Method of manufacturing an implantable medical device and implantable medical device and base for such implantable device

Abstract

A method for forming a braided tubular base for an implantable medical device is disclosed. The method includes providing a braiding head having a forming element and a plurality of spools. The method includes providing a plurality of first stage wires and forming a plurality of first stage vertices. The method includes providing a plurality of second stage wires and forming a plurality of second stage vertices. Each second stage vertex is located between two adjacent first stage vertices. The method also includes braiding such a tubular base for a medical implant, medical implants made from such a braided tubular base and corresponding methods of manufacture of medical implants based on such a braided tubular base.

Description

Technical Field

[0001] This invention relates to the manufacture of medical implants, and more particularly to the braiding of threads or strands and methods thereof, as well as a substrate made from such braids for forming medical implants, including, in particular, shunt devices, such as diaphragm shunts, wherein such implants are made of a braided web of strands. More specifically, this invention relates to a method for forming a braided tubular substrate for implantable medical devices. This invention relates to a method involving a braiding head with shaping elements and multiple spools during the braiding process. The invention also relates to a method for braiding a tubular substrate for medical implants from such a braided tubular substrate, and medical implants made from such a braided tubular substrate and corresponding manufacturing methods. Background Technology

[0002] Various braided medical devices are used to treat a wide range of patient conditions. In some cases, such devices may be necessary to close lumens, blood vessels, cavities, channels, orifices, or chambers. Braided devices can also be used for shunts. When delivering or implanting such devices into a patient, the braided device must be flexible enough to allow for safe delivery to the target site within the patient via a delivery device such as a catheter. Ease of delivery of medical devices is crucial, manifested in several ways, such as adhering to time constraints for rapid treatment or ensuring overall safe positioning or manipulation of the device at the target site.

[0003] Braided medical devices typically consist of one or more metal wires or bundles used to braid a substrate, which are then used to form the medical device, usually by heat setting. The ends of the metal wires or bundles are typically secured together to prevent the braid from unraveling, for example in fasteners, bundles, or fixation devices that typically extend from the medical device.

[0004] Some braiding machines can be configured and set to braid substrates with open and / or closed ends. Different braiding techniques and settings have been used to braid robust yet flexible substrates for medical devices.

[0005] For example, medical devices made of tubular braided fabric have been disclosed in patent documents such as US6,468,303B1 and WO99 / 12478A1, with fixation devices, such as clamps, at each opposite end of the device. However, fixation devices, particularly in the left heart, can increase the risk of blood clotting or other complications because, for example, the distal clamp protrudes from the device. This can be particularly problematic in the left heart, leading to a high risk of adverse complications such as stroke or cardiac tissue puncture caused by blood pins during device deployment. International patent application WO2005 / 020822A1 discloses an occlusion device, and international patent application WO2016 / 038115A1 discloses a shunt device, both of which disclose devices made of braided matrix. These medical devices have only one fixation device, such as a clamp, at the proximal end.

[0006] In another example, U.S. Patent Application Publication No. US9,877,726B2 discloses an occlusion device with a clamp at one end and a braided opening at the other, the opening being bound together with sutures to restrict the opening to form a closed, smooth surface. This device is an occlusion device for cutting off blood flow through the atrial septum. Even with a tiny opening at the distal end, the disclosure describes closing the opening by manually tightening the sutures, as the device's purpose is to cut off blood flow. Without the sutures securing the suture loops at the distal end of the occlusion device, the sutures at the opening would spread or even unravel. Therefore, the structure and manufacturing cost of the opening edge disclosed in U.S. Patent Application Publication No. US9,877,726B2 could be improved.

[0007] International patent application WO2012 / 110355A1 discloses a medical device having an expandable braided mesh composed of intersecting threads forming loops at at least one long end. The medical device is a tubular stent. The peripheral structure of the braid can be improved, at least in terms of structural integrity and stability.

[0008] U.S. patent application US2007 / 112380A1 discloses a self-expanding occlusion device for occluding the atrial appendage of a patient's heart, comprising a braid of fine threads or filaments given a suitable contour shape through molding and heat treatment processes. The medical device has a distal central opening at which the thread returns from a peripheral loop at a disc element. The aim is to minimize the channel size, as the device is an occlusion device. No thread apexes are arranged at the opening or its edges. The structure around the braid can be improved, at least in terms of structural integrity and stability.

[0009] US Patent No. 9,545,300B2 discloses a self-expanding implantable medical device formed from one or more non-interlocking filaments. The stent, stent graft, occlusion device, and filter are made of one or more filaments employing a non-interlocking cross pattern. The device may have a central opening for passing the device through a guidewire during delivery. However, the aim is to keep the channel as small as possible, as the device is an occlusion device. No wire vertices are arranged at the opening or its edges. The structure around the braid can be improved, at least in terms of structural integrity and stability.

[0010] European patent application EP3146915A1 discloses a left atrial appendage occluder and its manufacturing method. The manufacturing method includes weaving a thin, elongated mesh, followed by preheating, shaping, and final heat treatment to complete the fabrication of the occluder. The device does not have an opening or a straight passage. A mold with protruding elements is also disclosed to provide recessed elements in a medical device after heat setting.

[0011] Utility model patent CN203634215U discloses a plugging device with improved sealing, comprising at least one disc-shaped structure and a waist portion connected to the at least one disc-shaped structure. The device does not have an opening or a straight passage.

[0012] Therefore, there is a need to further improve the weaving of medical devices, the substrates for such devices, and the manufacturing methods for such substrates and / or devices. Summary of the Invention

[0013] Therefore, embodiments of the present invention preferably seek to mitigate, alleviate, or eliminate one or more defects, disadvantages, or problems in the art, such as those described above, by providing apparatus and methods according to the appended claims, alone or in any combination. The invention is defined only by the appended claims, and in particular by the scope of the appended independent claims. References to "embodiments" throughout the specification that are not within the scope of the appended claims are merely possible exemplary implementations and are therefore not part of the invention. This disclosure may include more than one invention. Specific technical effects and advantages of particular features or steps of this disclosure are mentioned below.

[0014] In one example, a method for forming a braided tubular matrix for an implantable medical device is disclosed. The method includes providing a braided head with shaping elements and a plurality of spools. The method includes providing a plurality of first-level filaments and forming a plurality of first-level vertices of the first-level filaments, for example, the vertices of these filaments being hooked in pairs, overlapping, onto corresponding shaping elements of the braided head. The method includes providing a plurality of second-level filaments and forming a plurality of second-level vertices. Thus, each second-level vertex is located between two adjacent shaping elements. When the first-level vertices are formed in pairs, the second-level vertices are located “between” these first-level vertices of the first-level filaments on the corresponding adjacent shaping elements. The term “between” does not include being directly between, such as located on a straight line between adjacent shaping elements, or located exactly in the middle between shaping elements, but includes offset, such as toward a central axis or one or the other of two adjacent shaping elements. See also Figure 2 Examples are given in the text. Preferably, the method includes hooking such a second-level wire onto two adjacent forming elements, such that the second-level vertices of such wire are respectively arranged between the forming elements. The invention also includes medical implants manufactured from such braided tubular substrates, and medical implants made from such braided tubular substrates, preferably manufactured by the aforementioned manufacturing method.

[0015] In one aspect of this disclosure, a method for forming a braided tubular matrix for medical implants is provided. The method includes providing a plurality of shaping elements at one end of a braiding head, as exemplified. The braiding head typically has a central axis (CA). The shaping elements are arranged in a first arrangement around said central axis. This structure is a configuration of the shaping elements with the central axis located at its center. The shaping elements are arranged on a top portion of the braiding head. Preferably, this structure is circular. In the example, the structure may be non-circular, such as elliptical. The shaping elements are preferably arranged on a dome (also called an inverted cup or cup-shaped) portion that causes the cylindrical braiding head to narrow towards the end of the braiding head in the top region of the braiding head. The shaping elements are preferably arranged at a distance from the cylindrical wall of the dome towards the central axis of the braiding head in the top region of the dome. The method includes providing multiple pairs of first-level wires, as exemplified. Multiple sets of first-level apexes are formed by hooking each pair of first-level wires onto the first and second shaping elements. Furthermore, multiple pairs of second-level wires are also provided. By hooking each pair of second-level wires onto the first and second forming elements, multiple sets of second-level vertices are formed, each second-level vertex located between adjacent first-level vertices, thus "enclosing" the first-level vertices. The term "enclosing" as used herein means "partially surrounding," "partially surrounding," or "partially overlapping," for example, as... Figure 2As shown. In particular, the return loop of the wire with a vertex can “encircle” other return loops at its vertex. Therefore, the term “encircle” does not mean completely wrapping, covering, or surrounding. Preferably, each of all forming elements is used to hook onto multiple pairs of first-level wires. Preferably, each of all forming elements is used to hook onto second-level wires, and each second-level wire hooks a pair (two) of forming elements, while adjacent second-level wires hook overlapping pairs of forming elements next to the first forming element in the first pair of forming elements. An example of forming elements arranged in a sequentially numbered arrangement starting from “one” (e.g., a loop structure) is that the first second-level wire hooks forming elements “one” and “two”, the next element hooks forming elements “two” and “three”, the next element hooks forming elements “three” and “four”, and so on, until the circumference around the braid head is completed. Subsequently, the first and second-level wires are braided onto the aforementioned tubular base. In this way, the tubular substrate forms a favorable perimeter for the opening at the distal end of the substrate, which is defined by the apexes of the first and second stage wires, as described in further detail below.

[0016] The arrangement of threads with first and second level vertices improves the durability of the resulting tubular braid, particularly regarding the stability and robustness of the braid's opening circumference. Wear or unraveling is effectively prevented without the need for fixing devices (because the distal end of the tubular braid does not have the ends of the threads, but rather the vertices of the aforementioned interlaced threads). The arrangement of the vertices of the aforementioned thread return loops provides a self-fixing circumference for the opening. Therefore, this braid can improve patient safety in medical devices manufactured from such a braid, which has multiple pairs of threads interlaced with the first vertices and at least partially overlapping second level vertices.

[0017] The tubular matrix manufactured according to the method of the present invention, and medical devices made from such a matrix having the structural features disclosed herein, also possess flexibility, which facilitates the operation of the tubular matrix. This flexibility also increases the service life of medical devices based on this flexible structure, particularly in applications where the device is in constant motion, such as in a beating heart. The tubular matrix is ​​easily formed into a medical device. As described above, when braiding the tubular matrix, the loose thread ends are located on the same side. When forming the medical device, all free thread ends are on one side, and the medical device can be formed with only one closing element at one end for securing any loose thread ends of the braid and preventing the braid from abrading and / or unraveling. In this case, patient safety can be improved by limiting the number of protruding elements in the medical device. This can reduce the risk of blood clotting associated with implantable medical devices formed from braided matrix. At the same time, by arranging the thread apexes around the periphery, advantageous edges for the opening can be formed, thereby preventing excessive growth / endothelialization of the opening.

[0018] This is particularly beneficial when placing medical devices on the septal wall or atrial septum. The formation of the envelope apex can provide rigidity and flexibility to the tubular matrix, thereby enabling the formation of a variety of medical devices, such as occlusion devices or shunt devices.

[0019] By using multiple wires or bundles to form a set of vertices, an opening can be formed by a braiding device. This opening can remain open on its own and facilitates the fabrication of diverting or blocking devices.

[0020] In some examples, the method includes providing a braiding machine with multiple spools. The spools can be arranged in a second and a third concentric arrangement (loading condition) outward from the central axis of the braiding head. During operation of the braiding machine, the spools move between the concentric arrangements in a known "five-spindle dance pattern". A first-level vertex group can be formed by a first-level thread and a second-level thread. The ends of the first-level thread can be led from the first vertex to the first spools of the second and third arrangements, respectively. The first spools of the second and third arrangements can be concentrically aligned. The ends of the second-level thread can be led from the vertex to the second spools of the second and third arrangements, respectively. The second spools of the second and third arrangements can be concentrically aligned. The second spools of the second arrangement can be adjacent to the first spools of the second arrangement. The second spools of the third arrangement can be adjacent to the first spools of the third arrangement.

[0021] In some examples, each pair of first and second spools may be adjacent to third and fourth spools that are not connected to any first-level wires.

[0022] In some examples, the set of second-level vertices can be formed by first-level and second-level wires. One end of the first or second-level wire can lead to a third spool in a second arrangement. The third spool can be adjacent to the second spool in the second arrangement. The other end of the first or second-level wire can lead to a fourth spool in a third arrangement. One end of the second-level wire can lead to a third spool in a third arrangement. The third spool in the third arrangement can be adjacent to the second spool in the third arrangement. The other end of the second-level wire can lead to a fourth spool in a second arrangement. The fourth spool can be adjacent to the first spool of another set of first-level vertices. This construction can improve the flexibility of the braided tubular matrix.

[0023] In some examples, spools can be provided at a 1:4 ratio of forming elements to spools. This setup on the braiding machine facilitates the setting of the yarn. This setup can improve the flexibility and durability of the braided tubular matrix. In some examples, spools can be provided at a 1:8 ratio of forming elements to spools.

[0024] In some examples, forty spools may be provided in the second arrangement. Forty spools may be provided in the third arrangement. The spools in the second and third arrangements may be arranged consecutively. In some examples, the step of providing multiple forming elements may include providing ten forming elements.

[0025] Different numbers of molding elements and spools may be advantageous for providing braided tubular substrates of various sizes.

[0026] In another aspect, a method is provided for forming an implantable medical device from a braided tubular matrix. The method includes forming a tubular matrix according to any of the examples described above. The method further includes heat-treating the tubular matrix to form the implantable medical device from the braided tubular matrix.

[0027] In another aspect, a method for forming an implantable medical device is provided. The method includes braiding a tubular substrate, preferably according to any of the examples described above. The tubular substrate includes multiple sets of first-level vertices. The substrate includes multiple sets of second-level vertices, each second-level vertices located between adjacent first-level vertices. The method further includes providing a mold structure. The method includes inserting the tubular braid into the mold structure. The method includes inserting pins into the tubular braid in the mold structure to form a channel through the implantable medical device. The method further includes heat-setting the mold structure to form the implantable medical device.

[0028] In some examples, the pin can be inserted into the center of the mold. The pin can have a tapered tip, providing a simpler, more time-saving, and less costly manufacturing method.

[0029] In some examples, the method may include securing at least a portion of the ends of the wires together.

[0030] In some examples, the method may include securing the wire at a distance off the central axis of the implantable medical device.

[0031] On the other hand, a tubular substrate for medical implants is provided, preferably a shunt or occlusion device. The substrate has multiple first-stage wires and multiple second-stage wires. The substrate includes multiple sets of first-stage vertices. The substrate also includes multiple sets of second-stage vertices, each set of second-stage vertices located between adjacent first-stage vertices.

[0032] On the other hand, an implantable medical device is provided, preferably made of the tubular substrate described above. The implantable medical device includes a plurality of first-level wires and a plurality of second-level wires. The implantable medical device includes multiple sets of first-level vertices. The implantable medical device also includes multiple sets of second-level vertices, each set of second-level vertices located between two adjacent first-level vertices.

[0033] In some examples, the implantable medical device may include a channel passing through the implantable medical device. In such examples, the channel includes an opening with an edge having a return loop of wire arranged with first-level vertices and second-level vertices. The channel has a second opposing opening, which is preferably formed in a mold using a pin-heat-formed tubular braid as described herein.

[0034] Therefore, the aforementioned opening can be advantageously located at the end of the substrate without any element extending beyond the end. Thus, the medical device can provide an advantageous opening at its end without protruding elements (e.g., wire harnesses, fixation devices, etc.). Such an opening provided by the substrate manufactured by the method described herein advantageously provides a long-term opening at the end (or through the channel of the medical device) of the medical device formed from the substrate (preferably by using a mold and thermosetting process). Therefore, during implantation, the opening advantageously does not extend beyond the opening or cause endothelialization of the opening. Furthermore, the substrate thus formed provides robust guidance at the edge of its end opening for molding elements (e.g., pins) inserted into the braid of the substrate, for example, when inserted into a mold to form the medical device. Therefore, the resulting tubular braided substrate is advantageous for the safe and reliable manufacture of implantable medical devices (e.g., shunt devices or occluders / blockers) with openings at their ends and preferably with straight channels. Brief description of the attached figures

[0035] From the following description of embodiments of the present invention, these and other aspects, features, and advantages that can be achieved by the embodiments of the present invention will be clearly illustrated in conjunction with the accompanying drawings, wherein:

[0036] Figure 1 This is a schematic top view of a braiding machine, which includes a braiding head with multiple forming elements, multiple spools, and multiple strands hooked onto the forming elements and whose ends are connected to the spools.

[0037] Figure 1A This is a side view of an example of a braiding head 102, which has a cylindrical body portion, a dome (cup-shaped) top portion, and a plurality of forming elements 100;

[0038] Figure 1B This is an elevation view showing the top detail of the braided head 102;

[0039] Figure 2 This is a schematic top view of a braiding machine, which includes a braiding head with multiple forming elements, multiple spools, and multiple strands hooked onto the forming elements and whose ends are connected to the spools.

[0040] Figure 3A This is a schematic side view of a braided tubular matrix having a proximal end and a distal end, wherein the ends of the wires are located at the proximal end and the ends of the wires are fixed together.

[0041] Figure 3B This is a schematic diagram of the distal end of an example tubular matrix, with an elliptical opening at the end;

[0042] Figure 3C and 3D These are schematic side views of an example of a tubular matrix with an opening having a diameter smaller than that of the braided tubular matrix;

[0043] Figure 3E This is an elevation view of an example of a braided tubular substrate manufactured according to the method disclosed herein;

[0044] Figure 4A This is a schematic side view of the mold structure used to form medical devices;

[0045] Figure 4B This is a schematic side view of a braided tubular substrate partially inserted into a mold structure;

[0046] Figure 4C This is a schematic diagram of a pin inserted into a mold structure to form a channel through a medical device;

[0047] Figure 4D It is a schematic top view of a braided tubular substrate inserted into a mold structure, wherein the ends of the braided substrate extend on the top side;

[0048] Figure 4E It is a schematic top view of the mold structure, which has a braided tubular base and pins passing through the mold structure to form a central channel through the medical device. The ends of the wires extend from the mold structure and are offset from the central channel by a certain distance.

[0049] Figure 5 , Figure 6A and Figure 6B This is a flowchart illustrating some examples of methods of this disclosure;

[0050] Figure 7A and Figure 7B This is a schematic diagram of an example of an implantable medical device 400, in which the through-channel is made of a braided tubular substrate 300. Detailed Implementation

[0051] Specific embodiments of the present disclosure will now be described with reference to the accompanying drawings. However, the invention can be embodied in many different forms and should not be construed as limited to the embodiments described herein; rather, these embodiments are provided to make the disclosure thorough and complete, and to fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments shown in the drawings is not intended to limit the invention. In the drawings, the same reference numerals denote the same elements.

[0052] The following description focuses on embodiments of the present invention applicable to methods and apparatus for forming implantable medical devices, particularly methods for weaving tubular substrates and tubular substrates for forming implantable medical devices.

[0053] Many implantable medical devices are made from braided substrates. The braided substrate of this invention is woven using a commonly used 3D braiding machine, which includes a braiding head with shaping elements and spools. The shaping elements are typically arranged around the central portion of the braiding head. The spools are arranged sequentially in different planes extending outward from the center of the braiding head and outward from the shaping elements.

[0054] These common knitting machines can form open or closed knitting substrates, depending on the intended use of the substrate.

[0055] When the braiding machine has been set with yarn according to the present disclosure, the machine moves the bobbin around the axis of the braiding head in a certain pattern to braid the connected yarn or thread into a braided fabric.

[0056] Figure 1A and 1B An example of a braided head 102 without any wire or strands is shown.

[0057] Now go to Figure 1 , Figure 1 The yarn arrangement on the braided head 102 is shown. This example illustrates... Figure 1A and 1B A schematic top view of the braided head 102 shown.

[0058] The braiding head 102 may have a circular cross-section, as shown in the exemplary figure, and in this embodiment, a central axis CA is located at the center of the braiding head 102. In other embodiments (not shown), the braiding head may have a non-circular cross-sectional shape, i.e., a cylindrical base, resulting in a circular cross-section for the corresponding braiding performed on the braiding head. The braiding head 102 has a longitudinal extension along the central axis CA. At the top of the braiding head 102, a plurality of forming elements 100 are arranged outward from the central axis. The forming elements are arranged outward from the central axis CA in a first arrangement. The first arrangement may have a circular, elliptical, or any shape suitable for forming the desired medical device. The forming elements are arranged within the periphery of the braiding head 102. Each forming element 100 may be arranged at the same distance from the central axis CA. However, changing the distance of at least one forming element 100 can change the end of the braided tubular substrate. This may be advantageous for facilitating the manufacture of implantable medical devices of different sizes. It may be advantageous for facilitating the manufacture of different types of implantable medical devices.

[0059] In some examples, the braiding head 102 includes ten forming elements 100, such as Figure 1A , Figure 1 and Figure 2 As shown. However, this is merely an example of a specific number of molded elements 100. For example, Figure 1B The braiding head shown has more forming elements 100.

[0060] Outward, in a second plane below the top of the braiding head 102, a second arrangement 202 comprising multiple bobbins is shown. This second plane is in the longitudinal direction of the braiding head 102. Outward from the second arrangement of bobbins 202, a third arrangement 204 comprising multiple bobbins is shown. The bobbins of the second arrangement 202 and the third arrangement 204 can be arranged continuously outward from the central axis CA. The bobbins of the second and third arrangements are preferably arranged outside the periphery of the braiding head. When circulating around the central axis, the bobbins of the first and second arrangements can move relative to each other in a wavy pattern, as is known, for example, in the five-joint column braiding technique. The braid is then formed downward from the top of the braiding head. Other support elements of the braiding machine may be present (not shown), such as retaining rings movable along the braiding head, to assist in the downward formation of the braid along the braiding head when the bobbins are in braiding motion.

[0061] The innovative setup of the braiding machine described herein includes connecting and arranging the yarns used for braiding the fabric onto the braiding machine. In the illustrated embodiment, a setup is shown for a plurality of first-stage yarns 104 for forming the first stage of the braid in a tubular matrix.

[0062] Each forming element 100 has two first-level wires 104 hooked around it. Each first-level wire 104 hooks around the forming element 100, forming a apex at the corresponding forming element 100. Each forming element 100 (in Figure 1 and 2 In the example (numbered 1 to 10), two first-level vertices are provided for the setup. When setting up the first-level wire, the wire is connected to the first spool, hooked or wrapped around the forming element 100, and led out to the second spool and connected there.

[0063] For example, wire 104 is hooked onto the molding element 100, which is labeled with reference numeral 1. The wire is wrapped around the molding element, which is labeled with reference numeral 1. Its two ends are respectively fixed to a first spool and a second spool (e.g., ...). Figure 1 or Figure 2 (As shown by reference numeral 1 near the central axis). This forms the first-level apex of the particular wire. The second wire 104 is hooked onto the same forming element 100, which is also marked with reference numeral 1. This second wire also wraps around the forming element, which is also marked with reference numeral 1. Its two ends are respectively fixed to the third and fourth spools (as shown in the attached figure). Figure 2(As shown by reference numeral 2 near the central axis in the attached figure). This forms the first-level vertex of this particular second-level wire around the same forming element. When the wire is properly tensioned in the spool, the vertex is at the forming element (here, the... Figure 2 The molding elements overlap at point 1).

[0064] This process is repeated on each forming element 100 (two wires are wrapped around the forming element). Thus, the first and second first-level wires 104 form a set of first-level vertices. Similarly, the first and second first-level wires 104 can form a set of first-level wires. Therefore, the braiding machine is configured to provide multiple sets of first-level wires 104 and to form multiple sets of first-level vertices using the first-level wires 104.

[0065] The spools in the second and third arrangements 202, 204 can be arranged into groups 206. Each group includes at least one spool from the second arrangement 202 and at least one spool from the third arrangement 204. The first spool 202a of the second arrangement 202 and the first spool 204a of the third arrangement 204 can form a pair of spools 222. Each group 206 may include at least one pair of spools 222. Each group 206 may include two pairs of spools 222. Preferably, each group 206 includes four pairs of spools 222. For example, the group includes first and second spools (first wire), third and fourth spools (second wire), etc., but the wires are not yet connected. These remaining spools will be attached to the ends of other wires, such as... Figure 2 An example is shown and described below.

[0066] In a schematic top view of the braiding machine, each group 206 includes four spools in a second arrangement 202 and four spools in a third arrangement 204.

[0067] Each group includes a first spool 202a from the second arrangement 202. The group includes a second spool 202b from the second arrangement 202. The group includes a third spool 202c from the second arrangement 202. The group includes a fourth spool 202d from the second arrangement 202.

[0068] The group also includes a first spool 204a from the third arrangement 204. The group includes a second spool 204b from the third arrangement 204. The group includes a third spool 204c from the third arrangement 204. The group includes a fourth spool 204d from the third arrangement 204.

[0069] As previously described, in the embodiment shown in this invention, the first end of the first first-level wire 104 is connected to the first spool 202a of the second arrangement 202, and then the first first-level wire 104 is wound around the forming element 100. The second end of the first first-level wire 104 is led out from the forming element to the first spool 204a of the third arrangement 204 and connected thereto, thereby forming the first vertex in a set of first-level vertices.

[0070] The second first-level wire 104 forms the second vertex. The first end of the second first-level wire 104 is connected to the second spool 202b of the second arrangement 202. Then, the second-level wire, together with the first first-level wire 104, is hooked onto the same forming element 100. The second end of the second first-level wire extends to the second spool 204b of the third arrangement 204, thereby forming the second first-level vertex. The first and second vertices overlap each other around the forming element 100.

[0071] The first and second spools 202a and 202b of the second arrangement 202 are adjacent to each other. The first and second spools 204a and 204b of the third arrangement 204 are adjacent to each other.

[0072] The third spools 202c, 204c and the fourth spools 202d, 204d of the second arrangement 202 and the third arrangement 204 are preferably not connected to any primary wire 104. The third spools 202c, 204c and the fourth spools 202d, 204d of the second arrangement 202 and the third arrangement 204 are adjacent to the first spools 202a, 204a and the second spools 202b, 204b of the second arrangement 202 and the third arrangement 204.

[0073] A second set of first-level vertices is formed by hooking a pair of first-level wires 104 onto another forming element 100. The ends of the first-level wires 104 of the second set of first-level vertices are led out to the spools of the second set 222.

[0074] The second group of first-level vertices has first spools arranged in the second and third rows, which are adjacent to the fourth spools arranged in the second and third rows of the first group. This leaves two pairs of 222 spools unused between each group of first-level wires 104 in the arrangement of the first-level wires 104.

[0075] Now go to Figure 2 The diagram shows a schematic top view of an exemplary braiding machine in a configuration for forming a braided tubular matrix, which includes a plurality of first-level vertices and a plurality of second-level vertices. Each second-level vertices is formed by second-level wire 106.

[0076] Each second-level vertex is formed by connecting the first end of the first second-level wire 106 to the third spool 202c of the second arrangement 202. The first second-level wire 106 is wound around and hooked onto two adjacent forming elements 100. The second end of the first second-level wire 106 is led out to the fourth spool 204d of the third arrangement 204. Thus, the first second-level vertex is formed. The first and second second-level wires 106 are preferably hooked onto the same two forming elements 100.

[0077] The fourth spool 204d is preferably the fourth spool 204d in a spool group 206 that is different from the third spool 202c connected to the first end of the first and second level wires 106.

[0078] The second-level vertex can be formed by hooking the second-level wire around at least two forming elements 100. In some examples, the second-level vertex can be formed by hooking the second-level wire around three or four forming elements 100. The two forming elements are always the outer forming elements of a set of at least two adjacent (or consecutively arranged) forming elements, used to hook onto the return loop of the corresponding second-level wire.

[0079] Each secondary vertex is located between two adjacent sets of primary vertices. When forming secondary vertices, they are positioned "above" and at least partially overlap two sets of primary vertices. In some examples, secondary vertices may wrap around two adjacent sets of primary vertices. This can provide rigidity to the tubular matrix to hold open ends and maintain the matrix's flexibility to form a medical device.

[0080] For example, in a non-limiting example, the first and second-level wires 106 are wound around the forming elements 100 shown in the example, which are labeled with reference numerals 1 and 2. Therefore, the apexes of the first and second-level wires 106 are located between adjacent forming elements 100 labeled with reference numerals 1 and 2. The first end of the first and second-level wires 106 is fixed to a spool 204 labeled with reference numeral 3A. The second end of the first and second-level wires 106 is fixed to a spool 202 labeled with reference numeral 8A. The second and second-level wires 106 are wound around the forming elements 100 shown in the example, which are labeled with reference numerals 1 and 2. Therefore, the apexes of the first and second-level wires 106 are also located between adjacent forming elements 100 labeled with reference numerals 1 and 2. The first end of the second and second-level wires 106 is fixed to a spool 202 labeled with reference numeral 3B. The second end of the first and second-level wires 106 is fixed to a spool 204 labeled with reference numeral 8B.

[0081] like Figure 2 As shown, this step is repeated for the second-level wire 106, for example, around the forming elements 2 and 3 (the apex is located between 2 and 3) and the spools 7A, 12A and 7B, 12B respectively, and so on, until all spools are loaded with wire.

[0082] The second-level wire 106 is connected to the third spool 204c of the third arrangement 204. The second-level wire 106 is hooked onto the same forming element 100 as the first-level wire 106. The second end of the second-level wire extends to the fourth spool 204d of the third arrangement 204. The fourth spool 202d is preferably the fourth spool 202d in a different spool group 206 than the third spool 204c to which the first end of the second-level wire 106 is connected. The different spool groups 206 used to form the second-level vertex group can be adjacent groups 206 to each other.

[0083] The first and second level wires can form a first set of second level vertices. A second set of second level vertices is formed by hooking another pair of second level wires 106 around two other forming elements 100. Preferably, a set of second level wires 106 is hooked around every two adjacent forming elements 100. This means that the first set of second level vertices is formed around the first and second forming elements 100. The second set of second level vertices can be hooked around the third and fourth forming elements. Therefore, a third set of second level vertices can be formed around the second and third forming elements 100. Thus, the third set of second level vertices can at least partially overlap with the first and second sets of second level wires.

[0084] Each group of second-level vertices can be located between two adjacent groups of second-level vertices.

[0085] In the arrangement shown, the first-level vertices at least partially overlap with the second-level vertices (enveloping them as defined herein).

[0086] Preferably, each of all forming elements is used to hook onto a first-level wire pair. Preferably, each of all forming elements is used to hook onto a second-level wire, with each second-level wire hooked onto a pair of forming elements, and adjacent second-level wires hooked onto an overlapping pair of forming elements next to the first forming element in the first pair. An example of forming elements numbered sequentially from "one" (e.g., in a circular structure) is that the first second-level wire hooks onto forming elements "one" and "two", the next element hooks onto forming elements "two" and "three", the next element hooks onto "three" and "four", and so on, until a circle around the braided head is completed.

[0087] Therefore, each set of second-level vertices can be located between two adjacent sets of first-level vertices. The weaving process can then begin until a tubular matrix is ​​formed through weaving. This means that after connecting the first-level thread 104 and the second-level thread 106 to the braiding machine, the machine can weave the tubular matrix. During the weaving process, the first-level thread 104 can form a first-level mesh structure of the tubular braid. The second-level thread 106 can form a second-level mesh structure of the same tubular braid. The tubular matrix (e.g., woven into a tubular braid) can have openings. The openings can have the shape of the arrangement of the forming elements 100. Therefore, the opening can be located at one end of the matrix, in this example, the distal end of the matrix. The opening can then be part of a through-channel 410 of the medical device 400, as described below.

[0088] Advantageously, the braided material at one end of the braided tubular matrix forms a stable and robust edge for the opening.

[0089] Therefore, in some embodiments, the opening can be located at one end of the substrate without any element extending beyond the end, while the braid prevents abrasion or unraveling. Thus, a medical device with an opening at one end can be formed from the substrate without protruding elements (such as wire harnesses, fixation devices, etc.). This opening provided by the substrate manufactured as described herein provides a permanent opening at one end (or through the channel of the medical device) formed from the substrate (preferably using a mold and thermosetting process). Therefore, it is advantageous that, during implantation, the opening does not extend beyond the opening or cause endothelialization of the opening. Furthermore, the substrate thus formed provides a robust guide at the edge of the opening at its end for the molding elements (e.g., pins) inserted into the braid of the substrate when inserted into a mold to form the medical device. Therefore, the resulting tubular braided substrate facilitates the safe and reliable manufacture of implantable medical devices (e.g., shunt devices or occluders / blockers).

[0090] In short, such as Figure 5As shown, in some embodiments, method 5 is provided for forming a braided tubular substrate, preferably with an opening at its end. The substrate is suitable for shaping a medical implant. An example of method 5 includes step 510 of providing a plurality of shaping elements 100 at one end of a braiding head 102. The shaping elements 102 are arranged in a first arrangement on top of the braiding head 102. When the braiding head has a central axis CA, the shaping elements are arranged in the first arrangement around the central axis CA. Furthermore, method 5 includes step 520 of providing a plurality of pairs of first-level wires 104. Method 5 includes step 530 of forming a plurality of sets of first-level vertices by hooking each pair of first-level wires 104 onto the first and second shaping elements. Method 5 includes step 540 of providing a plurality of pairs of second-level wires 106. Method 5 includes step 550 of forming a plurality of sets of second-level vertices by hooking each pair of second-level wires 106 onto the first and second shaping elements 100 surrounding the first-level vertices, each set of second-level vertices being located between adjacent first-level vertices. Method 5 includes step 560, in which first-stage wire 104 and second-stage wire 106 are then braided onto braiding head 102, starting from the forming element 100 at the top of the tubular substrate.

[0091] This arrangement is a configuration of forming elements with the CA (Cyclic Aperture) at its center. The forming elements are arranged on the top portion of the braiding head. Preferably, the arrangement is circular. In examples, the arrangement can be non-circular, such as elliptical. The forming elements are preferably arranged on a dome (also called an inverted cup or cup-shaped) portion, which causes the cylindrical braiding head to narrow towards the end of the braiding head in the top region of the braiding head. The forming elements are preferably arranged at a distance from the cylindrical wall of the CA of the braiding head in the top region of the dome.

[0092] In some preferred embodiments, method 5 includes the further step of providing a plurality of spools 202, 204 arranged outward from the central axis CA of the braiding head 102 in a second and third concentric arrangement, and forming a set of first-level vertices by first and second-level yarns, the ends of the first-level yarns extending from the first vertices to the second and third arranged first spools, respectively, wherein the second and third arranged first spools are concentrically arranged, the ends of the second-level yarns extending from the vertices to the second and third arranged second spools, respectively, the second and third arranged second spools being concentrically arranged, the second arranged second spools being adjacent to the second arranged first spools, and the third arranged second spools being adjacent to the third arranged first spools. Preferably, each pair of first and second spools is adjacent to a pair of third and fourth spools, and no first-level yarn is connected to them.

[0093] In some preferred embodiments, method 5 may additionally or alternatively include the step of forming a set of second-level vertices, the set of second-level vertices being formed by a first second-level wire and a second second-level wire, wherein one end of the first second-level wire leads to a third spool of a second arrangement adjacent to a second spool of the second arrangement, and the other end leads to a fourth spool of the third arrangement. One end of the second-level wire of the second vertex leads to a third spool of a third arrangement adjacent to a second spool of the third arrangement, and the other end leads to a fourth spool of the second arrangement, wherein the fourth spool is adjacent to a first spool of another set of first-level vertices.

[0094] In some preferred embodiments, method 5 additionally or alternatively includes the step of providing a plurality of spools, which includes providing the forming element 100 in a ratio of 1:4 to the spools 202, 204.

[0095] In some preferred embodiments, method 5 additionally or alternatively includes the step of providing a plurality of spools 202, 204, including providing forty spools 202 in a second arrangement and forty spools 204 in a third arrangement.

[0096] In some preferred embodiments, method 5 additionally or alternatively includes the step of providing a plurality of molding elements 100, which includes providing ten molding elements 100.

[0097] Figure 3A A schematic diagram of a braided tubular matrix is ​​shown. Figure 3E Another example is shown. The braided tubular matrix 300 has a distal portion 304 and a proximal portion 306. The braided tubular matrix 300 can be cylindrical. The cylinder can be circular (in the cross-section of the tubular body). Therefore, the braided tubular matrix 300 can have a hollow mesh structure.

[0098] In some embodiments, the tubular base 300 has a cross-sectional diameter D1 at its bottom, and the tubular body is preferably cylindrical, which is generally determined by the shape of the braided head 102. The opening 308 at the end of the tubular base 300 may have an opening diameter D2. In preferred embodiments, the cross-sectional diameter D1 of the tubular base 300 is generally wider than the opening diameter D2. In some embodiments, D2 may be the same as D1 (straight tube shape). In some embodiments, D2 may even be larger than D1 (funnel shape).

[0099] The braided tubular substrate 300 includes an opening 308 at its distal end 304. The opening has edges with a defined shape. In some embodiments, the edge shape of the opening may be rounded. In some embodiments, it may be elliptical.

[0100] At the proximal end 306 of the braided tubular base 300, the free ends of the braided yarns extend freely. These ends may be gathered in one or more fasteners 302. The fasteners may be removable or permanent. Typically, the fasteners are, for example, yarns removably wrapped around the unbraided bundle before heat setting. They can be removed after heat setting when the risk of unraveling is reduced. The fasteners prevent the ends of the braided tubular base 300 opposite the openings from unraveling or abrading.

[0101] Another type of fixation device can be a clamp, weld, bolt, or any other suitable fixation device for securing the free ends of the wire together. Permanent fixation devices are typically applied after the braided tubular substrate 300 has been heat-set onto the medical device, as described below. In some examples, the ends of the wires may be braided inward into the hollow of the braided tubular substrate to prevent the free ends from protruding from the substrate. Fixation device 302 may preferably be configured to mate with a delivery device. In some examples, the fixation device may be magnetically connected to the delivery device. In some examples, the fixation device includes a retainer on which the delivery device can fasten the medical device.

[0102] Figures 3b-3d show schematic diagrams of some examples of openings 308 that may be formed at the distal end 304 of the braided tubular substrate 300.

[0103] The shape of the opening typically depends on the arrangement of the forming elements 100 in the braiding machine. Therefore, by changing the arrangement of the forming elements 100, the opening edge can have various forms and shapes. In the case where the forming elements 100 are arranged in an elliptical shape, the opening 308 of the braid will be elliptical. Similarly, the size of the opening 308 depends on the arrangement of the forming elements 100 and their position relative to the central axis CA of the braiding head 102.

[0104] The braiding head 102 can have a circular shape, forming a dome (inverted cup) shape at the distal end of the tubular substrate when the forming element 100 is arranged within the circular portion. Therefore, the opening can have a smaller diameter than the cross-section of the braided tubular substrate 300. This arrangement is an arrangement of forming elements with CA located at its center. The forming element is arranged on top of the braiding head. Preferably, this arrangement is a circular structure. In the example, the arrangement can be non-circular, such as elliptical. The forming element is preferably arranged on the dome (also called an inverted cup or cup-shaped) portion, which causes the cylindrical braiding head to narrow towards the end of the braiding head in the top region of the braiding head. The forming element is preferably arranged at a distance from the cylindrical wall of CA of the braiding head in the top region of the dome.

[0105] Figure 3BThe embodiment shown has an opening diameter D2, which is almost the same as the cross-sectional diameter D1 of the braided tubular matrix. This configuration may be suitable for manufacturing, for example, occlusion devices or shunt devices, where the braid is inverted. This means that the opening of the braid can be folded outward when inserted into a mold to form a medical device.

[0106] Figure 3C The illustrated embodiment has an opening diameter D2 smaller than the cross-sectional diameter D1 of the braided tubular substrate. This configuration can be advantageous when manufacturing medical devices including straight-through channels. The opening can serve as a guide for any channel-forming device (e.g., a pin described below) passing through the medical device. The braided tubular substrate 300 can be readily inserted into the die structure 208 such that the distal portion 304 can be folded inward to form a double-layered braided mesh. Thus, the edge of the opening 308 at the distal end 304 is positioned at the center of the distal double-layered element after heat setting. The medical device thus formed has robust edge openings and a double-layered element, such as a typically disc-shaped element, with advantageously improved mechanical stability and peripheral properties as described herein. Loops of the braided thread return at the edge of the opening with their apexes.

[0107] Figure 3D The embodiment shown has an opening diameter D2, which is very narrow compared to the cross-sectional diameter D1 of the braided tubular matrix. Such a small opening may be advantageous for creating an occlusion device with a substantially smooth surface. The braid can be configured to have an opening so narrow that it does not compromise the occlusion capability of the final medical device.

[0108] Now go to Figure 4A , Figure 4A A schematic cross-sectional view of mold structure 208 is shown. It should be noted that this is merely an example of a mold structure, and mold structures used for manufacturing medical devices from braided substrates may have features different from those shown in the figure.

[0109] To form a medical device, a braided tubular substrate 300 is inserted into a mold structure 208.

[0110] A braided tubular substrate 300 can be inserted into the mold structure 208, allowing the distal portion 304 to be folded inward to form a double-layered braided mesh. Thus, the edge of the opening 308 at the distal end 304 is positioned at the center of the distal double-layered element after heat setting. The resulting medical device has robust edge openings and a double-layered element, such as a typically disc-shaped element, with advantageously improved mechanical stability and peripheral properties as described herein. Loops of the braid return to the edge of the opening at their apex.

[0111] In another example, the distal portion 304 can be folded outward when inserted into the mold structure 108. When the distal portion is folded outward from the central channel, an inverted braided structure can be formed. Thus, in some examples, an implantable medical device with an inverted braid can be formed.

[0112] Figure 4B The diagram shows a tubular braided substrate 300 inserted into a mold structure 208. All ends of the wires extend to one side of the mold structure 208. This is a stage prior to the addition of a portion of the mold structure that forces / determines the position of the device's retaining element 302 relative to the device's central axis after heat setting. The mold structure 208 may include portions that allow the retaining element 320 to be located off-center from the medical device's central axis. The mold structure 208 may also include portions that allow the retaining element 320 to be located along the medical device's central axis.

[0113] like Figure 4C As shown, the mold structure 208 may include a pin 210. The pin 210 can be inserted into the mold structure 208 to form a channel through the medical implant. The pin 210 may have a tapered tip. The pin 210 can be inserted into the center of the mold structure 208 to form a channel through the center of the medical implant. Therefore, a medical device with an improved through-channel is advantageously provided.

[0114] Figure 4D-4E The closure of the mold structure 208 is disclosed. The ends of the wires are pushed to one side of the mold structure 208 by pins 210. This is made particularly easy by the tapered tip of the pins 210. This simplifies manufacturing and is therefore cost-effective, as the pins 210 “find” the gaps between the wires passing through the braided tubular base 300 when inserted into the mold in the desired shape for heat setting.

[0115] The mold structure 208 may have an opening 303 at a distance from the center of the mold structure, through which the ends of the first-stage wire 104 and / or the second-stage wire 106 extend from the mold structure 208 (typically a bundle of wires including the ends). The wire ends may be secured before the tubular substrate is inserted into the mold. A portion of the ends extending from end 303 may be secured together at this opening, see [reference needed]. Figure 4E .

[0116] After the braided tubular substrate 300 is inserted into the mold structure 208, the braided tubular substrate 300 is preferably subjected to a heat-setting process. This may include heating the mold structure 208, wherein the inserted braided tubular substrate 300 retains the shape of the desired implantable medical device. Heat setting forms the shape of the implantable medical device made from the braided tubular substrate 300. After being removed from the mold following the heat-setting process, the braided tubular substrate 300 retains the set shape and forms the shape of the implantable medical device. Pins 208 facilitate the formation of heat-setting channels, such as channel 410, for the implantable medical device.

[0117] After heat-setting the tubular substrate in the insert mold, the ends of the wires can be secured. Securement of the wire ends prevents the braid from unraveling, which can be a problem even after heat-setting the medical device. For example, the bundles are welded together to form a spherical securing element 302. In some examples, clamps can be used when securing a portion of the wire ends together. This coagulation welding method is disclosed in the publication text of PCT International Application No. WO2009 / 016265A2, which is incorporated herein by reference in its entirety. Specifically, the coagulation welding of a bundle of wires described in PCT Application No. WO2009 / 016265A2 is incorporated herein by reference.

[0118] Figure 7A and Figure 7B This is a schematic diagram of an example of an implantable medical device 400 having a straight channel 410 with a braided tubular substrate 300 (made by method 5) manufactured in this manner (method 6a / 6b).

[0119] In short, such as Figure 6A As shown, in some embodiments, a method 6a for forming an implantable medical device is provided. In some examples, method 6a preferably includes a step 610 of forming a braided tubular substrate 102, as described in the examples above. Method 6a includes a step 620 of heat-treating the tubular substrate to form an implantable medical device from the braided tubular substrate. The heat treatment is preferably performed based on a mold as described above. Thus, a medical device (e.g., device 400) is manufactured by method 6a.

[0120] To further summarize the contents of this disclosure, such as Figure 6B As shown, a method 6b for forming an implantable medical device is provided, preferably having a through channel 410. Method 6b includes a step 630 of weaving a tubular substrate 102, similar to step 610 of method 6a, and in some examples as described above. The tubular substrate 102 includes multiple sets of first-level vertices and multiple sets of second-level vertices, each second-level vertex located between adjacent first-level vertices.

[0121] Method 6b includes step 640, which involves providing a mold structure 208 and inserting a braided tubular substrate 102 into the mold structure 208 to form a medical device with the tubular substrate 102. Method 6b includes step 650, which involves inserting a pin 210 through the braided tubular substrate 102 inserted into the mold structure 208 to form a channel through the braided tubular substrate 102 and across the mold structure 208.

[0122] Method 6b includes step 650, which involves heat-setting the mold structure 208 using the braided tubular substrate 102 and pins 210 to form an implantable medical device 400, similar to step 620 of method 6a.

[0123] In some preferred embodiments, method 6b further includes, or alternatively includes, the further step of inserting a pin into the center of the mold, wherein the pin preferably has a tapered tip.

[0124] In some preferred embodiments, method 6b additionally or alternatively includes the further step of securing at least a portion of the wire ends of the braided tubular substrate together.

[0125] In some preferred embodiments, method 6b additionally or alternatively includes the further step of securing the wire at a distance offset from the central axis of the implantable medical device.

[0126] Medical implants can be occlusion devices. In some examples, a membrane can be added to a medical implant to improve occlusion of selected portions thereof. Medical implants can be shunt devices, such as the atrial flow regulator described in the same applicant's patent application publication number WO2016 / 038115A1, which is incorporated herein by reference in its entirety (having improved features provided by the tubular matrix technology disclosed in this application). The membrane can be fixed above the opening and / or at the through-channel. The membrane is arranged to be at least partially removed or perforated after implantation. Thus, an occlusion device (providing cessation of blood flow) is provided that can be converted into a shunt device (allowing blood to flow through the device after implantation). The membrane can be biodegradable. After a desired implantation time, the membrane will dissolve in the body and provide a through-channel. Alternatively, the membrane can be non-biodegradable and punctured during surgery. The membrane can be controllably removed from the body. For example, ultrasound, radiofrequency, or similar radiation may cause the membrane to disintegrate or trigger a degradation process. The membrane can dissolve, thereby preventing debris from entering the bloodstream. The membrane can be re-closed, for example, by a suture device, etc. Alternatively, the through-channel 410 may include a valve unit. The valve unit can be inserted into the through-channel 410. In some examples, the valve unit may be an integral part of the medical device 400. In some examples, the valve unit may be inserted into and / or secured to the through-channel 410 of the medical device 400. When secured to the edge of the opening, the robust design of the edge described herein can particularly advantageously retain the valve. In some examples, the valve unit may be a so-called stent valve that expands or can expand into the through-channel 410. The valve unit can provide unidirectional flow, for example through leaflets in the through-channel. The valve unit may have two operating states (closed / open), for example, operated and selected by an external magnetic trigger or bistable mechanism. The valve may open or close after implantation for a period of time, for example, by holding the valve in a position by a biodegradable locking unit. Therefore, advantageous treatment procedures can be provided for patient care, avoiding invasive contact with the medical device after implantation.

[0127] Medical implants can be anchoring structures used to improve the anchoring of various implantable medical devices. Opening edges can provide advantageous connections between other structures and the medical device during implantation.

[0128] The first-stage wire 104 may have the same thickness as the second-stage wire 106. The first-stage wire 104 may have a different thickness than the second-stage wire 106. The first-stage wire 104 may be thinner than the second-stage wire 106. The first-stage wire 104 may be thicker than the second-stage wire 106. This can provide advantageous mechanical strength for medical devices formed from this configuration of base wire thickness.

[0129] The primary wire 104 can be made of shape memory materials, such as shape memory metal alloys. The primary wire 104 can be made of biodegradable materials. The primary wire 104 can be made of bioabsorbable materials. The primary wire 104 can be made of magnesium. The primary wire 104 can be made of nickel-titanium alloys. This can provide favorable desired degradation properties for medical devices formed from such selected matrix wire materials.

[0130] The second-stage wire 106 can be made of shape memory material. The second-stage wire 106 can be made of biodegradable material. The second-stage wire 106 can be made of bioabsorbable material. The second-stage wire 106 can be made of magnesium. The second-stage wire 106 can be made of nickel-titanium alloy. This can provide advantageous desired degradation properties for medical devices formed from such selected matrix wire materials. In some embodiments, the first-stage wire 104 and / or the second-stage wire 106 can be made of any other metal or elastic material suitable for the human body. The first-stage wire 104 and the second-stage wire 106 can be made of the same material or different materials.

[0131] The present invention has been described above with reference to specific embodiments. However, within the scope of this disclosure, other embodiments besides those described above are also possible.

[0132] Although modifications and variations may be proposed by those skilled in the art, the inventors intend that all reasonable and appropriate modifications and variations that fall within the scope of the inventors' contributions to the art be reflected within the scope of the patent grant.

[0133] The reference numerals in the attached figures are listed below.

[0134] 100- Molding element 102- Braiding head

[0135] CA - Braided Head Center Shaft 104 - First-Level Wire

[0136] 106 - Second-level wire; 202 - Spools in the second arrangement

[0137] 202a - First spool in the second arrangement; 202b - Second spool in the second arrangement

[0138] 202c - The third spool in the second arrangement; 202d - The fourth spool in the second arrangement.

[0139] 204 - The spool in the third arrangement; 204a - The first spool in the third arrangement.

[0140] 204b - Second spool in the third arrangement; 204c - Third spool in the third arrangement.

[0141] 204d - The fourth spool in the third arrangement; 206 - A group of spools.

[0142] 208-Mold Structure 210-Pin

[0143] 222-Paired yarn 300-Braided tubular matrix

[0144] 302-Fixed element; 303-Opening offset center

[0145] 304 - Distal portion of the braid; 306 - Proximal portion of the braid.

[0146] 308 - Opening of tubular matrix; 400 - Implantable medical device

[0147] 410-Straight-through-channel 5-Method

[0148] 510-560 Method Steps 6a - Method

[0149] Method 610-620, Step 6b - Method

[0150] Method steps 630-660: D1 - Cross-sectional diameter of the braided tubular matrix

[0151] D2 - Opening diameter

Claims

1. A method of forming a braided tubular substrate (300) for an implantable medical device (400), said braided tubular substrate (300) having an opening (308) at its end, said method comprising: A plurality of forming elements (100) are provided at one end region of a braiding head (102), the braiding head (102) having a central axis (CA), and the forming elements (100) are arranged in a first arrangement around the central axis (CA). Multiple pairs of first-level wires (104) are provided; Multiple secondary cables are available (106); Its features are, Multiple sets of first-level vertices are formed by hooking one pair of first-level wires (104) from multiple pairs of first-level wires (104) onto a first forming element (100) and hooking another pair of first-level wires (104) from multiple pairs of first-level wires (104) onto a second forming element (100) adjacent to the first forming element (100); Multiple second-level vertices are formed by hooking each second-level wire (106) onto a pair of different and adjacent first and second forming elements (100); Then the first-level wire (104) and the second-level wire (106) are woven onto the tubular substrate (300).

2. The method of claim 1, wherein the forming elements (100) are arranged in a first circular arrangement having the central axis (CA) located at the center.

3. The method according to claim 2, wherein the forming element (100) is disposed at a distance from the cylindrical wall toward the central axis (CA) toward the braiding head (102).

4. The method according to claim 2, wherein the forming element (100) is disposed at a distance from the cylindrical wall toward the central axis (CA) of the braiding head (102), and wherein the end region of the braiding head (102) is dome-shaped.

5. The method according to claim 1, further comprising: A plurality of spools (202, 204) are provided arranged outward from the central axis (CA) of the braiding head (102) in a second concentric arrangement and a third concentric arrangement, wherein the first-level vertex group is formed by a first-level wire (104) and a second-level wire (104). The ends of the first-level wire (104) extend from the first vertex to the second concentrically arranged first spool (202a) and the third concentrically arranged first spool (204a), respectively, wherein the second concentrically arranged first spool (202a) and the third concentrically arranged first spool (204a) are concentrically aligned. The ends of the second first-level wire extend from the vertex to the second concentrically arranged second spool (202b) and the third concentrically arranged second spool (204b), respectively, and the second concentrically arranged second spool (202b) and the third concentrically arranged second spool (204b) are concentrically aligned. In this arrangement, the second spool (202b) in the second concentric arrangement is adjacent to the first spool (202a) in the second concentric arrangement. Furthermore, the second spool (204b) of the third concentric arrangement is adjacent to the first spool (204a) of the third concentric arrangement.

6. The method according to claim 5, wherein, Each pair of the first spools (202a, 204a) and the second spools (202b, 204b) is adjacent to a pair of the third spools (202c, 204c) and the fourth spools (202d, 204d), without any first-stage wire connected to it.

7. The method according to claim 6, wherein the second-level vertex group is formed by a first second-level wire and a second second-level wire, one end of the first second-level wire extends to the second concentrically arranged third spool (202c), the other end of the first second-level wire extends to the third concentrically arranged fourth spool (202d), the second concentrically arranged third spool (202c) is adjacent to the second concentrically arranged second spool (202b), and One end of the second-level wire at the second vertex extends to the third spool (204c) of the third concentric arrangement, and the other end of the second-level wire at the second vertex extends to the fourth spool (204d) of the second concentric arrangement. The third spool (204c) of the third concentric arrangement is adjacent to the second spool (204b) of the third concentric arrangement. The fourth line axis (202d, 204d) is adjacent to the first line axis (202a, 204a) of another first-level vertex group.

8. The method according to claim 5, wherein, Providing multiple spools (202, 204) includes providing molding elements (100) and spools (202, 204) in a ratio of 1:4, and / or providing multiple spools (202, 204) includes providing 40 spools (202) in a second concentric arrangement and providing 40 spools (204) in a third concentric arrangement.

9. The method of claim 1, wherein providing a plurality of molding elements (100) includes providing 10 molding elements (100).

10. The method of claim 1, wherein each of the second-level vertices is located between two adjacent forming elements (100). Offset toward the central axis (CA), And each of the second-level vertices is located between the first-level vertices formed on the adjacent molding elements (100).

11. The method according to any one of claims 1-10, wherein the second-stage wire is hooked onto adjacent pairs of forming elements (100), This causes the second-level wires to be arranged to overlap each other.

12. A method for forming an implantable medical device (400), comprising: Forming a braided tubular matrix (300) according to any one of claims 1-11. as well as The braided tubular substrate (300) is heat-treated to form the implantable medical device (400) from the braided tubular substrate (300).

13. A method of forming an implantable medical device (400) having a direct access channel (410), the method comprising: The method according to any one of claims 1-11 weaves a braided tubular matrix (300) composed of yarns (104, 106), wherein the braided tubular matrix (300) includes the yarns (104, 106) and the yarns (104, 106) are arranged to have a plurality of first-level vertices and a plurality of second-level vertices; A mold structure (208) is provided, and the braided tubular substrate (300) is inserted into the mold structure (208); The stud (210) is passed through the braided tubular base (300) inserted into the mold structure (208) to form a straight channel (410). The braided tubular substrate (300), which is inserted into the mold structure (208) and inserted by the stud (210), is heat-set to form the implantable medical device (400) having the through channel (410).

14. The method according to claim 13, wherein the stud (210) is inserted into the center of the mold structure (208), and / or wherein the stud (210) has a tapered tip.

15. The method of claim 14, further comprising securing opposite ends of the wires of the braided tubular substrate (300) together to prevent the braid of the tubular substrate (300) from unraveling, and comprising securing the wires at a distance offset from the central axis (CA) of the implantable medical device (400) to provide, during formation, the centrally located through-passage (410) in the implantable medical device (400).

16. A braided tubular substrate (300) for an implantable medical device (400), the braided tubular substrate (300) including an opening (308) at its end, wherein the edge of the opening (308) is formed by a member: Multiple primary wires (104) and multiple secondary wires (106). Multiple sets of first-level vertices, and Multiple second-level vertices, wherein the braided tubular matrix (300) is manufactured by the method according to any one of claims 1-11.

17. The braided tubular matrix (300) according to claim 16, wherein the implantable medical device (400) is a shunt device or an occluder.

18. An implantable medical device (400) made of a braided tubular substrate (300) according to claim 16 and manufactured by the method according to claim 12 or any one of claims 13 to 15, the implantable medical device (400) comprising an opening (308) having an edge at its end, wherein the edge is provided with: Multiple first-level wires (104) and multiple second-level wires (106); Multiple sets of first-level vertices, and Multiple second-level vertices.

19. The implantable medical device (400) of claim 18, wherein the implantable medical device (400) includes a through channel (410) that extends through the implantable medical device (400) including the opening (308).

20. The implantable medical device (400) of claim 18, wherein the implantable medical device (400) includes a through channel (410) extending through the implantable medical device (400) including the opening (308), and wherein the through channel (410) is disposed at the center of the implantable medical device (400).

21. The implantable medical device of claim 19, wherein the implantable medical device (400) is a shunt device that allows blood to flow through the through-channel (410) when implanted.

22. The implantable medical device (400) according to any one of claims 18 to 21, wherein a removable and / or re-puncturable membrane is provided to close the opening (308).

Images