Medical device for occluding left atrial appendage

Abstract

A medical implant for occluding a left atrial appendage includes an expandable frame configured to transition between a first configuration and a second configuration, and an occluding element secured to the expandable frame. The expandable frame includes a plurality of interconnected struts extending from a proximal hub. The plurality of interconnected struts includes a first plurality of struts and a second plurality of struts. In a second configuration, the first plurality of struts each extend radially from the proximal hub along a first strut path to one of the first plurality of strut intersections, and the second plurality of struts each extend radially from the proximal hub along a second strut path to one of the second plurality of strut intersections. In the second configuration, the first plurality of struts forms a recess in the expandable frame and the second plurality of struts extends into the recess.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 356,535, filed on June 29, 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 rapidly 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 organ attached to the left atrium of the heart that extends in a sac-like shape. In patients with atrial fibrillation, the left atrial appendage may not contract properly with the left atrium, causing stationary blood to pool inside it, which may lead to the formation of unwanted thrombi within the left atrial appendage. Thrombi that form in the left atrial appendage may break away from the area and enter the bloodstream. Thrombi that migrate through blood vessels may eventually block smaller vessels downstream, leading to 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 is covered with tissue (a process called endothelialization), effectively removing the left atrial appendage from the circulatory system and reducing or eliminating the number of thrombi that may enter the bloodstream from the left atrial appendage.

[0006] The present disclosure relates to medical implants for occluding the left atrial appendage. In known medical devices, systems and methods, each has certain advantages and disadvantages. There is a 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 convert between a first structure and a second structure and an occluding element fixed to the expandable frame. The expandable frame may include a proximal hub and a plurality of interconnected struts extending from the proximal hub and coupled together at a plurality of strut intersections. The plurality of interconnected struts may include a first plurality of struts and a second plurality of struts. In the second structure, the first plurality of struts may each extend radially from the proximal hub along a first strut path to a strut intersection in the first plurality of strut intersections. In the second structure, the second plurality of struts may each extend radially from the proximal hub along a second strut path to a strut intersection in the second plurality of strut intersections.

[0008] Additionally or alternatively to any examples described herein, the second plurality of strut intersections are disposed radially outward from the first plurality of strut intersections.

[0009] Additionally or alternatively to any examples described herein, the second plurality of strut intersections are disposed proximate a radially outermost extent of the expandable frame in the second configuration.

[0010] Additionally or alternatively to any examples described herein, each strut of the second plurality of struts is free of any other connection to the expandable frame between the proximal hub and the second plurality of strut intersections.

[0011] Additionally or alternatively to any examples described herein, the first strut path extends distally from the proximal hub to the first bend and then extends proximally from the first bend to a strut intersection of the first plurality of strut intersections.

[0012] In addition to or alternatively to any examples described herein, a second strut path extends distally from the proximal hub to a first bend, proximally from the first bend to a second bend, distally from the second bend to a third bend, proximally from the third bend to a fourth bend, the fourth bend being coupled to one of a second plurality of strut intersections.

[0013] Additionally or alternatively to any examples described herein, a distal-most extent of the first bend of the first strut pathway is disposed distal to a distal-most extent of the first bend of the second strut pathway.

[0014] In addition to or alternatively to any examples described herein, the first bend of the first strut path is concave in the proximal direction and the second bend of the second strut path is concave in the distal direction, such that the first bend of the first strut path is open toward a center of the second bend of the second strut path and the second bend of the second strut path is open toward a center of the first bend of the first strut path.

[0015] Additionally or alternatively to any examples described herein, the first strut path extends from one of the first plurality of strut intersections to one of the second plurality of strut intersections via an additional segment of a plurality of interconnected struts to define an extended first strut path.

[0016] Additionally or alternatively to any examples described herein, the extended first strut path, if straightened, defines a first length, and the second strut path, if straightened, defines a second length. The first length is substantially equal to the second length.

[0017] Additionally or alternatively to any of the examples described herein, in the second configuration, the first plurality of struts form a recess that is open in a proximal direction, and the second plurality of struts extend proximally into the recess.

[0018] Additionally or alternatively to any examples described herein, in the second configuration, the second plurality of struts prevents the occlusive element from deflecting into the recess.

[0019] In addition to any examples described herein or alternatively, the medical device system may include a catheter, a core wire movably disposed in the lumen of the catheter, and a medical implant for occluding the left atrial appendage, which is releasably connected to the distal portion of the core wire. The medical implant may include an expandable framework configured to convert between a first configuration and a second configuration, and an occlusive element affixed to the expandable framework. The expandable framework may include a proximal hub and a plurality of interconnected struts, which extend from the proximal hub and are coupled together at a plurality of strut intersections. A plurality of interconnected struts may include a first plurality of struts and a second plurality of struts. In the second configuration, the first plurality of struts may each extend radially from the proximal hub along a first strut path to a strut intersection in the first plurality of strut intersections. In the second configuration, the second plurality of struts may each extend radially from the proximal hub along a second strut path to a strut intersection in the second plurality of strut intersections.

[0020] Additionally or alternatively to any examples described herein, the expandable frame is configured to be in a first configuration when the medical implant is disposed within the lumen of the catheter and to transition toward a second configuration when the medical implant is disposed outside the lumen of the catheter.

[0021] Additionally or alternatively to any of the examples described herein, the medical implant includes a plurality of anchoring members extending radially outward from the expandable frame in the second configuration.

[0022] Additionally or alternatively to any examples described herein, at least some of the plurality of anchoring members extend through the occlusive element.

[0023] In addition to or alternatively to any of the examples described herein, a medical implant for occluding the left atrial appendage may include an expandable frame configured to convert between a first configuration and a second configuration and an occluding element disposed on the expandable frame. The expandable frame includes a proximal hub and a plurality of interconnected struts extending from the proximal hub and coupled together at a plurality of strut intersections. The plurality of interconnected struts include a first plurality of struts and a second plurality of struts. In the second configuration, the first plurality of struts form a recess defined by a radially inward boundary and a radially outward boundary in the expandable frame, and the recess extends distally between the radially inward boundary and the radially outward boundary and is open in a proximal direction. In the second configuration, the second plurality of struts extend into the recess.

[0024] Additionally or alternatively to any examples described herein, the recess has a depth measured distally from a plane coincident with the proximal end of the proximal hub and oriented perpendicular to a longitudinal axis extending through the proximal hub. The second plurality of struts extend proximally within the recess to within 50% of the depth of the plane.

[0025] Additionally or alternatively to any examples described herein, the second plurality of struts are integrally formed with the plurality of interconnected struts as a single unitary structure.

[0026] Additionally or alternatively to any examples described herein, the second plurality of struts is formed separately from the plurality of interconnected struts and subsequently fixedly attached to the plurality of interconnected struts.

[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 following figures and detailed description 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 in conjunction with the accompanying drawings, in which:

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

[0030] FIG3 is a perspective view of the construction of a prior art medical implant;

[0031] Figure 4 is a perspective view showing selected aspects of a medical implant according to the present disclosure;

[0032] Figure 5 Shows Figure 4 selected aspects of medical implants;

[0033] Figure 6 It shows Figure 4 side cross-sectional views of selected aspects of a medical implant;

[0034] Figure 7 shows a portion of a plan view of an expandable stent according to the present disclosure;

[0035] Figure 8 Shows Figure 6 selected aspects of alternative configurations of expandable stents; and

[0036] Fig. 9 Shows Figure 6 Selected aspects of alternative configurations of expandable stents.

[0037] 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 purpose is to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0038] 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.

[0039] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0040] 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 a number 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 ordinary and customary definitions, as understood from the context of the specification and consistent with the context of the specification.

[0041] 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).

[0042] 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.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] 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.

[0051] 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 may be configured to occlude the left atrial appendage of a patient.

[0052] The medical implant 100 may include an expandable stent configured in a first configuration (e.g., Figure 1 ) and a second configuration (e.g., Figure 2 ), in which the medical implant 100 is in the first configuration and is disposed in the lumen 42 near the distal opening, and in the second configuration, 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, the medical implant 100 and / or the expandable stent is configured to transition between the first configuration and the second configuration.

[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 exemplary 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 of 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 technician.

[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 medical implants disclosed herein can be used in accordance with and / or in association with the above-described medical device system 10.

[0055] FIG3 illustrates selected aspects of a prior art medical implant 200. The medical implant 200 includes a frame 210 and a covering 220. As shown in FIG3, since the covering 220 may be loose on the frame 210 for ease of recapture, and / or since the frame 210 cannot fully expand and absorb any slack in the covering 220 due to anatomical limitations, after the medical implant 200 is deployed, the covering 220 may fall into a recess 230 formed in the frame 210. In this case, due to changes in pressure, flow, etc. in the patient's body when the heart beats, blood dynamics may cause the covering 220 to vibrate. This vibration may cause incomplete endothelialization and / or the formation of blood clots on the covering 220, which may be harmful to the patient's health. Therefore, it may be desirable to explore alternative structures that can reduce and / or eliminate the possibility of loose and / or vibrating coverings.

[0056] Figure 4-Figure 5 1 shows selected aspects of a medical implant 100 according to the present disclosure. The medical implant 100 includes an expandable frame 110 configured in a first configuration (e.g., Figure 1 ) and a second configuration (e.g., Figure 2 , Figure 4 ) between. The first configuration may be a radially contracted configuration, and the second configuration may be a radially expanded configuration. In some embodiments, the expandable frame 110 may include a proximal hub 112 and a plurality of interconnected struts 120 extending from the proximal hub 112. In some embodiments, the expandable frame 110 may include a proximal hub 112, a distal hub 114, and a plurality of interconnected struts 120 extending between the proximal hub 112 and the distal hub 114 and coupled together at a plurality of strut intersections 130.

[0057] The expandable frame 110 can have a longitudinal axis 111 extending through a proximal hub 112. In some embodiments, the longitudinal axis 111 can extend from the proximal hub 112 to the distal hub 114. The proximal hub 112 of the expandable frame 110 can be configured to be releasably attached or connected to the distal end of the core wire 30. The proximal hub 112 of the expandable frame 110 can include a threaded insert 113 fixedly attached to the expandable frame 110, the threaded insert 113 being configured to engage a threaded member disposed at the distal end of the core wire 30 of the medical device system 10 to releasably connect the medical implant 100 to the distal end of the core wire 30. 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 disposed in a first 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, the expandable frame 110 can be configured to transition toward the second configuration.

[0058] The expandable frame 110 can include a plurality of anchoring members 118, each anchoring member having a free end extending radially outward in the second configuration and connected at a base to the expandable frame 110. The plurality of anchoring members 118 are configured to engage a wall of the left atrial appendage in the second configuration.

[0059] The medical implant 100 includes an occlusive element 126 disposed on and / or secured to the expandable frame 110 and / or the plurality of interconnected struts 120. In some embodiments, at least some of the plurality of anchoring members 118 extend through the occlusive element 126. In at least some embodiments, when the expandable frame 110 is in the second configuration, the occlusive element 126 can present a generally planar configuration across the proximal end of the expandable frame 110 and / or the plurality of interconnected struts 120, such as Figure 4 shown.

[0060] In some embodiments, as described herein, the occlusive element 126 can be supported by the expandable frame 110. Without limitation, the plurality of interconnected struts 120 can include a first plurality of struts 140 and a second plurality of struts 160, such as Figure 5As shown. Additional multiple struts are also contemplated. The multiple strut crosses 130 may include a first multiple strut crosses 132 and a second multiple strut crosses 134. In the first configuration, the first multiple strut crosses 132 and the second multiple strut crosses 134 may be disposed distally of the proximal hub 112, and in the second configuration, the first multiple strut crosses 132 and the second multiple strut crosses 134 may be disposed radially outwardly relative to the proximal hub 112, and wherein in the second configuration, the second multiple strut crosses 134 may be disposed radially outwardly from the first multiple strut crosses 132. In some embodiments, in the second configuration, the second multiple strut crosses 134 may be disposed proximal to the radially outermost extent of the expandable frame 110. In the first configuration and the second configuration, the first multiple strut crosses 132 and the second multiple strut crosses 134 may be disposed proximal to the distal hub 114. In at least some embodiments, the second plurality of struts 160 and / or each of the second plurality of struts 160 can be free of any other connection to the expandable frame 110 between the proximal hub 112 and the second plurality of strut intersections 134 .

[0061] like Figure 5 and Figure 6 As shown, in the second configuration, the first plurality of struts 140 form a recess 180 in the expandable frame 110 that is open in the proximal direction. The recess 180 can be defined by a radially inward boundary 182 and a radially outward boundary 184. The recess 180 can extend distally between the radially inward boundary 182 and the radially outward boundary 184 and be open in the proximal direction. In the second configuration, the recess 180 can have a depth 186 measured distally from a plane 188 that coincides with the proximal end of the proximal hub 112 and is oriented perpendicular to the longitudinal axis 111 extending through the proximal hub 112 and / or from the proximal hub 112 to the distal hub 114, as shown in FIG. Figure 6 For clarity, some features of the expandable frame 110 have been removed from the illustration. Figure 6 For discussion purposes, plane 188 may be located near the top of recess 180 and depth 186 may be measured to the bottom of recess 180.

[0062] In the second configuration, the second plurality of struts 160 extend proximally into the recess 180. In some embodiments, in the second configuration, the second plurality of struts 160 extend proximally within the recess 180 to within 50% of the depth 186 of the plane 188. Described another way, in the second configuration, the proximal portion of the second plurality of struts 160 disposed within the recess 180 can extend within the recess 180 closer to the plane 188 and / or the top of the recess 180 than to the bottom of the recess 180. In some embodiments, in the second configuration, the second plurality of struts 160 extend proximally within the recess 180 to within 25% of the depth 186 of the plane 188. Other configurations are also contemplated. In the second configuration, the second plurality of struts 160 can prevent the occlusive element 126 from deflecting into the recess 180 formed by the first plurality of struts 140.

[0063] In the second configuration, the first plurality of struts 140 can each extend radially from the proximal hub 112 along a first strut path to one of the strut intersections in the first plurality of strut intersections 132. In the second configuration, the second plurality of struts 160 can each extend radially from the proximal hub 112 along a second strut path to one of the strut intersections in the second plurality of strut intersections 134.

[0064] In the second configuration, the first strut path may extend distally from the proximal hub 112 to the first bend 142, and then proximally from the first bend 142 to one of the strut intersections 132. In the second configuration, the second strut path may extend distally from the proximal hub 112 to the first bend 162, proximally from the first bend 162 to the second bend 164, and distally from the second bend 164 to the third bend 166. In some embodiments, the second strut path may extend proximally from the third bend 166 to a fourth bend 168 coupled to one of the strut intersections 134 in the second plurality of strut intersections 134. In some embodiments, the fourth bend 168 of the second strut path may be directly connected to one of the strut intersections 134 in the second plurality of strut intersections 134. In some embodiments, the distal-most extent of the first bend 142 of the first strut path is disposed distal to the distal-most extent of the first bend 162 of the second strut path.

[0065] In some embodiments, first bend 142 of the first strut pathway can be concave in the proximal direction (e.g., toward plane 188), and second bend 164 of the second strut pathway can be concave in the distal direction (e.g., away from plane 188), such that first bend 142 of the first strut pathway faces second bend 164 of the second strut pathway. In some embodiments, first bend 142 of the first strut pathway opens toward a center of second bend 164 of the second strut pathway, and second bend 164 of the second strut pathway opens toward a center of first bend 142 of the first strut pathway.

[0066] In some embodiments, in the second configuration, the first strut path is continued radially outward from one of the first plurality of strut intersections 132 to one of the second plurality of strut intersections 134 via the additional segment 150 of the plurality of interconnected struts 120 to define an extended first strut path. In at least some embodiments, the extended first strut path (if straightened) defines a first length 190 (e.g., a combined length of one of the plurality of first struts 140 and the additional segment 150) from the proximal hub 112 to one of the second plurality of strut intersections 134, such as Figure 7 The second strut path (if straightened) defines a second length 192 (e.g., the length of one strut in the second plurality of struts 160) from the proximal hub 112 to one strut intersection in the second plurality of strut intersections 134, as shown in FIG. Figure 7 Detailed portion of the plan view of the pattern is shown. In at least some embodiments, the first length 190 is substantially equal to the second length 192. Other configurations are also contemplated.

[0067] like Figure 7 As shown, in a first configuration, a plurality of interconnected struts 120 (e.g., first plurality of struts 140 and / or second plurality of struts 160) of expandable frame 110 may be oriented to be substantially parallel to each other and / or to a longitudinal axis 111 of expandable frame 110. In some embodiments, in a first configuration, each of a plurality of interconnected struts 120 (e.g., first plurality of struts 140 and / or second plurality of struts 160) of expandable frame 110 may include and / or have its own longitudinal axis oriented to be substantially parallel to longitudinal axis 111 of expandable frame 110.

[0068] Figure 8-Figure 9 Shows Figure 4-Figure 6An alternative configuration of a medical implant 100. The medical implant 100 may include an occlusive element 126 disposed on and / or affixed to an expandable frame 110 and / or a plurality of interconnected struts 120. Figure 8-Figure 9 In FIG. 1 , the blocking element 126 is not shown.

[0069] The plurality of interconnected struts 120 may include a first plurality of struts 140 and a second plurality of struts 160. Additional plurality of struts are also contemplated. The plurality of strut intersections 130 may include a first plurality of strut intersections 132 as described herein. In some embodiments, additional plurality of strut intersections are also contemplated, including but not limited to a second plurality of strut intersections 134. In the first configuration, the first plurality of strut intersections 132 may be disposed distally of the proximal hub 112, and in the second configuration, the first plurality of strut intersections 132 may be disposed radially outwardly relative to the proximal hub 112. In the first configuration and the second configuration, the first plurality of strut intersections 132 may be disposed proximal to the distal hub 114.

[0070] like Figure 8 and Fig. 9 As shown, in the second configuration, the first plurality of struts 140 form a recess 180 in the expandable frame 110 that is open in the proximal direction. The recess 180 can be defined by a radially inward boundary 182 and a radially outward boundary 184. The recess 180 can extend distally between the radially inward boundary 182 and the radially outward boundary 184 and be open in the proximal direction. In the second configuration, the recess 180 can have a depth 186 measured distally from a plane 188 that coincides with the proximal end of the proximal hub 112 and is oriented perpendicular to the longitudinal axis 111 extending through the proximal hub 112 and / or from the proximal hub 112 to the distal hub 114. For clarity, some features of the expandable frame 110 have been removed from view to facilitate discussion. For discussion purposes, the plane 188 can be set near the top of the recess 180, and the depth 186 can be measured to the bottom of the recess 180.

[0071] In the second configuration, the second plurality of struts 160 extend into the recess 180. In some embodiments, in the second configuration, the proximal-most extent of the second plurality of struts 160 extends within the recess 180 to within 50% of the depth 186 from the plane 188. Stated another way, in the second configuration, the proximal-most portion of the second plurality of struts 160 disposed within the recess 180 may extend within the recess 180 closer to the plane 188 and / or the top of the recess 180 than to the bottom of the recess 180. In some embodiments, in the second configuration, the proximal-most extent of the second plurality of struts 160 extends within the recess 180 to within 25% of the depth 186 from the plane 188. In some embodiments, in the second configuration, the proximal-most extent of the second plurality of struts 160 extends within the recess 180 to within 10% of the depth 186 from the plane 188. Other configurations are also contemplated. In the second configuration, the second plurality of struts 160 can prevent the occlusive element 126 from deflecting into the recess 180 formed by the first plurality of struts 140 .

[0072] In the second configuration, the first plurality of struts 140 can each extend radially along a first strut path from the proximal hub 112 to a strut intersection in the first plurality of strut intersections 132. In the second configuration, the second plurality of struts 160 can each extend radially along a second strut path at least partially across the recess 180. In at least some embodiments, the second plurality of struts 160 and / or each of the second plurality of struts 160 can be attached and / or connected to the expandable frame 110 at a single point.

[0073] In the second configuration, the first strut path can extend distally from the proximal hub 112 to the first bend 142 and then extend proximally from the first bend 142 to one of the first plurality of strut intersections 132 .

[0074] In some embodiments, the second plurality of struts 160 can be fixedly attached to the expandable frame 110 at one of the strut intersections of the first plurality of strut intersections 132, such as Figure 8 As shown. In some embodiments, the second plurality of struts 160 can be integrally formed with the expandable frame 110 and / or the plurality of interconnected struts 120 as a single unitary structure. In some embodiments, the second plurality of struts 160 can be formed separately from the expandable frame 110 and / or the plurality of interconnected struts 120 and subsequently fixedly attached to the expandable frame and / or the plurality of interconnected struts. Thus, the single point at which the second plurality of struts 160 and / or each of the second plurality of struts 160 is attached or connected to the expandable frame 110 and / or the plurality of interconnected struts 120 can be one of the strut intersections in the first plurality of strut intersections 132.

[0075] In some embodiments, in the first configuration, the second plurality of struts 160 can extend proximally from one of the first plurality of strut intersections 132, and in the second configuration, the second plurality of struts 160 can extend radially inward from one of the first plurality of strut intersections 132 toward the proximal hub 112. In some embodiments, in the second configuration, the second plurality of struts 160 can include a generally straight portion 170 extending radially inward from one of the first plurality of strut intersections 132 to a distal bend 172 that bends distally away from the generally straight portion 170 and / or the flat surface 188 to a free end 174. The generally straight portion 170 can be configured to prevent the occluding element 126 from deflecting into the recess 180 in the second configuration.

[0076] In some embodiments, the second plurality of struts 160 may be fixedly attached to the proximal hub 112 at the first end 175, such as Fig. 9 As shown. In some embodiments, the second plurality of struts 160 can be integrally formed with the expandable frame 110, the proximal hub 112, and / or the plurality of interconnected struts 120 as a single unitary structure. In some embodiments, the second plurality of struts 160 can be formed separately from the expandable frame 110, the proximal hub 112, and / or the plurality of interconnected struts 120, and subsequently fixedly attached thereto. Thus, the second plurality of struts 160 and / or each of the second plurality of struts 160 can be attached or connected to the expandable frame 110, the proximal hub 112, and / or the single point at which the expandable frame 110 is attached or connected can be the proximal hub 112.

[0077] In some embodiments, the second plurality of struts 160 can extend distally from the proximal hub 112 in the first configuration, and the second plurality of struts 160 can extend radially outward from the proximal hub 112 in the second configuration. In some embodiments, in the second configuration, the second plurality of struts 160 can extend distally and radially outward from the proximal hub 112 to a ring 176 that curves proximally toward the plane 188 and radially inward toward the proximal hub 112, and then curves distally away from the plane 188 back to the free end 178. The ring 176 of the second plurality of struts 160 can be configured to prevent the occluding element 126 from deflecting into the recess 180 in the second configuration.

[0078] The method for manufacturing the medical implant 100 may include forming and / or cutting an expandable frame 110 in a first configuration from a single tubular member. Alternatively, the method for manufacturing the medical implant 100 may include forming and / or cutting an expandable frame 110 from a flat sheet material that is subsequently rolled and / or formed into a tubular member. After the flat sheet material is formed into the tubular member, the tubular member may be welded or otherwise fixedly fixedly connected into a tubular shape. In some embodiments, forming and / or cutting the expandable frame 110 may be completed via laser, water jet, machining, etc. Other manufacturing methods and / or processes are also contemplated. It should be understood that in some embodiments, forming and / or cutting the expandable frame 110 from a single tubular member may be preferred, and the description of the planar pattern does not constitute a preference for forming and / or cutting the expandable frame 110 from a flat sheet material.

[0079] In some embodiments, the first plurality of struts 140 and / or the second plurality of struts 160 can be integrally formed with the plurality of interconnected struts 120 as a single unitary structure to form the expandable frame 110. In some alternative embodiments, the second plurality of struts 160 can be formed separately from the plurality of interconnected struts 120 and subsequently fixedly attached to the plurality of interconnected struts to form the expandable frame 110. In some embodiments, the second plurality of struts 160 can be fixedly attached to the plurality of interconnected struts 120 by welding, brazing, adhesive bonding, etc. Other configurations are also contemplated.

[0080] After forming and / or cutting the expandable frame 110, the method may include forming the expandable frame 110 into the second configuration. As part of forming the expandable frame 110 into the second configuration, the method may include bending each of the plurality of anchoring members 118. In some embodiments, each anchoring member may be bent individually. In some embodiments, two or more anchoring members may be bent together as a group. In some embodiments, after forming the expandable frame 110 into the second configuration, the method may include heat setting the expandable frame 110 and / or the plurality of anchoring members 118 into the second configuration. Other configurations and / or sequences of operations are also contemplated.

[0081] In some embodiments, a method of manufacturing a medical implant 100 may include securing an occlusive element 126 to an expandable frame 110. In some embodiments, in a second configuration, at least some of the plurality of anchoring members 118 may extend through the occlusive element 126. In some embodiments, the occlusive element 126 may be disposed on, along, and / or above an outer surface of the expandable frame 110. In some embodiments, in a second configuration, the occlusive element 126 may cover at least 20% of the expandable frame 110. In some embodiments, in a second configuration, the occlusive element 126 may cover at least 30% of the expandable frame 110. In some embodiments, in a second configuration, the occlusive element 126 may cover at least 40% of the expandable frame 110. In some embodiments, in a second configuration, the occlusive element 126 may cover at least 50% of the expandable frame 110. In some embodiments, in a second configuration, the occlusive element 126 may cover at least 60% of the expandable frame 110. In some embodiments, in a second configuration, the occlusive element 126 may cover at least 70% of the expandable frame 110. Other configurations may also be contemplated.

[0082] The material that can be used for the various parts of medical implant, system and manufacturing method 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 anchoring members, occlusive elements etc.) and / or its elements or parts.

[0083] 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.

[0084] 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. 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.

[0085] 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.

[0086] 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.

[0087] 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.

[0088] 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.

[0089] 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.

[0090] 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 first configuration and a second 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 and coupled together at a plurality of strut intersections; wherein the plurality of interconnected struts comprises a first plurality of struts and a second plurality of struts; wherein, in the second configuration, each of the first plurality of struts extends radially from the proximal hub along a first strut path to a strut intersection of a first plurality of strut intersections; Wherein, in the second configuration, each of the second plurality of struts extends radially from the proximal hub along a second strut path to a strut intersection of a second plurality of strut intersections.

2. The medical implant according to claim 1, wherein The second plurality of strut intersections are disposed radially outward of the first plurality of strut intersections.

3. The medical implant according to claim 2, wherein: Each strut of the second plurality of struts is free of any other connection to the expandable frame between the proximal hub and the second plurality of strut intersections.

4. The medical implant according to any one of claims 1 to 3, wherein: The first strut path extends distally from the proximal hub to a first bend and then proximally from the first bend to a strut intersection of the first plurality of strut intersections.

5. The medical implant according to claim 4, wherein: The second strut path extends distally from the proximal hub to a first bend, proximally from the first bend to a second bend, distally from the second bend to a third bend, and proximally from the third bend to a fourth bend coupled to one of the second plurality of strut intersections.

6. The medical implant according to claim 5, wherein The distal-most extent of the first bend of the first strut pathway is disposed distally of the distal-most extent of the first bend of the second strut pathway.

7. The medical implant according to any one of claims 5-6, wherein: The first bend of the first strut path is concave in the proximal direction, and the second bend of the second strut path is concave in the distal direction, so that the first bend of the first strut path is open toward the center of the second bend of the second strut path, and the second bend of the second strut path is open toward the center of the first bend of the first strut path.

8. The medical implant according to any one of claims 1 to 7, wherein: the first strut path continuing from one of the first plurality of strut intersections to one of the second plurality of strut intersections via additional segments of the plurality of interconnected struts to define an extended first strut path; wherein the extended first strut path, if straightened, defines a first length, and the second strut path, if straightened, defines a second length; Wherein, the first length is substantially equal to the second length.

9. The medical implant according to any one of claims 1 to 8, wherein: In the second configuration, the first plurality of struts form a recess that is open in a proximal direction, and the second plurality of struts extend proximally into the recess.

10. The medical implant according to claim 9, wherein In the second configuration, the second plurality of struts prevent deflection of the occlusive element into the recess.

11. A medical implant for occluding a left atrial appendage, comprising: an expandable frame configured to transition between a first configuration and a second configuration; as well as an occlusive element disposed on the expandable frame; wherein the expandable frame comprises a proximal hub and a plurality of interconnected struts extending from the proximal hub and coupled together at a plurality of strut intersections; wherein the plurality of interconnected struts comprises a first plurality of struts and a second plurality of struts; wherein, in the second configuration, the first plurality of struts form a recess in the expandable frame, the recess being defined by a radially inward boundary and a radially outward boundary, and the recess extending distally between the radially inward boundary and the radially outward boundary and being open in a proximal direction; Wherein, in the second configuration, the second plurality of struts extend into the recess.

12. The medical implant according to claim 11, wherein the recess having a depth measured distally from a plane coincident with a proximal end of the proximal hub and oriented perpendicular to a longitudinal axis extending through the proximal hub; wherein the second plurality of struts extend proximally within the recess to within 50% of the depth from the plane.

13. The medical implant according to any one of claims 11-12, wherein: The second plurality of struts are integrally formed with the plurality of interconnected struts as a single unitary structure.

14. The medical implant according to any one of claims 11-12, wherein: The second plurality of struts is formed separately from the plurality of interconnected struts and is subsequently fixedly attached to the plurality of interconnected struts.

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 to 10 or the medical implant according to any one of claims 11 to 14; Therein, the medical implant is releasably connected to the distal portion of the core wire.

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