An occluder

Abstract

The present invention discloses an occluder, comprising a shaping part and a mesh frame having a closed upper end and a fusion tail end; the mesh frame comprises an upper disk surface, a waist portion and a lower disk surface formed in sequence, the closed upper end is arranged on the upper disk surface, and the fusion tail end is arranged on the lower disk surface; the shaping part comprises a central shaping piece, the distal end of the central shaping piece is connected to the closed upper end, the distal end is connected to the fusion tail end, and the central shaping piece is an elastic piece whose natural length is less than or equal to the distance between the fusion tail end and the closed upper end. The occluder provided by the present invention can better adapt to the structural changes of the occluder during the release and implantation process, and can restore the structural form without the help of external force after being implanted in the body, and can improve the occlusion effect at the same time.

Description

Technical Field

[0001] The present invention relates to the technical field of medical implant devices, and in particular to an occluder. Background Art

[0002] Congenital heart disease includes several types such as atrial septal defect, ventricular septal defect, patent ductus arteriosus, patent foramen ovale, etc. With the development of interventional medical devices and interventional surgical techniques, minimally invasive interventional surgery by implanting cardiac occluders for occlusion treatment has become the mainstream treatment method. In related technologies, occluders are usually made of nickel-titanium alloy materials, and the superelastic properties of nickel-titanium alloy are used to achieve occlusion treatment at the defect location.

[0003] However, a certain rate of complications will occur when metal occluders are used for treatment. Moreover, nickel-titanium alloy materials are non-degradable and will remain in the heart permanently after being implanted in the human body. In response to the above problems, some degradable occluders have appeared on the market. However, since the elasticity of degradable materials is relatively weaker than that of nickel-titanium alloys, they cannot be fixed after being implanted in the human body, and the occlusion effect is poor. External force is often required to assist in shaping. Moreover, this type of degradable occluder has a complex structure and is difficult for the operator to operate, which often increases the risk of surgical failure. Summary of the invention

[0004] In order to overcome the problems existing in the related art to a certain extent, the present application provides an occluder, which can better adapt to the structural changes of the occluder during the release and implantation process, and can restore the structural form without external force after implantation, while improving the occlusion effect. The specific technical solution is as follows:

[0005] An occluder comprises a shaping portion and a mesh frame having a closed upper end and a fused tail end;

[0006] The mesh frame comprises an upper plate surface, a waist portion and a lower plate surface which are formed in sequence, the upper end of the closing opening is arranged on the upper plate surface, and the welding tail end is arranged on the lower plate surface;

[0007] The shaping portion includes a central shaping piece, the distal end of which is connected to the upper end of the closing opening, and the distal end is connected to the welding tail end, and the central shaping piece is an elastic piece whose natural length is less than or equal to the distance between the welding tail end and the upper end of the closing opening.

[0008] In some embodiments, the shaping portion further comprises a first peripheral shaping member arranged around the central shaping member, the first peripheral shaping member is composed of a plurality of elastic members, and the proximal end of the first peripheral shaping member is fixed to the central shaping member, and the distal end of the first peripheral shaping member is fixed to the upper disk surface;

[0009] Preferably, the first peripheral shaping member is an umbrella-shaped structure coaxial with the central shaping member.

[0010] In some embodiments, the shaping portion further comprises a second peripheral shaping member, the second peripheral shaping member is composed of a plurality of elastic members, and the distal end of the second peripheral shaping member is fixed to the central shaping member, and the proximal end of the second peripheral shaping member is fixed to the lower plate surface;

[0011] Preferably, the second peripheral shaping member is an umbrella-shaped structure coaxial with the central shaping member.

[0012] In some embodiments, a first loop structure is formed at the distal end of the first peripheral shaping member and / or the proximal end of the second peripheral shaping member, and the first loop structure is used to connect with the mesh frame to form a fixed knot;

[0013] Preferably, the first ring structure is connected to the mesh skeleton by knotting or crimping;

[0014] Preferably, a developing ring is pressed onto the outer side of the fixing knot.

[0015] In some embodiments, the distal end of the central shaping member passes through the opening of the upper end of the closing opening and is connected to the upper end of the closing opening;

[0016] Preferably, the central shaping member is connected to the upper end of the closing opening by knotting or crimping;

[0017] Preferably, a second ring structure is formed at the distal end of the central shaping member, and the second ring structure is used to connect with the upper end of the closing opening to form a fixing knot, and a developing ring is provided on the fixing knot.

[0018] In some embodiments, the fusion tail is a solid structure;

[0019] Preferably, the welding tail end is a columnar body with external threads.

[0020] Preferably, the proximal end of the central shaping member is embedded in the welding tail end.

[0021] In some embodiments, the elastic member is a spring, and the spring is formed by heat-treating a memory metal.

[0022] In some embodiments, the spring is a linear spring or a progressive spring.

[0023] In some embodiments, the spring is cylindrical, conical, convex, concave or non-circular in shape;

[0024] Preferably, the central shaping member is a cylindrical linear spring, and the first peripheral shaping member and the second peripheral shaping member are non-circular linear springs.

[0025] In some embodiments, the mesh skeleton is made of a degradable polymer material.

[0026] In some embodiments, the mesh skeleton is further provided with a flow-blocking film, and the flow-blocking film comprises an upper plate film located on the inner wall of the upper plate surface, a waist film located at the waist, and a lower plate film located on the inner wall of the lower plate surface;

[0027] Preferably, the upper plate membrane, the waist membrane and the lower plate membrane are all made of degradable materials, and are all sewn to the mesh skeleton by degradable sutures.

[0028] The technical solution provided by the embodiments of the present application has at least the following beneficial effects:

[0029] The occluder provided in the present application is particularly suitable for occluders made of degradable materials. After being implanted in the human body, it can naturally restore its structural form without the need for artificial external force, completely block the defect, and improve the blocking effect.

[0030] Specifically, the present application is based on the setting of the shaping part, wherein the two ends of the central shaping part are respectively connected to the closing upper end and the molten tail end of the mesh skeleton, and are elastic parts whose natural length is smaller than the distance between the molten tail end and the closing upper end. Then, during the operation, due to the supporting effect of the central shaping part, the upper disk surface and the lower disk surface can roughly restore the inherent shape of their structure. When the occluder is implanted in the defective part, since the central shaping part has memory resilience, the upper disk surface and the lower disk surface of the occluder will be tightly fitted to the surface of the defective part under the physical action of the elastic part, thereby achieving complete occlusion of the defective part.

[0031] Therefore, the occluder provided in the present application can naturally restore its structural form without being subjected to external artificial forces, thereby improving the occluding effect.

[0032] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the present application and, together with the description, serve to explain the principles of the present application.

[0034] Figure 1 A schematic diagram of the structure of an occluder provided by an embodiment of the present invention;

[0035] Figure 2 A schematic structural diagram of an occluder provided in another embodiment of the present invention;

[0036] Figure 3 for Figure 2 AA section view;

[0037] Figure 4 A schematic diagram of the structure of a shaping portion provided by an embodiment of the present invention;

[0038] Figure 5 A schematic structural diagram of a first peripheral shaping member provided by an embodiment of the present invention;

[0039] Figure 6 A schematic diagram of a structure in which a central shaping member is connected to a welding tail end provided by an embodiment of the present invention;

[0040] Figure 7 A schematic diagram of the structure of a cylindrical linear spring in which the elastic member provided by one embodiment of the present invention is a cylindrical linear spring;

[0041] Figure 8 A schematic structural diagram of an elastic member provided by an embodiment of the present invention, in which the elastic member is a non-cylindrical linear spring;

[0042] Fig. 9 A schematic structural diagram of an elastic member provided by an embodiment of the present invention, in which the elastic member is a concave linear spring;

[0043] Fig.10 A schematic diagram of the structure of an elastic member provided by an embodiment of the present invention, in which the elastic member is a convex linear spring;

[0044] Fig.11 A schematic diagram of a structure in which the elastic member provided by one embodiment of the present invention is a progressive spring;

[0045] Fig.12 A schematic diagram of a state in which an occluder provided by an embodiment of the present invention is accommodated in a loading sheath;

[0046] Fig.13 A schematic diagram of a state in which an occluder provided by an embodiment of the present invention leaves a loading sheath;

[0047] Fig.14 A schematic diagram of a state of an occluder after self-expansion provided by an embodiment of the present invention;

[0048] Description of reference numerals:

[0049] 100, mesh frame; 110, upper plate; 120, waist; 130, lower plate; 140, welded tail end; 150, upper end closing;

[0050] 200, flow-blocking film; 210, upper plate film; 220, waist film; 230, lower plate film;

[0051] 300, shaping part; 310, central shaping part; 311, second ring structure; 320, first peripheral shaping part; 321, first ring structure; 322, developing ring; 330, second peripheral shaping part;

[0052] 400, loading sheath;

[0053] 500. conveying device;

[0054] 600. Hook. DETAILED DESCRIPTION

[0055] Exemplary embodiments will be described in detail herein, examples of which are shown in the accompanying drawings. When the following description refers to the drawings, unless otherwise indicated, the same numbers in different drawings represent the same or similar elements. The implementations described in the following exemplary embodiments do not represent all implementations consistent with the present application. Instead, they are merely examples of methods consistent with some aspects of the present application as detailed in the appended claims.

[0056] In the related art, the occluder made of degradable materials has poor elasticity, weak force between the upper disk surface and / or the lower disk surface, and is difficult to be fixed after being implanted in the human body. Therefore, it is impossible to completely occlude the defect and the occlusion effect is poor.

[0057] Based on the analysis and discovery of the above problems, this application is proposed.

[0058] The present application provides an occluder, comprising a shaping portion and a mesh frame having a closed upper end and a fused tail end;

[0059] The mesh frame comprises an upper plate surface, a waist portion and a lower plate surface which are formed in sequence, the upper end of the closing opening is arranged on the upper plate surface, and the welding tail end is arranged on the lower plate surface;

[0060] The shaping portion includes a central shaping piece, the distal end of which is connected to the upper end of the closing opening, and the distal end is connected to the welding tail end, and the central shaping piece is an elastic piece whose natural length is less than or equal to the distance between the welding tail end and the upper end of the closing opening.

[0061] The occluder provided by the present application is particularly suitable for occluders made of degradable materials. After being implanted in the human body, it can naturally restore the structural form without artificial external force, completely block the missing part, and improve the blocking effect. Specifically, the present application is based on the setting of the shaping part, wherein the two ends of the central shaping part are respectively connected to the upper end and the molten tail end of the mesh skeleton, and the elastic part has a natural length less than the spacing between the molten tail end and the upper end of the closing. During the operation, due to the supporting effect of the central shaping part, the upper disk surface and the lower disk surface can roughly restore the inherent form of its structure. When the occluder is implanted in the missing part, because the central shaping part has memory resilience, the upper disk surface and the lower disk surface of the occluder will fit closely to the surface where the missing part is located under the physical action of the elastic part, so as to achieve complete blocking of the missing part. Therefore, the occluder provided by the present application can naturally restore the structural form without being subjected to artificial external force, thereby improving the blocking effect.

[0062] In some optional embodiments, the shaping part further comprises a first peripheral shaping piece arranged around the central shaping piece, the first peripheral shaping piece is composed of a plurality of elastic pieces, and the proximal end of the first peripheral shaping piece is fixed on the central shaping piece, and the distal end of the first peripheral shaping piece is fixed on the upper disk surface; preferably, the first peripheral shaping piece is an umbrella-shaped structure coaxial with the central shaping piece. In these embodiments, based on the first peripheral shaping piece being an elastic piece, it has memory resilience, which can better adapt to the structural changes of the occluder during the recovery and implantation process, and increase the self-expansion effect. Specifically, when the occluder is put into the delivery device, the mesh skeleton will be compressed accordingly, so that the first peripheral shaping piece is approximately linear and close to the central shaping piece, so as to ensure that the occluder can be smoothly recovered into the loading sheath; when the delivery device is pushed, the occluder is released from the loading sheath, and because the first peripheral shaping piece has memory resilience, the upper disk surface will naturally expand and form under the physical action of the first peripheral shaping piece. The occluder can naturally restore its structural form without being affected by external forces, thus achieving a self-expansion effect. When the first peripheral shaping member is set as an umbrella-shaped structure coaxial with the central shaping member, the self-expansion effect of the upper disk is more stable, the force is more balanced, and the occlusion effect is further improved.

[0063] In some optional embodiments, the shaping portion further includes a second peripheral shaping piece, which is composed of a plurality of elastic pieces, and the distal end of the second peripheral shaping piece is fixed to the central shaping piece, and the proximal end of the second peripheral shaping piece is fixed to the lower disc surface; preferably, the second peripheral shaping piece is an umbrella-shaped structure coaxial with the central shaping piece. In these embodiments, the second peripheral shaping piece connected to the lower disc surface is added, so as to effectively ensure that the upper and lower disc surfaces are more completely restored in shape after being released from the loading sheath based on the physical effect of the elastic pieces, so that the occlusion of the occluder during the operation is more complete. When the second peripheral shaping piece is set as an umbrella-shaped structure coaxial with the central shaping piece, the self-expansion effect of the lower disc surface is better and more stable, the force is more balanced, and the occlusion effect is further improved.

[0064] In some optional embodiments, the distal end of the first peripheral shaping member and / or the proximal end of the second peripheral shaping member are formed with a first ring structure, and the first ring structure is used to connect with the mesh frame to form a fixed knot; preferably, the first ring structure is connected to the mesh frame by knotting or crimping; preferably, a developing ring is pressed on the outside of the fixed knot. In these embodiments, the first peripheral shaping member and / or the second peripheral shaping member can be combined with the mesh frame in a variety of ways, wherein the provision of the first ring structure facilitates connection with the mesh frame by knotting or crimping, and also facilitates providing an installation site for the developing ring. The provision of the developing ring facilitates visualization of the occlusion surgery.

[0065] In some optional embodiments, the distal end of the central shaping piece passes through the opening of the upper end of the closing and is connected to the upper end of the closing; preferably, the central shaping piece is connected to the upper end of the closing by knotting or crimping; preferably, the distal end of the central shaping piece is formed with a second ring structure, and the second ring structure is used to connect with the upper end of the closing to form a fixed knot, and the fixed knot is provided with a developing ring. In these embodiments, the distal end of the central shaping piece passes through the opening of the upper end of the closing and is connected thereto, so that the connection is more stable. Of course, the connection method is not limited to knotting or crimping, and can also be other connection methods such as welding.

[0066] In some optional embodiments, the welding tail end is a solid structure; preferably, the welding tail end is a columnar body with external threads. Preferably, the proximal end of the central shaping piece is embedded in the welding tail end. In these embodiments, the welding tail end is set as a solid structure, which can completely block the thrombus in the auricle and avoid the risk of it being squeezed out. It is set as a columnar body with external threads, which is convenient for connection with the conveying device, and the proximal end of the shaping piece is embedded in the welding tail end, which can increase the firmness of the connection between the two.

[0067] In some optional embodiments, the elastic member is a spring, and the spring is formed by heat-treating a memory metal. In these embodiments, the elastic member is formed in such a way that it has super memory elasticity and a better self-expansion effect.

[0068] In some optional embodiments, the spring is a linear spring or a progressive spring.

[0069] In some optional embodiments, the shape of the spring is cylindrical, conical, convex, concave or non-circular; preferably, the central shaped member is a cylindrical linear spring, and the first peripheral shaped member and the second peripheral shaped member are non-circular linear springs. In these embodiments, the elastic member can be wound into different shapes based on the structural morphology of the occluder or the pathological defect requirements of the operation.

[0070] In some optional embodiments, the mesh skeleton is made of a degradable polymer material. In these embodiments, the mesh skeleton made of a degradable polymer material can be absorbed by the human body to avoid complications. Combined with the setting of the shaping part, the occluder can have a good occluding effect and self-expansion.

[0071] In some optional embodiments, the mesh frame is further provided with a flow-blocking film, which includes an upper plate film located on the inner wall of the upper plate surface, a waist film located at the waist, and a lower plate film located on the inner wall of the lower plate surface; preferably, the upper plate film, the waist film, and the lower plate film are all made of degradable materials and are sewn to the mesh frame by degradable sutures. In these embodiments, the first peripheral shaping member and the second peripheral shaping member are both connected to the mesh frame through the flow-blocking film.

[0072] In order to more clearly understand the occluder provided by the embodiment of the present disclosure, the specific embodiments of the present invention will be described below with reference to the accompanying drawings. In this process, the thickness of the lines or the size of the structural elements shown in the drawings may be shown in an exaggerated manner for the clarity and convenience of the description.

[0073] Example 1

[0074] The present application discloses an occluder, which may be an atrial septal occluder, a ventricular septal occluder, etc., for example Figure 1The left atrial appendage occluder shown is suitable for occluding the left atrial appendage. Since the pathological position of the left atrial appendage has a special structure, a hook 600 is usually provided. However, no matter what position the occluder described in the present application is used for occluding, its structure includes a shaping portion 300, a flow-blocking membrane 200, and a mesh frame 100 with a closed upper end 150 and a welded tail end 140; the mesh frame 100 is made of a degradable polymer material and will be slowly absorbed by the human body after being implanted in the human body to avoid the occurrence of complications. The mesh frame 100 includes an upper plate surface 110, a waist portion 120 and a lower plate surface 130 formed in sequence. Figure 1 The upper disk surface 110 of the left atrial appendage occluder shown is a fixed disk for placement in the left atrial appendage, the lower disk surface 130 is an occluding disk, the waist 120 is a naturally formed connection between the fixed disk and the occluding disk, the closing upper end 150 is arranged on the upper disk surface 110, and the welding tail end 140 is arranged on the lower disk surface 130; the flow blocking membrane 200 includes an upper disk membrane 210 sewn on the inner wall of the upper disk surface 110 by degradable sutures, a waist membrane 220 located at the waist 120, and a lower disk membrane 230 sewn on the inner wall of the lower disk surface 130 by degradable sutures; the shaping part 300 includes a central shaping part (in Figure 1 In the figure, the central shaping member can refer to 300), the distal end of the central shaping member is connected to the closing upper end 150, and the distal end is connected to the welding tail end 140, and the central shaping member is an elastic member whose natural length is less than or equal to the distance between the welding tail end 140 and the closing upper end 150.

[0075] The occluder provided by the present application is particularly suitable for occluders made of degradable materials. After being implanted in the human body, it can naturally restore the structural form without artificial external force, completely block the missing part, and improve the blocking effect. Specifically, the present application is based on the setting of the shaping part 300, wherein the two ends of the central shaping part are respectively connected to the closing upper end 150 and the melting tail end 140 of the mesh skeleton 100, and the elastic part is less than the natural length of the spacing between the melting tail end 140 and the closing upper end 150. During the operation, due to the supporting effect of the central shaping part, the upper disk surface 110 and the lower disk surface 130 can roughly restore the inherent form of its structure. When the occluder is implanted in the missing part, because the central shaping part has memory resilience, the upper disk surface 110 and the lower disk surface 130 of the occluder will fit closely to the surface where the missing part is located under the physical action of the elastic part, so as to achieve complete blocking of the missing part. Therefore, the occluder provided by the present application can naturally restore the structural form without being subjected to artificial external force, thereby improving the blocking effect.

[0076] Example 2

[0077] See also Figure 2In this embodiment, the occluder is different from that in Embodiment 1 in that the diameter of the upper disk surface 110 is larger than the diameter of the lower disk surface 130, and the size of the waist 120 is suitable for the defect position. By placing the waist 120 in the defect position, the upper and lower ends of the defect are covered by the upper disk surface 110 and the lower disk surface 130.

[0078] Also, see Figure 3-4 In this embodiment, the shaping part 300 also includes a first peripheral shaping part 320 arranged around the central shaping part 310. The first peripheral shaping part 320 is composed of a plurality of elastic parts, and the proximal end of the first peripheral shaping part 320 is fixed to the central shaping part 320, and the distal end of the first peripheral shaping part 320 passes through the upper disk membrane 210 and is fixed to the upper disk surface 110; wherein, in this embodiment, the elastic parts used to constitute the central shaping part 300 and the first peripheral shaping part 310 are formed by heat treatment of memory metal, which has super memory elasticity and good self-expansion effect. The shape of the elastic part can be wound based on the structural shape of the occluder or the pathological defect requirements of the operation, such as Figure 7 The cylindrical linear spring shown, Figure 8 The non-cylindrical linear spring shown, Fig. 9 The concave linear spring shown, Fig.10 The convex linear spring shown, and Fig.11 The progressive spring shown, for example, is designed with inconsistent thickness and density. The advantage is that when the pressure is not too great, the part with a lower elastic coefficient can absorb the ups and downs of the upper disk surface 110 and / or the lower disk surface 120, thereby ensuring the patient's comfort. When the pressure increases to a certain extent, the thicker part of the spring plays a role in supporting the occluder; while the thickness and density of the linear spring remain unchanged from top to bottom, and the elastic coefficient is a fixed value. This design of spring can enable the occluder to obtain a more stable and linear dynamic response. In this embodiment, the central shaping member 310 adopts a cylindrical linear spring, the first peripheral shaping member 320 adopts a non-circular linear spring, and the first peripheral shaping member 320 is set to an umbrella-shaped structure coaxial with the central shaping member 310, so that it can better adapt to the structural changes of the occluder during the recovery and implantation process and increase the self-expansion effect.

[0079] Among them, see Figure 3-5In this embodiment, the distal end of the first peripheral shaping member 320 passes through the braided wire on the upper disk surface 110 and is wound into a first ring structure 321. After the first ring structure 321 is wound, it is knotted to form a fixed knot. Of course, it can also be wound to form a spring or welded to the braided wire on the upper disk surface 110. Then, a developing ring 322 is put on the outside of the fixed knot and pressed to fix it. The developing ring 322 can be a platinum ring to facilitate the visualization of the occlusion operation. The proximal end of the first peripheral shaping member 320 can be fixed to the middle of the central shaping member 310 by welding, knotting, or crimping.

[0080] See also Figure 3-4 and Figure 6 The distal end of the central shaping piece 310 passes through the opening of the closing upper end 150 and is connected to the closing upper end 150; the proximal end of the central shaping piece 310 is embedded in the welding tail end 140. The central shaping piece 310 and the closing upper end 150 can be connected by knotting or crimping; in this embodiment, the distal end of the central shaping piece 310 is formed with a second ring structure 311, which is used to connect with the closing upper end 150 to form a fixed knot, and a developing ring 322 is provided on the fixed knot.

[0081] Please continue reading Figure 6 The welding tail end 140 is a solid structure, which can completely prevent the risk of thrombus being squeezed out. The welding tail end 140 is a columnar body with external threads, which can be easily connected to the delivery device 500.

[0082] See also Fig.12 When the occluder of this embodiment is received into the loading sheath tube 400, the mesh skeleton will be compressed accordingly, so that the first peripheral shaping member 320 is approximately linear and converges toward the central shaping member 310, thereby ensuring that the occluder can be smoothly recovered into the loading sheath tube 400; please refer to Fig.13 When the delivery device 500 is pushed, the occluder is released from the loading sheath 400. At this time, due to the memory resilience of the first peripheral shaping member 320, the upper disk surface 110 will naturally expand and form under the physical action of the first peripheral shaping member 320. The occluder can naturally restore its structural form without being affected by artificial external forces, thereby achieving a self-expansion effect. When the first peripheral shaping member 320 is set as an umbrella-shaped structure coaxial with the central shaping member 310, the self-expansion effect of the upper disk surface 110 is better and more stable, the force is more balanced, and the blocking effect is further improved.

[0083] Example 3

[0084] See also Fig.14In the present embodiment, the shaping portion further comprises a second peripheral shaping member 330, which is composed of a plurality of elastic members, and the distal end of the second peripheral shaping member 330 is fixed to the middle of the central shaping member 310. Unlike the first peripheral shaping member 320, the proximal end of the second peripheral shaping member 330 is fixed to the lower disk surface 130. In the present embodiment, in order to make the self-expansion effect of the lower disk surface 130 more stable and the force more balanced, the second peripheral shaping member 330 is arranged as an umbrella-shaped structure coaxial with the central shaping member 310.

[0085] In this embodiment, a second peripheral shaping member 330 connected to the lower disk surface 130 is added, which can effectively ensure that after the upper disk surface 110 and the lower disk surface 130 are released from the loading sheath 400, their shapes are restored more completely based on the physical action of the elastic member, thereby making the occlusion of the occluder more complete during the operation.

[0086] It is understood that the same or similar parts in the above embodiments can refer to each other, and the content not described in detail in some embodiments can refer to the same or similar content in other embodiments. It should be noted that the terms in the description of this application are defined in consideration of the functions in the present invention, and may vary according to the intentions or conventions of the users and operators. Therefore, the definition of such terms should be defined based on the content of this specification as a whole.

[0087] For example, the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. indicate positions or positional relationships based on the positions or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance.

[0088] In the description of this specification, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0089] The description with reference to the terms "one embodiment", "some embodiments", "examples", "specific examples", or "some examples" means that the specific features, structures, materials, or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present application. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described may be combined in any one or more embodiments or examples in a suitable manner.

[0090] Although the embodiments of the present application have been shown and described above, it can be understood that the above embodiments are exemplary and cannot be understood as limitations on the present application. Ordinary technicians in this field can change, modify, replace and modify the above embodiments within the scope of the present application.

Claims

1. An occluder, characterized in that: It includes a shaping part and a mesh frame with a closed upper end and a welded tail end; The mesh frame comprises an upper plate surface, a waist portion and a lower plate surface which are formed in sequence, the upper end of the closing opening is arranged on the upper plate surface, and the welding tail end is arranged on the lower plate surface; The shaping part includes a central shaping piece, the distal end of which is connected to the upper end of the closing opening, and the distal end is connected to the welding tail end, and the central shaping piece is an elastic piece whose natural length is less than or equal to the distance between the welding tail end and the upper end of the closing opening; the shaping part also includes a first peripheral shaping piece arranged around the central shaping piece, the first peripheral shaping piece is composed of a plurality of elastic pieces, and the proximal end of the first peripheral shaping piece is fixed to the central shaping piece, and the distal end of the first peripheral shaping piece is fixed to the upper disk surface; The first peripheral shaping member is an umbrella-shaped structure coaxial with the central shaping member.

2. The occluder according to claim 1, characterized in that: The shaping portion further comprises a second peripheral shaping piece, which is composed of a plurality of elastic pieces, and a distal end of the second peripheral shaping piece is fixed on the central shaping piece, and a proximal end of the second peripheral shaping piece is fixed on the lower disk surface.

3. The occluder according to claim 2, characterized in that: The second peripheral shaping member is an umbrella-shaped structure coaxial with the central shaping member.

4. The occluder according to claim 3, characterized in that: A first loop structure is formed at the distal end of the first peripheral shaping member and / or the proximal end of the second peripheral shaping member, and the first loop structure is used to connect with the mesh frame to form a fixing knot.

5. The occluder according to claim 4, characterized in that: The first ring structure is connected to the mesh frame by knotting or crimping.

6. The occluder according to claim 4, characterized in that: A developing ring is pressed on the outer side of the fixing knot.

7. The occluder according to claim 1, characterized in that: The distal end of the central shaping piece passes through the opening of the upper end of the closing opening and is connected to the upper end of the closing opening.

8. The occluder according to claim 7, characterized in that: The central shaping piece is connected to the upper end of the closing opening by knotting or crimping.

9. The occluder according to claim 7, characterized in that: A second ring structure is formed at the distal end of the central shaping member, and the second ring structure is used to connect with the upper end of the closing opening to form a fixing knot, and a developing ring is provided on the fixing knot.

10. The occluder according to claim 1, characterized in that: The welding tail end is a solid structure.

11. The occluder according to claim 1, characterized in that: The welding tail end is a columnar body with external threads.

12. The occluder according to claim 1, characterized in that: The proximal end of the central shaping piece is embedded in the welding tail end.

13. The occluder according to any one of claims 2 to 12, characterized in that: The elastic member is a spring, and the spring is formed by heat treatment of memory metal.

14. The occluder according to claim 13, characterized in that: The elastic member is made of a degradable magnesium alloy or a non-degradable nickel-titanium alloy.

15. The occluder according to claim 13, characterized in that: The spring is a linear spring or a progressive spring.

16. The occluder according to claim 13, characterized in that: The spring has a cylindrical, conical, convex, concave or non-circular shape.

17. The occluder according to claim 2, characterized in that: The central shaping member is a cylindrical linear spring, and the first peripheral shaping member and the second peripheral shaping member are non-circular linear springs.

18. The occluder according to claim 1, characterized in that: The mesh skeleton is made of degradable polymer material.

19. The occluder according to claim 1, characterized in that: The mesh frame is also provided with a flow-blocking film, which includes an upper plate film located on the inner wall of the upper plate surface, a waist film located at the waist, and a lower plate film located on the inner wall of the lower plate surface.

20. The occluder according to claim 19, characterized in that: The upper plate membrane, the waist membrane and the lower plate membrane are all made of degradable materials and are all sewn on the mesh frame by degradable sutures.

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