extend away from the body.

8. The medical implant according to any one of claims 5 to 7, wherein: In the second configuration, the plurality of elongated anchor appendages extend distally an axial distance from the body and extend outwardly a radial distance from the body.

9. The medical implant according to claim 8, wherein: The axial distance is greater than the radial distance.

10. The medical implant according to claim 8, wherein The radial distance is greater than the axial distance.

11. The medical implant according to any one of claims 5 to 10, wherein: The plurality of elongated anchor appendages are self-biased toward the second configuration.

12. The medical implant according to claim 11, wherein The plurality of elongated anchoring attachments are pulled to the first configuration by at least one tether.

13. The medical implant according to any one of claims 1 to 12, wherein: the plurality of interconnected struts extending from the proximal hub to a distal hub to define the body in the expanded configuration; Wherein, the plurality of elongated anchor attachments are fixedly attached to and extend from an outer periphery of the body.

14. The medical implant according to claim 13, wherein: Each of the plurality of elongated anchor attachments is fixedly attached to the outer periphery of the body at a single location.

15. A medical device system comprising: catheter; a core wire movably disposed in the lumen of the catheter; as well as The medical implant according to any one of claims 1-14, wherein the medical implant is releasably connected to the distal portion of the core wire.

Images