Medical implant and method of manufacturing a medical implant

Abstract

A method of manufacturing a medical implant for occluding a left atrial appendage may include cutting an expandable stent in a first configuration, where the expandable stent includes a plurality of struts having ends joined together at intersections and a plurality of anchoring members extending from the plurality of struts, such that each anchoring member extends from an intermediate portion of one of the plurality of struts; forming the expandable stent into a second configuration, where forming the expandable stent into the second configuration includes bending each anchoring member along a bending axis thereof, the bending axis being oriented parallel to a longitudinal axis of a respective one of the plurality of struts; and heat setting the expandable stent into a second configuration. The method may include securing the occluding element to the expandable stent.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 350,520, filed on June 9, 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 for making and using the medical devices and systems. More specifically, the present disclosure relates to a medical implant for occluding a left atrial appendage and a method for making the medical implant. Background Art

[0004] Diseases and / or medical conditions that affect the cardiovascular system are prevalent throughout the world. Traditionally, treatments for the cardiovascular system have typically 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 affects more than 30 million people worldwide, according to some estimates. Atrial fibrillation is an irregular, chaotic beating of the upper chambers of the heart. Electrical impulses are discharged so quickly that the atrial muscles quiver or fibrillate. Episodes of atrial fibrillation may last for minutes or 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 the risk of stroke. The left atrial appendage is a small organ attached to the left atrium of the heart as a pouch-like extension. In patients with atrial fibrillation, the left atrial appendage may not contract properly with the left atrium, causing stagnant 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 vessels downstream and thereby cause a stroke or heart attack. Clinical studies have shown that the majority of blood clots in patients with atrial fibrillation are located in the left atrial appendage. As a treatment approach, a medical device has been developed that is positioned in the left atrial appendage and deployed to seal the left atrial appendage opening. Over time, the exposed surface across the left atrial appendage opening is covered with tissue (a process known as 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 a medical implant for occluding the left atrial appendage and / or a method for manufacturing the medical implant. 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 of manufacturing and using medical devices and systems. Summary of the invention

[0007] In one example, a method for manufacturing a medical implant for occluding a left atrial appendage may include: cutting an expandable stent in a first configuration, wherein the expandable stent includes a plurality of struts having ends joined together at an intersection and a plurality of anchoring members extending from the plurality of struts such that each anchoring member extends from a middle portion of one of the plurality of struts; forming the expandable stent into a second configuration, wherein forming the expandable stent into the second configuration includes bending each anchoring member along a bending axis thereof, the bending axis being oriented parallel to a longitudinal axis of its corresponding strut among the plurality of struts; and heat setting the expandable stent into the second configuration.

[0008] Additionally or alternatively to any examples described herein, the expandable stent is laser cut.

[0009] Additionally or alternatively to any examples described herein, the first configuration is a radially collapsed configuration and the second configuration is a radially expanded configuration.

[0010] Additionally or alternatively to any examples described herein, each anchoring member extends radially outward from the plurality of struts after bending.

[0011] Additionally or alternatively to any examples described herein, forming the expandable stent into the second configuration includes preventing the plurality of struts from twisting.

[0012] Additionally or alternatively to any examples described herein, bending each anchoring member includes preventing its respective strut from rotating about a longitudinal axis of the respective strut when the anchoring member is bent.

[0013] Additionally or alternatively to any examples described herein, the expandable stent is formed from a unitary tubular member.

[0014] Additionally or alternatively to any examples described herein, bending each anchoring member includes inserting a punch into the interior of the expandable stent and moving the punch radially outward relative to the plurality of struts.

[0015] Additionally or alternatively to any of the examples described herein, moving the punch radially outward relative to the plurality of struts simultaneously bends more than one of the plurality of anchor members.

[0016] Additionally or alternatively to any examples described herein, bending each anchoring member includes inserting a mold into the interior of the expandable stent, positioning its corresponding strut over a groove formed in the mold, and pushing the corresponding strut into the groove with a punch.

[0017] Additionally or alternatively to any of the examples described herein, the expandable stent is formed from a flat sheet of material.

[0018] Additionally or alternatively to any examples described herein, bending each anchoring member includes moving a punch through the expandable stent without moving the plurality of struts.

[0019] Additionally or alternatively to any examples described herein, bending each anchoring member includes positioning its corresponding strut over a groove formed in a die and pushing the corresponding strut into the groove with a punch.

[0020] Additionally or alternatively to any of the examples described herein, the method may further include forming the flat sheet of material into a tubular member.

[0021] In addition to or in lieu of any examples described herein, a method of manufacturing a medical implant for occluding a left atrial appendage may include: cutting an expandable stent in a first configuration, wherein the expandable stent includes a plurality of struts having ends joined together at an intersection and a plurality of anchoring members extending from the plurality of struts such that each anchoring member extends from a middle portion of one of the plurality of struts; forming the expandable stent into a second configuration, wherein forming the expandable stent into the second configuration includes bending each anchoring member along a bending axis thereof, the bending axis being oriented parallel to a longitudinal axis of its corresponding strut among the plurality of struts; heat setting the expandable stent into the second configuration; and securing a occluding element to the expandable stent.

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

[0023] Additionally or alternatively to any examples described herein, the occluding element is disposed along an outer surface of the expandable stent.

[0024] Additionally or alternatively to any examples described herein, in the second configuration, the occluding element covers at least 30% of the expandable stent.

[0025] In addition to or as an alternative to any of the examples described herein, a medical implant for occluding a left atrial appendage may include an expandable stent configured to transition from a radially collapsed configuration to a radially expanded configuration. The expandable stent may include a plurality of struts having ends joined together at an intersection and a plurality of anchoring members extending from the plurality of struts, such that each anchoring member extends from a middle portion of one of the plurality of struts. In the radially expanded configuration, each anchoring member may have a bending axis oriented parallel to the longitudinal axis of each anchoring member and its corresponding strut in the plurality of struts, and the plurality of anchoring members may extend radially outward from the plurality of struts.

[0026] Additionally or alternatively to any examples described herein, in the radially collapsed configuration, each bending axis is oriented parallel to a central longitudinal axis of the expandable stent.

[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 taken in conjunction with the accompanying drawings, in which:

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

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

[0031] FIG. 4 shows a flat version of the expandable stent of the medical implant of FIG. 3 ;

[0032] FIG5 is a detailed view of a portion of the flat version of FIG4;

[0033] Figure 6 is a perspective view of a portion of a flat version of an expandable stent according to the present disclosure;

[0034] Figure 7-Figure 8 Shows the manufacturing Figure 6 Selected aspects of the method of expanding a stent;

[0035] Fig. 9 After forming the anchoring member Figure 6 selected aspects of an expandable stent;

[0036] Figure 10-10A Shows Fig. 9 selected aspects of alternative configurations of expandable stents;

[0037] Fig.11is a perspective view of a portion of a flat version of an expandable stent according to the present disclosure;

[0038] Figure 12-14 Shows the manufacturing Fig.11 Selected aspects of the method of expanding a stent; and

[0039] Fig.15 After forming the anchoring member Fig.11 Selected aspects of an expandable stent.

[0040] Although various aspects of the present disclosure are applicable to various modifications and alternative forms, the details thereof have been shown by way of example in the drawings and will be described in detail. However, it should be understood that it is not intended to limit the various aspects of the present disclosure to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents and substitutes that fall within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0041] The following description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, wherein the same reference numerals represent the same elements in the several 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 may be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and the accompanying drawings illustrate exemplary aspects of the present disclosure.

[0042] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0043] All numerical values ​​herein are assumed to be 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 one skilled in the art considers to be equivalent to the recited 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 indicated, 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 and consistent with the context of this specification.

[0044] 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).

[0045] Although some suitable sizes, ranges and / or values ​​are disclosed in connection with various components, features and / or specifications, those skilled in the art, in light of this disclosure, will appreciate that the desired sizes, ranges and / or values ​​may deviate from those explicitly disclosed.

[0046] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its meaning 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 these features may be plural or repeated in the disclosed embodiments. Each instance of these features may be included and / or contained in a single disclosure, unless explicitly stated to the contrary. For the purposes of simplicity and clarity, not all elements of the present disclosure must be shown in each figure or discussed in detail below. However, it should be understood that the following discussion may apply equally to any and / or all components that have more than one, unless explicitly stated to the contrary.

[0047] Related terms such as "proximal", "distal", "advance", "retract" and variations thereof can generally be considered based on the positioning, orientation and / or operation of various elements relative to the user / operator / manipulator of the device, where "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, in order to facilitate understanding of the present disclosure, the terms "proximal" and "distal" can be specified arbitrarily, and such situations will be obvious to those skilled in the art. Other related terms such as "upstream", "downstream", "inflow" and "outflow" refer to the direction of fluid flow in a lumen (such as a body cavity), a blood vessel or in a device. There are also other related terms such as "axial", "circumferential", "longitudinal", "lateral", "radial", etc. and / or variations thereof generally refer to the direction and / or orientation relative to the central longitudinal axis of the disclosed structure or device.

[0048] The term "range" may be understood to refer to the maximum measured value of the described or determined dimension, unless the range or dimension in question is preceded by "minimum" or determined as "minimum", which may be understood to refer to the minimum measured value of the described or determined dimension. For example, "external range" may be understood to refer to the maximum external dimension, "radial range" may be understood to refer to the maximum radial dimension, "longitudinal range" may be understood to refer to the maximum longitudinal dimension, etc. Each instance of "range" may be different (e.g., axial, longitudinal, lateral, radial, circumferential, etc.), and will be apparent to those skilled in the art from the context of individual use. Typically, "range" may be considered to be the maximum dimension measured according to the intended use, while "minimum range" may be considered to be the minimum dimension measured according to the intended use. In some cases, "range" may be measured orthogonally in a plane and / or cross section, but it will be apparent from a particular context that it may be measured differently - such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), etc.

[0049] The terms "unitary" and "integral" shall generally refer to one or more elements that are made or constructed from a single structure or basic unit / element. Unitary and / or integral elements shall exclude structures and / or features that are made by assembling or otherwise connecting together multiple discrete structures or elements.

[0050] It should be noted that references in the specification to "an embodiment", "some embodiments", "other embodiments", etc. indicate that the described embodiments may include a particular feature, structure, or characteristic, but not every embodiment necessarily includes the particular feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in conjunction with one embodiment, it is within the knowledge of those skilled in the art to use the particular feature, structure, or characteristic in conjunction with other embodiments, whether or not explicitly described, unless otherwise expressly stated. That is, the various independent elements described below, even if not explicitly shown in a particular combination, are still considered to be combinable or arrangable with each other to form other additional embodiments or to supplement and / or enrich the described embodiments, as would be understood by those of ordinary skill in the art.

[0051] For the sake of clarity, certain identification numbers of terms (e.g., first, second, third, fourth, etc.) can be used throughout the specification and / or claims to name and / or distinguish various described and / or claimed features. It should be understood that the numerical terms are not intended to be restrictive, but merely exemplary. In some embodiments, for the sake of brevity and clarity, the numerical terms previously used can be changed and deviated from. That is, the feature identified as a "first" element can be referred to as a "second" element, a "third" element, etc., afterwards, or can be omitted completely, and / or different features can be referred to as a "first" element. The meaning and / or name in each case are obvious to a skilled practitioner.

[0052] The accompanying drawings show selected parts and / or arrangement of medical implants, systems and methods for manufacturing the medical implants and systems. It should be noted that in any given figure, for simplicity, some features of medical implants, systems and methods may not be shown, or may be schematically shown. Additional details about some elements can be shown in more detail in other figures. It should be noted that, for ease of understanding, some features of the present disclosure can be described in the singular, even if these features can be plural or repeated in the disclosed embodiments. Each example of feature can include and / or be included in a single disclosure, unless there is a clear statement to the contrary. Therefore, it should be understood that the following discussion can be equally applicable to any and / or all of the parts present in medical implants, systems and manufacturing methods that are more than one, unless there is a clear statement to the contrary. Devices and / or methods disclosed herein can provide many desired features and benefits, as described in more detail below.

[0053] Figure 1 Selected components and / or arrangements of the medical device system 10 are schematically shown. The medical device system 10 can be used to deliver and / or deploy various medical implants (e.g., cardiovascular medical implants, occlusive medical implants, replacement heart valve implants, etc.) to one or more locations within the anatomical structure, which in some embodiments include but are not limited to the heart. In some embodiments, the medical device system 10 may include a delivery device that can be used to deliver a replacement heart valve implant (e.g., a replacement mitral valve, a replacement aortic valve, etc.) percutaneously to an area of ​​interest in the anatomical structure, such as a native heart valve. However, this is not intended to be limiting, as the medical device system 10 and / or the delivery device can also be used for other interventions, including valve repair, valvuloplasty, etc., or other similar interventions.

[0054] The medical device system 10 includes: a catheter 40 having a lumen 42 extending from a proximal opening to a distal opening; a core wire 30 slidably disposed in the lumen 42; and a medical implant 100 (e.g., a cardiovascular medical implant, an occlusive medical implant, etc.) having an expandable stent configured in a first configuration (e.g., Figure 1 ) and a second configuration (e.g., Figure 2 ), wherein, in a first configuration, the medical implant 100 is disposed in the lumen 42, proximal to the distal opening, wherein, 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 are configured to transition between the first configuration and the second configuration. The medical implant 100 may be disposed and / or releasably connected to the distal portion of the core wire 30. The core wire 30 may be slidably and / or rotatably disposed in the lumen 42 of the catheter 40. In some embodiments, the proximal end of the core wire 30 may extend proximal to the proximal end of the catheter 40 and / or the proximal opening of the lumen 42 for manual manipulation by a clinician or practitioner. In some embodiments, the example medical implant 100 may be removably attached, coupled or otherwise connected to the distal end of the core wire 30. 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 of the example occlusive implants disclosed herein can be used in accordance with and / or associated with the above-described example medical device systems 10.

[0055] FIG3 illustrates selected aspects of the medical implant 100. The medical implant 100 includes an expandable stent 110 configured in a first configuration (eg, Figure 1 ) and a second configuration (e.g., Figure 2-3). The first configuration may be a radially collapsed configuration, and the second configuration may be a radially expanded configuration. The expandable stent 110 may have a central longitudinal axis 111. The proximal end 114 of the expandable stent 110 may be configured to be releasably attached or connected to the distal end of the core wire 30. The proximal end 114 of the expandable stent 110 includes a threaded insert configured to engage a threaded member disposed at the distal end of the core wire 30. The expandable stent 110 includes a plurality of anchoring members 112, each of which is connected to the expandable stent 110 at an intersection 116 between adjacent struts of the expandable stent 110. The expandable stent 110 includes a plurality of struts, wherein the ends of adjacent struts in the plurality of struts are coupled together, connected, etc. at the intersection 116. In the second configuration, the free ends 118 of the plurality of anchoring members 112 extend radially outward from the expandable stent 110. In the second configuration, the plurality of anchoring members 112 are configured to engage the wall of the left atrial appendage. The medical implant 100 includes an occlusive element 120 coupled to an expandable stent 110 .

[0056] The method of manufacturing the medical implant 100 may include forming and / or cutting the expandable stent 110 from an integral tubular member in a first configuration. Alternatively, the method of manufacturing the medical implant 100 may include forming and / or cutting the expandable stent 110 from a flat sheet of material, which 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 firmly fixed into a tubular shape. After cutting the expandable stent 110, the method may include forming the expandable stent 110 into a second configuration. As part of forming the expandable stent 110 into the second configuration, the method may include bending each anchoring member in a plurality of anchoring members 112. After forming the expandable stent 110 into the second configuration, the method may include heat setting the expandable stent 110 into the second configuration.

[0057] FIG. 4 is a flat style view of the expandable stent 110 of FIG. 3 , and FIG. 5 is a detailed view of a portion of FIG. 4 . The flat style is used herein to improve the clarity of the present disclosure. However, it should be understood that in some embodiments, it may be preferred to form and / or cut the expandable stent from a unitary tubular member, and the illustration of the flat style does not constitute a preference for forming and / or cutting the expandable stent from a flat sheet of material.

[0058] As shown, the expandable stent 110 includes a plurality of anchoring members 112 connected to the expandable stent 110 at an intersection 116. Each of the plurality of anchoring members 112 includes a free end 118 extending away from the intersection 116. In a first configuration, the plurality of anchoring members 112 are oriented substantially parallel to the struts of the expandable stent 110. As part of forming the expandable stent 110 into a second configuration, the method includes bending the free end 118 away from the expandable stent 110 about a bending axis to the orientation shown in FIG. 3. Each of the plurality of anchoring members 112 extends radially outward from the plurality of struts after bending. In the first configuration, the bending axis of each anchoring member is oriented transversely or perpendicularly to the central longitudinal axis 111 of the expandable stent 110, and / or the bending axis is oriented transversely or perpendicularly to the longitudinal axis of the struts of the expandable stent 110. The bending axis may deviate from the central longitudinal axis 111 of the expandable stent 110 (e.g., the bending axis does not intersect the central longitudinal axis 111). Existing configurations and / or methods may require that each of the plurality of anchoring members 112 be formed and / or bent individually (eg, one at a time).

[0059] The process of bending the free ends 118 of the plurality of anchoring members 112 includes and / or introduces significant variations in the height 119 of the anchoring members, as shown in FIG. 3 , and significant variations in the angles of the free ends 118 relative to the central longitudinal axis 111 of the expandable stent 110 and / or relative to adjacent struts of the expandable stent 110. In order to properly anchor after deployment, multiple manufacturing specifications must be maintained within design tolerances. Manufacturing specifications may include height, angle, radius, bevel, etc. The complexity and difficulty associated with the bending process of forming the plurality of anchoring members 112 and the number of anchoring members create opportunities for the expandable stent 110 to exceed specifications. For example, the free ends 118 may experience rebound after bending. Rebound is a normal byproduct of the bending process and may affect at least the height and / or angle of the anchoring member. Rebound may be at least partially compensated, but may sometimes be unpredictable and / or inconsistent. Disclosed herein are methods and / or structures that can significantly reduce variations within the expandable stent 110, thereby reducing scrap rates, reducing manufacturing costs, and / or improving quality.

[0060] Figure 6 Detailed views of a portion of a flat version of an alternative configuration for an expandable stent 110 are shown that is intended to remedy at least some of the difficulties that arise when bending the plurality of anchoring members 112 of FIGS. 3-5 . Figure 6As shown, the expandable stent 110 may include a plurality of struts 130 that are oriented in a first configuration to be generally parallel to each other and / or a central longitudinal axis 111 of the expandable stent 110. Each strut of the plurality of struts 130 may include and / or have a longitudinal axis 132 that is oriented in the first configuration to be generally parallel to the central longitudinal axis 111 of the expandable stent 110.

[0061] The expandable stent 110 may include a plurality of anchoring members 140, each of which extends laterally and / or circumferentially from a middle portion of one of the plurality of struts 130 of the expandable stent 110. Each of the plurality of anchoring members 140 may include a first end securely attached to and / or integrally formed with the middle portion of the strut and a free end 142 opposite the first end. In some embodiments, each anchoring member may extend from the first end in a distal direction, and the free end 142 of each anchoring member may be formed in a hook shape having a tip extending in a proximal direction.

[0062] In some embodiments, the plurality of struts 130 may be longitudinally discontinuous (e.g., the struts do not extend in a straight line between the ends). In some embodiments, at least some of the plurality of struts 130 may each include an offset portion 134 and / or a support portion 136 that is longitudinally offset from and / or longitudinally spaced from the offset portion 134. In some embodiments, the offset portion 134 and / or the support portion 136 may be laterally and / or circumferentially offset from the longitudinal axis 132 of the strut. In some embodiments, the offset portion 134 and / or the support portion 136 may extend laterally and / or circumferentially from the strut and / or the longitudinal axis 132 of the strut.

[0063] In some embodiments, in the first configuration, the free end 142 of each of the plurality of anchor members 140 can extend laterally and / or circumferentially through the longitudinal axis 132 of an adjacent one of the plurality of struts 130. In some embodiments, the offset portion 134 can extend around the free end 142 of the anchor member of an adjacent one of the plurality of struts 130. In some embodiments, each support portion 136 can be laterally and / or circumferentially disposed relative to the longitudinal axis 132 of the strut opposite to a first end of one of the plurality of anchor members 140.

[0064] A method of making the medical implant 100 may include cutting the expandable stent 110 in a first configuration, as discussed herein, to produce, for example, Figure 6In some embodiments, the expandable stent 110 can be cut with a laser. In some embodiments, the expandable stent 110 can be cut with a water jet. In some embodiments, the expandable stent 110 can be machined. Other manufacturing methods and / or processes are also contemplated.

[0065] In some embodiments, the method may include forming the expandable stent 110 into a second configuration, at least in part similar to Figure 7-Figure 8 In some embodiments, forming the expandable stent 110 into the second configuration may include constraining the expandable stent 110 and / or the plurality of struts 130. In some embodiments, constraining the expandable stent 110 and / or the plurality of struts 130 may include grasping and / or clamping at least some of the plurality of struts 130. In some embodiments, constraining the expandable stent 110 and / or the plurality of struts 130 may include pressing at least one restraining plate 150 against the expandable stent 110 and / or the plurality of struts 130, as shown. Figure 7 In some embodiments, constraining the expandable stent 110 and / or the plurality of struts 130 may include pressing at least one constraint plate 150 against the offset portion 134 and / or the support portion 136. In some embodiments, the expandable stent 110, the plurality of struts 130, the offset portion 134, and / or the support portion 136 may be secured against a mold, a substrate, or some other suitable structure by at least one constraint plate 150. At least one constraint plate 150 may include a cutout 152 that is substantially aligned with the offset portion 134 of the plurality of struts 130.

[0066] In some embodiments, forming the expandable stent 110 into the second configuration can include bending each anchoring member along its bending axis. In the first configuration, the bending axis can be oriented substantially parallel to the longitudinal axis 132 of its respective one of the plurality of struts 130. In some embodiments, in the second configuration, bending each anchoring member along its bending axis can orient at least a portion of the anchoring member to approximately 90 degrees relative to its respective strut. In some embodiments, in the second configuration, bending each anchoring member along its bending axis can orient the entire anchoring member to approximately 90 degrees relative to its respective strut.

[0067] In some embodiments, the expandable stent 110 can be formed from a unitary tubular member. In some embodiments, forming the expandable stent 110 into the second configuration and / or bending each anchoring member can include inserting a punch 160 into the interior of the expandable stent 110 (at Figure 7-Figure 8 In the illustrated view, this can be understood as being located below the expandable stent 110), and moving the punch radially outward relative to the plurality of struts 130, such as Figure 8As the plurality of anchor members 140 are bent, the cutouts 152 in the at least one constraint plate 150 can permit the free ends 142 of the plurality of anchor members 140 to pass through the at least one constraint plate 150. After bending and / or in the second configuration, each anchor member can extend radially outward from the plurality of struts 130. In some embodiments, moving the punch 160 radially outward relative to the plurality of struts 130 can cause more than one of the plurality of anchor members 140 to bend simultaneously. This can reduce the number of bending operations required to form the expandable stent 110 into the second configuration, thereby improving manufacturing efficiency and / or reducing costs.

[0068] In some embodiments, the expandable stent 110 can be formed from a flat sheet of material. In some embodiments, forming the expandable stent 110 into the second configuration and / or bending each anchoring member can include moving the punch 160 through the expandable stent 110 without moving the plurality of struts 130, such as Figure 8 As shown. When the plurality of anchoring members 140 are bent, the cutouts 152 in the at least one constraint plate 150 may permit the free ends 142 of the plurality of anchoring members 140 to pass through the at least one constraint plate 150. In some embodiments, moving the punch 160 through the expandable stent 110 may cause more than one of the plurality of anchoring members 140 to bend simultaneously. This may reduce the number of bending operations required to form the expandable stent 110 into the second configuration, thereby improving manufacturing efficiency and / or reducing costs. The method may further include forming the flat sheet of material into a tubular member such that in the second configuration, each anchoring member extends radially outward from the plurality of struts 130.

[0069] In some embodiments, forming the expandable stent 110 into the second configuration and / or bending each anchoring member can include preventing the plurality of struts 130 from twisting. Fig. 9As can be seen in the figure, after the plurality of anchoring members 140 are bent, none of the plurality of struts 130 are twisted. In some embodiments, bending each anchoring member can include preventing its corresponding strut from rotating about the longitudinal axis 132 of the corresponding strut when the anchoring member is bent. In at least some embodiments, constraining the plurality of struts 130, the offset portion 134, and / or the support portion 136 with at least one constraint plate 150 can prevent the plurality of struts 130 from twisting and / or rotating about the longitudinal axis 132 when the punch 160 moves through the expandable stent 110 and / or when the punch 160 moves radially outward relative to the plurality of struts 130 so that each anchoring member it contacts is bent along its bending axis. In some embodiments, each anchoring member can bend about and / or along an edge of at least one constraint plate 150. In a first configuration, the bending axis of each anchoring member can be oriented to be substantially parallel to the longitudinal axis 132 of the corresponding strut of each anchoring member in the plurality of struts 130. In a first configuration, the bending axis can be oriented to be substantially parallel to the central longitudinal axis 111 of the expandable stent 110. In at least some embodiments, the bending axis can be oriented along an edge of at least one of the binding plates 150 and / or can coincide with an edge of at least one of the binding plates. In some embodiments, the bending axis can be disposed along and / or proximate to an edge of a corresponding strut of each anchoring member. In some embodiments, the bending axis can be disposed at and / or proximate to a first end of each anchoring member.

[0070] Fig.10 is a perspective view illustrating an alternative configuration of a plurality of anchoring members 140 extending laterally and / or circumferentially from a mid-portion of one of a plurality of struts 130 of an expandable stent 110 . Fig. 10A yes Fig.10 An end view of an alternative construction of Figure 6-Figure 9 As discussed above, each of the plurality of anchor members 140 can be bent along its bending axis. In at least some embodiments, the bending axis can be oriented substantially parallel to the longitudinal axis 132 of each anchor member's respective strut in the plurality of struts 130. In some embodiments, the bending axis can be spaced apart from the respective strut of each anchor member such that the anchor member bends along the main body portion 144 of the anchor member at a location between the first end and the free end 142, thereby orienting at least a portion of the anchor member at approximately 90 degrees relative to its respective strut in the second configuration.

[0071] Figure 11-Figure 15 Selected aspects of a method of making an alternative configuration of expandable stent 110 are shown. Fig.11Detailed views of a portion of a flattened version of an alternative configuration for an expandable stent 110 are shown that is intended to remedy at least some of the difficulties that arise when the plurality of anchoring members 112 of FIGS. 3-5 are bent. Fig.11 As shown, the expandable stent 110 may include a plurality of struts 230 that are oriented in a first configuration to be generally parallel to each other and / or to a central longitudinal axis 111 of the expandable stent 110. Each strut of the plurality of struts 230 may include and / or have a longitudinal axis 232 that is oriented in a first configuration to be generally parallel to the central longitudinal axis 111 of the expandable stent 110.

[0072] The expandable stent 110 may include a plurality of anchoring members 240, each of which extends laterally and / or circumferentially from the middle portion of one of the plurality of struts 230 of the expandable stent 110. Each of the plurality of anchoring members 240 may include a first end firmly attached to the middle portion of the strut and / or integrally formed with the middle portion of the strut and a free end 242 opposite the first end. In some embodiments, each anchoring member may extend in a distal direction from the first end, and the free end 242 of each anchoring member may be formed into a hook shape having a tip extending in a proximal direction. In some embodiments, the plurality of struts 230 may be longitudinally continuous (e.g., the struts extend in a straight line between the ends). The anchoring members on adjacent struts in the plurality of struts 230 may be longitudinally offset and / or longitudinally spaced apart from each other. In some embodiments, each of the plurality of struts 230 may include a pair of anchoring members in the plurality of anchoring members 240, the pair of anchoring members extending from opposite sides of the strut at a common axial position along the strut. In some embodiments, each of the plurality of struts 230 may include multiple pairs of anchoring members 240, wherein each pair of anchoring members extends from opposite sides of the strut at its own common axial position along the strut (e.g., a first pair of anchoring members extends from opposite sides of the strut at a first position, a second pair of anchoring members extends from opposite sides of the strut at a second position, and so on).

[0073] A method of making the medical implant 100 may include cutting the expandable stent 110 in a first configuration, as discussed herein, to produce, for example, Fig.11 In some embodiments, the expandable stent 110 can be cut with a laser. In some embodiments, the expandable stent 110 can be cut with a water jet. In some embodiments, the expandable stent 110 can be machined. Other manufacturing methods and / or processes are also contemplated.

[0074] In some embodiments, forming the expandable stent 110 into the second configuration may include bending each anchoring member along its bending axis. The process of bending each anchoring member along its bending axis using a single strut from the plurality of struts 230 is described in detail below. Figure 12-Figure 15 It is shown in, where Fig.15 A plurality of anchoring members 240 are shown after bending and / or in a second configuration. In some embodiments, a plurality of struts in the plurality of struts 230 can be processed one at a time, simultaneously, etc. In some embodiments, each of the plurality of struts 230 can be processed one at a time, sequentially, etc. In the first configuration, the bending axis can be oriented substantially parallel to the longitudinal axis 232 of its respective one of the plurality of struts 230. In some embodiments, in the second configuration, bending each anchoring member along its bending axis can orient at least a portion of the anchoring member at approximately 90 degrees relative to its respective strut. In some embodiments, in the second configuration, bending each anchoring member along its bending axis can orient the free end 242 of the anchoring member at approximately 90 degrees relative to its respective strut.

[0075] In some embodiments, the expandable stent 110 can be formed from a unitary tubular member. In some embodiments, forming the expandable stent 110 into the second configuration and / or bending each anchoring member can include inserting the mold 250 into the interior of the expandable stent 110 (at Figure 12-14 In the view shown, this can be understood to be located below the expandable stent 110.) Bending each anchoring member can include positioning its corresponding one of the plurality of struts 230 over a groove 252 formed in the mold 250, as in Fig.12 Bending each anchoring member may include pushing, pressing, pushing, moving, etc., a corresponding one of the plurality of struts 230 into the groove 252 of the die 250 with the punch 260, as in Fig.13 . In some embodiments, the punch 260 can be moved radially inward toward the die 250. In some embodiments, the die 250 can be moved radially outward toward the punch 260. A corresponding one of the plurality of struts 230 can be squeezed, clamped, clamped, etc. between the punch 260 and the die 250. After bending and / or in the second configuration, each anchoring member can extend radially outward from the plurality of struts 230. In some embodiments, pushing, pressing, urging, moving, etc. a corresponding one of the plurality of struts 230 into the groove 252 of the die 250 with the punch 260 can cause more than one of the plurality of anchoring members 240 to be bent simultaneously. This can reduce the number of bending operations required to form the expandable stent 110 into the second configuration, thereby improving manufacturing efficiency and / or reducing costs.

[0076] In some embodiments, expandable stent 110 can be formed from a flat sheet of material. In some embodiments, forming expandable stent 110 into the second configuration and / or bending each anchoring member can include positioning a corresponding one of the plurality of struts 230 over a groove 252 formed in mold 250, as in Fig.12 In some embodiments, the longitudinal axis 232 of a corresponding one of the plurality of struts 230 can be aligned with and / or parallel to the groove 252 formed in the mold 250. Bending each anchoring member can include pushing, pressing, pushing, moving, etc., a corresponding one of the plurality of struts 230 into the groove 252 of the mold 250 with a punch 260, as in Fig.13 . In some embodiments, the punch 260 can be moved toward the die 250. In some embodiments, the die 250 can be moved toward the punch 260. Corresponding ones of the plurality of struts 230 can be squeezed, clamped, clamped, etc. between the punch 260 and the die 250. In some embodiments, pushing, pressing, pushing, moving, etc. corresponding ones of the plurality of struts 230 into the groove 252 of the die 250 with the punch 260 can cause more than one of the plurality of anchoring members 240 to be bent simultaneously. This can reduce the number of bending operations required to form the expandable stent 110 into the second configuration, thereby improving manufacturing efficiency and / or reducing costs. The method can further include forming the flat sheet of material into a tubular member such that in the second configuration, each anchoring member extends radially outward from the plurality of struts 230.

[0077] In some embodiments, forming the expandable stent 110 into the second configuration and / or bending each anchoring member can include preventing the plurality of struts 230 from twisting. Figure 14-15230 after the plurality of anchoring members 240 are bent. In some embodiments, bending each anchoring member may include preventing its corresponding strut from rotating about the longitudinal axis 232 of the corresponding strut when the anchoring member is bent. In at least some embodiments, squeezing, clamping, cinching, etc., the plurality of struts 230 between the punch 260 and the die 250 may prevent the plurality of struts 230 from twisting and / or rotating about the longitudinal axis 232 when the punch 260 is moved toward the die 250 so that each anchoring member it contacts is bent along its bending axis. In some embodiments, each anchoring member may bend about and / or along an edge of the punch 260. In a first configuration, the bending axis of each anchoring member may be oriented substantially parallel to the longitudinal axis 232 of each anchoring member's corresponding strut in the plurality of struts 230. In a first configuration, the bending axis may be oriented substantially parallel to the central longitudinal axis 111 of the expandable stent 110. In at least some embodiments, the bending axis may be oriented along the edge of the punch 260 and / or may coincide with the edge of the punch. In some embodiments, the bending axis can be disposed along and / or adjacent to an edge of a corresponding strut of each anchoring member. In some embodiments, the bending axis can be disposed at and / or adjacent to a first end of each anchoring member.

[0078] In some embodiments, the method of manufacturing the medical implant 100 may include heat setting the expandable stent 110 and / or the plurality of anchoring members 240 to the second configuration. In some embodiments, the method of manufacturing the medical implant 100 may include heat setting the expandable stent 110 and / or the plurality of anchoring members 240 to the second configuration after the plurality of anchoring members 240 are bent radially outward from the plurality of struts 230. In some embodiments, the method of manufacturing the medical implant 100 may include heat setting at least some of the plurality of anchoring members 240 after some of the plurality of anchoring members 240 are bent radially outward from the plurality of struts 230 and before all of the plurality of anchoring members 240 have been bent radially outward from the plurality of struts 230. In some embodiments, the method of manufacturing the medical implant 100 may include heat setting the expandable stent 110 and / or the plurality of anchoring members 240 to the second configuration after all of the plurality of anchoring members 240 are bent radially outward from the plurality of struts 230. Other configurations and / or operational sequences are also contemplated.

[0079] In some embodiments, a method of manufacturing a medical implant 100 may include securing an occlusive element 120 to an expandable stent 110. In some embodiments, in the second configuration, at least some of the plurality of anchoring members 240 may extend through the occlusive element 120. In some embodiments, the occlusive element 120 may be disposed along an outer surface of the expandable stent 110. In some embodiments, in the second configuration, the occlusive element 120 may cover at least 20% of the expandable stent 110. In some embodiments, in the second configuration, the occlusive element 120 may cover at least 30% of the expandable stent 110. In some embodiments, in the second configuration, the occlusive element 120 may cover at least 40% of the expandable stent 110. In some embodiments, in the second configuration, the occlusive element 120 may cover at least 50% of the expandable stent 110. In some embodiments, in the second configuration, the occlusive element 120 may cover at least 60% of the expandable stent 110. In some embodiments, in the second configuration, the occlusive element 120 may cover at least 70% of the expandable stent 110. Other configurations are also contemplated.

[0080] The manufacturing method described herein can produce an expandable stent 110 with significantly less variability. For example, although bending the anchoring member to form each hook shape individually (e.g., FIG. 3 ) can have a height tolerance of + / -0.005 inches, forming the hook shape via a cutting step can have a height tolerance of + / -0.001 inches or less. In this example, the variability can be reduced by about 5 times, about 8 times, 10 times, etc. In another example, although bending the anchoring member to form each hook shape individually (e.g., FIG. 3 ) can have an angular tolerance of + / -10 degrees, forming the hook shape via a cutting step can have an angular tolerance of + / -1 degree or less. In this example, the variability can be reduced by about 8 times, about 10 times, about 12 times, about 14 times, etc. Therefore, the incidence of manufacturing waste can be significantly reduced, thereby increasing production and reducing the cost of goods. These are merely examples, and additional and / or other benefits are also envisioned and / or expected.

[0081] The materials that can be used for the various parts of medical implants, systems, and manufacturing methods disclosed herein can include those materials that are usually associated with medical devices. For simplicity, the following discussion is with reference to the system. However, this is not intended to limit the system, device, and / or method described herein, because the discussion can be applied to other elements, members, parts, or devices disclosed herein, such as, but not limited to, expandable stents, multiple pillars, multiple anchoring members, occlusive elements, etc. and / or its elements or parts.

[0082] 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.

[0083] 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 / ethers, polyether block amides (PEBA, for example, available under the trade name 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 paraphenyleneterephthalamide (poly paraphenyleneterephthalamide) (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 ), biocompatible polymers, other suitable materials, or copolymers, combinations, mixtures, polymer / metal composites thereof, etc. 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% LCP.

[0084] Some examples of suitable metals and metal alloys include: stainless steel, 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 C- UNS:N10276, such as other etc.), nickel-copper alloys (e.g., UNS: N04400, such as 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (such as UNS: R30035, such as MP35- etc.), nickel-molybdenum alloys (such as UNS: N10665, 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 (such as UNS: R30003, such as etc.); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.

[0085] 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 are capable of producing relatively bright images on a fluoroscopic screen or other imaging techniques (e.g., ultrasound, etc.) during medical procedures. 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, and the like. In addition, other radiopaque marker bands and / or coils may also be incorporated into the design of the system to achieve the same results.

[0086] 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 (e.g., 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 MP35- etc.), Nitinol, etc., and other materials.

[0087] In some embodiments, the system may include textile materials. Some examples of suitable textile materials may include synthetic yarns, which may be flat, shaped, twisted, textured, pre-shrinked or unshrinked. The synthetic biocompatible yarns suitable for use in the present invention include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyester, polypropylene, polyethylene, polyurethane, polyolefins, ethylene polymers (polyvinyl), polymethyl acetate, polyamide, naphthalene dicarboxyl derivatives (naphthalene dicarboxylene derivatives), natural silk and polytetrafluoroethylene. In addition, at least one of the synthetic yarns may be a metal yarn or a glass or ceramic yarn or fiber. Useful metal yarns include yarns made of stainless steel, platinum, gold, titanium, tantalum or nickel-cobalt-chromium-based alloys or yarns containing these materials. Yarn may further include carbon, glass or ceramic fibers. In some embodiments, yarn may be made of thermoplastic material, including, but not limited to, polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, etc. Yarn may be a multifilament, a monofilament or a staple type. The type and denier of the selected yarn can be chosen in such a way as to form a biocompatible system.

[0088] In some embodiments, the systems and / or other elements disclosed herein may include and / or be treated with suitable therapeutic agents. 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 mesalazine); antitumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (such as lidocaine, bupivacaine, and ropivacaine); Caine); anticoagulants (such as D-Phe-Pro-Arg chloromethyl ketone, compounds containing RGD peptides, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors and tick antiplatelet peptides); vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcription activators and translation promoters); vascular cell growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies to growth factors, bifunctional molecules composed of growth factors and cytotoxins, bifunctional molecules composed of antibodies and cytotoxins); cholesterol-lowering agents; vasodilators; and agents that interfere with endogenous vascular mechanisms of action.

[0089] It should be understood that the present disclosure is in many respects merely illustrative. Changes may be made in detail, particularly in shape, size, and arrangement of steps, without exceeding the scope of the present disclosure. To the extent appropriate, this may include using any feature of an example embodiment in other embodiments. Of course, the scope of the present disclosure is limited by the language of the appended claims.

Claims

1. A method for manufacturing a medical implant for occluding a left atrial appendage, the method comprising: cutting the expandable stent in the first configuration; wherein the expandable stent comprises a plurality of struts having ends joined together at intersections and a plurality of anchoring members extending from the plurality of struts such that each anchoring member extends from a mid-portion of one of the plurality of struts; forming the expandable stent into a second configuration; wherein forming the expandable stent into the second configuration comprises bending each anchoring member along a bending axis thereof, the bending axis being oriented parallel to a longitudinal axis of its respective one of the plurality of struts; and The expandable stent is heat set into the second configuration.

2. The method according to claim 1, wherein: The first configuration is a radially collapsed configuration and the second configuration is a radially expanded configuration.

3. The method according to any one of claims 1 to 2, wherein: Each anchoring member extends radially outward from the plurality of struts after bending.

4. The method according to any one of claims 1 to 3, wherein: Forming the expandable stent into the second configuration includes preventing twisting of the plurality of struts.

5. The method according to claim 4, wherein: Bend each anchor member including preventing its respective strut from rotating about a longitudinal axis of the respective strut when the anchor member bends.

6. The method according to any one of claims 1 to 5, wherein: The expandable stent is formed from a unitary tubular member.

7. The method according to claim 6, wherein: Bending each anchoring member comprises: inserting a punch into the interior of the expandable stent; and The punch is moved radially outward relative to the plurality of struts.

8. The method according to claim 7, wherein: Moving the punch radially outward relative to the plurality of struts causes more than one of the plurality of anchor members to bend simultaneously.

9. The method according to claim 6, wherein: Bending each anchoring member comprises: inserting a mold into the interior of the expandable stent; positioning their respective struts over grooves formed in the mold; and The punch is used to push the corresponding pillar into the groove.

10. The method according to any one of claims 1 to 5, wherein: The expandable stent is formed from a flat sheet of material.

11. The method according to claim 10, wherein: Bending each anchoring member includes moving the punch through the expandable stent without moving the plurality of struts.

12. The method according to claim 10, wherein: Bending each anchoring member comprises: positioning their respective pillars over grooves formed in the mold; and The punch is used to push the corresponding pillar into the groove.

13. The method of any one of claims 10-12, further comprising forming the flat sheet of material into a tubular member.

14. The method according to any one of claims 1 to 13, further comprising: An occlusive element is secured to the expandable stent.

15. A medical implant for occluding a left atrial appendage, the medical implant comprising: an expandable stent configured to transition from a radially collapsed configuration to a radially expanded configuration; wherein the expandable stent comprises a plurality of struts having ends joined together at intersections and a plurality of anchoring members extending from the plurality of struts such that each anchoring member extends from a mid-portion of one of the plurality of struts; Wherein, in the radial expansion structure: each anchor member having a longitudinal axis oriented parallel to each anchor member and its corresponding strut of the plurality of struts; and The plurality of anchoring members extend radially outward from the plurality of struts.

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