Occluder and method of manufacturing an occluder

Abstract

The application provides a closure device and a preparation method thereof. The closure device comprises at least one closure disc, and the closure disc comprises a support framework, the support framework comprises a first support member and a second support member connected to each other, the first support member is made of a metal material, and the second support member is made of a degradable material; and the second support member is arranged in at least one annular region around an axis of the closure disc. That is, the degradable material is used to replace part of the metal material in the closure disc, thereby reducing the content of metal in the closure device and reducing the release of metal ions. Moreover, the degradable material will not remain in the body after degradation, thereby reducing the occurrence of complications. During loading and releasing, the first support member made of the metal material pulls the second support member made of the degradable material in the circumferential direction, so that the closure device exhibits good resilience during compression and expansion, thereby making up for the defects of the degradable material in the mechanical properties when applied to the field of closure devices.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an occluder and a method for preparing the occluder. Background Technology

[0002] Patent foramen ovale (PFO) is a common type of congenital heart disease. Currently, various types of occluder devices are available for treating congenital heart disease. These occluders are delivered to the lesion site in the patient's heart via catheter and guidewire through the femoral vein or femoral artery, thereby achieving a cure.

[0003] Currently, the most common patent foramen ovale (PFO) occluders used clinically include metal skeleton occluders without a flow-blocking membrane and metal skeleton occluders with a flow-blocking membrane. The flow-blocking membrane can be made of polyester, polytetrafluoroethylene (PTFE), or PET. The metal skeleton is made of materials such as cobalt-based alloys or nickel-titanium alloys. These occluders generally consist of a dense mesh metal skeleton and a flow-blocking membrane, resulting in a relatively high metal content and increasing the risk of metal ion release into the body. Summary of the Invention

[0004] The purpose of this invention is to provide an occluder that can be released into the human body and a method for preparing the occluder, so as to solve the problems in the prior art.

[0005] To solve the above-mentioned technical problems, the present invention adopts the following technical solution: a occlusion device, comprising at least one occlusion disc; the occlusion disc includes a support frame, the support frame includes a first support member and a second support member connected to each other, the first support member is made of metal material, and the second support member is made of biodegradable material; the second support member is disposed in at least one annular region around the axis of the occlusion disc.

[0006] In some embodiments, the geometric center of the support frame is located in the annular region, and the first support member is used to form at least the periphery of the support frame.

[0007] In some embodiments, the first support member includes a plurality of first support rods arranged circumferentially along the support frame. Each first support rod includes a radial segment and a circumferential segment. At least one end of the circumferential segment is connected to one end of the radial segment. The end of the radial segment away from the circumferential segment is located at the geometric center of the support frame. The circumferential segments of the plurality of first support rods are arranged sequentially along the circumference of the support frame to form the periphery of the support frame.

[0008] The second support member includes a plurality of second support rods spaced circumferentially along the support frame. The inner ends of the plurality of second support rods are coupled to the geometric center of the support frame, and the outer ends extend outward and are connected to the corresponding first support rods.

[0009] In some embodiments, a radial segment of one of the first support rods and an adjacent first support rod enclose a closed region, and the second support rod is disposed within the closed region.

[0010] In some embodiments, each of the circumferential segments of the first support rod is provided with radial segments at both ends, the two radial segments being a left radial segment and a right radial segment, and the right radial segment of the first support rod extends in contact with the left radial segment of the adjacent first support rod.

[0011] In each of the first support rods, the circumferential segment and the two radial segments together enclose a closed area, and the second support rod is disposed within the closed area.

[0012] In some embodiments, in any two adjacent first support rods, the left radial segment or the right radial segment of one first support rod extends into the enclosed area of ​​the other first support rod.

[0013] In some embodiments, the central region of the circumferential segment has a connection point that connects the two second support rods.

[0014] In some embodiments, the circumferential segment includes two arc-shaped portions arranged sequentially along the circumference of the support frame, and the connection point is formed at the junction of the two arc-shaped portions.

[0015] In some embodiments, one end of the circumferential segment away from the radial segment is connected to the outer end of at least one of the second support rods.

[0016] In some embodiments, one end of the circumferential segment away from the radial segment is simultaneously connected to the outer end of at least one of the second support rods and the radial segment adjacent to the first support rod.

[0017] In some embodiments, the first support member further includes at least one peripheral rod; the peripheral rod and the plurality of circumferential segments together form the periphery of the support frame;

[0018] The outer peripheral rod and the adjacent first support rod together form a closed area, the second support rod is located within the closed area, and the outer end of the second support rod is connected to the corresponding outer peripheral rod.

[0019] In some embodiments, the second support member includes a plurality of second support rods spaced apart circumferentially along the support frame, wherein the inner end of each second support rod is located at the geometric center of the support frame and the outer end is away from the geometric center of the support frame;

[0020] The first support member includes a plurality of first support rods connected sequentially along the circumference of the support frame, and the two ends of each first support rod are respectively connected to the outer ends of two adjacent second support rods.

[0021] In some embodiments, the second support rod is arc-shaped, and in any two adjacent second support rods, the convex surface of one second support rod is disposed opposite to the concave surface of the other second support rod.

[0022] In some embodiments, at least one first support rod has a first end connected to a pair of second support rods, the pair of second support rods being arc-shaped and having their concave surfaces facing each other.

[0023] In some embodiments, the annular region extends from the geometric center of the support frame to its periphery, and the second support forms the periphery of the support frame, with the first support disposed within the annular region.

[0024] In some embodiments, the second support member includes a plurality of second support rods arranged circumferentially along the support frame. Each second support rod includes a radial segment and a circumferential segment connected to each other. The end of the radial segment away from the circumferential segment is located at the geometric center of the support frame. The circumferential segments of the plurality of second support rods are arranged sequentially along the circumference of the support frame to form the periphery of the support frame. Each second support rod and the adjacent second support rod enclose a closed area.

[0025] The first support member includes a plurality of first support rods arranged circumferentially along the support frame, and the plurality of first support rods are all located within the enclosed area.

[0026] In some embodiments, one end of the first support rod is connected to the circumferential segment of the corresponding second support rod, and the other end extends to the geometric center of the support frame and / or to the radial segment connected to the circumferential segment of the corresponding second support rod.

[0027] In some embodiments, a first end of the first support rod is connected to the geometric center of the support frame or the radial segment, and a second end of the first support rod is radially spaced from the circumferential segment.

[0028] In some embodiments, the first support member further includes a support ring, the support ring being connected to the second ends of a plurality of the first support rods.

[0029] In some embodiments, the annular region is disposed between the geometric center and the periphery of the support frame, and the first support member is disposed at least at the geometric center and the periphery of the support frame.

[0030] In some embodiments, the first support member includes a plurality of first support rods arranged circumferentially along the support frame. Each first support rod includes a radial segment and a circumferential segment. One end of the radial segment is located at the geometric center of the support frame, and the circumferential segments of the plurality of first support rods are sequentially arranged to form the periphery of the support frame.

[0031] The second support member includes a plurality of second support rods, each of which connects the corresponding radial segment and the circumferential segment.

[0032] In some embodiments, the first support member includes a plurality of first support rods arranged circumferentially along the support frame. Each first support rod includes a radial segment and a circumferential segment. One end of the radial segment is located at the geometric center of the support frame. The circumferential segments of the plurality of first support rods are connected in sequence to form the periphery of the support frame. The radial segments of the first support rod and another adjacent first support rod form a closed region.

[0033] The second support member includes a plurality of second support rods;

[0034] Each of the enclosed areas includes at least one second support rod, and at least one end of the second support rod is connected to the radial segment or the circumferential segment.

[0035] In some embodiments, the first support member further includes at least one connecting rod, and each of the connecting rods is correspondingly disposed within the enclosed area;

[0036] One end of the second support rod is connected to the connecting rod.

[0037] In some embodiments, the annular region is disposed at the periphery of the support frame, the second support member is used to form the periphery of the support frame, and the first support member is disposed at least between the geometric center and the annular region.

[0038] In some embodiments, the first support member includes a plurality of first support rods spaced apart circumferentially along the support frame, wherein a first end of each first support rod is located at the geometric center of the support frame and a second end is located away from the geometric center of the support frame;

[0039] The second support member includes a plurality of second support rods arranged sequentially along the periphery of the support frame, and the two ends of each second support rod are respectively connected to the second end of the corresponding first support rod.

[0040] In some embodiments, the first support rod is arc-shaped, and in any two adjacent first support rods, the convex surface of one first support rod is disposed opposite to the concave surface of the other first support rod.

[0041] In some embodiments, at least one second support rod has its first end connected to a pair of first support rods, the pair of first support rods being arc-shaped and having their concave surfaces facing each other.

[0042] In some embodiments, the first support member includes two interconnected first rods, wherein one first rod includes multiple metal wires forming a gap between the multiple metal wires, and the other first rod is inserted into the gap of the one first rod.

[0043] In some embodiments, the first support member includes at least one first rod, the first rod including a plurality of metal wires, wherein gaps are formed between the plurality of metal wires, and the second support member includes at least one second rod, the second rod being inserted into the gaps of the first rod.

[0044] In some embodiments, the second rod is inserted into the connection of the first rod and is also bonded to each other.

[0045] In some embodiments, the second support member is bonded to the first support member.

[0046] In some embodiments, the second support member includes two second rods bonded together.

[0047] In some embodiments, the occluder further includes a retaining ring located at the geometric center for converging the end of the support frame, the retaining ring being used to connect with the first support member and / or the second support member; the second support member is bonded to the retaining ring.

[0048] In some embodiments, along the axial direction of the occluder, the support frame includes a multi-layer support structure, each layer of the support structure including the second support member, and the second support members in the multi-layer support structure are correspondingly arranged.

[0049] In some embodiments, the occluder includes two occluder discs spaced apart along the axial direction; both occluder discs include the second support member, and the second support members of the two occluder discs are correspondingly arranged.

[0050] In some embodiments, the first support member is made of a biodegradable metal material.

[0051] The present invention also provides a method for preparing a plugging device, comprising the following steps:

[0052] The first support component was prepared using metallic materials;

[0053] The second support component was prepared using a biodegradable material;

[0054] The first support member and the second support member are connected to each other according to a preset shape, and the second support member is arranged in at least one annular region around the axis of the preset shape to obtain the support frame of the occluder.

[0055] In some embodiments, the structure connected to the second support member and the second support member are bonded together.

[0056] As can be seen from the above technical solution, the present invention has at least the following advantages and positive effects:

[0057] In the occlusion device of the present invention, at least one occlusion disc includes a first support member and a second support member. The second support member is made of a biodegradable material, and along the circumference of the occlusion disc, the area covered by the second support member is at least one annular region around the axis of the occlusion disc. That is, biodegradable material replaces part of the metal material in the occlusion disc, thereby reducing the metal content in the occlusion device and reducing the release of metal ions. Furthermore, the biodegradable material does not remain in the body after degradation, reducing the occurrence of complications.

[0058] In addition, the biodegradable material in the sealing disc is disposed in at least one annular area around the axis of the sealing disc. During the loading and release of the sealing disc, the first support member of the metal material pulls the second support member of the biodegradable material in the circumferential direction, so that the sealing device exhibits good resilience during compression and expansion, which makes up for the mechanical performance defects of biodegradable materials in the field of sealing devices. Attached Figure Description

[0059] Figure 1 This is a schematic diagram of the structure of the first embodiment of the occluder of the present invention.

[0060] Figure 2 yes Figure 1 A schematic diagram of the sealing disc of the middle sealing device.

[0061] Figure 3 This is a schematic diagram of the sealing disc in the second embodiment of the sealing device of the present invention.

[0062] Figure 4 This is a schematic diagram of the sealing disc in the third embodiment of the sealing device of the present invention.

[0063] Figure 5 This is a schematic diagram of the fourth embodiment of the occluder of the present invention.

[0064] Figure 6 This is a schematic diagram of the sealing disc in the fourth embodiment of the sealing device of the present invention.

[0065] Figure 7 yes Figure 6 A schematic diagram of the structure of the first support rod.

[0066] Figure 8 This is a schematic diagram of a modified version of the sealing disc in the fourth embodiment of the sealing device of the present invention.

[0067] Figure 9 This is a schematic diagram of another modification of the sealing disc in the fourth embodiment of the sealing device of the present invention.

[0068] Figure 10 This is a structural schematic diagram of another modification of the sealing disc in the fourth embodiment of the sealing device of the present invention.

[0069] Figure 11 This is a structural schematic diagram of another modification of the sealing disc in the fourth embodiment of the sealing device of the present invention.

[0070] Figure 12 This is a schematic diagram of the structure of the first rod in this invention.

[0071] Figure 13 This is a schematic diagram of the structure of the second rod in this invention.

[0072] Figure 14 This is a schematic diagram of the structure after the first rods are interlocked in this invention.

[0073] Figure 15 This is a schematic diagram of the structure after the second rod is bonded together in this invention.

[0074] Figure 16 This is a schematic diagram of the structure after the second rod and the first rod are interlocked in this invention.

[0075] Figure 17 yes Figure 16 A schematic diagram of the structure after bonding at the intersection points.

[0076] Figure 18 This is a schematic diagram of the structure of the mold for weaving the first support member in this invention.

[0077] Figure 19 yes Figure 18 Top view of the mold.

[0078] Figure 20 yes Figure 18 A schematic diagram of the winding groove in the intermediate mold.

[0079] Figure 21 This is a schematic diagram of the structure in which the first support rod passes through the central hole.

[0080] Figure 22 This is a schematic diagram of the sealing disc in the fifth embodiment of the sealing device of the present invention.

[0081] Figure 23 yes Figure 21 A schematic diagram of the structure of the first support rod.

[0082] Figure 24 This is a schematic diagram of a modified version of the sealing disc in the fifth embodiment of the sealing device of the present invention.

[0083] Figure 25 This is a schematic diagram of the sealing disc in the sixth embodiment of the sealing device of the present invention.

[0084] Figure 26 This is a schematic diagram of a modified version of the sealing disc in the sixth embodiment of the sealing device of the present invention.

[0085] Figure 27 This is a schematic diagram of the sealing disc in the seventh embodiment of the sealing device of the present invention.

[0086] Figure 28 This is a schematic diagram of a modified version of the sealing disc in the seventh embodiment of the sealing device of the present invention.

[0087] Figure 29 This is a schematic diagram of the sealing disc in the eighth embodiment of the sealing device of the present invention.

[0088] Figure 30 This is a schematic diagram of the sealing disc in the ninth embodiment of the sealing device of the present invention.

[0089] Figure 31 This is a schematic diagram of the sealing disc in the tenth embodiment of the sealing device of the present invention.

[0090] Figure 32 This is a schematic diagram of the sealing disc in the eleventh embodiment of the sealing device of the present invention.

[0091] Figure 33 This is a schematic diagram of a modified version of the sealing disc in the eleventh embodiment of the sealing device of the present invention.

[0092] Figure 34 This is a schematic diagram of the sealing disc in the twelfth embodiment of the sealing device of the present invention.

[0093] Figure 35 This is a schematic diagram of the sealing disc in the thirteenth embodiment of the sealing device of the present invention.

[0094] Figure 36 This is a schematic diagram of one modification of the sealing disc in the thirteenth embodiment of the sealing device of the present invention.

[0095] The annotations in the attached figures are explained as follows:

[0096] 800, Occlusion device; 10a, Occlusion disc; 50a, Connector; 1a, Support frame; 11a, Fixing ring; 12a, First support rod; 121a, Radial section; 122a, Circumferential section; 13a, Second support rod; 2a, Flow-blocking membrane;

[0097] 1b, Support frame; 11b, Fixing ring; 12b, First support rod; 121b, Radial section; 122b, Circumferential section; 13b, Second support rod; 14b, Support ring;

[0098] 1c, Support frame; 11c, Fixing ring; 12c, First support rod; 121c, Radial section; 122c, Circumferential section; 123c, Outer peripheral rod; 1231c, Arc-shaped part; 13c, Second support rod;

[0099] 900, Occlusion device; 10d, Occlusion disc; 50d, Connector; 1d, Support frame; 11d, Fixing ring; 12d, First support rod; 121d, Radial section; 122d, Circumferential section; 1221d, Arc-shaped part; 13d, Second support rod; 2d, Flow-blocking membrane; 15d, First rod body; 151d, Metal wire; 16d, Second rod body;

[0100] 1e, Support frame; 11e, Fixing ring; 12e, First support rod; 121e, Radial section; 1211e, Left radial section; 1212e, Right radial section; 122e, Circumferential section; 1221e, Arc-shaped part; 13e, Second support rod;

[0101] 1f, Support frame; 11f, Fixing ring; 12f, First support rod; 13f, Second support rod;

[0102] 1g, Support frame; 11g, Fixing ring; 12g, First support rod; 13g, Second support rod; 131g, Radial section; 132g, Circumferential section;

[0103] 1h, Support frame; 11h, Fixing ring; 12h, First support rod; 13h, Second support rod; 14h, Support ring;

[0104] 1i, Support frame; 11i, Fixing ring; 12i, First support rod; 13i, Second support rod;

[0105] 1j, Support frame; 11j, Fixing ring; 12j, First support rod; 121j, Radial section; 122j, Circumferential section; 13j, Second support rod;

[0106] 1k, Support frame; 11k, Fixing ring; 12k, First support rod; 121k, Radial section; 122k, Circumferential section; 13k, Second support rod;

[0107] 1m, Support frame; 11m, Fixing ring; 12m, First support rod; 13m, Second support rod; 14m, Connecting rod;

[0108] 1n, Support frame; 11n, Fixing ring; 12n, First support rod; 13n, Second support rod;

[0109] 3. Mold; 31. Base; 311. Center hole; 312. Lower positioning hole; 313. Lower mounting hole; 314. Winding groove; 3141. Winding section; 315. Indicator groove; 32. Fixing component; 321. Upper positioning hole. Detailed Implementation

[0110] Typical embodiments embodying the features and advantages of the present invention will be described in detail in the following description. It should be understood that the present invention can have various variations in different embodiments without departing from the scope of the present invention, and the descriptions and illustrations herein are for illustrative purposes only and not intended to limit the present invention.

[0111] This invention provides an occluder for sealing defects in the vascular system. These defects include, but are not limited to, the foramen ovale, ductus arteriosus, atrial septal defect, and ventricular septal defect. This application uses the foramen ovale as an example to illustrate the advantages of the occlusion system in treating patent foramen ovale. It is understood that the defect can also be any of the other defects mentioned above.

[0112] The occluder in this application, based on the metal skeleton in existing technologies, uses a biodegradable material to replace part of the metal skeleton, thereby reducing the metal content in the occluder and the release of metal ions. Furthermore, the biodegradable material does not remain in the body after degradation, reducing the occurrence of complications.

[0113] The following is a description through specific embodiments.

[0114] First embodiment of the plugging device

[0115] The occlusion device includes at least one occlusion plate. See also... Figure 1 In this embodiment, the occluder 800 includes two occlusion discs 10a and a connector 50a connecting the two occlusion discs 10a. In other embodiments, the occluder 800 may omit one of the occlusion discs 10a, that is, it may only include a single formed occlusion disc 10a or an occlusion plug. The specific choice can be made according to actual needs.

[0116] In this embodiment, the two sealing discs 10a are used to cover different openings of the foramen ovale, namely the two openings of the foramen ovale located in the left and right atria.

[0117] In this embodiment, the two sealing discs 10a have similar structures. Please refer to [link / reference]. Figure 2 , Figure 2 The sealing disc 10a shown is Figure 1 One of the two blocking plates in the middle, 10a. This is understandable. Figure 2The specific structure of the sealing disc 10a shown can be applied to the other of the two sealing discs 10a as long as there is no contradiction in principle and function. In modified embodiments, the two sealing discs 10a can adopt different specific technical solutions; otherwise, the size of the two sealing discs 10a and the position of the flow-blocking membrane 2a can be different.

[0118] like Figure 2 As shown, each sealing plate 10a includes a support frame 1a and a flow-blocking membrane 2a covering the support frame 1a.

[0119] The flow-blocking membrane 2a can be made of either a biodegradable or non-biodegradable material. The flow-blocking membrane 2a is formed by covering the support frame 1a through methods such as sewing, bonding, electrospinning, impregnation, or spraying to obtain the sealing disc 10a.

[0120] Specifically, in this embodiment, the support frame 1a is a single-layer disk structure, that is, there is only one layer of support structure in the axial direction, such as a support mesh. In other embodiments, the support frame 1a can also be a double-layer disk structure, that is, a mesh structure is formed on both the distal and proximal sides.

[0121] The support frame 1a includes a first support member and a second support member that are interconnected. The first support member is made of metal, and the second support member is made of a biodegradable material. The second support member is disposed within at least one annular region around the axis of the sealing disc 10a. Figure 2 In the diagram, the annular region refers to the area extending from the geometric center of the supporting skeleton 1a to the dashed circle.

[0122] It should be noted that the biodegradable material in this application refers to a polymeric material that can be gradually degraded, eroded, and metabolized by the human body after implantation, such as copolymers or blends of one or more of polylactic acid (PLA), polyglycolic acid (PGA), polydioxanone (PDO), polycaprolactone (PCL), polyglyconate, polyhydroxybutyrate, polyanhydride, and polyphosphoester. In some embodiments, the biodegradable material in this application can be a biodegradable metallic material, such as a magnesium alloy, iron alloy, or zinc alloy.

[0123] Of the two sealing discs 10a, at least one sealing disc 10a's support frame 1a adopts the above-described structure. That is, both sealing discs 10a's support frames 1a can adopt the above-described structure, or one support frame 1a can adopt the above-described structure, while the other support frame 1a adopts the structure in related technologies. The specific choice can be made according to actual needs.

[0124] The support skeleton 1a of the occluder 800 in this application incorporates biodegradable materials, which reduces the use of metal materials, thereby reducing the metal content of the occluder 800 and the release of metal ions. The biodegradable skeleton will not remain in the body after degradation, thus reducing the occurrence of complications.

[0125] In addition, the biodegradable material in the sealing disc 10a is disposed in at least one annular region around the axis of the sealing disc 10a. During the loading and unloading process of the sealing disc 10a, the first support member of the metal material pulls the second support member of the biodegradable material in the circumferential direction, so that the sealing device 800 exhibits good resilience during compression and expansion, which makes up for the defects in mechanical performance of biodegradable materials in the field of sealing device 800.

[0126] Furthermore, the support framework 1a in the occlusion disc 10a uses a biodegradable second support component. After implantation, the second support component is gradually decomposed and absorbed by the tissue endothelial cells. In some embodiments, the second support component will eventually be completely converted into water and carbon dioxide and absorbed by the human body. After the second support component degrades, it is beneficial to increase the area of ​​the mesh on the support framework 1a of the occlusion disc 10a, thereby reducing irritation to the human body.

[0127] In particular, in this embodiment, after the occluder 800 is implanted into the human body, the two occluder discs 10a are separated by a diaphragm in the axial direction. When the two occluder discs 10a are provided with a second support at the corresponding position, after the second support is completely degraded, it is possible to puncture the diaphragm at the corresponding position to form a stoma, so that subsequent interventional surgery can enter the left atrium from the right atrium, reducing the difficulty of the second interventional surgery.

[0128] In a modified embodiment, the support frame 1a includes a multi-layer support structure along the axial direction of the occluder 800. For example, each occluder disc 10a is a double-layer disc structure, and each layer of the support structure includes a second support member, with the second support members in the multi-layer support structure being correspondingly arranged.

[0129] The following details the support frame 1a in this embodiment.

[0130] Specifically, the geometric center of the support frame 1a is located in the annular region, and the first support member is used to form at least the periphery of the support frame 1a. In this embodiment, see further... Figure 2 The annular region refers to the area extending from the geometric center to the dashed line.

[0131] The first support member includes a plurality of first support rods 12a arranged circumferentially along the support frame 1a. In this embodiment, the number of first support rods 12a is 5. In other embodiments, the number of first support rods 12a may be 6, 8, or other numbers, depending on actual needs.

[0132] Furthermore, the five first support rods 12a are evenly arranged around the circumference of the support frame 1a, that is, symmetrically arranged along the axial direction of the support frame 1a.

[0133] The first support rod 12a includes a radial segment 121a and a circumferential segment 122a. The radial segment 121a extends approximately radially along the support frame 1a, and the circumferential segment 122a extends approximately circumferentially along the support frame 1a.

[0134] Specifically, in this embodiment, the first support rod 12a includes a radial segment 121a and a circumferential segment 122a. One end of the radial segment 121a is located at the geometric center of the support frame 1a, and the other end is away from the geometric center of the support frame 1a and connected to the circumferential segment 122a. That is, one end of the circumferential segment 122a is connected to one end of the radial segment 121a, and the end of the radial segment 121a away from the circumferential segment 122a is located at the geometric center of the support frame 1a.

[0135] In this embodiment, the radial segment 121a is arc-shaped, and in any two adjacent radial segments 121a, the convex surface of one radial segment 121a is opposite to the concave surface of the other radial segment 121a. In other embodiments, the radial segment 121a may also be straight.

[0136] The circumferential segment 122a is arc-shaped. The concave surface of each circumferential segment 122a faces the geometric center of the support frame 1a. The circumferential segments 122a of the multiple first support rods 12a are arranged sequentially along the circumference of the support frame 1a to form the periphery of the support frame 1a.

[0137] The first support component is made of metal, specifically the first support rod 12a. This metal can be a non-degradable material, such as cobalt-based alloys, nickel-titanium alloys, or stainless steel. Alternatively, it can be a biodegradable material, such as magnesium alloys, iron alloys, or zinc alloys.

[0138] The first support rod 12a can be formed by weaving various metal wires as described above, or by cutting a whole metal rod / tube.

[0139] The second support member includes a plurality of second support rods 13a spaced circumferentially along the support frame 1a. The inner ends of the plurality of second support rods 13a are connected to the geometric center of the support frame 1a, and the outer ends extend outward and are connected to the corresponding first support rods 12a.

[0140] Multiple second support rods 13a are arranged in a one-to-one correspondence with multiple first support rods 12a. That is, the number of second support rods 13a is also 5.

[0141] In this embodiment, the outer end of the second support rod 13a is connected to the end of the circumferential segment 122a away from the radial segment 121a. That is, the annular region extends from the geometric center of the support frame 1a to the outer end of the second support rod 13a. In other words, in this embodiment, the end of the circumferential segment 122a away from the radial segment 121a is connected to the outer end of the second support rod 13a.

[0142] In this embodiment, the second support rod 13a is linear. The corresponding first support rod 12a and second support rod 13a enclose a support ring, and within the same support ring, the concave surface of the radial segment 121a of the first support rod 12a faces the second support rod 13a. In other embodiments, within the same support ring, the convex surface of the radial segment 121a of the first support rod 12a faces the second support rod 13a. In a modified embodiment, the second support rod 13a can also be arc-shaped. The concave surface of the second support rod 13a can be opposite to the concave or convex surface of the corresponding radial segment 121a of the first support rod 12a, or the convex surface of the second support rod 13a can be opposite to the concave or convex surface of the corresponding radial segment 121a of the first support rod 12a. The second support rod 13a can also be Y-shaped or other shapes, depending on the specific circumstances.

[0143] In this embodiment, the first support rod 12a and the corresponding second support rod 13a together enclose a closed area. In this embodiment, multiple closed areas are arranged in an overlapping manner near the geometric center of the sealing disk 10a along the circumference of the support frame 1a. In some embodiments, multiple closed areas are spaced apart along the circumference of the support frame 1a; that is, multiple support rings are spaced apart.

[0144] The second support component is made of a biodegradable material, meaning that each of the second support rods 13a is made of a biodegradable material.

[0145] The second support rod 13a is bonded to the first support rod 12a, specifically, the outer end of the second support rod 13a is bonded to the end of the circumferential segment 122a away from the radial segment 121a. Bonding is achieved using an organic solvent. The organic solvent is one or a mixture of several of the following in any proportion: dichloromethane, trichloromethane, chloroform, DMF, ethanol, and acetone.

[0146] Furthermore, the support frame 1a also includes a fixing ring 11a located at the geometric center for converging the ends of the support frame 1a.

[0147] The fixing ring 11a is annular and is used to connect with the first support member and the second support member. The first support member and the fixing ring 11a can be welded together, while the second support member and the fixing ring 11a are bonded together.

[0148] The bonding between the second support member and the fixing ring 11a can be referenced to the bonding between the second support rod 13a and the first support rod 12a, and will not be described again here.

[0149] In this embodiment, the support frame 1a of the occluder 800 includes a first support member and a second support member, wherein the second support member is made of a biodegradable material. Compared with the occluder 800 in related technologies, the support frame 1a in this embodiment uses partially biodegradable materials, thereby reducing the metal content and the release of metal ions. Furthermore, the biodegradable material does not remain in the body after degradation, reducing the occurrence of complications. In the support frame 1a, the connection between the first support rod 12a made of metal and the second support rod 13a made of biodegradable material allows the occluder 800 to exhibit good resilience when entering and exiting the sheath. After the second support member degrades, the mesh openings of the support frame 1a become larger, facilitating puncture and formation of a stoma through the larger mesh openings, allowing subsequent interventional procedures to enter the left atrium from the right atrium, reducing the difficulty of secondary interventional procedures.

[0150] Second embodiment of the plugging device

[0151] Please see Figure 3 The structure shown in this embodiment differs from the first embodiment of the occluder in that the first support member further includes a support ring 14b. The support ring 14b forms the periphery of the support frame 1b.

[0152] The support ring 14b is connected to the outer periphery of a plurality of first support rods 12b. Specifically, the first support rods 12b include a radial segment 121b and a circumferential segment 122b, and the support ring 14b is connected to the plurality of circumferential segments 122b.

[0153] The material of the support ring 14b is the same as that of the first support rod 12b, both being metal.

[0154] When the support ring 14b is connected to the first support rod 12b, it can be done by welding, inserting, and / or wrapping and knotting. Specifically, in some embodiments, when the first support rod 12b is directly cut from a whole metal tube, the inner circumference of the support ring 14b is welded to the outer circumference of the circumferential segment 122b.

[0155] In an altered embodiment, when at least one first support rod 12b includes multiple metal braided wires, gaps are formed between the multiple metal braided wires, and a support ring 14b is inserted into the gaps of the circumferential section 122b of the first support rod 12b and welded at the intersection of the two to improve the connection strength.

[0156] The multiple first support rods 12b in the same support frame 1b can each include multiple metal braided wires, or they can each be cut from a whole metal tube, or they can be a combination of both.

[0157] Other features of the occluder in this embodiment, such as the fixing ring 11b, can be referred to in the first embodiment and will not be described in detail hereafter.

[0158] Third embodiment of the plugging device

[0159] Please see Figure 4 The structure shown in this embodiment differs from the first embodiment of the occluder in that the first support member further includes at least one outer peripheral rod 123c, and the outer peripheral rod 123c and multiple circumferential segments 122c together form the periphery of the support frame 1c.

[0160] The outer peripheral rod 123c and the adjacent first support rod 12c together form a closed area, and the second support rod 13c is located within the closed area.

[0161] Specifically, in this embodiment, there are two first support rods 12c and two outer peripheral rods 123c.

[0162] The first support rod 12c forms a ring. Specifically, the first support rod 12c includes two radial segments 121c and a circumferential segment 122c. Both radial segments 121c are arc-shaped, and their concave surfaces face each other. The two ends of the circumferential segment 122c are connected to the two radial segments 121c respectively. The circumferential segment 122c is arc-shaped, and its concave surface faces the geometric center of the support frame 1c. The two radial segments 121c and the circumferential segment 122c together form an elliptical shape.

[0163] Two first support rods 12c are spaced apart circumferentially along the support frame 1c. Outer peripheral rods 123c connect the two first support rods 12c to their circumferential segments 122c. In this embodiment, there are two outer peripheral rods 123c, and the two outer peripheral rods 123c and the two circumferential segments 122c together form the periphery of the support frame 1c.

[0164] The outer peripheral rod 123c connects the radial segment 121c and the circumferential segment 122c on the same support ring. The outer peripheral rod 123c and the radial segment 121c of the two adjacent first support rods 12c together enclose a closed area.

[0165] The second support rod 13c is disposed within the aforementioned enclosed area. In this embodiment, there are two second support rods 13c in each enclosed area.

[0166] The inner end of the second support rod 13c is located at the geometric center, and the outer end of the second support rod 13c is connected to the corresponding outer peripheral rod 123c.

[0167] Specifically, the second support rod 13c is arc-shaped, and the concave surfaces of the second support rod 13c located in the same enclosed area are arranged opposite each other.

[0168] Preferably, each outer peripheral rod 123c includes two arc-shaped portions 1231c arranged sequentially along the circumference of the support frame 1c. Both ends of the two arc-shaped portions 1231c are recessed towards the geometric center of the plug, while the portion between the ends protrudes away from the geometric center, i.e., the concave surface of the arc-shaped portion 1231c faces the geometric center. A connection point is formed at the junction of the two arc-shaped portions 1231c. This connection point connects to the outer ends of the two second support rods 13c. The concave surfaces of the two second support rods 13c connected to the connection point are arranged opposite each other.

[0169] Furthermore, within the closed area enclosed by the radial segment 121c and circumferential segment 122c of each first support rod 12c, two second support rods 13c are also provided, with the convex surfaces of the two second support rods 13c facing each other, and the outer ends of the two second support rods 13c being connected to the two ends of the circumferential segment 122c respectively.

[0170] In this embodiment, the distal end of the radial segment 121c of the first support rod 12c, the end of the outer peripheral rod 123c, and the outer end of the second support rod 13c are connected to a single point. In an alternative embodiment, the connection points of the outer peripheral rod 123c and the second support rod 13c on the first support rod 12c do not coincide.

[0171] In other variations, the number of second support rods 13c can be other numbers, which can be set according to actual needs.

[0172] Other features of the occluder in this embodiment, such as the fixing ring 11c, can be referred to in the first embodiment and will not be described in detail hereafter.

[0173] Fourth embodiment of the plugging device

[0174] See Figure 5 The figure shows a schematic diagram of the occluder 900 in this embodiment. The occluder 900 in this embodiment includes two occlusion discs 10d and a connector 50d connecting the two occlusion discs 10d. The difference between this embodiment and the first embodiment of the occluder 900 lies in the structure of the occlusion discs 10d. Specifically, in this embodiment, the radial segment 121d of one of the first support rods 12d of the support frame 1d can enclose an enclosed area with the adjacent first support rod 12d, and a second support rod 13d is disposed within the enclosed area.

[0175] Combination Figure 6 and Figure 7 The first support rod 12d supporting the frame 1d includes a radial segment 121d and a circumferential segment 122d. The radial segment 121d extends approximately radially along the support frame 1d, and the circumferential segment 122d extends approximately circumferentially along the support frame 1d.

[0176] One end of the circumferential segment 122d is connected to the radial segment 121d on the same first support rod 12d, and the other end of the circumferential segment 122d is connected to the radial segment 121d on an adjacent first support rod 12d, thereby forming a closed area. Specifically, the radial segment 121d is arc-shaped. Furthermore, in any two adjacent first support rods 12d, the concave surface of one radial segment 121d is positioned opposite the convex surface of the other radial segment 121d.

[0177] The circumferential segment 122d is arc-shaped, and the concave surface of the circumferential segment 122d faces the geometric center of the supporting frame 1d. The circumferential segments 122d of multiple first supporting rods 12d together form the periphery of the supporting frame 1d.

[0178] In any two adjacent first support rods 12d, the radial segment 121d of one first support rod 12d and the other first support rod 12d together form a closed area.

[0179] Specifically, one end of the radial segment 121d of one of the first support rods 12d is located at the geometric center, and the other end can be connected to the radial segment 121d of another first support rod 12d, or to the circumferential segment 122d of another first support rod 12d, or simultaneously connected to both the radial segment 121d and the circumferential segment 122d of another first support rod 12d. For example, in this embodiment, the other end of the radial segment 121d of the first support rod 12d is connected between the radial segment 121d and the circumferential segment 122d of another first support rod 12d.

[0180] The second support member includes multiple second support rods 13d. Each second support rod 13d is disposed within the enclosed area.

[0181] The second support rod 13d has an inner end and an outer end. The inner end is located at the geometric center of the support frame 1d, and the outer end is far from the geometric center of the support frame 1d and is connected to the circumferential segment 122d of the first support rod 12d.

[0182] That is, the second support member is located in the central region of the sealing plate 10d, and this central region is annular. Specifically, the central region refers to the annular area extending outward from the geometric center of the support frame 1d, but excluding the periphery of the support frame 1d. Specifically, in Figure 6 In the diagram, the annular region refers to the area extending from the geometric center of the supporting skeleton 1d to the dashed circle.

[0183] Specifically, the second support rod 13d is arc-shaped. The multiple second support rods 13d of the second support member can be arranged in various ways. For example, see [reference needed]. Figure 6Multiple second support rods 13d are arranged at circumferential intervals along the support frame 1d, and among adjacent second support rods 13d, the convex surface of one second support rod 13d is arranged opposite to the concave surface of the adjacent second support rod 13d.

[0184] Preferably, the circumferential segment 122d of each first support rod 12d includes two arc-shaped portions 1221d arranged sequentially along the circumference of the support frame 1d, and the connection point of the two arc-shaped portions 1221d forms a connection point. The connection point between the arc-shaped portions 1221d of two adjacent first support rods 12d also forms a connection point.

[0185] The number of connection points between the multiple second support rods 13d and the first support member is arranged in a one-to-one correspondence, that is, the outer ends of the multiple second support rods 13d are respectively connected to the connection points of the first support member. Specifically, in this embodiment, there are three first support rods 12d, each with three connection points, and one connection point between any two adjacent first support rods 12d, that is, a total of six connection points. There are also six second support rods 13d. In other words, each connection point of the circumferential segment 122d is connected to the outer end of a second support rod 13d, that is, the end of the circumferential segment 122d away from the radial segment 121d.

[0186] Meanwhile, the end of the circumferential segment 122d that is away from the radial segment 121d in the same first support rod 12d is connected to the outer end of a second support rod 13d and the radial segment 121d of the adjacent first support rod 12d.

[0187] In the modified embodiment, see Figure 8 Among the plurality of second support rods 13d, there are pairs of second support rods 13d. The concave surfaces of the pairs of second support rods 13d are arranged opposite each other, and the outer ends of the pairs of second support rods 13d are connected to the same connection point, which is the connection point between the two arcuate portions 1221d in the same first support rod 12d.

[0188] In another modified embodiment, see [link to relevant documentation]. Figure 9 Among the multiple second support rods 13d, there are pairs of second support rods 13d. The concave surfaces of the pairs of second support rods 13d are arranged opposite each other, and the middle parts of the two second support rods 13d are connected at an intersection. The outer ends of the two second support rods 13d are respectively connected to adjacent connection points.

[0189] In yet another modified implementation, see [link to relevant documentation]. Figure 10 , and Figure 6The difference in the implementation method lies in that two second support rods 13d are connected at the connection point of the two arc-shaped portions 1221d in each of the first support rods 12d, and the concave surfaces of the two second support rods 13d are arranged opposite each other, thereby pulling the connection point in different directions. This helps to improve the uniformity of force at the connection point, reduce the degree of deformation at the connection point, and facilitate the reliable connection between the flow-blocking membrane 2d and the support frame 1d, thus avoiding damage to the flow-blocking membrane 2d. The length of the added second support rod 13d in this embodiment is not limited. One end of the second support rod 13d can be connected to the fixing member, and the length of the second support rod 13d can also be relatively short, that is, connected between the connection point and a radial segment 121d.

[0190] In other embodiments, the second support rod 13d may also be straight, Y-shaped, or other shapes, depending on actual needs.

[0191] See Figure 11 The figure shows Figure 10 The modified implementation method is that the two intersecting second support rods 13d are integrally formed into a Y-shaped second support rod 13d.

[0192] exist Figure 6 , Figure 8 , Figure 9 , Figure 10 as well as Figure 11 In various embodiments, the support frame 1d includes connections between first support rods 12d, connections between second support rods 13d, and connections between first support rods 12d and second support rods 13d. The materials of the first support rod 12d and the second support rod 13d, as well as the connection methods of the aforementioned components, are described in detail below.

[0193] Specifically, the first support member includes two interconnected first rods 15d, one of which includes multiple metal wires 151d, with gaps formed between the multiple metal wires 151d, and the other first rod 15d is inserted into the gap of one of the first rods 15d. Figure 12 The structure of the first rod 15d is shown. In this embodiment, the number of metal wires 151d in each first rod 15d is 2 to 10, preferably an even number.

[0194] See Figure 13 The figure shows a first rod 15d inserted into the gap of another first rod 15d. The first rod 15d refers to all the rods in the first support member. In a modified embodiment, for example... Figure 3 In the embodiment shown, the first rod 15d refers to the first support rod 12d and the support ring in the first support member. Figure 4In the illustrated embodiment, the first rod 15d refers to the first support rod 12d and the outer peripheral rod. Specifically, in this embodiment, the first rod 15d refers to the first support rod 12d. Preferably, any two adjacent first support rods 12d are connected by one first support rod 12d passing through the gap of the other first support rod 12d.

[0195] It should be noted that, Figure 13 This is used to illustrate the interpenetrating relationship between the first rods 15d. The extension directions of the two first rods 15d are examples. The extension directions of the interpenetrating first rods 15d in various embodiments of this application can be the same as... Figure 13 The directions of extension are different.

[0196] The second support member includes two second rods 16d that are bonded together. Figure 14 The structure of one of the second rods, 16d, is shown. Figure 15 Two second rods 16d bonded together are shown.

[0197] The second rod 16d is made of a biodegradable material. The biodegradable material is a copolymer or blend of one or more of the following: polylactic acid (PLA), polyglycolic acid (PGA), polydioxanone (PDO), polycaprolactone (PCL), polyglyconate, polyhydroxybutyrate, polyanhydride, and polyphosphoester. Specifically, the second rods 16d are bonded together using an organic solvent. The organic solvent is one or a mixture of several of the following in any proportion: dichloromethane, chloroform, chloroform, DMF, ethanol, and acetone.

[0198] The specific bonding method is as follows: An organic solvent is applied to the pre-connected position of the two second rods 16d, causing the two second rods 16d to at least partially dissolve into a solution at the connection point and fuse together. After the organic solvent evaporates, the intersection of the two second rods 16d is joined together. Figure 15 As shown.

[0199] In this embodiment, the second rod 16d specifically refers to the second support rod 13d. Preferably, any two adjacent second support rods 13d are connected by adhesive bonding.

[0200] In other embodiments, the second rods 16d connected to each other in the second support member can also be integrally molded. For example, in some embodiments, the second rods 16d can be obtained by cutting on a sheet, thereby forming a pattern of multiple interconnected second support rods 13d in one step, thus omitting the step of bonding the second rods 16d to each other.

[0201] When the second support member is connected to the first support member, the second support rod 13d is inserted into the gap of the first support rod 12d.

[0202] Specifically, at least one second rod 16d is inserted into the first rod 15d. See also Figure 16 The diagram illustrates a structure in which a second support rod 13d is inserted into the gap of a first support rod 12d. In this embodiment, each second support rod 13d is inserted into the gap of its corresponding first support rod 12d. In other embodiments, the number of first support rods 12d that can be inserted into the second support rod 13d can be set according to actual needs.

[0203] Preferably, the second rod 16d is inserted into the connection point of the first rod 15d and is also bonded to each other. That is, each second support rod 13d is inserted into the connection point of the corresponding first support rod 12d and is also bonded to each other.

[0204] The first support rod 12d and the second support rod 13d are also bonded together with an organic solvent.

[0205] The specific bonding method is as follows: An organic solvent is applied to the intersection after interlacing. The second support rod 13d dissolves into a liquid under the action of the organic solvent. After the organic solvent evaporates, it adheres to the first support rod 12d. The biodegradable material of the second support rod 13d completely fills the intersection of the first support rod 12d, making the second support rod 13d and the first support rod 12d tightly bonded and fixed. Figure 17 As shown.

[0206] In the modified embodiment, the second support member and the first support member are directly bonded to each other. That is, the second support rod 13d and the first support rod 12d are not intersected, but directly bonded.

[0207] The specific bonding method is as follows: an organic solvent is applied to the position where the second support rod 13d and the first support rod 12d need to be connected, so that the second support rod 13d is at least partially dissolved into a solution at the connection point. After the organic solvent evaporates, the second support rod 13d and the first support rod 12d at the connection point are completely fused into one.

[0208] Furthermore, the support frame 1d also includes a retaining ring 11d located at the geometric center for converging the ends of the support frame 1d. The retaining ring 11d is annular and is used to connect with the first support member and the second support member. The first support member and the retaining ring 11d can be welded together, and the second support member and the retaining ring 11d are bonded together.

[0209] The bonding between the second support member and the fixing ring 11d can be referenced from the bonding between the second support member and the first support member, and will not be repeated here.

[0210] In other embodiments, the retaining ring 11d may be connected only to the first support member or only to the second support member.

[0211] In this embodiment, the support frame 1d and the second support member, i.e., the biodegradable support rod, are located in the central area and connected to the fixing ring 11d. This allows the first support member to pull the second support member, i.e., the metal support rod, back to the preset shape after heat setting during the loading and releasing process of the occluder 900, thereby pulling the biodegradable support rod and making the occlusion disc 10d exhibit good resilience.

[0212] Furthermore, the second support member located in the central area is also provided with a first support member on its outer periphery, so that both ends of the second support member in the radial direction are pulled by the first support member, making it easier for the first support member to drive it to rebound. Therefore, the second support member is provided in the central area, making the loading and releasing of the plugger 900 smoother and facilitating the sealing.

[0213] Specifically, the manufacturing method of the plug 900 is as follows:

[0214] S1. The first support component is prepared using metallic materials.

[0215] In one exemplary embodiment, step S1 includes the following specific steps:

[0216] S11. Wind the multi-strand metal wire 151d.

[0217] Specifically, one end of the multi-strand metal wire 151d is fixed, and the other end is fixed in the rotating mechanism. For example, one end of the multi-strand metal wire 151d is neatly fixed to an electric drill. The multi-strand metal wire 151d rotates under the drive of the rotating mechanism, achieving multi-strand wire winding.

[0218] In this embodiment, the winding time is 3-200s.

[0219] S12, heat setting.

[0220] Specifically, the multi-strand metal wire 151d after winding in step S11 is heat-set. The heat-setting conditions are a temperature of 250-600℃ and a time of 0.5-5 minutes.

[0221] S13. Repeat steps S11 and S12 several times to obtain a metal support rod.

[0222] The number of times steps S11 and S12 are repeated is 2-10.

[0223] Select the evenly wound portion as the metal support rod, such as Figure 12 As shown.

[0224] S14. Cut the metal support rod in step S13 according to the preset size to obtain the first support rod 12d. Then, weave the first support rod 12d on the mold to form the preset shape of the first support rod 12d, and then form the first support member.

[0225] Exemplarily, this embodiment provides a mold for weaving a first support member. See also Figure 18 and Figure 19 The mold includes a base and multiple fasteners. The base supports the fasteners. In this embodiment, the base is cylindrical. In other embodiments, the base may be cuboid or other shapes.

[0226] The specific dimensions of the mold can be: diameter D1 of 10-100mm, diameter D2 of 8-100mm, and height L of 1-100mm. The mold dimensions can be set according to actual needs.

[0227] The base consists of a bottom surface and a top surface. The top surface has a center hole, a lower positioning hole, a lower mounting hole, a winding groove, and an indicator groove.

[0228] The central hole penetrates the top and bottom surfaces of the base and is located at the geometric center of the base, for inserting the ends of multiple first support rods 12d and multiple second support rods 13d.

[0229] The winding groove comprises multiple winding sections. See also... Figure 20 A winding segment in the winding groove is represented by a dashed line to clearly show the shape of the winding segment. Each winding segment is an open-loop annular groove, such as an open-loop circular groove or an elliptical annular groove. Each first support rod 12d is used to accommodate the corresponding winding segment, and under the guidance of the winding segment, each first support rod 12d is woven according to a preset route.

[0230] In this embodiment, the winding groove includes three winding sections, corresponding to the three first support rods 12d in this embodiment, and the three first support rods 12d are woven according to the winding sections.

[0231] The lower positioning holes are located at the intersections of the winding sections and at the circumferential ends of each annular winding section. The lower positioning holes are used to insert stainless steel rods, which are then inserted into the positioning holes to position the support rods. The lower positioning holes at the intersections are used to align with the upper positioning holes.

[0232] In this embodiment, the indicator groove is annular and surrounds the intersections of the winding sections to indicate the areas where the fastener needs to be pressed. In other embodiments, other indicator patterns may be used.

[0233] The fastener is detachably mounted on the base. For example, the fastener has an upper mounting hole, and the base has a lower mounting hole with internal threads. The upper mounting hole is used to align with the lower mounting hole, and a bolt passes through the upper mounting hole and engages with the internal threads in the lower mounting hole.

[0234] The fastener is strip-shaped, consisting of a free end and a fixed end. An upper mounting hole is located at the fixed end. Normally, the bolts do not need to be tightened, allowing the free end to rotate circumferentially around the fixed end to press and fix the metal support rod onto the base. The free end also has an upper positioning hole for inserting a stainless steel rod. The upper positioning hole corresponds to the positioning hole.

[0235] The method for weaving the first support member using a mold in this embodiment is as follows:

[0236] Remove all or part of the fasteners, or rotate the free end of the fastener that obstructs the weaving of the first support member to the side away from the corresponding winding groove to facilitate weaving.

[0237] Bring the two ends of the selected first support rod 12d close together, and let them both pass through the center hole on the bottom surface of the base, as shown. Figure 21 As shown. The portion of the first support rod 12d protruding from one side of the top surface is woven into the winding groove along the direction of a winding section, that is, the first support rod 12d forms two annular parts around the edge, and the excess portion of the first support rod 12d is pulled out from one side of the bottom surface.

[0238] The first support rod 12d is connected to the first support rod 12d by interlocking with each other.

[0239] S2. The second support component is prepared using biodegradable materials.

[0240] In one exemplary embodiment, step S2 includes the following steps:

[0241] S21. A biodegradable support rod is prepared using biodegradable materials as raw materials.

[0242] S22. Cut the second support rod 13d according to the preset size.

[0243] It is understandable that, in the modified implementation, Y-shaped biodegradable support rods are directly manufactured, or irregularly shaped biodegradable support rods corresponding to the shapes of the three biodegradable support rods are manufactured.

[0244] S3. Connect the first support member and the second support member to each other according to a preset shape, and place the second support member in at least one annular area around the axis of the preset shape to obtain the support frame 1d of the blocker 900.

[0245] The second support member is also woven using the same mold used to weave the first support member in step S1, and the specific method is as follows:

[0246] The second support rod 13d is arranged along the winding groove inside the more than one annular edge formed by the first support rod 12d, as follows: Figure 20 As shown, one, two, or three second support rods 13d can be selectively arranged on the inner side of each first support rod 12d. See reference for details. Figure 20 The area enclosed by the dashed line is divided into three winding slots. One end of each of the three winding slots is located at the central hole, and the other end is connected to the winding section indicated by the dashed line (i.e., the weaving position of the first support rod 12d).

[0247] The second support member and the first support member can be woven simultaneously, or the second support member can be woven after the first support member has been woven.

[0248] Specifically, the first and second support members are connected by adhesive bonding. For details, please refer to the preceding text; further explanation is omitted here.

[0249] In this embodiment, the support frame 1d of the occluder 900 includes a first support member and a second support member, wherein the second support member is made of a biodegradable material. Compared with the occluder 900 in related technologies, the support frame 1d in this embodiment uses partially biodegradable materials, thereby reducing the metal content and the release of metal ions. Furthermore, the biodegradable material does not remain in the body after degradation, reducing the occurrence of complications. In the support frame 1d, the weaving of the metal support rods and the biodegradable support rods gives the occluder 900 good resilience when entering and exiting the sheath. The first support rod 12d on the support frame 1d extends from the geometric center to the periphery, with three first support rods 12d around the circumference. The other rods are all made of biodegradable materials. Even when not fully degraded, the mesh size is significantly larger than that of the existing woven occluder 900, resulting in a simpler structure. After the occlusion disc 10d degrades, it can form even larger mesh sizes, facilitating subsequent interventional puncture.

[0250] Fifth embodiment of the plugging device

[0251] The difference between this embodiment and the fourth embodiment of the occluder is that each of the circumferential segments 122e of the first support rod 12e in this embodiment is provided with radial segments 121e at both ends.

[0252] Combination Figure 9 and Figure 22 , Figure 22 It shows that Figure 9 A schematic diagram of the improved first support component based on the existing structure.

[0253] Specifically, in this embodiment, the two radial segments 121e are a left radial segment 1211e and a right radial segment 1212e, and the right radial segment 1212e of the first support rod 12e extends in contact with the left radial segment 1211e of the adjacent first support rod 12e. The two radial segments 121e extend in contact with each other to reduce the weaving difficulty of the sealing disc. If one of the two parallel radial segments 121e needs to be removed, that radial segment 121e needs to be trimmed. If necessary, welding or gluing should be performed at the connection point of the circumferential segment 122e. The parallel extension of the two radial segments 121e also helps to improve the mechanical strength and wall adhesion of the sealing disc.

[0254] See Figure 23 In each first support rod 12e, the circumferential segment 122e and the two radial segments 121e together enclose a closed area, and the second support rod 13e is set in the closed area.

[0255] In any two adjacent first support rods 12e, the left radial segment 1211e or the right radial segment 1212e of one first support rod 12e extends into the enclosed area of ​​the other first support rod 12e. That is, the enclosed area formed by one of the first support rods 12e includes the left radial segment 1211e of one support rod, the right radial segment 1212e of the other first support rod 12e, and the second support rod 13e.

[0256] Specifically, the left radial segment 1211e or the right radial segment 1212e of one of the first support rods 12e intersects with another first support rod 12e, thereby extending into the closed area of ​​the other first support rod 12e.

[0257] Similarly, the circumferential segment 122e includes two arc-shaped portions 1221e arranged sequentially along the circumference of the support frame 1e. The ends of the arc-shaped portions 1221e are closer to the geometric center relative to the other parts of the arc-shaped portions 1221e, and the ends of the two arc-shaped portions 1221e are connected together to form a connection point. That is, the middle region of the circumferential segment 122e has a connection point, and the connection point connects to a second support rod 13e.

[0258] See Figure 24 , and Figure 22 The difference in the implementation method is that two second support rods 13e are connected at the connection point of the two arc-shaped portions 1221e in each first support rod 12e, and the concave surfaces of the two second support rods 13e are arranged opposite each other.

[0259] Within the enclosed area of ​​the same first support rod 12e, there are three second support rods 13e: a left second support rod 13e, a middle second support rod 13e, and a right second support rod 13e. The right second support rod 13e is the one closest to the second support rod 13e formed by the radial segment 121e. Relative to... Figure 22 The addition of a second support rod 13e on the right side, with the concave surface of the second support rod 13e facing the concave surface of the middle support rod, allows for pulling of the connection point in different directions. This helps to improve the uniformity of force distribution at the connection point, reduce the degree of deformation at the connection point, facilitate the maintenance of a reliable connection between the flow-blocking membrane and the support frame 1e, and avoid damage to the flow-blocking membrane.

[0260] Furthermore, within the closed area enclosed by one of the first support rods 12e, the outer end of the second support rod 13e, which is close to the right radial segment 1212e, is connected to the circumferential segment 122e, and the inner end is connected to the middle region of the left radial segment 1211e of the other first support rod 12e.

[0261] Compared to the fourth embodiment of the occluder, the proportion of the first support rod 12e, i.e. the metal support rod, is increased in the central region of the occluder disc, which improves the mechanical strength and resilience of the support frame 1e, making it easier for the occluder disc to rebound to the preset shape after heat setting after release. Furthermore, it does not significantly reduce the size of the degraded mesh, thus having less impact on subsequent atrial septal punctures.

[0262] Other features of the occluder in this embodiment, such as the fixing ring 11e, can be referred to in the fourth embodiment and will not be described in detail hereafter.

[0263] Sixth embodiment of the plugging device

[0264] Please see Figure 25 The structure shown in this embodiment differs from the fourth embodiment of the occluder in that the first support member is located in the peripheral area of ​​the support frame 1f.

[0265] The peripheral region refers to a ring-shaped area that includes the periphery of the supporting skeleton 1f, but excludes the geometric center of the supporting skeleton 1f. Figure 25 In the middle, the area extending away from the geometric center, bounded by the dashed circle, is the perimeter.

[0266] Specifically, the second support member includes a plurality of second support rods 13f spaced circumferentially along the support frame 1f. The inner end of each second support rod 13f is located at the geometric center of the support frame 1f, and the outer end is located away from the geometric center of the support frame 1f. The plurality of second support rods 13f radiate from the geometric center to the periphery of the second support member. In an exemplary embodiment, the second support member is umbrella-shaped.

[0267] In this embodiment, the second support rod 13f is arc-shaped, and in any two adjacent second support rods 13f, the convex surface of one second support rod 13f is opposite to the concave surface of the other second support rod 13f.

[0268] The first support member includes a plurality of first support rods 12f connected sequentially along the circumference of the support frame 1f, with each end of the first support rod 12f connected to the outer ends of two adjacent second support rods 13f. The plurality of first support rods 12f form the periphery of the support frame 1f.

[0269] Specifically, in this embodiment, the first support rod 12f is arc-shaped, and the concave surface of the first support rod 12f faces the geometric center. The ends of two adjacent first support rods 12f are connected to form a connection point.

[0270] Each of the second support rods 13f has a connection point at its outer end.

[0271] Specifically, in this embodiment, the number of second support rods 13f is the same as that of first support rods 12f. The outer end of each second support rod 13f is connected to the connection point of two adjacent first support rods 12f.

[0272] In this embodiment, the first support member made of metal is set in the peripheral area, and the second support member made of biodegradable material extends from the geometric center to the central area of ​​the first support member. After the second support member degrades, that is, after the central area is degraded, the mesh of the support skeleton 1f is larger, which is conducive to puncturing and forming a stoma on the larger mesh of the support skeleton 1f, so that subsequent interventional surgery can enter the left atrium from the right atrium, reducing the difficulty of the secondary interventional surgery.

[0273] In the modified implementation method, see Figure 26 At least one end of a first support rod 12f is connected to a pair of second support rods 13f. The pair of second support rods 13f are arc-shaped and their concave surfaces are arranged opposite each other, thereby pulling the connection point in different directions. This helps to improve the uniformity of the force on the connection point, reduce the degree of deformation of the connection point, facilitate the maintenance of a reliable connection between the flow-blocking membrane and the support frame 1f, and avoid damage to the flow-blocking membrane.

[0274] Other features of the fixing ring 11f of the occluder in this embodiment can be referred to in the fourth embodiment, and will not be described in detail hereafter.

[0275] Seventh embodiment of the plugging device

[0276] Please see Figure 27 The structure shown in this embodiment differs from the fourth embodiment of the occluder in that: the annular region where the second support rod 13g is located extends from the geometric center of the support frame 1g to the periphery, and the second support member forms the periphery of the support frame 1g, while the first support member is disposed within the annular region.

[0277] Specifically, the second support member includes a plurality of second support rods 13g arranged circumferentially along the support frame 1g. Each second support rod 13g includes a radial segment 131g and a circumferential segment 132g that are interconnected. The circumferential segment 132g extends along the periphery of the sealing plate, and the end of the radial segment 131g away from the circumferential segment 132g is located at the geometric center of the support frame 1g.

[0278] Multiple second support rods 13g are arranged in circumferential segments 132g along the circumference of the support frame 1g to form the periphery of the support frame 1g.

[0279] Each second support rod 13g, together with its adjacent second support rod 13g, forms a closed area. Specifically, the radial segment 131g of the second support rod 13g, together with its adjacent second support rod 13g, forms a closed area.

[0280] The first support member includes at least one first support rod 12g arranged circumferentially along the support frame 1g, and each first support rod 12g is located within a closed area.

[0281] In an exemplary embodiment, a first support rod 12g is provided in each enclosed area, with one end of the first support rod 12g located at the geometric center of the support skeleton 1g and the other end extending away from the geometric center. In this embodiment, the other end of the first support rod 12g is connected to the corresponding circumferential segment 132g. Preferably, the first support rod 12g is connected to the center of the circumferential segment 132g along its length. Therefore, after the second support member degrades, the support skeleton 1g is left with multiple second support rods 13g spaced apart circumferentially, so that the support skeleton 1g does not form a complete mesh. This facilitates the formation of a stoma by puncturing between the first support rods 12g, allowing subsequent interventional surgery to enter the left atrium from the right atrium, reducing the difficulty of the secondary interventional surgery.

[0282] In one modified embodiment, at least two first support rods 12g are provided in each enclosed area. One support rod extends radially, with one end located at the geometric center of the support frame 1g and the other end extending to the circumferential segment 132g. The two ends of the other support rod are connected to the circumferential segment 132g and the radial segment 131g, respectively.

[0283] Specifically, such as Figure 28 As shown, three first support rods 12g are provided in each enclosed area. One of the support rods extends radially and is defined as the first radial support rod. The other two first support rods 12g are defined as first lateral support rods, which are arranged on both sides of the first radial support rod. The first radial support rod and one end of the two first lateral support rods are connected to each other and connected to the circumferential segment 132g.

[0284] The ends of the two first lateral support rods away from the circumferential segment 132g are respectively connected to the radial segment 131g. The radial segments 131g corresponding to the two first lateral support rods are located at both ends of the circumferential segment 132g. That is, the other ends of the two first lateral support rods extend to the radial segments 131g that are connected to the circumferential segments 132g of the corresponding second support rods 13g.

[0285] Compared to Figure 27 The implementation method in the text, Figure 28 The increased number of first support rods 12g in each closed area improves mechanical performance and makes the plug exhibit good resilience when entering and exiting the sheath.

[0286] Furthermore, the two first lateral support rods are symmetrically arranged about the first radial support rod.

[0287] Other features of the occluder in this embodiment, such as the fixing ring 11g, can be referred to in the fourth embodiment and will not be described in detail hereafter.

[0288] Eighth embodiment of the plugging device

[0289] Please see Figure 29 The structure shown in this embodiment differs from the seventh embodiment of the occluder in that: one end of the first support rod 12h is connected to the geometric center of the support frame 1h, and the other end of the first support rod 12h is radially spaced from the circumferential segment of the second support rod 13h.

[0290] Furthermore, the radial segments of the first support rod 12h and the second support rod 13h are spaced apart along the circumferential direction of the support frame 1h.

[0291] Furthermore, the first support member also includes a support ring 14h. The support ring 14h connects the ends of a plurality of first support rods 12h away from the geometric center. The support ring 14h and the circumferential segments of the second support rods 13h are spaced apart along the radial direction of the support frame 1h.

[0292] In this embodiment, the addition of the first support ring 14h increases the amount of metal material in the support frame 1h, thereby improving mechanical properties and giving the occluder good resilience when entering and exiting the sheath. The constraint of the support ring 14h on the end of the first support rod 12h furthest from the geometric center facilitates sheathing of the occluder. Furthermore, after the second support component degrades, the constraint of the support ring 14h on the end of the first support rod 12h furthest from the geometric center reduces the occluder's stimulation of the tissue.

[0293] In the modified embodiment, one end of the first support rod 12h is connected to the radial segment, and the other end is connected to the radial segment of another second support rod 13h. Furthermore, the included angle between the first support rod 12h and the corresponding radial segment can be set according to specific requirements.

[0294] Other features of the occluder in this embodiment, such as the fixing ring 11h, can be referred to in the seventh embodiment and will not be described in detail hereafter.

[0295] Ninth embodiment of the plugging device

[0296] Please refer to the structure shown in 30. The difference between this embodiment and the seventh embodiment of the occluder is the number and arrangement of the first support rods 12i within the closed area.

[0297] In this embodiment, the enclosed area has a pair of first support rods 12i. The enclosed area is also formed by the radial segment of one of the second support rods 13i and the adjacent second support rod 13i.

[0298] One end of each first support rod 12i is located at the geometric center of the support frame 1i, and the other end is connected to the circumferential segment of the corresponding second support rod 13i.

[0299] In the paired first support rods 12i, the ends located at the geometric center are spaced apart circumferentially along the support frame 1i, while the ends away from the geometric center are connected. In other embodiments, the ends away from the geometric center may also be spaced apart circumferentially along the support frame 1i, while the ends located at the geometric center are connected.

[0300] Specifically, in this embodiment, two pairs of paired first support rods 12i are provided in each enclosed area. In other embodiments, the number of pairs of second support rods 13i in each enclosed area can be set according to actual conditions.

[0301] Other features of the occluder in this embodiment, such as the fixing ring 11i, can be referred to in the seventh embodiment and will not be described in detail hereafter.

[0302] Tenth embodiment of the plugging device

[0303] exist Figure 31 In the top view of the sealing plate, two dashed circles are added, dividing the sealing plate into three regions: the central region, the edge region, and the middle region. The central region refers to the area from the dashed circle closest to the geometric center to the geometric center itself, including the geometric center of the support frame 1j. The edge region refers to the area including the perimeter of the support frame 1j, specifically the area from the dashed circle furthest from the geometric center to the perimeter of the support frame 1j. The middle region is the area between the central region and the edge region. Figure 31 Specifically, it refers to the area between the two dashed circles.

[0304] Please refer to the structure shown in Figure 31. The difference between this embodiment and the fourth embodiment of the occluder is that the second support member is disposed in the annular region between the central region and the edge region. In this embodiment, the annular region is the central region.

[0305] The first support member is used to form at least the periphery of the support frame 1j and is connected to at least the geometric center of the support frame 1j. Specifically, the first support member is disposed in the central region and the edge region.

[0306] The first support member includes a plurality of first support rods 12j arranged circumferentially along the support frame 1j. The first support rod 12j includes a radial segment 121j and a circumferential segment 122j. One end of the radial segment 121j is located at the geometric center of the support frame 1j, and the other end is located away from the geometric center of the support frame 1j.

[0307] The circumferential segments 122j of multiple first support rods 12j are sequentially arranged to form the periphery of the support frame 1j.

[0308] In this embodiment, the radial segment 121j and the circumferential segment 122j of the first support rod 12j are spaced apart from each other and connected by the second support member.

[0309] Specifically, the second support member includes a plurality of second support rods 13j, each second support rod 13j being connected to the radial segment 121j and the circumferential segment 122j of the corresponding first support rod 12j.

[0310] In this embodiment, there are six first support rods 12j, namely six radial segments 121j and six circumferential segments 122j. There are twelve second support rods 13j, that is, one first support rod 12j corresponds to two second support rods 13j. Specifically, in one first support rod 12j and the corresponding two second support rods 13j, the end of the radial segment 121j of the first support rod 12j away from the geometric center is connected to both of the above-mentioned second support rods 13j. The ends of the two second support rods 13j away from the radial segment 121j extend in different directions and are respectively connected to the two ends of the circumferential segments 122j of the corresponding first support rod 12j.

[0311] The second support rod 13j can be straight or curved. The specific shape can be set according to the actual situation.

[0312] Other features of the occluder in this embodiment, such as the fixing ring 11j, can be referred to in the fourth embodiment and will not be described in detail hereafter.

[0313] Eleventh embodiment of the plugging device

[0314] Please refer to the structure shown in Figure 32. The difference between this embodiment and the tenth embodiment of the occluder is that the first support member extends from the center of the support frame 1k to the periphery. That is, the first support member is provided in the central region, the middle region and the edge region of the support frame 1k.

[0315] The first support member includes a plurality of first support rods 12k arranged circumferentially along the support frame 1k. Each first support rod 12k includes a radial segment 121k and a circumferential segment 122k. One end of the radial segment 121k is located at the geometric center of the support frame 1k, and the other end is located away from the geometric center of the support frame 1k. The circumferential segments 122k of the plurality of first support rods 12k are arranged sequentially to form the periphery of the support frame 1k.

[0316] The first support member forms multiple ring-shaped structures. Specifically, the radial segment 121k of the first support rod 12k and the adjacent first support rod 12k together form a ring structure, i.e., a closed area.

[0317] The second support member includes a plurality of second support rods 13k. Each second support rod 13k is located within an enclosed area. In this embodiment, one second support rod 13k is provided in each enclosed area. In other embodiments, a plurality of second support rods 13k may be provided in each enclosed area along the radial direction of the support frame 1k, or a plurality of second support rods 13k may be provided in each enclosed area along both the radial and circumferential directions of the support frame 1k.

[0318] like Figure 32 As shown, within the enclosed area, the two ends of the second support rod 13k are respectively connected to radial segments 121k. Furthermore, along the radial direction of the support frame 1k, there is a gap between the second support rod 13k and the geometric center of the support frame 1k, and a gap between the second support rod 13k and the periphery of the support frame 1k. That is, the second support member is located between the geometric center and the periphery of the support frame 1k.

[0319] Furthermore, each of the second support rods 13k is arc-shaped, with its concave surface facing the geometric center of the support frame 1k. Multiple second support rods 13k are sequentially arranged along the circumference of the support frame 1k to form a ring structure.

[0320] In the modified implementation method, such as Figure 33 As shown, each second support rod 13k is straight. Furthermore, multiple second support rods 13k can be arranged radially at intervals along the support frame 1k within each enclosed area. It is understood that the second support rods 13k can also be arc-shaped, wavy, or other shapes.

[0321] Other features of the occluder in this embodiment, such as the fixing ring 11k, can be referred to in the fourth embodiment and will not be described in detail hereafter.

[0322] Twelfth embodiment of the plugging device

[0323] Please refer to the structure shown in 34. The difference between this embodiment and the eleventh embodiment of the occluder is that the first support member also includes a connecting rod 14m.

[0324] In this embodiment, a connecting rod 14m is provided in each enclosed area, meaning that each connecting rod 14m is correspondingly located within the enclosed area. One end of the connecting rod 14m is connected to the geometric center of the sealing plate, and the other end is connected to at least one second support rod 13m. Specifically, along the circumference of the support frame 1m, the second support rod 13m can be connected to both sides of the connecting rod 14m.

[0325] In this embodiment, the connecting rod 14m is connected to two second support rods 13m on both sides. Each side has two second support rods 13m. Within the same enclosed area, the connecting rod 14m and the second support rods 13m are connected in a fishbone pattern.

[0326] One end of each second support rod 13m is connected to the connecting rod 14m. That is, one end of the second support rod 13m is connected to the connecting rod 14m, and the other end is connected to the circumferential section of the enclosed area. In an alternative embodiment, the other end of the second support rod 13m is connected to the radial section.

[0327] The number of connecting rods 14m can be set according to actual needs, such as one, two, or other numbers. In this embodiment, the connecting rods 14m are straight. In other embodiments, the connecting rods 14m can also be arc-shaped, Y-shaped, elliptical, or other shapes.

[0328] Other features of the occluder in this embodiment, such as the fixing ring 11m, can be referred to in the tenth embodiment and will not be described in detail here.

[0329] Thirteenth embodiment of the plugging device

[0330] Please refer to the structure shown in 35. The difference between this embodiment and the fourth embodiment of the plug is that: the annular region is set at the periphery of the support frame 1n, the second support member is used to form the periphery of the support frame 1n, and the first support member is at least set between the geometric center and the annular region.

[0331] The central region refers to a part of the area including the geometric center of the supporting skeleton 1n, and the edge region refers to a part of the area including the periphery of the supporting skeleton 1n.

[0332] exist Figure 35 In the diagram, the central region refers to the area from the dashed circle closest to the geometric center to the geometric center itself, while the edge region refers to the area between two dashed circles.

[0333] Specifically, the first support member is located in the central region, and the second support member is located in the edge region.

[0334] The first support member includes a plurality of first support rods 12n spaced apart circumferentially along the support frame 1n. One end of each first support rod 12n is located at the geometric center of the support frame 1n, and the other end is away from the geometric center of the support frame 1n and diverges outwards to the periphery.

[0335] Specifically, in this embodiment, the first support rod 12n is arc-shaped, and in any two adjacent first support rods 12n, the convex surface of one first support rod 12n is opposite to the concave surface of the other first support rod 12n.

[0336] The second support member includes a plurality of second support rods 13n arranged sequentially along the periphery of the support frame 1n. Each second support rod 13n has its two ends connected to the ends of two first support rods 12n furthest from their geometric centers. Specifically, a second support rod 13n begins at the end of one of the first support rods 12n furthest from its geometric center and extends circumferentially along the support frame 1n to the end of the adjacent first support rod 12n furthest from its geometric center.

[0337] Specifically, the second support rod 13n is arc-shaped, with both ends extending toward the geometric center of the sealing plate, and the portion between the two ends extending away from the geometric center, that is, the concave surface of the second support rod 13n faces the geometric center of the support frame 1n.

[0338] After the second support member in this embodiment degrades, the first support member on the support skeleton 1n does not form a complete mesh, which is conducive to forming a stoma by puncturing between adjacent first support rods 12n in the first support member, so that subsequent interventional surgery can enter the left atrium from the right atrium, reducing the difficulty of the second interventional surgery.

[0339] In one modified implementation, see Figure 36 In contrast Figure 35 In the implementation method described, all the first support rods 12n are arranged in pairs, with the concave surfaces of each pair of first support rods 12n facing each other, and the ends of the paired first support rods 12n furthest from the geometric center are connected to the end of the same second support rod 13n. Compared to Figure 35 In the implementation method described above, the number of first support rods 12n, i.e., metal support rods, is increased in the central region of the occluder, which improves the mechanical strength and resilience of the support frame 1n, making it easier for the occluder disc to spring back to the preset shape after heat setting after release.

[0340] Figure 36 In the modified embodiment shown, the number of paired first support rods 12n can also be set according to actual needs, for example, the paired first support rods 12n can be one pair, two pairs or other numbers.

[0341] Other features of the occluder in this embodiment, such as the fixing ring 11n, can be referred to in the fourth embodiment and will not be described in detail hereafter.

[0342] In the above embodiments, the positions of the first support member and the second support member in the occluder can be interchanged.

[0343] For the same occluder with two occluder discs, the two occluder discs can be occluder discs from different embodiments, or they can be occluder discs from the same embodiment.

[0344] As can be seen from the above technical solution, the present invention has at least the following advantages and positive effects:

[0345] In the occlusion device of the present invention, at least one occlusion disc includes a first support member and a second support member. The second support member is made of a biodegradable material, and along the circumference of the occlusion disc, the area covered by the second support member is at least one annular region around the axis of the occlusion disc. That is, biodegradable material replaces part of the metal material in the occlusion disc, thereby reducing the metal content in the occlusion device and reducing the release of metal ions. Furthermore, the biodegradable material does not remain in the body after degradation, reducing the occurrence of complications.

[0346] In addition, the biodegradable material in the sealing disc is disposed in at least one annular area around the axis of the sealing disc. During the loading and release of the sealing disc, the first support member of the metal material pulls the second support member of the biodegradable material in the circumferential direction, so that the sealing device exhibits good resilience during compression and expansion, which makes up for the mechanical performance defects of biodegradable materials in the field of sealing devices.

[0347] It should be noted that the specific technical solutions in the above embodiments are applicable to each other.

[0348] Although the invention has been described with reference to several typical embodiments, it should be understood that the terminology used is illustrative and exemplary, and not restrictive. Since the invention can be embodied in many forms without departing from the spirit or essence of the invention, it should be understood that the above embodiments are not limited to any of the foregoing details, but should be interpreted broadly within the spirit and scope defined by the appended claims. Therefore, all variations and modifications falling within the scope of the claims or their equivalents should be covered by the appended claims.

Claims

1. A sealing device, characterized in that, It includes at least one sealing disc; the sealing disc includes a support frame, the support frame includes a first support member and a second support member connected to each other, the first support member is made of metal, and the second support member is made of biodegradable material; the second support member is disposed in at least one annular region around the axis of the sealing disc; The first support member includes a plurality of first support rods arranged circumferentially along the support frame, and the second support member includes a plurality of second support rods spaced apart circumferentially along the support frame. The inner ends of the plurality of second support rods are connected to the geometric center of the support frame, and the outer ends extend outward and are connected to the corresponding first support rods. The first support rod includes a radial segment and a circumferential segment. Each of the two ends of the circumferential segment of the first support rod is provided with the radial segment. The two radial segments are a left radial segment and a right radial segment, and the right radial segment of the first support rod extends in contact with the left radial segment of the adjacent first support rod. In each of the first support rods, the circumferential segment and the two radial segments together enclose a closed area, and the second support rod is disposed within the closed area; the end of the radial segment away from the circumferential segment is located at the geometric center of the support frame, and the circumferential segments of the plurality of first support rods are arranged sequentially along the circumference of the support frame to form the periphery of the support frame.

2. The occluder according to claim 1, characterized in that, The geometric center of the support frame is located in the annular region, and the first support member is used to form at least the periphery of the support frame.

3. The occluder according to claim 2, characterized in that, At least one end of the circumferential segment is connected to one end of the radial segment.

4. The occluder according to claim 3, characterized in that, In any two adjacent first support rods, the left radial segment or the right radial segment of one of the first support rods extends into the enclosed area of ​​the other first support rod.

5. The plugging device according to claim 3, characterized in that, The central region of the circumferential segment has a connection point that connects the two second support rods.

6. The occluder according to claim 5, characterized in that, The circumferential segment includes two arc-shaped portions arranged sequentially along the circumference of the supporting frame, and the connection point is formed at the junction of the two arc-shaped portions.

7. The plugging device according to claim 1, characterized in that, The first support member includes two interconnected first rods, one of which includes multiple metal wires forming gaps between them, and the other first rod is inserted into the gap of the first rod.

8. The occluder according to claim 1, characterized in that, The first support member includes at least one first rod, the first rod includes multiple metal wires, wherein the multiple metal wires form gaps between them, and the second support member includes at least one second rod, the second rod being inserted into the gaps of the first rod.

9. The occluder according to claim 8, characterized in that, The second rod is inserted into the connection point of the first rod and is also bonded to each other.

10. The occluder according to claim 1, characterized in that, The second support member is bonded to the first support member.

11. The occluder according to claim 1, characterized in that, The second support member includes two second rods bonded together.

12. The occluder according to claim 1, characterized in that, The occluder also includes a retaining ring located at the geometric center for converging the end of the support frame, the retaining ring being used to connect with the first support member and / or the second support member; the second support member is bonded to the retaining ring.

13. The occluder according to claim 1, characterized in that, Along the axial direction of the plug, the support frame includes a multi-layer support structure, each layer of the support structure including the second support member, and the second support members in the multi-layer support structure are correspondingly arranged.

14. The plugging device according to claim 1, characterized in that, The plugging device includes two plugging discs spaced apart along the axial direction; each of the two plugging discs includes the second support member, and the second support members of the two plugging discs are correspondingly arranged.

15. The plugging device according to claim 1, characterized in that, The first support component is made of a biodegradable metal material.

16. A method for preparing a plugging device, wherein the plugging device is the plugging device according to any one of claims 1 to 15, characterized in that, Includes the following steps: The first support component was prepared using metallic materials; The second support component was prepared using a biodegradable material; The first support member and the second support member are connected to each other according to a preset shape, and the second support member is arranged in at least one annular region around the axis of the preset shape to obtain the support frame of the occluder.

17. The method for preparing the plugging device according to claim 16, characterized in that, The structure connected to the second support member and the second support member are bonded together.

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