Method for manufacturing a medical implantable device, a medical implantable device, and a base body for such an implantable device

Abstract

A method for forming a braided tubular base body for a medical implantable device is disclosed. The method includes providing a braiding head having a shaping element and a plurality of bobbins. The method includes providing a plurality of first-stage wires and forming a plurality of first-stage apices. The method includes providing a plurality of second-stage wires and forming a plurality of second-stage apices. Each second-stage apices is disposed between two adjacent first-stage apices. The method further includes braiding such a tubular base body for a medical implant as well as a medical implant made from such a braided tubular base body, and also includes a corresponding manufacturing method for a medical implant based on such a braided tubular base body.

Description

[Technical Field]

[0001] The present disclosure relates to the manufacture of medical implants, particularly involving the braiding of wires or strands and methods thereof, as well as base bodies manufactured with such braiding to form medical implants, particularly including shunt devices such as septal shunt devices, where such implants are comprised of a braided mesh of strands. Even more specifically, the present disclosure relates to a method for forming a braided tubular base body for a medical implantable device. The present disclosure relates to a braiding head having a shaping element and a method including multiple bobbins in the braiding process. The present disclosure further relates to a method for braiding a tubular base body for a medical implant from such a braided tubular base body, as well as medical implants made from such a braided tubular base body and corresponding manufacturing methods. [Background technology]

[0002] Various braided medical devices are used to treat various patient conditions. In certain situations, it may be necessary to use such devices to occlude a patient's lumen, blood vessel, ventricle, channel, hole, or cavity. Braided devices may also be used in shunt procedures. When such devices are delivered or implanted within a patient's body, it is important that the braided device has sufficient flexibility for safe delivery to a target site in the patient via a delivery device such as a catheter. The ease with which a medical device can be delivered is critical for several reasons, such as time constraints for rapid treatment or requirements for complying with the overall safe positioning or manipulation of the device at the target site.

[0003] Braided medical devices often comprise one or more wires or strands that are used to braid a base body that is then used to form the medical device, often by heat-setting. The ends of the wires or strands are typically secured together to prevent the braid from unraveling, for example, by fasteners, bundles, or fastening means that often protrude from the medical device.

[0004] Some braiding machines can be configured and set up to braid a base body that may have open and / or closed ends. A variety of braiding techniques and set ups have been used to braid strong, flexible base bodies for medical devices.

[0005] For example, U.S. Patent No. 6,468,303 and International Publication No. WO 99 / 12478 disclose medical devices made from a tubular braid and each device has a fixation means, such as a clamp, at each opposite end. However, particularly in the left ventricle, the fixation means can increase the risk of blood clotting or other complications, for example, because the distal clamp protrudes from the device. This can be particularly problematic in the left ventricle, increasing the risk of undesirable complications such as stroke or puncture of cardiac tissue due to a blood clot during device deployment. International Publication No. WO 2005 / 020822 discloses an occlusion device, and International Publication No. WO 2016 / 038115 discloses a shunt device, both of which are made from a braided base. The latter medical device has a single fixation means, such as a clamp, at only the proximal end.

[0006] In another example, U.S. Pat. No. 9,877,726 discloses an occlusion device having a clamp at one end and a braided opening at the other end, which is tied together with sutures to constrain the opening and form a closed, smooth surface. The device is for blocking blood flow through a hole in the atrial septum. Although a small opening is disclosed at the distal end, because the purpose of the device is to block blood flow, the disclosure relates to closing the opening by manually tightening the sutures. If the wire loops at the distal end of the occlusion device are not held together with sutures, the wires in the opening may unravel or even unravel. Therefore, the structure and manufacturing costs of the periphery of the opening disclosed in U.S. Pat. No. 9,877,726 could be improved.

[0007] WO 2012 / 110355 discloses a medical device having an expandable braided mesh of wires that cross each other and form loops on at least one long edge of the braided mesh. The medical device is a tubular stent. The peripheral structure of the braid can be improved with respect to at least its structural integrity and stability.

[0008] U.S. Patent Application Publication No. 2007 / 112380 discloses a self-expanding occlusion device for occluding an atrial appendage in a patient's heart, which includes a braid of thin wires or threads that allows for appropriate shaping through molding and heat treatment procedures. The medical device has a distal central opening where the wires return from peripheral loops to a disk element. Because the device is an occlusion device, the goal is to keep the channel as small as possible. No wire tips are located at the opening or its periphery. The structure of the periphery of the braid can be improved, at least in terms of its structural integrity and stability.

[0009] U.S. Patent No. 9,545,300 discloses self-expanding implantable medical devices formed from one or more non-interlocking filaments. Stents, stent grafts, occlusion devices, and filters are fabricated from one or more filaments utilizing a non-interlocking crossing pattern. The devices may have a central opening for threading the device over a guidewire during delivery. However, because the device is an occlusion device, the goal is to keep the channel as small as possible. No wire crests are located at or around the opening. The peripheral braid structure may be improved, at least with respect to its structural integrity and stability.

[0010] EP 3146915 A1 discloses a left atrial appendage occluder and a method for manufacturing the same. The method includes weaving an elongated web, followed by preheating, shaping, and final heat treatment to achieve the left atrial appendage occluder. The device does not have any openings or through channels. A mold with protruding elements for creating recessed elements in the medical device during heat setting is disclosed.

[0011] China Utility Model Application Publication No. 203634215 discloses an occlusion device with improved insertion function, which includes at least one disc-shaped structure and a waist portion connected to the at least one disc-shaped structure, and the device has no openings or through-channels.

[0012] As a result, there is a need for further improved braided medical devices, base bodies for such devices, and manufacturing methods for such base bodies and / or devices. Summary of the Invention

[0013] Accordingly, embodiments of the present invention seek to mitigate, alleviate, or eliminate one or more deficiencies, disadvantages, or problems in the art, such as those identified above, singly or in any combination, by preferably providing apparatus, and methods in accordance with the appended claims. The present invention is defined solely by the appended claims, and particularly by the appended independent claims. References throughout this specification to "embodiments" that do not fall within the scope of the appended claims merely represent possible example implementations and, therefore, are not part of the present invention. The present disclosure may include multiple inventions. Specific technical effects and advantages of specific features or steps of the present disclosure are set forth below.

[0014] In one example, a method for forming a braided tubular base body for a medical implantable device is disclosed. The method includes providing a braiding head having form elements and a plurality of bobbins. The method includes providing a plurality of first-stage wires and forming a plurality of first-stage apexes of the first-stage wires, such as apexes of pairs of these wires hooked in overlapping pairs on respective form elements of the braiding head. The method also includes providing a plurality of second-stage wires and forming a plurality of second-stage apexes. Thus, each second-stage apex is positioned between two adjacent form elements. When the first-stage apexes are formed in pairs, the second-stage apexes are positioned "between" such first-stage apexes of the first-stage wires on the respective adjacent form elements. The term "between" is not limited to being on a straight line between adjacent form elements or exactly centered between form elements, but includes, for example, an offset toward the central axis (CA) or either of the two adjacent form elements. See the example provided in Figure 2. Preferably, the method includes the step of hooking such second stage wires between two adjacent forming elements such that second stage apexes of the second stage wires are respectively disposed between the forming elements. The present disclosure further includes the step of manufacturing a medical implant from such a braided tubular base body, as well as the step of manufacturing a medical implant made from such a braided tubular base body, preferably by the manufacturing method described above.

[0015] In one embodiment of the present disclosure, a method for forming a braided tubular base body for a medical implant is provided. The method, in an example, includes providing a plurality of shape elements at one end of a braid head. The braid head generally has a central axis (CA). The shape elements are arranged in a first arrangement centered on the central axis (CA). The arrangement is an arrangement of the shape elements centered on the central axis (CA). The shape elements are arranged at an upper portion of the braid head. Preferably, the arrangement is circular. In an example, the arrangement may be non-circular, such as elliptical. The shape elements are preferably arranged in a dome-shaped (also called an inverted cup or cup-shaped) portion that narrows the cylindrical braid head at an upper region of the braid head toward the end of the braid head. The shape elements are preferably arranged at a distance from the cylindrical wall toward the central axis (CA) of the braid head on the dome-shaped upper region, and the method, in an example, includes providing a plurality of pairs of first-stage wires. A plurality of groups of first-stage tops are formed by hooking each pair of first-stage wires onto first and second shape elements. Further, a plurality of pairs of second-stage wires are provided. A plurality of groups of second-stage apexes, each located between adjacent first-stage apexes, are formed by hooking each pair of second-stage wires to first and second form elements that "envelop" the first-stage apexes. The term "enveloping" as used herein means "partially encircling," "partially surrounding," or "partially overlapping," as seen, for example, in FIG. 2 . In particular, return loops of wires having apexes can "envelop" other return loops with their apexes. Thus, the term "enveloping" does not mean completely wrapping, covering, or surrounding. Preferably, each of all form elements is used to hook a pair of first-stage wires.Preferably, each of the shape elements is used to hook onto a second-stage wire, with each second-stage wire hooked onto a pair of shape elements, with adjacent second-stage wires hooked onto an overlapping pair of shape elements adjacent to the first shape element of the first pair of shape elements. As an example of an arrangement of shape elements numbered consecutively (e.g., arranged in a circle) starting with "1," the first second-stage wire is hooked onto shape elements "1" and "2," the next element is hooked onto shape elements "2" and "3," the next element is hooked onto shape elements "3" and "4," and so on, until a circle around the braiding head is completed. The first and second stage wires are then braided onto the tubular base body. In this way, the tubular base body is formed with an advantageous perimeter for an opening at the distal end of the base body, bounded by the tops of the first and second stage wires, as described in more detail below.

[0016] The arrangement of wires with first-stage and second-stage apices can improve the durability of the tubular braid thus produced, particularly in terms of stability and robustness around the opening of the braid. Fraying or unraveling is effectively prevented without the need for fastening means (since the distal end of the tubular braid does not have wire ends but has interwoven apices as described). The arrangement of wire return loop apices as described provides a self-securing periphery of the opening. Thus, the braids of the present invention can improve patient safety of medical devices manufactured from such braids having the described intertwining of wires in paired groups having first apices and at least partially overlapping second-stage apices.

[0017] Tubular base bodies manufactured according to the disclosed methods and having the structural features disclosed herein, as well as medical devices manufactured therefrom, further provide flexibility that facilitates handling of the tubular base body. Flexibility also extends the lifespan of medical devices based on such flexible structures, particularly in applications where the device is constantly moving, such as during heartbeats. The tubular base body is easily formed into medical devices. As already mentioned above, when braiding the tubular base body, loose wire ends are on the same side. If all the free wire ends are on one side, the medical device can be formed with only one closure element on one end to secure the loose ends of the braid strands and prevent fraying and / or unraveling of the braid. In such cases, patient safety can be improved by limiting the number of elements protruding from the medical device. This can reduce the risk of blood clotting associated with medical implantable devices formed with braided base bodies. At the same time, an advantageous perimeter of the opening is provided by the placement of the wire apex at the perimeter, which prevents overgrowth / endothelialization of the opening.

[0018] This is particularly beneficial when the medical device is placed within the septal wall or atrial septum. The formation of the enveloping apex provides rigidity and flexibility to the tubular base body, allowing for the formation of a variety of medical devices, such as occlusion devices and shunt devices.

[0019] By using multiple wires or strands to form the apex groupings, the braided setup can form an opening that can hold itself open, which can facilitate the creation of a shunt or occlusion device.

[0020] In some examples, the method includes providing a plurality of bobbins (including a braiding machine). The bobbins may be arranged in second and third concentric arrangements (loaded states) outward from a central axis of the braiding head. When the braiding machine is operated, the bobbins move between the concentric arrangements in a known "maypole dancing pattern." A group of first stage apexes may be formed by first and second first stage wires. An end of the first first stage wire may be guided from the first apex to a first bobbin in the second arrangement and a first bobbin in the third arrangement, respectively. The first bobbins in the second and third arrangements may be aligned concentrically. An end of the second first stage wire may be guided from the apex to a second bobbin in the second arrangement and a second bobbin in the third arrangement, respectively. The second bobbins in the second and third arrangements may be aligned concentrically. A second bobbin in the second arrangement may be adjacent to a first bobbin in the second arrangement. A second bobbin in the third arrangement may be adjacent to a first bobbin in the third arrangement.

[0021] In some examples, the first and second bobbins of each pair may be adjacent to the third and fourth bobbins of the pair that do not have a first-stage wire connected to them.

[0022] In some examples, a group of second-stage apexes may be formed by a first-stage wire and a second-stage wire. One end of a first second-stage wire may be led to a third bobbin in the second arrangement. The third bobbin may be adjacent to a second bobbin in the second arrangement. The other end of the first second-stage wire may be led to a fourth bobbin in the third arrangement. One end of the second-stage wire may be led to a third bobbin in the third arrangement. The third bobbin in the third arrangement may be adjacent to a second bobbin in the third arrangement. The other end of the second-stage wire may be led to a fourth bobbin in the second arrangement. The fourth bobbin may be adjacent to a first bobbin in another group of first-stage apexes. Such a configuration may improve the flexibility of the braided tubular base body.

[0023] In some examples, the bobbins may be provided with a form element to bobbin ratio of 1:4. Such a setup of the braiding machine may facilitate wire setup. Such a setup may improve the flexibility and durability of the braided tubular base body. In some examples, the bobbins may be provided with a form element to bobbin ratio of 1:8.

[0024] In some examples, 40 bobbins may be provided in the second arrangement. 40 bobbins may be provided in the third arrangement. The second and third arrangements of bobbins may be arranged consecutively. In some examples, providing the plurality of form elements may include providing 10 form elements.

[0025] To provide braided tubular base bodies of various sizes, different numbers of form elements and bobbins may be advantageous.

[0026] In another aspect, a method for forming a medical implantable device from a braided tubular base body is provided, the method comprising forming a tubular base body according to any one of the examples above, the method further comprising heat treating the tubular base body to form the medical implantable device from the braided tubular base body.

[0027] In another aspect, a method for forming a medical implantable device is provided. The method includes braiding a tubular base body, preferably according to any one of the examples above. The tubular base body includes a plurality of groups of first-stage apices. The tubular base body includes a plurality of groups of second-stage apices, each second-stage apices being located between adjacent first-stage apices. The method further includes providing a mold structure. The method includes inserting the tubular braid into the mold structure. The method includes inserting pegs into the mold structure through the tubular braid to form channels through the medical implantable device. The method further includes treating the mold structure with heat setting to form the medical implantable device.

[0028] In some instances, the peg may be inserted into the center of the mold, with the peg having a conical tip providing an easier, less time consuming, and more cost effective manufacturing method.

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

[0030] In some examples, the method can include anchoring the wire at an offset distance from a central axis of the medical implantable device.

[0031] In another aspect, a tubular base body for a medical implant, preferably a shunt or occlusion device, is provided. The tubular base body has a plurality of first stage wires and a plurality of second stage wires. The tubular base body includes a plurality of groups of first stage apices. The tubular base body further includes a plurality of groups of second stage apices, each group positioned between adjacent first stage apices.

[0032] In another embodiment, a medical implantable device is provided, preferably made from the tubular base body of the above embodiment. The medical implantable device includes a plurality of first stage wires and a plurality of second stage wires. The medical implantable device includes a plurality of groups of first stage apices. The medical implantable device further includes a plurality of groups of second stage apices, each group being located between two adjacent first stage apices.

[0033] In some examples, the medical implantable device can include a channel extending therethrough. The channel, in such examples, includes an opening with a periphery, the opening having a wire return loop disposed around the periphery of the opening with a first stage apex and a second stage apex. The channel has a second, opposing opening, preferably formed by heat-setting a tubular braid in a mold using pegs as described herein.

[0034] Thus, the aforementioned openings can advantageously be provided at the end of the base body without elements extending beyond the end. Thus, medical devices can be provided with such openings at their end without protruding elements (wire bundles, fastening means, etc.). Such openings provided by the base body manufactured as described herein advantageously provide long-lasting openings at the end of the medical device (or a channel through the medical device) formed from the base body (preferably by using a mold and heat-setting process). Thus, the openings advantageously do not extend over the opening or cause endothelialization upon implantation. Furthermore, the base body thus formed provides a sturdy guide around the opening at its end for a form element, such as a peg, inserted into the braid of the base body when inserted into a mold to form the medical device. Thus, the resulting tubular braided base body advantageously facilitates the safe and reliable manufacture of medical implantable devices having openings at their end, preferably having a through-channel (such as a shunt or occlusion device / occluder). [Brief explanation of the drawings]

[0035] These and other aspects, features and advantages of possible embodiments of the present invention will become apparent and elucidated from the following description of embodiments of the invention, which refers to the accompanying drawings.

[0036] [Figure 1A] 1 is a side view of an example of a braiding head 102 with a cylindrical body, a dome-shaped (cup-shaped) top, and multiple form elements 100. FIG. [Figure 1B] FIG. 1 is an elevational view of the upper detail of the braiding head 102. [Figure 1] 1 is a schematic top view of a braiding machine including a braiding head having a plurality of form elements, a plurality of bobbins, and a plurality of wires hooked onto the form elements and having ends connected to the bobbins. [Figure 2]1 is a schematic top view of a braiding machine including a braiding head having a plurality of form elements, a plurality of bobbins, and a plurality of wires hooked onto the form elements and having ends connected to the bobbins. [Figure 3A] 1 is a schematic side view of a braided tubular base body having a proximal end and a distal end, with wire ends at the proximal end and wire ends secured together; [Figure 3B] 1 is a schematic diagram of the distal end of an example tubular base body having an oval opening at the end. FIG. [Figure 3C] FIG. 10 is a schematic side view of an example of a distal end of a tubular base body having an opening with a diameter smaller than the diameter of the braided tubular base body. [Figure 3D] FIG. 10 is a schematic side view of an example of a distal end of a tubular base body having an opening with a diameter smaller than the diameter of the braided tubular base body. [Figure 3E] 1 is an elevational view of an example of a braided tubular base body manufactured according to the methods disclosed herein. [Figure 4A] 1 is a schematic side view of a mold configuration for forming a medical device. [Figure 4B] FIG. 1 is a schematic side view of a braided tubular base body partially inserted into a mold structure. [Figure 4C] FIG. 10 is a schematic diagram of a peg being inserted into a mold structure to form a channel through a medical device. [Figure 4D] 1 is a schematic top view of a braided tubular base body inserted into a mold structure, with the ends of the braided base body extending upward. [Figure 4E] FIG. 1 is a schematic top view of a mold structure having a braided tubular base body therein and pegs passing through the mold structure to form a central channel through the medical device, with the ends of the wires extending from the mold structure at a distance offset from the central channel. [Figure 5] 1 is a flowchart illustrating some example methods of the present disclosure. [Figure 6A] 1 is a flowchart illustrating some example methods of the present disclosure. [Figure 6B]1 is a flowchart illustrating some example methods of the present disclosure. [Figure 7A] FIG. 4 is a schematic diagram of an example of a medical implantable device 400, in an example with a through channel made from a braided tubular base body 300. [Figure 7B] FIG. 4 is a schematic diagram of an example of a medical implantable device 400, in an example with a through channel made from a braided tubular base body 300. DETAILED DESCRIPTION OF THE INVENTION

[0037] Specific embodiments of the present disclosure will now be described with reference to the accompanying drawings. However, the present invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this invention will be thorough and complete, and will fully convey the scope of the present disclosure to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention. In the drawings, like numbers refer to like elements.

[0038] The following description focuses on one embodiment of the present invention applicable to methods and apparatus for forming medical implantable devices, and in particular to a method for braiding a tubular base body and a tubular base body for forming into a medical implantable device.

[0039] Many medical implantable devices are made from a braided base. The braided base of the present disclosure is braided using a commonly used 3D braiding machine that includes a braiding head with shaped elements and bobbins. The shaped elements are often arranged around the central portion of the braiding head. The bobbins are arranged in different planes in the direction from the center of the braiding head to the outside and the direction from the shaped elements to the outside.

[0040] These common braiding machines can form open-ended or closed-ended braided substrates depending on the braided substrate used.

[0041] Once the wire is set up in the braider according to the present disclosure, the braider moves the bobbin in a pattern about the axis of the braiding head to braid the attached wire or thread.

[0042] An example of a braiding head 102 without any wires or strands loaded is shown in Figures 1A and 1B.

[0043] Returning now to Figure 1, there is shown the wire setup on the braiding head 102. This example shows a schematic top view of the braiding head 102 shown in Figures 1A and 1B.

[0044] The braiding head 102 may have a circular cross-section as shown in the exemplary figures, and in such embodiments, has a central axis CA 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 that results in a circular cross-section of the corresponding braid created on the braiding head. The braiding head 102 extends longitudinally in the direction of the central axis CA. A plurality of shape elements 100 are arranged on the top of the braiding head 102, extending outward from the central axis CA. The shape elements are arranged in a first arrangement extending outward from the central axis CA. The first arrangement may be circular, elliptical, or any shape suitable for the desired medical device to be formed. The shape elements are arranged within the periphery of the braiding head 102. Each shape element 100 may be positioned at the same distance from the central axis CA. However, varying the distance of at least one of the shape elements 100 may change the end of the braided tubular base body. This may be advantageous for facilitating the manufacture of medical implantable devices of various sizes. Advantageously, this can facilitate the fabrication of a wide variety of medical implantable devices.

[0045] 1A, 1, and 2, the braiding head 102 includes ten form elements 100. However, this is only an example of a specific number of form elements 100. For example, the braiding head shown in FIG. 1B has more form elements 100.

[0046] A second arrangement 202 including multiple bobbins is illustrated on the outside in a second plane below the top of the braiding head 102. The second plane is in the longitudinal direction of the braiding head 102. A third arrangement 204 including multiple bobbins is illustrated outside the second arrangement 202 of bobbins. The bobbins in the second arrangement 202 and the third arrangement 204 may be arranged consecutively outward from the central axis CA. The bobbins in the second and third arrangements are preferably arranged on the outside of the periphery of the braiding head. The bobbins in the first and second arrangements may shift relative to each other in a wave-like pattern as they are circulated around the central axis, as is known, for example, in maypole braiding techniques. The braid is then formed from the top of the braiding head downward. Other support elements of the braiding machine may be present (not shown), such as movable holders along the braiding head to assist in creating the braid downward as the bobbins are braided.

[0047] The innovative setup described herein for the braiding machine involves attaching and positioning the wires used to perform the braiding on the braiding machine. In the embodiment shown, a setup is shown for multiple first stage wires 104 to form the first stage braid of the tubular base body.

[0048] Each form element 100 has two first stage wires 104 hooked around it. Each first stage wire 104 hooked around a form element 100 forms a vertex on the corresponding form element 100. Each form element 100 (numbered 1 through 10 in the example of FIGS. 1 and 2) provides two first stage vertices for the setup. When setting up a first stage wire, the wire is attached to and hooked onto a first bobbin or routed around the form element 100 and routed to and connected to a second bobbin.

[0049] For example, a wire 104 is hooked onto the shape element 100 numbered 1. This wire is wound around the shape element numbered 1. The two ends of the wire are fixed to the first and second bobbins, respectively (adjacent to reference number 1 toward the central axis CA as seen in FIG. 11 or FIG. 2). This forms a first-stage apex of this particular wire. A second wire 104 is hooked onto the same shape element 100 numbered 1. This second wire is also wound around the shape element numbered 1. The two ends of the wire are fixed to the third and fourth bobbins, respectively (adjacent to reference number 2 toward the central axis CA as seen in FIG. 2). This forms a first-stage apex of this particular second wire around the same shape element. When the wire is properly tensioned in the bobbin, the apex will overlap at the shape element, here shape element 1 in FIG. 2.

[0050] This (two wires wrapped around a form element) is repeated for each form element 100. Thus, a first and second first stage wire 104 form a group of first stage apexes. Similarly, a first stage wire 104 and a second first stage wire can form a group of first stage wires. Thus, setting up the braiding machine includes providing multiple groups of first stage wires 104 and forming multiple groups of first stage apexes with the first stage wires 104.

[0051] The bobbins in the second and third arrangements 202, 204 may be arranged in groups 206. Each group may include at least one bobbin from the second arrangement 202 and at least one bobbin from the third arrangement 204. A first bobbin 202a in the second arrangement 202 and a first bobbin 204a in the third arrangement 204 may form a pair of bobbins 222. Each group 206 may include at least one pair of bobbins 222. Each group 206 may include two pairs of bobbins 222. Preferably, each group 206 includes four pairs of bobbins 222. For example, a group may include the first and second bobbins (first wire), the third and fourth bobbins (second wire), etc., with no wires yet connected. These remaining bobbins are secured to the ends of other wires, as shown in the example of FIG. 2 and described below.

[0052] In the schematic top view of the braiding machine, each group 206 comprises four bobbins in the second arrangement 202 and four bobbins in the third arrangement 204 .

[0053] Each group includes a first bobbin 202a from the second arrangement 202. A group includes a second bobbin 202b from the second arrangement 202. A group includes a third bobbin 202c from the second arrangement 202. A group includes a fourth bobbin 202d from the second arrangement 202.

[0054] The group further comprises a first bobbin 204a from the third arrangement 204. The group comprises a second bobbin 204b from the third arrangement 204. The group comprises a third bobbin 204c from the third arrangement 204. The group comprises a fourth bobbin 204d from the third arrangement 204.

[0055] As mentioned above, in the illustrated example of the present disclosure, a first end of the first first stage wire 104 is connected to a first bobbin 202a of the second arrangement 202. The first first stage wire 104 is then wrapped around the forming element 100. A second end of the first first stage wire 104 is led from the forming element to a first bobbin 204a of the third arrangement 204 and connected thereto, thereby forming a first apex of a group of first stage apexes.

[0056] A second apex is formed by the second first-stage wire 104. A first end of the second first-stage wire 104 is connected to the second bobbin 202b of the second arrangement 202. The second-stage wire is then hooked around the same forming element 100 as the first first-stage wire 104. A second end of the second first-stage wire is led to the second bobbin 204b of the third arrangement 204. This forms a second first-stage apex. The first apex and the second apex overlap each other around the forming element 100.

[0057] The first bobbin 202a and the second bobbin 202b of the second arrangement 202 are disposed adjacent to each other. The first bobbin 204a and the second bobbin 204b of the third arrangement 204 are disposed adjacent to each other.

[0058] The third bobbins 202c, 204c and fourth bobbins 202d, 204d of the second and third arrangements 202, 204 are preferably left without the first-stage wire 104 connected. The third bobbins 202c, 204c and fourth bobbins 202d, 204d of the second and third arrangements 202, 204 are adjacent to the first bobbins 202a, 204a and second bobbins 202b, 204b of the second and third arrangements 202, 204.

[0059] A second group of first stage apexes is formed by hooking a pair of first stage wires 104 around another forming element 100. The ends of the first stage wires 104 of the second group of first stage apexes are led to the bobbins 222 of the second group.

[0060] The second group at the top of the first stage has a first bobbin in the second and third locations adjacent to a fourth bobbin in the second and third locations of the first group, thereby leaving two pairs of bobbins 222 free between each group of first stage wires 104 in the first stage wire 104 setup.

[0061] 2, there is shown a schematic top view of an exemplary braiding machine in a setup for forming a braided tubular base body comprising a plurality of first stage apices and a plurality of second stage apices, each of which is formed by a second stage wire 106.

[0062] Each second-stage apex is formed by connecting a first end of a first second-stage wire 106 to the third bobbin 202c of the second arrangement 202. The first second-stage wire 106 is guided around and hooked onto two adjacent forming elements 100. The second end of the first second-stage wire 106 is guided to the fourth bobbin 204d of the third arrangement 204. This forms a first second-stage apex. The first and second second-stage wires 106 are preferably hooked around the same two forming elements 100.

[0063] The fourth bobbin 204d is preferably the fourth bobbin 204d of a group of bobbins 206 that is different from the third bobbin 202c to which the first end of the first second-stage wire 106 is connected.

[0064] A second stage apex can be formed by hooking the second stage wire around at least two form elements 100. In some examples, a second stage apex can be formed by hooking the second stage wire around three or four form elements 100. The two form elements are always the outer form elements of a group of at least two adjacent (or consecutively arranged) form elements for hooking onto the return loop of the respective second stage wire.

[0065] Each second stage apices is positioned or disposed between two adjacent groups of first stage apices. When forming the second stage apices, the second stage apices are disposed "over" and at least partially overlap the two groups of first stage apices. In some examples, the second stage apices may encase two adjacent groups of first stage apices. This provides rigidity to the tubular base body, maintains the open ends, and keeps the tubular base body flexible to form the medical device.

[0066] For example, in a non-limiting example, a first second stage wire 106 is wound around form elements 100 having numbers 1 and 2 in the illustrated example. Thus, the top of this first second stage wire 106 is disposed between adjacent form elements 100 having numbers 1 and 2. A first end of this first second stage wire 106 is secured to bobbin 204 having number 3A. A second end of this first second stage wire 106 is secured to bobbin 202 having number 8A. A second second stage wire 106 is wound around form elements 100 having numbers 1 and 2 in the illustrated example. Thus, the top of this first second stage wire 106 is also disposed between adjacent form elements 100 having numbers 1 and 2. A first end of this second second stage wire 106 is secured to bobbin 202 having number 3B. A second end of this first second stage wire 106 is secured to bobbin 204 having number 8B.

[0067] This is repeated for second stage wire 106 as illustrated in FIG. 2, for example around form elements 2 and 3 (the tops between 2 and 3), and bobbins 7A, 12A, and 7B, 12B, respectively, until all bobbins are loaded with wire.

[0068] The second second stage wire 106 is connected to the third bobbin 204c of the third arrangement 204. The second second stage wire 106 is hooked around the same form element 100 as the first second stage wire 106. The second end of the second second stage wire is led to the fourth bobbin 204d of the third arrangement 204. The fourth bobbin 202d is preferably the fourth bobbin 202d of a different bobbin group 206 from the third bobbin 204c to which the first end of the second second stage wire 106 is connected. The different groups 206 of bobbins forming the second stage top group may be adjacent groups 206 to each other.

[0069] The first-stage wires and the second-stage wires may form a first group of second-stage apexes. A second group of second-stage apexes is formed by hooking another pair of second-stage wires 106 around two other forming elements 100. Preferably, a group of second-stage wires 106 is hooked around each of two adjacent forming elements 100. This means that the first group of second-stage apexes is formed around the first and second forming elements 100. The second group of second-stage apexes may be hooked around the third and fourth forming elements. Thus, a third group of second-stage apexes may be formed around the second and third forming elements 100. Thus, the third group of second-stage apexes may at least partially overlap the first and second groups of second-stage wires.

[0070] Each group of second stage apices may be disposed between two adjacent groups of second stage apices.

[0071] In the arrangement shown, the first stage apex at least partially overlaps (envelops as defined herein) the second stage apex.

[0072] Preferably, each of all shape elements is used to hook a pair of first-stage wires. Preferably, each of all shape elements is used to hook a second-stage wire, with each second-stage wire hooked to a pair (two) of shape elements, with adjacent second-stage wires hooked to an overlapping pair of shape elements adjacent to the first shape element of the first pair of shape elements. As an example of an arrangement of consecutively numbered shape elements (e.g., arranged in a circle) starting with "1," the first second-stage wire is hooked to shape elements "1" and "2," the next element is hooked to shape elements "2" and "3," the next element is hooked to shape elements "3" and "4," and so on until a circle around the braiding head is completed.

[0073] Thus, each group of second-stage apexes can be positioned between two adjacent groups of first-stage apexes. The braiding process then begins, forming a tubular base body through braiding. This means that after the first-stage wire 104 and the second-stage wire 106 are connected to the braiding machine, the braiding machine can braid the tubular base body. During braiding, the first-stage wire 104 can form the first-stage mesh structure of the tubular braid. The second-stage wire 106 can form the second-stage mesh structure of the same tubular braid. The tubular base body braided like a tubular braid can have openings. The openings can have the shape of the configuration of the form elements 100. Thus, the openings can be provided at the end of the base body, in this example, at the distal end of the base body. The openings can then become part of the through-channels 410 of the medical device 400, as described below.

[0074] Advantageously, therefore, the braid set up at one end of the braided tubular base body provides a stable and sturdy periphery of the opening.

[0075] Thus, in some embodiments, openings can be provided at the end of the base body without elements extending beyond the end, while fraying and unraveling are prevented by the braiding as described. Thus, medical devices can be provided with openings at their end without protruding elements (wire bundles, fastening means, etc.) by forming them from the base body. Such openings provided by base bodies manufactured as described herein provide long-lasting openings at the end of the medical device (or channels through the medical device) formed from the base body (preferably by using a mold and heat-setting process). Thus, the openings advantageously do not enlarge or cause endothelialization upon implantation. Furthermore, the base body thus formed provides a sturdy guide around the opening at its end for a feature, such as a peg, inserted into the braid of the base body when inserted into a mold to form the medical device. Thus, the resulting tubular braided base body advantageously facilitates the manufacture of implantable medical devices (such as shunts or occlusion devices / occluders) in a safe and reliable manner.

[0076] In summary, as shown in FIG. 5 , some embodiments provide a method 5 for forming a braided tubular base body, preferably having an opening at its end. The braided tubular base body is suitable for forming 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 provided at an upper portion of the braiding head 102 in a first arrangement. If the braiding head has a central axis CA, the shaping elements are provided in the first arrangement around the central axis CA. Method 5 further includes step 520 of providing a plurality of pairs of first-stage wires 104. Method 5 includes step 530 of forming a plurality of groups of first-stage apexes by hooking each pair of first-stage wires 104 onto first and second shaping elements. Method 5 also includes step 540 of providing a plurality of pairs of second-stage wires 106. Method 5 includes step 550 of forming multiple groups of second stage apices, each group positioned between adjacent first stage apices, by hooking each pair of second stage wires 106 onto first and second forming elements 100 that encase the first stage apices. Method 5 then includes step 560 of braiding the first stage wires 104 and second stage wires 106 onto the braiding head 102, starting from the forming elements 100 at the top of the tubular base body.

[0077] The arrangement is an arrangement of the shape elements around a central axis CA. The shape elements are arranged on the upper part of the braiding head. Preferably, the arrangement is a circular arrangement. In some cases, the arrangement may be non-circular, such as elliptical. The shape elements are preferably arranged in a dome-shaped (also called an inverted cup or cup-shaped) portion that narrows the cylindrical braiding head in the upper region of the braiding head toward the end of the braiding head. The shape elements are preferably arranged at a distance from the cylindrical wall toward the central axis CA of the braiding head on the dome-shaped upper region.

[0078] In some preferred embodiments, method 5 includes the further step of providing a plurality of bobbins 202, 204 arranged in second and third concentric arrangements outward from the central axis CA of the braiding head 102, forming a group of first stage apexes with the first and second first stage wires. The end of the first first stage wire is led from the first apex to a first bobbin in the second arrangement and a first bobbin in the third arrangement, respectively, with the first bobbins in the second and third arrangements being concentrically aligned. The end of the second first stage wire is led from the apex to a second bobbin in the second arrangement and a second bobbin in the third arrangement, respectively, with the second bobbins in the second and third arrangements being concentrically aligned. The second bobbins in the second arrangement are adjacent to the first bobbins in the second arrangement, and the second bobbins in the third arrangement are adjacent to the first bobbins in the third arrangement. Preferably, the first and second bobbins of each pair are adjacent to the third and fourth bobbins of the pair to which no first stage wire is connected.

[0079] In some preferred embodiments, method 5 additionally or alternatively includes the further step of forming a group of second-stage apexes formed by first and second second-stage wires, wherein one end of the first second-stage wire is led to a third bobbin in the second arrangement adjacent to a second bobbin in the second arrangement, while the other end is led to a fourth bobbin in the third arrangement. One end of the second-stage wire of the second apex is led to a third bobbin in the third arrangement adjacent to a second bobbin in the third arrangement, and the other end is led to a fourth bobbin in the second arrangement. The fourth bobbin is adjacent to a first bobbin of another group of first-stage apexes.

[0080] In some preferred embodiments, method 5 additionally or alternatively includes providing a plurality of bobbins in a ratio of form elements 100 to bobbins 202, 204 of 1:4.

[0081] In some preferred embodiments, method 5 additionally or alternatively includes providing a plurality of bobbins 202, 204, including providing 40 bobbins 202 in the second arrangement and 40 bobbins 204 in the third arrangement.

[0082] In some preferred embodiments, method 5 additionally or alternatively includes providing ten form elements 100 .

[0083] A schematic diagram of a braided tubular base body is shown in Figure 3A. Another example is shown in Figure 3E. The braided tubular base body 300 has a distal end portion 304 and a proximal end portion 306. The braided tubular base body 300 may have a cylindrical shape. The cylindrical shape may be a circular cylinder (in the cross section of the tubular body). Therefore, the braided tubular base body 300 may have a hollow mesh structure.

[0084] The tubular base body 300 has a cross-sectional diameter D1, which is preferably cylindrical, in certain embodiments, as generally determined by the shape of the braiding head 102. The opening 308 at the end of the tubular base body 300 can have an opening diameter D2. The cross-sectional diameter D1 of the tubular base body 300 is generally wider than the opening diameter D2 in preferred embodiments. In certain embodiments, D2 can be the same as D1 (straight tube shape). In certain embodiments, D2 can be larger than D1 (funnel shape).

[0085] The braided tubular base body 300 includes an opening 308 at the distal end 304. The opening has a periphery with a defined shape. In certain embodiments, the shape of the periphery of the opening can be circular. In some embodiments, it can be oval.

[0086] At the proximal end 306 of the braided tubular base body 300, the free ends of the braided wires extend freely. These ends may be held together by one or more fasteners 302. The fasteners may be removable or permanently placed. Typically, the fastener is, for example, a wire removably wrapped around the unbraided wire bundle before heat setting. This may be removed after heat setting when the risk of fraying is mitigated. The fastener prevents the end of the braided tubular base body 300 opposite the opening from unraveling or fraying.

[0087] Other types of fasteners may be clamps, welds, bolts, or other suitable fasteners for holding the free ends of the wires together. Permanent fasteners are generally applied to the medical device after heat-setting the braided tubular base body 300, as described below. In some examples, the ends of the wires may be braided internally into the hollow portion of the braided tubular base body to prevent the free ends from protruding from the base body. The fasteners 302 may preferably be configured to mate with a delivery device. In some examples, the fasteners are magnetically connectable to the delivery device. In some examples, the fasteners include clasps onto which the delivery device may clasp the medical device.

[0088] 3b-3d illustrate schematic diagrams of some example openings 308 that may be formed in the distal end 304 of the braided tubular base body 300. FIG.

[0089] The shape of the opening is generally determined by how the forming elements 100 are positioned within the braiding machine. Thus, various configurations and shapes of the opening perimeter are possible by varying the positioning of the forming elements 100. If the forming elements 100 are positioned in an oval shape, the braid opening 308 will also be oval. Similarly, the size of the opening 308 is determined by the positioning of the forming elements 100 and their positioning on the braiding head 102 relative to its central axis CA.

[0090] The braiding head 102 may have a round shape, and when the shape element 100 is placed inside this round portion, the distal end of the tubular base body becomes dome-shaped (inverted cup-shaped). Therefore, the opening may have a smaller diameter than the cross-section of the braided tubular base body 300. The shape element is placed around the central axis CA. The shape element is placed at the top of the braiding head. Preferably, the shape element is a circular arrangement. In some cases, the shape element may be non-circular, such as an ellipse. The shape element is preferably placed in a dome-shaped (also called an inverted cup-shaped or cup-shaped) portion that narrows the cylindrical braiding head in the upper region of the braiding head toward the end of the braiding head. The shape element is preferably placed at a distance from the cylindrical wall toward the central axis CA of the braiding head on the dome-shaped upper region.

[0091] The embodiment shown in Figure 3B has an opening diameter D2 that is approximately the same size as the cross-sectional diameter D1 of the braided tubular base body. Such a configuration may be suitable, for example, for making an occlusion or shunt device in which the braid is everted, meaning that the opening in the braid can be folded outward when inserted into a mold to form the medical device.

[0092] The embodiment shown in FIG. 3C has an opening diameter D2 that is smaller than the cross-sectional diameter D1 of the braided tubular base body. Such a configuration can be beneficial when fabricating medical devices with through-channels. The opening can be used as a guide for a channel-forming device (e.g., a peg, as described below) to penetrate the medical device. The braided tubular base body 300 can be easily inserted into the mold structure 208 so that the distal end portion 304 can be folded inward to create a double-layered braided mesh. Thus, the periphery of the opening 308 at the distal end 304 is oriented toward the center of the distal double-layered element after heat setting. The medical device thus formed has a robust peripheral opening and a double-layered element, such as a generally disk-shaped element, advantageously providing improved mechanical stability and peripheral properties as described herein. The wire loops of the braid are folded back with their apexes at the periphery of the opening.

[0093] The embodiment shown in Figure 3D has a very narrow opening diameter D2 compared to the cross-sectional diameter D1 of the braided tubular base body. To create an occlusion device with a substantially smooth surface, a small opening that is simply an opening can be beneficial. The braid can be set up so that the opening is narrow enough that it does not impair the occlusion capabilities of the final medical device.

[0094] 4A, there is shown a schematic cross-sectional view of mold structure 208. It should be noted that this is only one example of a mold structure, and that mold structures used to fabricate medical devices from braided base bodies may have different features than those disclosed in the figure.

[0095] To form the medical device, the braided tubular base body 300 is inserted into a mold structure 208 .

[0096] The braided tubular base body 300 can be inserted into the mold structure 208 so that the distal end portion 304 can be folded inward to create a double-layered braided mesh. Thus, the periphery of the opening 308 at the distal end 304 is oriented toward the center of the distal double-layered element after heat setting. The medical device thus formed has a sturdy peripheral opening and a double-layered element, such as a generally disk-shaped element, advantageously providing improved mechanical stability and peripheral properties as described herein. The wire loops of the braid are folded back with their apexes at the periphery of the opening.

[0097] In another example, the distal end portion 304 may be folded outward as it is inserted into the mold structure 108. Bending the distal end outward from the central channel may form an inverted braid structure. Thus, in some examples, a medical implantable device having an inverted braid may be formed.

[0098] 4B shows the tubular braid base body 300 being inserted into the mold structure 208. All of the wire ends extend to one side of the mold structure 208. This is before adding portions of the mold structure that constrain / determine where the device's fixation elements 302 will be located relative to the central axis of the device after heat setting. The mold structure 208 may include portions that allow for placement of the fixation elements 320 at a location offset from the central axis of the medical device. The mold structure 208 may include portions that allow for placement of the fixation elements 320 along the central axis of the medical device.

[0099] 4C, mold structure 208 may include peg 210. Peg 210 may be inserted into mold structure 208 to form a channel through the medical implant. Peg 210 may have a conical tip. Peg 210 may be inserted into the center of mold structure 208 to form a channel through the center of the medical implant. Advantageously, therefore, a medical device with an improved through-channel may be provided.

[0100] 4D-4E disclose the closed state of the mold structure 208. The ends of the wires are pressed against the sides of the mold structure 208 by the pegs 210. This is particularly facilitated by the conical tips of the pegs 210. In this way, when the pegs 210 are inserted into the mold in the desired heat-set shape, they "find it's way" through the spaces between the wires of the braided tubular base body 300, simplifying and therefore cost-effective manufacturing.

[0101] Mold structure 208 has an opening 303 at an offset distance from the center of the mold structure through which the ends of first-stage wire 104 and / or second-stage wire 106 (typically as a wire bundle including the wire ends) protrude from mold structure 208. The wire ends may be secured when inserted into the mold prior to heat-setting the tubular base body. The portions of the ends protruding from end 303 may be secured together at this opening (see FIG. 4E).

[0102] Upon insertion of the braided tubular base body 300 into the mold structure 208, the braided tubular base body 300 is preferably treated by heat setting. This may involve heating the mold structure 208 with the braided tubular base body 300 inserted therein to hold the desired shape of the medical implantable device. Heat setting forms the shape of the medical implantable device made from the braided tubular base body 300. Upon removal from the mold after the heat setting process, the braided tubular base body 300 retains its set shape and forms the shape of the medical implantable device. The pegs 208 facilitate the formation of heat-set through channels of the medical implantable device, such as through channel 410.

[0103] The wire ends may be secured after the tubular base body inserted into the mold is heat-set. Securing the wire ends prevents fraying of the braid, which can be a problem even after the medical device is heat-set. For example, the bundles may be welded together to form a spherical securing element 302. In some instances, a clamp may be used to secure some of the wire ends together. Such solidification welding methods are disclosed in WO 2009 / 016265, which is incorporated herein by reference in its entirety. In particular, the solidification welding of wire bundles described in WO 2009 / 016265 is incorporated by reference.

[0104] 7A and 7B are schematic diagrams of an example of a medical implantable device 400 having a braided tubular base body 300 (made by Method 5) with a through channel 410 made by the method (Methods 6a / 6b).

[0105] In summary, as shown in FIG. 6A, in some embodiments, a method 6a for forming a medical implantable device is provided. Method 6a preferably includes, in some instances, step 610, forming a braided tubular base body 102, as described in the examples above. Method 6a also includes step 620, heat-treating the tubular base body to form the medical implantable device from the braided tubular base body. The heat-treating is preferably performed based on a mold as described above. Thus, a medical device such as device 400 is manufactured by method 6a.

[0106] Further summarizing the present disclosure, as shown in Figure 6B, there is provided a method 6b for forming a medical implantable device, preferably with a through channel 410. Method 6b includes a step 630 of braiding a tubular base body 102, similar to step 610 of method 6a, and in some instances as described in the examples above. The tubular base body 102 includes a plurality of groups of first stage apices and a plurality of groups of second stage apices, each second stage apices located between adjacent first stage apices.

[0107] Method 6b includes step 640 of providing a mold structure 208 and inserting a braided tubular base body 102 into the mold structure 208 to form a medical device of the tubular base body 102. Method 6b includes step 650 of inserting a peg 210 through the braided tubular base body 102 inserted into the mold structure 208 to form a channel through the braided tubular base body 102 and across the mold structure 208.

[0108] Method 6b includes step 650 of heat setting mold structure 208 with braided tubular base body 102 and pegs 210 to form medical implantable device 400, similar to step 620 of method 6a.

[0109] In some preferred embodiments, method 6b additionally or alternatively comprises the further step of inserting a peg into the center of the mold, the peg preferably having a conical tip.

[0110] In some preferred embodiments, method 6b additionally or alternatively includes the further step of securing together at least some of the ends of the wires of the braided tubular base body.

[0111] In some preferred embodiments, method 6b additionally or alternatively includes the further step of securing the wire at an offset distance from the central axis of the medical implantable device.

[0112] The medical implant may be an occlusion device. In some instances, a membrane may be added to the medical implant to improve occlusion at selected portions thereof. The medical implant may be a shunt device, such as the atrial blood flow regulator described in the same applicant's International Publication No. 2016 / 038115, the entire contents of which are incorporated herein by reference (the inventive tubular base body technology disclosed therein provides improved properties). A membrane may be fixed over the opening and / or through-channel. The membrane is positioned to be at least partially removed or penetrated after implantation. Thus, an occlusion device (stopping blood flow) is provided that can be converted into a shunt device (allowing blood flow through the device's channel upon implantation). The membrane may be degradable. After a specific desired implantation time, the membrane dissolves in the body, providing a through-channel. Alternatively, the membrane may be non-degradable and surgically perforated. The membrane may be controllably removed from outside the body. For example, ultrasound, radiofrequency, or similar radiation may lead to membrane disintegration or trigger a degradation process. The membrane can be dissolved to avoid introducing debris into the bloodstream. The membrane can be resealed, for example with a stapler.

[0113] Alternatively, the through channel 410 may include a valve unit. The valve unit may be inserted through the through channel 410. The valve unit may, in certain examples, be an integral part of the medical device 400. The valve unit may, in certain examples, be inserted into and / or secured to the through channel 410 of the medical device 400. When secured to the periphery of the opening, the robust design of the periphery, as described herein, may provide particularly advantageous retention of the valve. In certain examples, the valve unit may be a so-called stent valve that is expanded or expandable within the through channel 410. The valve unit may provide unidirectional flow, for example, by leaflets within the through channel. The valve unit may have two operating states (closed / open), activated and selected, for example, by an external magnetic trigger or a bistable mechanism. The valve may open or close after a specific implantation time, for example, by a biodegradable locking unit that holds the valve in a specific position. Thus, advantageous therapeutic procedures may be provided for patient treatment, avoiding invasive access to the medical device after implantation.

[0114] The medical implant may be a fixation structure for improving fixation of different medical implantable devices. The periphery of the opening may provide advantageous attachment of other structures to the medical device when implanted.

[0115] The first stage wire 104 can have the same thickness as the second stage wire 106. The first stage wire 104 can have a different thickness than the second stage wire 106. The first stage wire 104 can be thinner than the second stage wire 106. The first stage wire 104 can be thicker than the second stage wire 106. This can provide advantageous mechanical strength to medical devices formed from such base wire thickness configurations.

[0116] The first stage wire 104 may be made from a shape memory material, such as a shape memory metal alloy. The first stage wire 104 may be made from a biodegradable material. The first stage wire 104 may be made from a bioabsorbable material. The first stage wire 104 may be formed from magnesium. The first stage wire 104 may be made from a nickel-titanium alloy. This may provide beneficial and desirable degradation characteristics for medical devices formed from the selected base wire material.

[0117] The second stage wire 106 may be made from a shape memory material. The second stage wire 106 may be made from a biodegradable material. The second stage wire 106 may be made from a bioabsorbable material. The second stage wire 106 may be formed from magnesium. The second stage wire 106 may be made from a nickel-titanium alloy. This may provide advantageous and desirable degradation characteristics for medical devices formed from the selected base wire material. The first stage wire 104 and / or the second stage wire 106 may, in some embodiments, be made from any other metallic or elastic material suitable for the human body. The first stage wire 104 and the second stage wire 106 may be made from the same material or different materials.

[0118] Although the present invention has been described above with reference to specific embodiments, other embodiments than those described above are equally possible within the scope of this disclosure.

[0119] Although modifications and variations may be suggested by those skilled in the art, it is the intent of the inventors to incorporate within the scope of the patent granted all such variations and variations as are reasonably and appropriately made within the scope of their contribution to the art. [Explanation of symbols]

[0120] 100 shape elements 102 Braided Head CA Braiding Head Center Axis 104 First Stage Wire 106 Second Stage Wire 202 Second arrangement bobbin 202a: first bobbin of second arrangement 202b second bobbin of second arrangement 202c a third bobbin of the second arrangement 202d Fourth bobbin of second arrangement 204 Third Arrangement Bobbin 204a: the first bobbin of the third arrangement 204b second bobbin of third arrangement 204c Third bobbin of third arrangement 204d Fourth bobbin of third arrangement 206 Bobbin Group 208 Mold structure 210 Pegs 222 pairs of bobbins 300 Braided tubular base body 302 Fixed Elements 303 Opening offset center 304 Distal end portion of braided body 306 Proximal end portion of braided body 308 Opening of tubular base body 400 Implantable Medical Devices 410 Through Channel 5 ways 510~560 Method steps 6a method 610~620 Method steps 6b Method 630~660 Method steps D1 Cross-sectional diameter of the braided tubular base body D2 Opening diameter

Claims

1. 1. A method of forming a braided tubular base body having openings at its ends for a medical implant, the method comprising: providing a plurality of form elements (100) in one end region of a braiding head (102), said braiding head having a central axis (CA), said form elements being arranged in a first arrangement around said central axis (CA); providing a plurality of pairs of first-stage wires (104); forming a plurality of groups of first stage apexes by hooking one pair of the plurality of pairs of first stage wires (104) to a first forming element and another pair of the plurality of pairs of first stage wires (104) to a second forming element adjacent to the first forming element; providing a plurality of second-stage wires (106); forming a plurality of second stage apexes by hooking each of the second stage wires (106) to a different pair of adjacent first and second forming elements (100); thereafter braiding said first stage wires (104) and said second stage wires (106) into a tubular base body.

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

3. 3. The method according to claim 2, wherein the shaping elements are arranged at a distance from a cylindrical wall towards a central axis (CA) of the braiding head, and the end region of the braiding head is preferably dome-shaped.

4. The method comprises: providing a plurality of bobbins (202, 204) arranged in second and third concentric arrangements outward from the central axis (CA) of the braiding head (102), wherein the first stage apex groups are formed by first and second first stage wires; The ends of the first first-stage wire are guided from a first apex to first bobbins of a second arrangement and first bobbins of a third arrangement, respectively, and the first bobbins of the second and third arrangements are aligned concentrically; The ends of the second first-stage wires are respectively guided from the top to the second bobbins of the second arrangement and the second bobbins of the third arrangement, and the second bobbins of the second and third arrangements are concentrically aligned; the second bobbin in the second arrangement is adjacent to the first bobbin in the second arrangement; The method of any one of claims 1 to 3, wherein the second bobbin in the third arrangement is adjacent to the first bobbin in the third arrangement.

5. 5. The method of claim 4, wherein the first and second bobbins of each pair are adjacent to the third and fourth bobbins of the pair that do not have a first stage wire connected thereto.

6. The second stage apex group is formed by first and second second stage wires, one end of the first second stage wire is led to a third bobbin of the second arrangement adjacent to the second bobbin of the second arrangement, and the other end of the first second stage wire is led to a fourth bobbin of the third arrangement; One end of the second top second stage wire is led to a third bobbin of the third arrangement adjacent to the second bobbin of the third arrangement, and the other end is led to a fourth bobbin of the second arrangement; 6. The method of claim 4 or 5, wherein the fourth bobbin is adjacent to a first bobbin of another group at the top of the first stage.

7. The method according to any one of claims 4 to 6, wherein the step of providing a plurality of bobbins comprises providing a ratio of form elements (100) to bobbins (202, 204) of 1:

4.

8. 8. The method of claim 4, wherein providing a plurality of bobbins (202, 204) comprises providing 40 bobbins (202) in the second arrangement and 40 bobbins (204) in the third arrangement.

9. The method of any one of claims 1 to 8, wherein providing a plurality of form elements (100) comprises providing ten form elements (100).

10. The method according to any one of claims 1 to 9, wherein each of said second stage apexes is located between two adjacent form elements, preferably offset towards said central axis (CA).

11. The method of claim 10 , wherein each second stage crest is disposed between first stage crests formed on adjacent feature elements.

12. The method according to any one of claims 1 to 11, wherein second stage wires are hooked onto adjacent pairs of forming elements, whereby the second stage wires are arranged overlapping each other.

13. 1. A method for forming a medical implantable device, said method comprising: forming a braided tubular base body according to any one of claims 1 to 12; and heat treating the braided tubular base body to form the medical implantable device from the braided tubular base body.

14. 1. A method of forming a medical implantable device having a through channel, the method comprising:

13. A process for braiding a tubular base of wires according to the method of any one of claims 1 to 12, wherein the tubular base comprises wires arranged in a plurality of groups of first stage apices and a plurality of groups of second stage apices of the wires; providing a mold structure and inserting the braided tubular base body into the mold structure; inserting pegs through the braided tubular base body inserted into the mold structure to form channels; and heat setting the braided tubular base body with the pegs inserted into the mold structure to form the medical implantable device with the through channel.

15. The method of claim 14 , wherein the peg is inserted into the center of the mold.

16. 16. The method of claim 14 or 15, wherein the peg has a conical tip.

17. 17. The method according to claim 15 or 16, further comprising fixing both ends of the braided wire of the tubular base body to prevent fraying of the braid of the tubular base body.

18. 18. The method of claim 17, further comprising the step of fixing the wire at a distance offset from a central axis of the medical implantable device so as to provide the through channel, when formed, that is positioned at the center of the medical implantable device.

19. A braided tubular base body (300) for a medical implant, preferably a shunt or occlusion device, said braided tubular base body having an opening at an end thereof, said opening having a periphery comprising: a plurality of first stage wires and a plurality of second stage wires; a plurality of groups of first stage tops; a plurality of groups of second stage tips; A braided tubular base body (300), wherein said base body is manufactured according to the method of any one of claims 1 to 13.

20. 20. A medical implantable device (400) made from a tubular base body according to claim 19 and manufactured according to the method of claim 13 or 14, wherein the medical implantable device comprises an opening at an end thereof having a periphery, the periphery comprising: a plurality of first stage wires and a plurality of second stage wires; a plurality of groups of first stage tops; and a plurality of second stage apices disposed thereon.

21. 21. The medical implantable device (400) of claim 20, wherein the medical implantable device comprises a through channel (410) through the medical implantable device that includes the opening.

22. 22. The medical implantable device (400) of claim 21, wherein the through channel is centrally located in the medical implantable device.

23. 23. The medical implantable device (400) of claim 21 or 22, wherein the medical implantable device is a shunt device that allows blood flow through the through channel when implanted.

24. The medical implantable device (400) of any one of claims 20 to 22, wherein a removable and / or re-puncturable membrane is arranged to close said opening.

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