Medical implant and method for manufacturing a medical implant

Abstract

A method of manufacturing a medical implant for occluding a left atrial appendage includes cutting an expandable framework into a first configuration, the expandable framework including a plurality of struts having ends joined to each other at intersections, and a plurality of anchor members extending from the plurality of struts, each anchor member extending from an intermediate portion of one of the plurality of struts; forming the expandable framework into a second configuration, the forming including bending each anchor member along its bending axis, the bending axis being oriented parallel to the longitudinal axis of its respective one of the plurality of struts; heat-setting the expandable framework in the second configuration; and may include fixing an occlusion element to the expandable framework.

Description

Technical Field

[0001] The present disclosure relates to medical devices and systems, and methods for manufacturing and using medical devices and systems. More specifically, the present disclosure relates to a medical implant for occluding the left atrial appendage and a method of manufacturing the medical implant.

Background Art

[0002] Diseases and / or conditions affecting the cardiovascular system are prevalent throughout the world. Conventionally, treatment of the cardiovascular system has often been performed by directly accessing the affected part of the system. More recently, less invasive therapies have been developed and are widely accepted among patients and clinicians.

[0003] Atrial fibrillation is a common persistent arrhythmia that, according to some estimates, affects more than 30 million people worldwide. Atrial fibrillation is an irregular and chaotic beating of the atria, the upper chambers of the heart. Because electrical impulses are released very rapidly, the atrial muscle quivers or fibrillates. Episodes of atrial fibrillation can last for minutes or days. The most serious consequence of atrial fibrillation is ischemic stroke. It is estimated that up to 20% of all strokes are related to atrial fibrillation. Most patients with atrial fibrillation require treatment to reduce their stroke risk, regardless of the severity of their symptoms or the frequency of their episodes. The left atrial appendage is a small organ that attaches 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 blood to pool inside the left atrial appendage and potentially leading to the formation of unwanted blood clots within the left atrial appendage. Blood clots formed within the left atrial appendage can break away and enter the bloodstream. A blood clot moving through the blood vessels can eventually block a narrow blood vessel downstream, causing a stroke or heart attack. Clinical studies have shown that in patients with atrial fibrillation, the majority of blood clots are found in the left atrial appendage. As a treatment, medical devices have been developed that are positioned within the left atrial appendage and deployed to close the small openings of the left atrial appendage. Over time, the exposed surface spanning the small openings of the left atrial appendage becomes covered with tissue (a process called endothelialization), effectively removing the left atrial appendage from the circulatory system and reducing or eliminating the number of blood clots that can enter the bloodstream from the left atrial appendage.

[0004] The present disclosure relates to a medical implant for occluding the left atrial appendage and / or a method of manufacturing a medical implant. Each of the known medical devices, systems, and methods has specific advantages and disadvantages. There is a continuing need to provide alternative medical devices and systems, as well as alternative methods of manufacturing and using medical devices and systems. SUMMARY OF THE INVENTION

[0005] In one example, a method of manufacturing a medical implant for occluding a left atrial appendage includes cutting an expandable framework into a first configuration, the expandable framework including a plurality of struts having ends joined to each other at intersections, and a plurality of anchor members extending from the plurality of struts, each anchor member extending from an intermediate portion of one of the plurality of struts, and forming the expandable framework into a second configuration, forming the expandable framework into the second configuration including bending each anchor member along its bending axis, the bending axis being oriented parallel to the longitudinal axis of its respective strut of the plurality of struts, and heat setting the expandable framework in the second configuration.

[0006] In addition to or as an alternative to any of the examples described herein, the expandable framework is cut with a laser. In addition to or as an alternative to any of the examples described herein, the first configuration is a radially contracted configuration and the second configuration is a radially expanded configuration.

[0007] In addition to or as an alternative to any of the examples described herein, each anchor member extends radially outward from the plurality of struts after bending. In addition to or as an alternative to any of the examples described herein, forming the expandable framework into the second configuration includes preventing the plurality of struts from twisting.

[0008] In addition to or as an alternative to any of the examples described herein, bending each anchor member includes preventing its respective strut from rotating about the longitudinal axis of its respective strut when bending the anchor member.

[0009] In addition to or as an alternative to any of the examples described herein, the expandable framework is formed from a single tubular member. In addition to or as an alternative to any of the examples described herein, bending each anchor member includes inserting a punch inside the expandable framework and moving the punch radially outwardly with respect to a plurality of struts.

[0010] In addition to or as an alternative to any of the examples described herein, moving the punch radially outwardly with respect to a plurality of struts simultaneously bends two or more of the plurality of anchor members.

[0011] In addition to or as an alternative to any of the examples described herein, bending each anchor member includes inserting a die inside the expandable framework, positioning each respective strut over a groove formed in the die, and urging each respective strut into the groove using a punch.

[0012] In addition to or as an alternative to any of the examples described herein, the expandable framework is formed from a flat sheet of material. In addition to or as an alternative to any of the examples described herein, bending each anchor member includes moving the punch through the expandable framework without moving the plurality of struts.

[0013] In addition to or as an alternative to any of the examples described herein, bending each anchor member includes positioning each respective strut over a groove formed in the die and urging each respective strut into the groove using a punch.

[0014] In addition to or as an alternative to any of the examples described herein, the method may further include forming the flat sheet of material into a tubular member. In addition to or as an alternative to any of the examples described herein, a method of manufacturing a medical implant for occluding a left atrial appendage includes cutting an expandable framework into a first configuration, the expandable framework including a plurality of struts having ends joined to each other at intersections and a plurality of anchor members extending from the plurality of struts, each anchor member extending from an intermediate portion of one of the plurality of struts, cutting, shaping the expandable framework into a second configuration, shaping the expandable framework into the second configuration including bending each anchor member along its bending axis, the bending axis being oriented parallel to the longitudinal axis of its respective one of the plurality of struts, shaping, heat setting the expandable framework in the second configuration, and securing an occlusion element to the expandable framework.

[0015] In addition to or as an alternative to any of the examples described herein, at least some of the plurality of anchor members extend through the occlusion element in the second configuration. In addition to or as an alternative to any of the examples described herein, the occlusion element is disposed along an outer surface of the expandable framework.

[0016] In addition to or as an alternative to any of the examples described herein, the occlusion element covers at least 30% of the expandable framework in the second configuration. In addition to or as an alternative to any of the examples described herein, a medical implant for occluding a left atrial appendage may comprise an expandable framework configured to transition from a radially contracted configuration to a radially expanded configuration. The expandable framework may include a plurality of struts having ends joined to each other at intersections and a plurality of anchor members extending from the plurality of struts, each anchor member extending from an intermediate portion of one of the plurality of struts. In the radially expanded configuration, each anchor member may have a bending axis oriented parallel to the longitudinal axis of its respective one of the plurality of struts and parallel to each anchor member, and the plurality of anchor members may extend radially outward from the plurality of struts.

[0017] In addition to or as an alternative to any of the examples described herein, each bending axis is oriented parallel to the central longitudinal axis of a framework that is expandable in a radially contracted configuration. The above summaries of some embodiments, aspects, and / or examples are not intended to describe every embodiment or all implementations of the present disclosure. The following drawings and "Detailed Description of the Invention" illustrate these embodiments more specifically.

[0018] The present disclosure can be more fully understood by considering the following "Detailed Description of the Invention" in connection with the accompanying drawings.

Brief Description of the Drawings

[0019]

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DETAILED DESCRIPTION OF THE INVENTION

[0020] Aspects of the present disclosure are applicable to various modifications and alternative forms, the details of which are shown by way of example in the drawings and are described in detail. However, it should be understood that the intention is not to limit the aspects of the present disclosure to the specific embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternative forms that fall within the spirit and scope of the present disclosure.

[0021] The following description should be read with reference to the drawings, which are not necessarily to scale, but like reference numerals indicate like elements throughout several views. The detailed description and the 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 illustrated can be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and the drawings show exemplary aspects of the present disclosure.

[0022] For the terms defined below, these definitions shall apply unless different definitions are provided in the claims or elsewhere in this specification. In this specification, all numerical values are assumed to be modified by the term "about", whether or not explicitly indicated. The term "about" in the context of a numerical value generally refers to a range of numbers that a person of ordinary skill in the art would consider equivalent (e.g., having the same function or result) to the recited value. In many cases, the term "about" may include numbers rounded to the nearest significant digit. Other uses of the term "about" (e.g., in contexts other than numerical values) may be understood from the context of this specification and are assumed to have their ordinary customary definitions that are consistent with the context of this specification, unless otherwise specified.

[0023] The recitation of a numerical range by endpoints includes all numbers within that range including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although some suitable dimensions, ranges, and / or values for various components, features, and / or specifications are disclosed, one of ordinary skill in the art, being triggered by this disclosure, would understand that the desired dimensions, ranges, and / or values may deviate from those explicitly disclosed.

[0024] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in the sense of "and / or" unless the context clearly dictates otherwise. It should be noted that for ease of understanding, some features of the present disclosure may be described in the singular even when those features may be plural or repeated within the embodiments in which they are disclosed. Each example of a feature includes and / or may be encompassed by a singular disclosure unless the contrary is clearly stated. For simplicity and clarity, not all elements of the present disclosure are necessarily shown in each figure or described in detail below. However, it will be understood that the following description may be equally applicable to any and / or all of two or more existing components unless the contrary is explicitly stated.

[0025] Relative terms such as "proximal", "distal", "advancing", "retreating", and variations thereof may generally be considered with respect to the position, orientation, and / or movement of various elements relative to the user / operator / manipulator of the device, where "proximal" and "retreating" indicate or refer to being closer to or towards the user, and "distal" and "advancing" indicate or refer to being farther from or away from the user. In some cases, the terms "proximal" and "distal" may be arbitrarily assigned for ease of understanding of the present disclosure, and in such cases, it will be readily apparent to those skilled in the art. Other relative terms such as "upstream", "downstream", "inflow", and "outflow" refer to the direction of fluid flow within a body lumen, blood vessel, etc., or within a device. Still other relative terms and / or variations thereof such as "axial", "circumferential", "longitudinal", "transverse", "radial", etc. generally refer to the direction and / or orientation with respect to the central longitudinal axis of the disclosed structure or device.

[0026] The term "range" can be understood to mean the maximum measured dimension of the recited or specified dimension, unless or until the range or dimension is qualified with "minimum" which can be understood to mean the minimum measured value of the recited or specified dimension. For example, an "outer range" may be understood to mean the maximum outer dimension, a "radial range" may be understood to mean the maximum radial dimension, and a "longitudinal range" may be understood to mean the maximum longitudinal dimension. Each instance of "range" may be different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.) and will be apparent to one of ordinary skill in the art from the context of the individual use. Generally, a "range" can be considered the maximum dimension measured according to the intended use, while a "minimum range" can be considered the minimum dimension measured according to the intended use. In some cases, a "range" can be measured orthogonally within a plane and / or cross-section, but is not limited to such and may be measured differently, such as angularly, radially, circumferentially (e.g., along an arc), etc., as is apparent from the particular context.

[0027] The terms "monolithic" and "unitary" shall generally refer to an element (singly or plurally) made of or consisting of a single structure or base unit / element. Monolithic and / or unitary elements shall exclude structures and / or features made by assembling or otherwise joining together a plurality of distinct structures or elements.

[0028] References to "one embodiment", "some embodiments", "other embodiments", etc. in this specification are to be noted as indicating that the described embodiments may include certain features, structures, or characteristics, but not all embodiments necessarily include the specific features, structures, or characteristics. Further, such phrases do not necessarily refer to the same embodiment. Additionally, when a particular feature, structure, or characteristic is described in relation to an embodiment, unless the contrary is explicitly stated, whether or not it is explicitly described, using the particular feature, structure, or characteristic in relation to other embodiments would be within the knowledge of those skilled in the art. That is, the various individual elements described below, even if not explicitly shown in a particular combination, are intended to be combinable or arrangeable with each other to form other additional embodiments or to complement and / or enhance the described embodiments as would be understood by those skilled in the art.

[0029] For purposes of clarification, throughout the specification and / or claims, a particular identification numerical nomenclature (e.g., first, second, third, fourth, etc.) may be used to name and / or distinguish the various features of the specification and / or claims. It is to be understood that the numerical nomenclature is not intended to be limiting and is merely illustrative. In some embodiments, for the sake of brevity and clarity, changes and departures from the previously used numerical nomenclature may occur. That is, a feature identified as a "first" element may later be referred to as a "second" element, a "third" element, etc., or may be completely omitted, and / or a different feature may be referred to as the "first" element. The meaning and / or name in each instance will be apparent to those skilled in the art.

[0030] The figures show selected components and / or arrangements of medical implants, systems, and methods for manufacturing them. Note that in any given figure, some features of the medical implants, systems, and methods may not be shown for simplicity or may be shown schematically. Further details regarding some elements may be shown in more detail in other figures. For ease of understanding, note that some features of the present disclosure may be described in the singular, even where those features may be plural or repeated within the disclosed embodiments. Each example of a feature includes, and / or may be encompassed by, a singular disclosure unless the contrary is explicitly stated. Accordingly, it will be understood that the following description applies equally to any and / or all of the components present in two or more within the medical implant, system, and manufacturing method, unless the contrary is explicitly stated. The devices and / or methods disclosed herein may provide several desirable features and advantages, as will be described in more detail below.

[0031] Figure 1 schematically shows selected components and / or arrangements of a medical device system 10. 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 an anatomical structure, which in some embodiments includes but is not limited to the heart. In some embodiments, the medical device system 10 may include a delivery device that can be used to percutaneously deliver a replacement heart valve implant (e.g., a replacement mitral valve, a replacement aortic valve, etc.) to a target area within an anatomical structure such as a native heart valve. However, this is not intended to be limiting, and the medical device system 10 and / or the delivery device may be used for other interventions including but not limited to valve repair, valvuloplasty, or other similar interventions.

[0032] 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 within the lumen 42, and a medical implant 100 having an expandable framework (e.g., a cardiovascular medical implant, an occlusive medical implant, etc.). The expandable framework is configured to transition between a first configuration (e.g., FIG. 1) in which the medical implant 100 is disposed within the lumen 42 in proximity to the distal opening and a second configuration (e.g., FIG. 2). The medical implant 100 and / or the expandable framework are configured to transition between the first and second configurations when the medical implant 100 is disposed at the distal opening of the lumen 42 and / or distal to the catheter 40 and / or when the medical implant 100 is not constrained by the catheter 40. The medical implant 100 can be disposed and / or releasably connected to the distal portion of the core wire 30. The core wire 30 can be slidably and / or rotatably disposed within the lumen 42 of the 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 proximal to the proximal opening of the lumen 42 for manual operation by a clinician or operator. In some embodiments, the exemplary medical implant 100 may be removably attached, joined, 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, the core wire 30, the catheter 40, and / or the medical implant 100 are described below. It is contemplated that any and / or all of the exemplary occlusive implants disclosed herein can be used in accordance with and / or associated with the exemplary medical device system 10 described above.

[0033] Figure 3 shows a selected embodiment of the medical implant 100. The medical implant 100 includes an expandable framework 110 configured to transition between a first configuration (e.g., FIG. 1) and a second configuration (e.g., FIGS. 2-3). The first configuration may be a radially contracted configuration, and the second configuration may be a radially expanded configuration. The expandable framework 110 may have a central longitudinal axis 111. The proximal end 114 of the expandable framework 110 may be configured to releasably attach or connect to the distal end of the core wire 30. The proximal end 114 of the expandable framework 110 includes a threaded insert configured to engage a threaded member disposed at the distal end of the core wire 30. The expandable framework 110 includes a plurality of anchor members 112 each connected to the expandable framework 110 at an intersection 116 between adjacent struts of the expandable framework 110. The expandable framework 110 includes a plurality of struts, and the ends of adjacent struts among the plurality of struts are joined, connected, etc. to each other at the intersection 116. The free ends 118 of the plurality of anchor members 112 extend radially outward from the expandable framework 110 in the second configuration. The plurality of anchor members 112 are configured to engage the wall of the left atrial appendage in the second configuration. The medical implant 100 includes an occlusion element 120 connected to the expandable framework 110.

[0034] The method of manufacturing the medical implant 100 may include forming and / or cutting an expandable framework 110 in a first configuration from a single tubular member. Alternatively, the method of manufacturing the medical implant 100 may include forming and / or cutting an expandable framework 110 from a flat material sheet that is wound and / or shaped to later become a tubular member. After shaping the flat material sheet into a tubular member, the tubular member can be firmly fixed in a tubular shape by welding or other means. The method may include forming the expandable framework 110 into a second configuration after cutting the expandable framework 110. The method may include bending each of the plurality of anchor members 112 as part of forming the expandable framework 110 into a second configuration. The method may include heat setting the expandable framework 110 in the second configuration after forming the expandable framework 110 into the second configuration.

[0035] FIG. 4 is a flat pattern view of the expandable framework 110 of FIG. 3, and FIG. 5 is a detailed view of a portion of FIG. 4. The flat pattern view 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 an expandable framework from a single tubular member, and the illustration of a flat pattern does not mean that it is preferred to form and / or cut an expandable framework from a flat material sheet.

[0036] As shown, the expandable framework 110 includes a plurality of anchor members 112 connected to the expandable framework 110 at intersection 116. Each anchor member of the plurality of anchor members 112 includes a free end 118 that extends away from the intersection 116. The plurality of anchor members 112 are oriented substantially parallel to the struts of the expandable framework 110 in a first configuration. The method includes bending the free end 118 away from the expandable framework 110 about a bending axis in the orientation shown in FIG. 3 as part of shaping the expandable framework 110 into a second configuration. Each anchor member of the plurality of anchor members 112 extends radially outward from the plurality of struts after bending. The bending axis of each anchor member is oriented transverse or perpendicular to the central longitudinal axis 111 of the expandable framework 110 and / or the bending axis is oriented transverse or perpendicular to the longitudinal axis of the struts of the expandable framework 110 in the first configuration. The bending axis may be oblique to the central longitudinal axis 111 of the expandable framework 110 (e.g., the bending axis does not intersect the central longitudinal axis 111). In existing configurations and / or methods, it may be necessary for the plurality of anchor members 112 to be formed and / or bent individually (e.g., one at a time).

[0037] In the process of bending the free ends 118 of the plurality of anchor members 112, there are significant variations included and / or introduced in the height 119 of the anchor member shown in FIG. 3, as well as in the angle of the free end 118 with respect to the central longitudinal axis 111 of the expandable framework 110, and / or in the angle of the free end 118 with respect to adjacent struts of the expandable framework 110. In order to be properly installed after deployment, several manufacturing specifications need to be maintained within the design tolerance. The manufacturing specifications can include height, angle, radius, inclination, etc. Due to the complexity and difficulty associated with the bending process for forming the plurality of anchor members 112, as well as the number of anchor members, there is a possibility that the expandable framework 110 will be out of specification. For example, the free end 118 may bounce back after bending. The bounce-back is a normal by-product of the bending process and can affect at least the height and / or angle of the anchor member. The bounce-back can be at least partially corrected, but sometimes it is unpredictable and / or inconsistent. Disclosed herein are methods and / or configurations that can significantly reduce the variations within the expandable framework 110, thereby reducing the scrap rate, reducing the manufacturing cost, and / or improving the quality.

[0038] FIG. 6 shows a detailed view of a portion of a flat pattern of an alternative configuration of the expandable framework 110 intended to improve at least some of the problems that occur when bending the plurality of anchor members 112 of FIGS. 3-5. As shown in FIG. 6, the expandable framework 110 can include, in a first configuration, a plurality of struts 130 that are oriented generally parallel to each other and / or to the central longitudinal axis 111 of the expandable framework 110. Each strut of the plurality of struts 130 can include and / or have a longitudinal axis 132 that is oriented generally parallel to the central longitudinal axis 111 of the expandable framework 110 in the first configuration.

[0039] The expandable framework 110 may include a plurality of anchor members 140 that extend laterally and / or circumferentially from an intermediate portion of one of the plurality of struts 130 of the expandable framework 110. Each anchor member of the plurality of anchor members 140 may include a first end fixedly attached to and / or integrally formed with the intermediate portion of the strut, and a free end 142 opposite the first end. In some embodiments, each anchor member may extend distally from the first end, and the free end 142 of each anchor member may be shaped into a hook shape having a tip extending proximally.

[0040] In some embodiments, the plurality of struts 130 may be longitudinally discontinuous (e.g., the struts do not extend linearly 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 apart 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.

[0041] In some embodiments, the free end 142 of each anchor member of the plurality of anchor members 140 may extend laterally and / or circumferentially across the longitudinal axis 132 of an adjacent strut among the plurality of struts 130 in a first configuration. In some embodiments, the offset portion 134 may extend around the free end 142 of an anchor member of an adjacent strut among the plurality of struts 130. In some embodiments, each support portion 136 may be disposed laterally and / or circumferentially opposite the first end of one of the anchor members of the plurality of anchor members 140 with respect to the longitudinal axis 132 of the strut.

[0042] The method of manufacturing the medical implant 100 may include, for example, cutting the expandable framework 110 into a first configuration as described herein to manufacture the configuration shown in FIG. 6. In some embodiments, the expandable framework 110 may be cut with a laser. In some embodiments, the expandable framework 110 may be cut with a water jet. In some embodiments, the expandable framework 110 may be machined. Other manufacturing methods and / or processes are also contemplated.

[0043] In some embodiments, the method may include shaping the expandable framework 110 into a second configuration as at least partially shown in FIGS. 7-8. In some embodiments, shaping the expandable framework 110 into a second configuration may include constraining the expandable framework 110 and / or the plurality of struts 130. In some embodiments, constraining the expandable framework 110 and / or the plurality of struts 130 may include gripping and / or clamping at least some of the plurality of struts 130. In some embodiments, constraining the expandable framework 110 and / or the plurality of struts 130 may include pressing at least one constraining plate 150 against the expandable framework 110 and / or the plurality of struts 130 as shown in FIG. 7. In some embodiments, constraining the expandable framework 110 and / or the plurality of struts 130 may include pressing at least one constraining plate 150 against the offset portion 134 and / or the support portion 136. In some embodiments, the expandable framework 110, the plurality of struts 130, the offset portion 134, and / or the support portion 136 may be fixed to a die, a base plate, or some other suitable structure by at least one constraining plate 150. The at least one constraining plate 150 may include a notch 152 that generally aligns with the offset portion 134 of the plurality of struts 130.

[0044] In some embodiments, shaping the expandable framework 110 into the second configuration may include bending each anchor member along its bending axis. The bending axis may be oriented generally parallel to the longitudinal axis 132 of each respective strut among the plurality of struts 130 in the first configuration. In some embodiments, by bending each anchor member along its bending axis, at least a portion of the anchor member may be oriented at approximately 90 degrees with respect to its respective strut in the second configuration. In some embodiments, by bending each anchor member along its bending axis, the entire anchor member may be oriented at approximately 90 degrees with respect to its respective strut in the second configuration.

[0045] In some embodiments, the expandable framework 110 may be formed from a single tubular member. In some embodiments, shaping the expandable framework 110 into the second configuration and / or bending each anchor member may include inserting a punch 160 inside the expandable framework 110. The punch 160 may be understood to be below the expandable framework 110 in the figures shown in FIGS. 7-8, and may also include moving the punch radially outward with respect to the plurality of struts 130 as shown in FIG. 8. The notch 152 of at least one restraint plate 150 may enable the free ends 142 of the plurality of anchor members 140 to pass through the at least one restraint plate 150 when bending the plurality of anchor members 140. Each anchor member may extend radially outward from the plurality of struts 130 after bending and / or in the second configuration. In some embodiments, by moving the punch 160 radially outward with respect to the plurality of struts 130, two or more of the plurality of anchor members 140 may be bent simultaneously. This may reduce the number of bending operations required to shape the expandable framework 110 into the second configuration, thereby improving manufacturing efficiency and / or cost.

[0046] In some embodiments, the expandable framework 110 may be formed from a flat sheet of material. In some embodiments, shaping the expandable framework 110 into the second configuration and / or bending each anchor member may include moving the punch 160 through the expandable framework 110 without moving the plurality of struts 130, as shown in FIG. 8. The notch 152 of at least one restraint plate 150 may enable the free ends 142 of the plurality of anchor members 140 to pass through the at least one restraint plate 150 when bending the plurality of anchor members 140. In some embodiments, moving the punch 160 through the expandable framework 110 may bend two or more of the plurality of anchor members 140 simultaneously. This may reduce the number of bending operations required to shape the expandable framework 110 into the second configuration, thereby improving manufacturing efficiency and / or cost. The method may further include shaping the flat sheet of material into a tubular member such that each anchor member extends radially outward from the plurality of struts 130 in the second configuration.

[0047] In some embodiments, shaping the expandable framework 110 into a second configuration and / or bending each anchor member may include preventing the plurality of struts 130 from twisting. As seen in FIG. 9, after the plurality of anchor members 140 are bent, none of the plurality of struts 130 are twisted. In some embodiments, bending each anchor member may include preventing each respective strut from rotating about its respective longitudinal axis 132 when the anchor member is bent. In at least some embodiments, by using at least one restraint plate 150 to restrain the plurality of struts 130, the offset portion 134, and / or the support portion 136, the punch 160 is moved through the expandable framework 110 and / or the punch 160 is moved radially outwardly relative to the plurality of struts 130, such that when the punch 160 bends each anchor member it contacts along its bending axis, the plurality of struts 130 are prevented from twisting and / or rotating about the longitudinal axis 132. In some embodiments, each anchor member may be bent about and / or along the edge of at least one restraint plate 150. The bending axis of each anchor member may be oriented generally parallel to the longitudinal axis 132 of each respective strut of the plurality of struts 130 in the first configuration. The bending axis may be oriented generally parallel to the central longitudinal axis 111 of the expandable framework 110 in the first configuration. In at least some embodiments, the bending axis may be oriented along and / or coincide with the edge of at least one restraint plate 150. In some embodiments, the bending axis may be disposed along and / or immediately adjacent to the edge of each respective strut of each anchor member. In some embodiments, the bending axis may be disposed at and / or immediately adjacent to the first end of each anchor member.

[0048] FIG. 10 is a perspective view showing an alternative configuration of a plurality of anchor members 140 extending laterally and / or circumferentially from an intermediate portion of one of the plurality of struts 130 of the expandable framework 110. FIG. 10A is an end view of the alternative configuration of FIG. 10. Similar to the plurality of anchor members 140 described above with respect to FIGS. 6-9, each anchor member can be bent along its bending axis. In at least some embodiments, the bending axis may be oriented generally parallel to the longitudinal axis 132 of each respective strut of the plurality of struts 130. In some embodiments, the bending axis may be spaced from each respective strut of the anchor member, and the anchor member is bent along the body portion 144 of the anchor member at a position between the first end and the free end 142, thereby orienting at least a portion of the anchor member at approximately 90 degrees with respect to its respective strut in the second configuration.

[0049] FIGS. 11-15 show selected aspects of a method of manufacturing an alternative configuration of the expandable framework 110. FIG. 11 shows a detailed view of a portion of a flat pattern of an alternative configuration of the expandable framework 110 intended to address at least some of the problems that occur when bending the plurality of anchor members 112 of FIGS. 3-5. As shown in FIG. 11, the expandable framework 110 may include a plurality of struts 230 oriented generally parallel to each other and / or to the central longitudinal axis 111 of the expandable framework 110 in a first configuration. Each strut of the plurality of struts 230 may include and / or have a longitudinal axis 232 oriented generally parallel to the central longitudinal axis 111 of the expandable framework 110 in the first configuration.

[0050] The expandable framework 110 may include a plurality of anchor members 240 that extend respectively in the lateral and / or circumferential directions from an intermediate portion of one of the plurality of struts 230 of the expandable framework 110. Each anchor member of the plurality of anchor members 240 may include a first end fixedly attached to and / or integrally formed with the intermediate portion of the strut, and a free end 242 opposite the first end. In some embodiments, each anchor member may extend distally from the first end, and the free end 242 of each anchor member may be shaped like a hook having a tip extending proximally. In some embodiments, the plurality of struts 230 may be longitudinally continuous (e.g., the struts extend linearly between the ends). The anchor members of adjacent struts among the plurality of struts 230 may be longitudinally offset from each other and / or longitudinally spaced apart from each other. In some embodiments, each strut of the plurality of struts 230 may include a pair of the plurality of anchor members 240 that extend from both sides of the strut at a common axial position along the strut. In some embodiments, each strut of the plurality of struts 230 may include a plurality of pairs of the plurality of anchor members 240, and each pair extends from both sides of the strut at its own common axial position along the strut (e.g., the first pair extends from both sides of the strut at the first position, the second pair extends from both sides of the strut at the second position, etc.).

[0051] The method of manufacturing the medical implant 100 may include, for example, cutting the expandable framework 110 into a first configuration as described herein to manufacture the configuration shown in FIG. 11. In some embodiments, the expandable framework 110 may be cut with a laser. In some embodiments, the expandable framework 110 may be cut with a water jet. In some embodiments, the expandable framework 110 may be machined. Other manufacturing methods and / or processes are also contemplated.

[0052] In some embodiments, shaping the expandable framework 110 into the second configuration may include bending each anchor member along its bending axis. The process of bending each anchor member along its bending axis is shown in FIGS. 12-15 using a single one of the plurality of struts 230, and FIG. 15 shows the plurality of anchor members 240 after bending and / or in the second configuration. In some embodiments, a plurality of the plurality of struts 230 may be processed at once, simultaneously, etc. In some embodiments, each of the plurality of struts 230 may be processed one at a time, sequentially, etc. The bending axis may be oriented generally parallel to the longitudinal axis 232 of each of the plurality of struts 230 in the first configuration. In some embodiments, by bending each anchor member along its bending axis, at least a portion of the anchor member may be oriented at approximately 90 degrees relative to its respective strut in the second configuration. In some embodiments, by bending each anchor member along its bending axis, the free end 242 of the anchor member may be oriented at approximately 90 degrees relative to its respective strut in the second configuration.

[0053] In some embodiments, the expandable framework 110 may be formed from a single tubular member. In some embodiments, shaping the expandable framework 110 into a second configuration and / or bending each anchor member includes inserting the die 250 inside the expandable framework 110, and the die 250 may be understood to be below the expandable framework 110 in the figures shown in FIGS. 12-14. Bending each anchor member may include positioning each of the plurality of struts 230 thereon in a groove 252 formed in the die 250, as seen in FIG. 12. Bending each anchor member may include using the punch 260 to bias, press, push, move, etc., each of the plurality of struts 230 into the groove 252 of the die 250, as seen in FIG. 13. In some embodiments, the punch 260 may be moved radially inwards towards the die 250. In some embodiments, the die 250 may be moved radially outwards towards the punch 260. Each of the plurality of struts 230 may be squeezed, clamped, pinched, etc. between the punch 260 and the die 250. Each anchor member may extend radially outwards from the plurality of struts 230 after bending and / or in the second configuration. In some embodiments, two or more of the plurality of anchor members 240 may be bent simultaneously by using the punch 260 to bias, press, push, move, etc., each of the plurality of struts 230 into the groove 252 of the die 250. This may reduce the number of bending operations required to shape the expandable framework 110 into the second configuration, thereby improving manufacturing efficiency and / or cost.

[0054] In some embodiments, the expandable framework 110 may be formed from a flat sheet of material. In some embodiments, shaping the expandable framework 110 into the second configuration and / or bending each anchor member may include positioning each respective one of the plurality of struts 230 over a groove 252 formed in the die 250, as seen in FIG. 12. In some embodiments, the longitudinal axis 232 of each respective one of the plurality of struts 230 may be aligned with and / or parallel to the groove 252 formed in the die 250. Bending each anchor member may include, as seen in FIG. 13, using the punch 260 to bias, press, push, move, etc., each respective one of the plurality of struts 230 within the groove 252 of the die 250. In some embodiments, the punch 260 may be moved toward the die 250. In some embodiments, the die 250 may be moved toward the punch 260. Each respective one of the plurality of struts 230 may be squeezed, clamped, etc., between the punch 260 and the die 250. In some embodiments, using the punch 260 to bias, press, push, move, etc., each respective one of the plurality of struts 230 within the groove 252 of the die 250 may bend two or more of the plurality of anchor members 240 simultaneously. This may reduce the number of bending operations required to shape the expandable framework 110 into the second configuration, thereby improving manufacturing efficiency and / or cost. The method may further include shaping the flat sheet of material into a tubular member such that each anchor member extends radially outwardly from the plurality of struts 230 in the second configuration.

[0055] In some embodiments, shaping the expandable framework 110 into a second configuration and / or bending each anchor member may include preventing the plurality of struts 230 from twisting. As seen in FIGS. 14-15, after the plurality of anchor members 240 are bent, the plurality of struts 230 are not twisted. In some embodiments, bending each anchor member may include preventing each respective strut from rotating about its respective longitudinal axis 232 when bending the anchor member. In at least some embodiments, the plurality of struts 230 may be compressed, clamped, crimped, etc. between a punch 260 and a die 250 such that the punch 260 is moved toward the die 250, thereby preventing the plurality of struts 230 from twisting and / or rotating about the longitudinal axis 232 when bending each anchor member that the punch 260 contacts along its bending axis. In some embodiments, each anchor member may be bent about and / or along the edge of the punch 260. The bending axis of each anchor member may be oriented generally parallel to the longitudinal axis 232 of each respective strut of the plurality of struts 230 in the first configuration. The bending axis may be oriented generally parallel to the central longitudinal axis 111 of the expandable framework 110 in the first configuration. In at least some embodiments, the bending axis may be oriented along and / or coincide with the edge of the punch 260. In some embodiments, the bending axis may be disposed along and / or adjacent to the edge of each respective strut of each anchor member. In some embodiments, the bending axis may be disposed at and / or directly adjacent to the first end of each anchor member.

[0056] In some embodiments, a method of manufacturing the medical implant 100 may include heat setting the expandable framework 110 of the second configuration and / or the plurality of anchor members 240. In some embodiments, a method of manufacturing the medical implant 100 may include heat setting the expandable framework 110 of the second configuration and / or the plurality of anchor members 240 after bending the plurality of anchor members 240 radially outward from the plurality of struts 230. In some embodiments, a method of manufacturing the medical implant 100 may include heat setting at least some of the plurality of anchor members 240 after bending some of the plurality of anchor members 240 radially outward from the plurality of struts 230 and before bending all of the plurality of anchor members 240 radially outward from the plurality of struts 230. In some embodiments, a method of manufacturing the medical implant 100 may include heat setting the expandable framework 110 of the second configuration and / or the plurality of anchor members 240 after bending all of the plurality of anchor members 240 radially outward from the plurality of struts 230. Other configurations and / or orders of operations are contemplated.

[0057] In some embodiments, a method of manufacturing a medical implant 100 may include fixing an occlusion element 120 to an expandable framework 110. In some embodiments, at least some of the plurality of anchor members 240 may extend through the occlusion element 120 in a second configuration. In some embodiments, the occlusion element 120 may be disposed along an outer surface of the expandable framework 110. In some embodiments, the occlusion element 120 may cover at least 20% of the expandable framework 110 in a second configuration. In some embodiments, the occlusion element 120 may cover at least 30% of the expandable framework 110 in a second configuration. In some embodiments, the occlusion element 120 may cover at least 40% of the expandable framework 110 in a second configuration. In some embodiments, the occlusion element 120 may cover at least 50% of the expandable framework 110 in a second configuration. In some embodiments, the occlusion element 120 may cover at least 60% of the expandable framework 110 in a second configuration. In some embodiments, the occlusion element 120 may cover at least 70% of the expandable framework 110 in a second configuration. Other configurations are contemplated.

[0058] In the manufacturing method described herein, an expandable framework 110 with significantly reduced variations can be manufactured. For example, when bending the anchor member to individually form each hook shape (e.g., FIG. 3), the height tolerance can be + / - 0.005 inches, whereas when forming the hook shape by a cutting step, the height tolerance can be + / - 0.001 inches or less. In this example, the variation can be reduced by about 5 times, about 8 times, 10 times, etc. In another example, when bending the anchor member to individually form each hook shape (e.g., FIG. 3), the angle tolerance can be + / - 10 degrees, whereas when forming the hook shape in a cutting step, the angle tolerance can be + / - 1 degree or less. In this example, the variation can be reduced by about 8 times, about 10 times, about 12 times, about 14 times, etc. As a result, the generation of manufacturing scrap can be significantly reduced, thereby improving throughput and reducing the cost of the product. These are merely examples, and additional and / or other benefits are also contemplated and / or expected.

[0059] The materials that can be used for the various components of the medical implants, systems, and manufacturing methods disclosed herein may include those commonly associated with medical devices. For the purpose of simplification, in the following description, the system is referred to. However, this is not intended to limit the systems, devices, and / or methods described herein, and the considerations apply to other elements, members, components, or devices disclosed herein, such as an expandable framework, a plurality of struts, a plurality of anchor members, an occlusion element, etc., and / or elements or components thereof, but are not limited thereto.

[0060] In some embodiments, the system and / or its components may be made of metal, metal alloy, polymer (some examples of which are disclosed below), metal-polymer composite material, ceramic, combinations thereof, etc., or other suitable materials.

[0061] Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN®), polyether block ester, polyurethane (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., ARNITEL®), ether or ester copolymers (e.g., butylene / poly(alkylene ether) phthalate, and / or other polyester elastomers such as HYTREL®), polyamide (e.g., DURETHAN® or CRISTAMID™), elastomeric polyamide, block polyamide / ether, polyether block amide (PEBA, available under the trade name PEBAX®, for example), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), MARLEX® high density polyethylene, MARLEX® low density polyethylene, linear low density polyethylene (e.g., REXELL™), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyether imide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., GRILAMID®), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, polyurethane silicone copolymer (e.g., Elast-Eon™ or ChronoSil™), 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 blended with liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0062] Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloys such as linear elastic and / or superelastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS:N06625 such as INCONEL® 625, UNS:N06022 such as HASTELLOY® C-22®, UNS:N10276 such as HASTELLOY® C276™, and other HASTELLOY® alloys), nickel-copper alloys (e.g., UNS:N04400 such as MONEL® 400, NICKELVAC™ 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N™), nickel-molybdenum alloys (e.g., UNS:N10665 such as HASTELLOY® ALLOY B2™), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS:R30003 such as ELGILOY®, PHYNOX®); platinum-enriched stainless steel; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.

[0063] In some embodiments, part or all of the system and / or its components may be doped with a radiopaque material, made of a radiopaque material, or otherwise include a radiopaque material. A radiopaque material is understood to be a material that can generate a relatively bright image on a fluoroscopic screen or another imaging technique (such as ultrasound, etc.) during a medical procedure. This relatively bright image helps the user determine the position of the system. Some examples of radiopaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials filled with radiopaque fillers, etc. Additionally, other radiopaque marker bands and / or coils may be incorporated into the system design to achieve the same result.

[0064] 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 parts may be made of materials that do not substantially distort the image and do not create substantial artifacts (such as gaps within the image). For example, certain ferromagnetic materials may not be suitable as they can potentially create artifacts in the MRI image. The system or a part thereof may also be made of materials that can be imaged by an MRI device. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (such as UNS:R44003 like ELGILOY®, PHYNOX® etc.), nickel-cobalt-chromium-molybdenum alloys (such as UNS:R44035 like MP35-N™ etc.), nitinol, etc., and others.

[0065] In some embodiments, the system may include a textile material. Some examples of suitable textile materials can include synthetic yarns that can be flat, shaped, twisted, textured, pre-shrunk, or unshrunk. Suitable synthetic biocompatible yarns for use in the present invention include polyesters including polyethylene terephthalate (PET) polyester, polypropylene, polyethylene, polyurethane, polyolefin, polyvinyl, polymethylacetates, polyamide, naphthalene dicarboxylic acid derivatives, natural silk, and polytetrafluoroethylene, but are not limited thereto. Further, at least one of the synthetic yarns may be a metal yarn, a glass or ceramic yarn, or a fiber. Useful metal yarns include those made from or containing stainless steel, platinum, gold, titanium, tantalum, or Ni-Co-Cr alloys. The yarn may further include carbon fibers, glass fibers, or ceramic fibers. In some embodiments, the yarn may be made from a thermoplastic material including, but not limited to, polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, etc. The yarn may be of the multifilament type, monofilament type, or staple type. The type and denier of the yarn selected may be selected to form a biocompatible system.

[0066] In some embodiments, the systems and / or other elements disclosed herein may contain a suitable therapeutic agent and / or may be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents include antithrombotic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrorphanyl proline arginine chloromethyl ketone)); antiprotein agents and / or antibacterial agents (such as 2-methacryloyloxyethyl phosphorylcholine (MPC) and its polymers or copolymers); growth inhibitors (such as enoxaparin, angiotensin, monoclonal antibodies capable of blocking smooth muscle cell growth, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine); antitumor agents / anti-proliferative agents / anti-mitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilone, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (such as lidocaine, bupivacaine, and ropivacaine); anticoagulants (such as D-Phe-Pro-Arg chloromethyl ketone, RGD peptide-containing compounds, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, anti-platelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick anti-platelet peptides); vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional activators, and translation promoters); vascular cell growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional inhibitors, translation inhibitors, replication inhibitors, inhibitory antibodies, antibodies against 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 the endogenous vasomotor mechanism.

[0067] It should be understood that the present disclosure is merely illustrative in many respects. Without exceeding the scope of the present disclosure, details, particularly with regard to the shape, size, and configuration of the process, can be changed. This may include using any of the features of one exemplary embodiment in other embodiments within an appropriate scope. The scope of the present disclosure is, of course, defined by the language expressed in the appended claims.

Claims

1. A method for manufacturing a medical implant for occluding a left atrial appendage, comprising: cutting an expandable framework into a first configuration, wherein the expandable framework includes a plurality of struts having ends joined to each other at intersections and a plurality of anchor members extending from the plurality of struts, each anchor member extending from an intermediate portion of one of the plurality of struts, and cutting; forming the expandable framework into a second configuration, wherein forming the expandable framework into the second configuration includes bending each anchor member along its bending axis, the bending axis being oriented parallel to the longitudinal axis of each respective one of the plurality of struts, and forming; heat-setting the expandable framework in the second configuration.

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

3. The method according to claim 1 or 2, wherein each anchor 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 framework into the second configuration includes preventing the plurality of struts from twisting.

5. The method according to claim 4, wherein bending each anchor member includes preventing each respective strut from rotating about the longitudinal axis of each respective strut when bending the anchor member.

6. The method according to any one of claims 1 to 5, wherein the expandable framework is formed from a single tubular member.

7. Bending each anchor member includes: inserting a punch into the expandable framework; moving the punch radially outward with respect to the plurality of struts.

8. The method according to claim 7, wherein moving the punch radially outward with respect to the plurality of struts simultaneously bends two or more of the plurality of anchor members.

9. Bending each anchor member includes: inserting a die into the expandable framework; positioning each respective strut over a groove formed in the die; urging each respective strut into the groove using a punch.

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

11. The method according to claim 10, wherein bending each anchor member includes moving a punch through the expandable framework without moving the plurality of struts.

12. Bending each anchor member includes positioning each respective strut over a groove formed in a die, and urging each respective strut into the groove using a punch.

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

14. fixing a closure element to the expandable framework. The method according to any one of claims 1 to 13, further comprising.

15. A medical implant for occluding a left atrial appendage, comprising an expandable framework configured to transition from a radially contracted configuration to a radially expanded configuration, wherein the expandable framework includes a plurality of struts having ends joined to each other at intersections, and a plurality of anchor members extending from the plurality of struts, each anchor member extending from an intermediate portion of one of the plurality of struts. In the radially expanded configuration, each anchor member has a longitudinal axis of its respective one of the plurality of struts and a bending axis oriented parallel to each anchor member, and the plurality of anchor members extend radially outward from the plurality of struts.

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